ACIP votes to recommend Novavax COVID-19 vaccine for US adults
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The Advisory Committee on Immunization Practices voted unanimously 12-0 to recommend the adjuvanted, recombinant spike protein nanoparticle vaccine for anyone aged 18 years or older.
CDC Director Rochelle P. Walensky, MD, MPH, later endorsed the recommendation, giving the U.S. a fourth COVID-19 vaccine option.
“[W]e have expanded the options available to adults in the U.S. by recommending another safe and effective COVID-19 vaccine,” Walensky said.
Data shared during the meeting showed that approximately 26 million to 37 million U.S. adults have not received a single dose of COVID-19 vaccine, despite recent increases in cases and hospitalizations associated with the BA.4 and BA.5 omicron subvariants of SARS-CoV-2.
Additional data showed that unvaccinated adults are 3.5 times more likely to be hospitalized, and unvaccinated people aged 12 years or older have nine times the risk for death compared with those who are vaccinated and boosted.
Experts have expressed hope that people hesitant to receive one of the other COVID-19 vaccines may be more open to Novavax’s more traditional protein-based vaccine, but Evelyn Twentyman, MD, MPH, chief medical officer for the CDC’s COVID-19 Vaccine Task Force, cited recently published survey findings in which 77% of unvaccinated U.S. adults said they would not get a protein-based shot.
“The primary target population for the Novavax vaccine will be the 10% to 13% who are unvaccinated,” Oliver Brooks, MD, FAAP, chief medical officer for Watts Healthcare in California, said during the meeting. “We need to really focus on that population with the hopes that this adjuvanted, recombinant spike protein vaccine will change them over from being unvaccinated to being vaccinated.”
The meeting also included previously presented data on the vaccine’s efficacy and safety profile. According to the data, the vaccine is approximately 90.4% effective in preventing mild, moderate or severe COVID-19 and 79% effective in a subset of people aged 65 years or older. Additionally, the vaccine had favorable safety data that showed the most commonly reported side effects being pain/tenderness, redness and swelling at the injection site; fatigue; muscle pain; headache; joint pain; nausea/vomiting; and fever.
The FDA granted the vaccine an emergency use authorization on July 14.
“If you have been waiting for a COVID-19 vaccine built on a different technology than those previously available, now is the time to join the millions of Americans who have been vaccinated,” Walensky said. “With COVID-19 cases on the rise again across parts of the country, vaccination is critical to help protect against the complications of severe COVID-19 disease.”
[Editor’s note: This story was updated to reflect Walensky’s endorsement of the recommendation.]
References:
CDC. ACIP presentation slides: July 19, 2022, meeting. https://www.cdc.gov/vaccines/acip/meetings/slides-2022-07-19.html. Accessed on July 19, 2022.
Galvin G. Novavax’s traditional vaccine for COVID-19 could hit the U.S. soon. Most unvaccinated adults wouldn’t be swayed. Morning Consult. July 5, 2022. Accessed July 19, 2022. https://morningconsult.com/2022/07/05/novavax-protein-based-covid-vaccine-survey/.
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CDC. ACIP presentation slides: July 19, 2022, meeting. https://www.cdc.gov/vaccines/acip/meetings/slides-2022-07-19.html. Accessed on July 19, 2022.
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