After months of delays the US Food and Drug Administration (FDA) has finally issued an emergency use authorization (EUA) for the Novavax COVID-19 vaccine. Once doses are available this will be the first protein-based COVID vaccine authorized in the United States.
The FDA’s authorization follows a tumultuous couple of years, with trial delays and manufacturing issues slowing the development of a vaccine that in early 2020 was initially announced as part of Operation Warp Speed, next to Pfizer and Moderna’s mRNA vaccines. Despite the hurdles, Novavax’s vaccine has been available across the world for many months. Indonesia, India and the European Union all approved use of the vaccine late last year, while Australia is already using it as a fourth booster option.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, has previously defended his agency’s delays in authorization of the vaccine. He has argued the FDA’s standards for authorization are higher than other countries, particularly in the area of manufacturing.
“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 Marks in a statement accompanying the new EUA for Novavax.
The FDA’s authorization notably does not cover use of the vaccine as a booster. The EUA currently only allows the vaccine to be used as a primary two-dose series for those currently unvaccinated against COVID-19. Robert Califf, current FDA Commissioner, noted the vaccine is currently aimed at those yet to receive any of the pre-existing COVID vaccines.
“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,” said Califf. “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.”
The Novavax COVID-19 vaccine is a protein subunit vaccine. It is made by growing modified versions of the SARS-CoV-2 spike protein on moth cells. Those spike proteins are then harvested and assembled onto nanoparticles designed to resemble the structure of the virus. An adjuvant containing extract from a Soapbark tree is then added to the mixture to boost the body’s immune response.
A few days before this FDA announcement the US government revealed it has purchased 3.2 million doses of the Novavax vaccine, enough to treat 1.6 million Americans. The vaccine is hoped to be accessible within weeks following further approval from a Centers for Disease Control and Prevention (CDC) advisory panel.
Source: FDA