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Novavax needs 6 months to produce annual COVID shots that match new variants


People pose with syringe with needle in front of displayed Novavax logo in this illustration taken, December 11, 2021. REUTERS/Dado Ruvic/Illustration

Novavax Inc (NVAX.O) said on Thursday it would require six months to produce a COVID-19 vaccine designed to match whichever coronavirus variants are circulating for an annual immunization program each fall season in the United States.

The company suggested that the U.S. Food and Drug Administration select the prevalent variant of coronavirus in the first quarter each year, similar to the model employed to choose the composition for annual flu shots.

The FDA in documents released on Monday proposed June for deciding on an annual COVID shot’s make-up.

Novavax’s protein-based vaccine requires manufacturing changes that take longer to implement than the messenger RNA vaccines produced by Pfizer Inc (PFE.N)/BioNTech SE (22UAy.DE) and Moderna Inc (MRNA.O). It took those companies about three months to produce the currently available boosters updated to target newer Omicron subvariants.
“We recognize the tension between selecting a strain as late as possible to increase the likelihood of recommending a matching strain versus providing adequate time to ensure vaccine availability,” Novavax Chief Medical Officer Filip Dubovsky said during a presentation for the FDA’s vaccine advisory panel.

The FDA is seeking recommendations from its panel of external experts on adopting an annual COVID shot for the United States and the process for choosing the vaccine’s targets each year.