The U.S. Food and Drug Administration’s Advisory Board has recommended emergency approval of the Govit-19 vaccine developed by Pfizer and Bioendech. This recommendation is expected to signal that the first approval of the Govit-19 vaccine for use in the United States is imminent. . It marks a major milestone in an epidemic that has killed more than 285,000 Americans and 1.5 million people worldwide. If approved by the FDA, the United States would be the third country in the world to authorize the use of the Pfizer / Bioentech vaccine. Of the wider public population behind the UK and Canada, this would be the most populous country to do so. In additional data on the vaccine published in the New England Journal of Medicine on Thursday, Pfizer and Bioendech said the vaccine was 95% effective in a randomized controlled trial of more than 43,000 people. An editorial in the magazine described the development of the vaccine as a “success” for science. “Most vaccines have been in development for decades, but this could move from conception to large-scale processing within a year,” wrote Dr. Eric Jay, editor-in-chief of the magazine, Rubin. The vaccine uses messenger RNA technology to stimulate the immune system to introduce the body to the spike protein found on the outside of the corona virus. This requires two weeks and is administered at three-week intervals. Scientists are still studying how long the vaccine will protect people, the safety and effectiveness of the vaccine in children and pregnant women, and the rate of asymptomatic disease in vaccinated recipients. Vote, Joe Biden called the move “a bright light in an unnecessarily dark time.” “Selected vaccines are not the same as vaccines,” Hoover said. “Our challenge now is to measure production and distribution to distribute 100 million views in the first 100 days of my administration,” he said. “Before I took office, the Trump administration had to negotiate with Pfizer and Moderna to buy the volume and act quickly to measure productivity for the American people and the world. We need Congress to fund our distribution efforts. “The referendum was delayed and there was no disagreement. Four members of the 22-member panel voted against granting emergency accreditation after a late debate on whether 16- and 17-year-olds should be disqualified. A nurse in London holds a file of the Pfizer / BioNTech Govit-19 vaccine. : Frank Austin / Episom experts argued that the subcommittee’s data were “thin” and should be recommended for further study, but others argued that safety and efficacy data to date were sufficient for emergency use, not least because the group was unlikely to receive the vaccine for several months because of supply restrictions. Because “we have clear evidence of goodness, on the other hand we have theoretical risk,” said Dr. Paul Affid, a vaccine specialist at the Philadelphia Children’s Hospital. Fourth, another key concern of the team is how to continue blind placebo controlled trials. This is because once emergency recognition has been granted, it is unethical to prevent test participants from finding out if they have received a placebo, and eventually getting vaccinated. The FDA can approve the vaccine for emergency use at any time after the advisory board meeting. , And the Trump administration is pushing for quicker approval. But the FDA should signal that it is properly considering safety and performance concerns. Vaccines generally have a longer list of approvals than many drugs because they are given to healthy adults. Accepting a vaccine too quickly can arouse public suspicion and lead to higher vaccine reluctance. Consent very slowly risks more lives. The virus kills more than 2,000 Americans a day and 80 Americans an hour. According to a recent study by the Millbank Quarterly, the FDA takes 78% of the action recommended by its advisory committees. The panel’s recommendation comes as the epidemic is pushing the US health system to the brink. More than 192,000 Americans a day are diagnosed with Govt-19, and hospitals in many states are overcrowded and health workers are running out. This week, for the first time in the epidemics, more than 3,000 people died of Govt-19 in a single day. But even this alarming number is considered a serious calculation by the US Centers for Disease Control and Prevention (CDC). Infections, hospitalizations and deaths are two to seven times lower than the actual number of viruses, the advisory board meeting said on Thursday. “Reporting deaths has changed over time,” said Dr. Aaron Hall, chairman of the CDC. Branch of respiratory viruses. However, he added: “The death toll could underestimate the actual death toll.” A sign outside Pfizer headquarters in New York City. Photo: Angela Weiss / AFP / Getty Images The CDC estimates that Covid-19 has caused 2.4 million hospitalizations, 44.8 infections and 52.9 million infections. Thanksgiving is upon us, which means the holiday season is in full swing. Will not be a bullet. If the Pfizer vaccine is a very limited product, it will initially only vaccinate about 20 million people. The CDC Advisory Council has recommended that states allocate those limited items to health workers and the elderly living in long-term care facilities, with a population of about 23 million. That means Americans must continue to travel social distance, wear masks, wash their hands and avoid crowds – even if the vaccine brings the virus within control. Furthermore, Pfizer’s vaccine poses serious logistical challenges because it must be stored at -94F (-70C), transported in dry ice in special containers, staff must be trained on how to handle these containers, and the vaccine can be shipped in smaller quantities than 975. With this in mind, experts believe the second vaccine – only a week behind the approval process – will be recommended for approval soon. The second vaccine was developed by the National Institute of Allergy and Infectious Diseases and Modern. The trial for the vaccine candidate is scheduled for December 17.
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