Pfizer Covid Vaccine Gets Emergency Use Approval by US Panel
An expert panel advising the US Food and Drug Administration (FDA) gave the green signal to the emergency use approval of Pfizer vaccine on Thursday. Voting was conducted to reach the conclusion with 17 in favour, four against and one abstention. The committee had to evaluate whether, “based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh its risk for use in individuals 16 years of age and older?”
FDA is not bound to follow the advice, however, it is expected that it will follow the recommendation in the coming days. The panel comprised independent experts and researchers, including infectious disease specialists, biostatisticians and other scientists. “I think the data was pretty compelling that the benefits greatly outweigh the risks. I wish there could have been slightly more enrollment of minorities in the trial. But I think the numbers were sufficient to make a decision,” Dr. James Hildreth, a member of the FDA advisory panel told CNN.
Pfizer scientist Kathrin Jansen informed the expert committee that the vaccine is the result of the innovative messenger RNA technology. Pfizer’s vaccine has already got approval in the United Kingdom, Bahrain and Canada.
Besides Pfizer, Moderna, AstraZeneca among other pharmaceutical companies have developed vaccines and governments are seeking emergency approvals for frontline workers, senior citizens and those who are more vulnerable to the disease. Meanwhile, Moderna has begun a study of its vaccine in adolescents as the US has started to distribute its first shots among adults.
On Wednesday, Britain reported that two health care workers showed major allergic reactions after Pfizer vaccine dose. Hence, there will be a warning label on the vaccine if it gets final approval.
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