The Food and Drug Administration (FDA)’s Vaccines and Related Biological Products Advisory Committee voted 21 to 0 (with 1 abstention) in favor of recommending Emergency Use Authorization (EUA) for the Novavax COVID-19 vaccine (NVX-CoV2373) for individuals 18 years of age and older.
NVX-CoV2373 is engineered from the genetic sequence of SARS-CoV-2 using the Company’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein. The vaccine candidate contains the Company’s saponin-based Matrix-M™ adjuvant technology to enhance and prolong immune responses.
The FDA panel reviewed data from the phase 3 PREVENT-19 trial (ClinicalTrials.gov Identifier: NCT04611802), a randomized, placebo-controlled study that evaluated the efficacy, safety and immunogenicity of NVX-CoV2373 in 29,949 participants 18 years of age and older in the US and Mexico. Participants were randomly assigned 2:1 to receive 2 intramuscular injections of either NVX-CoV2373 or placebo administered 21 days apart.
The primary endpoint was the first occurrence of PCR-confirmed symptomatic COVID-19 with onset at least 7 days after the second dose in serologically negative adult participants at baseline.
Results showed that NVX-CoV2373 met the primary endpoint demonstrating vaccine efficacy of 90.4% (95% CI, 82.9-94.6; P <.001), with 14 cases observed in the vaccine arm compared with 63 in the placebo arm; all cases observed in the vaccine arm were mild. The vaccine also demonstrated 100% efficacy (95% CI, 87-100) against moderate and severe COVID-19, with all cases reported in the placebo arm (10 moderate cases and 4 severe cases).
The most common adverse reactions reported were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise.
Myocarditis events were identified across the clinical program. In the FDA briefing document, it was noted that data from passing surveillance in other countries indicated a higher than expected rate of myocarditis and pericarditis associated with the vaccine, leading the panel to conclude that further evaluation was needed to inform the risk of myocarditis/pericarditis.
Responding to the committee’s concerns, Novavax said: “Based on our interpretation of all the clinical data supporting NVX-CoV2373, including over 50,000 participants in clinical trials, we believe there is insufficient evidence to establish a causal relationship. We will continue to monitor all adverse events, including myocarditis and pericarditis.”
While not bound to the panel’s recommendations, the FDA will take them into consideration when making a decision on the EUA. If the authorization is granted, NVX-CoV2373 would be the first protein-based COVID-19 vaccine available in the US. The vaccine has already received authorization in more than 40 countries.
- FDA advisory committee recommends Emergency Use Authorization of Novavax COVID-19 vaccine for people aged 18 years and older. News release. Accessed June 8, 2022. https://www.prnewswire.com/news-releases/fda-advisory-committee-recommends-emergency-use-authorization-of-novavax-covid-19-vaccine-for-people-aged-18-years-and-older-301563439.html
- Novavax statement on US FDA briefing document related to myocarditis/pericarditis. News release. Accessed June 8, 2022. https://ir.novavax.com/Novavax-Statement-on-US-FDA-Briefing-Document-Related-to-Myocarditis-Pericarditis