Novavax’s COVID-19 vaccine gets nod from WHO as FDA submission looms
WHO has issued two emergency use listings for Novavax’s COVID-19 vaccine following the publication of positive results from a phase 3 trial, and the company said it expects to begin submitting data to the FDA by the end of the year.
The first emergency use listing (EUL) was issued by WHO last week for the vaccine, named Covovax, that is produced by the Serum Institute of India under license from Novavax. The EUL made the vaccine available to the COVAX initiative, “giving a much-needed boost to ongoing efforts to vaccinate more people in lower-income countries,” WHO said.
“Even with new variants emerging, vaccines remain one of the most effective tools to protect people against serious illness and death from SARS-COV-2,” WHO Assistant-Director General for Access to Medicines and Health Products Mariângela Simão, MD, MSc, said in a press release.
“This listing aims to increase access particularly in lower-income countries, 41 of which have still not been able to vaccinate 10% of their populations, while 98 countries have not reached 40%,” Simão said.
WHO on Monday granted a second EUL to the vaccine being marketed by Novavax in Europe and other markets as Nuvaxovid. It came the same day that the European Medicines Agency recommended granting a conditional marketing authorization for the vaccine in the European Union.
The vaccine has not been authorized for use in the United States, but Novavax said last week that it expects to submit its complete CMC data package to the FDA by the end of next week.
The phase 3 findings published in The New England Journal of Medicine last week align with data announced by Novavax in a press release in June.
Researchers assessed the vaccine — an adjuvanted, recombinant spike protein nanoparticle vaccine — among 29,949 participants in a randomized, observer-blind, placebo-controlled study conducted from Dec. 27, 2020, to Feb. 18, 2021, in the United States and Mexico.
Among all participants, 19,714 received the vaccine and 9,868 received a placebo. Over the course of 3 months, 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%).
Four severe cases of COVID-19 occurred, all the placebo group, yielding an efficacy of 100% against severe disease (95% CI, 87%-100%).
“This vaccine has many attractive features,” Karen L. Kotloff, MD, coauthor of the study and professor of pediatrics at the University of Maryland, told Healio. “It is made from a small piece of protein like many currently licensed vaccines in the U.S. and has convenient refrigerator storage requirements, so it will be an important addition to the COVID-19 vaccine portfolio, in the U.S. and in countries where supply is lacking.”
Novavax announces submission of New Drug Application in Japan for approval of COVID-19 vaccine. https://ir.novavax.com/2021-12-15-Novavax-Announces-Submission-of-New-Drug-Application-in-Japan-for-Approval-of-COVID-19-Vaccine. Published Dec. 15, 2021. Accessed Dec. 20, 2021.
Novavax receives positive European Medicines Agency recommendations for conditional marketing authorization of its COVID-19 vaccine. https://ir.novavax.com/2021-12-20-Novavax-Receives-Positive-European-Medicines-Agency-Recommendation-for-Conditional-Marketing-Authorization-of-its-COVID-19-Vaccine. Published Dec. 20, 2021. Accessed Dec. 20, 2021.
Novavax statement on PREVENT-19 phase 3 clinical trial results publication in the New England Journal of Medicine. https://ir.novavax.com/Novavax-Statement-on-PREVENT-19-Phase-3-Clinical-Trial-Results-Publication-in-the-New-England-Journal-of-Medicine. Published Dec. 15, 2021. Accessed Dec. 20, 2021.
WHO. COVID-19 vaccines WHO EUL issued. https://extranet.who.int/pqweb/vaccines/vaccinescovid-19-vaccine-eul-issued. Accessed Dec. 20, 2021.
WHO lists 9th COVID-19 vaccine for emergency use with aim to increase access to vaccines in lower-income countries. https://www.who.int/news/item/17-12-2021-who-lists-9th-covid-19-vaccine-for-emergency-use-with-aim-to-increase-access-to-vaccination-in-lower-income-countries. Published Dec. 17, 2021. Accessed Dec. 20, 2021.
World Health Organization grants second emergency use listing for Novavax COVID-19 vaccine. https://ir.novavax.com/2021-12-20-World-Health-Organization-Grants-Second-Emergency-Use-Listing-for-Novavax-COVID-19-Vaccine. Published Dec. 20, 2021. Accessed Dec. 20, 2021.