Federal health researchers and vaccine maker Novavax announced Monday that they will begin a Phase 3 trial for Novavax’s COVID-19 vaccine candidate in the United States, the fifth shot in the country to reach its most important final phase of the test .
“We came so fast, but we have to get to the finish line,” said Dr. Francis Collins, director of the National Institutes of Health, said in a statement. “Several vaccinations are needed with different approaches to ensure that everyone is protected safely and effectively against this deadly disease.”
Novavax plans to enroll approximately 30,000 people on 115 sites in the United States and Mexico to test the shot, known as NVX-CoV2373. The company is also conducting a Phase 3 trial of the vaccine in the UK, where registration was completed last month.
Similar to other COVID-19 vaccines, the two-shot regimen of Novavax is designed to increase the body’s immune response to the characteristic coronavirus protein. While the mRNA vaccines rolled out by Pfizer and Modern Relying on the body cells that produce antigens to hone the body’s defenses, Novavax produces its own antigens that mimic the protein of the virus. The antigen “cannot repeat or cause COVID-19,” Novavax said.
The company in Maryland has announced promising data from early trials of the vaccine indicating that the shot is safe and effective, eliciting only mild reactions typical of other vaccines and ‘robust antibody responses’ to the coronavirus.
If it proves to be effective in Phase 3 trials, Novavax’s vaccine will have one advantage over the versions currently manufactured by Pfizer-BioNTech and Moderna, which must be frozen – in the case of Pfizer, at ultra-cold temperatures. The Novavax vials can be distributed over standard supply chains at refrigerator temperatures, without the need for special freezers.
Novavax
In addition to Pfizer and Moderna, whose vaccines have begun rolling out in the U.S. in recent weeks, there are two other vaccine developers conducting Phase 3 trials in the United States: Johnson & Johnson’s Janssen and AstraZeneca. In October, Novavax said the Phase 3 trial was experiencing delays due to problems with large-scale dose production. Unlike pharmaceutical recipes like Pfizer, Novavax relies on contractors to produce the doses.
Novavax is also one of the companies receiving an addition of funds from the Trump administration to encourage the development of vaccines, with $ 1.6 billion allocated by Operation Warp Speed over the summer.
But because other vaccines are already available to the public, Novavax may face an additional hurdle as it moves into the final phase of testing.
Pfizer and Moderna attributed the great enthusiasm to participate in their trials – and the rapid spread of COVID-19 in the United States – to expedite their Phase 3 testing to completion. But in its announcement Monday, Novavax acknowledged that some Americans may be reluctant to get a placebo in the Novavax trial, instead of waiting to secure their own dose of Pfizer-BioNTech or Moderna. vaccines are now being distributed across the United States.
“We realize that volunteers considering our trial may have questions about the potential impact on their ability to receive an authorized vaccine when it is available to them,” said Dr. Gregory Glenn, the firm’s president of research and development, said in a news release.
“We want to reassure participants that we are working to ensure that their involvement in our trial does not adversely affect their ability to be vaccinated at the right time.”