Novavax stock surges 20% as vaccine OKs seem near

Posted: 17 December 2021 4:02 pm

EMA and WHO could have approval decision by next week.

Novavax stock has jumped more than 20% since Thursday’s news that key approvals of its Covid vaccine could be right around the corner.
The European Medicines Agency (EMA) sent out a tweet early Thursday morning that a meeting had been scheduled for Monday, Dec. 20 to review the application for the vaccine developed by Novavax. Additionally, the World Health Organization expert panel on vaccines met on Thursday to draft recommendations on the use of the Novavax vaccine. Novavax stock opened Thursday at $178.97 and hit a session high of $197.99 midday before closing at $194.92. It was trading above $217 after midday Friday.
Shares of Novavax have been quite volatile over the last two years and big news like EMA or WHO approval or that the company has filed with the US Food and Drug Administration (FDA) could send the stock even higher.

Recent developments with Novavax

Aside from the possible EMA and WHO approvals that could come within days, the Maryland-based biotechnology company announced late Wednesday night that its partner Takeda Pharmaceutical had submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan. This is the latest of a series of regulatory submissions the company has made over the last few months. Pending approval, Takeda aims to begin distribution of the vaccine in early 2022.
The Novavax vaccine has already been approved for emergency use in Indonesia and the Philippines and has filed for Emergency Use Authorization (EUA) in India. It’s also submitted regulatory filings in the UK, Australia, New Zealand, Canada, Singapore, United Arab Emirates, South Korea, the European Union and the WHO.
The company is also on track to submit its application to the US FDA by year’s end.

Competitors BioNtech and Moderna down on Novavax news

Shares of vaccine competitors BioNTech and Moderna traded lower Thursday, possibly on news that the Novavax vaccine is progressing.
BioNTech stock traded sideways for most of the day before closing almost 2% down Thursday.
Moderna, despite gaining approval in Japan for use of its vaccine as a booster, also sank. The stock closed 0.77% for the day.
Moderna and BioNTech, working with Pfizer, make the two widely circulated vaccines that Novavax would compete with.

Is the Novavax vaccine better against Omicon?

We don’t yet know what degree of protection the Novavax vaccine will provide against the Omicron variant.
The company last announced on Dec. 2 that it was evaluating its vaccine against the variant and that it had already begun developing an Omicron-specific vaccine. Other Variants of Concern (VoC) emerged during Novavax’ clinical trial earlier this year, allowing the company to see how its vaccine protected against other strains of the virus. Tests showed that the Novavax vaccine is effective against the Alpha, Beta and Delta Variants of Concern (VOCs). News is mixed about the level of protection provided against the Omicron variant by currently-available vaccines. But it seems a booster will likely help protect against severe symptoms at the very least.

How has Novavax stock performed compared to BioNTech and Moderna?

Shares of Novavax, BioNtech and Moderna all saw enormous growth as the pandemic unfolded.
Moderna stock gained more than 2,100% between January 2020 and August 2021, while BioNTech stock saw gains of over 1,000% over the same period. Both are down around 40% from these previous highs, closing Thursday at $282.02 and $283.68, respectively.
Novavax stock ran from around $8 per share in February 2020 to a high of $331.68 a year later, a gain of over 4,000%. Shares have since pulled back, closing Thursday at $194.92. This is around 41% off its previous high. But Novavax still has several major short-term catalysts ahead of it. Big news, like winning EMA and WHO approval and filing with the FDA, could drive the stock even higher.

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