Covid-19 vaccine dosing schedule: “ If it moves, it won’t be the FDA that will make it move ”

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CNN confirmed to the FDA on Wednesday that if a manufacturer requests a change in its emergency use authorization, the manufacturer would have to submit data to the FDA in support of the requested change.

If changes are proposed to the dosing schedules for the Covid-19 vaccine in the future, the FDA likely wouldn’t make the proposals, said David Benkeser, a biostatistician at Emory University whose research includes work on the preventive vaccines.

“If this moves, it won’t be the FDA that will. They are bound by legal operations that dictate how drugs are approved in the country, so it’s no surprise to hear them say their strong preference is to stick with what we know works, ”Benkeser said, adding that any changes most likely would be submitted to the FDA for review and then the agency would review the data to support those changes.

“They’re going to want to see correlated data,” Benkeser said. “And if we can establish and validate a correlate, I think they will be happy to consider other dosing regimens, as well as new vaccines next year.”

“ Suggesting changes … is premature ”

Health officials have speculated on the possibility of expanding the vaccine supply by giving people a single dose instead of two doses, or perhaps cutting the doses in half. British officials created an outcry saying they would consider such changes.

FDA Commissioner Dr. Stephen Hahn and Dr. Peter Marks, who heads the FDA’s vaccine division, released a statement Monday saying that “suggesting changes to the dosage or schedules authorized by the FDA of these vaccines are premature and not firmly rooted in the available evidence “.

In Britain, doctors decided last week to extend the 21-day period between the administration of the first and second doses of the Pfizer / BioNTech Covid-19 vaccine in order to stretch the vaccine supply.

Pfizer said it did not have data showing that a single dose of its vaccine would provide protection against the disease after more than 21 days.

“Pfizer and BioNTech’s Phase 3 study for the Covid-19 vaccine was designed to assess the safety and efficacy of the vaccine on a two-dose schedule, separated by 21 days,” Pfizer said in a statement Thursday. “There is no data to show that protection after the first dose is maintained after 21 days.”

UK chief medical officers defend delay of second dose of Pfizer Covid-19 vaccine

In the United States, the Infectious Diseases Society of America noted in a statement Tuesday that the country faces hurdles and challenges with the deployment of Covid-19 vaccines – but the group agrees with the FDA that “changes in the authorized use of the vaccines, including the dosage which has been informed by clinical trial data, would be premature and potentially harmful. “

“Such changes now risk both undermining vaccine effectiveness and eroding the public confidence necessary for successful vaccine adoption. As always, our approach to this pandemic must be science-based. , leadership, funding, collaboration and cooperation “. Dr Barbara D. Alexander, President of IDSA, and Dr Rajesh Gandhi, President of the Association of HIV Medicine, wrote in the joint statement.

‘It’s a unique moment’

The overall development of Covid-19 vaccines – including dosage regimens and the arming process – has been unprecedented, added Benkeser of Emory University.

“In many ways, it’s a unique moment,” said Benkeser. In the past, “there have been epidemics and science had to react very quickly to produce a vaccine. Ebola, for example, was one where we got a vaccine on the ground that seemed very effective – but the epidemic Ebola has never been on the scale of Covid. ”It took years for an Ebola vaccine to be approved.

Now initiatives to deliver Covid-19 vaccines to people in the United States are criticized as being slow and clumsy, but the rollout “is likely to gain momentum” in the coming weeks, Dr Anthony Fauci said on Tuesday .

“It’s been a slow start and we need to do better across the board, but I think we’ll pick up the momentum as we get past the holiday season in the first two weeks of January,” said Fauci, director of the National Institute of Allergy and Infectious Diseases, said Newsday’s Randi Marshall at a virtual event.

“We have to be very careful, Randi, not to jump to a conclusion based on a very short period of time because we are just getting started,” Fauci said.

“The government and locals, including governors and mayors and others, have just started in recent weeks in December, right in the middle of the holiday season,” Fauci said. “I think we should wait until the first and second week of January to see if we can catch up.”

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