FDA says updated COVID-19 shots should target KP.2 strain

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The federal Food and Drug Administration is advising vaccine manufacturers to ensure that new vaccines for 2024 and 2025 are targeting the KP.2 variant of COVID-19.

The agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously on the recommendation during a meeting earlier this month and also voted to recommend a vaccine composition that targets the virus’s JN.1 lineage.

During the meeting, the advisory committee was informed of the manufacturing timelines, and reviewed the available data. The data included information on the circulation of SARS-CoV-2 virus variants; current vaccine effectiveness; human immunogenicity data of current vaccines against recently circulating virus variants; the antigenic characterization of circulating virus variants; animal immunogenicity data on new candidate vaccines expressing or containing updated spike components; and preliminary human immunogenicity data on JN.1 candidate vaccines.

WHAT’S THE IMPACT?

The FDA has continued to monitor the circulating strains of SARS-CoV-2, it said.

Along with a recent rise in COVID-19 cases in certain pockets of the country, and based on current data, the agency has determined that the preferred JN.1-lineage for the next round of COVID-19 vaccines is the KP.2 strain, if feasible. This change is intended to ensure the vaccines more closely match circulating coronavirus strains.

The FDA has communicated this change to the manufacturers of the licensed and authorized COVID-19 vaccines. The agency does not anticipate that a change to KP.2 will delay the availability of the vaccines in the U.S.

It said it will continue to monitor the safety and effectiveness of the COVID-19 vaccines and the evolution of the SARS-CoV-2 virus.

THE LARGER TREND

In January the FDA ended its emergency use authorization for Paxlovid, which had been given to those considered high risk for progression to severe COVID-19, including hospitalization or death.

The FDA originally issued an EUA for Paxlovid just before Christmas 2021. Importantly, the drug is not authorized for the prevention of COVID-19, or for treating those already requiring hospitalization due to severe or critical COVID-19. It’s also not a substitute for vaccination in those for whom the shot and a booster dose are recommended.

Last week, the Biomedical Advanced Research and Development Authority (BARDA) said it was setting aside up to $500 million in Project NextGen funding to plan and execute multiple Phase 2b clinical trials evaluating novel vaccines administered as a nasal spray or as a pill to protect against symptomatic COVID-19.

Data published by Pfizer in May of last year found Paxlovid proved ineffective at preventing coronavirus infection among people living in the same house as an infected person. While there were risk reductions of 32% and 37% in adults who had received Paxlovid for five and 10 days, respectively, the results were not statistically significant. It’s a disappointing finding for a drug that sought to prevent infection from household contact.
 

Jeff Lagasse is editor of Healthcare Finance News.
Email: [email protected]
Healthcare Finance News is a HIMSS Media publication.

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