Page 32 of 89 FirstFirst ... 22 30 31 32 33 34 42 82 ... LastLast
Results 776 to 800 of 2212

Thread: COVID-19 Novel Coronavirus pandemic

  1. #776
    Moderator puzzld's Avatar
    Join Date
    Aug 2007
    Posts
    21,600
    Rep Power
    21474874
    How the Sturgis Motorcycle Rally may have spread coronavirus across the Upper Midwest
    Within weeks of the gathering that drew nearly half a million bikers, the Dakotas, along with Wyoming, Minnesota and Montana, were leading the nation in new coronavirus infections per capita.

    It had been a long ride back from Sturgis, S.D., so when he first felt an ache at the back of his throat, Kenny Cervantes figured he was just tired. He?d traveled the 400-some miles on his Harley, rumbling through wide-open farm and prairie land on his way home to Riverdale, Neb., where his girlfriend was waiting.

    A lifelong motorcycle enthusiast, the 50-year-old construction worker and father of five had been determined to go to the Sturgis Motorcycle Rally, a holy grail for bikers. Even when his girlfriend, Angie Balcom, decided to stay back because she was worried about being around so many people during a pandemic, Cervantes was adamant about going.

    ?I don?t think there was nothing that was going to stop me,? he said.

    Back home, Cervantes took Tylenol for his throat and went to bed early. But he woke up the next morning coughing so hard he struggled to catch his breath. Over the next few days, the pain in his chest made him fear that his heart might stop, and a test later confirmed he had the novel coronavirus, which causes the disease covid-19. He was admitted to the hospital 11 days later, on Aug. 27. Soon, his girlfriend and his sister were sick, and Cervantes was going over everything he did and every place he visited in Sturgis, wondering where the virus had found him.

    Within weeks of the gathering, the Dakotas, along with Wyoming, Minnesota and Montana, were leading the nation in new coronavirus infections per capita. The surge was especially pronounced in North and South Dakota, where cases and hospitalization rates continued their juggernaut rise into October. Experts say they will never be able to determine how many of those cases originated at the 10-day rally, given the failure of state and local health officials to identify and monitor attendees returning home, or to trace chains of transmission after people got sick. Some, however, believe the nearly 500,000-person gathering played a role in the outbreak now consuming the Upper Midwest.

    More than 330 coronavirus cases and one death were directly linked to the rally as of mid-September, according to a Washington Post survey of health departments in 23 states that provided information. But experts say that tally represents just the tip of the iceberg, since contact tracing often doesn?t capture the source of an infection, and asymptomatic spread goes unnoticed.

    In many ways, Sturgis is an object lesson in the patchwork U.S. response to a virus that has proved remarkably adept at exploiting such gaps to become resurgent. While some states and localities banned even relatively small groups of people, others, like South Dakota, imposed no restrictions ? in this case allowing the largest gathering of people in the United States and perhaps anywhere in the world amid the pandemic and creating huge vulnerabilities as tens of thousands of attendees traveled back home to every state in the nation.

    Many went unmasked to an event public health officials pleaded with them to skip, putting themselves and others at risk, because they were skeptical about the risks, or felt the entreaties infringed on their personal liberties. Rallygoers jammed bars, restaurants, tattoo parlors and concert venues; South Dakota officials later identified four such businesses as sites of potential exposure after learning that infected people had visited them.

    Despite the concerns expressed by health experts ahead of the event, efforts to urge returnees to self-quarantine lacked enforcement clout and were largely unsuccessful, and the work by state and local officials to identify chains of transmission and stop them was inconsistent and uncoordinated.

    Those efforts became further complicated when some suspected of having the virus refused to be tested, said Kris Ehresmann, director of infectious-disease epidemiology at the Minnesota Department of Health.

    Such challenges made it all but impossible to trace the infections attendees may have spread to others after they got home. Several infections tied to a wedding in Minnesota, for instance, ?linked back to someone who had gone to Sturgis,? Ehresmann said. Those were not tallied with the Sturgis outbreak because ?the web just gets too complicated,? she said.

    ?When it comes to infectious diseases, it?s often the case that the weakest link in the chain is a risk to everybody,? said Josh Michaud, an epidemiologist and associate director for global health policy for the nonprofit Kaiser Family Foundation. "Holding a half-million-person rally in the midst of a pandemic is emblematic of a nation as a whole that maybe isn?t taking [the novel coronavirus] as seriously as we should.?

    The Aug. 7-16 gathering has drawn intense interest from scientists and health officials, and will likely be studied for years to come because of its singularity. It?s not just that Sturgis went on after the pandemic sidelined most everything else. It also drew people from across the country, all of them converging on one region, packing the small city?s Main Street and the bars and restaurants along it. And in contrast with participants in the Black Lives Matter protests this summer, many Sturgis attendees spent time clustered indoors at bars, restaurants and tattoo parlors, where experts say the virus is most likely to spread, especially among those without masks.

    Attendees came from every state, with just under half hailing from the Great Plains and substantial numbers journeying from as far as California, Illinois and Arizona, according to an analysis by the Center for New Data, a nonprofit group that uses cellphone location data to tackle public issues. The analysis, shared with The Washington Post, shows just how intertwined the South Dakota rally was with the rest of the country ? and how far the decisions of individual attendees could have ricocheted.

    Cervantes feels certain he got the virus from his Sturgis trip, and shared that with the contact tracer from the Two Rivers Public Health Department who phoned him after his case was recorded. Nebraska borders South Dakota, and health officials there expected they might see rally-related infections.

    Yet his illness was not classified as a Sturgis case, suggesting that even under the best of circumstances, infections might go uncounted. With so much still unknown, it worries him to think people might look at the rally and conclude that massive events aren?t concerning after all ? that the risk is worth it.

    That was how he saw it before he got sick. He recalls having a fleeting thought as he guided his motorcycle through the turns of the famed Needles Highway two months ago, taking in the sweeping views and rock formations close enough to touch: ?If I catch the virus and die, I will be a happy man. I have lived.?

    He hadn?t imagined that within a matter of days, he would feel that death was hovering right at his door.
    ?No right decision?

    As the coronavirus scuttled gatherings big and small, from the 2020 Olympics to birthday parties, weddings and funerals, Sturgis officials mulled postponing this year?s rally. The event is synonymous with the 7,000-person city nestled amid state and national park land, where the Harley-Davidson Rally Point Plaza is a defining feature downtown.

    But this year, a survey found that 60 percent of residents wanted the rally postponed. At council meetings, people lined up to argue. A nurse warned there wouldn?t be enough hospital beds if the event went forward, while a business owner said she would lose her building if it didn?t. Calling off this year?s rally, its 80th anniversary, would mean a loss of around $2 million for the city, authorities said. It had only been done during World War II.

    ?There absolutely was no right decision,? said city council member Terry Keszler.

    Officials also knew that canceling would have been an uphill battle: South Dakota Gov. Kristi L. Noem, a Republican, was one of the few state leaders who never restricted mass gatherings, managing the pandemic by emphasizing personal responsibility over government mandates. Because the rally encompasses hundreds of miles beyond city limits, the council?s authority was limited.

    Another concern was that crowds would come regardless of their decision, and, Keszler said, ?we had to prepare for it, or it would have been such a mess it?s not even funny.?

    The council ultimately voted to allow the event with the understanding that ?the covid thing wasn?t going to stop people,? as Keszler put it.

    That supposition was likely correct: There is evidence that those who ventured to Sturgis were engaging in riskier behavior than most Americans in response to the pandemic, by leaving home more often and covering more ground, according to the Center for New Data analysis.

    Using data from X-Mode, a company that collects location information from smartphone users who grant permission to various apps, the Covid Alliance, a project of the Center for New Data, found 11,000 probable Sturgis rallygoers. The researchers analyzed where those individuals came from and their mobility during the pandemic and

    Continued at link
    https://www.washingtonpost.com/healt...-rally-spread/
    Quote Originally Posted by bowieluva View Post
    lol at Nestle being some vicious smiter, she's the nicest person on this site besides probably puzzld. Or at least the last person to resort to smiting.
    Quote Originally Posted by nestlequikie View Post
    Why on earth would I smite you when I can ban you?

  2. #777
    Senior Member curiouscat's Avatar
    Join Date
    Feb 2014
    Posts
    2,522
    Rep Power
    21474849
    Everyone that went to the Sturgis Rally deserve to die.
    Quote Originally Posted by Boston Babe 73 View Post
    I don't have a thousand dollars hanging around to buy a fart in a jar lol.

  3. #778
    Senior Member
    Join Date
    May 2020
    Posts
    4,558
    Rep Power
    0

  4. #779
    Senior Member
    Join Date
    May 2020
    Posts
    4,558
    Rep Power
    0
    https://www.timesheraldonline.com/20...of-fake-names/

    A controversial anti-lockdown declaration and petition whose principal authors and signatories from around the world include four Stanford University doctors has pulled its online signature list following a report that it included dozens of fake names.

    Sky News, a British television and online news outlet, reported “Dr. Johnny Bananas” and “Dr. Person Fakename” were among those listed as supporting the online Great Barrington Declaration open letter calling for opening schools and businesses with “focused protection” of the elderly and ill most at risk of COVID-19.

    The declaration, hatched this month at the American Institute for Economic Research, a free-market think tank in the western Massachusetts town of Great Barrington, now claims some 40,000 medical scientists and practitioners and more than 450,000 concerned citizens have signed on electronically in support.

    But this week, its organizers replaced an online complete list of those who signed on to the declaration with a statement that “we will update this page with a static list of verified and approved signatures as time allows.” The AIER did not respond to questions.

    The declaration calls for allowing “those who are at minimal risk of death to live their lives normally to build up immunity to the virus through natural infection, while better protecting those who are at highest risk.” Its three principal authors are Stanford medical professor Dr. Jay Bhattacharya, Harvard Medical School professor Dr. Martin Kulldorff and Oxford University theoretical epidemiology professor Dr. Sunetra Gupta.

    Among its 35 identified principal co-signers are three from Stanford, making it among the most represented university affiliations: Dr. Rajiv Bhatia, an assistant professor in clinical care and population health, Dr. Laura Lazzeroni, professor of psychiatry, and Dr. Michael Levitt, a structural biology professor.

    Though lockdown criticism isn’t new, the declaration marked the most organized effort to date among health experts around the world who say they are doing more harm than good.

    But the declaration also has drawn blistering criticism from other health experts who argue such an approach will only lead to new surges in infections and deaths from the new coronavirus.

    Among the most vocal are Dr. Gregg Gonsalves, an assistant professor of epidemiology at Yale Universtity, who questioned on Twitter this week “how many are you willing to sacrifice” for herd immunity. In the Bay Area, Santa Clara County Executive Jeff Smith and Dr. George Rutherford at the University of California-San Francisco also have criticized the concept.

  5. #780
    Senior Member
    Join Date
    May 2020
    Posts
    4,558
    Rep Power
    0
    Senior Catholic leaders in the United States and Canada, along with other antiabortion groups, are raising ethical objections to promising COVID-19 vaccine candidates that are manufactured using cells derived from human fetuses electively aborted decades ago. They have not sought to block government funding for the vaccines, which include two candidate vaccines that the Trump administration plans to support with an investment of up to $1.7 billion, as well as a third candidate made by a Chinese company in collaboration with Canada’s National Research Council (NRC). But they are urging funders and policymakers to ensure that companies develop other vaccines that do not rely on such human fetal cell lines and, in the United States, asking the government to “incentivize” firms to only make vaccines that don’t rely on fetal cells.

    “It is critically important that Americans have access to a vaccine that is produced ethically: no American should be forced to choose between being vaccinated against this potentially deadly virus and violating his or her conscience,” members of the U.S. Conference of Catholic Bishops and 20 other religious, medical, and political organizations that oppose abortion wrote to Stephen Hahn, commissioner of the U.S. Food and Drug Administration (FDA), in April. “Thankfully, other [COVID-19] vaccines … utilize cell lines not connected to unethical procedures and methods.”

    “We urge your government to fund the development of vaccines that do not create an ethical dilemma for many Canadians,” wrote Archbishop of Winnipeg Richard Gagnon, president of the Canadian Conference of Catholic Bishops, and 17 other antiabortion religious, medical, and politic groups and individuals in a 21 May letter to Prime Minister Justin Trudeau. “The … manufacture of vaccines using such ethically-tainted human cell lines demonstrates profound disrespect for the dignity of the human person.”

    FDA and senior White House officials did not respond to emails requesting comment on the letter to Hahn. In Canada, the health ministry has promised to respond to the letter to Trudeau, says Moira McQueen, executive director of the Canadian Catholic Bioethics Institute and lead signatory on the letter.

    Cells derived from elective abortions have been used since the 1960s to manufacture vaccines, including current vaccines against rubella, chickenpox, hepatitis A, and shingles. They have also been used to make approved drugs against diseases including hemophilia, rheumatoid arthritis, and cystic fibrosis. Now, research groups around the world are working to develop more than 130 candidate vaccines against COVID-19, according to the World Health Organization; 10 had entered human trials as of 2 June.

    At least five of the candidate COVID-19 vaccines use one of two human fetal cell lines: HEK-293, a kidney cell line widely used in research and industry that comes from a fetus aborted in about 1972; and PER.C6, a proprietary cell line owned by Janssen, a subsidiary of Johnson & Johnson, developed from retinal cells from an 18-week-old fetus aborted in 1985. Both cell lines were developed in the lab of molecular biologist Alex van der Eb at Leiden University. Two of the five vaccines have entered human trials (see table, below). In four of the vaccines, the human fetal cells are used as miniature “factories” to generate vast quantities of adenoviruses, disabled so that they cannot replicate, that are used as vehicles to ferry genes from the novel coronavirus that causes COVID-19. When the adenoviruses are given as a vaccine, recipients’ cells begin to produce proteins from the coronavirus, hopefully triggering a protective immune response.

    The fifth vaccine, which has shown promise in monkeys and is headed for human trials as soon as this summer, is what is known as a protein subunit vaccine. Researchers at the University of Pittsburgh use HEK-293 cells to manufacture the coronavirus’ spike protein—a vital part of its structure—which is used to trigger an immune response. The vaccine is delivered through a skin patch with 400 tiny needles.

    The fetal cell lines are key to producing both types of vaccine. “HEK-293 [cells] are essential for making protein subunit vaccines,” says Andrea Gambotto, a vaccine scientist at the University of Pittsburgh School of Medicine and the vaccine’s lead developer. Their human origin is important, he says: “Cultured [nonhuman] animal cells can produce the same proteins, but they would be decorated with different sugar molecules, which—in the case of vaccines—runs the risk of failing to evoke a robust and specific immune response.” (Among the developers of the five vaccines, only Gambotto responded to a request for comment.)

    David Prentice, vice president and research director at the Charlotte Lozier Institute, which opposes abortion, notes researchers making adenovirus vaccines have modified HEK-293 cells to be adept at packaging new genes—such as those that direct cells to assemble the coronavirus spike protein—into adenoviruses. But he adds that other technologies are available, including using cells captured from amniocentesis that are engineered to make replication-deficient adenoviruses.

    “The use of cells from electively aborted fetuses for vaccine production makes these five COVID-19 vaccine programs unethical, because they exploit the innocent human beings who were aborted,” Prentice and a co-author—molecular biologist James Sherley, a Lozier Institute associate scholar and director of the adult stem cell company Asymmetrex—wrote in a position paper published last month.

    But Arthur Caplan, a bioethicist at the New York University School of Medicine, counters: “There are better ways to win the abortion wars than telling people not to use a vaccine. These are long-over abortions. These cells are decades old, and even major religious leaders like the pope have acknowledged that for the greater good it’s not worth the symbolism to put the community at risk.”

    The Vatican’s Pontifical Academy for Life declared in 2005 and reaffirmed in 2017 that in the absence of alternatives, Catholics could, in good conscience, receive vaccines made using historical human fetal cell lines.

    A vaccine made by the Chinese company CanSino Biologics was the first COVID-19 vaccine to enter phase II human trials. It was developed using adapted HEK-293 cells that the company licensed from Canada’s NRC, where the cells were developed. (NRC-developed HEK-293 cells have already been used to develop an approved Ebola vaccine.) Last month, NRC announced a collaboration with CanSino Biologics under which it is preparing to run late-stage clinical trials of the vaccine in Canada, and scale up facilities to produce the vaccine in quantity.

    The two U.S.-backed vaccines that have drawn criticism from antiabortion groups are on a short list of candidates targeted to get financial and logistical support from the U.S. government under the White House’s Operation Warp Speed, which aims to accelerate the development and approval of at least one COVID-19 vaccine by January 2021, according to a 3 June report in The New York Times.

    One of the Warp Speed candidates, made by Janssen Research & Development, uses PER.C6 cells. The second, from University of Oxford researchers and AstraZeneca, uses HEK-293 cells. Both have received U.S. government commitments of, respectively, $456 million and $1.2 billion, if they meet milestones, through the Biomedical Advanced Research Development Authority (BARDA).

    Another vaccine that relies on HEK-293, being developed by two companies owned by the billionaire scientist and businessman Patrick Soon-Shiong, made an earlier, Warp Speed long list of 14 promising candidates, according to a press release from one of companies, NantKwest.

    Prentice says: “As they are choosing—BARDA and the Warp Speed people— what vaccines to move ahead, they should at least recognize that there is some portion of the population who would like an alternative vaccine they can take in good conscience.”

    Caplan disagrees. “If you are going to say the government shouldn’t fund things that a minority of people object to, you will have a very long list of things that won’t get funded by the government, from research on weapons of war to contraceptive research.”

    The Trump administration has restricted the use of human fetal tissue from elective abortions in biomedical research. One year ago, it adopted a policy that forbids researchers at the National Institutes of Health (NIH) from using fetal tissue from elective abortions in their studies. And it imposed an extra layer of review on non-NIH scientists seeking agency funding to do research using such tissue. But the policy did not stop either group from using decades-old fetal cell lines like HEK-293 and PER.C6.

    *Clarification, 8 June, 12:10 p.m.: This story has been updated to clarify that the Vatican approves of Catholics receiving vaccines manufactured using human fetal cells only in the absence of alternatives.
    https://www.sciencemag.org/news/2020...se-fetal-cells

  6. #781
    Senior Member
    Join Date
    May 2020
    Posts
    4,558
    Rep Power
    0
    https://www.hawaiinewsnow.com/2020/0...olation-kauai/

    HONOLULU, Hawaii (HawaiiNewsNow) - One of the most iconic music producers of the last 35 years was cited on Kauai this earlier this week for violating the island’s emergency quarantine restrictions, according to a Kauai Police Department spokesperson.

    Rick Rubin, 57, won the Grammy Award for ’Best Album’ in 2007 for his work on The Dixie Chick’s Taking the Long Way and again in 2012 for Adele’s 21 ― the best-selling album of the 21st century, according to Billboard.

    He’s also helped produce albums for artists like The Beastie Boys, Metallica, Jay-Z and Johnny Cash over the course of his career.

    Kauai police officials say Rubin arrived on Kauai by plane on Monday and was cited at around 6 a.m. Tuesday morning for walking on an empty area of Anini Beach near the property where he was staying.

    Hawaii currently has strict 14-day quarantine orders in place for anyone arriving in Hawaii from outside the state.

    Plans to allow residents and visitors to avoid quarantine by providing documentation that showed a negative COVID-19 test within 72 hours of flying have been repeatedly delayed by Gov. Ige as cases across the state surged.

    Rubin was issued a court date of December 9 on Kauai.

  7. #782
    Senior Member
    Join Date
    May 2020
    Posts
    4,558
    Rep Power
    0

  8. #783
    Senior Member
    Join Date
    May 2020
    Posts
    4,558
    Rep Power
    0
    https://www.kansascity.com/news/coro...246473655.html

    Dozens of employees at a hospital in western Kansas have tested positive for the coronavirus as its COVID-19 rooms fill up.

    More than 50 employees at the Gove County Medical Center have been infected with the virus, the hospital said in a statement Tuesday. At least 25 staff members have recovered and two are hospitalized.

    That absence of employees, the medical center said, has “been felt facility-wide.”

    Gove County, with a population of 2,600, is one of many rural Kansas counties being stressed by the pandemic and its late arrival.

    Those infected in the county, which is more than 300 miles west of Kansas City, include its sheriff, its emergency management director and the hospital’s CEO, The Associated Press reported.

    The county’s 22-bed medical center only has a handful of beds dedicated to COVID-19 patients and not enough staff to monitor the most serious cases around the clock.

    The facility said “many of the regional hospitals” in western Kansas are also experiencing capacity occupancy.

    Infections in Gove County doubled during the two weeks ending Wednesday, from 37 to 75, and that spike was proportionally among the largest in Kansas, according to the state Department of Health and Environment. But locally, doctors say the number is actually far higher — 140, with 88 in the past two weeks and almost all of them since Sept. 1.

    Within a recent 10 days, seven county residents died — including six in the medical center’s long-term care.

    “As a healthcare facility, we laugh, and we love with those that we care for, and mourn when they leave us,” the facility wrote on Facebook. “We offer our condolences to the families along with prayers for those affected by these deaths.”

    The county’s 22-bed medical center only has a handful of beds dedicated to COVID-19 patients and not enough staff to monitor the most serious cases around the clock.

    The facility said “many of the regional hospitals” in western Kansas are also experiencing capacity occupancy.

    Infections in Gove County doubled during the two weeks ending Wednesday, from 37 to 75, and that spike was proportionally among the largest in Kansas, according to the state Department of Health and Environment. But locally, doctors say the number is actually far higher — 140, with 88 in the past two weeks and almost all of them since Sept. 1.

    Within a recent 10 days, seven county residents died — including six in the medical center’s long-term care.

    “As a healthcare facility, we laugh, and we love with those that we care for, and mourn when they leave us,” the facility wrote on Facebook. “We offer our condolences to the families along with prayers for those affected by these deaths.”

  9. #784
    Senior Member
    Join Date
    May 2020
    Posts
    4,558
    Rep Power
    0

  10. #785
    Moderator
    Join Date
    Jan 2013
    Posts
    11,768
    Rep Power
    21474859
    Another friend of mine has COVID. He woke up and realized he had lost his sense of smell and taste. He said other than that he has had no symptoms besides a moderate cough. He's in his mid/late 60's, so I am hoping that he continues with no other symptoms.

  11. #786
    Senior Member
    Join Date
    May 2020
    Posts
    4,558
    Rep Power
    0
    https://www.fiercebiotech.com/biotec...ay-hold-report

    Here is a Roundup of COVID-19 Trials as of today

    It’s been a minute, but AstraZeneca has gotten the FDA’s all-clear to restart the U.S. study of its COVID-19 vaccine.

    Although the agency couldn’t rule out a link between AstraZeneca’s vaccine and side effects observed in one patient, it did not find the vaccine was responsible for them, a person familiar with the matter told the The Wall Street Journal.

    The British pharma slammed the brakes on the program in early September, when a patient in the U.K. developed an inflammatory side effect. The pause came just one week after the 30,000-patient U.S. trial had kicked off.

    U.K. regulators OK’d the resumption of the study a week later, with their counterparts in Brazil, India and South Africa doing the same in the following weeks. However, the FDA kept the U.S. trial on hold as it reviewed data around that side effect—transverse myelitis, or inflammation of the spinal cord that can be triggered by infections.

    Now, the FDA has finished that review and told AstraZeneca it can restart the U.S. trial, the pharma giant confirmed on Friday.

    The news comes days after reports emerged that the trial could restart as soon as this week, with Reuters reporting on Wednesday that the FDA “has come to the same conclusion as the other drug regulators." On Wednesday, Brazil’s health authority, Anvisa, announced that a patient participating in the study had died, but that the trial would carry on.
    Since AstraZeneca's U.S. trial was put on hold, Johnson & Johnson has suspended a 60,000-patient study of its own COVID-19 vaccine because of an “unexplained illness in a study participant.” Unlike AstraZeneca’s hold, though, J&J’s pause was voluntary. The company did not immediately know if the patient who fell ill received the vaccine or placebo, and it is waiting on an independent monitoring board to analyze the data.

    https://www.fiercebiotech.com/biotec...9-trial-report

    A patient has died in the global study of AstraZeneca and the University of Oxford’s COVID-19 vaccine, Brazil’s health authority, Anvisa announced on Wednesday. But despite the death, the study will carry on as normal, Reuters reports.

    The person who died was Brazilian, said the Federal University of Sao Paulo, which is helping coordinate the trial in Brazil, the news service said. It's not yet clear whether the death was related to the vaccine candidate.

    "We cannot comment on individual cases in an ongoing trial of the Oxford vaccine as we adhere strictly to medical confidentiality and clinical trial regulations, but we can confirm that all required review processes have been followed,” an AstraZeneca spokesperson said in an email.

    “All significant medical events are carefully assessed by trial investigators, an independent safety monitoring committee and the regulatory authorities," the spokesperson added. "These assessments have not led to any concerns about continuation of the ongoing study."


    The news comes a month after AstraZeneca, along with partner Oxford University, paused the study because a patient developed transverse myelitis, or inflammation of the spinal cord that can be triggered by infections. The duo has since restarted the trial in certain countries, including Brazil, but the U.S. phase 3 study remains on hold—though that may be changing soon, Reuters reported on Tuesday.

    U.K. regulators supported the resumption of the trial a week after the pause, with their counterparts in Brazil, India and South Africa following suit soon after. However, the FDA has taken longer to review the situation, forcing AstraZeneca to wait to resume a U.S. phase 3 trial that only began shortly before the safety concern emerged.

    The U.S. trial could be back on track as soon as this week, Reuters reported, citing comments from four unnamed sources and a draft letter to U.K. trial participants dated Oct. 14. The FDA “has come to the same conclusion as the other drug regulators," and the U.S. study would resume shortly, the letter said.

    AstraZeneca isn't the only COVID-19 vaccine maker that's hit a roadblock. Just last week, Johnson & Johnson suspended its own study because a patient developed an "unexplained illness." Like AstraZeneca, J&J did not immediately know if the patient had received the vaccine candidate or placebo.

  12. #787
    Senior Member
    Join Date
    May 2020
    Posts
    4,558
    Rep Power
    0
    https://www.fiercebiotech.com/biotec...id-19-patients

    Here are more in the roundups

    A randomized phase 2 clinical trial has found convalescent plasma has no effect on progression to severe disease or all-cause mortality in COVID-19 patients. The data raise significant doubts about the efficacy of an intervention that has been given to more than 100,000 people in the U.S.

    Plasma taken from patients who survived COVID-19 was an obvious early therapeutic response to the coronavirus outbreak. There is a long history of using convalescent plasma to treat infectious diseases, and, with many thousands of patients surviving infection with SARS-CoV-2, a large pool of potential donors was available. In the absence of other treatment options, 100,000 U.S. patients received plasma between April and August under the FDA’s expanded access protocol (EAP).

    Now, a team from the Indian Council of Medical Research has shed light on whether the therapy is effective in a paper published in The BMJ. The researchers enrolled 464 adults hospitalized with moderate COVID-19. Half received convalescent plasma on top of standard of care. The other half just received standard of care.

    In the convalescent plasma arm, 19% of patients progressed to severe disease or died in the 28 days after enrollment, compared to 18% of people in the control cohort. The lack of difference between the two arms caused the trial to miss its primary endpoint. Limiting the analysis to patients who got plasma with detectable antibody titers had no effect on the outcome.

    Secondary endpoints linked convalescent plasma to small improvements in the resolution of fatigue and shortness of breath. However, as Beth Pathak of the Women’s Institute for Independent Social Enquiry said in an accompanying editorial, the unblinded design of the trial means “knowledge of treatment status could have influenced the reporting of subjective symptoms.” Plasma was no better than control against objective measures such as days on respiratory support and in hospital.

    Yet the trial generated some more robust evidence that convalescent plasma acts on SARS-CoV-2. Notably, 68% of patients in the plasma arm tested negative for SARS-CoV-2 RNA on Day 7, versus 55% in the control group. The difference, while slight, suggests the neutralizing antibodies found in convalescent plasma may help patients eliminate the virus.

    The failure of the apparent effect of plasma on viral clearance to translate into reductions in disease progression and death raises questions. Pathak’s analysis of those questions covers the thrombotic aspects of COVID-19 and the fact that therapeutic plasma has prothrombotic properties, at least when given to patients with acute bleeding and complex coagulopathies.

    “It is notable that progression to severe disease or death occurred in 20% (13/64) of patients who received convalescent plasma with no detected neutralizing antibodies compared with 18% (41/229) of controls,” Pathak wrote.

    Pathak called for further investigation of the prothrombotic risks of convalescent plasma. The Indian trial did not include thrombotic events as a pre-specified outcome, and analyses of the U.S. EAP data excluded most cardiac and thrombotic events from the reported adverse rates on the grounds they were deemed unrelated to plasma.

    It is also possible that plasma would perform better in a different population of COVID-19 patients. The Indian trial enrolled hospitalized patients. Based on the typical progression of COVID-19, the subjects were likely infected days before entering the trial. Treating patients sooner could achieve better results, although early intervention may only be justified in high-risk individuals.

  13. #788
    Senior Member
    Join Date
    May 2020
    Posts
    4,558
    Rep Power
    0
    https://www.fiercebiotech.com/biotec...d-19-antiviral


    Roche is paying Atea Pharmaceuticals $350 million upfront for the ex-U.S. rights to COVID-19 antiviral AT-527. The oral direct-acting antiviral is set to enter a phase 3 trial in non-hospitalized patients early next year, giving Roche and Atea a shot at establishing it as the go-to early treatment for COVID-19.

    Atea put its COVID-19 program on the map in May when it raised $215 million in a round led by Bain Capital Life Sciences. Up to that point, Atea was perhaps best known for being set up by Jean-Pierre Sommadossi, co-founder of Sovaldi developer Pharmasset.

    Reflecting Sommadossi’s background, Atea initially studied its oral purine nucleotide prodrug AT-527 in hepatitis C, before the pandemic and in vitro evidence of efficacy in coronaviruses persuaded it to target SARS-CoV-2. A phase 2 trial of 190 hospitalized patients with moderate COVID-19 got started in May and is due to wrap up around the end of the year, according to ClinicalTrials.go

    “AT-527 is expected to be ideally suited to combat COVID-19 as it inhibits viral replication by interfering with viral RNA polymerase, a key component in the replication machinery of RNA viruses,” Sommadossi said in a statement.

    The phase 2 results will provide a clearer picture of whether AT-527 is efficacious in COVID-19, but Roche has already seen enough to bet $350 million and commit to milestones and royalties. The outlay secures Roche ex-U.S. rights to AT-527. Atea will retain responsibility for distributing the drug in the U.S., although it has an option to ask for the support of Roche’s Genentech.

    While AT-527 is currently in development in hospitalized patients, Roche centered its discussion of the value of the drug on its potential role in non-hospitalized patients. As an oral small molecule, AT-527 has several potential advantages over anti-SARS-CoV-2 antibodies outside of hospital settings. AT-527 stands to be cheaper, easier to administer and manufactured at larger quantities.

    Atea and Roche plan to start a phase 3 trial in non-hospitalized patients in the first quarter of 2021. By then, the U.S. and other countries may have begun vaccinating their populations against the novel coronavirus, thereby beginning the process of bringing the pandemic under control. However, with the rollout of immunization programs taking time and vaccines likely to only offer partial protection, Atea and Roche are betting there will remain a need for treatments for some time.

    Roche foresees AT-527 being used to treat patients early, perhaps even in post-exposure prophylactic settings. Widespread access to an effective early treatment could stop some cases from progressing to severe COVID-19, thereby improving patient outcomes and reducing the burden on healthcare systems.

    The deal opens up another front in Roche’s response to the pandemic. In August, Roche secured the ex-U.S. rights to Regeneron’s REGN-COV2, securing itself a leading spot in the race to bring COVID-19 antibody therapies to market. The deals position Roche to apply its development and manufacturing muscle to drugs with the potential to defang SARS-CoV-2.
    https://www.biospace.com/article/fda...d-19-vaccines/

    Typically, the U.S. Food and Drug Administration (FDA)’s advisory committees meet ahead of a decision on whether to approve a drug or therapy to provide expert recommendations. Yesterday’s advisory committee meeting held by the Vaccines and Related Biological Products Advisory Committee was a little bit different, as the group held a nine-hour virtual meeting to discuss the COVID-19 vaccine development programs and where to go next.

    There is, as of yet, no vaccine that has been submitted to the agency for approval, although there are high hopes for several: Pfizer and BioNTech’s, which may be submitted for emergency use authorization (EUA) by Thanksgiving; Moderna, which is predicting submission sometime in December; and AstraZeneca and the University of Oxford, possibly by the end of the year, with the U.S. arm of their Phase III trial restarting after being placed on a clinical hold when a UK patient reported a serious side effect.

    In the meeting, both the FDA and the U.S. Centers for Disease Control and Prevention (CDC) presented details about COVID-19 and the requirements for a vaccine. Although there was a definite emphasis on effectiveness and safety, Marion Gruber, director of CDC’s office of Vaccine Research & Review, pointed out that about 700 Americans die from COVID-19 every day, so there is pressure to come up with a vaccine.

    Paul Offit, one of the committee members, who is director of the Vaccine Education Center and an attending physician at Children’s Hospital of Philadelphia, has been a noted critic of the efforts so far, particularly the Trump administration’s optimistic timelines. However, he did say, after the meeting, “I’m reassured.” The EUA process the FDA described was “much much closer” to the full licensing process than he had thought earlier.

    “I think we have a language problem,” he added. “This is much, much, much closer to what is typically a BLA, licensure process, than to how at least the public or frankly I perceive an EUA process, so I think we have to make that clear, not just to the general public but to the medical public.”

    One of the bigger areas of discussion and concern was the FDA’s requirement for sponsor companies to submit a median of two months of safety data.

    “Isn’t two months a little short?” asked Sheldon Toubman, the committee’s consumer advocate, a staff attorney of the New Haven Legal Assistance Association.

    Another committee member, Stanley Perlman, professor of microbiology and immunology, professor of pediatrics and the Mark Stinski Chair in Virology at the University of Iowa Health Care, suggested the two-month requirement should be extended, because data from other coronaviruses indicate immunity can diminish around that point.

    Doran Fink, clinical deputy director of the FDA’s Center for Biologics Evaluation and Research (CBER)’s Division of Vaccines and Related Products Applications, answered that the agency was “really trying to strike a balance” between required safety data while not delaying the vaccine to save lives.

    There were also discussions about the diversity in the clinical trials as well as the public’s concerns over the safety of the vaccine. Another topic was how politics has undermined the public’s trust in the regulatory agencies involved in the pandemic response.

    There was nothing for the committee to vote on—typically for a drug an adcom votes on whether to recommend a drug or vaccine for approval. Even if the adcom votes against approval, the FDA is not required to follow their recommendation, although they usually do.

    The committee was made up of 15 people, all distinguished physicians, scientists and other experts in the field. This particular meeting provided the experts an opportunity to give the FDA feedback in the middle of the process, as well, some think, to evaluate how their messaging is being handled by the media and received by the public.

    “Note how FDA mentioned several times that an EUA vaccine could reach millions—FDA wants to be real sure it does due diligence,” said John Grabenstein, general manager of Vaccine Dynamics and editor for the Immunization Action Coalition.

    One of the speakers during the session was from the Reagan-Udal Foundation for the FDA, a Congressional-established non-profit that is working on a public relations campaign to counteract public concerns about the safety of COVID-19 vaccines.

    Claire Hannan, executive director of the Association of Immunization Managers, testified during a public comment period, saying, “Holding open online meetings allows the public to see for themselves how the process works is key.”

  14. #789
    Senior Member
    Join Date
    May 2020
    Posts
    4,558
    Rep Power
    0

  15. #790
    Senior Member
    Join Date
    May 2020
    Posts
    4,558
    Rep Power
    0
    https://fox40.com/news/national-and-...rough-sept-26/

    MEXICO CITY (AP) — Mexican health authorities acknowledge the country’s true death toll from the coronavirus pandemic is far higher than previously thought, saying there were 193,170 “excess” deaths in the year up to Sept. 26.

    Of those, 139,153 are now judged to be attributable to COVID-19. Mexico’s official, test-confirmed death toll is only about 89,000, but officials previously acknowledged many people didn’t get tested or their tests were mishandled.

    Authorities had previously presented an estimated death toll of 103,882, after taking into account mishandled tests. But the Health Department said Sunday they had analyzed databases to come up with the latest figure.

    The analysis picked up symptoms related to COVID-19 mentioned on death certificates even if they weren’t listed as the cause of death.

  16. #791
    Senior Member
    Join Date
    May 2020
    Posts
    4,558
    Rep Power
    0
    https://www.timesheraldonline.com/20...ource=Connatix

    Even as COVID-19 transmission appears to be increasing across California, it is being outpaced by most other states and, according to the New York Times, is no longer the national leader in overall cases.

    The state’s daily average of new cases remained elevated from where it had been for about a month after counties around the state reported another 4,959 cases of the virus Monday, according to data compiled by this news organization. At about 4,420 per day, California is averaging about 43% more cases now than it was two weeks ago, with new spikes in nearly every population center of the state.

    Over the weekend, California crossed the 900,000-case milestone. But by the time it reached 910,000 cases, as it did Monday, Texas had overtaken it in total cases, with more than 916,000, according to the data collected by New York Times. Like this news organization, the Times collects data from local health departments, which report new cases before they are reflected in the official state tally.

    Data from the Texas Department of Health and Human Services show 867,075 confirmed cases, while data from the California Department of Public Health show 901,010 confirmed cases as of Monday.

    California, home to some 39.5 million people, became the national leader in cumulative cases in the third week of July — in retrospect, at the height of this summer’s second wave — when it passed New York, with just short of 420,000 cases at the time. In the three months since, the virus waned but has now come roaring back with signs of rising transmission in nearly all 50 states.

    Texas, with about 10 million fewer residents, experienced a similar summer surge to California’s — only with more cases, hospitalizations and deaths per-capita. Each state corralled that outbreak and plateaued through the early fall, but in California, that was at one of the lowest infection rates in the nation — between 7.5 and 9 cases per 100,000 per day. In Texas, the per-capita rate has not fallen below 12 cases per 100,000 per day.

    Now, Texas is reporting about 40% more new cases per day than California, despite a population about three-fourths the size. Like nearly everywhere else in the country, cases are on the rise in both states; each has reported nearly identical 43% increases in the past two weeks.

    However, even with the recent increases, California reported fewer cases per-capita in the past week than all but eight other states and Washington, D.C, according to the Times’ data.

    The Lone Star State had already surpassed California’s death toll, though both trail New York by a wide margin. On Monday, California reported an additional 40 fatalities, according to data compiled by this news organization, which increased its total to 17,400, or about a thousand shy of the total in Texas. On a per-capita basis, California’s overall death toll ranks 23rd among all states — about four times lower than the highest rate in New Jersey and one-third lower than the national average.

    Unlike this summer, neither Sunbelt State is at the heart of the third wave sweeping across the country. Nine of the 10 highest infection rates, per-capita, in the past week are in Midwestern or Mountain West states, according to the Times’ data, and those at the top — North and South Dakota, Wisconsin, Montana — have rates eclipsing the highest seen at previous peaks.

    In Idaho, which has the sixth-highest per-capita infection rate, hospitals will reportedly soon begin triaging patients to facilities in Seattle and Portland. In Utah, where the per-capita rate is seventh-highest, hospitals have warned they will soon have to ration care for patients.

    Nationwide, hospitalizations have soared by 45% in the past month, according to the COVID Tracking Project. In California, there were still about 4% fewer patients currently hospitalized than there were a month ago, according to the latest data from CDPH. However, health experts have said hospitalizations are a lagging indicator and can trail cases by two to three weeks; California’s recent increase has only occurred in the past week.
    There is another metric that indicates California’s increase in cases reflects a real rise in transmission: the statewide positivity rate, which had fallen to an all-time low of 2.4% last Monday, increased by a full point in less than a week to 3.4% as of Sunday. On Monday, it fell back to 3.2% for a net increase of four-fifths of a point in the span of a week — its most rapid rise since early August.

    The positivity rate has increased similarly nationwide — up a full point in the past week — but is still nearly double that of California’s, where the 3.2% rate is still lower than all but nine states and Washington, D.C. Nationally, 6.3% of tests came back positive in the past week — the highest rate of positive tests since early August, or the tail end of this summer’s second wave.

  17. #792
    Senior Member
    Join Date
    May 2020
    Posts
    4,558
    Rep Power
    0

  18. #793
    Senior Member
    Join Date
    May 2020
    Posts
    4,558
    Rep Power
    0
    https://www.kron4.com/health/coronav...ve-covid-tier/

    BENICIA, Calif. (KRON) ? As other county?s move ahead to less restrictive reopening tiers, Solano County could move backward next week.

    After seeing a spike in cases, Solano County?s health officer warned that the county?s on track to move to the state?s most restrictive purple tier.

    Over the last two weeks, Solano County saw a spike in cases averaging about 40 cases per day right now.

    For them to stay in the red tier which is where they are now, the county will have to get that number down to under 31 cases per day, which is something that businesses here in Benicia say is crucial for their survival.

    After seeing a rise in coronavirus cases, Solano County is moving in the wrong direction, heading backwards from the state?s red tier to its most restrictive purple tier.

    ?Definitely disappointing because I love working and getting to see people,? an employee said.

    Businesses in Benicia say the jump in cases is disheartening, not only for the community but also for the lifeblood of their local economy.

    The purple prohibits most non-essential indoor business operations and would cause some businesses to close or change their current plans.

    Everybody does need to do their part and be diligent, especially right now. We are in normal flu season so taking extra precautions is going to help our little businesses in town stay in businesses,? owner of Daughter of Luna, Michelle Young said.

    Solano County Health Officer Dr. Bela Matyas warns that the county has to get its act together.

    ?Unfortunate reality is that we are seeing case numbers that are higher than they should be for us to remain in red and unfortunately that puts us at risk of going back to purple. The cause of it is people getting together with family and friends and letting their guard down so the disease spreads and we had several weeks ago several events that we believe accounted for that spike,? Dr. Matyas said.

    Dr. Matyas says the spike could be temporary, at least he?s hoping that?s the case.

    He points to several recent events as examples of behavior that is detrimental to the county?s progression in re-opening.

    ?Funeral involving 300 people with no social distancing. We had a wedding in a home with 40 people, no social distancing, no masks and there was some type of event, an invitation only event with a large number of people. Again, no social distancing. And we had dozens of cases from these events and that?s a lot of cases for a county our size,? Dr. Matyas said.

    Dr. Matyas says the county was averaging 27 positive coronavirus cases per day about a month ago but in the last two weeks, that number jumped to 41 positive cases per day ? A number that would put the county back on the state?s purple tier list if they get the same results next week.

    Hopefully, Solano County can get its average case numbers under 31 by next week to remain in the red tier.

    It?s another important reminder ahead of Halloween and the holidays to keep your guard up and continue to practice social distancing, while also wearing a mask.

  19. #794
    Senior Member
    Join Date
    May 2020
    Posts
    4,558
    Rep Power
    0
    https://www.nbcnews.com/politics/pol...g-day-n1245449

    WASHINGTON — Donald Trump Jr. falsely claimed Thursday that Covid-19 deaths have dwindled to "almost nothing," despite there being around 1,000 reported in the United States the same day.

    In an interview on Fox News' “The Ingraham Angle," the president's son said that medical experts who have been talking about a surge in cases are "truly morons."

    “I went through the CDC data because I kept hearing about new infections, but I was like, 'Well, why aren't they talking about deaths?'" Trump Jr. said, referring to the Centers for Disease Control and Prevention. "Oh, oh, because the number is almost nothing. Because we've gotten control of this thing, we understand how it works. They have the therapeutics to be able to deal with this."

    "It's gone to almost nothing," he repeated, adding that the U.S. is "outperforming Europe in a positive way."

    He mocked Democrats who have advocated in favor of certain restrictions. "Why don't we shut down for 10 or 15 years?" said Trump Jr., who said that children can learn on their iPhones.

    His comments came on the same day that the U.S. reported record-breaking new Covid-19 infections, with nearly 90,000 positive cases, according to the Johns Hopkins’ Coronavirus Resource Center. Nearly 1,000 people in the U.S. also died of the virus Thursday.

    CORRECTION: (Oct. 30, 2020, 9:01 a.m. ET): A previous version of this article misstated what Donald Trump Jr. was referring to in a quote. He said the number of Covid-19 deaths was “almost nothing,” not the number of Covid-19 infections.

  20. #795
    Senior Member
    Join Date
    May 2020
    Posts
    4,558
    Rep Power
    0




    Here are the latest COVID-19 news.

  21. #796
    Senior Member
    Join Date
    May 2020
    Posts
    4,558
    Rep Power
    0
    https://www.fiercebiotech.com/medtec...s-smartwatches

    By casting a broad, digital net to pick up the signs of coronavirus outbreaks, researchers hope to build an early warning system that uses data from people’s wearable activity trackers.

    Now, initial data from a study by the Scripps Research Translational Institute showed that devices such as smartwatches and Fitbits may be capable of spotting COVID-19 cases, and could aid in public health efforts to slow the spread of the disease.

    Launched in March, the DETECT study and its smartphone app collects daily activity data from participants and matches it with their self-reported symptoms, as well as any diagnostic tests they may take.

    Results from the study’s first six weeks, spanning over 30,000 participants, showed that significant changes in a person’s normal heart rate, sleep quality and daily movement could help pinpoint new infections.

    "One of the greatest challenges in stopping COVID-19 from spreading is the ability to quickly identify, trace and isolate infected individuals," said the study’s first author, Giorgio Quer, director of artificial intelligence at Scripps.

    "Early identification of those who are pre-symptomatic or even asymptomatic would be especially valuable, as people may potentially be even more infectious during this period. That's the ultimate goal," Quer said. The study’s results were published in Nature Medicine.

    RELATED: Fitbit posts early findings showing its trackers can identify cases of COVID-19 before symptoms take hold

    These methods could be combined with more common, but less effective, ways of screening for COVID-19, such as temperature readings and asking about a person’s travel history—approaches that are likely to miss asymptomatic cases. In addition, fevers alone were recorded in less than a third of COVID-19 patients during their admission to a hospital, the researchers said.

    In addition, “infrequent viral tests, with often-delayed results, don't offer the real-time insights we need to control the spread of the virus," said Scripps epidemiologist Jennifer Radin.

    In the study, the data model was able to predict which people were positive for COVID-19 with about 80% accuracy—typically as they began to sleep more, and move less. But this also included specific deviations from daily patterns that pointed more toward a coronavirus infection than other illnesses, they said.

    "What's exciting here is that we now have a validated digital signal for COVID-19. The next step is to use this to prevent emerging outbreaks from spreading," said Eric Topol, Scripps’ director and founder. "Roughly 100 million Americans already have a wearable tracker or smartwatch and can help us; all we need is a tiny fraction of them—just 1% or 2%—to use the app."

    RELATED: NIH to fund 7 digital health projects aimed at COVID-19

    Earlier this year, Fitbit—which collaborates with Scripps’ DETECT study—delivered preliminary results from a similar study of its own algorithms, which has enrolled more than 100,000 participants.

    At the time, the system provided 70% specificity, or a 30% rate of false positives, but it could prove valuable in prompting people to seek testing earlier and to isolate themselves sooner to avoid transmitting the virus.

    The company also showed that its devices could detect nearly half of COVID-19 cases at least one day before the participant reported any symptoms, such as fever, cough or muscle aches.

    And this week, Fitbit received an award of nearly $2.5 million from the U.S. Army’s medical research division, to move forward with the algorithm’s development and potentially use it to screen military personnel for the disease.

    “Our research shows that our bodies start to fight the disease before more visible symptoms appear and we believe Fitbit can reliably detect these signals, giving us an incredible opportunity to get ahead of this virus and help alert people that they could be sick before they unknowingly spread it to others,” said Amy McDonough, general manager of Fitbit Health Solutions.

    The award will help launch a prospective study with Northwell Health’s Feinstein Institutes for Medical Research to help validate the early detection program. Fitbit also said it will work with the FDA and other regulators to determine the best path for bringing these features to the general public.

    https://www.fiercebiotech.com/biotec...o-end-november

    Novavax delayed the start of a large phase 3 trial for its COVID-19 vaccine in the U.S. and Mexico, thanks to delays in scaling up vaccine manufacturing. It aims to kick off the study at the end of November.

    The news comes as the company ramps up a separate phase 3 study for the vaccine in the U.K., which has expanded to 15,000 patients from its original goal of 10,000, Novavax said in a statement Tuesday. More than 5,500 have enrolled so far, and Novavax expects to report data from the U.K. trial as soon as the first quarter of 2021.

    RELATED: Novavax kick-starts phase 3 of COVID-19 vaccine in U.K. as cases surge across the country

    The company will also present data from the phase 1/2 study of the candidate, NVX-CoV2373, on Friday at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

    The phase 1/2 trial tested four dose regimens of the vaccine, adjuvanted and unadjuvanted, in healthy adults up to 59 years old. Early results reported in August showed that two dose levels of the vaccine triggered an immune response similar to those seen in patients who had recovered from the disease. At the time, the data had not yet been peer reviewed.

    Novavax’s candidate uses nanoparticle technology to create an antigen from the coronavirus spike protein, along with the company’s Matrix-M adjuvant to boost patients’ immune response. Although the Maryland-based biotech was initially left off the list of U.S. governments finalists for Operation Warp Speed, it later scored a $1.6 billion deal with the initiative—the project’s largest funding commitment at the time.

    Novavax has never brought a product to market, but it’s also developing a flu vaccine candidate that is nearing an FDA submission. It’s using the Operation Warp Speed funding to push its COVID-19 vaccine through late-stage development. It hopes to enroll 30,000 patients in the U.S. phase 3 program.

    RELATED: Novavax inks $1.6B Warp Speed deal to fund COVID vaccine's phase 3 testing, manufacturing

    With drug and vaccine makers working at breakneck speeds, Novavax isn’t the only company facing delays. Moderna delayed the phase 3 study of its mRNA vaccine this summer, while Johnson & Johnson and AstraZeneca both put their vaccine trials on hold in the following months. Both J&J and AstraZeneca’s studies are back on track.

  22. #797
    Senior Member
    Join Date
    May 2020
    Posts
    4,558
    Rep Power
    0
    https://www.fiercebiotech.com/biotec...efeating-covid

    Novartis is spending $69 million upfront on a pair of experimental drugs from Fierce 15 winner Molecular Partners.

    The deal is for MP0420 and MP0423, two antivirals out of the biotech’s so-called DARPin tech, which Molecular Partners says has “multi-specific target binding with the potential to prevent viral escape via mutations, the possibility for subcutaneous administration, long half-life for sustained activity, the potential to bypass cold storage and typically high-yield, highly scalable production in bacterial fermenters.”

    This would be a novel way of trying to stop the virus, although both meds are still very early-stage with much to prove. It’s also the first real major step and collab for Novartis amid the pandemic.

    MP0420 is the furthest along, with a phase 1 slated for next month to be undertaken by Molecular Partners. It will also work on the remaining preclinical stage for MP0423. If all goes well, Novartis will then step in and conduct phase 2 and phase 3, with Molecular Partners as sponsor of these tests.

    Should Novartis hit up its option to fully license these meds, it would then be responsible for all further development and sales.

    The pair will also work together to scale up manufacturing capacity in collaboration with Novartis’ generics and biosimilar biz Sandoz.

    The pact could have an extra $165 million thrown in if Novartis takes up the option on both drugs, though Molecular Partners will forgo royalties in lower-income countries, should they gain approval, to help lower costs.

    RELATED: AbbVie's Allergan, Molecular Partners hit by FDA eye drug rejection

    “Our team rapidly mobilized to deliver a unique DARPin-based approach to address the overwhelming need for effective therapeutics against COVID-19,” said Patrick Amstutz, Ph.D., CEO of Molecular Partners.

    “As a class, DARPins have demonstrated over years of clinical research a number of characteristics that enhance their profile as antiviral therapeutics for a global pandemic. We have built on this long-term research with these two candidates, which have demonstrated extremely potent neutralization of the virus through inhibiting multiple viral mechanisms.”

    Molecular Partners already has several Big Pharma pacts, including with Amgen and AbbVie/Allergan, though the latter hit a block this year when its partnered eye drug Abicipar pegol was hit with a complete response letter over safety issues. This also uses its DARPin tech.

    It did have a major $1 billion cancer deal with fellow Swiss major Roche, but the Big Pharma backed out of the deal in 2015.

    Read More On

  23. #798
    Senior Member
    Join Date
    May 2020
    Posts
    4,558
    Rep Power
    0
    https://www.fiercebiotech.com/medtec...co-and-oakland

    OAKLAND, CALIFORNIA—Amid fanfare in March, California officials celebrated the launch of a multimillion-dollar contract with Verily—Google’s health-focused sister company—that they said would vastly expand COVID-19 testing among the state’s impoverished and underserved communities.

    But seven months later, San Francisco and Alameda counties—two of the state’s most populous—have severed ties with the company’s testing sites amid concerns about patients’ data privacy and complaints that funding intended to boost testing in low-income Black and Latino neighborhoods instead was benefiting higher-income residents in other communities.

    San Francisco and Alameda are among at least 28 counties, including Los Angeles, where California has paid Verily to boost testing capacity through contracts collectively worth $55 million, according to a spokesperson for the California Governor’s Office of Emergency Services. About half of them have received COVID-19 tests through six mobile units that travel among rural areas.

    Gov. Gavin Newsom has heralded the investment as a game changer in addressing persistent inequities in access to COVID-19 testing across the state that tend to fall along lines of ethnicity and income. The goal, he said in April, touting six new Verily testing sites, was to “make sure we’re truly testing California broadly defined, not just parts of California and those that somehow have the privilege of getting ahead of the line.”

    Yet the roadblocks for getting underrepresented populations to use the program soon became apparent to Alameda County officials. In a June letter (PDF) to California Secretary of Health Mark Ghaly, Oakland Mayor Libby Schaaf and other members of the county’s COVID-19 Racial Disparities Task Force raised numerous concerns about the Verily protocols.

    Among their complaints: People signing up for a test through Verily had to do so online, using an existing or newly created Gmail account; the sign-ups were offered only in English or Spanish; and participants were asked to provide sensitive personal information, including their home address and whether they were managing chronic health conditions such as diabetes, obesity or congestive heart failure, which could expose their data to third-party use.

    “It is critical in this crisis that we continue to build trust between government and healthcare providers and vulnerable communities,” the task force members wrote.

    Verily had two sites in Alameda County, and one was shuttered by May. The second, located at an Oakland church, closed in August and is set to reopen using a different testing vendor. Alameda County testing director Jocelyn Freeman Garrick, M.D., said that while the Verily sites helped the county reach testing goals in terms of raw numbers, they were phased out because of long wait times of a week or more for results, and because the tests were not reaching the residents in greatest need.

    Verily does not manufacture the COVID-19 tests used at its California sites. It contracts with major corporations such as Quest Diagnostics and Thermo Fisher Scientific to provide the test kits and perform the lab work. What Verily provides is a digital platform where people are screened for symptoms, schedule testing appointments at participating sites and check back for test results.

    Noha Aboelata, M.D., is CEO of Roots Community Health Center, an East Oakland clinic that serves mostly African Americans and is one of the original Verily sites in Oakland. Her experience with Verily is best described as a tale of two lines.

    In May, Aboelata worked with Verily to establish a walk-up site at her clinic, rather than the drive-thru model the company typically uses. There would be two lines: one for people who scheduled their appointments through Verily’s online portal and a second for people who had not preregistered with Verily. Roots would staff both lines, and Verily would supply test kits and personal protective equipment including masks, which were “like gold” at the time, Aboelata said.

    Problems emerged almost immediately, she said. People were suspicious of the requirement that they sign up with a Gmail account and the request for personal information such as health status and risk factors. “You don’t necessarily want to share that with Google,” Aboelata said.

    Then there was the language in the privacy policy that allows for sharing data with third parties. “That always is going to raise suspicion and concern in our community,” she said.

    The people who ended up in the Verily-registered line, she said, tended to be white and to come from wealthier ZIP codes outside East Oakland. And because Verily never changed the website language describing Roots as a drive-thru site, many were angry at having to walk up.

    “We had people coming from all over the Bay Area who were frustrated that they had to park in Oakland, where they had probably never been and didn’t seem to want to be,” she said. “They were creating quite a scene, and some were saying, ‘I want to talk to the manager.’” She had to ask a few people to leave. “One of them was saying, ‘This is so Oakland, and I hope you all get the virus.’ It was pretty awful.”

    The Roots line for clients who did not register through Verily, on the other hand, was made up mostly of people of color from the community who long had come to the clinic for medical care, she said.

    When Aboelata looked at the data, the disparities were obvious: 12.9% of people tested in the non-Verily line were positive for COVID-19, while just 1.5% of people tested in the Verily-registered line were positive. For Aboelata, it was clear that the two lines were testing two entirely different populations.

    After just six days of testing, Aboelata asked Verily to leave.

    “From where we sit, this is an old story,” she said. “Corporations that are not really invested in the community come helicoptering in, bearing gifts, but what they’re taking away is much more valuable.” That thing of value, Aboelata believes, are the data Verily requests from everyone who signs up for a test.

    In San Francisco, Verily mobile testing clinics have also been sidelined. County officials declined to provide an explanation. However, multiple people with knowledge of the testing efforts said the Verily registration process proved chaotic for homeless people and others in the Tenderloin district, one of the city’s poorest neighborhoods.

    Kenneth Kim, clinical director of Glide, an outreach center that helped run the Tenderloin site, said many homeless residents coming in for testing had Gmail accounts, as Verily required, but could not remember their passwords. When staffers at the testing site tried to help them retrieve their passwords, they found that Google’s two-factor authentication process required users to have the same phone number as when they signed up, which few of the homeless participants did.

    Jonathan Fuchs, M.D., who leads San Francisco County’s testing strategy at the Department of Public Health, confirmed that the partnership with Verily was “currently on hold.” He declined to provide further details.

    In response to questions, Verily spokesperson Kathleen Parkes said the program requires users to register with Gmail accounts because Google’s authentication procedures safeguard sensitive data and protect “against unknown individuals sending or receiving information with serious consequences for health or well-being.” Conversations with San Francisco and Alameda remain “active,” Parkes said. The company did not respond to specific questions about the testing disparities cited by community leaders.

    Verily’s role in COVID-19 testing has been shadowed by controversy since President Donald Trump told reporters at a Rose Garden news conference in March that “Google” was developing a screening website and testing tool. “Google has 1,700 engineers working on this right now,” he said. “They’ve made tremendous progress.”

  24. #799
    Senior Member
    Join Date
    May 2020
    Posts
    4,558
    Rep Power
    0
    https://sciencebasedmedicine.org/the...ifters-so-far/


    Alex Jones too

    Mike Adams
    Mike Adams is no stranger to this blog. He promotes a variety of conspiracy theories offering something to everyone on both the far-right and the far-left, and his vast collection of websites was recently cited by the Institute for Strategic Dialogue as possibly the “largest coordinated disinformation network in the world” outside of Russia. He is an HIV/AIDs denialist, a 9/11 “Truther”, anti-vaccine, anti-chemotherapy (arguably anti-medicine), anti-fluoride, an Obama “birther”, and a climate change denialist. He believes that non-human (i.e., alien) entities are controlling “globalists” who intend to force-vaccinate us all for population control…or…something. Like Jones, Adams has been banned from Google News, Apple, YouTube, Pinterest, Twitter, and Facebook, but Adams’ dozens (possibly over 100) of websites means his content is still shared widely across social media platforms. Beyond disinformation, Adams is all about the grift. His online store (nope, not linking to it) sells supplements, potions and even products to help you become a “prepper” for when the globalists-controlled-by-aliens bring you the COVID vaccine. None of this is new for Adams, he’s been “prepping” for the past 20 years, dating back to his apocalyptic predictions about Y2K.

    Joe Mercola
    Any list of people providing questionable health advice seems to bring out the same names, and the next one is also well known to this blog. Joe Mercola is an osteopath and huckster who sells a wide variety of products and is also a strong verbal and financial supporter of the anti-vaccine movement. He is noted to currently claim that dozens of vitamins, supplements and other products on his blog can prevent or treat COVID-19 infections. He mixes this with false and misleading COVID-19 statements in attempts to boost the sales of products on his website. According to the Center for Science in the Public Interest, he claimed that contracting the virus after using his supplements will confer greater protection than a COVID-19 vaccine, a claim that is stunning in its foolishness.

    Jim Bakker
    Jim Bakker is a televangelist and convicted felon who hosts The Jim Bakker Show. He was warned by the FDA in February to stop promoting his own colloidal silver product as a COVID-19 treatment. In March the state of Missouri (where Bakker is based) filed a lawsuit against him to stop him from advertising or selling his products as a COVID treatment. This was followed by a warning from the FDA and a cease-and-desist letter from the state of New York. Subsequently his ability to accept credit cards was apparently cut off and he was said to be on the brink of bankruptcy. In June, the state of Arkansas joined Missouri by also suing Bakker for selling colloidal silver products as a COVID-19 treatment.

    Mike Lindell
    Steven Novella wrote about Mike Lindell, CEO of MyPillow, back in September. Oleandrin is a chemical extracted from the oleander plant. It, like thousands of other chemicals derived from natural sources, has been isolated, purified, and studied for possible medicinal value. An in-vitro (laboratory) test of oleandrin found that it may have anti-viral properties. This is promising, but that’s as far as the evidence goes. There is no in-vivo (in human) trials to show that oleandrin is safe or effective as a treatment. David Juurlink, a physician and toxicologist, noted that the presumed effective concentration is well within the toxic range for humans. Oleandrin causes nausea and vomiting, and then, arrhythmias and sometimes death. Oleandrin received more attention that it deserved through Lindell’s promotion of the chemical to the Trump administration. The FDA put a stop to this and rejected an application to treat oleandrin as a dietary supplement, because it considers the chemical to meet the definition of a drug. We shouldn’t see any oleandrin products anytime soon, considering its toxicity and lack of effectiveness. Juurlink noted,

    No one should take oleandrin to prevent COVID…Anyone gullible and foolish enough to take it despite this advice should get their affairs in order beforehand.

    Keith Middlebrook
    Way back in March, actor Keith Middlebrook was arrested by the FBI in a sting operation where he was delivering a COVID preventative/cure to a potential “investor”, who was an undercover agent. Middlebrook had been promoting pills and some sort of injectable liquid to his millions of Instagram followers, claiming they provided immunity or a cure. Middlebrook was seeking investors, promising a guaranteed return of $30 million after an initial investment of $300,000. Since his initial arrest and subsequent release, Middlebrook continues to insist that his products are legitimate and he continues to reject the label of “con man”.

    Dave Asprey
    Dave Asprey is the man behind the “Bulletproof” brand – the guy who popularized putting oil and butter in your coffee. He has built his “biohacking” brand into an empire of books, podcasts, and product sales. Asprey’s output combines cherry-picked science with pseudoscience, wrapped up in a self-experimentation ethos that superficially sounds compelling but falls short in actual evidence. Asprey decided to “hack coronavirus” earlier this year and endorsed a long list of products like andrographis, probiotics, vitamins, coenzyme Q10, omega fatty acids, black cumin seed oil, hydroxytyrosol, sulforaphane and l-glutamine, and directing readers to his own products for sale. The Federal Trade Commission asked him to stop:

    It is unlawful under the FTC Act, 15 U.S.C. ? 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. For COVID-19, no such study is currently known to exist for the products identified above. Thus, any Coronavirus-related prevention claims regarding such products are not supported by competent and reliable scientific evidence. You must immediately cease making all such claims.

    Dominique Fradin-Read and compounding pharmacies
    Dominique Fradin-Read is a medical doctor and contributor to Gwyneth Paltrow’s growing Goop empire, creating the “Madame Ovary” supplement regimen (just $90/month). In October an NPR story reported that Fradin-Read was endorsing an unapproved drug, thymosin alpha-1. She is not alone in the promotion of this chemical, but is probably the most well-known advocate for claiming it has value to prevent or treat COVID infections. Thymosin alpha-1 is a hormone secreted by the thymus which has been isolated and its biological effects are now being studied, as well as its potential as a drug product. In 2000 the FDA granted thymalfasin (a synthetic analog of thymosin alpha-1) injection (Zadaxin) orphan drug status for the treatment of liver cancer, which was followed in 2006 with the designation for malignant melanoma. It is approved as a drug is some countries, but not the US, where it is not currently approved by the FDA for the treatment of any indication, COVID or otherwise. Consequently, it is not sold as a commercial product. However, this has not prevented Fradin-Read from promoting it, which can be obtained from an array of compounding pharmacies. I have blogged about compounding pharmacies before, which can manufacture drug products not otherwise commercially available. While compounding pharmacies can provide invaluable services and access to needed, customized drug products, their products are not tested for quality or safety by the FDA. In worst-case scenarios, when quality and safety standards are ignored, contaminated products from compounding pharmacies can kill. Some compounding pharmacies have jumped on the thymosin alpha-1 bandwagon. NPR notes:

    NPR found medical practices widely marketing thymosin alpha-1 for COVID-19 based in Michigan, Tennessee, Texas, Florida, Iowa, New York and California, among other places. Not every practice discloses how much it charges for these injections online, but a handful of companies list prices in the range of $369 for a one-month supply, or $400 for a “ten-syringe set.” Most of the medical practices that promoted the drug are not specialized in infectious diseases but rather focus on plastic surgery or promote “wellness,” “anti-aging” and “regenerative” medicine.

    The FTC and the FDA have begun taking action against companies that claim thymosin alpha-1 can be used to prevent or treat COVID infections.

  25. #800
    Senior Member
    Join Date
    May 2020
    Posts
    4,558
    Rep Power
    0
    https://sciencebasedmedicine.org/cov...ity-improving/

    More on the Roundup


    Over the course of the pandemic the death rate in people diagnosed with COVID-19 (the case-fatality rate) has declined. It’s not easy to unpack all the reasons this may be the case, but it may help us understand this pandemic. This is an extremely contagious and deadly disease, and nothing has changed that, but there is evidence we are making some progress.

    One recent study looking at the case fatality rate in the New York region from March to August found that the death rate for those admitted to the hospital dropped from 27% to 3%. They also found many possible reasons for this dramatic decrease. One is the fact that in March New York hospitals were overwhelmed with COVID cases. They did not have enough ICU beds or ventilators, and doctors were crushed beneath the initial wave of cases of a disease they had no experience with. In fact, out of desperation, some hospitals were placing two patients on a single ventilator. So simply “flattening the curve” and reducing pressure on hospitals is one important factor.

    Another study out of the UK found that from March to June the fatality rate of COVID patients admitted to the ICU decreased from 41% to 21%. This was even after controlling for demographic and medical history factors, so this was likely not due to patients being healthier at baseline. The study attributed the improvement to two factors – the decrease in stress on hospital systems (again), and improvements in the care of critically ill patients with COVID. This latter reason is the most encouraging reason for the decline – the steep learning curve of knowing how to treat those who are seriously ill with COVID. Doctors have learned through direct experience how to better manage COVID patients, and many interventions became standard practice between March and August. For example, it is better to rest patients on their stomach than their back, and it is better to delay ventilation as long as possible. The discovery that steroids can reduce the risk of cytokine storm was perhaps a significant improvement. Some patients now get convalescent plasma, something that obviously could not have happened early on. Remdesevir was given emergency use authorization, but a recent study by the WHO found no survival benefit from this drug (or from hydroxychloroquine; a combination of the anti-HIV drugs lopinavir and ritonavir; and interferon).

    While we still do not have a cure for COVID-19 or a proven effective anti-viral, management has significantly improved and this has definitely contributed to survival. However – this is not the only effect, and may not even be the major effect.

    The recent WHO study also found that as the pandemic progresses, younger and healthier people are being infected. They naturally have a higher survival rate, even if they become sick enough to get admitted to a hospital. It seems from this data, to put it bluntly, that the first surge of the pandemic in the New York region killed many vulnerable people, and now there are simply fewer of them alive to catch and die from the virus. Now we are seeing larger numbers of people infected, but they are healthier at baseline, so the case fatality rate drops.

    As a side point, some have used the fact that the pandemic tends to kill older sicker people to minimize the significance of the death toll, as if these are mostly people who would have died soon anyway. But that is not the case. The pandemic does not mostly kill people who were already on death’s door (although certainly that describes some victims). The chronic conditions that make people vulnerable to dying from COVID, such as hypertension, obesity, or asthma, are also compatible with years of quality life. Anyone with an elderly parent who has chronic illnesses but is still a valued and loved member of the family would bristle at the suggestion that their death is no big deal.
    https://sciencebasedmedicine.org/vac...e-of-pandemic/

    Trump gutted the National Vaccine Program Office
    It was with dismay that I read a story in The New York Times on Friday by Carl Zimmer reporting that last year the Trump Administration shut down a key office responsible for coordinating government programs monitoring vaccine safety and folded it into an office focused on infectious diseases. Noting that the first coronavirus vaccines will likely be approved next year, if not even earlier, and rolled out to millions of people in the US, Zimmer observes:

    As the first coronavirus vaccines arrive in the coming year, government researchers will face a monumental challenge: monitoring the health of hundreds of millions of Americans to ensure the vaccines don’t cause harm.

    Purely by chance, thousands of vaccinated people will have heart attacks, strokes and other illnesses shortly after the injections. Sorting out whether the vaccines had anything to do with their ailments will be a thorny problem, requiring a vast, coordinated effort by state and federal agencies, hospitals, drug makers and insurers to discern patterns in a flood of data. Findings will need to be clearly communicated to a distrustful public swamped with disinformation.

    This has, of course, always been the most difficult issue when it comes to monitoring vaccine safety. People are pattern-seeking animals. We’re extremely good at noticing patterns and creating meaning or inferring causation from those patterns, even if the meanings or causations inferred are completely false. One commonly used example to illustrate this point is that if you ate some wild berries and then sickened, it would likely be beneficial to see the link between eating berries and illness, and then to avoid those berries in the future, even if the berries were not, in fact, the cause of the illness. Another commonly used example is early humans on the savannah. Rustling of the grass might indicate that a predator is near and be an indication to flee or get ready to fight, or it might be just the wind. Rapidly concluding that the rustle in the grass is a dangerous predator when it is actually just the wind doesn’t cost much, but believing that a dangerous predator is just the wind could easily mean that the early human ends up in the belly of a lion. The bottom line is that there likely was selective pressure in evolution against dismissing patterns (or for seeing them), whether they mean what we think they mean or not.

    This pattern-seeking behavior is not well-suited to a task like evaluating drug safety. Many of us will conclude, after taking a drug or receiving a vaccine, that anything bad that happens soon afterward was likely caused by the drug or the vaccine, even when it is far more likely that it was random chance (i.e., coincidence), and nothing more. Such is the case with vaccines and autism. The ages during which children receive a lot of vaccines just happens to correspond to the ages where parents most frequently first start noticing the signs of autism spectrum disorders, as can be shown by an estimate of how many cases of autism we would expect to see diagnosed within one week or even 30 days of receiving vaccines. The numbers are much larger than most people would guess. Basically, our brains appear to be hard-wired to find patterns, and we have a hard time accepting that coincidence is very common. That’s why we need data and epidemiology to separate coincidence from actual correlation above what we would expect by random chance alone. It’s also why vaccine safety monitoring systems are so important.

    Of course, I began expressing concerns about the likely problems President Trump would cause for science, especially drug approval and safety, beginning even before he took office and then during the first 100 days, such as his including two ultra-libertarians who thought that the FDA should only require evidence of safety and not efficacy before approving a drug, one of whom thought that voluntary reporting systems and the free market alone would be enough to assure the safety of drugs and devices, like a “Yelp” or “Uber” for pharmaceuticals, in his short list for candidates for FDA Commissioner. The third was a bona fide pharma shill, Scott Gottlieb. He was the “least bad” of the three and ultimately became FDA Commissioner. Surprisingly, he was generally not too bad, but unfortunately he only lasted a couple of years.

    In any event, the Trump administration is focused on getting COVID-19 vaccines to market, but seems a lot less concerned about what comes next, such as how to distribute the vaccines rapidly and equitably, and how to monitor their longer term safety:

Thread Information

Users Browsing this Thread

There are currently 146 users browsing this thread. (0 members and 146 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
  •