An independent advisory group to the Food and Drug Administration (FDA) voted in favor of authorizing the COVID vaccine made by drugmaker Novavax for adults ages 18 and older on Tuesday, June 7.
Twenty-one members of the advisory committee voted yes, and none voted no; while one person abstained. The FDA will next decide whether to authorize the shot for emergency use, which would make Novavax the fourth coronavirus vaccine available in the United States. The FDA often follows the recommendations of the advisory group, according to Channel News Asia.
Novavax's jab, if it is authorized, would be the only protein-based COVID vaccine distributed in the United States. That formulation is more traditional than the ones used by Pfizer and Moderna which utilize mRNA shots. The FDA has approved several protein-based vaccines in the past, including one for shingles and another for hepatitis B.
Novavax's COVID vaccine effective in trial
Because of that, some members of the FDA committee think it might appeal to American residents who have thus far opted not to get vaccinated. Dr. Peter Marks, who is the director of the FDA's Center for Biologics Evaluation and Research, said at the meeting that having a protein-based alternative may be more comfortable for some people in terms of their acceptance of vaccines.
According to the Centers for Disease Control and Prevention (CDC), one-third of the people in the United States are not fully vaccinated for COVID-19, and 22 percent of them have not received a single dose of COVID vaccine.
Novavax's vaccine appeared highly effective in its clinical trial. It lowered the risk of symptomatic COVID by 90 percent in a group of more than 30,000 people in Mexico and the U.S. It did not determine, though, the vaccine's efficacy against the virus's omicron variant as the trial was conducted from December 2020 to February 2021, when the alpha variant of the coronavirus was dominant.
Dr. Mark Sawyer, an infectious disease specialist at Rady Children's Hospital in San Diego and also a committee member, told NBC News that it is quite disappointing that they don't have any data in the omicron era but the data is quite similar to what they have approved in the past with other vaccines.
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Novavax's vaccine can be stored in a regular refigerator
The World Health Organization (WHO) authorized the COVID vaccine of Novavax for emergency use back in December. It has also been authorized in the European Union, India, Indonesia, Australia, Philippines, United Kingdom, and South Korea. Novavax revealed on Tuesday that 744,000 doses had been administered worldwide as of April.
One advantage of Novavax's vaccine is that it can be stored in a regular refrigerator for up to six months, whereas mRNA vaccines of Pfizer and Moderna must be kept at subzero temperatures, making the shots harder to transport.
According to CDC data, the U.S. has already discarded 82.1 million COVID vaccine doses from December 2020 through mid-May. Fox 29 reported that is more than 11 percent of the doses distributed by the federal government.
