By all accounts, the vaccine approval process is moving faster than ever. However, the FDA has yet to release a timeline for its completion and the data is still under review.
President Joe Biden told CNN’s Don Lemon at a CNN town hall on Wednesday that he expects Covid-19 vaccines to gain full approval “quickly”.
“They don’t promise me any specific date, but my expectation, talking to the group of scientists we have assembled … and others in the field, is that at some point, maybe at the beginning of the school year, at the end of August, starting in September, October, they will get final approval, ”Biden said.
Earlier Wednesday, National Institutes of Health director Dr Francis Collins told CNN’s Jim Acosta that full approval could come in “the next two months.”
Vaccine maker Pfizer appears to be furthest along in the process.
Acting FDA Commissioner Dr Janet Woodcock said the FDA intends to complete the review before the January deadline.
Because the FDA has already reviewed the materials of manufacture and reviewed the clinical data from the start, Tice said, “We don’t expect him to hit the six-month priority review clock.”
The Moderna timeline
“We are still in the process of completing our ongoing submission, which we announced on June 1. It is not yet complete,” said Ray Jordan, spokesperson for Moderna. “This is not the case that the FDA has our final submission and we are waiting to hear from them.”
Moderna expects its materials to be completed this fall. The approval timeline would then be subject to the FDA’s regulatory review process, Moderna said.
Where is the process now
Historically, getting a vaccine licensed by the fall would be quick, especially with everything the FDA has to review.
At this point, what takes time is the agency has to go through everything, they can’t skip a page, and there’s a lot of everything.
The Covid-19 vaccines received clearance based on provisional data which showed the vaccines to be safe and effective for only about three months. “Although, when something is 95% effective, you can assume that it will probably be very effective for a while,” Offit said.
For full approval, the FDA has at least six months of efficacy data to review. “People say ‘why is it taking so long?’ Well, the FDA wants to make sure it has a duration of protection, a long-term effect, “Tice said.” It’s not that the agency, I think, has any concerns about the vaccine in. itself, it’s just for the authorization requirements, you have to have this additional data. “
“The FDA doesn’t skimp on the quality, purity, and potency of your products.”
Offit believes the review of the data should proceed fairly quickly, as the FDA has always obtained data. What often takes time is that the FDA must also validate the process that makes the vaccine for approval. Each step must be validated.
“Whether it’s the computers that are used or that clean the vats, or whatever it is, there are a lot of checkboxes to make sure there is consistency from each batch to the next,” he said. declared Offit.
This means that an interdisciplinary team of FDA experts reviews millions of documents, performs its own analysis, gets the clarification it needs from vaccine manufacturers, and subjects the manufacturing process to a thorough inspection.
And it’s not just an FDA person doing the review, Baylor said. There is a secondary and tertiary examination. So a clinician would review the material, then a supervisor would review it, and then it would go to the division director.
“We have reviews that go through long into the night, really, it’s not a 9 to 5 review,” Baylor said. “The public doesn’t know about it, but yes people are forgoing their vacations and working weekends, Saturdays and Sundays. You work late into the night.”
“The FDA doesn’t sit around twiddling its thumbs,” Baylor said.
Calls to go faster
While historically the process has evolved rapidly, for some it is not fast enough.
“I was frustrated because I know it should have been approved by now,” Topol said. “Janet Woodcock said that was one of the highest priorities. No, it has to be number one.”
Why full approval is important
Yet, as vaccination rates have dropped dramatically in the United States, some have indicated that approval is a sure way to speed up the process.
“If it was approved with full FDA approval – which we all expect to happen very soon … Maybe in the next few months – then the legal capacity to warrant will become much stronger,” Collins, NIH director, said.
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