When the Pfizer anti Covid vaccine data will be public

23 November 20203 years ago babelfish

Pfizer will make data on the Covid vaccine available from December 2024. Here's how and why, according to what is read in the protocol of the pharmaceutical company

While the emergency commissioner Domenico Arcuri asks the regional administrations for information on local structures that could distribute the first doses of Pfizer's vaccine, which should arrive within the first weeks of 2021, the immunologist Andrea Crisanti slows down and asks to see the data .

Request, that of Crisanti, which has produced not a few criticisms ( as reported in the article by Start Magazine ), but which is not surprising, however, if you look at when the data on Pfizer's vaccine can be made public.

Let's go step by step.

PFIZER: DATA AVAILABLE AFTER 24 MONTHS

Let's start with the times. “Pfizer provides researchers with secure access to patient-level data or full CSRs for the purpose of“ genuine scientific research ”that contributes to the scientific understanding of the disease, target or class of compounds. Pfizer will make data from these studies available 24 months after the completion of the study, ”the Pfizer protocol reads.

What does it mean? The clinical study, as per registration, should be completed in December 2022. Calculating the 24 months, Pfizer will make the data available only in December 2024. Between requests, verifications and submissions, the data could only be seen in 2025.

WHO WILL GET THE DATA ON THE PFIZER VACCINE

It's still. “Data requests will be considered by qualified researchers with the appropriate skills to perform the proposed analyzes. Research teams must include a bio-statistician. The data will not be provided to candidates with significant conflicts of interest, including individuals requesting access for commercial / competitive or legal purposes, ”Pfizer explains in the protocol.

ADMINISTRATION ALREADY STARTED

So, looking at the times, it is easy to assume that Pfizer's data will be released only and exclusively in 24 months, when the vaccine "will already have been administered to billions of people", writes on Twitter Andrea Capocci, PhD in Friborg (Switzerland) in theoretical physics, research fellow at the Physics department of the Sapienza University of Rome.

ACCESS TO DATA? "THIS IS NOT A STRANGE NEED"

In light of all this, therefore, Crisanti's request seems understandable: “Accessing raw data is not a strange or excessive requirement. Today, many scientific journals ask authors to make available raw data and not just aggregated ones. When it doesn't, there's often something underneath. The history of hydroxychloroquine is well known, ”explains Capocci on Twitter, recalling that the article in Lancet that rejected hydroxychloroquine was withdrawn 2 weeks after publication.

Accessing raw data is not a strange or excessive requirement. Today, many scientific journals ask authors to make available raw data and not just aggregated ones. When it doesn't, there's often something underneath. The history of hydroxychloroquine is well known. (6 / n)

– Andrea Capocci (@andcapocci) November 22, 2020

Here the Pfizer protocol.

This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/quando-saranno-pubblici-i-dati-del-vaccino-pfizer-anti-covid/ on Mon, 23 Nov 2020 14:54:20 +0000.