FOI release

Freedom of Information request on the ingredients in the Pfizer COVID-19 vaccination (FOI 22/403)

Published 31 May 2022

FOI 22/403

21st February 2022

Dear

Thank you for your email.

1) I am requesting the full make up and composition of the lipid nanoparticals in the Pfizer covid 19 vaccine ?

In other words I want to know what are the lipid nanopartical capsual made from ?

A full list of ingredients for the Pfizer vaccine is provided in the Information for Healthcare Professionals/Summary of Product Characteristics for this vaccine. A link to this information is provided below:

https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19

Further to this, an assessment of the lipid nanoparticles, including toxicology, is available in the Public Assessment Report (PAR) prepared by MHRA and by the EMA. For the MHRA PAR, please see the link above. For the EMA PAR, a link is provided below:

https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty

2) Once these lipid nanopartical are taken up by the cells and the RNA is released into the cytosal, what happens to the lipid nanoparticals ?

Once the lipid particles have been taken up by the cells and the RNA released, the lipid particles are broken down by the host cell and then harmlessly excreted from the body.

In a common vaccine the ingredients are supposed to stay in the arm muscle at the injection site, however this is not always the case.

3) Therefore I want a full explanation as to the consequences if these lipid nanoparticals and the ingredients gets into the blood flow and breaks through the brain membrane or the heart muscle ?

Please refer to question 1 and 2 the PARs published by MHRA and the EMA for an assessment of the lipid nanoparticles, which are linked above.

4) What is modified N1- methylpseudourine ?

Please refer to the PARs published by MHRA and the EMA, which are linked above.

5) Is human embryonic kidney or lung tissue used in the development/ manufacturing part of this Pfizer cv19 vaccine ?

No human embryonic kidney or lung cells are used in the manufacturing of the Pfizer vaccine. The HEK 293 cell line was used in the development of the Pfizer vaccine. Further information can be found in the PARs published by MHRA and the EMA, which we have provided via the links above.

6) Has the BR EWG come across any unsafe batches since the 11th September 2020 until present ?

And if so what are the Batch numbers ?

None of the batches of the Pfizer/BioNTech vaccine issued in the UK has been found to be unsafe by the MHRA, or the COVID-19 vaccine benefit risk expert working group.

7) During the Pfizer trial 1200 people died and 19000 had serious side affects (see attached document) on your own yellow card system almost 2000 people have died from these covid vaccines. So my last question is this, at what point or at what number of deaths will the MHRA revoke the temporary authorisation ?

Please note that the Pfizer document provided contains information on post marketing spontaneously reported adverse events, it is not trial data.

The Medicines and Healthcare products Regulatory Agency’s (MHRA’s) role is to continually monitor safety during widespread use of a vaccine. We have in place a proactive strategy to do this. We also work closely with our public health partners in reviewing the effectiveness and impact of the vaccines to ensure the benefits continue to outweigh any possible side effects.

Part of our monitoring role includes reviewing reports of suspected side effects. Any member of the public or health professional can submit suspected side effects through the Yellow Card scheme. The nature of Yellow Card reporting means that reported events are not always proven side effects. Some events may have happened anyway, regardless of vaccination. This is particularly the case when millions of people are vaccinated (over 130 million COVID-19 vaccines have been given in the UK alone to date), including elderly people and people who have underlying illness. We regularly review safety information from the COVID-19 vaccine manufacturers and are in regular contact with other regulators across the world to exchange safety data on the COVID-19 vaccines. This is considered in our assessments alongside the UK data.

Information about our analysis of safety data regarding COVID-19 vaccines is published in our weekly summary of COVID-19 vaccine Yellow Card reports which is available at: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting.

Please be assured that the MHRA continues to closely monitor the safety of the COVID-19 vaccines used in the UK.

If you have a query about the information provided, please reply to this email.

If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Yours sincerely

MHRA Customer Experience Centre