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Why does FDA spend 22 days reviewing clinical data of Johnson & Johnson new crown vaccine?

via:cnBeta.COM     time:2021/2/7 11:33:39     readed:186

In the anxiety caused by the epidemic, many Americans are eager to get vaccinated as soon as possible. But a vaccine from scientific research, clinical trials to commercial promotion needs to go through a very long time.This week, Johnson & Johnson submitted a large number of clinical trial data, and the U.S. Food and Drug Administration (FDA) announced that the data review results will not be released until February 26, that is, 22 days later.

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In the increasingly serious situation of COVID-19, there are many 22 senses. Hospitals are becoming more and more crowded and the number of deaths is increasing. FDA reviewed Pfizer / biontech vaccine data for 20 days and Moderna vaccine data for 17 days. Therefore, the 22 day data review time is not too long.

During the 22 day period, FDA researchers had to review the clinical data of 43783 people who had been submitted in the United States, Latin America and South Africa, where the new crown variation dominated. Usually, vaccine data audit takes several months. In order to promote vaccine work as soon as possible, FDA greatly shortens the audit time.

So what is the main content of FDA review in 22 days? At present, all information about vaccines comes from vaccine companies. Although relevant data show that vaccines are effective, FDA does not fully trust these vaccine companies. The most typical example is thalidomide.

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