Novavax Files for Interim Authorization of COVID-19 Vaccine in Singapore

Biotechnology company Novavax, Inc. (NVAX) has applied for the interim authorization of its COVID-19 vaccine to the Singapore Health Sciences Authority (HSA) under the Pandemic Special Access Route (PSAR).

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Novavax has submitted its recombinant nanoparticle protein-based COVID-19 vaccine, NVX-CoV2373 with Matrix-M™ adjuvant. The submission includes clinical data from two pivotal Phase 3 trials, both of which showed reassuring safety and tolerability profile.

One trial called PREVENT-19, which was conducted on 30,000 participants from the U.S. and Mexico, provided 100% protection against moderate and severe disease, and 90.4% efficacy.

The other trial conducted on 15,000 participants in the U.K. showed 96.4% efficacy against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant, and 89.7% efficacy overall.

Novavax and its manufacturing partner the Serum Institute of India Pvt. Ltd. (SII) have filed for regulatory approvals of the vaccine with multiple countries for both Emergency Use Authorization (EUA) and for Emergency Use Listing (EUL) with the World Health Organization (WHO).

Management Comments

Stanley C. Erck, President, and CEO of Novavax said, “Today’s filing reinforces our ongoing commitment to delivering our COVID-19 vaccine, built on a proven, well-understood vaccine platform, to help end the pandemic… Each additional market submission marks further progress in delivering our vaccine to the world, which we believe may help address major obstacles to global vaccination, including global distribution challenges and vaccine hesitancy.”

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Target Price

Overall, the stock has a Moderate Buy consensus rating based on 2 Buys and 1 Hold. The average Novavax price target of $249.67 implies 24.79% upside potential to current levels. Shares have gained 95% over the past year.

Blogger Opinion

TipRanks data shows that financial blogger opinions are 74% Bullish on NVAX, compared to a sector average of 68%.