Federal health researchers and vaccine maker Novavax announced on Monday that they will initiate a Phase 3 trial for Novavax’s COVID-19 vaccine candidate in the United States, marking the fifth time in the country to reach the main final phase of testing.
“We’ve come this far, so fast, but we have to make it to the finish,” said Dr. Francis Collins, director of the National Institutes of Health, said in a statement. “That will require multiple vaccines with different approaches to ensure that everyone is protected safely and effectively from this deadly disease.”
Novavax plans to enroll approximately 30,000 people at 115 locations in the United States and Mexico to test the recording, known as NVX-CoV2373. The company is also conducting a Phase 3 study of the vaccine in the UK, where enrollment was completed last month.
As with other COVID-19 vaccines, Novavax’s two-step regimen is designed to enhance the body’s immune response to the signature coronavirus spike protein. While the mRNA vaccines rolled out by Pfizer and Modern depending on the cells in the body that produce antigens to tighten the body’s defenses, Novavax produces its own antigens that mimic the virus’ spike protein. The antigen “cannot replicate, nor can it cause COVID-19,” Novavax stated.
The Maryland-based company has released promising data from early trials of the vaccine, showing that the injection is safe and effective, producing only mild responses typical of other vaccines and “robust antibody responses” to the coronavirus.
If it proves effective in the phase 3 studies, the Novavax vaccine would have one advantage over the versions currently produced by Pfizer-BioNTech and Moderna, which must be kept frozen – in the case of Pfizer, on ultra-cold temperatures. Novavax vials can be distributed across standard supply chains at refrigerator temperatures, without the need for specialized freezers.
Novavax
In addition to Pfizer and Moderna, whose vaccines have begun in the US in recent weeks, two other vaccine developers are engaged in Phase 3 trials in the United States: Johnson & Johnson’s Janssen and AstraZeneca. In October, Novavax said the phase 3 trial was delayed due to problems with the large-scale production of its doses. Unlike pharmaceutical behemoths like Pfizer, Novavax relies on contractors to manufacture its doses.
Novavax is also one of the companies to receive an infusion of funds from the Trump administration to boost vaccine development, which has been awarded $ 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 when it moves to the final testing phase.
Pfizer and Moderna had credited widespread enthusiasm for participating in their studies – and the rapid spread of COVID-19 in the United States – to accelerate their Phase 3 testing to completion. But in its announcement on Monday, Novavax acknowledged that some Americans might hesitate to risk getting a placebo in the Novavax trial, rather than wait to secure their own dose of Pfizer-BioNTech or Moderna. vaccines that are now being distributed in the United States.
“We recognize that volunteers considering our trial may have questions 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 director of research and development, in a press release.
“We want to reassure participants that we are working to ensure their involvement in our study does not adversely affect their ability to be vaccinated at the right time.”