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Thread: COVID-19 Novel Coronavirus pandemic

  1. #651
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    Quote Originally Posted by KimTisha View Post
    Isn't it great? When we returned from NJ after my father died, we loved having the roads, hotels, and restaurants to ourselves. We're getting ready to strike out on a 7,000 mile road trip around the US. Really looking forward to the "emptiness," to be honest - it'll make good photos. I'm immunosupressed so I'll wear my mask and take proper precautions, but I'm not afraid to travel. It helps that I'm ridiculously pragmatic and not afraid to die.
    Yes its been great! I flew from NYC to SF....only 5 people on this huge ass plane I had 5 seats to myself and layed down and slept for 5 hrs. Flew from Newark to Tampa, only 9 people. On our road trip the highways were empty, no traffic and no police! Hotels empty, hotel pools pretty much to ourselves no crowds. Beaches, no crowds. Restaraunts, empty which means 1st class service. Enjoy your roadtrip make lots of stops take lots of pictures!!! Drive Safe!!!

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    Los Angeles Mayor Eric Garcetti ordered the power cut at a swanky Hollywood Hills residence that police say held parties in violation of public health orders aimed at slowing the spread of the novel coronavirus and is the home of several TikTok stars, including Bryce Hall.

    The house on Appian Way was the site of at least two large gatherings in recent weeks, police said.

    Garcetti, who had threatened to cut off power and water to homes that defy rules about large gatherings during the COVID-19 pandemic, made the announcement Wednesday. His statement didn’t include the address or details about its residents.

    “With more than 2,000 Angelenos — and over 170,000 Americans — lost to COVID-19, we need every resident to undertake critical safeguards to stop the spread of this virus. That includes not hosting or attending parties that put themselves, their neighbors and many others at risk,” Garcetti said.

    A phone call to a woman who helps manage the property, according to local residents, wasn’t immediately returned Wednesday.

    Social media stars living together in upscale Los Angeles homes and documenting their lives on TikTok have become a trend, with this most recent group involving Hall calling themselves the “Sway House.” The group also held a party Friday night in Encino that drew police, a source said.

    Police had twice visited the Hollywood Hills residence, first on Aug. 8 and then on Aug. 14 after complaints of noise, according to the mayor’s statement.

    A spokeswoman for Sway House declined to comment.

    Hall, who has 12.9 million TikTok followers, released a video Wednesday showing him dancing, along with another young man, to the song “Electric Love.”

    “We will restore utilities when the order is made to do so,” Department of Water and Power spokesman Joe Ramallo said.

    Rob Wilcox, a spokesman for City Atty. Mike Feuer, said the office has received a criminal investigation and is reviewing whether to charge the owner of Appian Way party house. The home is owned by Frangipani Properties, according to public records.

    Under the mayor’s directive, police officers who respond to a large party at a property can request the utilities be cut within 48 hours. Homes where parties regularly occur are the target.

    Officials said this week that the city is considering cutting power to at least two other houses for violating coronavirus-related rules against social gatherings, according to police and city officials. Gatherings of any size of people from different households are prohibited under Los Angeles County’s coronavirus health order.

    Los Angeles police officers issued citations for noisy gatherings at 13 homes last weekend, warning the hosts that they could have their utilities cut if they continued to hold parties.

    The rise in influencer houses comes amid reports of house parties at which revelers shrug off concerns about the COVID-19 pandemic and ignore warnings from public health officials that gatherings help spread the virus through the community.
    https://www.latimes.com/california/s...-eric-garcetti

  3. #653
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  4. #654
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    https://www.biospace.com/article/pfi...id-19-vaccine/

    One of the leading groups in developing a COVID-19 vaccine, U.S.-based Pfizer and Germany’s BioNTech, released additional Phase I data from their ongoing U.S. trial of BNT162b2 (B2), their mRNA-based vaccine against COVID-19. The vaccine has otherwise advanced into a Phase II/III trial.

    The companies had released preliminary data on the vaccine on July 1, but that was for a different vaccine than the one they are taking into a 30,000-patient Phase III trial. The companies were originally testing four variations of their vaccine, each with a different combination of mRNA format and target antigen. The preliminary data announced on July 1 were for BNT1621b1 (B1). But on July 28, they announced they had selected BNT162b2 to take into larger studies.

    Today’s data describes key safety and immunogenicity data from the U.S. Phase I study for BNT162b. At the 30-microgram dose, seven days after the second dose, the vaccine elicited a neutralizing geometric mean titer (GMT) 1.6 times the GMT of the same panel, showing strong immunogenicity in younger and older adults. This is a way of comparing the immune responses. Also, B2 (as compared to B1) created fewer adverse events in participants than B1. The immune responses were similar between the two vaccine candidates.

    “Obviously, the better tolerated the vaccine, the more I think it will encourage public acceptance of a broad immunization,” said William Gruber, senior vice president of vaccine clinical research and development at Pfizer, according to STAT. “Both would have been great candidates. We were fortunate that B2 actually satisfied having both a favorable immune profile and fewer reactions.”

    In the B1 version, patients aged 18 to 55 years had adverse events believed to be related to the vaccine about 50% of the time at the 30-microgram dose. Patients between the ages of 65 and 85 had adverse events 16.7% of the time.

    However, with B2, the 18-to-55 group had adverse events related to the vaccine 16.7% of the time and no adverse events were reported in the older age group.

    All of the vaccines developed by Pfizer and BioNTech utilize mRNA, which is inserted into a tiny fat droplet called a lipid nanoparticle, which is used as a vector to deliver into cells. Once inside the body, the mRNA is translated into proteins that then stimulate an immune response to the SARS-CoV-2 virus so that if it encounters the virus, will respond and prevent infection. The B1 vaccine codes for part of a protein on the virus that binds to a receptor on the cells it needs to gain entry. The B2 vaccine codes for the entire protein, dubbed the spike (S) protein.

    They believe that by using the complete spike protein, the immune system appears to have more ways to identify and attack the virus. There may also be factors such as chemical modifications to the mRNA that account for the differences.

    Side effects were fairly typical of vaccines—soreness at the site of the injection, fever, chills, headache, and muscle or joint pain. In the older adults receiving B2, none reported redness or swelling at the injection site. But in the older group, the average level of antibodies against the virus was only 41% of what was observed in the younger group. The study, however, indicates that was still higher than antibody levels observed I patients who recovered from COVID-19.

    The median age of the younger cohort was 37 years, and the median age of the older cohort was 69 years. All patients in the B2 study were white and non-Hispanic, as well as more older women than older men.

    “It is important to us to continue sharing data and related information on our COVID-19 vaccine lead candidate,” said Ugur Sahin, co-founder and chief executive officer of BioNTech. “The favorable safety profile of BNT162b2 and the breadth of T-cell responses we previously announced have supported our decision to select this candidate for the pivotal Phase II/III study. As of today, we have already dosed more than 11,000 participants with BNT162b2 in that study.”

    The companies indicate they are on schedule to file for regulatory review for BNT162b2 (B2) as early as October 2020. If approved, they will be able to supply up to 100 million doses globally by the end of the year and about 1.3 billion by the end of 2021.
    https://www.biospace.com/article/rus...virus-vaccine/

    Following approval of its coronavirus vaccine, the first in the world, Russia plans to initiate a new study involving 40,000 people as the country looks to boost production and distribute the drug to patients in that country, as well as to patients in countries it has struck deals with.

    Russia approved its vaccine against the novel coronavirus earlier this month after the government assured the medication is safe and effective. The vaccine, dubbed Sputnik V, is an adenoviral vector vaccine developed by Moscow’s Gamaleya Institute. The two-vector vaccine has been genetically modified to infect cells than make those cells manufacture spike proteins of SARS-CoV-2, the novel virus that causes COVID-19.

    Russia had its vaccine in clinical testing for about two months before it approved the medication. The little data that is available, two Phase I/II studies posted to clinicaltrials.gov, show a total of 38 patients treated with the experimental vaccine. There is a question as to whether or not that is 38 per study for a total of 76, or 38 studied twice. Since its hasty approval, the vaccine has been viewed with skepticism from researchers over its potential as a long-term solution against the global pandemic, largely due to the speed with which it was approved and the small number of patients involved in the studies.

    The Russian Direct Investment Fund established a vaccine website to provide details of its clinical programs for Sputnik V.

    “The vaccine induced strong antibody and cellular immune response. Not a single participant of the current clinical trials got infected with COVID-19 after being administered with the vaccine,” according to the Russian website.

    Russia initially said it intended to launch a larger, post-approval Phase III study involving about 2,000 patients. But now that number of patients has grown.

    “Next week a previously planned post-registration, randomized, double-blind, placebo-controlled multicenter clinical study of the efficacy, immunogenicity and safety of the Sputnik V vaccine will begin in Russia, simultaneously with the vaccination of volunteers from risk groups. More than 40,000 people will take part in the study in more than 45 medical centers,” the Russian Direct Investment Fund, which worked alongside Moscow’s Gamaleya Institute to develop the vaccine, said in a statement.

    Denis Logunov, deputy director for scientific work of Gamaleya Research Institute of Epidemiology and Microbiology, told CNBC that the institute has agreed to a “huge protocol for 40,000 participants” as a sort of Phase III/ confirmatory trial for Sputnik V.

    “The purpose of this protocol is not that much to study the immunogenicity and safety of the vaccine, that goes without saying … But, additionally, we will have to assess the epidemic efficacy of this vaccine,” Logunov said, according to CNBC’s report.

    More than 22 million people have been infected with the novel coronavirus, according to the Johns Hopkins COVID-19 dashboard. Russia has reported 944,671 cases, with more than 16,000 related deaths.

  5. #655
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    https://ktvo.com/news/local/iowa-con...schools-reopen

    Here is the COVID-19 Roundup

    IOWA CITY, Iowa (AP) - Public health officials say a young child in Iowa died due to complications from coronavirus in June, the state's first death of a minor during the pandemic.

    The Iowa Department of Public Health says the state medical examiner concluded its case investigation into the death on Aug. 6 but it wasn't reported in the state's official statistics until Saturday, more than two weeks later.

    The department says it needed to make efforts to protect the child's identity and notify the family before releasing the information to the public.

    The announcement comes one day before dozens of school districts are prepared to begin the school year on Monday

    https://www.bbc.com/news/uk-england-manchester-53887559

    Police criticised for breaking up a child's 10th birthday party celebration say they "can't win" when enforcing enhanced coronavirus restrictions.

    Greater Manchester Police's Chief Constable revealed the force attended 126 incidents over the weekend.

    Officers were slammed by some for breaking up the child's party in Manchester and issuing a fine.

    But Ian Hopkins said it was not a "jelly and ice cream" event and saw "mostly adults celebrating".

    Police were "in a difficult position" with "lots of reports" of lockdown breaches, he said, and were trying to take a "very balanced and proportionate view".

    He continued: "We can't win. If we don't deal with them, people are saying it isn't fair and when we do deal with it people are saying it is heavy-handed.

    "Throughout this pandemic we have issued very few fixed penalty notices. And even this weekend we have only issued 19.

    "We don't get to everything. We just have to assess which [gatherings] appear to be the biggest and most problematic."

    Lockdown restrictions on social gatherings remain in Greater Manchester following a local spike in cases.

    As well as illegal gatherings, officers visited 172 licensed premises over the weekend.

    Mr Hopkins said "pretty much all" bars were showing "really good measures to keep people safe" but that was not the case with house parties.

    "It isn't safe. Social distancing is not taking place and that will lead to the virus spreading," he said.

    He said the force had received help this weekend from police forces in Durham, Humberside, North Yorkshire, Cheshire and North Wales.

    He said it meant an extra ?100,000 a week had to found to cover the costs.

    The child's 10th birthday party in Swinton was being attended by three families in a private garden after 20:00 BST on Friday.

    Mr Hopkins said the force was not "making an example of them" but defended the fine issued to the homeowner, adding: "Those people knew they were breaching the regulations".

    The party's host declined to comment when approached by the BBC.

    Officers were also called to what turned out to be a party for a terminally ill child.

    Mr Hopkins said officers used "discretion" and "had a quiet word" with the host before leaving.

  6. #656
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    https://www.bbc.com/news/health-53889823

    Hong Kong scientists are reporting the case of a healthy man in his 30s who became reinfected with coronavirus four and a half months after his first bout.

    They say genome sequencing shows the two strains of the virus are "clearly different", making it the world's first proven case of reinfection.

    The World Health Organization warns it is important not to jump to conclusions based on the case of one patient.

    And experts say reinfections may be rare and not necessarily serious.

    There have been more than 23 million cases of coronavirus infection around the world.
    Those infected develop an immune response as their bodies fight off the virus which helps to protect them against it returning.

    The strongest immune response has been found in the most seriously ill patients.

    But it is still not clear how strong this protection or immunity is - or how long it lasts.

    And the World Health Organization said larger studies over time of people who had previously had coronavirus were needed to find out more.

    This report, by the University of Hong Kong, due to be published in Clinical Infectious Diseases, says the man spent 14 days in hospital before recovering from the virus but then, despite having no further symptoms, tested positive for the virus a second time, following a saliva test during airport screening.

    "This is a very rare example of reinfection," said Brendan Wren, professor of microbial pathogenesis, at London School of Hygiene and Tropical Medicine.

    "And it should not negate the global drive to develop Covid-19 vaccines.

    "It is to be expected that the virus will naturally mutate over time."

    Dr Jeffrey Barrett, senior scientific consultant for the Covid-19 genome project at the Wellcome Sanger Institute, said: "Given the number of global infections to date, seeing one case of reinfection is not that surprising even if it is a very rare occurrence.

    "It may be that second infections, when they do occur, are not serious - though we don't know whether this person was infectious during their second episode."

    Prof Paul Hunter, from the University of East Anglia, said more information about this and other cases of reinfection was needed "before we can really understand the implications".

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    https://ktla.com/news/local-news/l-a...d-19-briefing/

    Los Angeles Mayor Eric Garcetti said Wednesday that people without symptoms should continue to get tested for COVID-19, despite new guidelines put out by the U.S. Centers for Disease Control and Prevention this week.

    ?I very strongly disagree with what the CDC put out saying that there should not be testing of people without symptoms,? the mayor said.

    The CDC changed its COVID-19 testing guidelines to say some people without symptoms may not need to be tested, even if they?ve been in close contact with someone who has the virus. Previously, the CDC had said testing was appropriate for people with recent or suspected exposure, even if they were asymptomatic.

    ?This is a devastating virus. Never forget that,? Garcetti said. ?If it doesn?t kill you, it can leave you with long-term damage.?

    L.A. was the first big city to offer widespread testing to non-symptomatic people, the mayor said, allowing 30% of cases to be caught that way.

    ?Often it?s those silent spreaders that have done the most damage,? he said. ?We will not stop providing tests for those who don?t have symptoms.?

    The change in federal testing guidelines was a result of pressure from the upper ranks of the Trump administration, a federal health official said, and Dr. Anthony Fauci, a key White House coronavirus task force member, said he was not part of the meeting when the new guidelines were discussed.

    L.A. County public health officials said Wednesday that the COVID-19 case rate has continued to drop and is now at fewer than 200 cases per 100,000 residents. And, the mayor said COVID-19 hospitalizations are at an all-time low since the beginning of the pandemic.

    But health officials continue to stress the importance of maintaining physical distance, regular hand-washing and wearing masks to help slow the spread of the virus until there is a vaccine.

    A new vaccine trial is coming to L.A. County, officials announced Wednesday, and those interested in participating can sign up online.

    And, the city of L.A. is working to accelerate research into rapid, at-home COVID-19 tests, which will dramatically ramp up testing capacity, according to Garcetti.

    The county reported 1,642 new coronavirus cases on Wednesday, bringing the total to 235,286. Additionally 58 new deaths were reported, raising the death toll countywide to 5,663.

    Garcetti also announced Wednesday that Los Angeles would make all city services contactless and digital.

    ?This directive is a critical step to not only modernize government, but to keep us safe as we open up city services, or the city services that have stayed open and they don?t put you at risk,? the mayor said. ?So this is about saving time and money. This is about keeping you safe and healthy. And this is about increasing the quality and reimagination of the service you get from the city.?

    City officials are working on creating a universal login for services including payment, direct assistance, public counter permits and library services.

    Garcetti also said last week that the L.A. Al Fresco program that provides outdoor dining permits will be extended through the end of 2020.

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    https://sciencebasedmedicine.org/tru...ous-lab-tests/

    The U.S. Department of Health and Human Services (HHS) announced last week that the FDA can no longer require some lab tests, including tests for COVID-19, to undergo FDA review prior to going on the market, a move that surprised many. The announcement covers only laboratory-developed tests (LDTs), that is, tests assembled and used within a single lab. This can include tests developed by academic and medical center labs as well as testing behemoths like Quest, Genova, and LabCorp. HHS did not exempt tests made by one company and sold to other labs or commercial firms.

    HHS also rescinded all previously-issued FDA guidance documents and informal statements of policy concerning LDTs, taking the position that any FDA regulation can be legally accomplished only through the process of notice and rulemaking or new legislation passed by Congress, both of which can take years.

    It is important to note that HHS’s decision covers all LDTs, not just those for COVID-19. As we’ll see later in this post, this not only has disturbing implications for testing during the pandemic, it is also a boon to quacks and fringe medical practitioners who were already exploiting the lax regulation of LDTs to fabricate dubious diagnoses and sell bogus treatments to patients.

    Before HHS rescinded the FDA’s authority altogether, the agency’s regulation of LDTs came in fits and starts. By way of background, the FDA regulates in vitro diagnostic devices (IVDs), which analyze human samples (such as blood, saliva, tissue, and urine) as medical devices. However, in the past, it did not use this authority to regulate a particular type of IVD, the laboratory-developed test.

    Instead, it focused on commercial test kits, which are broadly marketed to laboratories or directly to the public. These tests have to undergo the same pre-market approval process as other medical devices regulated by the FDA. In some cases, this means clinical studies demonstrating that the device is safe and effective for its intended use. An LDT could avoid this review, even when it’s used for the same purpose as an FDA-approved test. For example, there are both LDTs and FDA-approved tests for vitamin D. This has led to complaints of a double standard from labs facing the much stricter standard.

    There is some oversight of labs that offer LDTs. A federal law, The Clinical Laboratories Improvement Act (CLIA), requires assessment of whether a lab is able to test according to instructions and detect what is intended to be detected, that is, the test’s analytical validity. However, a key element is missing in that evaluation: clinical validity. Does the test accurately diagnose or predict the risk of a particular clinical outcome?

    For example, Great Plains Laboratory sells the “IgG Food MAP with XMAP? Technology”, an LDT, to health care practitioners. Because Great Plains is CLIA certified, this test, presumably, accurately “detects all food antibodies” as advertised and is therefore analytically valid. But do the test’s results give a clinician information to accurately diagnose or to predict risk? Not if the clinician is practicing science-based medicine.

    Historically, LDTs were developed by hospitals, researchers, and academic medical centers for their own use. That is no longer true. In the past 15 years or so, there has been an explosion in the use of LDTs by commercial labs and biotechnology companies. A few years ago, the FDA estimated that there were about 11,000 LDTs offered by 2,000 laboratories, giving impetus to stricter oversight of the burgeoning LDT market.

    In 2014, the FDA announced it would henceforth use its medical device regulatory authority to oversee LDTs. Then, in late 2016, the agency reversed course and announced it would not finalize its draft guidance on LDTs, although it maintained the agency retained the authority to regulate them (and took action against LDTs based on that authority just last year). There were efforts in Congress to come up with a regulatory solution via a new law, but those efforts have yet to bear fruit.

    Prior to HHS’s pulling the FDA’s jurisdiction, labs wanting to market COVID-19 LDTs were required to get emergency use authorizations (EUAs) from the FDA. Under this procedure, labs could begin using self-validated LDTs as long as they submitted an EUA to the FDA within 15 days.

    An FDA spokeswoman said in May that there were problems with some COVID-19 tests whose developers had applied for an EUA, indicating that the requirement was effective in weeding out bad tests. According to a New York Times report

    “Some of the laboratories didn’t do their validation properly, making it impossible to tell if they had a good test or not” [the agency spokeswoman] said. “Others included data that suggested the test did not perform well, likely missing far more positive cases than authorized tests.”

    Other laboratories, she added, had manufacturing problems such as contamination. And several made unsupported claims in their labels for home testing.

    At the time HHS took action, over 170 labs had notified the FDA that they had validated their own LDTs and were awaiting FDA authorization. HHS’s decision mooted that necessity.

    (Labs can still voluntarily seek an EUA, which will allow them to avail themselves of the liability protection afforded by the PREP Act. Labs bypassing FDA pre-market approval will forego this protection.)

    Pros and cons
    According to the Washington Post, the move

    came as a surprise to many at the FDA and was a point of intense disagreement between HHS Secretary Alex Azar and FDA Commissioner Stephen Hahn . . . [who] vociferously opposed the change, arguing that the agency has the authority to regulate [LDTs] during a public health emergency like the current pandemic.

    Public health experts told the Post that

    the shift could result in unreliable coronavirus tests on the market, potentially worsening the testing crisis that has dogged the United States if more people get erroneous results. They argued the change is unlikely to solve current testing problems, which at this point are largely due to shortages of supplies such as swabs and chemical reagents.

    Former FDA Commissioner Scott Gottlieb, who served in the Trump Administration, was critical as well, telling Axios:

    We’ll see a plethora of DTC [direct-to-consumer] Covid tests enter the market, where tests ship directly to consumers and are processed in a central lab operating outside FDA oversight.

    Dr. Michael Carome, director of Public Citizen’s Health Research Group told the New York Times:

    Suppose you get a Covid test and you actually have the infection and it comes back negative, . . . You may believe you’re OK and that may leave you in your home, exposing family and friends to the virus when you should quarantine.

    Critics include former FDA officials Peter Lurie and Alberto Gutierrez, the latter calling HHS’s action “Letting the Wild West be the Wild West”.

    Others, however, supported the move as helping “new and more innovative tests to market more quickly”, charging that the FDA’s review “sharply slowed testing” at the beginning of the pandemic, according to the Washington Post.

    “This is what we needed and asked for five months ago,” said Melissa Miller, director of the University of North Carolina Medical Center’s Clinical Molecular Microbiology Laboratory.

    And:

    The emergency use authorization “requirement meant well. But in my opinion was a disaster,” Michael Mina, an epidemiologist at the Harvard T.H. Chan School of Public Health, wrote on Twitter.

    FDA regulatory practitioners who had represented clients trying to obtain COVID-19 test EUAs were critical of the FDA as well, charging that

    the lack of adequate testing at the outset of the pandemic can be directly linked to FDA’s controversial laboratory-developed test (LDT) policy . . .

    Signaling the implications of the administration’s decision beyond the pandemic, Jeff Allen, president and chief executive of Friends of Cancer Research, told the Times

    “I think it’s quite alarming” . . . He noted that a growing number of tests are in development to help determine whether cancer patients are responsive to certain drugs. “It’s really important for the performance of those tests to be assured.”

    Mr. Allen and other critics also note that the new plan appears to leave the F.D.A. with no knowledge of what lab-developed tests are being devised, much less how they are performing.

    It is unclear whether the FDA will now have the authority to remove an LDT lacking clinical validity from the market. According to the Washington Post,

  11. #661
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    https://sciencebasedmedicine.org/covid-in-children/

    In the northern hemisphere children are returning to school, and in countries where COVID-19 is still spreading this is a serious concern. There is still a great deal we don’t know about the SARS-CoV-2 virus, although we are rapidly learning. One big question is the role that children play in the pandemic. Specifically, we need to know the risk of children catching the virus, if they do what is the risk they will develop clinical COVID-19 (as Clay discussed several months back – the risk seems generally low but there are reasons to be concerned), and either way what is the risk they will pass on the virus and become a vector for spread?

    A recent UK study adds some information to these questions. The study is being reported as “reassuring” but only relatively so. The study looked at 651 children admitted to the hospital with confirmed SARS-CoV-2. Of these children 18% were admitted to critical care and 1% died. This is less than the figures for adults (27% of those admitted to the hospital with COVID die), but I’m not sure parents would be “reassured” by a 1% mortality rate. However, they also found that these children who were admitted to ICU or died were far more likely (42%) to have an underlying medical condition – “the most common ones being illnesses affecting the brain and nervous system (11%), cancer (8%) and asthma (7%).”

    Also, 11% met the WHO MIS-C criteria – this is a multisystem inflammatory syndrome in children. This tended to occur in older children in this study. MIS-C is still a bit mysterious, but it appears that is a subset of children with COVID-19 they develop an autoimmune syndrome with inflammation affecting different organ systems. This can be a serious and even life-threatening illness. In general we are finding that the immune system’s reaction to COVID-19 is often more dangerous that the infection itself, especially in severe cases. There is something about the virus which affects certain people, probably due to the genetics of their immune function, in a way that triggers an extreme immune reaction.

    The study also found that the poor and minorities were more likely to be admitted and die from the disease.

    In terms of the susceptibility of children to COVID, it does appear to be much less than adults – but it’s not insignificant. This study does suggest that it would be relatively safe for the children themselves to return to school, with the caveat that children with serious underlying medical conditions probably shouldn’t.

    What about the question of whether or not children can be asymptomatic carriers of the virus, which could play a huge factor in spreading the pandemic as children return to school? Here we have a recent study from South Korea, which is the opposite of reassuring. South Korea has an extensive program of contact tracing, which follows infected people with serial testing until they clear the virus. This provides a great opportunity to trace how the virus spreads and who is spreading it.

    They found that children can have the SARS-CoV-2 virus detectable in nasal swabs for up to three weeks, even if they are asymptomatic. Further, they found that family contact of children currently attending school were the most likely contacts to contract COVID. Younger children 0-9 years old who were currently not in school were the least likely to pass on the virus.

    A recent comprehensive review of the research so far also finds that children are asymptomatic carriers of the virus, and that they generally have high viral loads. High viral loads generally translates to being highly contagious – there is more virus to shed and spread to others. Further, when children are symptomatic they tend to have mild non-specific symptoms, which can easily mimic a cold. So COVID may be harder to detect in children.

    We don’t know exactly what the risk is of asymptomatic children passing on the virus, but this study suggests it is not negligible. This, of course, would be the worst-case-scenario for opening schools – that children can be asymptomatic carriers and spreaders of the virus, bringing it back to the adults in their home. Meanwhile, the American Academic of Pediatric is urging a “safe” return to school this Fall, especially for younger children. They are concerned about the learning and socialization of children, especially since we have essentially already lost a semester. How do we balance these two concerns?

    In countries where the pandemic is still spreading, like the US, we need to carefully consider our strategy for returning children safely to school while containing the pandemic. Here the South Korea model may be instructional – use extensive testing and contact tracing to detect any spreaders and isolate them quickly. No such system is in place in the US, however.

    Basic precautions will help to some degree. Many schools are reducing the number of days children will be in school and instituting rules for social distancing, mask wearing, and hand hygiene. This will help. Younger children may find it harder to comply, but they are also less likely it appears to contract the virus and spread it in any case. Shifting as much as possible to online learning is also one strategy.

    Many schools, however, lack the resources to fully implement a COVID strategy for this fall. This is all a massive experiment, and we may not like the outcome.

  12. #662
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    https://sciencebasedmedicine.org/doe...-19-who-knows/

    Normally, I try to write my weekly post for this blog by Saturday. Unfortunately, for whatever reason, this weekend Sunday afternoon arrived, and I hadn’t yet written my post. Sure, I had started a post, but I wasn’t really happy with the topic or how it was coming out, which is probably why I hadn’t finished it by my usual time. Then, on Sunday afternoon, I started seeing stories like this one in The Washington Post:

    On the eve of the Republican National Convention where President Trump hopes to revive his flagging political fortunes, he will announce the emergency authorization of convalescent plasma for covid-19, a treatment that already has been given to more than 70,000 patients, according to officials familiar with the decision.

    In a tweet late Saturday night, White House press secretary Kayleigh McEnany said the announcement at 5:30 p.m. Sunday involved “a major therapeutic breakthrough on the China virus.” Officials confirmed on Sunday the treatment is convalescent plasma; they spoke on the condition of anonymity because they weren’t authorized to discuss the issue. The White House declined to comment.

    I must admit that when I heard about McEnany’s Tweet about an announcement of a “major therapeutic breakthrough” for COVID-19, I had a sneaking suspicion that it might be something like Oleandrin, the extract from the oleander plant whose utter lack of evidence of efficacy against COVID-19 (other than an in vitro study in cell culture) was discussed last week by our very own Steve Novella. It was just a sneaking suspicion, because, as has been discussed, oleander is toxic and there’s no evidence that it works against COVID in humans. That’s thin gruel even for Donald Trump to hold a press conference to make an announcement of a “therapeutic breakthrough”, even if the CEO and founder of MyPillow.com Mike Lindell had also endorsed Oleandrin. After all, if Anderson Cooper could slice, dice, and humiliate Lindell on live TV, I suspect that even Trump would be reluctant to come back for seconds.

    So it makes sense that the announcement would be about a treatment with some biological plausibility, and this announcement gave me the chance to take a look at the current evidence for the use of convalescent plasma to treat COVID-19.

    What is convalescent plasma?
    The use of convalescent plasma to treat infectious disease is a very old concept, dating back over 100 years. In brief, the use of convalescent plasma is a form of passive immunization in which plasma from patients who have survived an infectious disease is collected and used to treat patients with active disease. The idea behind the use of this plasma is quite simple, namely that the antibodies against the disease present in the convalescent plasma will bind to the microorganism causing the disease and thereby help a patient with the disease mount an effective immune response against the organism.

    Because I’m a history buff, I couldn’t resist reading a bit about the history of convalescent plasma as a treatment for infectious disease. Generally, it was thought that the first application of convalescent plasma for this indication was during the 1918 influenza pandemic, and, as noted in this article, there were several studies carried out during that pandemic suggesting that the plasma could be effective in decreasing mortality. A meta-analysis of eight reports from that time involving 1,703 patients was even published in 2006, confirming the benefit. True, the studies from the time were not randomized, double blind, or placebo-controlled, but the risk reduction for death was impressive, as this excerpt of the abstract shows:

    Eight relevant studies involving 1703 patients were found. Treated patients, who were often selected because of more severe illness, were compared with untreated controls with influenza pneumonia in the same hospital or ward. The overall crude case-fatality rate was 16% (54 of 336) among treated patients and 37% (452 of 1219) among controls. The range of absolute risk differences in mortality between the treatment and control groups was 8% to 26% (pooled risk difference, 21% [95% CI, 15% to 27%]). The overall crude case-fatality rate was 19% (28 of 148) among patients who received early treatment (after <4 days of pneumonia complications) and 59% (49 of 83) among patients who received late treatment (after ≥4 days of pneumonia complications). The range of absolute risk differences in mortality between the early treatment group and the late treatment group was 26% to 50% (pooled risk difference, 41% [CI, 29% to 54%]). Adverse effects included chill reactions and possible exacerbations of symptoms in a few patients.

    In actuality, though, this sort of therapy had been tried against polio in New York in 1916. The first documented use of convalescent plasma therapy was in Italy in 1906, when Francesco Cenci, a public health doctor working in a small town of Central Italy near Perugia, used serum from a 20 year old man who had just recovered from the measles to prevent measles infection in four children. Later in 1906, Cenci used convalescent serum to treat a child seriously ill with the measles complicated by pneumonia. Cenci also reported that a similar treatment had been made on two children in 1900, in the Pediatric Clinic of Rome directed by Luigi Concetti, that was thought to be the first to use serotherapy against diphtheria in Italy, after the seminal studies by Emil Behring and Shibasaburo Kitasato. By way of additional history, the first reference to antibodies came from Emil von Behring and Shibasabura Kitasato in 1890, when they showed that the transfer of serum from animals immunized against diphtheria to animals suffering from it could cure the infected animals, although investigators had been experimenting with such methods going back to 1880 or so. In any event, Behring was later awarded the Nobel Prize for this work in 1901.

    Since then, convalescent plasma has been tried and used for a variety of infectious diseases, with possible therapeutic efficacy claimed for the management of measles, Argentine haemorrhagic fever, influenza, chickenpox, infections by cytomegalovirus, parvovirus B19 and, more recently, Middle East respiratory syndrome coronavirus (MERS-CoV), H1N1 and H5N1 avian flu, and severe acute respiratory infections (SARI) viruses. Convalescent plasma has also been used in Ebola virus disease, with some reports of success dating back to the 1970s, when the disease was first described. Unfortunately, most of the studies of convalescent plasma for various infectious diseases have been of low quality, and many weren’t randomized. Unsurprisingly, with the rise of antibiotics and other antimicrobial therapies in the mid 20th century, interest in convalescent plasma to treat infectious disease waned, only to reappear periodically whenever there is a new epidemic or pandemic for which there is no effective treatment; i.e., Ebola virus, H1N1 influenza, severe acute respiratory syndrome (SARS) in 2003, and MERS in 2012. Indeed, successes using convalescent plasma for these latter two diseases established the precedent for using the same treatment for COVID-19.

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    Quote Originally Posted by curiouscat View Post
    And he's back.
    There was no warm welcome. No balloons. No banners. No champagne. No nothing. Perhaps I should have stay away longer lol.

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    This thread sucks now.

    Has anyone else heard of the virus mutating or reinfection?

    "The love for all living creatures is the most noble attribute of man" -Charles Darwin

    Quote Originally Posted by bowieluva View Post
    Chelsea, if you are a ghost and reading mds, I command you to walk into the light.

  15. #665
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    Quote Originally Posted by Angiebla View Post
    This thread sucks now.

    Has anyone else heard of the virus mutating or reinfection?
    https://www.forbes.com/sites/brucele.../#55f171b45094

    25 Year Old May Have Gotten Covid-19 Coronavirus Twice, And The Reinfection Might Have Been Worse

    https://www.livescience.com/coronavi...firmed-us.html
    Lab confirms first case of coronavirus reinfection in the US-The patient had symptoms both times.

    https://www.sciencemag.org/news/2020...o-reason-panic
    Some people can get the pandemic virus twice, a study suggests. That is no reason to panic

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    My dentist won't see me because of my husband's job being high risk. I hope the eye doctor will so that I can get my glasses.

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    https://www.wpri.com/news/us-and-wor...id-19-vaccine/

    PROVIDENCE, R.I. (AP) — The federal government has told states to prepare for a coronavirus vaccine to be ready to distribute by Nov. 1.

    The timeline raised concern among public health experts about an “October surprise” — a vaccine approval driven by political considerations ahead of a presidential election, rather than science.

    In a letter to governors dated Aug. 27, Robert Redfield, director of the U.S. Centers for Disease Control and Prevention, said states “in the near future” will receive permit applications from McKesson Corp., which has contracted with CDC to distribute vaccines to places including state and local health departments and hospitals.

    “CDC urgently requests your assistance in expediting applications for these distribution facilities and, if necessary, asks that you consider waiving requirements that would prevent these facilities from becoming fully operational by November 1, 2020,” Redfield wrote.

    He wrote that any waivers will not compromise the safety or effectiveness of the vaccine. The Associated Press obtained the letter, which was first reported by McClatchy.

    Redfield told Yahoo Finance that officials were preparing “for what I anticipate will be reality, is that there’ll be one or more vaccines available for us in November, December.”

    James S. Blumenstock, a senior vice president at the Association of State and Territorial Health Officials, said the CDC was offering “an aggressive but necessary timetable” but that public health agencies were mobilizing to prepare detailed plans.

    Several vaccine and public health experts pointed out that final stage trials of experimental vaccines are still recruiting, and are at best halfway through that process. The vaccines are two doses, and each is given a month apart. Several experts told the AP they did not understand how there could be adequate data on whether the vaccines work and are safe before Nov. 1.

    “Being ready is reasonable. Cutting short phase 3 trials before you get the information you need isn’t,” said Dr. Paul Offit, a Children’s Hospital of Philadelphia immunization expert who sits on the FDA’s vaccine advisory committee.

    Peter Hotez, dean of Baylor University’s tropical medicine school, said he was “very concerned” about whether the Food and Drug Administration would use an emergency use authorization to approve a vaccine before knowing whether it works and is safe.

    “It gives the appearance of a stunt rather than an expression of public health concern,″ Hotez said

    Michael Osterholm, a University of Minnesota infectious disease expert, said he was concerned about an “October surprise” with a vaccine being rushed through ahead of the election.

    “The public health community wants a safe and effective vaccine as much as anybody could want it,” Osterholm said. “But the data have to be clear and compelling, that the vaccine is effective and that it’s safe.”

    He said there was a “credibility gap” between doctors and the FDA about how rigorous products are being evaluated during the pandemic.

    Some states on Wednesday said they were working on next steps while still awaiting details from CDC.

    New Mexico Human Service Secretary David Scrase said the state was preparing to administer coronavirus vaccines on a limited basis starting in November to health care workers and residents of long-term care facilities. The broad public vaccine roll-out is slated for January. He said current vaccine provider networks are robust and adequate for the COVID-19 effort.

    Regarding the timing of the CDC request to expedite or waive permits for distribution centers to open Nov. 1, Scrase said, “I can’t tell you about the political motivations on that.”

    A spokesman for Tennessee Republican Gov. Bill Lee said the state was reviewing its next steps.

    “News of a vaccine is encouraging and a testament to the power of American innovation,” said the spokesman, Gillum Ferguson.
    OK then? but this sounds too much like the US wants to impress Russia over their speed to release a vaccine.

  18. #668
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    Quote Originally Posted by raisedbywolves View Post
    My dentist won't see me because of my husband's job being high risk. I hope the eye doctor will so that I can get my glasses.
    Thanks for the info.

    I had a dentist app a couple months back, but cancelled it because I didn't feel comfortable going.

    You should be fine with the eye doctor if you wear a mask.

    "The love for all living creatures is the most noble attribute of man" -Charles Darwin

    Quote Originally Posted by bowieluva View Post
    Chelsea, if you are a ghost and reading mds, I command you to walk into the light.

  19. #669
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    Quote Originally Posted by JohnLanders View Post
    https://www.wpri.com/news/us-and-wor...id-19-vaccine/



    OK then? but this sounds too much like the US wants to impress Russia over their speed to release a vaccine.

    This, and the fact that it's being rushed out just to give Trump votes.

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    Here is an update on Covid

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    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.

  23. #673
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    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.

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    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.

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    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.

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