By IDSE News Staff

The FDA issued an emergency use authorization (EUA) for a new protein-based COVID-19 vaccine made by Novavax Inc. to prevent COVID-19 in people who are 18 years of age and older.

“Patients and providers in the U.S. now have access to a protein-based COVID-19 vaccine backed by data that have demonstrated efficacy, safety and tolerability,” said Karen Kotloff, MD, a professor of pediatrics, at the University of Maryland School of Medicine, in Baltimore, the associate director of clinical studies at the Center for Vaccine Development and Global Health, and the COVID-19 Prevention Network co-lead for the PREVENT-19 trial. 

“Offering more vaccine technologies and options in our vaccination portfolio, including those built upon technologies that have been successfully used for years, will hopefully help to increase our country’s vaccination rate,” she said.

The FDA made its decision based on the ongoing pivotal phase 3, randomized, blinded, placebo-controlled PREVENT-19 trial, conducted in the United States and Mexico. The effectiveness of the vaccine was assessed in clinical trial participants who were 18 years of age and older and did not have evidence of SARS-CoV-2 infection through six days after receiving the second vaccine dose. 

Among the participants, approximately 17,200 received the vaccine and approximately 8,300 received saline placebo. 

Overall, the adjuvanted vaccine was 90.4% (95% CI, 83.8%-94.3%; P<0.001) effective in preventing mild, moderate or severe COVID-19, with 17 cases of COVID-19 occurring in the vaccine group and 79 in the placebo group. 

No cases of moderate or severe COVID-19 were reported in participants who received the vaccine, compared with nine cases of moderate COVID-19 and four of severe COVID-19 reported in placebo recipients. 

In the subset of participants who were 65 years of age and older, the vaccine was 78.6% effective. The clinical trial was conducted prior to the emergence of the delta and omicron variants, according to the FDA.
The safety of the vaccine was assessed in approximately 26,000 clinical trial participants who received the vaccine and approximately 25,000 who received placebo. The most commonly reported side effects by vaccine recipients included pain/tenderness, redness and swelling at the injection site, fatigue, muscle pain, headache, joint pain, nausea/vomiting, and fever. Approximately 21,000 vaccine recipients had at least two months of safety follow-up after their second dose.

The FDA said the data support that the known and potential benefits of the vaccine outweigh its known and potential risks in people at least 18 years of age, and that this vaccine may be effective in preventing COVID-19. 

The Novavax COVID-19 vaccine, adjuvanted is administered as a two-dose primary series, three weeks apart. The vaccine contains the SARS-CoV-2 spike protein and Matrix-M adjuvant to enhance the immune response of the vaccinated individual. The spike protein in this vaccine is produced in insect cells; the Matrix-M adjuvant contains saponin extracts from the bark of the soapbark tree, which is native to Chile.

“After a comprehensive analysis and evaluation of the data, and assessment of the manufacturing processes and information, as well as input from the FDA’s committee of external independent advisors, the FDA’s medical and scientific experts have determined that the vaccine meets the FDA’s high standards for safety and effectiveness for emergency use authorization,” said Peter Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation and Research. “Novavax COVID-19 Vaccine, Adjuvanted provides another alternative for adults and adds another vaccine to the COVID-19 vaccine supply for the United States. The American public can trust that this vaccine, like all vaccines that are used in the United States, has undergone the FDA’s rigorous and comprehensive scientific and regulatory review.”

The fact sheet for vaccination providers includes a warning that clinical trial data provide evidence for increased risks for myocarditis and pericarditis after administration of the Novavax vaccine. 

Novavax and vaccination providers must report all vaccine administration errors to the Vaccine Adverse Event Reporting System for which they become aware, and for Novavax to include a summary and analysis of all identified vaccine administration errors in monthly safety reports submitted to the FDA.

The FDA has evaluated the pharmacovigilance plan submitted by the company to monitor the safety of the Novavax COVID-19 vaccine, adjuvanted, as it will be used under an EUA to ensure that any safety concerns are identified and evaluated in a timely manner. As a condition of authorization, the company will conduct studies to further assess its safety, including studies to further assess the risks for myocarditis and pericarditis.

The FDA also expects Novavax to continue its clinical trials to obtain additional safety and effectiveness data and pursue approval (licensure). 

“Authorizing an additional COVID-19 vaccine expands the available vaccine options for the prevention of COVID-19, including the most severe outcomes that can occur such as hospitalization and death,” said FDA Commissioner Robert M. Califf, MD. “Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization. COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19 and I encourage anyone who is eligible for, but has not yet received a COVID-19 vaccine, to consider doing so.”

Doses of the Novavax COVID-19 vaccine, adjuvanted were shipped from the Serum Institute of India Pvt. Ltd., the world’s largest vaccine manufacturer by volume, and are now in the united States. The next step for the vaccine is a policy recommendation for use from the CDC.

Earlier this week, the Department of Health and Human Services, in collaboration with the Department of Defense, announced an agreement to secure an initial 3.2 million doses of the Novavax COVID-19 vaccine, adjuvanted. The vaccine doses will be made available for free to states, jurisdictions, federal pharmacy partners and federally qualified health centers.
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