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FDA advises vaccine manufacturers to make COVID-19 booster targeting KP.2 strain

FDA
Posted at 9:23 AM, Jun 24, 2024

TAMPA, Fla. — The FDA has issued an updated recommendation for the fall COVID-19 vaccine formula.

"Coverage in the fall is going to be interesting because we don’t know what will happen in the fall, right?” said Dr. Jill Roberts, associate professor for the USF College of Public Health.

That’s why vaccine advisors are tasked with making the best decision based on which COVID-19 strains are circulating.

“These two strains, the KP.2 and KP.3, are now counting for half of all of cases in the U.S.,” said Roberts.

They’re part of the FLiRT variants, which, in total, make up 62.9% of new COVID-19 cases in the United States right now, according to the latest CDC data. This is something the FDA has been closely monitoring.

“What’s likely going to happen is that the two strains are going to continue to take off. They’ll probably cover most of the percentage of all the strains that we see in the U.S.,” said Roberts.

A few days ago, the FDA told drugmakers to update the fall COVID-19 vaccine formula to target the KP.2 strain if possible to create a more effective vaccine for the fall.

This change in the recommendation comes just after the group voted earlier this month for the fall boosters to target the JN.1 variant.

“They changed their recommendation to say, 'Okay, let’s actually put these KP guys in the vaccine,'” said Roberts.

After further monitoring of the circulating strains, the FDA made the change since the spread of the JN.1 mutation has drastically declined in recent weeks.

The changes should not delay the vaccine rollout.

However, not all drug manufacturers can pivot that quickly since production of the new shots is already underway.

“And so your two mRNAs— Pfizer and Moderna, can change really fast. Novavax cannot because of the way that vaccine is actually made. It’s harder to change it, so it probably won’t. In fact, the company has already said, ‘we’re not going to change it, we’ve already started production for fall shots,’” said Roberts.

The FDA did not make a recommendation on who should get the new booster in the fall. That will be left up to the CDC.

That advisory meeting is scheduled for June 26-28.