The modified COVID-19 vaccine from Novavax has been approved by the U.S. Food and Drug Administration for use in emergency situations in people 12 years of age and older, the agency announced on Tuesday.
Shares of Novavax increased 12% to $7.95.
The Maryland-based company, which only has the updated COVID vaccination on the market, has implemented cost-cutting measures and is relying on sales of the revised injection to keep it afloat. According to the corporation, if not, it could not be able to maintain its financial stability.
The director of the American Centres for Disease Control and Prevention (CDC) approved the widespread use of competing upgraded COVID vaccines from Moderna and Pfizer, alongside German partner BioNTech. Those mRNA-based vaccines are advised for use throughout the nation’s autumn vaccination programme in people ages six months and older.
The approval of the Novavax shot now requires the CDC director, which is regarded as a formality.
Due to manufacturing challenges that postponed submitting for approval when COVID was raging, Novavax, whose protein-based shot harnesses a technique used for decades to fight infections, missed out on the pandemic vaccine windfall enjoyed by mRNA rivals.
The initial COVID vaccination from Novavax was authorised in the United States in July 2022, a long time after Pfizer and Moderna vaccines were in use.
Since some people have expressed worries about potential side effects and some people have expressed suspicion of the new technology as a result of COVID becoming politicised, FDA officials have stated that they believe there is an urgent need for alternatives to the mRNA-based shots.
Government statistics show that as of the beginning of May, less than 90,000 Novavax doses had been given.
Tens of millions of doses of the new shot, which the business previously said it had made, are prepared to be shipped to the United States upon authorization.
The dosages will be offered in “thousands of locations in the United States, including CVS and Rite Aid pharmacies as well as medical offices,” according to Novavax. According to the manufacturer, the vaccine will also be offered by government programmes like Vaccines for Children and the Bridge Access Programme.
The XBB.1.5 coronavirus strain is the target of all three of the revised vaccines. Omicron subvariant XBB.1.5, which dominated in the United States for the majority of this year, has subsequently been supplanted by other subvariants as the virus continues to change.
In May, the US government lifted the COVID public health emergency declaration, turning vaccination administration over to the private sector.