The Biotechnology Innovation Organization (BIO) has urged the US Department of Health and Human Services to publish the new criteria it developed for the emergency authorization of a coronavirus vaccine, the New York Times reports.
Last month, the Food and Drug Administration appeared poised to announce stricter standards for the emergency authorization of a SARS-CoV-2 vaccine, such as requiring vaccine makers to follow trial volunteers for a median two months after their last dose before seeking authorization. This, CNN noted at the time, would make it unlikely that any candidate vaccine would be able to receive authorization by the US election in early November. However, Politico then reported that President Donald Trump cast doubt on whether he would allow the new criteria to be adopted.
According to the Times, this state of affairs "is causing growing angst within the biotech industry." It reports that Michelle McMurry-Heath, the president and CEO of BIO, has sent a letter to Alex Azar, the health secretary, asking him to publicly release the guidelines. "The release of FDA guidance would provide scientists and researchers greater regulatory clarity and strengthen public confidence in any future vaccine that may be authorized or approved," she writes in the letter.