After much hype, Novavax was late to the COVID-19 vaccine party. And, now, it’s also late to the after-party, as it has secured FDA emergency authorization for its booster version of the shot seven weeks after Moderna and Pfizer-BioNTech scored their latest booster nods.
Additionally, while the new booster shots from Moderna and Pfizer are designed to defend against subvariants of omicron, Novavax’s version is not.
Still, the company sees a market for its product, touting Wednesday’s blessing as a chance to reach those who have yet to be boosted. People who originally received mRNA shots as their primary series are now eligible to receive Novavax’s traditional, protein-based jab as a booster.
“According to CDC data, almost 50 percent of adults who received their primary series have yet to receive their first booster dose,” Novavax CEO Stanley Erck explained in a release. “Offering another vaccine choice may help increase COVID-19 booster vaccination rates.”
In July, when Novavax received the green light for its two-dose primary vaccine, the company touted Nuvaxovid as a long-awaited alternative to the mRNA formulations of Moderna and Pfizer. But uptake has been disappointing as CDC data show that only 35,300 people have received the shots.
Meanwhile, more than 100 million in the U.S. who received the primary COVID-19 vaccine series have not been boosted, according to the CDC. Another group of people that may be interested in the Novavax booster is the 19 million in the U.S. who have received the Johnson & Johnson COVID-19 vaccine. Many of those recipients were attracted to it as a traditional, adenovirus shot.
Novavax’s booster go-ahead covers adults 18 and older who are at least six months removed from their primary series. Although the booster was not designed to defend against omicron, the company says it does elicit an immune response against subvariants including BA.5—now the dominant iteration in the U.S.
The booster authorization was based on data from a phase 3 trial in the U.K. that showed neutralizing antibody levels increased 27- to 34-fold in recipients who had received their primary series eight to 11 months prior to boosting with Novavax's shot.
The EU and several other countries have already authorized the Novavax shot for primary and booster use.
Early in the pandemic, the U.S. made a big bet on Novavax by providing $1.6 billion in funding. The vaccine performed well in clinical trials against the original version of the virus, but the small Maryland biotech struggled to acquire raw materials to produce the shot and got bogged down with other manufacturing issues.