The Trump administration is set to launch a major vaccination campaign early Monday that public health experts say is the best bet in the country to end an epidemic that has killed nearly 290,000 Americans and affected 15.4 million people so far. The Pfizer vaccine, developed by the company’s German partner Bioendech, was first subjected to FDA testing. It was 95 per cent effective in preventing the disease in a 44,000-person U.S. trial, the results of which were published in the New England Journal of Medicine on Thursday. Members of the FDA Advisory Board supported the approval of the vaccine, but there were questions about possible allergic reactions in the UK, with many experts failing to approve a short-term approval of the panel, which puts some teens and population groups at low risk for the virus. The team discussed whether participants in the U.S. clinical trial who received the placebo should receive the actual vaccine, and whether the data released this week could show that the vaccine can be given as a single dose instead of two, after showing rapid immunity after a jab. President-elect Joe Biden released a statement praising the progress toward a vaccine, saying it was “a bright light at an unnecessarily dark time”. The first edition misrepresented the administration of food and medicine, which is unlikely to occur for several months. Approval is a higher bar than the emergency approval currently on the table. “In a ham-handed attempt to get credit [Trump] Of administration [Operation Warp Speed], Biden panel falsely reports before FDA approval, “White House Undersecretary of State Brian Morkenstern tweeted after Fiden’s release that despite the FDA advisory panel voting in favor of the vaccine, who – and should not – is still lingering. There are questions: There are new concerns following reports from the UK this week that two health workers with serious, known allergies have had allergic reactions after handling the footage.The UK said on Wednesday that “people with significant allergic history should not receive the approved Pfizer vaccine” earlier this month. There are 10 million people [the United States] Those who take Epiphenes with them are now going to believe that they cannot get this vaccine because they have peanut allergies and they have egg allergies. That’s a lot of people, “said Paul Afid, a vaccine expert at the University of Pennsylvania.” We need to pierce those two people in the UK. ” Asked to add life-threatening allergic reactions as part of a so-called pharmaceutical awareness program, a list of adverse reactions they monitor for post-accreditation. , Said Marion Grooper, director of the FDA’s Office for Vaccine Research and Review, who carefully administers the vaccine to people with severe allergies. Six aphids suggested the test was done to quickly understand the risks and reassure the public that this is not a serious problem, “because as long as we have the best data this problem will not die.” But he did not suggest that the FDA should not approve the widespread vaccine population. The agency requested additional data on the safety and efficacy of the vaccine in adolescents, pregnant women and people with allergies, but that does not stop emergency recognition. Pfizer is one of the only manufacturers to study the vaccine in children under 12 years of age, but is currently seeking permission to use the vaccine in people 16 years of age and older. Young people in Pfizer’s clinical trials reported more adverse reactions and more severe reactions to the vaccine than older test volunteers, said Susan Wollersheim, medical officer for the FDA’s Department of Biology. But the overall reactions to the vaccine are relatively mild and include injection site pain, headache or fever one day after the injection. Some committee members expressed concern that the recognition should be limited to those over 16 and over 18 years of age before voting. The group eventually voted in favor of using the vaccine for those 16 and older, although teenagers may be one of the last to be vaccinated – and can wait until 2021. The FDA Advisory Committee also explored the thorny question when test volunteers who received placebo received a working vaccine. Pfizer sought permission to vaccinate members of its placebo team as soon as it was approved. The project caused tension with the company because it could effectively complete a randomized, controlled study without gathering enough data to answer questions about the long-term safety of the vaccine and the duration of protection it provides. Pfizer proposed the following participants six months after the completion of the second shot, before those in the placebo group were vaccinated. At Thursday’s meeting, members of the advisory board suggested an alternative program in which the placebo patients in the Pfizer test could be vaccinated first, such as essential workers or the elderly, within their own priority group. This will ensure that they do not progress more than individuals at high risk from the virus, but will still encourage them to stay in the study. Otherwise, test participants suspected of being in the placebo group may confirm that test by testing for antibodies and withdraw from the study. Pfizer representatives also pushed back on the single-dose vaccine suggestion, echoing the comments of CEO Albert Burla on Tuesday after positive reports emerged. “If someone tries to carry only a single dose, it is a huge mistake,” Burla said at a news conference. “We saw some protection from 12 days after the first dose, but protection was not complete.” “People need to take two doses to protect themselves,” he said.
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