Europe’s medicines regulator said Wednesday it could greenlight Novavax’s Covid-19 vaccine “within weeks” if data provided is able to demonstrate the shot’s efficacy and safety, a major boon for the Maryland-based biotech, which has been plagued with manufacturing difficulties and until November had not managed to bring a vaccine to market in its 34-year history.
- The European Medicines Agency (EMA) said it could consider the shot on an expedited time frame because it had “already reviewed a substantial portion” of the data during a rolling review.
- Novavax’s protein-based shot differs from four Covid-19 vaccines approved by the regulator—made by Pfizer-BioNTech, Moderna, Johnson & Johnson and AstraZeneca—and is made using an older kind of technology that could help overcome vaccine hesitancy in some people.
- The jab was first cleared for emergency use by regulators in Indonesia in early November and the Philippines on Wednesday, both produced by the Serum Institute of India, the world’s largest vaccine manufacturer by volume.
- Shares of Novavax rose more than 8% Wednesday.
While Novavax may be late to arrive, the shot has a number of advantages over existing vaccines and has the potential to dramatically boost vaccination rates worldwide. It appears to have an impressive efficacy on par with mRNA vaccines from the likes of Moderna and Pfizer and, unlike those vaccines, can be stored and shipped at normal refrigeration temperatures. The shot uses a protein that contains part of the coronavirus to stimulate an immune response, an older design—shots available in the U.S. rely on newer mRNA or viral-vector technologies—that some vaccine-hesitant individuals might be more comfortable with. Despite bringing no vaccine to market in its 34-year history, the U.S. government invested $1.6 billion in the company as part of Operation Warp Speed, more than any other vaccine maker at the time. Despite some successes in having regulators clear the shot pressure is rising as Novavax faces growing delays and manufacturing issues, many of which have been promised to low- and middle-income countries.
WHAT TO WATCH FOR
Novavax says it anticipates filing with the Food and Drug Administration (FDA) by the end of the year and is prioritizing clearance in less affluent countries left behind in the rollout of other vaccines. If endorsed by the FDA, it will represent a major milestone for the company and an important seal of approval for the vaccine from a widely respected regulator. The company has already filed for emergency authorization in India, the World Health Organization, Canada, the U.K. and Australia.