FDA VRBPAC Votes to Recommend Novavax COVID-19 Vaccine in Individuals 18 Years and Older

The Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) panel voted to recommend the Novavax COVID-19 vaccine, NVX-CoV2373, in individuals 18 years and older.

The committee voted on the following question:

“Based on the totality of scientific evidence available, do the benefits of Novavax COVID-19 Vaccine, Adjuvanted, when administered as a 2-dose series, outweigh its risks for use in individuals 18 years of age and older under the EUA?"

21 attendees voted yes and 1 attendee voted to abstain.

The Data

Novavax’s filing comes from data it submitted to FDA earlier this year and is based off of 2 phase 3 clinical trials they conducted with 1 using nearly 30,000 participants that were randomized between December 27, 2020 and February 18, 2021, and the other using nearly 15,000 participants who were randomized between September 28, 2020 to November 28, 2020.

Both studies’ results were published in the New England Journal of Medicine.

In the former, which was named the (301) PREVENT-19 trial, they had participants in the US and Mexico and the latter trial (302) had people from the United Kingdom participating.

In the 301 trial, the vaccine demonstrated an overall efficacy of 90.4%. In the UK study, the vaccine was found to be 89.7% effective against symptomatic COVID-19 caused by both B117 and non-B117 variants.

Today’s VRBPAC Proceedings

Early on, members were given an opportunity to ask questions, which was a departure from previous VRBPAC meetings. One example came when VRBPAC attendee Eric Rubin, MD, PhD, asked about the utility of having another COVID-19 vaccine.

Peter Marks, MD, PhD, said it could serve as a potential alternative for mRNA vaccines, which could be more comforting to some in the population. Marks also talked about the issue of vaccine uptake and that they should do everything they can to improve that.

After the brief question and answer session, the Centers for Disease Control and Prevention (CDC) reviewed some data and statistics including the following:

• 221 million Americans (71% of population) have received their primary series of the COVID-19 vaccine.
• In March, unvaccinated people 12 years and older had 17 times higher COVID-19 associated death rates compared to those with a primary series and booster dose.

Myocarditis. This has been one of the major ongoing concerns of the mRNA vaccines. Reporting during the meeting helped to offer updated data regarding this adverse event. Specifically in the US reports to VAERS of myocarditis found 1321 reports as of May 26 with 491.9 million primary series and first booster doses administered.

Some of the biggest takeaways from the CDC data included:

• First week of vaccination saw more cases of myocarditis. The median time to symptom onset after vaccination: 3 days (IQR: 2-5 days).
• Males suffered this adverse event considerably more than females. Females were shown to have a “substantially lower” number of these adverse events. Males resulted in 960 cases and in females 361 cases were documented.
• Younger males saw more cases of myocarditis, specifically adolescents and young adults. Median age: 28 years (IQR: 21-42 years).

This presentation was followed by representatives of Novavax who spoke of the vaccine’s efficacy and safety profile.

In the 301 trial, the safety profile demonstrated mostly mild to moderate local events that resolved in 1-2 to days according to Novavax. Pain and tenderness at the site of vaccination was reported to be the largest events with 60% in the 18-64 age group and 38% in 65 years and older. Erythema was reported in 1% of the aforementioned group and 0.7% in the older age group. Swelling was reported 0.9% in the younger group and 0.8% in the older group.

In the 301 trial there was only 1 myocarditis case and 1 case in the 302 study. Post-authorization (internationally), the company reported 35 spontaneous reports of potential myocarditis or pericarditis looking at a total of 744,000 doses administered worldwide.

The next step in the process after today's vote is for both the FDA and CDC to weigh in on this recommendation.