Novavax, a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced that the Food and Drug Administration Vaccines and Related Biological Products Advisory Committee voted 21 to 0, with one abstention, to recommend that the FDA grant emergency use authorization for the Novavax COVID-19 vaccine (NVX-CoV2373) for individuals aged 18 years old and older.
"The advisory committee's positive recommendation acknowledges the strength of our data and the importance of a protein-based COVID-19 vaccine developed using an innovative approach to traditional vaccine technology," said Stanley Erck, president and CEO of Novavax.
The VRBPAC considered data from the pivotal Phase 3 clinical trial, PREVENT-19, which enrolled approximately 30,000 participants aged 18 years old and older in the United States and Mexico, and was published in the New England Journal of Medicine.
"In today's VRBPAC meeting, we heard the overwhelming support for our vaccine from physicians, healthcare organizations and consumers who are eagerly anticipating a protein-based vaccine option," Erck said. "Consistent with submissions to regulatory authorities worldwide, we have already submitted an amendment with updated manufacturing information for the EUA to the FDA for review. We look forward to collaborating with the FDA as it makes its final decision."
In the trial, the Novavax COVID-19 vaccine demonstrated 90.4% efficacy (95% confidence interval [CI], 82.9 to 94.6; P<0.001) with a reassuring safety profile. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups. The most common adverse reactions observed during the trial (frequency category of very common ≥1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. The data showed that overall the rate of myocarditis was balanced between the vaccine and placebo arms (0.007% and 0.005%) and in the post-crossover portions of Novavax trials, the observed cases were all within the expected rate, the company said.
The FDA considers the recommendations of VRBPAC when making decisions on EUA.
The Novavax COVID-19 vaccine has received authorization for use in individuals aged 18 years old and over from more than 40 countries in addition to Emergency Use Listing from the World Health Organization.
NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine 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 company said.
Novavax COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing 10 doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2 degrees to 8 degrees Celsius, enabling the use of existing vaccine supply and cold chain channels. The use of the vaccine should be in accordance with official recommendations.
Novavax has established partnerships for the manufacture, commercialization and distribution of NVX-CoV2373 worldwide. Existing authorizations leverage Novavax's manufacturing partnership with Serum Institute of India, the world's largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax's global supply chain.