If the FDA committee endorses Novavax's shot, the drug regulator is almost certain to rapidly authorize it for use in the U.S.
are the three vaccines currently used in the U.S., and the FDA last week limited the use of J&J's shots.
FDA authorization of the vaccine would come right as the drug regulator is considering redesigning Covid shots this fall to target mutations the virus has developed over the past two years. All of the current vaccines, including Novavax, target the spike protein of the original strain of the virus that emerged in Wuhan, China, in 2019. As the virus has evolved, the shots have become less effective at blocking infections.
It's unclear how many shots the U.S. government would order should the vaccine receive authorization. Erck said Novavax is in discussions now with the U.S. on how the company can support demand. Novavax has received $1.8 billion from the U.S. government under Operation Warp Speed to deliver 100 million doses, though the government will decide how many shots it wants after FDA authorization.
Novavax delivered 42 million doses in the first quarter to markets where the vaccine is already authorized, including the European Union, Canada, South Korea, Australia, New Zealand and Indonesia. However, the company expects shipments and revenue to increase in the second quarter as its fulfills an order of 42 million doses from the EU, Trizzino told analysts during the earnings call.
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