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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 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.”

Pfizer timeline

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

In July, the company ad that the FDA has given its vaccine a priority review, which sets the regulatory clock at six months, which technically means the company needs to know if it has 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, program director of regulatory affairs and assistant professor of clinical research and leadership in the School of Medicine and Health Sciences at George Washington University.
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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 him 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, the director of the Vaccine Education Center thinks it could be as early as August.

The Moderna timeline

For the vaccine manufacturer Modern, 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 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.

“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 led the FDA Office of Vaccine Research and Review and I have gone through this process many times. 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 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.

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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 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.

Dr Eric Topol wrote an editorial for the “New York Times” earlier this month, who argued that the millions of people who have received these mRNA vaccines demonstrate 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, Pierre Marc argued that “any vaccine approval without the completion of the high-quality review and evaluation that Americans expect from the agency would undermine the statutory responsibilities of the FDA, affect trust in the agency, and little to help fight against vaccine hesitation ”.

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 A survey of U.S. adults released this week found that among one-third of adults surveyed who have not 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 demand 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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2/ https://www.cnn.com/2021/07/22/health/covid-19-vaccine-approval-when/index.html

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