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.”
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.”
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.
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. ema.europa.eu/en/news/cybera…
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.

bmj.com/content/372/bm…
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.
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.”
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

• • •

Missing some Tweet in this thread? You can try to force a refresh
 

Keep Current with Alex Berenson

Alex Berenson Profile picture

Stay in touch and get notified when new unrolls are available from this author!

Read all threads

This Thread may be Removed Anytime!

PDF

Twitter may remove this content at anytime! Save it as PDF for later use!

Try unrolling a thread yourself!

how to unroll video
  1. Follow @ThreadReaderApp to mention us!

  2. From a Twitter thread mention us with a keyword "unroll"
@threadreaderapp unroll

Practice here first or read more on our help page!

More from @AlexBerenson

18 Mar
1/ What I think and have said all along is that the question is far more complex. I am trying to follow and report the data, as always.

Do these vaccines "work" in the basic sense of causing us to make antibodies? Yes. Did trials show they reduced mild/moderate infections? Yes.
2/ Did the trials show that they reduced deaths or clinically serious cases? No, because not enough people at high risk were enrolled, though there was a trend towards fewer serious cases...
3/ Are we starting to see real-world evidence NOW of fewer deaths and serious cases in countries that vaccinated early? I'd say yes, but with big caveats; the trend seems to run the OTHER way in the days after the first dose, and we don't know how long the good trend will last...
Read 9 tweets
18 Mar
1/ Let’s talk about Israel.

The good news: three months after it started mass vaccinations, new cases are finally below their levels when the campaign began.

And serious cases and deaths are far below their January peaks.

Great, right? Vaccines work!

Mmm. Let’s look closer. ImageImageImageImage
2/ This analysis ignores two big issues. First, new and overall serious cases are STILL above where they were when vaccinations started Dec. 19. Deaths are roughly the same.

Vaccine advocates note correctly that most of those cases are in people who are not “fully vaccinated.” ImageImage
3/ But they fail to note that at this point, the people in high-risk groups - i.e. over 70 - who are not fully vaccinated probably CANNOT be. In other words, most of those people got the first shot but not the second, probably because they could not tolerate the side effects... Image
Read 7 tweets
18 Mar
1/ This fascinating piece last July from two Canadian immunologists highlighted the risks a #Covid vaccine would be far less effective in older people at far higher risk. Even the preclinical work for vaccines focuses on younger and not older animals...
nationalinterest.org/blog/reboot/co…
2/ What the immunologists couldn't have known was how @pfizer etc would deal with the problem: by enrolling only a relative handful of those older people in their pivotal clinical trials. Genius.

You think that decision was a coincidence?
3/ This is not a conspiracy theory, friends. This is not 5G or whatever.

It's much cannier than that.

It's the equivalent of enrolling a bunch of people WHO DON'T HAVE CANCER in tests for your oncology drug and then proudly proclaiming no one who got the drug died of cancer...
Read 4 tweets
16 Mar
TL: DR - Top officials @EMA_News feared @US_FDA faced massive political pressure to okay the mRNA vaccines quickly and Britain's "rush" to authorize might worsen the problem.

They also worried Pfizer CEO @AlbertBourla was trying to play US and European regulators off each other.
Man, I am disappointed.

THIS IS THE MOST IMPORTANT THREAD I HAVE EVER POSTED. Stop making it about Trump or Biden. It's about regulatory collapse in the US and Europe. Once the topline results came out, @Pfizer knew it was in control. IT WOULDN'T EVEN GIVE THE FDA 10 EXTRA DAYS.
Yes, Trump clumsily interfered in the approval process; but the Democrats would have done the same, only more cannily. The EMA faced exactly the same problem.

And maybe @Pfizer knew if the stampede slowed down people would have more time to look at what the data actually said.
Read 4 tweets
15 Mar
1/ Welcome to the mRNA Vaccine Church! Anyone can join! Simply accept these creeds on faith. Do not look for clinical trial evidence for them as you will find none!

Say it with me, believers!

The hoooly shot reduces #Covid deaths!

And all-cause deaths!

And is safe for all!
2/ Now, believers, you may find yourself doubting at times. Is this blessed blend of cholesterol and modified genetic material too good to be true?

BANISH THESE THOUGHTS! For verily they are the devil’s handiwork. And the devil has opened a book. He calls it VAERS.
3/ Believers must NEVER upon pain of excommunication examine the side effects in this book of mis-dis-information. Only apostles may open the pages of VAERS, and only to remind believers of the hooooly truth that correlation is not just NOT correlation but can never be!
Read 4 tweets
15 Mar
Fun fact: the @AstraZeneca vaccine has 54,571 adverse events reports in Europe, including at least 198 deaths (63 cardiac).

The @Pfizer mRNA vaccine has 102,100, including at least 957 deaths (276 cardiac).

Similar number of doses given. But it’s the AZN shot that’s in trouble?
I say “similar number” because I cannot find an exact EU-wide figure for either: AZN said today 37 million doses worldwide and 17 million people vaccinated in Europe (some with two doses); @pfizer was at 28 million doses delivered (not given) as of Feb. 17 and has sent more...
I suspect @AstraZeneca is ahead, actually. But even if @pfizer is, it is by a little - far less than the 5x gap in reported cardiac deaths.
Read 4 tweets

Did Thread Reader help you today?

Support us! We are indie developers!


This site is made by just two indie developers on a laptop doing marketing, support and development! Read more about the story.

Become a Premium Member ($3/month or $30/year) and get exclusive features!

Become Premium

Too expensive? Make a small donation by buying us coffee ($5) or help with server cost ($10)

Donate via Paypal Become our Patreon

Thank you for your support!

Follow Us on Twitter!