Story at a glance
- The Maryland-based company Novavax has a COVID-19 vaccine that is approved for emergency use internationally but not yet in the U.S.
- The FDA’s Advisory Committee has recommended it be granted emergency use authorization.
- The manufacturing process follows more traditional vaccine production and can be slower to build up supply.
Last week, the Federal Drug Administration’s (FDA) advisory committee recommended that Nuvaxovid receive emergency use authorization for people ages 18 and over. Outside of the U.S., the Novavax COVID-19 vaccine, named Nuvaxovid, has received emergency use authorization in more than 40 countries and is listed for emergency use by the World Health Organization. The committee voted 21 in favor and one abstention.
In the U.S., emergency use authorization could be on the way and provide a fourth vaccine option in addition to the two mRNA vaccines and the Johnson and Johnson vaccine. Nuvaxovid differ from the mRNA vaccines via Pfizer/BioNTech and Moderna. Here are a few of the key differences:
- Novavax vaccine contains the coronavirus spike protein, compared to mRNA vaccines that contain the genetic code to create the spike protein.
- It is made by turning insect cells into protein-producing factories, which then requires processing and purification.
- There’s also a major difference in the level of refrigeration required. The Novavax vaccine is more like the Johnson and Johnson vaccine in that it only requires regular refrigerator temperatures, unlike the mRNA vaccines, which require colder temperatures to maintain structural stability.
The FDA has concerns regarding manufacturing of the vaccine, which is a much more intensive process than for the mRNA vaccines. The agency is reviewing documents recently submitted regarding the manufacturing process, which is more similar to conventional processes used to produce influenza vaccines.
Some experts hope that vaccine skeptics may be more open to this vaccine that is made from traditional vaccine development technology. On the other hand, some people have been waiting for this vaccine, as they may be allergic to some of the components of the mRNA vaccines or did not have enough of an immune response to them.
Health officials may consider recommending it as a booster shot to those who have already received other shots. Researchers will also be interested in the durability of the immune response to the vaccine and how it fairs against newer variants. The efficacy of this vaccine from the clinical trials was reported last year, before the omicron wave, so it may be less effective against omicron strains.