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Novavax will finally get its day with the FDA

A Food and Drug Administration advisory committee has put Gaithersburg, Maryland-based Novavax’s COVID-19 vaccine on its June 7 agenda.

The Vaccines and Related Biological Products Advisory Panel includes independent physicians and scientists who make recommendations about vaccine authorization to the FDA, which most often follows those recommendations.

Novavax submitted its vaccine for FDA approval Dec. 31, 2021. Its COVID-19 vaccine is already approved or in use by several other countries in Asia and Europe.

If approved for use in the U.S., it would make Novavax a latecomer to the COVID vaccine arsenal, though its vaccine is different from the mRNA vaccines supplied by Pfizer and Moderna.

The Novavax vaccine is a more traditional protein-based vaccine that can also be stored at much higher refrigeration temperatures. Novavax has also said that because it is a traditional-type vaccine, some hesitant to get the mRNA vaccines might be more willing to take it.

“We continue to hear from physicians, healthcare organizations and consumers who are anxiously awaiting another vaccine option. We believe our vaccine, built on a well-understood protein-based vaccine platform, can play a part in fulfilling this need,” Novavax CEO Stanley Erck said in a statement Friday.

Novavax was among early participants in the federal government’s Operation Warp Speed, receiving $1.6 billion in 2020 to develop and manufacture a COVID vaccine.

In February, Novavax published research supporting its vaccine as effective in teens. It has also been testing a combination COVID and influenza vaccine.

Massachusetts court hears arguments in lawsuit alleging Meta designed apps to be addictive to kids

BOSTON (AP) — Massachusetts' highest court heard oral arguments Friday in the state's lawsuit arguing that Meta designed features on Facebook and Instagram to make them addictive to young users. The lawsuit, filed in 2023 by Attorney General Andrea Campbell, alleges that Meta did this to make a profit and that its actions affected hundreds of thousands of teenagers in Massachusetts who use the social media platforms. “We are making claims based only on the tools that Meta has developed because its own research shows they encourage addiction to the platform in a variety of ways,” said State Solicitor David Kravitz, adding that the state's claim has nothing to do the company's algorithms or failure to moderate content. Meta said Friday that it strongly disagrees with the allegations and is “confident the evidence will show our longstanding commitment to supporting young people.” Its attorney, Mark Mosier, argued in court that the lawsuit “would impose liabilities for performing traditional publishing functions” and that its actions are protected by the First Amendment.
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