GAITHERSBURG, Md. — If approved, Gaithersburg, Maryland-based Novavax would be the fourth available vaccine in the United States. The company filed for emergency use authorization with the Food and Drug Administration at the end of January.
More than two months later, there is still no answer from the FDA.
"It's been far too long since Novavax has asked for authorization and I think the FDA has been slow-walking it," said Lawrence Gostin, a Professor of Global Health Law at Georgetown University.
Gostin says another vaccine option is important for the U.S.
"The FDA should authorize it and it should be another vaccine in the toolbox for the United States and the world," he said.
In an interview with WUSA9 just days after filing for emergency use, a Novavax official told us, unlike Moderna and Pfizer's mRNA vaccines, many people are holding out for Novavax's protein-based shot, which is very similar to many childhood immunizations.
"We think that our vaccine can be an important option in making people feel more comfortable and confident in getting their vaccination," said Silvia Taylor with Novavax Global Corporate Affairs.
Clinical trials have proven this new vaccine to be 90% effective. If approved, those 18 years and older would be eligible for the shot.
"It may not be that there will be a very large uptake of Novavax, but there's a certain segment of the population that really wants to use a much more traditional vaccine and not a messenger RNA vaccine," said Gostin.
The timeline for getting to that point is still unclear. Gostin believes a number of factors contribute to the delay in approval, including Novavax's initial delay in filing, and the fact that the US has more than enough vaccine supply already.
The FDA sent the following statement regarding the delay:
While the FDA cannot predict how long its evaluation of the data and information will take, the agency will review the EUA request as expeditiously as possible using its thorough and science-based approach. The agency plans to schedule a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss the EUA request the FDA’s panel of outside scientific and medical experts.
Novavax did not comment on any specific questions, telling WUSA9 the timeline is in the hands of the FDA.