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1/ @US_FDA felt extreme pressure to allow the fast sale of @pfizer’s mRNA #Covid vaccine, emails from the European Medicines Agency show.
Just days after Pfizer posted its first big clinical trial results, a top EMA official warned FDA was being “pushed hard by Azar and US GOV.”pic.twitter.com/ZmIHhgJt2B
2/ Marco Cavaleri, the head of EMA vaccine strategy, made the warning. By Azar he meant Alex Azar, the then head of Health and Human Services, FDA’s parent agency. Minutes later, another senior EMA official replied, “Azar is pro-Trump... Trump Is still pulling strings on this.”pic.twitter.com/RGIarcTOOY
3/ An undated email from Cavaleri at about the same time reveals concerns at both FDA and EMA that Pfizer CEO @albertbourla wanted to play the agencies off each other to force them to move even faster...
4/ Cavaleri wrote the agencies had “agreed to keep channels open and share views so to avoid misleading messages getting through (Pfizer CEO lobbied Peter Marks telling him EMA wants the data earlier!) Marks is a senior FDA official.pic.twitter.com/bD1EN0crMe
5/ Even as the FDA and EMA worked together against Pfizer’s pressure, they worried British drug regulators would jump ahead to approve the vaccine, putting even more pressure on them – as ultimately occurred. “They are going to rush,” Cavaleri warned of the British on Nov. 16.
6/ Some background. Hackers stole these emails from EMA sometime in late November or early December. After more than a month of refusing to say so explicitly, on Jan. 25, the agency confirmed they are real. “Individual emails are authentic,” it wrote.https://www.ema.europa.eu/en/news/cyberattack-ema-update-6 …
7/ Most media outlets have largely ignored them, but
@serenatinari, a Swiss investigative reporter, wrote a smart piece for @bmj last week focusing on another issue they raise, about whether Pfizer was having problems making the mRNA in its vaccines.https://www.bmj.com/content/372/bmj.n627 …
8/ But the most explosive information in the emails is political, showing the pressure drug regulatory agencies felt to rush the sale of the vaccines after Pfizer and its partner @BioNTech_Group released the first results from their pivotal clinical trial on Mon., Nov. 9.
9/ Originally, the FDA told European regulators that late December would be the earliest it could finish its review. In his mid-November email, which has notes from his call with the FDA, Cavaleri wrote the FDA had said it hoped to authorize Pfizer’s shot by “end of the year.”
10/ The FDA planned an advisory committee hearing on Dec. 18, Cavaleri wrote. The FDA convenes advisory committees – unpaid expert panels - to look at the issues around controversial or complex drugs. The FDA didn’t anticipate okaying the vaccine immediately after the hearing.
11/ The FDA was also asking Pfizer not to submit its application for emergency use (called an EUA) until the end of November, Cavaleri wrote. Regulators seemed to fear the pressure on them would only increase once Pfizer revealed it had officially asked for authorization.
12/ But Pfizer didn't honor the FDA’s request. Instead it filed its application Nov. 20 - and said publicly it had done so. Three days later, the FDA told the EMA it was moving the advisory committee to Dec. 10, giving members less than three weeks to review the massive filing.
13/ Still, @US_FDA said it did not expect to okay Pfizer’s vaccine before Dec. 17. That relieved the Europeans, who feared their own political crisis if they took too long to examine the vaccine’s risks and benefits.pic.twitter.com/evBXmf8lSH
14/ Noel Wathion, the EMA’s deputy director, had explicitly warned senior officials on Nov. 19 that “we have more clarity now on what may not be easily acceptable... ie a delay of several weeks... the political fallout seems to be too high.”pic.twitter.com/vu4R6QvCGs
15/ The emails notably lack substantive discussion of the lack of evidence that the vaccines help the people most at risk, those over 80, who were largely excluded from the trials. Regulators also did not note the high rates of severe post-injection side effects...
16/ Instead the EMA regulators focused almost exclusively on manufacturing issues and the amount of non-working mRNA the vaccine contained; the emails do not make clear what if any concerns FDA might have had.
17/ Ultimately, Britain okayed Pfizer’s vaccine Dec. 2, barely two weeks after the trial ended. After Trump tweeted the FDA was a “big, old, slow turtle,” it followed on Dec. 11, and EMA on Dec. 21. The EMA has now received over 100,000 side effect reports for the vaccine. END
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