Topline
A Food and Drug Administration expert panel voted Wednesday to manufacture new COVID-19 vaccines to specifically target the JN.1 variant lineage—which makes up the most dominant strains circulating in the U.S.
Key Facts
The FDA’s independent Vaccines and Related Biological Products Advisory Committee voted unanimously Wednesday to create new COVID-19 vaccines that target the JN.1 variant and its sublineage.
The agency is expected to make a final decision on the new vaccine in the coming days.
Pfizer, Novax and Moderna each said their updated vaccines will be available this fall ahead of 2024-2025 flu season.
Evidence was presented during the meeting showing the JN.1 vaccines offered greater protection against the dominant FLiRT variants than the now-available XBB.1.5 vaccine.
FLiRT variants are subvariants of JN.1 that begin with either KP or JN with the same set of mutations they have each independently picked up, and they make up over 90% of all COVID-19 cases in the U.S. as of May 25, according to data from Centers for Disease Control and Prevention.
Dr. Peter Marks, the director of the Center for Biologics Evaluation and Research for the FDA, noted although there were some side effects like myocarditis, the new vaccines are safe and effective at protecting against the coronavirus.
The panel also discussed whether it should recommend the vaccines target a specific JN.1 variant—like JP.2 or JP.3—but most expressed a preference for an all-encompassing JN.1 vaccine, since it was adequate in protecting against all its subvariants.
Get Forbes Breaking News Text Alerts: We’re launching text message alerts so you’ll always know the biggest stories shaping the day’s headlines. Text “Alerts” to (201) 335-0739 or sign up here.
When Will Each Covid Vaccine Be Ready?
Each drugmaker gave different timelines for when their supplies will be ready. Bill Falstich, Pfizer’s vice president of global supply chain, primary care, said during the meeting his company’s vaccine will be ready immediately upon approval, and the company has “evaluated the expected demand… and we expect that we can supply the quantities needed.” Novavax said its vaccine will be ready by September 1 and it “will be able to meet projected demand,” while Moderna said it’s planning to have vaccines ready in August, pending FDA approval. Moderna also said it’s basing its supply projections largely on the demand from last fall, though it’s expecting a launch coinciding with the flu season.
Key Background
The panel decision is in line with the recommendations of other world health agencies. In April, both the World Health Organization and the European Medicines Agency recommended countries formulate their new vaccines to target the JN.1 sublineage, which all FliRT variants are a part of. JN.1 overtook the XBB lineage as the dominant variant circulating in the U.S. in late 2023, and its FLiRT subvariants overtook it as the dominant variant earlier this year. Although there isn’t evidence the FLiRT variants cause different symptoms, some experts believe they may be more transmissible. This is because early data suggests KP.2 may be “rather transmissible” since its two new mutations help “its ability to transmit, but also it now evades some of the pre-existing immunity in the population,” Dr. Andrew Pekosz, a virologist at Johns Hopkins University, told NBC. Because of the FLiRT variants’ potential to evade immunity, experts are concerned these variants may cause a spike in cases as people gather for several summer holidays, though U.S. cases and deaths have fallen by 0.1% and 14.3%, respectively, even though hospitalizations have risen by over 9% since March.
Big Number
134,782. That’s how many global cases of COVID-19 were reported to WHO in the 28 days ending in May 19. There were 29,500 cases reported to WHO during the week beginning on May 5, down from the 44.5 million cases reported during the peak of December 2022, though several countries—including the U.S.—haven’t reported updated numbers to WHO.
COVID’s New ‘FLiRT’ Variants—What To Know As Experts Fear Summer Surge (Forbes)
Read the full article here