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Approving a vaccine in the U.S. usually takes years, but COVID-19 vaccines are moving through in record time. What does that mean?

USA TODAY

Could an approved coronavirus vaccine be released prior to Election Day on Nov. 3? It’s extremely unlikely – but not impossible – experts say. 

President Donald Trump on Monday said, “vaccines are coming momentarily,” and he has promised on multiple occasions that one will be ready before the election, now less than a month away.

For that to happen, though, three things would be necessary:

  • First, extremely positive data from ongoing Phase 3 clinical trials would have to be released showing a candidate vaccine to be extraordinarily effective. 
  • Second, the vaccine manufacturer would have to apply to the U.S. Food and Drug Administration for its approval.
  • And third, the FDA likely would have to ignore its own guidelines for companies seeking authorization.

On Tuesday, the FDA updated those guidelines for COVID-19 vaccine emergency use authorizations, requiring at least two months of follow-up data after trial volunteers take the necessary doses.

“This is a scientific agency applying scientific standards,” said Gillian Woollett, a senior vice president and expert on FDA guidance and regulatory issues at the health care consulting firm Avalere Health.

Pfizer is furthest along in US Phase 3 vaccine trials after starting July 27

The updated guidance makes it a long shot that a vaccine could be approved for use before the election.

The timing is tight. There are four COVID-19 vaccines currently in Phase 3 clinical trials in the United States. The candidates from the two companies that started first, Moderna and Pfizer, both require two doses. Of those, the furthest along is the Pfizer vaccine. It requires two doses given 28 days apart.

Pfizer launched its U.S. Phase 3 trials on July 27. The second shots would have begun on Aug. 24. Two months of follow-up after that second shot would be Oct. 23. 

President Donald Trump says COVID-19 vaccines are coming ‘momentarily.’ Scientists say they’re not.

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U.S. Surgeon General Jerome Adams said during a stop in Texas Monday that a vaccine against COVID-19 could be ready as soon as the end of this year or early 2021. But he isn’t saying when Americans might be able to get it. (Sept. 28)

AP Domestic

It’s not clear, however, how many volunteers were immediately enrolled in the clinical trial but it likely started small. Such trials tend to start slowly so potential problems can be addressed. 

It could take several weeks or months for Pfizer, or any COVID-19 vaccine maker, to have enough volunteers go through both doses followed by the two-month follow-up to have enough data to present to FDA.

That’s when the real countdown begins. Only when a company, in this case, frontrunners Moderna, Pfizer, AstraZeneca, or Johnson & Johnson, applies for either a license or the more rapid emergency use authorization that the FDA can begin evaluating whether to allow a vaccine’s release.

This Aug. 2, 2018, file photo shows the U.S. Food and Drug Administration building behind FDA logos at a bus stop on the agency’s campus in Silver Spring, Md. (Photo: Jacquelyn Martin, AP)

The heads of nine biopharmaceutical companies working on a COVID-19 vaccine issued a letter Sept. 8 pledging to fully vet their candidates before asking for federal approval to market them.

Once an application is made, it must be evaluated by FDA, approved and then reviewed by the agency’s external review board, the Vaccines and Related Biological Products Advisory Committee.

For a vaccine to be available prior to the election, all of this would need to take place in 11 days. 

There’s a ‘high likelihood’ of success if vaccine trials go to their ‘designed end’

There are some ways the process could go more quickly. Phase 3 clinical trials don’t necessarily have to run their full course and include all 30,000 volunteers before a vaccine company makes an application to the FDA.

FDA officials have said it might be acceptable to stop a clinical trial earlier on if a vaccine’s Data Safety Monitoring Board finds it is working so well it would be immoral to hold it back.

Data Safety Monitoring Boards are outside groups of experts allowed to take “peeks” at the data before a clinical trial has finished to make sure the vaccine or medicine being tested is working and is not harmful.

It is rare, but not unheard of, for a clinical trial to be stopped because the results are so good the monitoring board feels the manufacturer should immediately apply for a license so that it can be made available. 

When will children get a COVID-19 vaccine? It’s going to be a while

But stopping a trial early could mean there might not be enough data available to show a vaccine candidate was safe and effective in older people at greatest risk for severe disease and illness, said Dr. Larry Corey, a professor of medicine at the University of Washington School of Medicine in Seattle.

Adding only a few more weeks could have a huge difference in what’s known about the vaccine, he said. 

Keeping a trial running just seven additional weeks triples the amount one can learn about vaccine efficacy, he said during a program Tuesday on scientific integrity in vaccine trials sponsored by Johns Hopkins University and the University of Washington.

“Allowing the trial to go to its designed end would provide a high likelihood that we would be able to determine that vaccine efficacy appears to benefit the elderly, those with health disparity and importantly reduce health complications,” Corey said. 

Could HHS Secretary Alex Azar bypass FDA and ‘put a vaccine out there’?

The final arbiter of the process will be the Vaccines and Related Biological Products Advisory Committee, which has a meeting scheduled for Oct. 22. According to the committee’s agenda, “no specific application will be discussed at this meeting.”

Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, is a member of the committee. He said he can’t see a way for a COVID-19 vaccine to go through the necessary oversight prior to the election. 

Where will your family be? Expert panel recommends who should be first in line for COVID-19 vaccine

The only way for that to happen, he said, would be if the head of the U.S. Department of Health and Human Services were to make the decision himself. In a memo published Sept. 15, HHS Secretary Alex Azar declared he has final authority over the nation’s health agencies, including the FDA.

The memo said the power to sign new rules is reserved to the secretary, a Trump appointee. 

“Alex Azar could say, ‘We’re in the midst of the pandemic, I am choosing to put a vaccine out there, I am bypassing the FDA,'” said Offit. 

Contact Elizabeth Weise at [email protected]

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