Novavax to Seek EUA in Q3 for Its COVID-19 Vaccine

Novavax said it plans to file for FDA Emergency Use Authorization (EUA) of its two-dose COVID-19 vaccine in the third quarter, supported by the strong efficacy data from its late-stage trial in which the recombinant DNA-based vaccine proved 100 percent effective in preventing moderate and severe disease, and more than 90 percent effective at preventing symptomatic infections.

The high efficacy rate puts NVX-CoV2373 within the same efficacy range as the two messenger RNA-based vaccines from Pfizer/BioNTech and Moderna that have been authorized by the FDA. By comparison, the single-shot Johnson & Johnson vaccine, which uses adenovirus-vector technology, was just 66 percent effective in preventing moderate and severe cases of COVID-19 in its global phase 3 trials.

The Novavax trial findings, from almost 30,000 patients across 119 sites in the U.S. and Mexico, include results from many participants infected with the SARS-CoV-2 variant fist identified in the UK — now known as the Alpha variant — which has become the predominant strain in the U.S.

The findings also show an efficacy rate of 91 percent among high-risk individuals, including those over 65 years old, those under 65 years old with certain comorbidities or those who are in occupations that involve frequent exposure to infection with the virus.

The company said it will have the capacity to produce 100 million vaccine doses a month by the end of the third quarter and 150 million doses a month by the end of the fourth quarter. — Jason Scott