Novavax has pushed back both its timeline for filing for authorization for its SARS-CoV-2 vaccine and its release of a report on its vaccine trial, Bloomberg reports.
Earlier this year, Novavax reported that its vaccine had nearly a 90 percent efficacy rate in preventing COVID-19 based on data from an initial UK trial. It further said that its vaccine was highly effective against the original viral stain and the B.1.1.7 variant, but had a lower efficacy rate against the B.1.351 variant.
In March, Novavax CEO Stanley Erck told CNBC that the company was aiming for May to receive Emergency Use Authorization from the US Food and Drug Administration. But as the Hill now writes, Novavax does not plan to apply for authorization in the US, UK, and Europe until the third quarter of the year. At the same time, it now plans to release its trial report at the end of the month, later than expected, the Washington Post adds.
"We know that we're delayed from where we thought we'd be at this point," Erck tells Reuters. "Now we're giving guidance that nearly all of the major challenges have been overcome and we can clearly see the light at the end of the tunnel."