Maryland's COVID-19 Vaccine Found Very Effective

Maryland-based Novavax Inc. announced late on December 15, 2021, the complete study results from the Phase 3 clinical trial of the NVX-CoV2373 (Nuvaxovid) COVID-19 vaccine were published in the New England Journal of Medicine (NEJM).

The NEJM reported the PREVENT-19 study achieved its endpoint of efficacy in preventing polymerase chain reaction (PCR)-confirmed, symptomatic mild, moderate, or severe COVID-19 with onset at least seven days after the second dose.

The phase 3 trial demonstrated 100% protection against moderate and severe disease, 93.2% efficacy against the predominantly circulating variants of concern and variants of interest, and 90.4% efficacy against COVID-19 of any severity during the time evaluated.

Furthermore, the solicited adverse events were predominantly mild-to-moderate and transient. And severe reactions were infrequent, and there were no safety concerns related to vaccination.

The PREVENT-19 study included nearly 30,000 adult participants at 119 locations in the U.S. and Mexico. It had a blinded 'crossover,' ensuring all participants received NVX-CoV2373 without compromising Food and Drug Administration (FDA)-required safety follow-up. 

Novavax stated in the press release it 'expects to submit its complete information package to FDA for review by the end of 2021.'

As of December 16, 2021, Indonesia and The Philippines had issued authorizations for Noavax's vaccine (Nuvaxovid, Covovax, TAK-019, NVX-CoV2373). And the company has filed for approvals in India, the U.K., Australia, New Zealand, Canada, the European Union, Singapore, South Korea, UAE, and Japan.

And for Emergency Use Listing with the World Health Organization.

The company's vaccines are genetically engineered using three-dimensional nanostructures of recombinant proteins critical to disease pathogenesis. For example, NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of the SARS-CoV-2 coronavirus.

The vaccine was made using Novavax's proprietary nanoparticle technology, Matrix-M, an adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies.

Novavax is a biotechnology company located in Gaithersburg, MD that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.

The NEJM paper, 'Efficacy and Safety of NVX-CoV2373 in Adults in the U.S. and Mexico,' may be accessed at this weblink.