Maryland-based company Novavax announced Monday that it has expanded its late-stage trial on its COVID-19 vaccine to include adolescents between the ages of 12-17, another step forward in the race to vaccinate children against the coronavirus.
“Through the expansion of our PREVENT-19 clinical trial, we hope to build upon the encouraging safety and efficacy data generated to-date in adults for our vaccine candidate and to play a significant global role in offering vaccination to as many people as possible across age groups to end the suffering caused by the pandemic,” Dr. Gregory Glenn, the company’s president of research and development said in a statement.
The Maryland-based company said they will include up to 3,000 adolescents aged 12-17 in its Phase 3 clinical trial, which will be conducted in up to 75 sites nationwide. The company is expected to release results from its Phase 3 trial during Q2 of 2021.
While COVID-19 vaccinations are not required to reopen schools, vaccinating children could go a long way toward getting kids and teachers back into schools nationwide.
In a recent U.K. trial, Novavax’s COVID-19 vaccine was over 96% effective against the original COVID-19 strain, as well as 86% effective against the variant first discovered in the United Kingdom, known as B.1.1.7. In a trial in South Africa, where the B.1.351 variant strain is prevalent, the vaccine showed 100% protection against severe disease.
Novavax’s regimen of two doses spread over a month is similar to those by Pfizer and Moderna. But unlike the Pfizer and Moderna shots, which utilize mRNA technology, Novavax’s vaccine candidate, known as NVX–CoV2373, contains a spike protein from the coronavirus, which stimulates the body to create antibodies and T-cell immune responses, according to Yale Medicine.
President Joe Biden mentioned the vaccine candidate last week at the White House when he answered a question about aiding other countries.
“The problem is right now we have to make sure we have other vaccines like Novavax and others coming on, probably,” Biden said. “And I think we will be in a position to share vaccines as well as know-how in countries who are in real need. That’s the hope and expectation.”
Shares in the company jumped after Biden’s mention.
According to Politico, the company could file for Emergency Use Authorization with the Food and Drug Administration in the coming weeks, potentially jumping AstraZeneca, which at one point was seen as a frontrunner to release its COVID-19 vaccine in the U.S.
Novavax has never brought a product to market before, but the company received $1.6 billion from the U.S. government last year as part of the Trump administration’s Operation Warp Speed initiative.
The company’s CEO told Reuters that Novavax expects to produce up to 150 million doses a month by May or June. Reuters also reports the company will start shipping vaccines to the European Union later in 2021.
