Contrary to the smug media narrative, the main drag on uptake of Covid vaccines are not “anti-vaxxers”, but the “vaccine hesitant”. People who are entirely comfortable with existing, proven vaccines, from polio to tetanus to the annual flu vax, but concerned about the rush to market and novel mechanism of the Covid vaccines. After all, vaccines usually take years of trials before approval. Even then, some end up being withdrawn when safety problems emerge afterward.
Now the new mRNA vaccine technology may well turn out to be the dawning of a new era of rapid-response vaccines. The fears of the vaccine hesitant may well prove to be unfounded.
But, as this piece published in the British Medical Journal points out, the supreme confidence of the Covid vaccine cheersquads seems misplaced, too. The BMJ asks: do the data we have really justify the first full approval of a covid-19 vaccine?
On 28 July 2021, Pfizer and BioNTech posted updated results for their ongoing phase 3 covid-19 vaccine trial. The preprint came almost a year to the day after the historical trial commenced, and nearly four months since the companies announced vaccine efficacy estimates “up to six months.”
The only problem is that the paper, while crucial to the FDA giving the vaccine full approval, is just a rehash of the same data published in April. The preprint is new: the data is not. As the BMJ notes, “it deserves careful scrutiny”.
The biggest concern with the vaccines is waning immunity. This is not a new problem, nor unique to Covid vaccines.
“Waning immunity” is a known problem for influenza vaccines, with some studies showing near zero effectiveness after just three months, meaning a vaccine taken early may ultimately provide no protection by the time “flu season” arrives some months later. If vaccine efficacy wanes over time, the crucial question becomes what level of effectiveness will the vaccine provide when a person is actually exposed to the virus? Unlike covid vaccines, influenza vaccine performance has always been judged over a full season, not a couple months.
So, early confident claims of 95% effectiveness fell to 64% by early July. By the end of that month, it had fallen to 39%. With notable understatement, the BMJ notes that “this is very low”.
Waning immunity is widely blamed on the tricky little Delta strain, but the decline in immunity was already visible by early March. Pfizer knew this by April, but did not publish the data until the end of July.
And it’s hard to imagine how the Delta variant could play a real role here, for 77% of trial participants were from the United States, where Delta was not established until months after data cut-off.
Waning efficacy is not just a minor quibble, and whether it is due to the vaccine itself, new Covid variants, or both, the bottom line remains that vaccines need to be effective.
The question also remains as to whether the positive commentary is justified. The problem of waning efficacy is hand-waved away by talking up the vaccine’s prophylaxis against severe disease.
Former FDA commissioner Scott Gottlieb, who is on Pfizer’s board, said: “Remember, the original premise behind these vaccines were [sic] that they would substantially reduce the risk of death and severe disease and hospitalization. And that was the data that came out of the initial clinical trials.”
Yet, the trials were not designed to study severe disease. In the data that supported Pfizer’s EUA, the company itself characterized the “severe covid-19” endpoint results as “preliminary evidence.”
The central question driving vaccine hesitancy is: are the vaccines safe and effective enough? Rushing approvals and hand-waving away inconvenient data is not the way to remedy that.
I reiterate our call: “slow down and get the science right—there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.”
FDA should be demanding that the companies complete the two year follow-up, as originally planned (even without a placebo group, much can still be learned about safety). They should demand adequate, controlled studies using patient outcomes in the now substantial population of people who have recovered from covid. And regulators should bolster public trust by helping ensure that everyone can access the underlying data.British Medical Journal
Many people distrust “Big Pharma”. Some are bona fide conspiracy theorists, many others people who merely observe the often bad behaviour of pharmaceutical companies and wonder whether they can be trusted at all.
Build appropriate trust based on honest data and rigorous assessments, and vaccine hesitancy will mostly disappear (the hard core of anti-vaxxers will never be persuaded).
But that’s just what pharmaceutical companies and regulators are not doing.
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