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

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By all accounts, the vaccine approval process is going faster than ever. However, the FDA has not yet released a timeline for when its work will be completed and the data is still under review.

On Wednesday, President Joe Biden told CNN’s Don Lemon during the CNN Townhall conference that he expects Covid-19 vaccines to receive full approval “quickly.”

“They don’t promise me any exact date, but my expectation, speaking to the group of scholars we’ve brought together … as well as others in the field, is that sometime, perhaps at the beginning of the school year, at the end of August, the beginning of September, October, They will get final approval.”

Earlier Wednesday, NIH Director Dr. Francis Collins told CNN reporter Jim Acosta that full approval could come in the “next two months.”

Pfizer’s timeline

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

In July, the company announced that the U.S. Food and Drug Administration had given its vaccine a priority review, setting the regulatory clock for six months, which technically means the company should know if it has won approval by January. The standard review 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 long,” said Melissa Tice, director of the Regulatory Affairs Program and Assistant Professor of Clinical Research and Leadership in the George Washington University School of Medicine and Health Sciences.

Since the FDA has already reviewed the manufacturing materials and is reviewing clinical data throughout, Tice said, “We do not expect the full priority review to last for six months.”

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

Our supplier schedule

As for vaccine maker Moderna, the company told CNN Wednesday that it had no specific time frame for approval. It’s still working with the Food and Drug Administration on the so-called rolling submission for approval — it’s sharing new data with the agency as soon as it’s created.

“We are still in the process of completing the rolling submission, which we announced on June 1. It is not complete at the moment,” said Ray Jordan, a spokesperson for Moderna. “It’s not that the FDA has our final delivery and that we’re waiting to hear from them.”

Moderna expects its materials to be complete this fall. Moderna said the approval timeframe will then be subject to the FDA’s regulatory review process.

Where is the process now

Historically, getting a vaccine license by the fall would be fast, especially with the Food and Drug Administration having to review.

At this point, what takes time is that the agency has to go through absolutely everything, can’t skip a page, and there’s too much of everything.

Norman Baylor, who ran the US Food and Drug Administration’s Office of Vaccine Research and Review and has gone through the process several times, said. He is the current CEO of Biologics Consulting.

The Covid-19 vaccines were given clearance based on provisional data that showed the vaccines were safe and effective for only three months. “Although when something is 95% effective, you can assume it will be very effective for some time,” Offit said.

For full approval, the Food and Drug Administration 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 protective duration and a long-term effect.” “It’s not that the agency, I think, has any concerns about the vaccine per se, it’s just as per the licensing requirements, you have to have that additional data. .”

“The FDA doesn’t fall short on making sure your products are quality, purity, and potency.”

Offit thinks the data review has to go very quickly, because the FDA has been getting the data all along. It often takes time that the Food and Drug Administration must also validate the process that makes the vaccine licensed. Each step must be validated.

“Whether it’s computers that are used or scrubbing sinks, or whatever, there are a lot of boxes to tick to make sure there’s consistency in each piece to the next,” Offit said.

This means that a multidisciplinary team of FDA experts sift through millions of documents, perform their own analysis, get any clarification they need from vaccine companies, and give the manufacturing process a thorough check.

It’s not just one person from the Food and Drug Administration doing the review, Baylor said. There is a secondary and university review. So the doctor reviews the materials and then the supervisor needs to review them and then they are submitted to the department manager.

“We have some reviewers who are reviewing long into the night, really, this is not a 9 to 5 review,” Baylor said. “The public isn’t aware, but yes, people take their vacations, work weekends, Saturdays and Sundays. You work until night.”

“The FDA doesn’t sit around polluting its thumb,” Baylor said.

Calls to move faster

Although the process has historically moved quickly, it is not fast enough for some.

Dr. Eric Topol wrote an op-ed in the New York Times earlier this month arguing that millions of people who have received mRNA vaccines have proven to be effective. “This is the most studied biological material in human history for safety and efficacy,” Topol told CNN.

“I was frustrated because I knew it had to be approved by now,” Topol said. Janet Woodcock made a statement that this was ‘among the highest priorities’. No, it should be priority number one.’

In response to Topol’s editorial, the current FDA director of the Center for Biological Evaluation and Research, Peter Marks, said that “any approval of a vaccine without completing the high-quality review and evaluation Americans expect the agency to do will undermine the FDA’s legal responsibilities, affecting confidence in the The agency does not do much to help combat vaccine hesitancy.”

Why full consent is important

However, with vaccination rates so low in the United States, some have pointed to approval as a surefire way to speed up the process.

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

“If it gets approved with the full approval of the Food and Drug Administration — which we all expect is coming very soon…maybe in the next couple of months — the legal capacity to authorize becomes a lot stronger,” Collins, the NIH director said.

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