Covid-19 vaccines and treatments: we must have raw data, now (BMJ Editorial)

British Medical Journal ^ | 01 2022 | Editorial Staff

[yesthatjallen]

Data should be fully and immediately available for public scrutiny

In the pages of The BMJ a decade ago, in the middle of a different pandemic, it came to light that governments around the world had spent billions stockpiling antivirals for influenza that had not been shown to reduce the risk of complications, hospital admissions, or death. The majority of trials that underpinned regulatory approval and government stockpiling of oseltamivir (Tamiflu) were sponsored by the manufacturer; most were unpublished, those that were published were ghostwritten by writers paid by the manufacturer, the people listed as principal authors lacked access to the raw data, and academics who requested access to the data for independent analysis were denied.

The Tamiflu saga heralded a decade of unprecedented attention to the importance of sharing clinical trial data. Public battles for drug company data, transparency campaigns with thousands of signatures, strengthened journal data sharing requirements, explicit commitments from companies to share data, new data access website portals, and landmark transparency policies from medicines regulators all promised a new era in data transparency.

Progress was made, but clearly not enough. The errors of the last pandemic are being repeated. Memories are short. Today, despite the global rollout of covid-19 vaccines and treatments, the anonymised participant level data underlying the trials for these new products remain inaccessible to doctors, researchers, and the public—and are likely to remain that way for years to come. This is morally indefensible for all trials, but especially for those involving major public health interventions.

Unacceptable delay

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. 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. Moderna says data “may be available … with publication of the final study results in 2022.” 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. 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.”

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. 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. The journals that have published these primary studies may argue that they faced an awkward dilemma, caught between making the summary findings available quickly and upholding the best ethical values that support timely access to underlying data. In our view, there is no dilemma; the anonymised individual participant data from clinical trials must be made available for independent scrutiny.

SNIP

[nickcarraway]

No, they must hide the data at all costs.

[MAGAthon]

how much more must be revealed before vaccine mandates are a thing of the past?

21 Jan: news.com.au: Israeli officials were ‘surprised and disappointed’ vaccines did not stop transmission
One of Israel’s top vaccine advisers has revealed he and his colleagues were “surprised and disappointed” by one element of the jab rollout.
by Frank Chung
Professor Cyrille Cohen, head of immunology at Bar Ilan University and a member of the advisory committee on vaccines for the Israeli government, made the comments in a wide-ranging and frank interview with UK news website UnHerd on Wednesday...

Prof Cohen said he and his colleagues “did believe at that time that vaccines can prevent transmission”.
“What we believed is that vaccines can prevent transmission perhaps shortly after (being administered) but not over a long period of time, and therefore yes, we were surprised to discover at the end of the day that no, the vaccines are not protecting us, they are not causing what we call ***sterilising immunity,” he said...

Prof Cohen agreed with Sayers that in the context of the highly transmissible Omicron variant, Israel’s “Green Pass” vaccine passport was no longer relevant.
“I tend to think so,” he said, adding that while it was still in place it was no longer being heavily enforced due to rising public opposition amid soaring Omicron cases.
“We don’t see virtually any difference between people vaccinated and non-vaccinated, both can get infected with the virus more or less at the same pace,” he said.
“We have to look at the future. We need better vaccines to prevent transmission.”...

His comments come after a leading Israeli immunologist slammed the government’s pandemic response over the past two years.
Writing for N12 News, Professor Ehud Qimron, head of microbiology and immunology at Tel Aviv University, called on the Israeli Ministry of Health to “admit failure”.
“You refused to admit that the vaccinated are contagious despite the observations,” he wrote. “Based on this, you hoped to achieve herd immunity by vaccination – and you failed in that as well.”...

Earlier this week, Israeli researchers said preliminary data from a study of more than 270 medical workers showed even a fourth dose was “not good enough” to prevent Omicron.

Meanwhile, a South African study investigating the first documented breakthrough cases of the new variant in people who had received boosters, published in The Lancet on Tuesday, concluded that booster shots of mRNA vaccines failed to block Omicron...

Pfizer’s Dr Bourla last week said two doses of its current Covid-19 vaccine offer “very limited protection, if any” against Omicron, while three doses “offer reasonable protection against hospitalisation and deaths”...
https://www.news.com.au/technology/science/human-body/israeli-officials-were-surprised-and-disappointed-vaccines-did-not-stop-transmission/news-story/9c925c5c0f7ae3b2e645519b5bd0dce6

[Steve_Seattle]

Sen. Eugene McCarthy (not to be confused with Joe) once said, "The media are like birds sitting on a wire. They sit and sit and sit, but when one flies away, all the others follow."

We may see that scenario play out in the next few months regarding Covid-19, the political responses to it, and the vaccines. Cracks are beginning to appear in the wall of propaganda that has surrounded these issues, and once journalists see the narrative beginning to change, they all instinctively jump on board.