Did the FDA and Pfizer hold the COVID vaccine until after Trump lost re-election?

What I saw inside the FDA deserves Congress oversight hearings

I wrote this story based on what I saw and heard first-hand while working at the FDA during the Trump administration. I used my notes and other materials from the time.

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President Trump said publicly for the first time on Tuesday the specifics about what many of us in his administration believe --  the Pfizer COVID vaccine was deliberately slowed down for political reasons.

In a statement blasting the Biden administration for putting a “hold” on the Johnson & Johnson vaccine for six cases of blood clots out of millions of doses, Trump included this:

perhaps all of this was done for politics or perhaps it’s the FDA’s love for Pfizer. The FDA, especially with long time bureaucrats within, has to be controlled.  They should not be able to do such damage for possibly political reasons, or maybe because their friends at Pfizer have suggested it….

Remember, it was the FDA working with Pfizer, who announced the vaccine approval two days after the 2020 Presidential Election.  They didn’t like me very much because I pushed them extremely hard.  But if I didn’t, you wouldn’t have a vaccine for 3-5 years, or maybe not at all. 

The two-day time frame that he referred to is not the public announcement of the Pfizer vaccine -- that was on Monday Nov. 9. 

Trump is talking about an internal announcement by career officials at the Food and Drug Administration (FDA) that Pfizer was ready to send in its COVID vaccine information. That has not been made public before now.  

On Nov. 5, I  was on a conference call with FDA Commissioner Stephen Hahn and top career officials who ran a COVID task force that oversaw authorizations and approvals for COVID tests, treatments and vaccines.  It was a strange time because the presidential appointees on the call -- like Hahn -- did not know if we would be in our jobs come January when the vaccination process would be in full swing. The presidential election had not yet been finalized as some states were too close to call. 

A senior official who was key to determining Emergency Use Authorization (EUA) for the vaccines announced the good news that the Pfizer request would be given to the FDA by Thanksgiving. “Timing isn’t good,” he joked about the holiday weekend. “But I’ll send them turkey sandwiches.” 

The timing was more than not good, it was suspicious. Two days after the election?

In political circles, it was assumed that Trump would win if he could announce a vaccine before the election. The country was traumatized by the pandemic and wanted news that it would end soon. 

At that point, it wasn’t yet over. There were states that were too close to call. What was holding back Pfizer from announcing when it had already told the FDA it was completed? 

Since Operation Warp Speed had created the new system for the FDA to have access to all the information from the pharmaceutical companies in real time -- watching the results of the large-scale clinical trials that started in July -- there wasn’t going to be a lot of new information to analyze once Pfizer sent in the final application. So announcing that Pfizer had completed the studies and was ready to go was a big deal. 

After the call,  I contacted an official at the White House to say that the vaccine was coming but neither Pfizer nor the FDA was planning to announce it yet. There were still procedural steps to take by the FDA before there could be shots in arms, so each day meant more people got COVID who could be inoculated.

I had been backchanneling to the White House since I saw the FDA slow down decisions solely because the agency was afraid it would look like it was making decisions based on what Trump wanted. 

Hahn was particularly gun shy after giving out the EUA for hydroxychloroquine and then pulling it back. Then he really messed up by exaggerating the benefits of convalescent plasma in a press conference with Trump. By this point, he was doing only what the FDA career officials said and not what the White House wanted, no matter who was right or wrong, from my perspective. 

It bothered me to watch delays that were not scientific or medical. Hahn had already pushed back on the vaccine progress already by adding in an additional two months of trials to study side effects. He did this against White House orders, and it was a new concept. But it pushed the vaccine announcement past the election. 

On Nov. 9, Pfizer announced that it had a vaccine ready that was 90 percent effective -- much higher than the 60-70 percent efficacy the public expected. It was great news and a big deal, but it would not benefit Pres. Trump who crafted Operation Warp Speed. 

A top level official who is close to Hahn told me that he did not know Pfizer was announcing on Monday- less than a week after the election - until after it happened.

The president tweeted that day these, which are no longer online: 

The @US_FDA and the Democrats didn’t want to have me get a Vaccine WIN, prior to the election, so instead it came out five days later – As I’ve said all along!

If Joe Biden were President, you wouldn’t have the Vaccine for another four years, nor would the @US_FDA have ever approved it so quickly. The bureaucracy would have destroyed millions of lives!

As I have long said, @Pfizer and the others would only announce a Vaccine after the Election, because they didn’t have the courage to do it before. Likewise, the @US_FDA should have announced it earlier, not for political purposes, but for saving lives!

The Pfizer EUA was finally submitted to the FDA on Nov. 20. The U.K. approved the Pfizer vaccines on Dec. 2.

The FDA, under pressure by the White House for slow walking again, finally announced it was ready to go on Dec. 11. 

As I said from the top, I am only reporting here about what I saw and heard first hand at the FDA. I am sure there were many high level conversations that I did not hear and documents I did not see at the agency.

And I have no way to know what FDA officials and Pfizer discussed in the weeks leading up to the election and the week afterwards, and that’s where Congress needs to act.

The families of those who died from COVID in the days or weeks after the vaccine was finally approved deserve to know the exact time and date when the company and the agency were ready to move forward.

Congress should use its oversight role to investigate the COVID vaccine EUA process to know if politics played a role in the timing. The oversight committees have the power to subpoena and investigate Pfizer for its materials about when it announced its vaccine was ready to go. FDA officials should be asked about their discussions with Pfizer when they are testifying on Capitol Hill. The public needs to know for sure that all future FDA authorizations are based solely on medical and health data and not politics.

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