FDA Panel Recommends Fall Booster Shots to Specifically Target Omicron Variant

Getty COVID vaccine

A panel of independent experts is recommending that the Food and Drug Administration roll out updated COVID-19 booster shots to specifically target the Omicron variant for the first time.

Scientists on the FDA's Vaccines and Related Biological Products Advisory Committee voted 19-2 in favor of redesigning booster shots Tuesday, with the hope that they can be rolled out in the fall, The New York Times reported.

The committee's hope is that a targeted rollout during autumn will soften the impact of an expected wave of winter infections brought on by declining vaccine immunity and the simple fact that people spend more time inside during the colder months, enabling COVID to spread more easily.

It follows a Centers for Disease Control and Prevention (CDC) announcement on Tuesday that the BA.4 and BA.5 sub-variants of Omicron now account for around 52% of all COVID cases in the U.S., Reuters reported.

"We have to give serious consideration to a booster campaign this fall to help protect us," Dr. Peter Marks, head of the FDA's vaccine division, told the expert panel Tuesday, reported CNBC.

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Getty A child getting a COVID-19 vaccine dose

"The better the match of the vaccine to the circulating strain, we believe may correspond to improved vaccine effectiveness and potentially to a better durability of protection," he added.

Despite this, the issue of COVID boosters remains something of an imprecise science due to the constant, ever-evolving nature of the virus.

The expectation is that while the FDA will take up the panel's recommendation, further booster shots may be needed on a regular basis, possibly alongside annual flu shots.

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"None of us has a crystal ball," added Marks on Tuesday, per the Times. "If you do, come over to my house right now. I really would like it."

"We're all troubled by the steady erosion of immune protection," added Dr. Mark Sawyer, from the University of California, San Diego School of Medicine. "We're going to be behind the eight ball if we wait longer."

Daniel Pockett/Getty A dose of Pfizer's COVID-19 vaccine

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The FDA panel's recommendation follows an announcement by Pfizer last Saturday that its tweaked COVID vaccines to target the Omicron variant have demonstrated substantially higher protection against the virus.

As the Omicron variant continues to spread across the country, Pfizer and its partner BioNTech have studied the impact of their updated boosters on the immune system to fight the contagious mutant.

One test involved a booster targeting Omicron specifically, and the other targeted both Omicron and the original virus. More than 1,200 middle-aged and older adults who volunteered to be involved in the study experienced massive increases in neutralizing antibody levels a month after administration, depending on the dose, the companies said.

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Candidates who were given Pfizer's omicron-only booster elicited 13.5 to 19.6 times higher Omicron-fighting antibodies. Meanwhile, candidates with the bivalent vaccine exhibited a 9.1 to 10.9 increase. All volunteers appeared to be well-tolerated to the tests in the study.

The results from the studies also suggest the vaccines are adequate for the Omicron BA.4 and BA.5, which are rapidly circulating in the U.S., according to the companies' statement.

"As we've said since the early days of the pandemic, we will follow the science and adapt our own approaches as needed to help address COVID-19 as the virus evolves," Albert Bourla, Chairman and Chief Executive Officer, Pfizer said in a statement. "Based on these data, we believe we have two very strong Omicron-adapted candidates that elicit a substantially higher immune response against Omicron than we've seen to date."