patrick.net

In the lead-up to the FDA’s issuance of its first Covid-19 vaccine EUA to Pfizer in Dec. 2020, there was a lot of political grumbling and legitimate concern that the White House might try to speed up the authorization process to help former President Donald Trump’s reelection campaign.

On the flip side, however, there was concern of the opposite, that the vaccine’s EUA might be unnecessarily delayed, leading to more deaths so as to avoid any misconception that the decision was politically motivated.

At the time, just prior to the first EUA, former President Trump and his deputies were reported to be privately criticizing FDA officials for not moving faster.

One senior official even told Politico on Dec. 2, 2020: “It’s crazy to imagine the European Union or U.K. may approve a vaccine developed in the United States before us though, right?”

And thanks to recently released text messages from FDA’s Freedom of Information Office, exchanges between FDA and White House officials further confirmed this spat over being first.

Fox News reporter John Roberts texted former FDA commissioner Steven Hahn on Dec. 1, 2020 — 10 days before the Pfizer vaccine EUA was issued — about the White House taking the FDA “to the woodshed” over its review pace, and asking Hahn if he wanted to clarify. Hahn then took the disparaging comment to former White House chief of staff Mark Meadows, seeking clarification.

The following morning, Hahn texted Meadows at 5:13 AM to inform him that the UK was about to sign off on Pfizer’s Covid-19 vaccine — which would make the UK’s decision faster than the US.

The UK’s MHRA signed off on the Pfizer vaccine later that morning, spurring a flurry of texts from Meadows to Hahn. Meadows also summoned Hahn and CBER Director Peter Marks to Meadows’ office, although the FDA’s FOIA office has redacted the bulk of the exchange.

The next six messages of the text exchange are almost entirely redacted, and then the night before the EUA is to be issued for Pfizer’s vaccine, Meadows asks Hahn to call him, which Hahn responds to say that he has, and then sends him this text:

Given the fact that more than 65,000 people died in Dec. 2020 from Covid-19, and the sensitive nature of getting the Pfizer Covid-19 vaccine out as rapidly as possible, as well as the political ramifications, it’s not surprising that the White House was this involved in wanting to be informed on the EUA timeline.

But these text messages also show some of the ways in which the White House kept the FDA commissioner on a short leash and pushed the FDA to speed its review process, even as the agency was working at a speed never before seen for any medical product in the agency’s history, particularly as it would be administered to hundreds of millions of people.

As with Pfizer’s EUA, Hahn also informed Meadows the night before the agency issued its EUA for Moderna’s Covid-19 vaccine.

The FDA’s FOIA office previously released text messages from Hahn’s discussions around former President Trump’s Covid-19 diagnosis, as well as earlier communications around what types of drugs might work against Covid.

Officials from within the White House also were forwarding potential, but ultimately ineffective Covid-19 treatment information to Hahn.

Top Trump advisor Hope Hicks forwarded an email on a treatment called “Cell Armour” to Katie Miller, former communications director for Vice President Mike Pence, who then forwarded it on to Hahn, who said he would look into it.

https://endpts.com/new-hahn-era-texts-show-the-extent-of-trump-white-houses-involvement-in-vaccine-eua-process/