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Novavax’s COVID-19 vaccine enters Phase 3 trials in the U.S.



Federal health researchers and vaccine manufacturer Novavax announced on Monday that they will begin Phase 3 trials of Novavax’s COVID-19 vaccine candidate in the United States. This is the fifth time that such a vaccine has reached the final critical testing stage in the country.

Dr. Francis Collins, director of the National Institutes of Health, said in a statement: “We go so fast, but we need to get to the end.” “This will require multiple vaccines using different methods to ensure that everyone is Safe and effective protection from this deadly disease.”

Novavax plans to recruit about 30,000 people at 1

15 sites in the United States and Mexico to test the lens, called NVX-CoV2373. The company is also conducting a Phase 3 trial of the vaccine in the UK, which was registered last month.

Similar to other COVID-19 vaccines, Novavax’s two-injection program is designed to enhance the body’s immune response to the unique coronavirus spike protein.and mRNA vaccine Pfizer launched with modern Novavax relies on the body’s antigen-producing cells to perfect the body’s defense capabilities, so it can make its own antigens that mimic viral spike proteins. Novavax said that this antigen “can neither replicate nor cause COVID-19.”

The Maryland-based company announced promising data from early trials of the vaccine, showing that the vaccine is safe and effective, causing only a mild response typical of other vaccines and a “strong antibody response” against the coronavirus.

If it proves to be effective in the Phase 3 trial, Novavax’s vaccine will have an advantage over Pfizer’s BioNTech and Moderna’s current vaccines, which must be kept frozen (taking Pfizer as an example). Super cold temperature. Novavax’s sample bottles can be distributed in the standard supply chain at refrigerator temperature without the need for a special freezer.

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Novavax scientists conduct vaccine development research. The company announced plans to conduct Phase 3 clinical trials of its COVID-19 candidate vaccine in the United States on December 28, 2020.

Novax


In addition to Pfizer and Moderna, which have launched vaccines in the United States in recent weeks, two other vaccine developers are also conducting phase 3 trials in the United States: Johnson & Johnson’s Janssen and AstraZeneca. In October, Novavax stated that its Phase 3 trial had encountered delays in mass production of its dose. Unlike pharmaceutical giants like Pfizer, Novavax relies on contractors to produce dosages.

Novavax is also one of the companies injecting funds from the Trump administration to stimulate vaccine development, with US$1.6 billion allocated by the Warp Speed ​​operation In summer.

But because other vaccines are already available to the public, Novavax may face additional obstacles as it enters the final stages of testing.

Pfizer and Moderna have received widespread enthusiasm for participating in the trial, and the rapid spread of COVID-19 in the United States has accelerated the completion of their Phase 3 testing. But Novavax admitted in Monday’s announcement that some Americans may hesitate to take a placebo in the Novavax trial, rather than waiting to get their own dose of Pfizer-BioNTech or Moderna Vaccine is being distributed now All of America.

Dr. Gregory Glenn, president of the company’s R&D department, said at a press conference: “We recognize that volunteers who are considering trials may have a potential impact on their ability to obtain authorized vaccines.”

“We want to assure participants that we are working hard to ensure that their participation in our trials will not negatively affect their ability to vaccinate at the appropriate time.”


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