by Freddie Sayers
Monday, 20
September 2021
Debate
09:36

Will Fauci bypass the FDA ruling on booster jabs?

In both the US and UK, leaders are sidelining their expert committees
by Freddie Sayers

After seven hours of evidence-sharing and discussion last Friday, acting chair of the American FDA Advisory Committee on Vaccines Dr Arnold Monto finally put the main question to a vote. Does the available safety and effectiveness data support a third booster dose of the Pfizer-Biotech vaccine being offered to all individuals aged 16 and over?

Within two minutes, the results were in: of 18 votes, all from senior doctors with a specialism in vaccines, only 2 were in favour and 16 were against. The committee had resoundingly rejected the plan. In doing so, it was in line with the views of the UK’s Professor Sarah Gilbert and in fact the WHO.

I’ve listened to chunks of the session — it is, as you would expect, extremely technical, and includes hundreds of slides balancing the risks and potential upsides; the committee then proposes an alternative scheme in which booster shots can be offered to specific populations such as the elderly and immunocompromised, and this idea is unanimously voted through. It is the sort of sober-minded discussion that you’d hope to find behind decisions about medical and delicate matters like vaccination programmes.

Within the hour the Financial Times had sent a news alert announcing the decision, saying it “deals a serious blow to the Biden administration”; the Guardian also described it as a “significant blow” to the President. Pfizer shares slumped.

It might strike you as odd that a technical decision about vaccine booster shots would be a “blow” to a government, and frankly it is odd. But that is where we now are: politicians are forming their own strong views about vaccines, quite apart from their expert committees. They have a clear bias towards showing taking action and moving fast, especially since they stand accused of doing neither at the start of the pandemic; they also watch opinion polls, which in this case showed a 76% majority of people in favour of booster shots.

Such was the enthusiasm this time that the Biden administration had already gone ahead and announced that it would be proceeding with “booster shots for all Americans beginning the week of 20 September” — subject to FDA approval. Two scientists on the FDA even quit in protest at the policy, publishing a scathing piece in the Lancet that outlined the dangers of proceeding too hastily with the booster shots.

Then yesterday Anthony Fauci, Chief Medical Advisor to the President, responded to the FDA ruling, and noticeably kept open the possibility that booster shots might go ahead in any case. “I think people need to understand that this is not the end of the story,” he told Sky News. Technically, neither the FDA nor the CDC need to follow the advice of their advisory committees. It seems likely that a way around the FDA’s verdict may will be found in time.

Back in the UK, the Government has already shown how to bypass awkward medical rulings, on the question of vaccinating 12-15 year olds. Like in the US, the Government had announced its intention to go ahead in advance of the decision by the JCVI, the committee that has had responsibility for vaccine decisions since 1963. Cabinet ministers had been sent onto the airwaves to apply pressure and express, with a hint of menace, the Government’s “frustration with their scientific advisors.”

The message got through: even though the committee rejected the idea of vaccinating teens on purely medical grounds, it left open a path for the Government to consider a “broader perspective” and proceed anyway — and they made full use of it. Within the week, the Chief Medical Officers of the four nations had waved through vaccinations for teenagers.

The trouble, of course, is that there is a significant minority of the population in both the US and the UK that fundamentally distrust the vaccination programme. Objections to it are wide-ranging, and many are downright outlandish. But bypassing expert medical committees to extend the programme and speed it up will only feed the distrust and entrench the sense that decisions are being made for political reasons. At the anti-vaccine passport march in London this past weekend, many protesters referred to the decision to vaccinate 12-15 year olds; one sign maker told UnHerd that her most popular signs all related that decision. “Hands off our children” was the first to sell out.

Politicians are oddly blind to their own part in fuelling this movement. They go on about “vaccine hesitancy” as if it were an inexplicable madness that must be suppressed, but then take precisely the steps you would choose in order to maximise mistrust.

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  • Again, I ask, are there more total death numbers from all causes in 2020 than there were in year 2019 and 2018 and 2017, etc.?
    Second question, what happened to the seasonal flu cases, did we all of sudden just up and discover a cure for the seasonal flu? Or, why have the seasonal flu case numbers flattened?

  • Defense contractors, Wall Street, and Pharma are all driven by quarter to quarter profits. It is a problem that has been going on for decades.
    The difference now is the Main Street doctor has looked the other way. There are a few who speak out, but until I see the “Medical Professionals” having REAL conversations about Big Food, diet, exercise, Anthony “Fraud” Fauci… – I will do my own research.
    Hiked 7 miles yesterday with my son with Autism, now having my celery juice in the AM to start the day here is the good old USA…

  • And as an addendum I would add that before vaccinating anybody or giving them a booster shot, the public health authorities would be well to assess their immune status vis a vis SARS-CoV2 both in terms of antibodies and T cell immunity. This would be a sensible approach as it would avoid vaccinating or boosting those who don’t need it. (Incidentally, as aside I was planning to do some work involving Vaccinia virus in the lab around 2000 had had to get a smallpox shot – before giving me the shot they tested my co-worker and I as to whether we already had immunity, given that we had both been vaccinated as children; my co-worker was no longer immune and therefore had the smallpox shot; I was still fully immune 30 years later and so they didn’t give me a smallpox booster).

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