FDA could delay decision on AstraZeneca COVID-19 vaccine

The combination of uncertainty about the safety of AstraZeneca’s COVID-19 vaccine and confidence in supplies of three FDA-authorized vaccines could lead FDA and the company to find ways to delay a decision about making the AstraZeneca vaccine available in the U.S., current and former HHS officials told BioCentury.

The precedents set with the first three COVID-19 vaccines from Pfizer Inc. (NYSE:PFE) and its partner BioNTech SE (NASDAQ:BNTX), Moderna Inc. (NASDAQ:MRNA), and Johnson & Johnson (NYSE:JNJ) are unlikely to be replicated with the vaccine from AstraZeneca plc (LSE:AZN; NASDAQ:AZN), the officials said. In those cases, HHS urged the companies to file EUAs quickly after data meeting FDA’s criteria were available. FDA then scrambled to review the data, convene advisory committee meetings, and issue EUAs within days of the meetings, and HHS acted to get the vaccines into the arms of vulnerable individuals as quickly as possible. ...