When will we have an FDA-approved vaccine?

When will we have an FDA-approved vaccine?

 

More than 339 million doses of Covid-19 vaccine have been administered across the US, and while studies show that the three vaccines authorized for emergency use in the United States work and are safe, none has been formally approved by the US Food and Drug Administration.   By all accounts, the approval process for the vaccines is moving faster than it ever has before. However, the FDA has yet to disclose a timeline for when its work will be complete, and data is still being reviewed.   Last Wednesday, President Joe Biden told a CNN town hall that he expects Covid-19 vaccines could get full approval "quickly.” Based on conversations he’s had with experts, he expects a final nod soon.   "They're not promising me any specific date, but my expectation, talking to the group of scientists we put together ... plus others in the field, is that sometime, maybe in the beginning of the school year, at the end of August, beginning September, October, they'll get a final approval," Biden said.   The Covid-19 vaccines received authorization based on interim data that showed the vaccines were safe and effective for only about three months. For full approval, the FDA has at least six months of efficacy data to review.   And in addition to the data, the FDA also has to validate the process to make the vaccines. "Whether it's the computers that are being used or cleaning out the vats, or whatever it is, it's a lot of boxes to tick to ensure that there's consistency in each lot to the next," said Dr. Paul Offitt, an FDA adviser.   And while a vaccine for those 12 and older might be approved soon, more safety and efficacy data is needed for children ages 5-11. Multiple people familiar with the Pfizer and Moderna pediatric trials told The New York Times that the FDA has asked the two companies to enlist more trial participants so they can better detect rare side effects.