“The elephant named 'waning immunity'
[T]he recent reports from Israel’s Ministry of Health caught my eye. In early July, they reported that efficacy [of the Pfizer product] against infection and symptomatic disease ‘fell to 64%.’ By late July, it had fallen to 39% where Delta is the dominant strain. This is very low. For context, the FDA’s expectation is of ‘at least 50%’ efficacy for any approvable vaccine [emphasis added].
Now Israel, which almost exclusively used Pfizer vaccine, has begun administering a third “booster” dose to all adults over 40. And starting 20 September 2021, the US plans to follow suit for all ‘fully vaccinated’ adults eight months past their second dose…
Enter Pfizer’s preprint. As an RCT reporting ‘up to six months of follow-up,’ it is notable that evidence of waning immunity was already visible in the data by the 13 March 2021 data cut-off.”
Approval imminent without data transparency, or even an advisory committee meeting?
Last December, with limited data, the FDA granted Pfizer’s vaccine an EUA, enabling access to all Americans who wanted one. It sent a clear message that the FDA could both address the enormous demand for vaccines without compromising on the science. A ‘full approval’ could remain a high bar.
But here we are, with FDA reportedly on the verge of granting a marketing license 13 months into the still ongoing, two year pivotal trial, with no reported data past 13 March 2021, unclear efficacy after six months due to unblinding, evidence of waning protection irrespective of the Delta variant, and limited reporting of safety data…
Prior to the preprint, my view, along with a group of around 30 clinicians, scientists, and patient advocates, was that there were simply too many open questions about all covid-19 vaccines to support approving any this year. The preprint has, unfortunately, addressed very few of those open questions, and has raised some new ones.
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.”