The FDA made it clear on Tuesday that before approving any vaccine, they would need to see follow-up data from volunteers two months after the second dose of the vaccine.It also means that it will be difficult for any vaccine manufacturer to obtain FDA approval before the end of October.U.S. President trump has promised the public "October surprise", that is, the government will distribute the vaccine on a large scale as soon as October.
However, the U.S. Food and Drug Administration (FDA) made it clear on October 6 that before approving any vaccine, they would need to see follow-up data from volunteers two months after the second dose of the new crown vaccine.
First financial reporter learned that the first large-scale clinical trial of new crown vaccine in the United States was only started at the end of July this year, and the second dose was 21 or 28 days after the first dose. Based on this, it is very difficult for any vaccine manufacturer to obtain FDA approval before the end of October, and Trump's "expectation" is likely to fail.
According to the latest FDA guidelines for vaccine manufacturers, data from phase III clinical studies should include a median follow-up period of at least two months after the completion of a complete vaccination program to provide sufficient information to assess the benefit risk profile of the vaccine, including adverse events, the subjects' new severe cases, and the adaptability of the vaccine (rather than first) And memory immune response played a protective role in the time of new crown cases.
Peter Max (Peter Marks), Ph.D., director of the Center for the Evaluation and Research of FDA Vaccine-approved Biologics, told the medical journal JAMA》:" It's normal to follow up for two months. We have to balance safety and urgency ."
At present, Moderna and Pfizer's new crown vaccine are the fastest-growing vaccines in the United States, both of which require two doses. Researchers testing the vaccine are waiting to see how many people are still infected with the new coronavirus after they have been vaccinated, and whether people who have received the real vaccine have fewer infections than those who have received a placebo.
What the researchers are most concerned about is the safety of the vaccine. "If we get a vaccine that's 70% or 80% effective and vaccinate it to 70% or 80% of the population, then it's possible to have 'mass immunity,'" Dr. marks said. So it's very important to increase people's confidence in vaccines. "
American FDA officials have made it clear that they want to talk to vaccine manufacturers, not just set strict rules to follow. For this purpose, the United States FDA will also convene public meetings of the Advisory Board on Vaccines and Related Biological Products. Collins (Francis Collins), director of the National Institutes of Health, told a vaccine seminar hosted by Johns Hopkins University and Washington University :" The Advisory Committee will make recommendations FDA will decide whether to accept them ."
A vaccine expert told the first financial reporter that most adverse reactions to vaccines usually occur between two and three months after people are vaccinated ." The U.S. FDA is right to make a decision requiring two months of follow-up after vaccination ."
It is worth mentioning that on October 6, local time, who director general Tan Desai said for the first time on the launch time of the new crown vaccine: "the new crown vaccine may be ready to be launched before the end of this year. We need vaccines, and hopefully by the end of this year, people will be vaccinated. "