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    Home > Active Ingredient News > Drugs Articles > The FDA panel voted in favour of the new crown vaccine, the EUA

    The FDA panel voted in favour of the new crown vaccine, the EUA

    • Last Update: 2020-12-28
    • Source: Internet
    • Author: User
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    Today, the FDA panel voted 17 to 4 against, with 1 abstention in favor of the new crown vaccine BNT162b2 developed by German biotech company BioNTeck in partnership with Pfizer for use by people over 16 years of age with no history of severe allergies.
    that the non-yes vote was mainly due to insufficient data on 16- and 17-year-olds, rather than a different interpretation of the risk-benefit ratio calculation.
    results of today's clinical trial of the vaccine were also officially published in NEJM, which officially announced 95% of the protective effect.
    -term side effects are mainly injection point pain, headache, and tiredness, long-term adverse reactions need to be observed.
    : This result should be said to be expected, the United Kingdom, Canada and other countries have approved the emergency use of the vaccine.
    15 million new crown cases and real infections in the U.S. are certainly well above that record, so mass immunization has come a long way.
    of course, the first half of the population immunization costly, the United States now has recorded more than 250,000 new deaths.
    vaccine and other similar products will make it safer for most people to gain resistance to the new crown, but because capacity constraints require many people to wait months for access, large numbers of people will still be infected.
    estimates that half of all people in the United States will eventually be immunized through natural infections and half through vaccines.
    the vaccine has shown 95 per cent protection against new coronary disease in large Phase III clinical trials, there are still many unknowns to be worked out in the coming years due to time haste.
    is long-term protection capability, which was observed for an average of only two months and longer.
    is the ability to protect special groups of people, and this trial recruits volunteers over the age of 16 who are free of immunodeficiency.
    Pfizer has begun trials for 12-15-year-olds, starting next April for children ages 5-11 and then children under the age of five.
    is the vaccine's efficacy in blocking infection, and in theory the vaccine can still infect and infect others, but with no symptoms of its own.
    is the effect on the long-term symptoms of the new crown.
    the vaccine may seem to prevent severe illness, but because the new crown has many long-term symptoms, the improvement of these symptoms is also a consideration.
    of course, these questions are mainly theoretical, reducing the number of diseased infections by 95% without these unproven effects is unlikely.
    more realistic question is whether a vaccine is strong enough to protect against group immunity, and the trial shows that a shot can protect about 80 percent.
    whether there is still motivation to take a shot three weeks later, if most people only take one shot the consequences of how serious.
    this balance is not easy, and the second-pin risk-benefit ratio is clearly different from the first-needle algorithm because the benefits are marginal but the risks are similar.
    second real problem is a serious side effect on individuals, with two severe allergic reactions already occurring in the UK.
    40,000 people in the trial, and the subgroups in the trial also performed in a basically balanced performance, there was uncertainty in the extravasse to 300 million people.
    clinical trials have entry criteria, volunteers are more closely observed, and real-world conditions are more complex.
    of course, the biggest question is long-term safety, especially for special groups such as pregnant women, and there is no alternative to long-term trials.
    2020 will forever be defined as the year of the new crown and the first year of mRNA technology, a precedent in human history that has never been so severely controlled by man-made factors in a year, and it is not common for a new technology to perform a hat-trick on its debut.
    I was impressed by a popular science book in the 1980s called The Road to Conquering Germs, where antibiotics and vaccines used to strike like aliens, and humans were largely helpless.
    's new crown battle is the most successful and efficient counterattack in the history of human and microbial confrontation, showing the power of modern biotechnology.
    new crown vaccine is one of the few true medical miracles that will go down in history like insulin and penicillin.
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