A few updates on the battle to get FDA to release the licensure documents for Pfizer’s vaccine, which will hopefully address most of the inquiries on this matter:
1. The FDA incredibly failed to send a representative to a federal court hearing in this matter on December 14th because of the “FDA’s protocols” regarding COVID-19. Meaning, despite the federal health agencies’ compliance rate with its mandatory vaccination policy of over 98.8% and its resounding claim that the vaccines are “effective,” the FDA is apparently still scared. Its actions speak volumes and cast serious doubt on its words.
2. Just prior to the Court hearing, the FDA released additional documents. These included a report on vaccine safety and a report on vaccine efficacy. There are many notable portions, but we will leave that to the scientists to analyze noting that, as the experts in the plaintiff’s group have explained, adequate analysis of the vaccines’ safety and efficacy is nearly impossible to complete without the full universe of documents.
3. Contrary to what has been reported elsewhere, there has been no decision issued in this case yet and any documents produced to date have been produced by the FDA apparently in the hopes of softening any decision the Court may render.
4. Regarding the hearing this week, the public will get to read the transcript when it is released, which we expect should be soon. In the meantime, it is noteworthy that the DOJ attorney who appeared without an FDA representative effectively argued that the American people and the plaintiff should just trust the FDA that it will produce documents as fast as possible even though it has now been over 110 days since the request was made to the FDA and it has produced on average only ~29 pages per day. The FDA also continued to maintain that it does not want the Court to require it to produce at a rate faster than 500 pages per month as it continued to harp on Pfizer’s interests and its trade secrets, for the most part ignoring the interests of the American people. For our part, we had the privilege of arguing many of the points that you can read below in our papers.