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US FDA authorizes Novavax’s updated COVID shot, shares rise

By Sriparna Roy and Michael Erman

(Reuters) -The U.S. Food and Drug Administration said on Tuesday it has authorized an updated version of Novavax’s COVID-19 vaccine for emergency use in individuals aged 12 years and older, and the company’s shares climbed more than 11%.

The Maryland-based company, whose COVID vaccine is its lone marketed product, has adopted cost-cutting measures and is counting on commercial sales of its updated shot to help it stay afloat. The company has said it may not be able to remain solvent otherwise.

The U.S. Centers for Disease Control and Prevention (CDC) director last month signed off on broad use of rival updated COVID vaccines from Pfizer Inc with German partner BioNTech, and from Moderna. Those mRNA-based shots are recommended for use in people ages six months and up during the country’s autumn vaccination campaign.

The CDC’s Advisory Committee on Immunization Practices (ACIP) will not meet again to discuss the Novavax shot, a spokesperson said.

“ACIP’s recommendation last month, which was then approved by the CDC director, was inclusive of all FDA-licensed or authorized updated COVID-19 vaccines including those expected to be licensed or authorized in the coming months,” the spokesperson added.

Novavax, whose protein-based shot uses a technology employed for decades to combat diseases, missed out on the pandemic vaccine windfall enjoyed by mRNA rivals due to manufacturing issues that delayed filing for approval when COVID was raging.

Novavax’s original COVID shot received U.S. authorization in July 2022, long after Pfizer and Moderna vaccines were in use.

FDA officials have said they believe there is an urgent need for alternatives to the mRNA-based shots, as some people have raised concerns about possible side effects, as well as mistrust by some of the new technology after COVID became politicized.

Fewer than 90,000 Novavax shots had been administered as of early May, according to government data.

The company had previously said it produced tens of millions of doses of its new shot and is ready to ship in the U.S.

Novavax said the doses will be available at “thousands of locations in the U.S. including CVS and Rite Aid pharmacies as well as physician offices”. The vaccine also will be available through government entities including the Bridge Access Program and Vaccines for Children, the company said.

All three of the updated shots target the XBB.1.5 variant of the coronavirus. XBB.1.5. is an Omicron subvariant that was dominant in the U.S. for much of this year but has since been overtaken by other variants as the virus continues to mutate.

The U.S. government ended the COVID public health emergency declaration in May, handing over the responsibility for vaccinations to the private sector.

Novavax has set the list price of its shot at $130 per dose, about in line with the $120 list for the Pfizer/BioNTech vaccine and $129 for Moderna’s.

Keep up with the latest medical breakthroughs and healthcare trends with our newsletter Reuters Health Rounds. Sign up here.

(Reporting by Sriparna Roy in Bengaluru; Editing by Bill Berkrot)


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