FDA Authorizes Novavax Covid Vaccine, in Hopes the Traditional Shot Will Convince Holdouts
StatNews | By Matthew Herper
The Food and Drug Administration on Wednesday authorized the Covid-19 vaccine developed by Novavax, a small Maryland biotech firm, for people 18 and over, voicing hope that the availability of a more traditional vaccine might help convince those skeptical of the Covid shots using new mRNA technology to get inoculated.
As with other Covid vaccines, the Novavax shot will be free to consumers, because the U.S. government will purchase the doses. But before the vaccine will be widely available, it must also be recommended by the director of the Centers for Disease Control and Prevention. That recommendation will likely follow a July 19 meeting of an expert committee convened by the CDC.
“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 prepared 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.”
The U.S. has received 3.2 million doses of the vaccine that are ready to be shipped to states once the vaccine is authorized and recommended by the CDC.
“Today’s FDA emergency use authorization of our COVID-19 vaccine provides the U.S. with access to the first protein-based COVID-19 vaccine,” said Stanley C. Erck, Novavax’s CEO. “This authorization reflects the strength of our COVID-19 vaccine’s efficacy and safety data, and it underscores the critical need to offer another vaccine option for the U.S. population while the pandemic continues.”
Unlike the vaccines from Pfizer/BioNTech and Moderna, the Novavax vaccine has had a bumpy path to the market. Novavax received $1.6 billion in support from the U.S. government’s Operation Warp Speed project in July 2020. At the time, the hope was that the company might begin making a vaccine by the beginning of 2021. But while the Moderna and Pfizer/BioNTech shots released data in November of 2020, results were not available for the Novavax vaccine until June of 2021.
There were also questions about the ability to produce the vaccine in large amounts. The original deal between Novavax and Operation Warp Speed would entitle the U.S. to 100 million doses of the vaccine. In the press release announcing the vaccine’s emergency use authorization, FDA officials emphasized that the vaccine had not only met the FDA’s bar for safety and efficacy but also “assessment of the manufacturing processes and information.”
In June, a panel of FDA advisers voted 21 to 0, with one abstention, that the Novavax vaccine’s benefits outweigh its risks.
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