Federal health researchers and vaccine maker Novavax announced Monday that they will begin a phase 3 study for Novavax COVID-19 vaccine candidate in the United States, marking the fifth such hit in the country to reach the final key testing .
“We have come so far, so fast, but we need to get to the finish line,” Dr. Francis Collins, director of the National Institutes of Health, said in a statement. This will require more vaccines using different approaches to ensure that everyone is safely and effectively protected from this deadly disease.
Novavax plans to enroll about 30,000 people at 115 sites in the United States and Mexico to test the shot, known as the NVX-CoV2373. The company is also conducting a phase 3 study of the vaccine in the United Kingdom, where registration was completed last month.
Similar to other COVID-19 vaccines, the Novavax two-shot regimen is designed to enhance the body’s immune response to the distinctive coronavirus protein. While mRNA vaccines launched by Pfizer and Modern relies on the body’s cells that produce antigens to perfect the body’s defenses, Novavax produces its own antigens that mimic the virus’s peak protein. The antigen “can neither replicate nor cause COVID-19,” Novavax said.
The Maryland-based company has announced promising data from early vaccine studies that indicate the vaccine is safe and effective, causing only mild reactions typical of other vaccines and “robust antibody responses” against coronavirus.
If it proves to be effective in the Phase 3 studies, the Novavax vaccine would have an advantage over the versions currently produced by Pfizer-BioNTech and Moderna, which must be kept frozen – in the case of Pfizer, at ultra-cold temperatures. Novavax vials could be dispensed on standard supply chains at refrigerator temperature without the need for specialized freezers.
Novavax
In addition to Pfizer and Moderna, whose vaccines have been launched in the United States in recent weeks, two other vaccine developers are undergoing phase 3 studies in the United States: Janssen and AstraZeneca from Johnson & Johnson. In October, Novavax said its phase 3 study faced delays in issues related to the large-scale manufacture of its doses. Unlike pharmaceutical pharmacies such as Pfizer, Novavax relies on contractors to produce its doses.
Novavax is also among the companies receiving an infusion of funds from the Trump administration to stimulate the development of the $ 1.6 billion vaccine by Operation Warp Speed over the summer.
But because other vaccines are already starting to become available to the public, Novavax may face an additional hurdle as it moves into the final phase of testing.
Pfizer and Moderna acknowledged their widespread enthusiasm for participating in their trials – and the rapid deployment of COVID-19 in the United States – in accelerating Phase 3 testing to completion. But in its announcement Monday, Novavax acknowledged that some Americans may be reluctant to risk receiving a placebo in the Novavax study compared to waiting to secure their own dose of Pfizer-BioNTech or Moderna. vaccines are now being distributed over the United States.
“We recognize that volunteers considering our study 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, president of the research and development firm. in a press release.
“We want to reassure participants that we are working to ensure that their involvement in our process does not have a negative impact on their ability to be vaccinated at the right time.”