Breaking News

Maryland COVID-19 Vaccine Seeks Authorization in Singapore

November 24, 2021 • 3:08 pm CST
(Precision Vaccinations)

Maryland-based Novavax, Inc. today announced its submission to the Singapore Health Sciences Authority (HSA) for the interim authorization of its recombinant nanoparticle protein-based Nuvaxovid COVID-19 vaccine under the Pandemic Special Access Route.

The filing includes clinical data from two pivotal Phase 3 clinical trials: PREVENT-19, which included 30,000 participants in the U.S. and Mexico and demonstrated 100% protection against moderate and severe disease and 90.4% efficacy.

And a trial of 15,000 participants in the U.K. demonstrated the efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant, and 89.7% efficacy overall.

In both trials, NVX-CoV2373 demonstrated a reassuring safety and tolerability profile.

"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," said Stanley C. Erck, President, and CEO, Novavax, in a press release.

"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."

Novavax COVID-19 vaccine (Nuvaxovid, Covovax, NVX-CoV2373) was made using Novavax's proprietary nanoparticle technology, Matrix-M, an adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies.

The chemistry, manufacturing, and controls data package submitted to HSA and other global regulatory agencies leverage Novavax's manufacturing partnership with Serum Institute of India Pvt. Ltd.