Feds to meet on potential need for annual COVID-19 vaccine

Federal regulators are set to meet Wednesday on the potential need for annual COVID-19 boosters and variant-specific vaccines.

The U.S. Food and Drug Administration will hold a virtual meeting of its Vaccines and Related Biological Products Advisory Committee to develop a framework for deciding whether additional doses of the vaccine will be needed, given the likelihood of rates spiking again and, if so, what kind and how often shots could be administered.

The meeting, expected to include testimony from the Centers for Disease Control and Prevention, the National Institutes of Health and independent experts, will come a week after the FDA authorized a second booster dose of the Pfizer and Moderna vaccines for adults 50 and older who received their first one at least four months ago.
An additional shot is also available for individuals who are moderately or severely immunocompromised, while the CDC, in its updated recommendations, added adults who received the Johnson & Johnson vaccine for both their primary dose and booster at least four months ago.

“As we prepare for future needs to address COVID-19, prevention in the form of vaccines remains our best defense against the disease and any potentially severe consequences,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said last week. “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."

A study conducted in Israel and published Tuesday by the New England Journal of Medicine found that people 60 and over who received a fourth dose of drugmaker Pfizer-BioNTech's COVID-19 vaccine had a lower rate of infection than those with three doses. And those who did contract COVID-19 after a fourth booster had a less severe case than people infected after three shots, according to the study. But that extra protection proved to be short-lived, with maximum protection peaking four weeks after the fourth booster and waning after eight weeks to almost no protection.

The FDA will not vote on any specific plans Wednesday.

Dr. Bruce Farber, chief of public health and epidemiology for Northwell Health, said the FDA is concerned about the next surge — likely in the fall — when the immunity of a large portion of the public who contracted omicron this past winter, along with those boosted around that time, will have waned.

"It's clear we are not going to get rid of this virus," he said. "But controlling it; having a normal life and having our events go on the way we are now may require us to have a yearly booster. It's a very small price to pay."

One consideration will be a vaccine dedicated specifically to battling the current subvariant, BA. 2, which has caused a slight uptick in positive cases. The current vaccine is based on the original strain of the virus, which has mutated several times over the past two years.

Dr. Sharon Nachman, chief of pediatric infectious diseases at Stony Brook Children’s Hospital, said while a variant-specific booster is possible — drugmakers are already deep into clinical trials — it's unclear if another shot will be needed or shown to be more effective than current vaccine formulas.

The virus, Nachman said, will likely mutate faster than vaccines can adapt. But the question is by how much.

"It's not that they'll be ahead of the vaccines. It's how many steps they'll be ahead," she said of potential variants. " … The hope is that they'll change — and we certainly saw that from delta to omicron — but even with that change there was still enough bang for the buck using the initial strain."

Tailoring a vaccine for emerging variants and offering it annually may sound familiar to those who receive their annual influenza shot. But medical experts point out that COVID-19 is more contagious, has higher mortality rates and is less of a seasonal virus than flu — heightening the need for the public to get vaccinated and boosted.

Despite the risk, experts said the population is permanently split on the vaccines.

"There will be roughly half of the people who will never get another shot and booster and another half who are probably going to be very religious about their boosters," Farber said. "That's the reality of the world we live in."

Elsewhere Tuesday, Mayor Eric Adams brushed off criticism that New York City is one of the only jurisdictions — if not the only one — still mandating masks for toddlers.

"There is no other city like New York City," Adams said on the CNN+ streaming service. "If we gauge our reactions, behaviors, based on other cities, we will make a big mistake." 

Citing COVID-19 case counts, Adams last week announced that the city would not be rescinding a mask mandate, as he previously announced, for preschoolers under the age of 5.

City Health Commissioner Ashwin Vasan on Tuesday urged doctors to alert patients about monoclonal antibody treatments for COVID-19, including the oral antiviral Paxlovid, and Evusheld, used to treat immunocompromised patients and those who may not sufficiently respond to the vaccines.

The antiviral treatments, Vasan said, can greatly reduce the risk of hospitalization or death when taken shortly after initial virus symptoms.

The state's 7-day COVID-19 positivity rate hit 3% Monday for the first time since February, while Long Island's rate was 3.1%, with 159 new cases in Nassau and 88 in Suffolk, according to state health department data.

The figures reflect a change in the state's COVID-19 policy as the federal Department of Health and Human Services no longer requires testing facilities to report negative rapid tests. The state's positivity rate, officials said, will be computed using only PCR results.

There were 10 reported COVID-19 deaths statewide Monday, including one in Nassau.

With Matthew Chayes

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By Robert Brodsky

robert.brodsky@newsday.com@BrodskyRobert

Robert Brodsky is a breaking news reporter who has worked at Newsday since 2011. He is a Queens College and American University alum.