The U.S. Food and Drug Administration (FDA) on Wednesday approved the COVID-19 vaccine from American vaccine maker Novavax, adding a fourth shot to the U.S.’s arsenal of anti-COVID weapons just as the highly transmissible Omicron subvariant BA.5 drives a surge of infections. Novavax’s approval culminates a vaccine development process that was at once plagued by regulatory and manufacturing issues and buoyed by data that consistently showed the jab’s effectiveness.
“This authorization reflects the strength of our COVID-19 vaccine’s efficacy and safety data, and it underscores the critical need to offer another vaccine option for the U.S. population while the pandemic continues,” Novavax CEO Stanley C. Erck said in a press release.
Novavax conducted its initial clinical trial in the spring of 2021, before the rise of more vaccine-evasive variants Delta and Omicron. At the time, the vaccine proved 90% effective against stopping infections and 100% effective in preventing deaths in the critical trial, matching the performance of Moderna’s and Pfizer’s mRNA jabs.
Novavax, headquartered in Gaithersburg, Md., developed a COVID jab that is protein-based; it relies on more traditional vaccine technology that deploys a harmless version of the spike protein to teach the immune system to create antibodies to fight off the virus. Newer mRNA technology employed by Pfizer and Moderna uses genetically engineered mRNA to create the antibodies. The Novavax vaccine also differs from Johnson & Johnson’s COVID shot in that the Novavax jab uses the actual spike protein of the coronavirus—rather than an adenovirus that encodes the spike protein—to elicit an immune response.
Experts are hopeful that Novavax’s COVID vaccine is different enough from those already on the market that it appeals to vaccine holdouts.
“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,” FDA Commissioner Robert M. Califf said in a press release. The U.S. government announced earlier this week that it had purchased 3.2 million doses of the Novavax vaccine, enough to vaccinate 1.6 million people. The U.S. Centers for Disease Control is expected to recommend deploying the shots when it meets on July 19.
For now, Novavax’s vaccine will only be available in the U.S. as a primary, two-dose regimen, meaning those who want a Novavax booster shot will likely have to wait several weeks or longer.
Novavax’s vaccine has been approved as both a primary vaccine and a booster in dozens of markets including in the European Union, Australia, and Japan. The company will soon seek authorization as a booster dose in the U.S. and is working on an Omicron-specific booster jab that it expects to roll out later this fall.
On July 1, Novavax said that its vaccine prompted “broad immune responses” against all COVID variants, including BA.5, in clinical data. Novavax has not publicly released the data, but some experts are optimistic that it might outperform mRNA vaccines against BA.5 owing to its technology.
“I wonder if we’re not witnessing some of the limitation that there may be [with] the mRNA vaccines. Yes, they were first out of the gate. But they don’t appear to have that breadth of protection,” Wayne A. Marasco, an FDA adviser and virology professor at the Dana-Farber Cancer Institute, told the Washington Post about the potential benefits of Novavax’s protein-based jab. Marasco said that Novavax’s data on new variants was impressive, and noted that the data also intrigued other FDA advisers.
John Moore, virologist at Weill Cornell, told the New York Times that Novavax’s vaccine likely produces fewer side effects than its mRNA counterparts, which may make it a popular booster option should the U.S. approve it for that use.
Novavax’s vaccine has garnered a devoted online fan base, the so-called Novastans, who are attracted to the vaccine as an alternative to mRNA shots. Some of the vaccine’s devotees put off getting a COVID vaccine until the U.S. government approved the Novavax shot.
Today, the Novastans are rejoicing.
“I am so happy for all my Novavites who truly endured, suffered in many ways, waited, prayed and hoped so they could get an alternative to [mRNA vaccines],” one user wrote on a Reddit forum dedicated to the vaccine. “[It’s] about time!” another user wrote.
Shareholders in Novavax, a 35-year-old company that had never brought a product to market until now, are likely celebrating too. Novavax’s stock price has jumped up 9% since Tuesday, when Politico broke the news that the FDA would officially approve Novavax’s vaccine the next day.
