- The Washington Times - Thursday, January 26, 2023

The Food and Drug Administration moved Thursday toward simplifying COVID-19 vaccination into a yearly process that tailors all the shots to circulating variants and provides the public with clear guidance about when they should roll up their sleeves.

An advisory committee voted, 21 to 0, to adopt a strategy in which the primary vaccines and booster shots are the same formulation.

Right now, only the newest “bivalent” booster has been fine-tuned to target the variants that are currently circulating. If regulators adopt the panel’s recommendation, then anyone who is initiating COVID-19 vaccination would also be getting the bivalent shots instead of the original versions of the vaccines.

More broadly, FDA officials told the advisory committee they are considering a COVID-19 vaccination strategy that looks a lot like the approach to seasonal flu. Scientists would figure out which strain of the coronavirus to target by June so that vaccines could be produced by September.

“Going forward, the FDA envisions an evidence-driven approach similar in many ways to the process used for influenza vaccines, to monitor and update as needed the composition used in all COVID-19 vaccines with the goal to induce or restore protective immunity through these periodic vaccination campaigns,” said Dr. David C. Kaslow, director of the Office of Vaccines Research and Review.

For months, scientists and government officials have said that getting a COVID-19 booster could be an annual event. Thursday’s meeting attempted to formalize that plan and outline how it might work.

The advisory committee did not vote explicitly on making COVID-19 vaccination an annual event, though it was framed that way in the discussion.

Some advisers grappled with whether an annual shot will be needed for all people or for certain populations.

“The issue of how frequently they should be administered is hard to say with precision at this particular point. I think we need to see what happens with disease burdens,” said Dr. Cody Meissner, chief of pediatric infectious diseases at Tufts Children’s Hospital. “We may or may not need annual vaccination.”

Under the emerging plan, all of the available vaccines — including the dominant messenger-RNA vaccines from Pfizer and Moderna and protein-based ones, like the version from Novavax — would be harmonized to target a specific strain.

Most adults and children would get one shot during each vaccine campaign, while high-risk older adults or individuals with compromised immunity might need additional doses. Young children getting immunized for the first time might need more than one dose.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the COVID-19 vaccines have saved lives but were developed in record time during a frantic period of the pandemic, and the virus continues to evolve.

“We’re now in a reasonable place to reflect on the COVID-19 vaccines to date to see if we can simplify the approach to vaccination in order to facilitate the process of optimally vaccinating and protecting the entire population moving forward,” Dr. Marks said.

The FDA is plotting out its next steps so drugmakers and regulators can plan for the year ahead.

In the coming months, they will have to decide whether the unified vaccine composition continues to fight the original strain from Wuhan, China, alongside circulating strains, or if they target the prevalent variants alone.

The most recent booster shots target both the original strain and descendants of the omicron strain discovered in late 2021.

A study from the Centers for Disease Control and Prevention this week found the fine-tuned boosters reduced the risk of symptomatic infection from the most prevalent strain — XBB.1.5 — by about half and reduced the risk of death by about 13-fold compared to the unvaccinated.

However, only about 15% of eligible Americans, or 50 million people, have received an updated booster.

For more information, visit The Washington Times COVID-19 resource page.

• Tom Howell Jr. can be reached at thowell@washingtontimes.com.

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