Another updated COVID vaccine could be available in the fall. Here’s what we know

COVID-19 vaccines are due for another update and new formulas could be available in the U.S. by the fall, according to the Food and Drug Administration.

But it’s not yet clear who would be advised to receive the updated shot.

Updating the shots to target newer coronavirus omicron subvariants currently circulating in the U.S. — those of the XBB lineage — received unanimous support in a vote held at the FDA’s Vaccines and Related Biological Products Advisory Committee meeting on June 15.

Now the FDA is advising vaccine manufacturers to develop COVID-19 shots with a formula targeting the XBB.1.5 subvariant.

Meanwhile, Pfizer, Moderna and Novavax have already been developing updated COVID-19 vaccines in preparation for fall.

The FDA committee’s recommendation comes after the mRNA COVID-19 vaccines made by Pfizer and Moderna were previously updated to include a component of their original vaccines and a second component targeting the omicron variant’s BA.4 and BA.5 strains.

In April, these “bivalent” shots were authorized by the FDA as the main mRNA vaccines available in the U.S. for those 6 months and older — replacing the companies’ original, monovalent vaccines that are no longer authorized, McClatchy News previously reported.

Why are the vaccines getting updated again?

In recommending a new, monovalent COVID-19 vaccine composition, the FDA said the current bivalent vaccines aren’t as effective in protecting against the latest virus variants.

“By several measures, including escape from antibody neutralization and waning protection, the currently available bivalent COVID-19 (Original plus Omicron BA.4/BA.5) vaccines appear less effective against currently circulating variants,” the FDA said.

Omicron BA.4 and BA.5 are no longer spreading in the U.S., according to the latest Centers for Disease Control and Prevention data.

When the FDA’s advisory committee met on June 15, it considered three subvariants — XBB.1.5, XBB.1.16 and XBB.2.3 — for the formula of COVID-19 vaccines in the fall before preference for XBB.1.5 was determined, according to the agency.

As of early June, XBB sublineages made up more than 95% of COVID-19 variants spreading in the U.S., the FDA said.

The latest CDC data shows the XBB.1.5 variant was the most dominant strain for the two-week period ending on June 10, making up 39.9% of cases.

What comes next?

The FDA will make an official decision soon on the vaccine composition to recommend to manufacturers, according to Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research.

The official recommendation will be based on the discussion at the FDA’s advisory committee meeting and won’t come “as any surprise,” Marks said in a message shared to Twitter.

Following the FDA’s official recommendation, the agency expects vaccine manufacturers to proceed with manufacturing their new shots, according to Marks.

Then, Marks said, the companies will gather the data needed to “inform our ultimate FDA actions in order to have vaccines evaluated with our safety and effectiveness standards for availability in the September time frame.”

Pfizer aims to have an updated COVID-19 vaccine candidate available before the fall begins, Faith Salamon, director of the company’s global media relations, said in a statement to McClatchy News.

“To prepare for multiple scenarios, Pfizer has been producing several updated COVID-19 vaccines at-risk, including both monovalent and bivalent formulations targeting circulating Omicron XBB.1.5 sublineages,” Salamon said.

Moderna also plans to ship out its updated vaccine, if approved, at the end of summer to be ready for fall, company spokesman Chris Ridley confirmed to McClatchy News.

“We’ve been working for a few months to develop an effective, variant-targeting vaccine for the fall vaccination season,” Ridley said. “Based on our own monitoring and analysis, we’ve been developing and testing XBB-targeting vaccines at risk, including preclinical and clinical testing.”

Moderna can “pivot quickly” when it comes to developing a new COVID-19 shot since it’s an mRNA vaccine, according to Ridley. A new COVID-19 vaccine formula can be developed in about 60 to 90 days for a new virus variant

Novavax said it has also created a protein-based, monovalent COVID-19 targeting XBB.1.5 and plans to have it ready and available, if authorized, in the fall.

The company is making the shots on a “commercial scale” and also seeks to ship out the vaccine across the globe, the release said.

“We believe we are in a better position to offer an alternative vaccine choice for individuals worldwide,” the company said.

At the FDA’s advisory committee meeting, animal immune response data on the updated vaccines were presented, as well as immune response data from one person given an updated vaccine, according to the agency.

If the updated vaccines are authorized for the fall, it’s unknown who will be advised to get it until officials issue guidance.

“I’m all for updating this vaccine, but I think we need to define...who really benefits from booster dosing? Because it’s not everybody,” Dr. Paul Offit, an FDA advisory committee member and pediatrician specializing in infectious diseases at the Children’s Hospital of Philadelphia, said at the meeting, according to NPR.

About 70% of Americans have received the primary series of COVID-19 vaccines as of May 2023, according to the CDC, with just 17% in the U.S. also getting the bivalent booster dose.

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