FDA panel votes for bivalent COVID-19 shots, debates 'annual' schedule

All COVID-19 vaccines should be targeted to the original and dominant strains, an FDA advisory panel said Jan. 26, but members debated whether a new modified vaccine every 12 months is optimal.  

After a daylong meeting discussing tentative changes to the nation's COVID-19 vaccine strategy, the FDA's Vaccines and Related Biological Products Advisory Committee voted 21-0 recommending the primary series also include the modified, bivalent vaccines. 

"Bivalent is better. Simple is better," one advisory committee member said.

The final decision to greenlight adapted COVID-19 shots in the future is up to the FDA and CDC.

Three more takeaways from the meeting: 

1. The panel discussed — but did not vote on — whether to model the COVID-19 vaccine regimen to copy an annual schedule similar to flu shots. Most argued against this approach because COVID-19 does not mutate on a yearly basis, meaning another tweaked vaccine may be necessary in the summer or every 18 months. 

2. One adviser questioned whether focusing solely on the bivalent model would compromise broad protection, but most showed interest in continuously updating the vaccine's composition. "It may be bigger bang for our buck," one panel member said.

3. The committee also debated simplifying the immunization schedule to direct two doses for children and immunocompromised people and one dose for the rest of the public. The consensus was there is not enough information about T-cell, B-cell, non-neutralizing antibody responses or data about protein-based and mucosal-based shots.

The possibility of annual COVID-19 shots has been floated by other infectious disease officials, including Anthony Fauci, MD, former director of the National Institute of Allergy and Infectious Diseases, for months.

"It is becoming increasingly clear that, looking forward with the COVID-19 pandemic, in the absence of a dramatically different variant, we likely are moving towards a path with a vaccination cadence similar to that of the annual influenza vaccine, with annual, updated COVID-19 shots matched to the currently circulating strains for most of the population," Dr. Fauci said in September. 

After the advisory panel's decision, other experts weighed in — some welcoming the news and others responding with hesitance.  

"As COVID-19 becomes endemic, we need to have the population vaccinated on a routine basis," Nagesh Borse, PhD, an infectious disease expert and deputy chief health officer with global health and aid organization Project Hope, told Becker's. "It's great that we have this push for an annual routine vaccine, but I think we have to always keep an eye on the new variants that are circulating. It's going to be a game of catching up as the new variants pop up elsewhere in the world." 

Widespread initial public confusion about the virus caused much anxiety around protective measures such as masking, shelter-in-place mandates and vaccination, but Bernadette Boden-Albala, DrPH, director and founding dean of the public health program at the University of California Irvine, said embracing a routine strategy will help the nation move forward steadily. 

"Going forward, strategies that the public has had experience with like annual vaccine campaigns similar to the annual flu vaccine are likely to be more readily accepted and manageable," Dr. Boden-Albala told Becker's. "Is this a perfect solution? No, but it's a strategy that the nation can get its arms around and a strategy which will likely save more lives and decrease significant disease transmission."  

Others pointed to recent CDC data, which found that of those who received the bivalent shot, individuals who waited eight months or longer to get the shot benefited from increased protection. 

"The longer you wait, the better the boost," Dan Barouch, MD, PhD, a vaccine researcher at Boston-based Harvard Medical School and Beth Israel Deaconess Medical Center and a lead developer of the Johnson & Johnson vaccine, told the Anchorage Daily News.

During a Jan. 24 World Health Organization news conference, experts said the vaccine should not yet be handled with seasonality in mind because there is still much unknown about the virus. 

"We don't know the periodicity of this yet," epidemiology expert Maria Van Kerkhove, MD, said during the meeting. "We haven't seen SARS-CoV-2 settle into a pattern in terms of its virus evolution, and we have not yet seen a seasonal pattern. … We may get to that, but we're not quite there yet."


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