FDA to consider changing COVID-19 vaccine formula for boosters in the fall

Virus Outbreak Updating Vaccines
Posted at 5:45 AM, Jun 28, 2022
and last updated 2022-06-28 07:45:46-04

TAMPA, Fla. — On Tuesday the Food and Drug Administration’s vaccine advisory committee will meet to consider changing the current COVID-19 vaccine formulas.

“We know that the vaccine is waning,” said Dr. Jill Roberts, Associate Professor for the USF College of Public Health.

The COVID-19 vaccines we have right now are based on the strain that circulated early in the pandemic, the Wuhan strain, with no coverage for the omicron variant.

“That’s one of the reasons we think that this transmission of omicron just went on unchecked was the vaccines just weren’t able to keep it down at all,” said Roberts.

Although health officials said the current shots are highly effective in preventing severe disease, they’re not stopping infection as well anymore.

It’s one of the reasons why the FDA is now asking its vaccine advisers to consider updating the COVID-19 vaccine formula.

Experts said this is especially important because data show there’s a risk of another major COVID-19 outbreak this winter due to a combination of waning immunity, further evolution of variants, and increased indoor activity.

“So what is that coronavirus vaccine going to really look like in the next form?” asked Roberts.

That’s the question the FDA committee is hoping to answer. They’re trying to figure out what should be in a new COVID-19 booster shot.

“We think omicron will be included. We think maybe delta will be included. Maybe the original coronavirus strain will be included but what else? What do we see on the horizon coming that could actually be a big player? That’s the part that gets really hard to say because we can’t see the future,” said Roberts.

FDA scientists said several vaccine manufacturers have prepared modified vaccines for use in clinical trials, trying to create a vaccine that’s more effective at stopping infection.

According to FDA briefing documents, both Moderna and Pfizer have released new data on vaccines with different omicron components and the shots appear to increase the immune response to the variant.

Those documents say the decision to recommend changing the strain composition of the COVID-19 vaccines is complex and should be data-driven. Implementing a new formula will require FDA authorization prior to deployment.

Doctors also hope vaccine advisers will talk about what a new recommendation with a new vaccine could look like.

“We know everyone wants to get this vaccine on a yearly schedule so we’re not having to boost and boost and boost. That’s not sustainable. People will stop boosting over time,” said Roberts.

Health officials have to make a decision quickly. The FDA previously said they had to decide if they were going to change the vaccine formulas and what would be in the new one, by the end of June so drug manufacturers have enough time to get them ready by the fall.

Tuesday’s meeting is scheduled for 8:30 a.m. to 5 p.m.

The advisory board will specifically be asked to vote on whether they recommend including an omicron-specific component in COVID-19 booster shots.