Background: State health officials in South Carolina on Thursday announced the first known U.S. cases of the Covid variant first found in South Africa. The people infected with the variant had not traveled to South Africa, and there is no known connection between them, South Carolina officials said, which suggests that the variant is spreading in the community.
Whats next: Novavax is still enrolling participants in its U.S. clinical trial. The company has enrolled 16,000 people so far and expects to recruit its goal of 30,000by early February.
Company executives told investors late Thursday they are in conversations with U.S. regulators to understand if the data from the U.K. and South African trials are adequate to apply for emergency authorization.
“We’re still awaiting final decisions from the agency if that’s an acceptable approach,” one Novavax executive said.
The FDA has said that the efficacy threshold for an EUA is 50 percent, the same bar that set by the World Health Organization but it has not clarified how that applies to recently emerged variants, such as those first spotted in the U.K., South Africa and Brazil. The agency has also told vaccine developers that they must test their vaccines in Phase III trials that enroll at lest 30,000 people.