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This week, I reported that Pfizer’s mRNA flu shot offered almost no clinical benefit in adults aged 18–64 — and that the harms were more significant than the headlines suggested.
But that was not the full story.
The New England Journal of Medicine (NEJM) did not publish any data from the older adults in the same trial — the very population most at risk from influenza and the main reason these vaccines exist.
Instead, the over-65 results were quietly uploaded to ClinicalTrials.gov, where they sat buried on a government website, out of sight and far from the scrutiny that comes with publication in a leading medical journal.
When MIT professor Retsef Levi discovered the missing cohort while reviewing the trial documents, he was stunned — not only by what the data showed, but by what it means when a flagship journal selectively reports findings that may directly shape public health decisions.
What he told me calls into question not just this study, but the integrity of the system that allowed it to happen.
Burying Data
Levi said the missing data in the NEJM article was “puzzling,” adding that “it seems like the reason for omitting the older participants was because the results were not favourable for the studied mRNA vaccine.”
The trial enrolled about 27,000 participants aged 65 and older. Their data make it clear: Pfizer’s mRNA flu shot did not outperform the traditional flu shot in the elderly.
On top of that, Pfizer’s shot caused slightly higher rates of mild-to-moderate local and systemic reactions — injection-site pain, fatigue — consistent with the well-known reactogenicity profile of mRNA products.
Levi said omitting data from this group was “unacceptable, especially since the over-65s are among the high-risk populations that influenza vaccines aim to protect.”
He did not soften his criticism of NEJM’s role.
“It’s either gross negligence in the review process, or worse, scientific misconduct,” said Levi, questioning how the public can trust a journal “if its review process either misses or hides major results in the trial.”
Rather than presenting the full dataset in the journal, Pfizer uploaded the unfavourable results on ClinicalTrials.gov, where they remained effectively invisible to clinicians and the public.
Levi said there was no question this was an egregious oversight.
“I do not see how NEJM can argue that the published article is transparent, when results are selectively reported, and moreover, negative results are not reported.”
The failure to publish the older cohort’s results has now placed NEJM — and its Editor-in-Chief, Dr Eric Rubin — under intense scrutiny.
Levi said, “I think that what we see here is a clear failure of the NEJM’s review process and integrity, and the ultimate responsibility rests with the Editor in Chief…Dr Rubin should be expected to provide a clear explanation as to how this has happened.”
The Eric Rubin Problem
Dr Eric Rubin presided over the decision to publish a Pfizer trial stripped of its most important age group, allowing a reputed journal to become complicit in the same selective reporting practices that have long undermined scientific publishing.
Rubin also sits on the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) — the same committee that may one day review Pfizer’s biological licence application for this very product.
His track record during the pandemic has been fraught.
In a 2021 VRBPAC meeting on Covid-19 vaccines for children, Rubin dismissed concerns about unknown safety gaps, saying, “We’re never going to learn about how safe the vaccine is unless we start giving it. And that’s just the way it goes.”
NEJM under his leadership also published the pivotal AstraZeneca Covid-19 vaccine trial — a paper that omitted adverse event data.
One of those missing cases involved participant Brianne Dressen, whose severe neurological complications were removed from the trial records. Dressen personally contacted Rubin asking him to correct the record and update the trial data.
But Rubin refused.
Asked whether someone in Rubin’s position can objectively assess a product when his own journal has published selective data about it, Levi said, “The personal integrity of members in government advisory committees is a critical factor to consider.”
Levi declined to comment on whether Rubin should remain on the committee, saying only that “this type of incident harms public trust in science and more broadly, public health recommendations.”
What Should Happen Next?
Publication ethics are clear.
COPE (the Committee on Publication Ethics) states that retraction is warranted when there is “scientific misconduct or honest error that significantly affects the reliability of the findings.”
Selective reporting of pre-specified primary or secondary outcomes — particularly when it conceals clinically relevant harms — fits that definition precisely. At a minimum, NEJM must issue a formal correction with the full dataset.
Levi would not be drawn on whether the study should be retracted, but he was unequivocal about the principle: “Proper scientific conduct requires scientists and academic journals to be transparent and truthful.”
This case is neither.
The Real Issue Now
What happened here is a textbook case of regulatory capture.
A manufacturer runs a trial. A major journal publishes only the flattering part. The negative data are buried on a federal website. And the journal’s editor-in-chief sits on the FDA committee that may soon decide whether the product should be licensed.
This is precisely the kind of institutional rot that Health Secretary Robert F. Kennedy, Jr. has vowed to root out.
The question now is whether he will call for Rubin’s resignation from VRBPAC — a test of how far he is willing to go in confronting industry influence and demanding full transparency in medical journals.
Because unless this system is forced into the open, selective reporting will continue to be standard practice in even the most prestigious journals. And the public will keep receiving a polished marketing story instead of the full scientific truth.
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