The U.S. is likely soon to have a fourth vaccine approved for the fight against COVID-19. Novavax just released the results of its Phase 3 clinical trial: Its two-dose vaccine demonstrates 90 percent overall efficacy and 100 percent protection against both moderate and severe COVID-19 disease. The doses are injected three weeks apart.
The company reports that 77 cases of COVID-19 were observed in its clinical trial involving nearly 30,000 participants. Of those cases, 63 occurred in the placebo group and 14 in the vaccine group. "All cases observed in the vaccine group were mild as defined by the trial protocol," notes the company's press release. "Ten moderate cases and four severe cases were observed, all in the placebo group, yielding a vaccine efficacy of 100% against moderate or severe disease." The vaccine's side effects were generally mild.
The Novavax vaccine uses a technology similar to hepatitis and pertussis vaccines, in which copies of viral proteins provoke the immune system to create antibodies that protect people when they are exposed to the actual viruses. In this case, Novavax employs the coronavirus spike protein that the virus uses to infect human cells.
More good news: The vaccine is highly effective against the more transmissible COVID-19 Alpha (B.1.1.7) variant first identified in the U.K., and it is somewhat effective against the B.1.351 (Beta) variant first identified in South Africa.
The next big step is to ask the Food and Drug Administration to approve the drug. Novavax plans to apply for that in the third quarter of this year. The company claims that once the vaccine is approved, it can reach manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of 2021.
Before being thawed out for administration, the mRNA vaccines developed by Pfizer/BioNTech and Moderna must be shipped at ultra-cold temperatures. The Novavax vaccine is stored and stable at 2° to 8°C, which makes it easier to distribute through existing vaccine supply chain channels. It could thus play a significant role in abating the ongoing pandemic in the poorer parts of the world.