COVID-19: FDA advisory group plans future strategies

• The COVID-19 advisory committee of the United States Food and Drug Administration (FDA) is meeting to formulate strategies for COVID-19 going forward.
• The group will be exploring future decisions that will need to be made as SARS-CoV-2 continues to evolve.
• The recent FDA decision on second boosters illustrates the complexities behind such decisions.

On Wednesday, April 6, 2022, the U.S. Federal Food and Drug Administration (FDA) is convening a virtual meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC). The committee’s task is to develop forward-looking strategies to guide the FDA’s future responses to the still-evolving SARS-CoV-2 virus.

VRBPAC will be discussing how to make future decisions regarding vaccine boosters and establishing standards for identifying upcoming SARS-CoV-2 variants of concern.

In a press release, Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, explains:

“Now is the time to discuss the need for future boosters as we aim to move forward safely, with COVID-19 becoming a virus like others such as influenza that we prepare for, protect against, and treat.”

To help the public understand the committee’s deliberative process, the FDA will release background materials from the meeting, as well as a list of committee members, and the meeting’s agenda. VRBPAC will not be voting on plans or products.

Public health: A moving target

The announcement of the meeting described its role in assisting the development of a framework to support decision-making on vaccine updates, the timing of booster vaccines, and the prioritization of vulnerable groups. However, a week before the conference, the FDA revealed that a decision had already been made for older and certain individuals with weakened immunity.

On March 29, the FDA announced support for an optional second Pfizer or Moderna booster at least 4 months after a previous booster or vaccine dose for people age 50 or older, and for certain people over age 12 with a weakened immune system.

The same day, the U.S. Centers for Disease Control (CDC) agreed, issuing their own “permissive recommendation.” Second boosters for others remain on the April 6 agenda.

Is immunity waning?

The decision to make the second booster optional, and not recommended outright, reflects the complexities of making such decisions.

Dr. William Schaffner, professor of infectious diseases at the Vanderbilt University Medical Center in Nashville, TN, told Medical News Today:

“It really is quite clear that we are a large, diverse country. And there are some places where there are plateaus or slight increases, but they’re not what we would call surges.”

Nonetheless, he said, the variant’s behavior in Europe has some worried that “within 2 to 3 weeks, we’re going to have that surge here, and it will find people who are newly susceptible or more susceptible in these high-risk groups, and they anticipated an uptick in hospitalizations.”

So far, Dr. Schaffner noted, most cases are mild.

“We can tolerate millions of colds. We don’t care about that, really.”

“But keeping people out of the hospital,” said Dr. Schaffner, “and not having them get serious disease and dying, is important. And also continuing to relieve the strain on the healthcare system.”

There are also Israeli and U.K. studies that indicate protection against SARS-CoV-2 may be waning somewhat for older people.

Vaccine fatigue

One concern among those wary of approving additional boosters is likely a keen awareness of “vaccine fatigue.”

“Look at the fact,” said Dr. Schaffner, “that half the population who is eligible has not yet received their third dose. So, the notion is we ought to be focusing on getting the third dose to people rather than creating more confusion with the fourth dose.”

Of particular concern is that another booster or vaccine may be required against COVID-19 next autumn. Experts are concerned that there may be no public tolerance for yet another shot.

It is also the case, said Dr. Schaffner, that “there are a lot of people who say, hmm, at the moment, the risk is diminishing almost on a daily basis. Why would we need a booster now?”

Some experts also caution that the impact of multiple boosters on the individual immune system is unknown.

However, “Here in the U.S., the data would indicate that if you’ve been vaccinated with three doses, that protection against serious disease is maintaining itself pretty well.”

Deciding for oneself

For now, only people 50 and older and people with weakened immunity have a choice to make regarding the optional second booster. If a person qualifies, and they have concerns, it is a good idea to discuss them with their physician.

It is worth noting, said Dr. Schaffner, “the vast majority of hospitalizations currently continue to [occur] in completely unvaccinated people and in persons who are only partially vaccinated.”

“Omicron, with its extraordinary, unprecedented degree of efficiency of transmissibility, will ultimately find just about everybody,” says Dr. Anthony Fauci.

“Those who have been vaccinated,” says Dr. Fauci, “and boosted would get exposed. Some, maybe a lot of them, will get [the infection] but will very likely, with some exceptions, do reasonably well in the sense of not having hospitalization and death.”

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