Why there is no fully approved Covid-19 vaccine yet and why it matters

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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’re not promising me any specific date, but my expectation, speaking to the group of scientists that we’ve assembled… August, starting in September, October, they’ll 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.”

Pfizer timeline

Vaccine maker Pfizer appears to be furthest along in the process.

In July, the company announced that the FDA had given its vaccine a priority review, which sets the regulatory clock at six months, which technically means the company should know if it has obtained approval by January. . A standard exam is 10 months.

Acting FDA Commissioner Dr Janet Woodcock said the FDA intends to complete the review before the January deadline.

“So we all know it won’t take that long,” said Melissa Tice, director of the regulatory affairs program and assistant professor of clinical research and leadership at the George Washington University School of Medicine & Health Sciences.
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Because the FDA has already reviewed the materials of manufacture and reviewed the clinical data from the start, Tice said, “We don’t expect it to hit the six-month priority review clock.”

Tice says she believes full approval for Pfizer’s vaccine could come in September. Some experts like Dr Paul Offit, director of the Vaccine Education Center think it could be as early as August.

The Moderna timeline

For vaccine maker Moderna, the company told CNN on Wednesday that it did not have a specific deadline for approval. He’s still working with the FDA on what’s called a continuous submission for approval – he shares new data with the agency as it’s generated.

“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 licensed vaccine 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.

“When we were looking at the requests back when they were on paper, there was so much that it didn’t fit into the elevator. This is the size of the request, you have a lot of data to look at. said Norman Baylor, who had headed the FDA’s Office of Vaccine Research and Review and has undergone this process on several occasions. He is the current CEO of Biologics Consulting.

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 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.

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“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 review millions of documents, perform their own analysis, get the clarification they need from vaccine manufacturers, and thoroughly inspect the manufacturing process.

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 until the end of 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.

Dr Eric Topol wrote an editorial for the “New York Times” earlier this month claiming that the millions of people who have received these mRNA vaccines show that these vaccines work. “It is the most studied biologic in human history for its safety and effectiveness,” Topol told CNN.

“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.”

In response to the editorial from Topol, the current director of the Center for Biologics Evaluation and Research at the FDA, Peter Marks argued that “any vaccine approval without the completion of high review and evaluation The quality Americans expect from the agency would undermine the FDA’s statutory responsibilities. , affect confidence in the agency, and do little to help address vaccine reluctance. “

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.

A Kaiser Family Foundation survey of American adults released this week found that among one-third of adults surveyed who haven’t yet been vaccinated, 16% said the vaccine was too new, too unknown, or not tested enough. Some said in this poll that they would not get a vaccine until it was needed. While companies are allowed to require the vaccine, experts believe more will make it a requirement if – and when – it gets full approval.

“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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