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. – To date, more than 339 million doses of the covid-19 vaccine have been applied to protect people from the coronavirus. Several studies show that the three vaccines licensed for emergency use in the United States work and are safe, and the government continues to distribute them in schools and stadiums. However, none have been formally approved by the US Food and Drug Administration (FDA).
Clearly, the vaccine approval process is moving faster than ever. However, the FDA has yet to reveal a timeline of when its work will be completed and the data is still being reviewed.
On Wednesday, President Joe Biden told Don Lemon during a CNN forum that he hopes covid-19 vaccines can get full approval “quickly.”
“I am not promised a specific date, but my expectation, speaking with the group of scientists that we gather … plus others in the field, is that sometime, perhaps at the beginning of the school year, at the end of August, starting September and October, they will get final approval, “Biden said.
Earlier Wednesday, the director of the National Institutes of Health, Dr. Francis Collins, told CNN’s Jim Acosta that full approval could come in “the next few months.”
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Vaccine maker Pfizer appears to be further along in the process.
In July, the company announced that the FDA gave its vaccine a priority review, which sets the regulatory clock for six months, and which means that technically the company must know if it has approval by January. A standard review is 10 months.
FDA Acting Commissioner Dr. Janet Woodcock has said the agency intends to complete the review before its 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 and Health Sciences.
Because the FDA has already reviewed the manufacturing materials and has been reviewing the clinical data the entire time, Tice said, “We do not expect the six-month priority review clock to expire.”
Tice says he believes full approval of the Pfizer vaccine could come in September. Some experts, like Dr. Paul Offit, director of the Center for Vaccine Education, believe it could be as early as August.
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As for the vaccine maker Moderna, the company told CNN on Wednesday that it does not have a specific deadline for approval. It is still working with the FDA on what is called an ongoing submission for approval – it shares new data with the agency as it is generated.
“We are still in the process of completing our ongoing shipment, which we announced on June 1. It is not complete at this time,” said Ray Jordan, a spokesman for Moderna. “It is not the case that the FDA has our final submission and that we are waiting to hear from them.”
Moderna expects its materials to be finished this fall. The timeline for approval would be subject to the FDA’s regulatory review process, Moderna said.
At what point is the process now
Historically, getting a licensed vaccine for the fall would be quick, especially with everything the FDA has to go through.
At this point, what takes time is that the agency has to go through absolutely everything, it cannot skip a page and there is a lot of everything.
“When we were reviewing the applications when they were on paper, there were so many that they would not fit on the forklift. This is how big the application is, you have a lot of data to review,” said Norman Baylor, who led the Office of Vaccine Review and Research at the FDA and went through this process multiple times. He is the current CEO of Biologics Consulting.
The covid-19 vaccines received authorization based on interim data that showed the vaccines were safe and effective for only about three months. “Although, when something is 95% effective, you can assume that it will probably be highly effective for a while,” Offit said.
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For full approval, the FDA has at least six months of efficacy data to review. “People are saying ‘why is it taking so long?’ Well, the FDA wants to make sure it has a protective duration and a long-term effect, “Tice said. “It is not that the agency, I think, has any concern about the vaccine itself, just because of the licensing requirements, it is necessary to have this additional data,” he adds.
“The FDA does not skimp on ensuring the quality, purity and potency of its products,” Tice further notes.
Offit believes that the data review should be done fairly quickly, as the FDA has been collecting data the entire time. What often takes time is that the FDA also has to validate the process that makes the vaccine licensed. Every step has to be validated.
“Whether it’s the computers that are being used or cleaning the tanks, or whatever, there are a lot of boxes to check to ensure that there is consistency from each batch to the next,” Offit said.
That means an interdisciplinary team of FDA experts is reviewing millions of documents, running their own analysis, getting any clarification you need from vaccine companies, and conducting a thorough inspection of the manufacturing process.
And it’s not just someone from the FDA doing the review, Baylor said. There is a secondary and tertiary review. So a doctor would review the material and then a supervisor would need to review it and then it would go to the division director.
“We have some reviewers that are reviewing late into the night, really, this is not a 9 to 5 review,” Baylor said. “People are not aware, but people are giving up their vacations, working on weekends, Saturdays and Sundays. You are working late into the night.”
“The FDA is not sitting around playing with its thumbs,” Baylor said.
Called to move faster
While historically the process has moved quickly, for some it is not fast enough.
Dr. Eric Topol wrote an editorial for The New York Times earlier this month that argued that the millions of people who have received these mRNA vaccines demonstrate that these vaccines work. “This is the most studied biological product in human history for its safety and efficacy,” Topol told CNN.
“I’ve been frustrated because I know it should have been approved by now,” Topol said. “Janet Woodcock made a statement that this was ‘one of the highest priorities.’ No, it has to be priority number one,” he added.
In response to Topol’s editorial, the current director of the FDA’s Center for Biologics Research and Evaluation, Peter Marks argued that “any approval of a vaccine without completing the high-quality review and evaluation that Americans expect the agency to do it would undermine responsibilities, affect trust in the agency, and do little to help combat doubts about COVID-19 vaccines. “
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However, as vaccination rates have fallen dramatically in the US, some have pointed to approval as a sure way to speed up the process.
A Kaiser Family Foundation survey of American adults released this week found that among a third of adults surveyed who are not yet vaccinated, 16% said the vaccine was too new, too unknown, or not tested enough. Some said in this survey that they would not receive a covid-19 vaccine until it was required.
While companies may 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 anticipate will come very soon … Maybe in the next few months, then the legal capacity to enforce a mandate becomes much stronger,” said Collins, the director of the NIH.