New Corona Vaccine was Launched on the Market in October or Failed

 

The US FDA made it clear on Tuesday that before approving any vaccines, they need to see follow-up data for volunteers two months after the second dose of the new crown vaccine. This also means that it will be difficult for any vaccine manufacturer to obtain FDA approval before the end of October. US President Trump once promised the public "October Surprise" that the government will distribute vaccines on a large scale as soon as October.

A reporter from China Business News 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, and the second dose was 21 days or 28 days after the first dose. Based on this, any vaccine manufacturer before the end of October It is difficult to obtain FDA approval, and Trump’s "expectations" are likely to fail.

According to the latest FDA guidelines for vaccine manufacturers, data from Phase III clinical studies should include a median follow-up time of at least two months after completing the complete vaccination plan to provide sufficient information to assess the benefit risk of the vaccine In summary, these data include adverse events, severe cases of neo-coronary in the study subjects, and neo-coronary cases that occurred during the time when the adaptive (rather than congenital) and memory immune response of the vaccine played a protective role.

In an interview with the medical journal JAMA, Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research of the U.S. FDA Approved Vaccine, said: "The practice of two months of follow-up is normal. We must balance safety and urgency. At present, the fastest-growing vaccines in clinical trials in the United States are the new corona vaccines 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 people who have received the real vaccine have fewer infections compared to people who received a placebo.

Researchers are most worried about the safety of the vaccine. Dr. Max said: "If we obtain a vaccine with 70% or 80% efficacy and vaccinate 70% or 80% of the population, then it is possible to form a'herd immunity'. So it is very important to increase people's confidence in the vaccine. important." US FDA officials have made it clear that they want to have a dialogue with vaccine manufacturers, not just make strict rules that must be followed. To this end, the US FDA will also hold a public meeting of the Advisory Committee on Vaccines and Related Biological Products. Francis Collins, director of the National Institutes of Health, said at a vaccine seminar hosted by Johns Hopkins University and the University of Washington: "The advisory committee will make recommendations, and the FDA will decide whether to accept these recommendations."

A vaccine expert told a reporter from China Business News that most adverse reactions to vaccines usually occur between two to three months after people are vaccinated. "The US FDA has made a requirement for two follow-up visits after vaccination. Yue’s decision is correct." It is worth mentioning that on October 6, local time, WHO Director-General Tedros Tedros said for the first time on the timetable for the launch of the new crown vaccine: “The new crown vaccine may be ready before the end of this year. We need a vaccine, and hope that people Can be vaccinated."