Gaithersburg, Maryland-based Novavax has received expanded emergency use approval for its COVID-19 vaccine in adolescents 12 to 17 years old.
The approval, announced late-Friday, comes about a month after Food and Drug Administration granted EUA for its protein-based vaccine for adults in the U.S.
The approval makes Novavax more competitive in the market for COVID vaccines in the U.S., as an alternative to messenger RNA vaccines, which are widely-used by Pfizer and Moderna.
“Having more vaccine options for use in both adults and adolescents, like the Novavax COVID-19 vaccine, will hopefully help increase vaccination rates, particularly as we prepare for ongoing surges of COVID-19 with the start of the fall and back-to-school season,” said Novavax CEO Stanley Erck.
In clinical trials, which took place when the Delta variant was the predominant strain, but before the current Omicron strain became dominant, the Novavax vaccine was measured to be 78% effective in teens.
Novavax will still require recommendation from the Centers for Disease Control and Prevention before its vaccine can be used in adolescents.
Novavax was among the first participants in the federal government’s Operation Warp Speed, receiving $1.6 billion in 2020 to develop a COVID-19 vaccine. It has already been approved for use in dozens of other countries.
In addition to being a more traditional protein-based vaccine, the Novavax doses can be stored at higher refrigeration temperatures, making it easier to distribute in harder to reach regions around the world.
Novavax stock reached an all-time high of $290 per share in February 2021. It currently trades at around $37 per share, losing 75% of its value this year. The company recently posted a second quarter net loss of $510 million.
