With each passing week, the United States is building up a greater amount of authorized vaccines from other companies, raising the question of whether the country should issue more emergency use or EUA authorizations.
“The law says that once you have enough doses, you don’t need the extra EUA anymore,” Dr Borio said.
A sign that the FDA is changing its approach to Covid-19 vaccines arrived last week. An American company called Ocugen had requested emergency clearance for Covaxin, a Covid-19 vaccine now in use in India. But on Thursday, the company announced that the FDA had recommended following the standard path to full approval, known as a biologics license application, which takes several additional months.
But because Novavax has been consulting the FDA for the past year about its trials, Erck said the company may be able to continue with plans to seek emergency use authorization.
“So far they have indicated that if you are in the process of getting an EUA, you can continue for an EUA,” Erck said. “Anyone could tell you that could change, but I don’t know how to predict it. “
Dr Paul Offit, a professor at the University of Pennsylvania and a member of the FDA’s vaccine advisory committee, said Novavax’s highly effective vaccine would be welcome. “The more the merrier,” he said. “I think there is room for a lot more vaccines because we are going to be dealing with this virus for years, if not decades. “
Novavax is preparing for this future by studying how its vaccine might work as a booster. A new version of the vaccine contains the proteins of the beta variant first identified in South Africa.