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Documents filed on Monday showed that advisers to the US Food and Drug Administration will vote on whether Covid-19 vaccines for 2024-25 should target the JN.1 variant.
Novavax shares jumped 11% in morning trading after the document was released. The company said last month that it would be able to offer a Covid vaccine in the United States this autumn only if regulators approve a shot it began manufacturing to target the JN.1 variant.
Also read: Moderna’s RSV shot receives FDA approval for use in older adults
Vaccine makers developing new booster shots may need to consider targeting one of the JN.1 subtypes, such as KP.2, because further evolution of the virus could move it away from older strains, FDA staff said in separate documents.
The documents were posted ahead of a meeting of advisers on Wednesday. The meeting was postponed from May 16 because the FDA asked for more time to “obtain surveillance data and other information” on the circulating virus.
The FDA staff’s review to update viral strains for vaccines in the US differs from the review by World Health Organization advisers, who in April recommended targeting only the JN.1 strain.
Also read: FDA warns parents to avoid infant formula distributed by Texas company due to contamination
Since then, the sub-variant KP.2 has become the dominant strain in the US, estimated to account for about 28.5% of cases in the two-week period ending May 25, according to data from the US Centers for Disease Control and Prevention.
“This change in epidemiology is concerning,” the reviewers said.
Variations in vaccine types from the global standard could also pose a challenge for COVID vaccine makers, particularly for Novavax as it makes a more traditional protein-based shot that takes longer to manufacture.
Vaccines based on messenger RNA (mRNA), such as those from Moderna, or Pfizer and its partner BioNTech, can be developed more quickly. In the past, Pfizer has said it could make a shot in 100 days.
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Published: June 03, 2024, 09:53 PM IST
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