FDA considers annual COVID shots to increase uptake 

Federal regulators are mulling a plan that would simplify COVID-19 vaccines by recommending them for most people in the fall, similar to the annual flu shot.

Medical experts who are members of the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee are set to meet on Jan. 26 to discuss and vote on the plan.

Officials hope by streamlining the vaccine process, more people will receive the shot. 

While FDA officials said most people will likely only need one annual dose of a COVID-19 vaccine, others including the very young, older adults and people with compromised immune systems may need two doses according to briefing documents posted Monday.

Some infectious disease experts, however, raised doubts about the plan, saying it's still not clear if everyone will need an annual shot. 

While more than 73% of people 5 and older in the U.S. have received their primary series of COVID-19 vaccinations, just 16.2% have received the updated bivalent booster shot, which was made available in September.

In Suffolk County, 14.8% of the eligible population 5 and older have received the updated booster while the figure is 17.1% for Nassau County. More than 90% of people in Nassau County in that same group and 83% of people in Suffolk County completed their primary vaccination series. 

While evidence supports the use of the bivalent booster, administration of the shots has been “associated with significant implementation complexities,” according to the documents posted on the FDA website.

“Given these complexities, and the available data, a move to a single vaccine composition for primary and booster vaccinations should be considered,” the briefing paper said. “This simplification of vaccine composition should reduce complexity, decrease vaccine administration errors due to the complexity of the number of different vial presentations, and potentially increase vaccine compliance by allowing clearer communication.”

Studies have shown the boosters also are associated with a reduction in hospitalization and death in older adults but are beneficial for younger people because illnesses tend to be more mild and cause less stress on the health care system, according to the paper.

“Though perhaps not identical, this pattern of response is analogous to that observed with annual influenza vaccination, a well-accepted intervention in individuals 6 months of age and older,” it read.

Currently, people must receive a primary series of COVID-19 vaccines before becoming eligible for a booster shot. The bivalent booster was designed to protect people from both the original strain of the SARS-CoV-2 virus that causes COVID-19 as well as several subvariants of the omicron variant that emerged over a year ago.

The report said most individuals would only need one dose of a vaccine for a period of time. But it added: "Two doses of an approved or authorized COVID-19 vaccine may be needed to induce the expected protective immunity for those who have a low likelihood of prior exposure (the very young) or those who may not generate a protective immune response (older and immunocompromised individuals)."

The report said it is likely an assessment of COVID-19 strains would be evaluated annually and members of the committee would help recommend in June which should be used in the annual vaccine for the fall. They could revisit the decision if an unusual variant emerges.

Dr. Deb Salas-Lopez, Northwell Health’s senior vice president for community and population health, said she believes making the COVID-19 vaccine an annual shot may convince more people to get it.

“You would be making it part of a routine,” she said. “Starting in September people know they have to get their flu shots.”

Salas-Lopez said there has also been some confusion among the public about the COVID-19 booster schedule.

“When do I get a booster? Is it 60 days after my last shot?” she said. “Doing it this way, provided the science is there, I think will take out the headache of people trying to follow the latest guidelines … Giving it alongside of other preventive immunizations makes it less mysterious, if you will."

Former Nassau County Health Commissioner Dr. Lawrence Eisenstein, vice president and chief public and community health officer for Catholic Health, said having a consistent approach may help people "trust the process and believe in the process."

"Not that there's anything been wrong with the process, but we've learned so much so quickly and the virus kept changing so quickly and our ability to respond kept changing so quickly that it appeared that the response was inconsistent, which it wasn't," Eisenstein said. "It was based on the best science. But I think that this will help there be more of a consistent accepted approach."

Suffolk County Health Commissioner Dr. Gregson Pigott said SARS-CoV-2 appears to be following a trend of rising during the winter months and the holiday season, similar to flu.

"Humans are creatures of habit, so it may be easier for many people to remember to get a once-a-year COVID vaccine along with their influenza vaccine," he told Newsday in an email.

Dr. Celine Gounder, an infectious disease expert and senior fellow at the Kaiser Family Foundation, wrote Monday on Twitter that it might make sense to give two shots a year to very young children, the elderly, immunocompromised people and pregnant women but "unclear whether everyone else needs boosters."

She also questioned the plan to use the bivalent vaccine composition for both primary and booster vaccines.

By Lisa L. Colangelo

lisa.colangelo@newsday.com@lisalcolangelo

Lisa joined Newsday as a staff writer in 2019. She previously worked at amNewYork, the New York Daily News and the Asbury Park Press covering politics, government and general assignment.