Page 31 of 35 FirstFirst ... 21 29 30 31 32 33 ... LastLast
Results 751 to 775 of 865

Thread: COVID-19 Novel Coronavirus pandemic

  1. #751
    Senior Member JohnLanders's Avatar
    Join Date
    May 2020
    Posts
    2,694
    Rep Power
    3974217
    https://losangeles.cbslocal.com/2020...-becomes-sick/

    LOS ANGELES (CBSLA/AP) ? Late-stage studies of AstraZeneca?s COVID-19 vaccine candidate are on temporary hold while the company investigates whether a patient suffered a serious side effect or an unrelated illness.

    In a statement issued Tuesday, the company said its ?standard review process triggered a pause to vaccination to allow review of safety data,? stating that a patient experienced a ?potentially unexplained illness.? The health news site STAT first reported the pause in testing, stating that the impacted patient was in the United Kingdom.

    An AstraZeneca spokesperson confirmed the pause in vaccinations covers studies in the U.S., which late last month began recruiting 30,000 people for the vaccine?s largest study. That trial includes participants in the Los Angeles area in a study being conducted by the Lundquist Institute, in partnership with the National Institutes of Health and AstraZeneca.

    ?This is an historic occasion for the nation, for the county of Los Angeles and particularly for the Lundquist Institute,? Dr. David Meyer, president and chief executive of the institute, said Friday when a Long Beach man became the first in that trial to receive the vaccine.

    It was not immediately clear what the impacts of the pause would be on that trial.

    The vaccine, developed by Oxford University, is also being tested in thousands of people in Britain and in smaller studies in Brazil and South Africa.

    Temporary holds of large medical studies are not unusual, and investigating any serious or unexpected reaction is a mandatory part of safety testing. AstraZeneca pointed out that it was possible the problem could be a coincidence; illnesses of all sorts could arise in studies of thousands of people.

    ?We are working to expedite the review of the single event to minimize any potential impact on the trial timeline,? the company statement said.

    Dr. Ashish Jha of Brown University said via Twitter that the significance of the interruption was unclear but that he was ?still optimistic? that an effective vaccine will be found in the coming months.

    ?But optimism isn?t evidence,? he wrote. ?Let?s let science drive this process.?

    The development came the same day that AstraZeneca and eight other drugmakers issued an unusual pledge, vowing to uphold the highest ethical and scientific standards in developing their vaccines.

    Two other vaccines are in huge, final-stage tests in the United States, one made by Moderna Inc. and the other by Pfizer and Germany?s BioNTech. Those two vaccines work differently than AstraZeneca?s, and the studies already have recruited about two-thirds of the needed volunteers.

    During the third and final stage of testing, researchers look for any signs of possible side effects that may have gone undetected in earlier patient research. Because of their large size, the studies are considered the most important phase of study for picking less common side effects and establishing safety.

    The trials also assess effectiveness by tracking who gets sick and who doesn?t between patients getting the vaccine and those receiving a dummy shot.

    The announcement follows worries that President Donald Trump will pressure the U.S. Food and Drug Administration to approve a vaccine before it was proven to be safe and effective.

    The U.S. has invested billions of dollars in efforts to quickly develop multiple vaccines against COVID-19, but public fears that a vaccine is unsafe or ineffective could be disastrous ? derailing the effort to vaccinate millions of Americans.

    Representatives for the FDA did not immediately respond to requests for comment.

    AstraZeneca?s U.S.-traded shares fell more than 6% in after-hours trading following reports of the trial being paused.

    https://www.cnbc.com/2020/09/08/coro...-election.html

    White House coronavirus advisor Dr. Anthony Fauci said Tuesday a coronavirus vaccine probably won?t be ready by the U.S. presidential election even as the Centers for Disease and Prevention asks states to ready distribution facilities by Nov. 1.

    At a health conference, Fauci said it?s more likely a vaccine will be ready by ?the end of the year? as drug companies Moderna and Pfizer race to complete patient enrollment for their late-stage vaccine trials by the end of September.

    ?It?s unlikely we?ll have a definitive answer? by the Nov. 3 election, the director of the National Institute of Allergy and Infectious Diseases said at the Research! America 2020 National Health Research Forum.

    The comments are also at odds with President Donald Trump, who suggested at a press conference Monday that a vaccine could be ready for distribution by Election Day.

    ?We could have a vaccine soon, maybe even before a very special day. You know what day I?m talking about,? Trump told reporters.

    Infectious disease experts and scientists have said they worry the vaccine approval process in the U.S. could be polluted by politics, not science.

    The CDC has asked governors and health departments to prepare to distribute a vaccine as soon as Nov. 1, just two days before the election. Dr. Stephen Hahn, commissioner of the Food and Drug Administration, has also said the agency is prepared to bypass the full federal approval process in order to make a vaccine available as soon as possible.

    Earlier Tuesday, nine drugmakers released a public letter pledging to ?uphold the integrity of the scientific process? as they work toward potential global regulatory filings and approvals of the first Covid-19 vaccines.

    ?We saw it critical to come out and reiterate our commitment,? Pfizer CEO Albert Bourla told NBC?s ?TODAY? on Tuesday. ?We will develop our product, develop our vaccine using the highest ethical standards.?

    On Thursday, Health and Human Services Secretary Alex Azar also tried to alleviate concerns about the review process, insisting the government?s Nov. 1 deadline for states is not linked to the presidential election.

    ?It has nothing to do with elections. This has to do with delivering safe, effective vaccines to the American people as quickly as possible and saving people?s lives,? Azar said on ?CBS This Morning.? ?Whether it?s Oct. 15, whether it?s Nov. 1, whether it?s Nov 15, it?s all about saving lives but meeting the FDA standards of safety and efficacy.?

    Dr. Moncef Slaoui, who is leading the Trump administration?s Operation War Speed initiative, told NPR a vaccine ready for public distribution in November is ?extremely unlikely.?

    The FDA has said it would authorize a coronavirus vaccine so long as it is safe and at least 50% effective. The flu vaccine, by comparison, generally reduces the risk of getting influenza by 40% to 60% compared with people who aren?t inoculated, according to the CDC. Hahn said the FDA wouldn?t authorize a vaccine that?s not safe, even if it is fairly effective.

    Fauci said Tuesday the trial results will also be reviewed by the Data and Safety Monitoring Board, an independent group of medical experts who observe patient safety and treatment data. He added he ?wouldn?t be surprised? if the U.S. had more than one vaccine.

    In the meantime, he said, the U.S. coronavirus response still needs to improve.

    He called the coronavirus outbreak in the U.S. a ?mixed bag? as new cases fall in the southern region of the country and cases surge in states such as Montana, the Dakotas, Michigan, Minnesota and Iowa.

    ?When you look at the country as a whole, we need to be doing much better than we?re doing,? he told told PBS? Judy Woodruff at the conference.

  2. #752
    Don't drink sanitizer! raisedbywolves's Avatar
    Join Date
    Jan 2013
    Posts
    16,510
    Rep Power
    21474860
    https://www.wftv.com/news/trending/c...POYPGOB6MUULY/


    The CEO of AstraZeneca, one of several pharmaceutical companies testing vaccines for COVID-19, told investors on a private call Wednesday morning that the company’s Phase 3 vaccine trials were paused Tuesday after a woman participating in the trial developed neurological symptoms, according to STAT News.

    Company officials on Tuesday announced they were pausing all trials worldwide of AZD1222, the COVID-19 vaccine developed by Oxford University, after a person participating in Phase 3 trials in the U.K. fell ill without explanation. In a news release Tuesday, AstraZeneca noted that illnesses sometimes happen by chance in large clinical trials and that such a pause is routine “whenever there is a potentially unexplained illness.”

    AstraZeneca’s CEO, Pascal Soriot, said Wednesday that a woman developed symptoms which appeared to be consistent with transverse myelitis, STAT News reported. Symptoms of the disorder, which is caused by an inflammation of the spinal cord, typically include weakness in the arms or legs, sensory symptoms like numbness or tingling, pain and bladder or bowel dysfunction, according to Johns Hopkins University.

    As of Wednesday, the woman’s diagnosis had yet to be confirmed, according to STAT News. Soriot said the woman’s condition was improving and that she could be discharged from a hospital soon, the news site reported.

    The pause Tuesday was not the first for clinical trials of AZD1222. Soriot said trials were paused in July after a person developed neurological symptoms, but that they resumed after the person was diagnosed with unrelated multiple sclerosis, according to STAT News.

    Officials with AstraZeneca began Phase 3 clinical trials of its vaccine candidate in the U.S. late last month. The trial was expected to include as many as 30,000 adults from various racial, ethnic and geographic groups.

    Two other vaccine candidates began final testing this summer in tens of thousands of people in the U.S. One was created by the National Institutes of Health and manufactured by Moderna Inc., and the other developed by Pfizer Inc. and Germany’s BioNTech.

    Health officials in the U.S. have said they expect to see a COVID-19 vaccine by the end of the year.

  3. #753
    Senior Member JohnLanders's Avatar
    Join Date
    May 2020
    Posts
    2,694
    Rep Power
    3974217
    https://www.biospace.com/article/9-c...ine-approvals/

    To quell concerns over the politicization of a potential vaccine for the novel coronavirus, nine pharmaceutical companies developing a preventative treatment signed a pledge promising to uphold the integrity of the scientific process ahead of any potential approval of a medication.

    The chief executive officers of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Moderna, Novavax, Pfizer, Merck and Sanofi all signed the pledge promising to ensure that any vaccine put forth by one or more of the companies meets the rigorous standards for approval that people expect for medications.

    Concerns about an early, before-its-ready approval of a vaccine against SARS-CoV-2, the virus that causes COVID-19, have been palpable, particularly since President Donald Trump predicted a vaccine could be available to the public by the end of the year. There have been rumors the U.S Food and Drug Administration could grant an Emergency Use Authorization to one of the vaccine candidates being supported by Operation Warp Speed due to political pressure.

    Such concerns increased following the FDA’s granting of EUA for convalescent plasma following a public lambasting of the agency by the president over an earlier decision to wait for more data. Following the EUA announcement, FDA Commissioner Stephen Hahn was forced to walk back some comments made during that EUA announcement that overstated some of the benefits of convalescent plasma in COVID-19 patients.

    For vaccine approvals, Hahn has promised that a vaccine would only be greenlit if the data supports the FDA’s threshold of 50% efficacy.

    Last week, Moncef Slaoui, the former head of GlaxoSmithKline’s vaccines operations who was tapped to helm Operation Warp Speed, the U.S. government’s response to the pandemic, said he will quit the initiative if a vaccine is pushed through Emergency Use Authorization before it’s met those scientific standards in order to serve a political agenda.

    “I would immediately resign if there is undue interference in this process,” Slaoui said last week.

    While the CEOs of companies that have received financial support from Operation Warp Speed did not threaten to resign their positions, they wanted to make clear they are committed to “developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles.”

    According to the pledge the CEOs released over the holiday weekend, they stressed the importance that a vaccine be reviewed under the clear guidelines the U.S. Food and Drug Administration and other regulatory agencies have established for COVID-19 drugs.

    “FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US. FDA’s guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines. More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations,” the pledge reads.

    The companies that signed the pledge vowed to make the safety and well-being of those who receive the vaccines their top priority and promised to only submit their vaccine candidates for regulatory approval or EUA after those drugs have demonstrated safety and efficacy in a Phase III clinical study.

    “We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved,” the CEOs said.

  4. #754
    Senior Member JohnLanders's Avatar
    Join Date
    May 2020
    Posts
    2,694
    Rep Power
    3974217
    https://www.biospace.com/article/pfi...id-19-vaccine/

    Preclinical data for Pfizer and BioNTech’s Phase II/III COVID-19 mRNA vaccine candidate generated BNT162b2 strong anti-viral effects against an infectious SARS-CoV-2 challenge, the two companies announced this morning.

    In preclinical studies with mice and primates, the vaccine candidate induced SARS-CoV-2 neutralizing antibodies in rhesus macaques, pseudovirus neutralizing antibodies in mice, and strong, antigen-specific CD4+ and CD8+ T cells in mice and macaques, the companies said. BNT162b2 encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S), which is the target of virus neutralizing antibodies. In July, the two companies selected BNT162b2 as their preferred candidate of choice for a Phase II/III study.

    As the two companies move forward in that study, they announced the preclinical data showed BNT162b2 immunization prevented lung infection in 100% of the SARS-CoV-2 challenged rhesus macaques, with no viral RNA detected in the lower respiratory tract of immunized and challenged animals. The BNT162b2 vaccination also cleared the nose of detectable viral RNA in 100% of the SARS-CoV-2 challenged rhesus macaques within three days after the infection.

    The companies published a manuscript describing the preclinical data on the preprint server bioRxiv. The data is undergoing scientific peer-review for potential publication.

    “Collectively, these preclinical results, combined with our clinical data collected to date, continue to support the promise and validity of our mRNA-based vaccine program against SARS-CoV-2 and selection of the BNT162b2 candidate, which we believe has the potential to prevent many millions of COVID-19 cases. We are encouraged by the data thus far and confident in our progress towards developing a safe and effective vaccine candidate to help address this current pandemic,” Kathrin U. Jansen, head of Vaccine Research and Development at Pfizer said in a statement.

    BioNTech Chief Executive Officer Ugur Sahin said the strong preclinical data presented this morning served as the basis for the company’s decision to move BNT162b2 into Phase III evaluation.

    “This is another development milestone for providing a safe and effective potential vaccine to the global community to help end this pandemic,” Sahin said in a statement.

    Pfizer and BioNTech initially had four vaccine candidates against COVID-19, but after extensive testing, BNT162b2 was selected as the best candidate to advance. And, from the data presented this morning, it’s easy to assess why that was the choice. In the preclinical study, BNT162b2 demonstrated protective anti-viral effects in rhesus macaques, with concomitant high neutralizing antibody titers and a TH1-biased cellular response in rhesus macaques and mice. BNT162b2 also induced potent SARS-CoV-2 neutralizing antibodies in vaccinated-macaques, and viral antigen-specific CD4+ and CD8+ T cells, the companies said in the announcement.

    Neutralizing antibody titers persisted to at least day 56, with higher geometric mean titers than those in a panel of human convalescent sera. BNT162b2 vaccination elicited a high frequency of CD4+ T cells that produced IFN-ɣ, IL-2 and TNF-α, and almost no IL-4-producing CD4+ cells were detectable, indicating a TH1-biased response, which is an immune profile thought to promote vaccine safety. BNT162b2 also elicited spike-specific IFN-ɣ-producing CD8+ T cell responses, which is thought to promote an anti-viral effect, the companies added.

    The Phase II/III study has enrolled more than 25,000 candidates in the United States, Argentine and Brazil. Additional enrollment is planned in Germany, Turkey and South Africa. The study is an event-driven trial.

    In addition to the preclinical data released this morning, Pfizer and BioNTech announced an agreement with the European Union for 200 million doses of the vaccine, should it pass late-stage muster. Delivery of the vaccine could begin by the end of 2020, the companies said.

  5. #755
    Senior Member JohnLanders's Avatar
    Join Date
    May 2020
    Posts
    2,694
    Rep Power
    3974217
    https://www.fiercepharma.com/manufac...gmaker-s-trial

    AstraZeneca was humming right along with its partnered COVID-19 vaccine with the University of Oxford before a sudden trial hold threw its plans into disarray. So what does that uncertainty mean for AstraZeneca's expectant manufacturing partners on the shot? For at least one, it could be no issue at all.

    Despite a major commitment from AstraZeneca to help produce bulk drug substance for the University of Oxford's adenovirus-based COVID-19 shot, Maryland's Emergent BioSolutions isn't likely to feel a financial pinch if the British drugmaker's candidate doesn't make it across the finish line, Cantor analysts wrote in a note to investors Wednesday.

    On the heels of AstraZeneca's troubling phase 3 trial hold, Emergent's share price dropped 5% in early Wednesday trading to $100.22 as investors appeared to show concern that AstraZeneca's setback would hit the CDMO's bottom line.

    But according to Cantor, Emergent wouldn't likely come out worse for wear if AstraZeneca's candidate flops, as the partners' contract includes protections for Emergent that will see it rake in most of the $174 million owed to it in year one of the deal.

    RELATED: AstraZeneca pledges $174M to ramp up coronavirus vaccine supply deal with Emergent

    Part of that deal, signed in July, is an $87 million portion for tech transfer and preparation that is underway, Cantor said. That money has already come Emergent's way, and further contract protections will see Emergent made whole on most of the rest, analysts argued.

    In fact, investors appeared to agree on that rosy outlook almost immediately, with Emergent's share price rebounding over the course of the day Wednesday to $106.36 at 12:30 p.m. ET.

    The only unknowns in the event of AstraZeneca's failure would be the second and third years of the proposed contract, which could be waived, according to Cantor. However, given Emergent's close relationship with the Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA), another vaccine maker could easily step into AstraZeneca's place to continue driving revenues for Emergent.

    Moreover, that alternate partner could secure an even longer-term CDMO contract with Emergent at its Baltimore Bayview facility, largely taking the manufacturer's risk off the table.

    RELATED: J&J sews up 5 years of coronavirus vaccine supply in $480M-plus deal with Emergent

    Despite the uncertainty of AstraZeneca's fate in the COVID-19 vaccine hunt, Emergent can rest easy knowing it has at least one other major player in the field on its side.

    In early July, Johnson & Johnson and Emergent inked a five-year work order worth at least $480 million to help produce the New Jersey-based drugmaker's COVID-19 vaccine candidate.

    Emergent will provide "large-scale" drug substance manufacturing for J&J's recombinant DNA shot beginning in 2021, starting with a $480 million order for the first two years of the deal. For the final three years, the partners will use a "flexible capacity deployment model" to provide annual batches as needed, Emergent said.

  6. #756
    Senior Member JohnLanders's Avatar
    Join Date
    May 2020
    Posts
    2,694
    Rep Power
    3974217
    https://www.businesswire.com/news/ho...sults-COVID-19

    BEIJING--(BUSINESS WIRE)--Sinovac Biotech Ltd. (NASDAQ: SVA) (“Sinovac” or the “Company”), a leading provider of biopharmaceutical products in China, announced that the inactivated COVID-19 vaccine candidate developed by Sinovac Life Sciences (Sinovac LS), or “CoronaVac,” shows good safety and immunogenicity on healthy adults aged 60 and above from its phase I/II clinical studies conducted in China, which is comparable to the result in healthy adults aged from 18 to 59 in the earlier studies.

    The phase I/II clinical trial on elderly volunteers were randomized, double-blinded and placebo controlled trials with two-dose immunization scheduled at 28 day intervals.

    CoronaVac was tested on a total of 421 healthy adults aged between 60 to 89 years old in the phase I/II clinical trial. The vaccine candidate appeared to be well tolerated for low dose, medium dose, and high dose groups. No vaccine-related serious adverse event was reported. Both the seroconversion rate and GMT level for elderly volunteers were comparable to the adult group aged 18 to 59 years old. According to the results, the medium dose was selected to enter into phase III trial. The seroconversion rate and GMT for the medium dose group was 98.0% and 42.2 in elderly volunteers, respectively; and 97.4% and 44.1 in healthy adults. The detailed data will be published in a peer reviewed journal.

    Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, “I am very pleased that our vaccine candidate shows promising results, especially on elderly volunteers who are a highly vulnerable group impacted by the COVID-19 pandemic. As Sinovac is accelerating its vaccine development against the fast spread of the virus, we have completed the construction of our production facility and have commenced production of CoronaVac. Sinovac remains committed to the development of vaccines to fight against the coronavirus.”

    About Sinovac
    Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacturing and commercialization of vaccines that protect against human infectious diseases. Sinovac’s product portfolio includes vaccines against enterovirus71 (EV71), hepatitis A and B, seasonal influenza, Quadrivalent Influenza vaccine (“QIV”), H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), varicella vaccine and mumps. Healive, the hepatitis A vaccine manufactured by the Company, has passed the assessment under WHO prequalification procedures in 2017. The EV71 vaccine, an innovative vaccine developed by Sinovac against hand foot and mouth disease caused by EV71, was commercialized in China in 2016. In 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine, which it has supplied to the Chinese Government’s vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the government stockpiling program. The Company is developing a number of new products including a Sabin-strain inactivated polio vaccine, pneumococcal polysaccharides vaccine, and a SARS-CoV-2 (commonly referred to as COVID-19) vaccine. Sinovac primarily sells its vaccines in China, while also exploring growth opportunities in international markets. The Company is registering its products in over 30 countries outside of China. For more information please see the Company’s website at www.sinovac.com.

    Safe Harbor Statement
    This announcement may include certain statements that are not descriptions of historical facts, but are forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Forward-looking statements involve risks, uncertainties and other factors that could cause actual results to differ materially from those contained in any such statements. In particular, the outcome of any litigation is uncertain, and the Company cannot predict the potential results of the litigation it filed or that could be filed against it by others. Additionally, the triggering of a shareholder rights plan is nearly unprecedented, and the Company cannot predict the impact on the Company or its stock price should its rights plan have been triggered.

  7. #757
    Senior Member JohnLanders's Avatar
    Join Date
    May 2020
    Posts
    2,694
    Rep Power
    3974217
    https://abcnews.go.com/Politics/stan...ry?id=72926212

    A group of 78 researchers and doctors from Stanford Medical School took aim this week at Dr. Scott Atlas, the expert President Donald Trump recently added to the White House pandemic response task force, for embracing and peddling what they described as "falsehoods and misrepresentations of science" in his public musings about the coronavirus.

    Atlas, a neuroradiologist by training with no background in treating infectious diseases, joined the president's medical advisory staff last month. Before doing so, he made frequent appearances on Fox News, where he often cast doubt on the efficacy of wearing masks and pushed for schools to reopen with in-person learning ? positions in line with Trump's own public sentiments.

    In a "Dear Colleagues" letter penned Wednesday, the Stanford experts wrote that they have a "moral and ethical responsibility" to push back on Atlas' controversial claims about mitigating the spread of the coronavirus, which they characterized as "opinions and statements [that] run counter to established science" and "undermine public health authorities and the credible science that guides effective public health policy."

    ABC News has reached out to Atlas through the White House for comment.

    The rebuke from experts at Stanford's medical school, where Atlas was once chief of neuroradiology, marked a significant backlash against one of the president's top advisors. At a White House press briefing in August, Trump introduced Atlas as a new member of the coronavirus task force, calling him "a very famous man who is also highly respected."

    In their letter, however, the Stanford experts tick through a set of widely accepted medical conclusions in conflict with Atlas' public statements and alleged private policy suggestions.

    MORE: The new doctor in Trump's pandemic response briefings: Scott Atlas agrees with him on masks, opening schools
    Without explicitly tying their list to Atlas' past statements, the set of conclusions -- which are based on a "preponderance of data," according to the letter -- include information about the use of face masks, asymptomatic spread and the risk posed to children.

    ADVERTISING

    Ads by Teads

    Their last point, for example, denounces the use of natural "herd immunity," the notion of allowing the disease to tear through the population to build up natural immunity, as "not a safe public health strategy."

    Last month, the Washington Post reported that Atlas advocated for the administration to embrace natural herd immunity, citing five unnamed sources. Atlas vehemently denied the report.

    "There is no policy of the President or this administration of achieving herd immunity. There never has been any such policy recommended to the President or to anyone else from me. That's a lie," Atlas said in a statement released by the White House.

    PHOTO: President Donald Trump introduces Dr. Scott Atlas during a news conference in at the White House, Aug. 12, 2020.
    Nichiolas Kamm/AFP via Getty Images
    Nichiolas Kamm/AFP via Getty Images
    President Donald Trump introduces Dr. Scott Atlas during a news conference in at the White House, Aug. 12, 2020.
    President Donald Trump introduces Dr. Scott Atlas during a news conference in at the White House, Aug. 12, 2020.
    Atlas doubled down on his defense to CNN's Michael Smerconish on Sunday.

    "It's not just a lie, it's an overt lie, it's a disgusting lie, and it's a harmful statement to make. I have never advised the president to push a herd immunity strategy," he said.

    MORE: Pfizer may win the COVID vaccine race. But distributing it could be another matter.
    Even so, both Trump and Atlas have pushed the concept of letting the virus circulate widely -- at least among young health people -- without using the term "herd immunity." Last month, the president expressed interest in exploring the option of allowing the disease to spread quickly and allow the populace to build up resistance.

    "Well, once you get to a certain number, you know, we use the word 'herd,' right, once you get to a certain number, it's going to go away," Trump said on Fox News. "So -- you know -- it doesn't have to be..."

    Atlas has also drawn ire for controversial statements about returning children to schools. He has questioned whether children can transmit the virus and complained that the U.S. is "the only country ? this hysterical about opening schools."

    MORE: 5 unanswered medical questions about coronavirus
    The Stanford experts noted that, "while infection is less common in children than in adults, serious short-term and long-term consequences of Covid-19 are increasingly described in children and young people."

    They concluded their letter by emphasizing the need to exercise "science-based decision-making," and warning that any policy proposals that fall short of that standard could undermine progress in combatting the disease.

    "Failure to follow the science ? or deliberately misrepresenting the science," the letter continues, "will lead to immense avoidable harm."

    Atlas is a senior fellow at Stanford's conservative Hoover Institution.

  8. #758

  9. #759
    Senior Member JohnLanders's Avatar
    Join Date
    May 2020
    Posts
    2,694
    Rep Power
    3974217
    https://ktla.com/news/nationworld/as...n-u-k-patient/


    Oxford University announced Saturday it was resuming a trial for a coronavirus vaccine it is developing with pharmaceutical company AstraZeneca, a move that comes days after the study was suspended following a reported side-effect in a U.K. patient.

    In a statement, the university confirmed the restart across all of its U.K. clinical trial sites after regulators gave the go-ahead following the pause on Sunday.

    “The independent review process has concluded and following the recommendations of both the independent safety review committee and the U.K. regulator, the MHRA, the trials will recommence in the U.K.,” it said.

    The vaccine being developed by Oxford and AstraZeneca is widely perceived to be one of the strongest contenders among the dozens of coronavirus vaccines in various stages of testing around the world.

    British Health Secretary Matt Hancock welcomed the restart, saying in a tweet that it was “good news for everyone” that the trial is “back up and running.”

    The university said in large trials such as this “it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety.”

    It said globally some 18,000 people have received its vaccine so far. Volunteers from some of the worst affected countries — Britain, Brazil, South Africa and the U.S. — are taking part in the trial.

    Although Oxford would not disclose information about the patient’s illness due to participant confidentiality, an AstraZeneca spokesman said earlier this week that a woman had developed severe neurological symptoms that prompted the pause. Specifically, the woman is said to have developed symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord.

    The university insisted that it is “committed to the safety of our participants and the highest standards of conduct in our studies and will continue to monitor safety closely.”
    Related Content

    AstraZeneca pauses COVID-19 vaccine study after ‘potentially unexplained’ illness

    Pauses in drug trials are commonplace and the temporary hold led to a sharp fall in AstraZeneca’s share price following the announcement Tuesday.

    The Oxford-AstraZeneca study had been previously stopped in July for several days after a participant developed neurological symptoms that turned out to be an undiagnosed case of multiple sclerosis that researchers said was unrelated to the vaccine.

    During the third and final stage of testing, researchers look for any signs of possible side effects that may have gone undetected in earlier patient research. Because of their large size, the studies are considered the most important study phase for picking up less common side effects and establishing safety. The trials also assess effectiveness by tracking who gets sick and who doesn’t between patients getting the vaccine and those receiving a dummy shot.

    Dr. Charlotte Summers, a lecturer in intensive care medicine at the University of Cambridge, said the pause was a sign that the Oxford team was putting safety issues first, but that it led to “much unhelpful speculation.”

    “To tackle the global COVID-19 pandemic, we need to develop vaccines and therapies that people feel comfortable using, therefore it is vital to maintaining public trust that we stick to the evidence and do not draw conclusions before information is available,” she said.

    Scientists and others around the world, including experts at the World Health Organization, have sought to keep a lid on expectations of an imminent breakthrough for coronavirus vaccines, stressing that vaccine trials are rarely straightforward.

    Italy’s health minister, Roberto Speranza, welcomed the resumption of the vaccine trial, but warned that prudence was still necessary.

    “Science is at work to give the world efficient and secure treatments and vaccines,” he said. “In the meantime, the key continues to be our behavior.”

    Italy, which was ground zero for Europe’s outbreak, is one of the main countries investing in the AstraZeneca vaccine.

    Two other vaccines are in huge, final-stage tests in the United States, one made by Moderna Inc. and the other by Pfizer and Germany’s BioNTech.

  10. #760
    Senior Member JohnLanders's Avatar
    Join Date
    May 2020
    Posts
    2,694
    Rep Power
    3974217
    https://ktla.com/news/nationworld/as...n-u-k-patient/


    Oxford University announced Saturday it was resuming a trial for a coronavirus vaccine it is developing with pharmaceutical company AstraZeneca, a move that comes days after the study was suspended following a reported side-effect in a U.K. patient.

    In a statement, the university confirmed the restart across all of its U.K. clinical trial sites after regulators gave the go-ahead following the pause on Sunday.

    ?The independent review process has concluded and following the recommendations of both the independent safety review committee and the U.K. regulator, the MHRA, the trials will recommence in the U.K.,? it said.

    The vaccine being developed by Oxford and AstraZeneca is widely perceived to be one of the strongest contenders among the dozens of coronavirus vaccines in various stages of testing around the world.

    British Health Secretary Matt Hancock welcomed the restart, saying in a tweet that it was ?good news for everyone? that the trial is ?back up and running.?

    The university said in large trials such as this ?it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety.?

    It said globally some 18,000 people have received its vaccine so far. Volunteers from some of the worst affected countries ? Britain, Brazil, South Africa and the U.S. ? are taking part in the trial.

    Although Oxford would not disclose information about the patient?s illness due to participant confidentiality, an AstraZeneca spokesman said earlier this week that a woman had developed severe neurological symptoms that prompted the pause. Specifically, the woman is said to have developed symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord.

    The university insisted that it is ?committed to the safety of our participants and the highest standards of conduct in our studies and will continue to monitor safety closely.?
    Related Content

    AstraZeneca pauses COVID-19 vaccine study after ?potentially unexplained? illness

    Pauses in drug trials are commonplace and the temporary hold led to a sharp fall in AstraZeneca?s share price following the announcement Tuesday.

    The Oxford-AstraZeneca study had been previously stopped in July for several days after a participant developed neurological symptoms that turned out to be an undiagnosed case of multiple sclerosis that researchers said was unrelated to the vaccine.

    During the third and final stage of testing, researchers look for any signs of possible side effects that may have gone undetected in earlier patient research. Because of their large size, the studies are considered the most important study phase for picking up less common side effects and establishing safety. The trials also assess effectiveness by tracking who gets sick and who doesn?t between patients getting the vaccine and those receiving a dummy shot.

    Dr. Charlotte Summers, a lecturer in intensive care medicine at the University of Cambridge, said the pause was a sign that the Oxford team was putting safety issues first, but that it led to ?much unhelpful speculation.?

    ?To tackle the global COVID-19 pandemic, we need to develop vaccines and therapies that people feel comfortable using, therefore it is vital to maintaining public trust that we stick to the evidence and do not draw conclusions before information is available,? she said.

    Scientists and others around the world, including experts at the World Health Organization, have sought to keep a lid on expectations of an imminent breakthrough for coronavirus vaccines, stressing that vaccine trials are rarely straightforward.

    Italy?s health minister, Roberto Speranza, welcomed the resumption of the vaccine trial, but warned that prudence was still necessary.

    ?Science is at work to give the world efficient and secure treatments and vaccines,? he said. ?In the meantime, the key continues to be our behavior.?

    Italy, which was ground zero for Europe?s outbreak, is one of the main countries investing in the AstraZeneca vaccine.

    Two other vaccines are in huge, final-stage tests in the United States, one made by Moderna Inc. and the other by Pfizer and Germany?s BioNTech.

  11. #761

  12. #762
    Senior Member curiouscat's Avatar
    Join Date
    Feb 2014
    Posts
    1,218
    Rep Power
    19461101
    I follow a few local restaurants on Facebook and I love it when they're transparent about what they're doing behind the scenes to make sure their customers' health and safety come first.
    I will not reward restaurants that have packed parking lots, because you know they're not trying to protect anyone from the coronavirus.
    Quote Originally Posted by raisedbywolves View Post
    "he had Skittles so he could have made drugs".
    Quote Originally Posted by daisylane View Post
    Yo mama such a ho, that Foursquare has made her vag a place to "check in".

  13. #763
    Senior Member JohnLanders's Avatar
    Join Date
    May 2020
    Posts
    2,694
    Rep Power
    3974217
    https://fox5sandiego.com/news/local-...ine-committee/

    SAN DIEGO (CNS) – Scripps Health announced Monday it has established a COVID-19 Vaccine Committee to recommend which coronavirus vaccine or vaccines to consider offering for patients, employees and physicians.

    The team of Scripps’ medical, pharmaceutical and vaccine experts will begin meeting this week. They will review and analyze the leading COVID-19 vaccines from an evidence-based perspective.

    “It’s our responsibility as a health care provider to be the voice of science and truth,” said Scripps Health President and CEO Chris Van Gorder. “There is a strong potential for public opinion to differ on which COVID-19 vaccine is best, with some people lacking faith in any of them. Our goal, through this committee, is to provide recommendations on a vaccine or vaccines based on an objective review of the available medical data and clinical information.”


    As restaurants, bars re-open amid coronavirus, CDC study urges caution
    Researchers worldwide are testing 48 COVID-19 vaccines in clinical trials on humans, and at least 93 pre-clinical vaccines are under active investigation in animals. Nine COVID-19 vaccines are in Phase 3 large-scale efficacy testing. According to Scripps, expectations are that the Food and Drug Administration could approve a vaccine by the end of the year.

    “Each meeting, we will review and evaluate the leading vaccine candidates,” said Dr. Anil Keswani, Scripps’ chief medical officer of ambulatory and accountable care. “Once options reach a stage of completion, we will advise Scripps’ clinical and administrative leadership as to which, if any, vaccines we recommend using from an objective medical and scientific perspective.”

    The 15-person committee includes members from disciplines such as immunology, epidemiology, oncology, pharmacology and obstetrics and gynecology.

    “Having seen the heartbreaking impact COVID-19 has on patients and families, both in the short and long term, our vaccine evaluation team will allow us to continue to provide cutting edge care during this challenging pandemic,” said Dr. Ghazala Sharieff, Scripps’ chief medical officer of acute care, clinical excellence and experience.

  14. #764
    Senior Member JohnLanders's Avatar
    Join Date
    May 2020
    Posts
    2,694
    Rep Power
    3974217
    https://fox40.com/news/national-and-...id-19-victims/

    Kudos to Indonesia if this is really true.

    INDONESIA (KXAN) ? Eight people who refused to wear face masks to prevent the spread of COVID-19 now must dig graves as punishment for violating Indonesian mandates requiring face coverings.

    The violators were ordered to dig graves for those who have died from the coronavirus, according to the Jakarta Post.

    ?There are only three available gravediggers at the moment, so I thought I might as well put these people to work with them,? local politician and Cerme District head Suyono told Tribun News.

    Suyono said that two people were assigned to each grave ? one to dig and one to line the hole with wooden boards for support. He said the violators did not participate in the actual burials, however.

    ?Hopefully, this can create a deterrent effect against violations,? he said.

    Indonesia made wearing masks mandatory on April 5, SBS News in Australia reports. In addition to grave digging, violators in the country have also had to sit in a hearse containing a casket and asked to reflect on their actions.

    Meanwhile, businesses that violated the rules have been temporarily shut down and ordered to clean sewers as punishment, a law enforcement coordinator reported.

    Since the outbreak of the pandemic, over 221,000 cases of COVID-19 have been reported in Indonesia, SBS said. This includes 8,841 deaths, according to Johns Hopkins University.

    Indonesia has the highest death numbers in Southeast Asia.

  15. #765
    Senior Member JohnLanders's Avatar
    Join Date
    May 2020
    Posts
    2,694
    Rep Power
    3974217
    https://www.fiercebiotech.com/medtec...jor-developers


    The FDA has published data outlining the limits of 58 different molecular coronavirus tests?illustrating the ability of each authorized diagnostic to detect smaller and smaller amounts of the virus that causes COVID-19.

    The data can be used to compare which manufacturer?s test is more sensitive than another?s, with each being evaluated under the same conditions using a single set of controlled reference samples distributed by the agency earlier this year.

    The FDA listed each diagnostic?s limit of detection, a statistic describing the lowest amount of virus particles present within a sample that could still provide a correct test result, measured in the number of individual units of RNA detectable by nucleic acid amplification, per milliliter.

    A test?s limit of detection differs from what is known as its analytical sensitivity?or the diagnostic?s ability to spot truly positive samples?which is in turn used to determine its overall rate of false-negative results.

    RELATED: FDA publishes validation data from 5 more COVID-19 antibody tests, both authorized and not

    According to the FDA, the limit of detection alone does not paint the full picture of how sensitive a particular test can be, and is not used by itself to determine whether a test receives an Emergency Use Authorization or a regulatory clearance.

    ?Instead, the data gives laboratories, healthcare providers and patients a new resource on the relative performance of available tests to better inform which tests they choose to use,? the agency said in its announcement.

    RELATED: Trump administration revokes FDA authority over lab-developed tests, including some COVID-19 diagnostics

    Topping the list, with a limit of detection of 180, was PerkinElmer?s coronavirus detection kit, using nasopharyngeal swabs in viral transport media.

    Close behind?by about a factor of three, in the 540 to 600 range?were tests from ScienCell Research Laboratories, BioCore, DiaCarta, Seasun Biomaterials and Hologic.

    PCR tests developed by BD, Quest Diagnostics, Helix and Roche all posted detection limits of 1,800?while Abbott?s RealTime assay and Cepheid?s Xpert Xpress rapid point-of-care test were set at 5,400.

    The original diagnostic panel supplied by the Centers for Disease Control and Prevention, during the earliest stages of the pandemic, was listed at 18,000. Tests by Diatherix Eurofins and Luminex?as well as Qiagen?s respiratory disease panel, which checks for COVID-19 plus a number of influenza strains, rhinovirus and respiratory syncytial virus?rounded out the list at 180,000.

    Rapid, point-of-care screening tests using dry collection swabs and no viral transport media were listed separately by the agency. They include Abbott?s ID NOW test, with a limit of detection of 300,000, and Quidel?s Lyra Direct assay at 540,000. The FDA also posted data from Fluidigm?s Advanta saliva-based test, which hit 54,000.

    The FDA began supplying its reference panel of testing samples to developers in May, and withheld the amount of viral material in each to provide a blinded evaluation. The agency said it has delivered the panels to more than 150 test makers.

    ?Reference panels can be used in many ways to support test development and authorization, but most importantly, they are a powerful tool in monitoring test performance and ensuring that Americans have access to diagnostics they can trust,? said the agency?s device center director, Jeff Shuren.

    The full list is available here, and will be updated as the FDA receives additional results.

  16. #766
    Senior Member JohnLanders's Avatar
    Join Date
    May 2020
    Posts
    2,694
    Rep Power
    3974217
    https://www.fiercebiotech.com/biotec...very-concerned


    Leaders at the National Institutes of Health (NIH) are “very concerned” about the adverse event that led AstraZeneca to pause its COVID-19 vaccine clinical trial, according to the intramural clinical director at one of its divisions.

    Talking to KHN, the National Institute for Neurological Disorders and Stroke’s Avindra Nath said “the highest levels of NIH are very concerned.” The comment comes amid a divergent global regulatory response to the adverse event. While the U.K. regulator has cleared the trial to resume, the FDA is still assessing the situation, and the NIH has begun an investigation into the case.

    The divergence may reflect differences in access to information and materials on either side of the Atlantic. Nath said the NIH is yet to access tissue or blood samples from the patient, who was part of the U.K. portion of the AZD1222 development program.
    AstraZeneca began the U.S. portion of the program shortly before putting the clinical trial on hold in response to an adverse event, which Nath and others have identified as a case of transverse myelitis. It is unclear how long it will take the FDA to gather the information it needs to decide whether to clear AstraZeneca to restart the study.

    Some observers think AstraZeneca could be doing more to help U.S. authorities assess the situation. Nath called for the company “to be more forthcoming,” adding that “we would like to see how we can help, but the lack of information makes it difficult to do so.”

    Jesse Goodman, the FDA’s lead vaccine regulator during the Obama era, also criticized the lack of information, arguing that it is currently impossible to understand what the diagnosis was or why the safety monitoring board had the confidence to support the resumption of dosing. AstraZeneca has cited patient privacy to explain the secrecy, but that has failed to quell the calls for information.

    “I think it would be really helpful to know what their assessment of these issues was,” Goodman said. “What was the diagnosis? If there wasn’t a clear diagnosis, what is it that led them to feel the trial could be restarted? There is so much interest and potential concern about a COVID-19 vaccine that the more information that can be provided, the more reassuring that would be.”

    AstraZeneca said investigators and participants “will be updated with the relevant information and this will be disclosed on global clinical registries.”

  17. #767
    Senior Member JohnLanders's Avatar
    Join Date
    May 2020
    Posts
    2,694
    Rep Power
    3974217
    https://www.fiercebiotech.com/resear...-animal-models

    Neutralizing monoclonal antibodies are promising tools in the fight against COVID-19, but their large size typically limits the administration route to an intravenous infusion.

    Now, a research team led by scientists at the University of Pittsburgh School of Medicine has identified an antibody component that’s 10 times smaller than a full-sized antibody. In mice and hamsters, a drug based on it was found to be highly effective in preventing and treating SARS-CoV-2, the novel coronavirus behind COVID-19, according to results published in Cell.

    Some members of the team have formed a startup called Abound Bio with the goal of bringing the candidate, dubbed Ab8, into clinical trials, possibly as an inhaled drug against COVID-19.

    “Ab8 not only has potential as therapy for COVID-19, but it also could be used to keep people from getting SARS-CoV-2 infections,” study co-author John Mellors, M.D., said in a statement. “Antibodies of larger size have worked against other infectious diseases and have been well tolerated, giving us hope that it could be an effective treatment for patients with COVID-19 and for protection of those who have never had the infection and are not immune.”

    The researchers starting by screening a library of about 100 billion antibody fragments to look for candidates that bound tightly to the spike protein on SARS-CoV-2’s surface, which the virus uses to enter and infect human cells.

    The chosen molecule is the variable domain of the heavy chain of an immunoglobulin, which is a type of antibody. A typical antibody consists of two heavy chains and two light chains. The heavy chain variable domain is essential for binding with an antigen.

    Ab8 was created by fusing the variable, heavy chain domain with part of the immunoglobulin tail region, giving it immune functions but doing so with a molecule that's about half the size of a full immunoglobulin.

    RELATED: COVID-19 vaccine packed into skin patch shows promise in mice

    That small size “could improve therapeutic efficacy for infectious diseases, such as COVID-19 because of greater penetration to sites of infection,” the researchers wrote in the study. In addition, because it efficiently penetrates tissue, it could be directly delivered through inhalation, another advantage for treating a respiratory disease, they added.

    Ab8 completely neutralized SARS-CoV-2 in lab dishes. In an adaptive mouse model, animals that got Ab8 were then challenged with SARS-CoV-2. The drug effectively inhibited the virus in lung tissue in a dose-dependent manner, with significant reduction of virus titer by tenfold, even at the lowest dose of 2 mg/kg, as compared to untreated controls, the researchers reported.

    The team further tested the drug’s effect in hamsters, which were recently shown to better represent the clinical signatures of COVID-19. Ab8 treatment successfully reduced viral load in the lung, as well as viral shedding from the nose and mouth, in both preventive and therapeutic settings. And the hamsters that got the drug showed less severe pneumonia than did the control animals.

    What’s more, Ab8 doesn’t appear to bind to human cells, a possible good sign that it won’t have negative side effects in people, the scientists argued.

    Drugs with alternative administration routes could be valued additions to the first wave of COVID-19 therapies and vaccines. Another University of Pittsburgh team recently developed a vaccine candidate, dubbed PittCoVacc, that delivers an immunization through a Band-Aid-like patch with microneedles made of sugar.

    Multiple neutralizing antibodies against SARS-CoV-2 are already in clinical trials. The Pitt-led team believes that small-sized Ab8, thanks to its increased diffusion through tissues, might be given as an inhaled drug rather than intravenously like most antibodies in development, potentially providing a more convenient option.

  18. #768
    Senior Member JohnLanders's Avatar
    Join Date
    May 2020
    Posts
    2,694
    Rep Power
    3974217
    https://www.fiercebiotech.com/biotec...alization-rate

    Eli Lilly has linked its anti-SARS-CoV-2 antibody to a lower rate of hospitalization in patients recently diagnosed with mild to moderate cases of COVID-19. However, two of the three doses, including the highest studied in the phase 2 trial, failed to beat placebo in terms of reducing viral load by Day 11.

    The study, BLAZE-1, assessed the effect of three doses of LY-CoV555 and placebo in 452 patients with mild to moderate COVID-19 symptoms and a positive SARS-CoV-2 test based on a sample taken no more than three days before dosing. Lilly’s primary endpoint looked at the change in viral load from baseline to Day 11.

    Only the 2800-mg dose met the primary endpoint. The other two doses—700 mg and 7000 mg—did no better than placebo by that yardstick. Typically, the highest dose of a drug has the biggest effect.


    Main navigation
    BIOTECH

    COVID-19

    RESEARCH

    CRO

    CELL & GENE THERAPY

    MEDTECH

    SPECIAL REPORTS
    Register for the ESMO Post Show Roundtable

    Highlights from the virtual conference

    Biotech
    Lilly links COVID-19 antibody to reduced hospitalization rate
    by Nick Paul Taylor | Sep 16, 2020 8:25am
    Lilly
    Eli Lilly's data drop is the first of a series of readouts on anti-SARS-CoV-2 antibodies. (Eli Lilly/LinkedIn)
    Share
    Facebook
    Twitter
    LinkedIn
    Email
    Print
    Eli Lilly has linked its anti-SARS-CoV-2 antibody to a lower rate of hospitalization in patients recently diagnosed with mild to moderate cases of COVID-19. However, two of the three doses, including the highest studied in the phase 2 trial, failed to beat placebo in terms of reducing viral load by Day 11.

    The study, BLAZE-1, assessed the effect of three doses of LY-CoV555 and placebo in 452 patients with mild to moderate COVID-19 symptoms and a positive SARS-CoV-2 test based on a sample taken no more than three days before dosing. Lilly’s primary endpoint looked at the change in viral load from baseline to Day 11.

    Only the 2800-mg dose met the primary endpoint. The other two doses—700 mg and 7000 mg—did no better than placebo by that yardstick. Typically, the highest dose of a drug has the biggest effect.

    VIRTUAL ROUNDTABLE
    ESMO Post Show: Highlights From the Virtual Conference
    Cancer experts and pharma execs will break down the headline-making data from ESMO, sharing their insights and analysis around the conference’s most closely watched studies. This discussion will examine how groundbreaking research unveiled over the weekend will change clinical practice and prime drugs for key new indications, and panelists will fill you in on the need-to-know takeaways from oncology’s hottest fields.
    SAVE YOUR SPOT
    Lilly is yet to share data or statistical analyses for the primary endpoint, making it impossible to get a handle on what it saw in the trial. The mixed primary endpoint data may partly be explained by the fact that most patients in all arms, including the placebo cohort, had nearly complete viral clearance by Day 11.

    That suggests the choice of endpoint may be the issue. Lilly said LY-CoV555 improved viral clearance at an earlier time point—Day 3—and fewer patients on the drug had persistently high viral loads later in the trial. Again, the lack of data makes it impossible to assess those potential benefits.

    Lilly was more forthcoming with secondary endpoint data. In the LY-CoV555 arm, 1.7% of people were hospitalized or visited the emergency room due to COVID-19, compared to 6% of their peers on placebo. Lilly said the difference corresponds to a 72% risk reduction. The numbers involved are tiny, though. Five of the 302 LY-CoV555 patients went to the hospital, compared to nine of the 150 people on placebo. It is possible that the apparent benefit of LY-CoV555 will evaporate in a larger study.

    Other aspects of the data point to the need for more research. Lilly said the rate of hospitalization in people with risk factors suggest “a more pronounced treatment effect” in such patients. Exploratory analyses also suggest the COVID-19 symptoms of patients on LY-CoV555 improved faster than their counterparts on placebo. More work is needed to confirm the findings.

    With no patients suffering drug-related serious adverse events, Lilly may be able to seek emergency use authorization on the strength of the clinical data, despite its limitations. Lilly is set to discuss the next steps with global regulators.

    BLAZE-1 is continuing, with Lilly amending the phase 2 last month to assess the effect of combining LY-CoV555 with another anti-SARS-CoV-2 antibody, LY-CoV016. Lilly took LY-CoV555, which AbCellera developed from the blood of a COVID-19 survivor, into the clinic as a single agent in part in an effort to maximize the output from its manufacturing capacity.

    Lilly continued to consider two-antibody cocktails, though, and is now trialing LY-CoV555 with its Shanghai Junshi Biosciences-partnered LY-CoV016. The two antibodies target different parts of the SARS-CoV-2 spike protein, suggesting the cocktail could be less susceptible to drug resistance.

    That could prove to be important. Lilly found variants that may confer resistance to LY-CoV555 in all arms of the trial. The variants were more common in patients treated with LY-CoV555 than people on placebo, although at 8% versus 6%, the difference may just be noise.

    The Lilly data drop is the first of a series of readouts on anti-SARS-CoV-2 antibodies. Lilly has other LY-CoV555 trials on the go, and peers including AstraZeneca, GlaxoSmithKline and Regeneron are also testing anti-SARS-CoV-2 antibodies in humans.

  19. #769
    Senior Member JohnLanders's Avatar
    Join Date
    May 2020
    Posts
    2,694
    Rep Power
    3974217
    https://ktla.com/news/local-news/gar...er-in-october/

    Mayor Eric Garcetti said Wednesday that Los Angeles is “slowly but surely moving in the right direction” as hospitalization rates continue a steady decline after peaking in July.

    “Our hospitalizations from COVID, right now, are at the lowest level they have been since the first outbreak here in LA.,” Garcetti said. “Your actions have saved the lives of thousands of your family members and neighbors.”

    If the overall decline in hospitalizations and deaths continue, L.A. could shift into the less restrictive Tier 2 of the state’s reopening plan sometime next month, public health officials said Wednesday.

    But gatherings with other households without face masks and other violations of physical distancing measures could lead to more troubling infection and death rates like those seen earlier in the pandemic, officials said.

    “Positive trends don’t mean that we’re out of the woods by any stretch,” Garcetti said. “The virus is still here, and we still have to act with vigilance.”

    While the county continues to see overall progress, the current transmission rate of 0.95 is “slightly higher than last week,” Garcetti said. But that rate still indicates that each case of coronavirus will lead to less than one new infection.

    Troubling spikes in hospitalization and infection rates followed in the weeks after the Fourth of July and Memorial Day, something health officials have attributed to gatherings in violation of social distancing on those holidays.

    According to the county’s Department of Public Health, officials will look at data at the end of September to see if any gatherings over Labor Day weekend lead to a surge like those seen after the Fourth of July and Memorial Day, particularly since record-breaking temperatures led to large crowds in Santa Monica.

    By the end of the month, health officials should be able to determine whether there really was increased transmission of the virus over Labor Day. And if there is such a surge, the county would not be able to roll back restrictions and move into Tier 2 of the state’s reopening plan yet.

    On Sunday, Garcetti criticized President Donald Trump’s leadership during the pandemic, saying he didn’t work hard enough to help stop the spread of the virus in cities like L.A.

    “If we had known and had leadership that didn’t say ‘calm,’ but actually allowed us to do the work and provided us the resources to do so we would have taken action much earlier, and thousands of lives in my city, and obviously, maybe tens of thousands if not 100,000 lives in America could have been saved,” Garcetti said on CNN’s “State of the Union.”

  20. #770

  21. #771
    Senior Member JohnLanders's Avatar
    Join Date
    May 2020
    Posts
    2,694
    Rep Power
    3974217
    https://sciencebasedmedicine.org/don...orseshoe-crab/


    I was trying to decide what to write about today and finding it rather difficult. Part of it might be because, in the States at least, it’s a long holiday weekend. Another part of the reason is that so many of the potential topics are so obvious, given the torrent of disinformation that last week brought about vaccines, COVID-19, and so many other medical topics. That being said, if there’s one thing I like to do, it’s to take on topics that no one else notices, which brings me to antivaxxers and horseshoe crabs.

    Yes, horseshoe crabs.

    Over at what I’ve long liked to refer to (along with The Huffington Post) as that “wretched hive of scum and antivaccine villainy”, Age of Autism (even though several other wretched hives of scum and antivaccine quackery have surpassed its wretchedness over the years), I came across this remarkable post urging vegans to be wary of any potential COVID-19 vaccine because of horseshoe crabs in a post entitled “Will Vegans Reject Covid Vaccine that Drains Horseshoe Crabs of Their Blood?“:

    Note: Can you be a Vegan, a true Vegan who does not consume animal products, and take a COVID vaccine that calls for the ex-sanguination [sic] of horseshoe crabs? What’s the difference between the cruel existence of veal, and hooking horsehoe [sic] crabs to a machine that drains their 30% of their blood, if when they are returned “home,” many die? Is taking any product that knowingly harms animals hypocritical? If you have never seen horseshoe crabs in the wild, you should. We used to see them often on Cape Cod. They are mesmerizing, ancient creatures.

    This isn’t a new tactic, either. Back in April, Sherri Tenpenny’s antivaccine website Vaxxter published an article with the title, “The Chilling Image Behind Every Vaccine“:

    The image is startling. The sight of crabs being forced in clamps and bled out in what appears much like a lab from Blade Runner. The horseshoe crab is 300 million years old and that’s what haunts the image before you. That’s 200 million years older than dinosaurs. But even this sea creature isn’t likely to survive pharma’s wrath.

    Horseshoe crabs are known for their unique blue blood. That blood will clot in the presence of specific bacterias, [sic] so pharma loves to use them to test out new medications, including vaccines.

    Accompanying the article is an image similar to this one:

    The reason the crabs’ blood is blue is because it uses copper in a protein called haemocyanin instead of iron in hemoglobin to bind oxygen. So there really is a precedent for calling Vulcans “blue-blooded”!

    Elsewhere, more recently other alternative medicine and antivaccine sites have been taking up the cry, attempting to demonize any new COVID-19 vaccine (and, of course, vaccines in general) with the cry being taken up by blogs and websites such as The Vaccine Reaction and The Alternative Daily.

    A regular reader might be wondering here: Why do pharmaceutical companies harvest the blood of horseshoe crabs to use for vaccines? In fact, I wondered that very thing and was rather amazed that I didn’t know about this particular practice, even after having written about vaccine safety issues for over 20 years. So this was a great learning opportunity for me to fill in a gap in my knowledge that I didn’t know that I had – and, hopefully, to fill in a gap that many SBM readers didn’t know they had either.

    Here’s the explanation. There is a substance in the blood of horseshoe crabs, limulus amebocyte lysate, that can be used to detect endotoxin, a toxin that is a component of the bacterial wall of gram-negative bacteria. (Gram-negative or gram-positive refers to the ability of a species of bacteria to be stained with Gram stain.) Endotoxin is a lipopolysaccharide (LPS) consisting of lipid A and something called the O-polysaccharide, which allows bacteria to adhere to certain tissues and contributes to resistance to being engulfed by certain immune cells. The lipid A portion of LPS is the cause of the molecule’s endotoxin activity, as immune cells in humans and animals recognize it as an indicator of the presence of bacteria and activate an immune response to it, no previous exposure to endotoxin required. Thus, endotoxin can cause a robust inflammatory reaction and is the most potent contributor to septic shock in patients with gram-negative sepsis.

    Which brings us to the reason why this extract from horseshoe crab blood is so important:

    Due to the severe consequences of an infection, an injectable healthcare product such as a vaccine or intravenous solution must be sterile or free of live bacteria, but the manufacturing process to kill any bacteria can result in release of LPS or endotoxin into the product. Just as with a bacterial infection or sepsis, if sufficient endotoxin gets into our blood stream or spinal fluid we can develop fever, shock, and organ failure. In extreme cases, it can even result in death.

    Therefore, injectables or implantables, products that come in contact with the blood stream or spinal fluid, are tested for sterility (the absence of live bacteria) as well as endotoxin. Testing for endotoxin helps assure product quality and safety.

    So you can see why testing to make sure that endotoxin is eliminated from a vaccine, a medical device, or any injectable product is so important. How is this product used? An article from 2014 published in The Atlantic describes how. After waxing poetic about how horseshoe crab blood is blue, not red, the article goes on to describe how the blood is used to detect endotoxin:

    The marvelous thing about horseshoe crab blood, though, isn’t the color. It’s a chemical found only in the amoebocytes of its blood cells that can detect mere traces of bacterial presence and trap them in inescapable clots.

    To take advantage of this biological idiosyncrasy, pharmaceutical companies burst the cells that contain the chemical, called coagulogen. Then, they can use the coagulogen to detect contamination in any solution that might come into contact with blood. If there are dangerous bacterial endotoxins in the liquid—even at a concentration of one part per trillion—the horseshoe crab blood extract will go to work, turning the solution into what scientist Fred Bang, who co-discovered the substance, called a “gel.”

    “This gel immobilized the bacteria but did not kill them,” Bang wrote in the 1956 paper announcing the substance. “The gel or clot was stable and tough and remained so for several weeks at room temperature.”

    If there is no bacterial contamination, then the coagulation does not occur, and the solution can be considered free of bacteria. It’s a simple, nearly instantaneous test that goes by the name of the LAL, or Limulus amebocyte lysate, test (after the species name of the crab, Limulus polyphemus).

    But why, you ask, did evolution endow the horseshoe crab with the ability to make coagulogen? The best guess is this. Horseshoe crabs live in a bacteria-rich environment near the shoreline, and their circulatory systems made the evolution of such a system advantageous. In 1956, a researcher named Fred Bang noted that when horseshoe crab blood comes into contact with endotoxin, cells called amebocytes clot and form a solid mass:

    And that bacteria-rich habitat is why, Bang speculated, the crabs evolved their marvelous chemical defense. Their circulatory systems work more like a spider’s than like ours. If we inhale something bad, that thing has to find its way through our bodies and into our bloodstreams, fighting its way through our white blood cells along the way. But if bacteria find their way under a horseshoe crab’s exoskeleton, they can roam free to do damage.

    “Large sinuses exist that allow blood direct contact with tissues,” the Woods Hole Marine Biological Laboratory’s history of the crab explains. “There are many wide open spaces and bacteria entering a crack in the shell of a horseshoe crab have easy access to large internal areas of the crab, a potentially deadly scenario.”

    The coagulogen changes the wide-open terrain of the horseshoe crab’s circulatory system. When the crab blood cells sense invaders, they release granules of the chemical, which becomes a gooey physical barrier to the movement of the bacteria, preventing the spread of infection. The best metaphor might be the superpower of the X-Men’s Iceman, but instead of using cold to encase enemies, the horseshoe crab instead uses its remarkable chemistry.

    A description of how Bang discovered limulus can be found here. In brief:

    Bang was studying the circulation of blood using horseshoe crabs when he found that one of his crabs died as a result of a Vibrio bacterial infection. The infection caused a strange disease in which almost the entire blood volume of the crab clotted into a semi-solid mass. Other bacteria had not produced this sort of reaction at all. Bang began to investigate further and found that only gram-negative bacteria produced this reaction. Furthermore, heat-treated bacteria (dead bacteria) continued to produce the reaction so it wasn’t a pathological disease but something different.

    Isn’t science cool? Isn’t evolution awesome? Imagine a chemical made by an organism that can react with another molecule at such low concentrations and basically immobilize it. Evolution’s done that for the humble horseshoe crab! And scientists figured out what the chemical is and how to use it to keep injectable medications and implantable devices safe.

  22. #772
    Senior Member JohnLanders's Avatar
    Join Date
    May 2020
    Posts
    2,694
    Rep Power
    3974217
    https://sciencebasedmedicine.org/don...orseshoe-crab/

    Of course, like most antivaccine propaganda, there is a grain of a reasonable point buried in the spin and exaggeration, the main question being: Why do we still use horseshoe crab blood to obtain the necessary molecule? Why haven’t we been able to come up with a substitute or figure out a way to synthesize the chemical without bleeding millions of horseshoe crabs, resulting in the deaths of a not-insignificant number of them? After all, horseshoe crab blood is one of the most expensive resources in the world, costing around $60,000 per gallon (around $15,581 per liter, for the rest of the world). Worse, around 10-30% of the crabs don’t survive after bleeding, as the bleeding appears to make the bled animals more lethargic, slower, and less likely to follow the tides the way that their untouched counterparts do.

    It turns out that there is a substitute. In 2016, a synthetic alternative to the use of horseshoe crab blood, recombinant factor C (rFC), was approved in Europe, and a handful of US drug companies also began using it, as was described in National Geographic in July in an article about how horseshoe crab blood will be critical to making a COVID-19 vaccine. The article also noted:

    But on June 1, 2020, the American Pharmacopeia, which sets the scientific standards for drugs and other products in the U.S., declined to place rFC on equal footing with crab lysate, claiming that its safety is still unproven.

    This is, of course, a valid issue from an environmental and ethical perspective. If the recombinant rFC is good enough for Europe, whose drug and medical device regulation is as stringent as that in the US, why isn’t it good enough for the US? In June, the Smithsonian reported:

    Now, an influential United States group has abandoned plans to list a synthetic alternative, called recombinant Factor C (rFC), alongside the tried and true blue fluid, reports John Miller for Reuters. The move by medical standards group U.S. Pharmacopeia (USP) would have given rFC equal standing with crab blood, which has long been the industry standard for testing, per Reuters.

    The gist of the USP’s rationale is that rFC requires more testing, and that the current crab-derived test has a 30-year track record of safe and effective use, reports the [New York] Times. Many expected the alternative test to be approved for widespread use as it was in Europe by the European Pharmacopeia, per the Times.

    For drug makers in the U.S., using the synthetic alternative will require a kind of application designed to demonstrate that the non-standard test is up to snuff—a hurdle that makes companies less likely to abandon the animal-based test, reports Caroline Delbert for Popular Mechanics.

    Certainly, it must be far less expensive and labor-intensive to manufacture the necessary component to detect endotoxin using recombinant methods than it is to bleed over a half million horseshoe crabs a year and then isolate the compound from the blood. Worse, as several articles noted, a combination of overharvesting and the bleeding is resulting in a decline in horseshoe crab populations, which are a vital food source for migratory birds and critical to the ocean ecosystem. It is a legitimate question to ask why we’re still isolating this vital compound in such a barbaric manner, but that’s not really what antivaxxers are about here. What they’re about here is spreading fear, uncertainty, and doubt about any potential new COVID-19 vaccine that uses the LAL test to verify that it is free of bacteria and endotoxin. It’s about demonization, not education.

    Hopefully, Delbert was correct in speculating at the end of her Popular Mechanics article:

    Eli Lilly is a huge company with deep pockets, but it’s said outright that the extra and different regulations on rFC are discouraging other companies, per the Guardian. The USP decision is a further obstacle, but the USP has approved alternative testing regimens in the past, like the sterility testing that also affects injectable and biological drugs. If its complaint is a lack of data, then the more people who adopt the synthetic regimen, the more data will accumulate on their side.

    And the sooner, the better.

    This co-optation of the story of how horseshoe crab blood is used to make a test that can detect minute traces of endotoxin in injectable drugs and using that story to try to convince vegans not to vaccinate is just a variation on a theme of a technique that antivaxxers have been using since long before I started paying attention to these issues. They take a belief system and then find an ingredient or something about vaccines that they can use to try to convince those with that belief system that vaccines are against what they believe. Examples abound, mostly with religious beliefs. For example, antivaxxers have long tried to convince Muslims and Jews that the gelatin derived from pigs that is used in some vaccines makes vaccines irredeemably against their religions, even though Rabbis and Islamic scholars have long pointed out that there is a reasonable exception for vaccines. Indeed, Rabbis and Jewish medical experts actively encourage Jews to be vaccinated, and Islamic legal scholars have rejected the claim that the use of gelatin from “impure animals” is against Islam. Another example of how antivaxxers try to weaponize beliefs against vaccines is their persistent drumbeat of criticism of the use of cell lines derived from human fetuses in the 1960s to grow up stocks of virus to be used in the manufacture of vaccines in order to turn those with religious beliefs against abortion against vaccines, a phenomenon I’ve written about more times than I can remember. It doesn’t matter that vaccines made using these cell lines have saved millions of lives and prevented billions of cases of infectious disease, or that the Catholic Church itself has stated that their use is acceptable. Every year, it seems, antivaxxers find new and more ridiculous ways to try to weaponize antiabortion beliefs against vaccines.

    The bottom line is that most antivaxxers are not vegan and that these antivaxxers don’t give a rodent’s posterior about horseshoe crabs. One also wonders whether they know or care about the implications of what they are saying. After all, it’s not just a COVID-19 vaccine that would use the LAL test to check for endotoxin that vegans would have to eschew if they accepted the “logic” of this antivaccine post by the wandering band of scientifically illiterate cranks at AoA. They would have to eschew nearly all IV fluids, injectable medications, implantable devices, and, yes, vaccines, given how widely the LAL test is used. They would, in fact, have to give up a large percentage of modern medicine.

    On second thought, maybe antivaxxers do realize the implication of their arguments. Maybe that’s what they want. Or maybe there’s no “maybe” about it.

  23. #773
    Senior Member JohnLanders's Avatar
    Join Date
    May 2020
    Posts
    2,694
    Rep Power
    3974217
    https://sciencebasedmedicine.org/new...rmed-movement/

    Jonathan Berman’s new book Anti-vaxxers: How to Challenge a Misinformed Movement has two goals: to provide a complete picture of the anti-vaccine movement and to provide a counterpoint to some of the misinformation that has been circulating. It succeeds admirably on both counts.

    In addition, it examines and critiques the strategies that have been used to dissuade people from their anti-vaccine beliefs. These fall into three broad categories:

    Reactive: engaging with anti-vaccine advocates with arguments and/or mockery
    Information-deficit strategies: making factual information available to the public
    Community-based strategies that take self-identity and values into consideration; the strategy most likely to succeed.

    Anti-vaxxers come in many flavors, and there is often a disparity between belief and behavior. Berman reports that in France, 41% of people disagreed with the statement that vaccines are safe, but 96% vaccinated their children. Vaccination rates are generally high, but there are pockets of resistance that can lead to (and have caused) outbreaks of preventable diseases.

    The history of vaccines and anti-vax attitudes
    Berman starts by explaining what vaccines are and how they work. He provides an informative history of vaccines, pointing out that Jenner was not the first to vaccinate with cowpox: a farmer named Benjamin Jesty preceded him by two decades, using a darning needle to transfer pus from an infected cow to his wife and children.

    Objections to vaccines were immediate, and the early anti-vaccine movement presaged today’s movement by ignoring the obvious success of vaccines and quibbling about scientific issues instead of addressing their real concerns such as individual rights, resistance to government mandates, the “natural order” of things, and social inequities.

    In 1905, the US Supreme Court ruled that states could restrict individual liberties to avoid great dangers to public safety, that they could punish vaccine refusers with fines or imprisonment but could not forcibly vaccinate, and that they must allow medical exemptions.

    To illustrate the success of smallpox vaccination, Berman says:

    If you lined up all the people who have lived since 1980 because smallpox was eliminated and took one minute to greet each of them, you would spend the next 144 years meeting people who did not die of smallpox.

    I didn’t check his math, but it’s undeniable that millions of people lived who would have died of smallpox if the vaccine did not exist.

    Did you know Gandhi was originally an anti-vaxxer? He called vaccination “a violation of the dictates of religion and morality”. His concern was that an oppressive government was taking away the bodily autonomy of the people he was fighting for. He changed his mind after seeing unvaccinated children die of smallpox.

    Vaccine injuries and laws
    Berman doesn’t omit vaccine failures, like the two polio vaccines in the 1930s that killed six children and paralyzed ten, and the 1955 pharmaceutical accident when an improperly inactivated virus resulted in 250 cases of paralytic polio and 11 deaths. But he explains that safety precautions are now in place to prevent a recurrence of such disasters. He describes some of the many occasions around the world where vaccine fears led to a decrease in vaccination rates which then predictably led to a resurgence of disease – and where the disease promptly subsided when vaccination rates went back up.

    He describes how lawsuits against vaccine manufacturers led to the National Childhood Vaccine Injury Act, which created the Special Masters court and provided compensation for patients who met certain criteria and protected the supply of necessary vaccines. The standard of evidence was a legal one, not scientific evidence that the vaccine had caused the injury (and this is still the case today).

    Today’s anti-vaxxers love to cite reports of vaccine harms from the Vaccine Adverse Event Reporting System (VAERS). It was set up as an early warning system for identification of possible adverse events, but a report to VAERS does not establish that the vaccine caused the reported event. Dr. James Laidler vividly demonstrated the fallacy of relying on VAERS by reporting that the flu vaccine had turned him into the Incredible Hulk. The report was accepted, although he later withdrew it after he had made his point.

    Doctors and others who encourage anti-vaxxers
    He covers the Wakefield fiasco in detail (covered by SBM many times). Wakefield’s study was retracted, and he was stripped of his license to practice medicine; but meanwhile he had alarmed many parents who refused the MMR vaccine in the belief that it caused autism. Numerous studies have since shown no evidence that vaccines can cause autism, but many parents are still fearful.

    He covers Dr. Robert Sears’ spurious reasons for delaying vaccines, which have no basis in fact (covered here on SBM also); delaying vaccines only creates serious risks for children. An entire chapter is devoted to a devastating critique of the film Vaxxed (which we have done many times here). Another chapter addresses the misinformation promoted by Robert F. Kennedy in his article “Deadly Immunity” and elsewhere, stoking fears of thimerosal (which is essentially absent from the American pediatric vaccine schedule today anyway; addressed by David Gorski).

    One chapter covers ineffective “alternatives'” to vaccination, including pox parties, breast-feeding, homeopathy, probiotics, vitamins, essential oils, chiropractic, Miracle Mineral Solution (MMS), hyperbaric oxygen, exorcisms, craniosacral therapy, and bogus autism cures including the “chemical castration” advocated by the Geiers.

    Religion and other factors
    He discusses placebo effects, fake news, social media, memes, and freedom of speech. A chapter on religions finds that nearly every major religion either encourages its members to vaccinate or is neutral on the subject. The so-called “religious exemption” does not reflect actual religious beliefs, but is a smokescreen that gives anti-vaxxers an excuse to bypass government regulations. It is a cynical ploy that exploits the privileged position of religion in society. Berman says:

    Freedom of religious belief is not the same as freedom of action based on religious belief…In the rare case that religious beliefs do conflict with vaccination, the state’s interest in public health may outweigh religious privilege.

    Anti-vaxxers would have you believe that Big Pharma is guilty of conspiracy and is lying to you for profit. Big Pharma is undoubtedly guilty of many sins, but that doesn’t mean vaccines are unsafe or ineffective.

    Who are the anti-vaxxers?
    Anti-vaxxers are not a homogeneous group. Some are activists who work to spread misinformation, others are merely vaccine-hesitant: they have heard things that worry them but haven’t entirely made up their minds. And some are willing to vaccinate but have not yet done so because of factors like financial barriers, poor access to medical care, or transportation difficulties. Those who don’t vaccinate tend to have:

    a lower level of trust in health care professionals, a lower level of trust in government, a concern that a child’s immune system could be “weakened” by too many immunizations, a belief that immunization requirements abridged freedom of choice and that parents know what’s best for their own children, a greater level of trust in alternative health practitioners, and a past history of having sought information from sources on the internet or alternative health practitioners.

    Anti-vaccine parents are deeply concerned with being good parents. They seek out information from sources they trust, like friends and family. They are more distrustful of people they don’t know personally. They are subject to the normal human tendencies, biases, and shortcuts of thinking. They distrust authorities and respond more favorably to stories than to statistics. They worry about chemicals with long names they don’t understand. They fear that putting things into our bodies that are not natural will make them impure.

    Changing minds
    People do change their minds, but we can’t do it for them. Perhaps a kind stranger answers their questions. Perhaps they connect with someone paralyzed by polio or blinded by measles. Perhaps an illness in their family prompts them to do more (and better) research.

    Vaccination is a success story. We should tell that story and should “sing louder than those who sing out of key”. Anti-vaxxers are motivated by the same desires that motivate us all: the desire to be a good parent and do what is best for our children. We can help by understanding the kinds of anti-vaccine arguments and how they are involved with group identity.

    Berman says, “We should learn how we can individually respond to the doubts of our friends, neighbors, and family members in a way that is compassionate, well-informed, and correct. Anti-vaccination activism is a local problem that demands local, personal solutions.”

    Conclusion: Everything worth knowing about the subject
    Berman’s book compiles everything worth knowing about the anti-vaccine movement into one convenient, well-referenced volume. It is well-written, concise (213 pages of text), and conveniently divided into 22 short, easily digested chapters. If you are anti-vaccine, you need to read this book but probably won’t. If you are pro-vaccine, it deserves a prominent place on your bookshelf among your reference books. It is a useful compendium that will help you respond appropriately when you encounter a victim of this misinformed movement. I urge everyone to read it. Even if you are as well-informed as I assumed I was, there is much more to learn and to think about.

  24. #774
    Senior Member JohnLanders's Avatar
    Join Date
    May 2020
    Posts
    2,694
    Rep Power
    3974217
    https://www.ktvb.com/article/news/he...e-d0f5e0673280

    BOISE, Idaho — Boise State assistant professor Luke Montrose combed through scientific data and other research, along with feedback from wildland firefighters, and confirmed a CDC study that found that excessive wildfire smoke makes people more prone to lung infections like the coronavirus.

    KTVB spoke with the assistant professor on Saturday to discuss what his findings mean for everyone affected by the wildfire smoke and the firefighters on the front lines, battling massive wildfires during a pandemic.


    "Firefighting is a really interesting situation because we're asking them to spend quite a bit of time on the front lines of the fire being exposed to smoke," Montrose explained during a video call. "That repeated exposure to these inhaled particulates, that are very small and get deep down into our lungs, has the capacity to reduce or suppress our immune system and by doing so leaves us very vulnerable to viral infection and that viral infection could be the seasonal flu it could also be coronavirus."


    Montrose added that everyone should try to limit their exposure to the wildfire smoke, especially with flu season on the way, so there isn't a spike in infections like COVID-19 this fall.

    "As far as protective equipment very little can be done for the firefighters," he said. "So what I would recommend to them would be, when possible, stay out of the smoke."

    Firefighters working a 14-hour shift should have a ten-hour window of staying out of the smoke so their lungs can clear out the particulates and heal.

    However, Montrose and the Center for Disease Control and Prevention agree that cloth face masks aren't effective in preventing people from inhaling smoke.


    "The particulate matter is very small and can't be caught by the cloth mask," Montrose explained. "[They are] 2.5 microns in diameter, that's about one 50th the size of a grain of sand."

    Montrose said agencies fighting the wildfires are doing their best to contain the fires and the coronavirus but like both, he wanted to spread awareness about the new risks that people face.


    "Our public health really depends on their health," he said, "and hopefully we're able to make it to the end of the season with enough crew members to keep the public safe."

  25. #775
    Senior Member JohnLanders's Avatar
    Join Date
    May 2020
    Posts
    2,694
    Rep Power
    3974217
    https://www.fiercebiotech.com/biotec...cine-protocols

    The clamor for more transparency from the leading pandemic vaccine contenders has been getting louder, especially after AstraZeneca’s trial was briefly stopped in the U.K. (and is still on hold in the U.S.).

    These growing calls for transparency have led Moderna (PDF), swiftly followed by Pfizer/BioNTech (and a pledge from AstraZeneca), to release their protocols this week, all of which are in the later stages of testing and likely to see data, and maybe emergency approvals, in the coming months.

    The way Pfizer is running its phase 3, in conjunction with BioNTech, is focused on speed; it did not share a timetable for competition, though CEO Albert Bourla has repeatedly said they should have data by the end of October.

    The normally secret protocol said the Big Pharma will have an interim analysis after just 32 people test positive, i.e., if six are positive in the vaccine group and 26 are positive in the placebo. For the final analysis, of 164 cases, it will need to hit 50% efficacy to be deemed a success by the FDA.

    Moderna said data should be reported by year-end or early next year, and AstraZeneca has previously given a similar timetable.

    Moderna’s protocol also gave more color, saying its first analysis of early trial data might not be conducted until late December, although company officials now say they expect the initial analysis in November.

    In terms of how it’s measuring efficacy, a total of 151 COVID-19 cases “will provide 90% power to detect a 60% reduction in hazard rate (60% vaccine efficacy [VE]), rejecting the null hypothesis,” it said in its protocol.

    “This is a case-driven study,” Moderna’s protocol said. “If the prespecified criteria for early efficacy are met at the time of either interim analysis or overall efficacy at the primary analysis, a final study report describing the efficacy and safety of mRNA-1273 will be prepared based on the data available at that time.

    “In the event that success criteria are met either at the time of the interim analyses or when the total number of cases toward the primary endpoint have accrued, participants will continue to be followed in a blinded fashion until month 25, to enable assessment of long-term safety and durability of VE . If the study concludes early, all participants will be requested to provide a final blood sample at the time of study conclusion.”

    Its first interim analysis (IA) will occur when around 35% of the total cases have been observed and the second at 70%, with the primary analysis to be “performed when approximately 151 cases have been observed in the study.”

    “There is no intention to stop the study early if the efficacy has been demonstrated at any of the IAs,” Moderna added. “If efficacy is demonstrated at an IA, the subsequent IA or primary analysis will be considered supportive in nature.”

    So far, 25,000 patients have been enrolled into Moderna’s trial, with 10,000 having had their second shot.

    U.S. President Donald Trump is banking a lot of political capital on these vaccines coming in before the election, or soon after, with pressure mounting for drugmakers—many of which are getting government cash—to get a vaccine out ASAP.

    Earlier this month, AstraZeneca, which has also promised to release its vaccine protocol (but at time of writing has not), and its partner the University of Oxford had to halt their phase 3 after a serious safety concern cropped up in one patient.

    The trial was briefly halted in the U.K. before resuming (although it's still on hold in the U.S.), with officials expressing concern about the event and many on bio-Twitter wondering why AstraZeneca is being coy about the exact details of what happened.

    Reports from the media, including CNN, suggested a rare nerve disease had hit one patient, but AstraZeneca has come out to flatly deny this. The diagnosis was “based on preliminary findings” and is inaccurate, it said in response to the articles. If it does publish its protocol, this information will not be a part of it.

    The release of the protocols has prompted kudos from some in the scientific community. “I want to acknowledge a good deed done,” said Peter Doshi, who is on the faculty at the University of Maryland School of Pharmacy in Baltimore and an editor with The BMJ, talking to The New York Times.

    “They have opened up, for the first time, the ability for researchers not involved in the trial to form their own independent judgment about the design of this study.”

    https://www.fiercepharma.com/manufac...-covid-19-shot

    With the fourth quarter fast approaching, it's do-or-die time for a group of drugmakers chasing the first approved vaccine for COVID-19. Sanofi and GlaxoSmithKline are running a bit behind other companies in terms of clinical testing, but that doesn't mean they aren't ready to ink their own momentous supply deals.

    Sanofi and GSK have signed a deal with the EU to supply up to 300 million doses of their recombinant protein-based COVID-19 vaccine after a regulatory approval that could come as early as the first half of 2021, the partners said Friday.

    To help meet the expected demand if their contender wins approval, both drugmakers are ramping up manufacturing for the antigen and adjuvant used in the shot, which is scheduled to enter phase 3 human testing later this year. With its souped-up manufacturing in place, Sanofi and GSK are aiming to produce around 1 billion doses per year, the companies said.

    The EU deal will not only provide Sanofi and GSK's shot to the region's member nations but will also free the bloc to divert some of those doses to low- and middle-income countries, the drugmakers said.


    Sanofi is working not only on the GSK-partnered recombinant-protein candidate but also on an mRNA-based prospect that's set to enter phase 1/2 testing in November. Working with partner Translate Bio, Sanofi hopes to eventually roll out between 90 million and 360 million doses per year if a regulatory approval comes through.

    RELATED: Pfizer, BioNTech near Euro supply deal for up to 300M doses of COVID-19 vaccine

    The EU's supply tie-up with Sanofi and GSK comes as the bloc works to secure doses from a suite of drugmakers at the forefront of the COVID-19 vaccine race.

    Earlier this month, Pfizer and BioNTech announced they were working to close a supply deal with the EU for up to 300 million doses of their mRNA-based vaccine starting at the end of the year.

    A final EU deal would be the single largest signed by Pfizer and BioNTech in their quest to distribute 100 million doses of their BNT162 shot by the close of 2020. The agreement would provide an initial order of 200 million doses to the EU's 27 members states with the option for an additional 100 million doses at a later date, the companies said.

    The EU also penned an agreement with AstraZeneca in August for 400 million doses of the University of Oxford's adenovirus-based shot, dubbed AZD1222.

    RELATED: Top vaccine players Sanofi, GSK win $2.1B Warp Speed funding for COVID-19 shot

    Sanofi and GSK's European deal is its first major supply pact in the region, but the drugmakers are also on the hook for a massive order from the U.S.

    In late July, the U.S. government agreed to pay Sanofi and GSK up to $2.1 billion to speed up clinical development and manufacturing of the pair’s candidate.

    More than half of the money was earmarked to run clinical trials, while the rest will go to manufacturing scale-up and delivery of an initial 100 million doses of the vaccine. The deal also gives the U.S. government an option for an additional 500 million doses over the long term.

Thread Information

Users Browsing this Thread

There are currently 1 users browsing this thread. (0 members and 1 guests)

Tags for this Thread

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •