Here we reproduce a letter written to an MP by a constituent.

The letter raises concerns about the potential risks of approving future mRNA vaccines under a “platform authorisation” model whereby updates are assumed to be safe because the underlying methodology is considered safe – the way seasonal egg based influenza vaccines were regulated. This means the Monkeypox mRNA vaccines and others need not be authorised on a product-specific basis as discussed in a May 2024 MHRA Board meeting, but can piggy back on the claims made about the safety of covid vaccines. 

The writer alleges regulatory mishandling of the Pfizer BNT162b2 vaccine’s safety data. He focuses on the issues around lymphadenopathy. Specifically, the rate seen in the trial product was only 0.4% but the rate seen when using the product made using the upscaled industrial process which was given to the public and used in the booster trial was 13 times higher at 2.5%. The latest monkeypox vaccine paper has spun this lymph node enlargement (which happens when the area called a germinal centre is active and enlarged) as a good thing saying, “robust germinal centre formation is a general feature of the mRNA-LNP platform.”

They express concerns that this higher reactogenicity is being normalised, despite evidence that at least 1 in 800 people experienced serious adverse reactions. There may be multiple causes of injury but the author focuses on the risk from bacterial endotoxins which contaminate products made using huge vats of E. coli bacteria. The writer calls for careful consideration of public health risks with future authorisations.

The letter is published anonymously in order to maintain the trust and channel of communication with this MP.

“Dear ……

“Please find attached a letter warning of perceived risk from future “mRNA platform” vaccines that takes a lead from my live stage one maladministration complaint alleging concealment of product potency after the FDA Booster trial report in September 2021 which deployed Batches EJ0553, EE8493 and ER9449 all of which the MHRA had authorised for use in the UK since December 2021, and whose yellow card profiles accompany the complaint.

“There is no instruction to make spike in the new monkeypox vaccine and yet the product potency and impact on draining lymph nodes is deemed comparable to the covid vaccine as set out in the letter. That implies the platform relies on a similar antagonist for the  lymphatic impact and that appears to be endotoxin

“The MHRA has acknowledged it has no safe test level for endotoxin, it cannot possibly be able to know if endotoxin adhesion to lipid nanoparticles is dangerous because it does not measure them.

• MHRA 2016

Minutes for Blood Consultative Committee (BCC) Meeting 17th March 2016, 13:00-16:00 MHRA Buckingham Palace Road Offices, G1

Page 36 “However, the accurate measurement of endotoxin in whole blood is difficult due to non-specific protein binding and technical factors such as the high haematocrit. “

• MHRA 2023

WRITTEN EVIDENCE SUBMITTED BY DEPARTMENT OF HEALTH AND SOCIAL CARE (DHSC), UK HEALTH SECURITY AGENCY (UKHSA), MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) (PHA0007) Science and Technology Committee Inquiry: the antimicrobial potential of bacteriophages

Paragraph 37. “There is no dosing knowledge for most phages, so accurate endotoxin levels (indicators for bacteria) are required to safely administer. Decisions on dosing therefore require expert pharmacy and clinical knowledge. Vulnerable patient groups may also be affected by the formulation details of phage’s, such as their phosphate and magnesium content, before administration. The time required to ascertain this information and undertake quality assurance of ULMs is a barrier in the current therapeutic pathway.”

“I am writing to place on record a warning about the risk to public health of UK authorisation for all future mRNA vaccines.

“The outgoing CEO of the MHRA in the May Board Meeting spoke of future mRNA authorisations being platform authorisations not product specific ones.

https://www.youtube.com/watch?v=PyenOy70MPE

“So, we know her legacy to her successor is to frame mRNA-based products as “Vaccine Platform” technology, in line with Industry jargon. This is wholly unsafe and risky.

“My current maladministration complaint alleges a regulatory cover up of BNT162b2 distributed product’s true reactogenicity and a denial of its adverse public health impact. The allegation does not touch MHRA’s December 2020 decision to authorise.

“I allege that following receipt of the BNT162b2 booster trial results, MHRA ignored the “lymphadenopathy signal”: the dramatic increase from 0.4% to 5.2% between injections 1 and 2 and booster injection 3 and instead treated this signal as an injection specific not platform specific reaction.

“For the reasons described in my complaint such a huge uplift in reactogenicity is not plausible in the same product. The evidence I have submitted shows that specific lymphadenopathy reaction or “signal” occurred only consequent to the issued product and not the clinical trial product. The evidence I have provided from the FDA, the EMA and the MHRA yellow card database shows the authorised product is 13x more reactive than the clinical trial product, using the culturing platform process.

“Lessons applied to Pfizer mRNA monkeypox product.

A production model of Pfizer’s mRNA monkeypox vaccine, BNT166, will soon be on the market. As with BNT162b2, it is a cell cultured derived product. It is described in the following study
A multivalent mRNA monkeypox virus vaccine (BNT166) protects mice and macaques from orthopoxvirus disease”

The important point is here (N.B. germinal centres are the active part of a lymph node)

“To explore whether BNT166 mRNAs have the potential to induce durable immunity, germinal centre induction was explored in lymph nodes at day 35 by flow cytometry (Figures S2A–S2C). Antigen-specific germinal centre B cells were observed for all mRNA treatments, consistent with a durable immune response following BNT166 vaccination. These observations align with the potent germinal centre induction observed in human recipients of BNT162b2, suggesting that robust germinal centre formation is a general feature of the mRNA-LNP platform.²⁶

“Lymph nodes. The “potency” so described does not refer to historic clinical trial potency. It refers to potency shown in the product type as used for booster injection 3. The words clinical trial is absent, and they are usually included in any reference to safety or immunogenicity. The phrase human recipients have a specific meaning – these are not recipients of the first 2 injections of the clinical trial – they are members of the public who received an “investigational medical product” so defined in the booster trial EMA report without informed consent and unwittingly part of an ongoing investigation.

“The Covid vaccine experience shows that the regulator is “regulating” a new normal excessive reactogenicity causing a high adverse event rate per 1000 doses. Covid is not smallpox, it is not a threat to most age groups. This “new normal” will be considered an acceptable future risk to take irrespective of infection risk or product immune benefit bestowed. 

“The evidence in my maladministration complaint shows that “potent” reactogenicity does not equate to immunogenicity. The lymphadenopathy signal uplift shows the Pfizer covid vaccine authorised product was considerably more potent, evidentially, than the C4591001 product used for injections 1 and 2. 

“That is alarming because the clinical trial product used for injections 1 and 2, apparently, was potent enough to generate the immune response necessary to demonstrate it was “effective”. It met the pyrogenic threshold. 

“MHRA published statements showing it relied on the C4591001 injection 1 and 2 trial results to authorise the distributed product, untested. Even the MHRA CEO has used the study of clinical trial C4591001 product efficacy to support authorisation of the distributed product.

https://www.youtube.com/watch?v=xUQfzTqPUm4

“Why did the MHRA not pause the 13x more reactive distributed product, that has no corresponding increased compensatory immune benefits, when it realised the product, it had authorised was 13x more reactive than the effective clinical trial product shown in the screen shot above?

“That failure to respond to clear evidence of excessive reactogenicity once the trial results and yellow card reports of that batch and EE8493 and ER9449 were gathered in September 2021, has destroyed established norms connecting vaccine potency and reactogenicity.

“The real-life evidence I have provided from yellow card evidence in the UK is that at least 1 in 800 people experienced serious adverse reaction with the Pfizer and Moderna mRNA distributed covid products. That real life reactivity profile is being used to promote safety of mRNA “Platform” products, including BNT166 monkeypox vaccine,

“I trust you understand the serious potential implications for UK public health from any future Pfizer/Moderna mRNA “platform” authorisations based on this precedent of an initially untested, AND excessively potent Pfizer product.

“Finally, I note that RSV vaccines roll out from August using an mRNA Pfizer product Abrysvo https://www.medicines.org.uk/emc/product/15309. This uses Recombinant DNA Technology (rDNA) mRNA means messenger RNA. rDNA means recombinant DNA. mRNA gets transcribed from the DNA and it translates amino acids to form protein. rDNA is a combination of various Genes from different or same species. Although the latter is a more stable form of product, as with mRNA, bacterial culturing is still involved in the manufacturing process and therefore endotoxins remain a concern for the rDNA “platform” as much as for the mRNA “platform”.

“Notably it is being offered simultaneously to older people and pregnant mums showing that viral risk is considered greater than for covid. In covid, older people were prioritised and pregnant mums only tagged in much later. Let us hope the additional monitoring required of it is more diligent than with BioNTech BNT162b2.

Yours sincerely”