The FDA made it clear Tuesday that it needs to see follow-up data two months after volunteers get a second dose of the new crown before approving any vaccine. It also means that it will be difficult for any vaccine manufacturer to get FDA approval by the end of October. U.S. President Donald Trump has promised a “October surprise” that the government will distribute vaccines on a massive scale as soon as October.
But the U.S. Food and Drug Administration (FDA) made it clear on October 6th that they needed to see follow-up data two months after volunteers were given a second dose of the new crown vaccine before approving any vaccine.
First Financial Reporter learned that the first large-scale clinical trial of the new crown vaccine in the United States only started at the end of July this year, the second dose of 21 days or 28 days after the first dose, in order to calculate that by the end of October any vaccine manufacturers will be difficult to obtain FDA approval, Trump’s “expectations” are likely to fall short.
According to the FDA’s newly released guidelines for vaccine manufacturers, data from Phase III clinical studies should include median follow-up time of at least two months after completion of a complete vaccination program to provide sufficient information to assess the vaccine’s benefit risk profile, including adverse events, new coronary cases in the study subjects, and new crown cases occurring within a time when the vaccine’s adaptability (rather than congenitality) and memory immune response are protective.
“It’s normal to follow for two months, and we have to balance safety and urgency,” Dr. Peter Marks, director of the FDA-approved Center for Biologics Evaluation and Research, told the medical journal JAMA. “
The fastest-growing vaccine currently in clinical trials in the United States is the new crown vaccine produced by Moderna and Pfizer, 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 being vaccinated, and whether fewer people have actually been vaccinated than those who have been given a placebo.
The researchers are most concerned about the safety of the vaccine. “If we get a vaccine that’s 70 or 80 percent effective and we vaccinate 70 or 80 percent of the population, it’s possible to create a ‘group immunity,'” Dr. Marks said. So it’s important to increase confidence in vaccines. “
FDA officials have made it clear that they want to talk to vaccine manufacturers, not just to set strict rules that must be followed. To that end, the FDA will also hold a public meeting of the Advisory Committee on Vaccines and Related Biologics. “The advisory committee will make recommendations and the FDA will decide whether to accept them,” Francis Collins, director of the National Institutes of Health, said at a vaccine seminar hosted by Johns Hopkins University and the University of Washington. “
One vaccine expert told First Financial that most adverse reactions to vaccines usually occur between two and three months after people are vaccinated, and that “the FDA is right to make a decision to require follow-up for two months after vaccination.” “
It is worth mentioning that on 6 October local time, WHO Director-General Tandesser said for the first time on the launch time of the new crown vaccine: “The new crown vaccine may be ready to be launched by the end of this year.” We need a vaccine, and hopefully by the end of the year people will be vaccinated. “