After the FDA advisory committee voted in favor of Pfizer’s EUA last Thursday–as almost everyone thought they would–the FDA had difficulty finishing the paperwork. The NYTimes reported:
People familiar with the F.D.A.’s situation say that regulators are now racing to complete a fact sheet, information for physicians and other required documents that go with the authorization.
The paperwork delay meant that the FDA was going to wait to issue the EUA until Monday. That’s when Trump called the FDA “a big, old, slow turtle” and yelled at Hahn to “Stop playing games and start saving lives!!!.” The FDA then sped up and issued the EUA on Friday. As a result, the first tranche of vaccines are being delivered today.
The advisory committee for the Moderna vaccine meets this coming Thursday. Here’s a polite request of the FDA–please have the fact sheet, information for physicians and other required documents ready to go. Thanks.
P.S. We would also be really grateful and, you know, it might save some lives if you allowed Moderna to start shipping now so the vaccine is on-site and ready to go on Friday. Please give it some thought and thanks again for your kind consideration. It’s been very stressful seeing thousands of people dying every day.