FDA committee recommends EUA for Novavax’s COVID-19 vaccine
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An FDA advisory committee on Tuesday recommended that Novavax’s two-dose COVID-19 vaccine be made available in the United States under an emergency use authorization.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21-0, with one abstention, to recommend the adjuvanted, recombinant spike protein nanoparticle vaccine for anyone aged 18 years or older, saying the benefits of the vaccine outweigh its risks.
The vote came more than 4 months after Novavax asked the FDA to consider the protein-based vaccine for an EUA, and after WHO issued two emergency use listings for the vaccine based on phase 3 trial data — an attempt to increase access in lower-income countries that have had trouble vaccinating their populations.
The FDA will now consider the VRBPAC’s recommendation. If it grants the EUA, the Novavax shot would become the fourth COVID-19 vaccine available in the U.S. The Pfizer-BioNTech and Moderna messenger RNA vaccines are both fully approved for adults — Pfizer’s shot is approved down to age 16 years — and Pfizer’s vaccine is also authorized for children as young as aged 5 years.
The Johnson & Johnson vaccine is still available under an EUA, although its use has been restricted because of the risk for a rare but potentially deadly blood-clotting syndrome.
Vaccine could address hesitancy
Some VRBPAC members wondered Tuesday about the necessity of the Novavax vaccine — something the FDA weighs when considering an EUA — with three other vaccines available.
Peter Marks, MD, PhD, who heads the FDA’s Center for Biologics Evaluation and Research, said the protein-based formula used for Novavax vaccine, which differs from the widely used mRNA vaccines, provides an alternative for people who have expressed hesitancy about mRNA technology.
“We do have a problem with vaccine uptake that is very serious in the United States,” Marks said. “Anything we can do to get people more comfortable to accept these potentially life-saving medical products is something we feel compelled to do.”
CDC data support Marks’ comments about vaccine uptake in the U.S., showing that less than 67% of eligible people are fully vaccinated, and less than 47% have received a booster shot.
Data presented during the meeting showed that unvaccinated Americans are at a four times greater risk for infection, 23 times great risk for hospitalization, and 20 times greater risk for death. Gregory A. Poland, MD, FIDSA, MACP, FRCP, director of the Mayo Clinic’s vaccine research group, said patients with COVID-19 who are hospitalized are also approximately 60% more likely to experience anxiety and depression, 46% more likely to have suicidal thoughts, and 34% more likely to develop opioid use disorders.
“These conditions are preventable if we get a handle on this pandemic and offer people options that they are more likely to choose, thereby encouraging them to get vaccinated,” Poland said.
‘Incredible potential’
The VRBPAC heard data from a multinational phase 3 randomized controlled trial that assessed the safety and efficacy of the vaccine among 30,000 participants aged 18 years or older who were randomized in a 2:1 ratio to receive the Novavax vaccine or placebo.
Over the course of the study, 14 cases of COVID-19 were detected in the vaccine arm and 63 in the placebo arm for a calculated efficacy of 90.4% (95% CI, 82.9%-94.6%). Additionally, four severe cases of COVID-19 were recorded — all the placebo group — yielding an efficacy of 100% against severe disease (95% CI, 87%-100%).
New data reported during the meeting found that as of Feb. 17, solicited adverse reactions were reported by a higher proportion of Novavax recipients than placebo recipients. These events were reported more frequently after the second dose compared with the first (57.9% vs. 78.7%) and were reported more frequently by adults aged 18 to 64 years than adults aged 65 years or older. Among common adverse events associated with the vaccine — including injection site pain or tenderness, fatigue, headache, and muscle pain — there were multiple reported cases of myocarditis and/or pericarditis.
According to data presented by the FDA, in a total clinical database of around 40,000 recipients of the Novavax vaccine, there have been six cases of myocarditis and/or pericarditis, including five that occurred within 20 days of vaccination. The FDA said the cases raise concern for a causal relationship but that “a causal association between vaccination and these events cannot be concluded based on available data.”
These types of events have also been observed among recipients of the mRNA vaccines. (The CDC’s Tom Shimabukuro, MD, MPH, MBA, said in another presentation Tuesday that “current evidence supports a causal association between mRNA COVID-19 vaccination and myocarditis and pericarditis.”)
“This vaccine has incredible potential and a lot has been learned about it that we did not hear about that’s likely to inform on the durability of protection, transmission, the impact of boosting, impact of mix-and-match, and the impact of circling variants,” Bruce Gellin, MD, PhD, chief of global public health strategy at The Rockefeller Foundation, said about the Novavax vaccine.
Gellin was the VRBPAC member who abstained from voting, although he described his abstention as a “conditional yes.”
“I am not voting against this vaccine, as I did worry that such a vote would be misinterpreted,” Gellin said.
He said his “conditional yes” is based on the expectation that the FDA will review additional data that the committee did not see Tuesday to inform its decision.
If the FDA authorizes the vaccine, the CDC’s Advisory Committee on Immunization Practices will meet to make clinical recommendations for its use.
References:
CDC. COVID data tracker – COVID-19 vaccinations in the United States. https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total. Updated June 7, 2022. Accessed June 7, 2022.
Perspective
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The Novavax COVID-19 vaccine should be available as a vaccine option in U.S., as it is in other countries. This is a vaccine that uses an innovative cell-based and adjuvant technology to deliver a protein-based immunization. From the data that have been released, the vaccine appears safe and effective and may be an option for individuals who — for whatever likely invalid reason — are reticent to use the options on the market currently.
Over 20% of American adults are not vaccinated, and perhaps some of them will avail themselves of this opportunity — though I suspect many of them will not because they have been infected by the wickedly flawed thinking that is characteristic of the anti-vaccine movement. Additionally, having another vaccine using a disparate technology is important for enhancing future mix-and-match booster strategies, as different presentations of the spike protein to the immune system may produce extra benefit than repeatedly boosting with the same product.
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FDA. Vaccines and Related Biological Products Advisory Committee June 7, 2022, meeting announcement. https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-june-7-2022-meeting-announcement. Accessed on June 7, 2022.
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