June 14, 2021
A fourth COVID-19 vaccine could become available in the U.S. later this year.
Novavax reported Monday that its two-dose regimen proved to be highly effective and safe in a late-stage clinical trial. The biotechnology company plans to seek authorization from the U.S. Food and Drug Administration in the third quarter.
The vaccine was found to have an overall efficacy rate of 90% and was 100% effective against moderate and severe coronavirus infections during the Phase 3 study. It also was 93% effective against variants of concern, as defined by the CDC, and 100% effective against other variants.
The most common side effects were mild to moderate injection site pain and tenderness that lasted less than three days. Fatigue, headache and muscle pain lasting less than two days also was common.
The results come as the U.S. and other G7 nations seek to allocate more COVID-19 vaccines to developing countries as part of an effort to bring an end to the global pandemic.
"Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines," Novavax CEO Stanley C. Erck said.
Novavax expects to produce 100 million vaccine doses per month by the end of the third quarter and 150 million doses per month by the end of this year.
The Phase 3 trial enrolled nearly 30,000 adult volunteers at 119 sites across the U.S. and Mexico, with two-thirds of participants receiving the two-shot vaccine three weeks apart.
Of the 77 study participants who contracted COVID-19, only 14 cases were observed in the group that received the vaccine. All of those cases were defined as mild. Fourteen moderate or severe cases were observed among the volunteers who received a placebo.
The vaccine also was found to be 91% effective at preventing illness in high-risk populations — defined as people ages 65 and older and younger adults with underlying health conditions.
Novavax officials said they will share more data from the trial once it become available.
The vaccine uses more traditional technology to trigger an immune response than those produced by Pfizer and Moderna, which rely on synthetic messenger RNA. It contains a full-length spike protein mixed with an adjuvant to boost immune response. The protein can neither cause COVID-19 nor replicate.
The vaccine also doesn't have any special storage requirements that could complicate distribution.
Novavax's Phase 3 trial began last December. It was designed to include a diverse study population, with adults ages 65 years and older constituting at least 25% of the volunteers and Black volunteers representing at least 15%.
The company currently is testing its vaccine on 2,200 adolescents ages 12-17.
If granted an emergency use authorization, Novavax would join Pfizer, Moderna and Johnson & Johnson as the four COVID-19 vaccines available in the U.S. It's one of six that the U.S. invested in as a part of Operation Warp Speed.