When all is said and done, the story of Covid vaccines will read as part political thriller, part murder mystery and all Greek tragedy. It began with a president whose central policy principle was a distaste for policy making, leaving him vulnerable to the ambitious, the opportunistic and the downright malevolent. As the chorus of pundits, reporters, celebrity doctors and NIH funded researchers repeated the mantra of "safe and effective," mRNA vaccines for Covid evolved from a quick response in a pinch to a symbol, impervious to inquiry, and suited up for all manner of political contests. These tales always end in tears and this time will be no different.
Alas, the narrative will ultimately be defeated by what people see and hear not what they are told. In the meantime, there is Judicial Watch and a number of other organizations filing lawsuits and FOIA requests.
I found the most recent release of Judicial Watch's FOIA request to be useful in answering the booster question. We know the original strategy of the Trump administration was to launch a "bake-off" of sorts exploring various vaccine platforms. It was the FDA's Peter Marks that pitched the idea to favored-but in-over-his-head, son-in-law, Jared Kushner, that a vaccine could be available soon (read: before the election). Of course, the ability to ramp mRNA vaccines quickly was well known at that point and for that reason, it became an early front runner.
Another advantage offered by mRNA vaccines delivered via lipid-free nanoparticles, as described in PFE's first contract with the government, is that they were "believed to abolish the risk of anti-vector immunity and permit boosting to maximize the level and duration of immune responses." In other words, boosters were always part of the game plan.
The thing that surprised most people was they way in which boosters were offered up with such alacrity so soon after the primary series had been deployed. The Biden administration, having taken ownership of the vaccine rollout as a way to "shut down the virus" found themselves unable to do so. By mid-July 2021, the Delta wave was peaking and it was becoming apparent that the original series of vaccines offered limited protection. Advances in President Biden's approval rating began to retreat.
Meanwhile, vaccines manufactured in early 2021 were reaching the end of their six month shelf life.
What to do?
Why, bring in those political strategists and blame the unvaccinated! It did work for a news cycle or two but eventually ceded to an even better response - for everyone involved but especially PFE and MRNA - boosters!
Here is where the recently released emails get so interesting. In early August 2021, unnamed physicians began inquiring of the FDA whether a third dose of the vaccine could be administered under research authority provided by the EUA. In another instance, a physician in Idaho Falls, ID posts on an infectious disease message board:
Israel, France, Germany, France, Russia, Hungary, and the UK have announced 'booster' shots.
Pfizer recommends it and I trust their guidance over the turmoil at our federal agencies. With
millions of doses of vaccine set to expire, you should do what you think is best for your patients. I
can't believe you would get pushback from anyone. Keep in mind, nearly everyone in this group is
six to seven months out from the second dose of the vaccine and many have significant daily
exposure to the virus.
The term booster is wrong in my opinion. We don't think of the third dose in other vaccines such
as the Hepatitis B series as a booster. We should think of it as the correct dosing of an mRNA
vaccine.
Richard Nathan
Idaho Falls, ID
(We should pause here to note that Dr. Nathan is a recipient of research funding from Sanofi and PFE. More here.)
Dr. Nathan's post hit the sweet spot to ensure political reaction. The Biden administration saw themselves as reducing turmoil at federal agencies post-Trump, not prolonging it. To be accused otherwise had to be dealt with decisively.
Presumably, the CDC, HHS and The White House were on the receiving end of similar advocacy because on August 5th, one of the FDA's lead vaccine regulators, Philip Krause writes:
Take a deep breath before reading this next paragraph. On that call, the CDC evidently stated that
they will assemble all the data they are aware of on third dosing in this setting and send it to us in
the hope that we will (very soon) authorize the third dose for immunocompromised as part of the
EUA. Peter told me that CBER IOD will triage this—I told him I need to be cc:ed on any of these
communications so we don’t get blindsided, but that we also need to protect the review team.
A deep breath was required, of course, because follow-up data from PFE was not due for months. The CDC, of course, does not direct drug approvals as they appear to be doing in Dr. Krause's account. Finally, "Peter," which in context appears to be Dr. Peter Marks, the Director of the Center for Biologics Evaluation and Research, indicates the IOD - Immediate Office of the Director - would triage the issue. That is code in government for "butt out."
Butt out they did. On August 12th the FDA issued a Decision Memorandum written not by Drs. Krause and Gruber but Dr. Marks and carrying none of the detail and supporting information found in prior decision memos. The FDA's decision relied primarily on two written papers that explored the benefits of a third mRNA vaccine on solid organ transplant recipients. It recommended a third dose for transplant patients and those with an "equivalent level of immunocompromise."
And with that gold standard that the FDA represented, turned to rust.
A few weeks later, on Aug. 31, the FDA's respected vaccine regulators, Phil Krause and Marion Gruber had resigned/retired.
Not coincidentally, on August 22nd, the FDA wrote a concurrence letter to PFE agreeing that the shelf life of the PFE vaccines could be extended from six months to nine.
Having won the political battle over the experienced and well regarded bureaucrats at the FDA, the CDC, HHS and White House had the sandbox to themselves where they were free to explore the absurd limits of a health policy designed to save a president and his party and perhaps forward the interests of PFE, not protect the public.
In the end it will do neither as the absurdity of Covid vaccine policy since early summer 2021 collides with the priorities of, well, the public. They have few venues in which to express themselves but one of them is on the first Tuesday in November.
In the process the PFE vaccine TAM shrinks, political and regulatory risks rise.
Let me know if you have any questions.
Emily Evans
Managing Director – Health Policy
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