FDA prepares for COVID-19 vaccine changes to address variants: Shot

Deputy FDA Commissioner Janet Woodcock said authorities are likely to hold an advisory board to consider changes to the COVID-19 vaccine in response to coronavirus variants.

Scott Hensley / NPR

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Scott Hensley / NPR

Deputy FDA Commissioner Janet Woodcock said authorities are likely to hold an advisory board to consider changes to the COVID-19 vaccine in response to coronavirus variants.

Scott Hensley / NPR

With two COVID-19 vaccines available in the United States and more vaccines under development, things are starting to turn around. However, the fact that viral mutations have been detected around the world means that someday an update may be needed to maintain the effectiveness of the vaccine.

The Food and Drug Administration is already working on a guide on how vaccine changes can be turned green.

“So we’ve been thinking about this for a while, because what we learned very early on when variants began to emerge was that this could happen, right?” FDA Peter Marks Said during a webcast with the American Medical Association January 29th. “That’s why we’re not going to be surprised.”

Marks, who heads the FDA’s Center for Biologics Evaluation and Research, aims to be “agile” when it comes to assessing fine-tuning the COVID-19 vaccine to be effective against coronavirus mutations. It states that there is.

This means that agencies need some small studies, but not large clinical trials that companies first adopted and took months to complete.

“They are probably studies involving hundreds rather than thousands, and when deploying something, make sure it’s doing what it says, and also these To help you understand some of the functions. Immune response. “

Deputy FDA Commissioner Janet Woodcock “We must be prepared for all contingencies,” he told reporters on February 4. She said the agency will release industry guidance on variants in the coming weeks.

It is unknown when the guidance will be used. “It will depend on how quickly the mutants appear, how much the vaccine does not provide protection, etc.,” Woodcock said in a press conference. “Therefore, the situation is very fluid, but I think it may not be enough to do a full-scale efficacy study that can be used to shift or add ingredients to existing vaccines.”

She also said authorities were most likely to convene an advisory board before approving mutation-related changes to existing vaccines. The same committee met at the end of last year to evaluate and discuss evidence about the Pfizer and Moderna vaccines before voting to recommend emergency use. The FDA usually follows the advice of the Commission.

“If I have the time, I think it’s very wise to set up an advisory board, because it provides maximum public transparency,” she said. Vaccine hesitation is already a problem, Woodcock said. “In fact, if we develop a mutant strain, the general public can be even more confused, but we hope it doesn’t happen.”

Three variants of concern have emerged in the United States. One was first seen in Brazil, the other was confirmed in South Africa, and the third swept the UK. Mutations found in these variants The virus can easily infect healthy human cells, making it difficult for the immune system to fight them off.

As of WednesdayAccording to the US Centers for Disease Control and Prevention, 944 coronavirus variants have been identified in the United States. All but 12 of these cases were related to the first variant found in the United Kingdom.

The United States is undoubtedly underestimated because it takes time to create a system for finding variants. The CDC has increased the sequence of coronavirus testing by about 10-fold over the past three weeks and hopes to learn more about the true prevalence of variants over time. CDC Director Rochelle Walensky I said at the White House briefing on Monday.

Meanwhile, the UK-identified variant could become the predominant strain of coronavirus in the United States by the end of March. Anthony Fauci, head of the National Institute of Allergy and Infectious DiseasesSaid during the briefing.

The data available show that the Pfizer and Modana vaccines are still “very effective” against British variants, Forch said. He added that continuing public health guidelines such as social distance and wearing masks and immunizing as many people as possible is “the best defense against the evolution of dispersal.”

Vaccines in the pipeline also appear to work against mutant strains, but they may not work as well.

For example, the vaccine produced by Novavax has been shown to be effective against the variants identified in the United Kingdom and South Africa, Not very effective against them.. in the meantime, South Africa has suspended the deployment of the AstraZeneca-Oxford vaccine Small studies have suggested that shots provide minimal protection against mild and moderate illness.

So far, the Moderna and Pfizer vaccines seem to be reliable for protection against mutant viruses. Paul Offit, a member of the FDA Advisory Board on Vaccines.. But preparing for the future would be wise.

“We should be prepared for this and the fact that these variants may become more tolerant,” Mr. Ofit said in a conference call hosted by Georgetown University. “If you look at people who are fully immunized with these vaccines, such as the mRNA vaccine, and nevertheless see them hospitalized when infected with the mutant, it’s time to cross the border. To date, that hasn’t happened. “

in the end, COVID-19 is in fashion, The vaccine may be renewed on a regular basis as well as the flu vaccine.

However, the FDA does not need clinical data to adjust influenza vaccines for each new season of influenza.Instead, it mainly reviews information about the manufacturing process, said Norman Baylor, Former Director of the FDA’s Vaccine Research and Review Bureau. He was speaking at a press conference hosted by Georgetown University.

“But one of the differences is that the flu vaccine is licensed. [for COVID-19] There is no license.And … it has minimal data, “he said, the COVID-19 vaccine Allow emergency use, But not yet approved. “So you want to see some data.” He said authorities measured antibody levels in the patient’s blood to see how well the updated vaccine was protected from the COVID-19 mutant. I think you will want to judge.

Renewal of FDA approval is not limited to influenza vaccines, says Jonathan Darrow, Lawyer Harvard Medical School Regulatory, Treatment and Law Program..

“In fact, it’s very common for the FDA to approve supplements for drug and vaccine changes,” says Darrow. “Changes can include new or expanding populations, new active ingredients called excipients in the manufacturing process, new Inactive ingredients, or new diseases treated by drugs.”

Says there are at least three scenarios that can be performed for COVID-19 vaccine renewal Genevieve Kanter, Health Economist, University of Pennsylvania Those who have studied the evaluation of FDA drugs and vaccines. The FDA may request an entirely new emergency use authorization. This allows the manufacturer to submit an amendment to an existing emergency use authorization. Alternatively, the original vaccine may contain sufficient follow-up data to achieve full FDA approval before renewal is required. In the final example, the update goes through a standard supplemental approval process for virus strain changes.

Based on what FDA officials said, the modified Emergency Use Authorization seems to be an option they are leaning on, she said.

Asked how long it would take for the FDA to accept a fine-tuned vaccine or perhaps a third booster shot, Canter said it was difficult to say. However, there are clues as to how the authorities dealt with the H1N1 pandemic in 2009, when the vaccine change took months.

The FDA approved the seasonal influenza vaccine in March 2009, but the World Health Organization issued a warning about H1N1 in June. Therefore, the vaccine for that year needed to be renewed.

“In July and late July of that year, an advisory board was convened to discuss vaccine-related clinical trials for the H1N1 strain, and by mid-September, four supplements were approved for H1N1,” Canter said. He said. “So they can definitely do it within two months.”

You can contact NPR’s Pharmaceutical Correspondent Sydney Lupkin. [email protected]..