FDA Authorizes Novavax COVID Vaccine

The Food and Drug Administration (FDA) authorized Novavax’s COVID vaccine for adults on Wednesday, offering a protein-based alternative to mRNA shots from other pharmaceutical companies.

The newly authorized vaccine is scheduled in two doses separated by 21 days.

“Authorizing an additional COVID-19 vaccine expands the available vaccine options for the prevention of COVID-19, including the most severe outcomes that can occur such as hospitalization and death,” said FDA Commissioner Robert M. Califf in a statement.

“Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization. COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19 and I encourage anyone who is eligible for, but has not yet received a COVID-19 vaccine, to consider doing so,” he added.

In addition to the FDA’s approval, Novavax will pursue support from the Centers for Disease Control and Prevention’s (CDC) advisory committee. The group is scheduled to meet next week to review the Novavax vaccine application.

The Biden administration announced Monday that the U.S. had secured 3.2 million doses of the Novavax vaccine. The shots will be shipped to states upon approval for individuals 18 and older.

“We remain committed to working to ensure that anyone eligible who wants a vaccine can get one,” Department of Health and Human Services (HHS) Coordination Operations and Response Element COO Jason Roos said in a Monday statement.

“While more than two-thirds of the American public are already fully vaccinated, we must maintain a sense of urgency to ensure all eligible individuals get vaccinated, particularly heading into the Fall. This latest vaccine would offer people another choice to help protect themselves from severe disease or hospitalization caused by COVID-19,” he added.

Despite the Novavax vaccine’s new approval in the U.S., the company’s shots are already in use in more than 40 nations and have been authorized by the European Union.

According to the statement by Novavax, its COVID vaccine uses older technology found in other vaccines, such as the shots for shingles or hepatitis.

The Novavax vaccine may also be important for some people who have refused other COVID vaccines due to concerns they were developed with lab-grown cell lines derived from a fetus aborted decades ago.

The Associated Press reported that Pfizer and Moderna used the practice in some early-stage testing of their vaccines, while Johnson & Johnson used the practice to grow viruses used to manufacture its vaccine. Novavax states that no human fetal-derived cell lines or tissue have been used in the development or manufacture of its vaccine.

If approved for military usage, Novavax could also offer an option for troops with religious accommodation requests, though such concerns have included a variety of reasons.

 


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