Covid-19 vaccines and treatments: we must have raw data, now/ BMJ

Three BMJ editors wrote a very strong editorial about the need to access the data on COVID vaccines, which have been kept from us. Here is an excerpt:

Pfizer’s pivotal covid vaccine trial was funded by the company and designed, run, analysed, and authored by Pfizer employees. The company and the contract research organisations that carried out the trial hold all the data.17 And Pfizer has indicated that it will not begin entertaining requests for trial data until May 2025, 24 months after the primary study completion date, which is listed on ClinicalTrials.gov as 15 May 2023 (NCT04368728).

The lack of access to data is consistent across vaccine manufacturers.16 Moderna says data “may be available … with publication of the final study results in 2022.”18 Datasets will be available “upon request and subject to review once the trial is complete,” which has an estimated primary completion date of 27 October 2022 (NCT04470427).

As of 31 December 2021, AstraZeneca may be ready to entertain requests for data from several of its large phase III trials.19 But actually obtaining data could be slow going. As its website explains, “timelines vary per request and can take up to a year upon full submission of the request.”20

Underlying data for covid-19 therapeutics are similarly hard to find. Published reports of Regeneron’s phase III trial of its monoclonal antibody therapy REGEN-COV flatly state that participant level data will not be made available to others.21 Should the drug be approved (and not just emergency authorised), sharing “will be considered.” For remdesivir, the US National Institutes of Health, which funded the trial, created a new portal to share data (https://accessclinicaldata.niaid.nih.gov/), but the dataset on offer is limited. An accompanying document explains: “The longitudinal data set only contains a small subset of the protocol and statistical analysis plan objectives.”

We are left with publications but no access to the underlying data on reasonable request. This is worrying for trial participants, researchers, clinicians, journal editors, policy makers, and the public… 

I wrote the following ‘rapid response’ yesterday.  Surprisingly, it was not posted, although in years past any reasonable comment went up on the website.

The BMJ Editors are absolutely correct about the need for granular, raw data from clinical trials to inform the public regarding the true efficacy and safety of new medical products.

But considered in the context of the COVID response, the refusal of manufacturers and regulators to release accumulated data is outrageous.  

1.  Almost all of these products were released to the public under emergency authorization, which requires a minimalist standard of evidence: “may be effective” [1]

2.  Because of this, in the US, the law requires that recipients be informed of the known and unknown significant benefits and risks of these products. [2]  But they are instead being given pablum such as “safe and effective,” [3] despite the fact that this is a term of art reserved for licensed products, which most are not.

3.   If recipients are injured by the products, or if they do not work as claimed, the injured parties are prohibited from suing the manufacturer for damages [4]–information that is highly relevant to assessing the manufacturer’s commitment to safety, yet it is not known to most of the public.

4.  These products are being given to millions of people during a short period of time, unlike the slow uptake over years of most licensed products.  Thus huge swathes of the population will have received them before adequate information about them enters the public domain.

Why is this acceptable to the regulatory agencies?  

Why is it okay to keep the public in the dark, despite laws to the contrary?

1. https://www.law.cornell.edu/uscode/text/21/360bbb-3

2. https://www.law.cornell.edu/uscode/text/21/360bbb-3

3. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/keythingstoknow.html

4. https://aspr.hhs.gov/legal/PREPact/Pages/default.aspx

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