Federal health researchers and vaccine maker Novavax announced Monday they will begin a phase 3 trial for Novavax’s COVID-19 vaccine candidate in the United States, the fifth opportunity in the country to reach its stage. end of tests.
“We’ve gotten this far, so fast, but we have to get to the finish line,” Dr. Francis Collins, director of the National Institutes of Health, said in a statement. “This will require multiple vaccines that use different methods to ensure everyone is protected safely and effectively against this deadly disease.”
Novavax plans to enroll about 30,000 people at 115 locations 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, Novavax’s two-shot regimen is designed to increase the body’s immune response against the distinctive coronavirus ear protein. While MRNA vaccines released by Pfizer i Modern relying on the body’s cells to produce antigens to perfect the body’s defenses, Novavax manufactures its own antigens that mimic the virus’s ear protein. Novavax stated that the antigen “cannot replicate or cause COVID-19.”
The Maryland-based company has announced promising data from the first vaccine trials indicating that the shot is safe and effective, causing only mild reactions typical of other vaccines and “robust antibody responses” against the coronavirus.
If it is shown to be effective in phase 3 trials, the Novavax vaccine would have an advantage over the versions currently produced by Pfizer-BioNTech and Moderna, which should be kept frozen, in the case of Pfizer, at ultra cold temperatures. Novavax vials could be distributed by standard supply chains at refrigerator temperature, without the need for specialized freezers.
Novavax
In addition to Pfizer and Moderna, whose vaccines began rolling out in the United States in recent weeks, two other vaccine developers have ongoing Phase 3 trials in the United States: Johnson & Johnson’s Janssen and AstraZeneca. In October, Novavax claimed that its phase 3 trial faced delays over problems related to the large-scale manufacture of its doses. Unlike large pharmacists like Pfizer, Novavax relies on contractors to produce the doses.
Novavax is also one of the companies receiving an infusion of funds from the Trump administration to stimulate the development of vaccines, awarded $ 1.6 billion by Operation Warp Speed during the summer.
But as other vaccines are already beginning to be available to the public, Novavax may face an additional hurdle as it moves into the final phase of testing.
Pfizer and Moderna had shown widespread enthusiasm for participating in their trials and the rapid spread of COVID-19 in the United States to accelerate Phase 3 testing to completion. But in its announcement Monday, Novavax acknowledged that some Americans might be hesitant to risk receiving a placebo at the Novavax trial instead of waiting to get their own dose of Pfizer-BioNTech or Moderna. vaccines are now being distributed across the United States.
“We recognize that volunteers who consider 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, president of research and development at the signature, in a press release.
“We want to assure participants that we are working to ensure that their participation in our trial does not adversely affect their ability to vaccinate at the right time.”