The U.S. Centers for Disease Control and Prevention (CDC) backed Novavax's (NASDAQ: NVAX) two-dose COVID vaccine as another primary series for adults this week after two years of trials and errors for the biotech company.
The CDC said in a statement that the vaccine will be available to the public in the coming weeks on Tuesday. Novavax's vaccine is the fourth to be authorized by the federal regulator, and will begin distribution and administration as more than 75% of U.S. adults are now fully vaccinated with either Pfizer (NYSE: PFE), Moderna (NASDAQ: MRNA) or Johnson & Johnson (NYSE: JNJ) COVID vaccines, according to CDC data.
This approval completes a two-year journey for Novavax, which was one of the earliest participants in the former Trump administration's program to fast-track the development and authorization of COVID vaccines--known as Operation Warp Speed. While Novavax had a promising start in 2020, the company had trouble scaling its manufacturing, leading the biotech to fall behind vaccine frontrunners like Pfizer and its partner BioNTech (NASDAQ: BNTX) and Moderna (NASDAQ: MRNA).
Novavax's vaccine was found to be 90% effective at preventing infection and 100% effective at preventing severe disease against the orignal SARS-CoV-2 virus that first emerged in Wuhan, China back in 2019. However, the company has not publish effectiveness data against the now dominant Omicron variant and its subvariants BA.4 and BA.5.
The underlying technology behind the vaccine has been used for more than 30 years in the United States, the CDC said, beginning with the first licensed hepatitis B vaccine. The vaccine uses inactive copies of the virus' spike protein (which is what the virus uses to infect healthy human cells) with the help of an adjuvant that helps the immune system response to the virus in the future.
This technology differs from the newer mRNA platform used by vaccines produced by Pfizer and Moderna. That technology delivers messenger RNA to human cells to create inactive copies of the spike protein to "train" the immune system to later attack an active virus. These two shots are the first mRNA vaccines to receive approval by the U.S. Food and Drug Administration (FDA).