Federal health researchers and vaccine maker Novavax announced on Monday that they will begin a Phase 3 test for Novavax’s COVID-19 candidate vaccine in the United States, marking the country’s fifth injection to reach its final testing stage.
“We got here so fast, but we need to get to the finish line,” said Dr. Francis Collins, director of the National Institutes of Health, in a statement. “This will require multiple vaccines using different approaches to ensure that everyone is safely and effectively protected from this deadly disease.”
Novavax plans to enroll some 30,000 people at 115 locations in the United States and Mexico to test the injection, known as NVX-CoV2373. The company is also conducting a Phase 3 trial of the vaccine in the UK, where enrollment was completed last month.
Similar to other COVID-19 vaccines, Novavax’s two-dose regimen is designed to increase the body’s immune response against peak coronavirus protein. While the mRNA vaccines launched by Pfizer and Modern Relying on the body’s cells that produce antigens to enhance the body’s defenses, Novavax makes its own antigens that mimic the virus’s spike protein. The antigen “cannot replicate, nor can it cause COVID-19,” said Novavax.
The Maryland-based company announced promising data from initial testing of the vaccine, indicating that the injection is safe and effective, eliciting only mild reactions typical of other vaccines and “robust antibody responses” against the coronavirus.
If it is effective in Phase 3 testing, the Novavax vaccine will have an advantage over the versions currently produced by Pfizer-BioNTech and Moderna, which must be kept frozen – in the case of Pfizer, in ultra-cold temperatures. Novavax bottles can be distributed in standard supply chains at refrigerator temperatures, without the need for specialized freezers.
Novavax
In addition to Pfizer and Moderna, whose vaccines began shipping in the United States in recent weeks, two other vaccine developers have Phase 3 trials underway in the United States: Johnson & Johnson’s AsansZeneca and Janssen. In October, Novavax said its Phase 3 test was lagging due to problems with large-scale manufacturing of its doses. Unlike pharmaceutical giants like Pfizer, Novavax relies on contractors to produce their doses.
Novavax is also among the companies that will receive an injection of funds from the Trump administration to stimulate the development of vaccines, awarded to $ 1.6 billion by Operation Warp Speed during the summer.
But, as other vaccines are already starting to become available to the public, Novavax may face an additional hurdle as it moves into the final testing phase.
Pfizer and Moderna had credited the widespread enthusiasm for participating in its tests – and the rapid spread of COVID-19 in the United States – by accelerating the completion of Phase 3 tests. But in its announcement on Monday, Novavax acknowledged that some Americans may hesitate to risk receiving a placebo in the Novavax study instead of waiting to secure their own dose of Pfizer-BioNTech or Moderna vaccines now being distributed across the United States.
“We recognize that volunteers considering our study may have doubts about the potential impact on their ability to receive an authorized vaccine when it becomes available to them,” said Dr. Gregory Glenn, the company’s president of research and development, in a press release.
“We want to reassure participants that we are working to ensure that their involvement in our study does not have a negative impact on their ability to be vaccinated at the appropriate time.”