
Novavax submits EUA to FDA for COVID-19 vaccine candidate
pharmafile | February 2, 2022 | News story | Research and Development |
Maryland-based Novavax has announced it is submitting an EUA request to the FDA, for its COVID-19 vaccine candidate.
Novavax initially planned to request this EUA by May 2021, but the company delayed the request due to several development and manufacturing obstacles. In collaboration with its manufacturing partner, Serum Institute of India, Novavax got the vaccine authorised in several countries, including Europe. It is also listed for emergency use by WHO, and is available in more than 170 countries.
The EUA submission is for people 18 years of age and older. In the two pivotal Phase III trials, the vaccine demonstrated an overall efficacy of approximately 90%. The PREVENT-19 trial enrolled about 30,000 people in the U.S. and Mexico. The second trial was in the U.K. and had about 15,000 participants. The U.K. trial achieved an overall efficacy of 89.7%. Overall, the PREVENT-19 trial demonstrated 90.4% efficacy.
NVX-CoV2373 is a protein-based vaccine. It was designed from the genetic sequence of the Wuhan strains of SARS-CoV-2. The vaccine is stored at two to eight degrees Celsius, which is advantageous as it can utilise existing vaccine supply and cold chain channels. If the FDA grants it the EUA, the first 100 million doses are ready for delivery.
“We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic,” stated Stanley Erck, Novavax’s president and CEO.
Lina Adams






