US health experts unanimously endorse updated COVID-19 vaccine for autumn usage.
The FDA's group of outside advisers voted unanimously on Wednesday, opting to recommend that vaccine makers create new Covid-19 shots that are more effective against the JN.1 strain of the coronavirus.
The question up for vote was, "For the 2024-2025 formula of Covid-19 vaccines in the U.S., does the committee recommend a monovalent JN.1-lineage vaccine composition?". All 16 of the advisers made their affirmative response. This decision now heads to the FDA.
In case the FDA agrees with their advisory committee, the updated shots will be monovalent, providing protection against just one Covid-19 variant. Some previous vaccines have been bivalent, meaning they've been formulated to protect against two variants.
Currently, there are a number of virus variants in circulation, but JN.1 and its descendants KP.2 and KP.3 are the ones most common in the U.S., according to the Centers for Disease Control and Prevention (CDC).
Tuesday marked the day the FDA informed the advisory committee that existing Covid-19 vaccines seem to be less effective against the variants currently circulating.
Covid-19 numbers are a lot lower at present. Only 3% to 4% of those getting tested are positive for the virus, Dr. Natalie Thornburg, acting chief of the Laboratory Branch of the Coronavirus and Other Respiratory Viruses Division of the National Center for Immunization and Respiratory Diseases at the CDC, announced. At the peak of the Omicron surge in 2021, the test positivity rate was 30%.
Rates of hospitalizations are also as low as they've been since March 2020, Thornburg asserted.
Many individuals currently possess some protection against the illness through either vaccination or because they've already had Covid-19.
Those getting the current Covid-19 vaccine - last updated in fall - still have protection against serious ailments and deaths across all age groups. However, as is typical, the protection provided by the vaccine declines over time, according to Dr. Ruth Link-Gelles, vaccine effectiveness program lead with the National Center for Immunization and Respiratory Diseases, who spoke to the committee.
Last season, during fall and winter, more than half a million Americans required hospital treatment due to Covid-19, and 40,000 individuals died as a result of Covid.
Those most at risk for severe illness and death remain unvaccinated. Furthermore, among children who were hospitalized, half had no underlying conditions, Link-Gelles highlighted.
"This, I believe, emphasizes the need for vaccinations for people of all conditions, status, or age," she concluded.
The Covid-19 vaccine manufacturers told the committee that they've already made some progress to deliberate on the composition of the vaccine in line with FDA's decision. Animal and lab studies show that Pfizer/BioNTech, Moderna, and Novavax’s shots targeting the JN.1 variant demonstrate promising results and are safe.
Novavax says its updated shot needs to be the JN.1 version as it takes around six months to produce one, and that's the version they've been working on. The company predicts that it could have the shot available in US warehouses by August.
Pfizer and Moderna’s mRNA vaccines can be developed more swiftly and are ready for either a JN.1 or KP.2 shot for autumn. Moderna anticipates supplying the US market by mid-August, while Pfizer says it's ready to distribute its shot right after approval.
The committee also discussed the potential for the vaccine to match JN.1 or KP.2, but didn't reach a consensus on this point. Most of the members preferred JN.1 so that Americans would have an option between an mRNA vaccine or a more conventional protein-based vaccine.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, reassured the committee that the FDA would give their recommendations due consideration as they make their final choice.
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The FDA's advisory committee recommended that vaccine makers create a monovalent JN.1-lineage vaccine, as previous vaccines were bivalent and protected against two variants. The committee's decision will now be considered by the FDA.
