Novavax announced that it has submitted a request to the U.S Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for NVX-CoV2373, its protein-based COVID-19 vaccine candidate for immunization of individuals 18 years of age and older against SARS-CoV-2Novavax initially planned to request EUA by May 2021, however, the filing was delayed multiple times over several development and manufacturing roadblocks. Working alongside its manufacturing partner, Serum Institute of IndiaNovavax was able to get the vaccine authorized in several countries, including Europe. It is also listed for emergency use by the World Health Organization and is available in more than 170 countries.

The EUA submission contains data from two pivotal Phase 3 clinical trials: PREVENT-19 which enrolled approximately 30,000 participants in the U.S. and Mexico and a trial with almost 15,000 participants in the U.K. The primary endpoint for both studies was the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline. PREVENT-19 achieved 90.4% efficacy overall and the other trial achieved overall efficacy of 89.7%. 

The most common adverse reactions observed during clinical studies (frequency category of very common ≥1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. 

Data from both trials were published in The New England Journal of Medicine. PREVENT-19 can be read here and data from the second phase 3 trial can be read here. Subscribe to the Trialsitenews “COVID-19” ChannelNo spam – we promise

As part of the PREVENT-19 trial, a booster study is ongoing to evaluate the safety and effectiveness of a third does of the vaccine, as well as a study in adolescents aged 12-17.

About NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2. NVX-CoV2373 was created using Novavax’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax’s patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart.

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