A key Food and Drug Administration Advisory Committee voted Thursday to 17 to 4, with one member voting Thursday to recommend approval of Pfizer and Bioendech’s corona virus vaccine for emergency use, with the final adjustment to widely distribute the last dose before the FDA. One person voted. If the FDA adopts the unrestricted recommendation of the Advisory Board on Vaccines and Related Biological Products – this is to be expected – it will mark a crucial moment in the Covid-19 epidemic, which has affected more than 15.4 million people and killed about 290,000 in the United States in less than a year. The team plays a key role in the recognition of influenza and other vaccines in the United States, verifying footage is safe for public use. While it does not have to follow the recommendation of the FDA Advisory Board, it often does. The FDA could grant emergency application approval for Pfizer’s vaccine early Friday, team member James Hildreth told NBC’s Weekend Today on Saturday. . Emergency utilization approval, or EUA, generally allows a drug or vaccine to be administered to a specific population or to organizations such as hospitalized patients because the company is constantly evaluating safety data. It is unclear whether the FDA and BioNtech vaccine will be approved by the FDA. Use in some groups. Some, including pregnant women and young children, may have to wait to be vaccinated in the United States until trials in those particular groups are completed. The FDA said Tuesday that it does not currently have enough information to make decisions about vaccine safety in children under 16, pregnant women and those with compromised immune systems. Regulators in Canada, the United Kingdom and Bahrain have destroyed most adult vaccines. The panel recommended that the vaccine be approved urgently for people 16 years of age and older. Prior to the vote, some experts at the meeting argued that its recommendation should be limited to those under the age of 18, adding that security data for 16- and 17-year-olds was “thin”. “I would like to join that line of people who advocate for it… I think the data is very thin, and it’s not enough to say that we are protected from low incidence of disease,” said Dr. Mark Sawyer, a voting member of the panel and epidemiologist at the University of California, San Diego School of Medicine, Said. The EUA is not the equivalent of a full endorsement, which usually takes months. Pfizer has only submitted two months of follow-up security data, but the agency usually requires six months for full approval. In a statement after the vote, Pfizer CEO Albert Burrell said the company was “delighted” to vote, and the FDA released an acknowledgment that be prepared to take the vaccine to those in the United States in an effort to help fight this devastating epidemic. “U.S. officials say they are ready to distribute the vaccine within the approved 24 hours. Initial doses will be limited by increasing production, and officials estimate that it will take months for everyone in the United States who wants to be vaccinated to receive the vaccine. Pfizer says it plans to send 50 million vaccines this year to 25 million people.” Enough to vaccinate.The vaccine is expected to be distributed in phases, with the most important U.S. workers and vulnerable people receiving it first.The Centers for Disease Control and Prevention has provided an outline for states to prioritize healthcare and nursing homes, but states can distribute the vaccine as they see fit. They plan to monitor any adverse reactions to Pfizer’s vaccine. Dr. Nancy Masonier, director of the National Center for Immunization and Respiratory Diseases of the CDC, said at a meeting of the agency on Thursday. Authorities will use a text-messaging system called V-SAFE to provide early signs of adverse reactions to the vaccine. The UK, which last week approved Pfizer’s vaccine for emergency use, launched mass vaccinations on Tuesday. Before being widely distributed among the population of the UK, the vaccine is being offered to leading health workers, nursing home workers and those over 80 years of age. Pfizer’s vaccine uses messenger RNA, or MRNA technology. This is a new approach to vaccines that use genetic material to stimulate the immune response. Late clinical trial data show that the vaccine is 95% effective in preventing goiter and is safe and prevents serious illness. To achieve maximum effectiveness, the vaccine requires two doses taken three weeks apart. The FDA has indicated that it approves a Govt-19 vaccine that is safe and at least 50% effective. The CDC reports that the flu vaccine, in general, reduces the risk of getting influenza by 40% to 60% compared to non-vaccinated individuals. Two days before the meeting, the FDA released the documents on its website. The data submitted by Pfizer is consistent with the recommendations put forward by the Agency for Emergency Use. This confirmed that the vaccine was very effective and did not raise any major safety concerns, and that additional safety information about the vaccine is still needed for children, pregnant women, and those with compromised immune systems. At the meeting, FDA vaccine reviewer Dr. Susan Wollersheim noted that the experimental data showed “numerical imbalance” in cases related to Bell’s argument, which caused a temporary weakness or paralysis of the muscles in the face. There are four cases in the vaccine group and none in the placebo group, he said. Although the frequency of cases does not exceed the general population, the FDA recommended further monitoring if the vaccine is still approved for widespread use. Pfizer’s vaccine requires a storage temperature of minus 94 degrees Fahrenheit, which poses potential logistics challenges for rural and inland cities without good health care infrastructure. In comparison, Moderna claims that its vaccine can be stored for up to six months at minus 4 degrees Fahrenheit. President Donald Trump’s corona virus vaccine jar Dr Monsieur Sloy has said the U.S. can distribute enough of 100 immunizations. By the end of February, nearly a third of the U.S. population was American. He said the entire American population could be vaccinated against Govt-19 by June. Pfizer said it completed its full-scale production lines in the United States and Europe last week and is confident it can deliver targeted levels. CNBC’s Nova Higgins-Dunn and Will Fuer contributed to the report. .
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