What did the MHRA do to ensure no harm came from production of unknown proteins following mRNA injections?

In short, failed spectacularly

In November 2023, a team from Cambridge published their research which showed that the vaccine mRNA did not just lead to spike protein production. The code could slip such that any number of unknown proteins could be produced. They demonstrated the problem by showing an immune response to one of the potential “off target” proteins.

The story of handling the safety implications of this finding is a litany of failure.

1. The researchers failed to alert anyone

The paper was originally submitted for publication to Nature on 25th January 2023. At this point, or perhaps some time prior once they were confident about their results, the concern should have been raised with the medical regulator. Huge numbers of people including children were being actively vaccinated at the time and this was a new concern that was of relevance to safety. 

The researchers knew it was relevant to safety. The heading of the first draft press release read “New sequence designs safeguard against hazardous immune responses to mRNA therapeutics,”

2. MHRA not alerted by Human Commission on Human Medicine for a year

The Human Commission on Human Medicine has a statutory duty “to advise the Health Ministers and the Licensing Authority (LA) on matters relating to human medicinal products including giving advice on the safety, quality and efficacy of human medicinal products where either the Commission thinks it appropriate or where it is asked to do so.” The Licensing Authority is the MHRA.

In December 2022, research about the frameshifting problem was presented. The minutes of this meeting were not shared with the head of safety at the MHRA for 11 months. They also raised the risk of autoimmunity resulting from misdirected T cell responses in their paper.

3. The chief safety officer did everything to try to hide the safety concern

On receiving a draft press release, Alison Cave, Chief Safety Officer, edited the wording to try and hide the safety concerns.

“In addition we feel the headline of the press release ‘New sequence designs safeguard against hazardous immune responses to mRNA therapeutics’ may imply that there were hazardous immune responses to the mRNA COVID-19 vaccines whereas the paper is in relation to the potential for off-target adverse effects to future mRNA-based therapeutics.  The press release also states that in relation to the Pfizer COVID-19 they found an ‘unintended immune response occurred in one third of those vaccinated – but with no ill-effects, in keeping with the extensive safety data available on these COVID-19 vaccines’. This may give the impression of equating to patients harm if the first part of the sentence is taken in isolation.“

There were only 21 patients tested. The MHRA decided there was nothing to investigate on the basis that the seven patients who produced one of the unknown proteins had no ill effects. A sample size of seven is clearly not big enough for a safety assessment. A huge number of potential misread proteins were possible and it is highly likely that broader testing would have detected the problem in a higher proportion. 

4. There was no further discussion

An email was sent the day the press release went out. A member of MHRA staff wrote to flag the paper the following day. Someone said they would forward that to the “team working on mRNA vaccines here” and then nothing more was heard.

No questions were asked about investigating what other proteins might have been produced.

No questions were asked about how long these proteins might circulate for.

No questions were asked about assessing the risk of autoimmunity from these unexpected antibodies.

In this instance, the Chief of Safety at the MHRA seemed to be more concerned with the appearance of safety than evidence of actual safety.