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Novavax announced on Monday its vaccine was found effective against COVID-19 and some variants of the virus in a late-stage study across the United States and Mexico, the Associated Press reported.
The vaccine was effective against several variants, including the variant first discovered in the U.K., which has been spreading in the U.S. and affecting high-risk groups.
Nearly 30,000 adults in the U.S. and Mexico participated in the study. Two-thirds of the participants received two doses of the vaccine three weeks apart, while the rest of the participants received placebo shots.
The study saw 77 cases of COVID-19 across all participants. The group that received the vaccine had 14 cases, all with mild cases. The rest were in the group that had not received the vaccine, with some moderate to severe cases.
"These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus," said Gregory M. Glenn, M.D., president of Research and Development at Novavax. "Our vaccine will be a critical part of the solution to COVID-19 and we are grateful to the study participants and trial staff who made this study possible, as well as our supporters, including the U.S. government."
The vaccine was about 90% effective overall and preliminary data showed it was safe, the company said.
For more reporting from the Associated Press, see below.
The results were reported in a press release, and Novavax plans to publish in a medical journal for peer review.
While demand for COVID-19 shots in the U.S. has dropped off dramatically, the need for more vaccines around the world remains critical. The Novavax vaccine, which is easy to store and transport, is expected to play an important role in boosting vaccine supplies in the developing world.
That help is still months away, however. The company says it plans to seek authorization for the shots in the U.S., Europe and elsewhere by the end of September and be able to produce up to 100 million doses a month by then.
"Many of our first doses will go to...low- and middle-income countries, and that was the goal to begin with," Novavax Chief Executive Stanley Erck told AP.
While more than half of the U.S. population has had at least one COVID-19 vaccine dose, less than 1 percent of people in the developing world have had one shot, according to Our World In Data.
Side effects were mostly mild—tenderness and pain at the injection site. There were no reports of unusual blood clots or heart problems, Erck said.
The Maryland-based company previously released findings from smaller studies in Britain and South Africa.
COVID-19 vaccines train the body to recognize the coronavirus, especially the spike protein that coats it, and get ready to fight the virus off. The Novavax vaccine is made with lab-grown copies of that protein. That's different from some of the other vaccines now widely used, which include genetic instructions for the body to make its own spike protein.
The Novavax vaccine can be stored in standard refrigerators, making it easier to distribute.
Novavax previously announced manufacturing delays due to supply shortages. The company now expects to reach production of 100 million doses a month by the end of September and 150 million doses a month by December.
The company has committed to supplying 110 million doses to the U.S. over the next year and a total of 1.1 billion doses to developing countries.
In May, vaccines alliance Gavi announced it had signed an agreement to buy 350 million doses of Novavax's vaccine, with deliveries estimated to begin in the third quarter. COVAX, the global initiative to provide vaccines to countries, is facing a critical shortage of vaccines after its biggest supplier in India suspended exports until the end of the year,
Novavax has been working on developing vaccines for more than three decades, but hasn't brought one to market. The company's coronavirus vaccine work is partly funded by the U.S. government.
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