FOI release

Freedom of Information request on ADR's, GLP, Prions, COVID-19 deaths & risk-benefit analysis (FOI 21/785)

Published 27 April 2022

6th August 2021 FOI 21/785

Dear

Thank you for your email.

Please see below our response to the seven points that you raise:

1) Do not cause prions. And if it does; will that affect its Emergency Use Authorization (EUA)? None of the vaccines “cause prions” and there is no evidence that the vaccine contains “mRNA molecules might cause ribosomes to create aberrant proteins, like prions.” Please also note that the authorisation of the vaccines under Regulation 174 has now been superseded by marketing authorisations. Please note that a marketing authorisation was granted for the Pfizer/BioNTech vaccine (Comirnaty) following a European Commission (EC) decision on 21 December 2020 (PLGB 53632/0002). Further information is available on the European Medicines Agency (EMA) website, a link to this is provided below: https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty

Please also note that a marketing authorisation was granted for the Moderna vaccine on 31 March 2021 following an EC Reliance Procedure (PLGB 53720/0002). Further information is available on the MHRA website and the EMA website, links to these are provided below:

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

https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-moderna

A marketing authorisation has been granted for the Janssen Covid-19 vaccine on 28 May 2021. Further information is available via the below link:

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

In addition, a marketing authorisation was granted for the Oxford/AstraZeneca vaccine on 24 June 2021 following an EC Reliance Procedure (PLGB 17901/0355). Further information is available on the MHRA website and the EMA website, links to these are provided below:

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

https://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria-previously-covid-19-vaccine-astrazeneca

2) Do not contain Graphene Oxide (GO) nanoparticles or similar scanning and toxic material. And if it contains GO (and yet not listed as its ingredients) will that affect its EUA status? A list of ingredients is provided in the Summary of Product Characteristics for each vaccine. None of vaccines contain graphene oxide or any other “similar scanning and toxic material.”

3) Its ADRs are not related for about 75% to Bleeding, Clotting and Ischaemic fatalities. And what is the evidence for to state that said reported vaccine’s ADRs are not related to its biodistribution? The MHRA continually monitors the safety of COVID-19 vaccines available in the UK. A weekly summary of Yellow Card reporting is published by the MHRA. These reports can be found at https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting

When interpreting spontaneous adverse event reports it is important to be aware that suspected ADRs should not be interpreted as being proven side effects of COVID-19 vaccines. Some events may have happened anyway, regardless of vaccination. This is particularly the case when millions of people are vaccinated, and especially when vaccines are being given to the most elderly people and people who have underlying illness.

All vaccines and medicines have some side effects. These side effects need to be continuously balanced against the expected benefits in preventing illness. Following widespread use of these vaccines across the UK, the vast majority of suspected adverse reaction reports so far confirm the safety profile seen in clinical trials. Most reports relate to injection-site reactions (sore arm for example) and generalised symptoms such as a ‘flu-like’ illness, headache, chills, fatigue, nausea, fever, dizziness, weakness, aching muscles, and rapid heartbeat. Generally, these reactions are not associated with more serious illness and likely reflect an expected, normal immune response to the vaccines. Cases of an extremely rare specific type of blood clot with low blood platelets continue to be investigated and updated advice has been provided.

The benefits of the vaccines in preventing COVID-19 and serious complications associated with COVID-19 far outweigh any currently known side effects. As with all vaccines and medicines, the safety of COVID-19 vaccines is continuously monitored and benefits and possible risks remain under review.

The MHRA continually monitors the safety of COVID-19 vaccines available in the UK. A weekly summary of Yellow Card reporting is published by the MHRA. These reports can be found at https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting

When interpreting spontaneous adverse event reports it is important to be aware that suspected ADRs should not be interpreted as being proven side effects of COVID-19 vaccines. Some events may have happened anyway, regardless of vaccination. This is particularly the case when millions of people are vaccinated, and especially when vaccines are being given to the most elderly people and people who have underlying illness.

All vaccines and medicines have some side effects. These side effects need to be continuously balanced against the expected benefits in preventing illness. Following widespread use of these vaccines across the UK, the vast majority of suspected adverse reaction reports so far confirm the safety profile seen in clinical trials. Most reports relate to injection-site reactions (sore arm for example) and generalised symptoms such as a ‘flu-like’ illness, headache, chills, fatigue, nausea, fever, dizziness, weakness, aching muscles, and rapid heartbeat. Generally, these reactions are not associated with more serious illness and likely reflect an expected, normal immune response to the vaccines. Cases of an extremely rare specific type of blood clot with low blood platelets continue to be investigated and updated advice has been provided.

The benefits of the vaccines in preventing COVID-19 and serious complications associated with COVID-19 far outweigh any currently known side effects. As with all vaccines and medicines, the safety of COVID-19 vaccines is continuously monitored and benefits and possible risks remain under review.

4) Its Good Laboratory Practices (GLP) were diligently verified by MHRA. And if not; then why is there of said ‘vaccines’ no a risk-benefit analysis? And its genotoxicity data were fully provided to MHRA. And if not; will that affect its EUA? All authorised vaccines presented non-clinical data from authorised non-clinical sites that work within Good Laboratory Practice (GLP) principles. Compliance with GLP was considered by the MHRA in its reviews. All non-clinical safety studies that were required to be conducted according to GLP were in compliance. No genotoxicity studies were provided for the Pfizer-BioNTech and Oxford-AstraZeneca COVID-19 vaccines in line with relevant guidance considering their components and short duration of use. The published MHRA and EU CHMP assessment reports provide more details and concluded the benefit-risk analysis was positive for the vaccines.

5) Its NNTV to prevent one COVID-case is not between 200–700, and its NNTV to prevent one COVID-death is not 9000 or more doses. And for each death prevented by vaccination; how many deaths and terminal injuries inflicted by vaccination will cause its EUA to be withdrawn?

The definition of a vaccine is ‘a substance used to stimulate the production of antibodies and provide immunity against one or several diseases, prepared from the causative agent of a disease, its products, or a synthetic substitute, treated to act as an antigen without inducing the disease.’ In accordance with this definition and as we have shown through the information we have published, all authorised vaccines are effective in the prevention of Covid-19 infection, and reduced the number of hospitalisations and deaths that occur.

Four COVID-19 vaccines have now been approved for use in the UK. Rigorous clinical trials have been undertaken to understand the immune response, safety profile and efficacy of these vaccines as part of the regulatory process. Ongoing monitoring of the vaccines ensures their safety, quality and efficacy. The benefits of the vaccines in preventing COVID-19 and serious complications associated with COVID-19 far outweigh any currently known side effects.

Studies linking community COVID-19 testing data, vaccination data and mortality data indicate that both the Pfizer-BioNTech and Oxford-AstraZeneca vaccines are around 70 to 85% effective at preventing death with COVID-19 after a single dose. Vaccine effectiveness against mortality with 2 doses of the Pfizer vaccine is around 95 to 99% and with 2 doses of the AstraZeneca vaccine around 75 to 99% (week 26 Vaccine Surveillance Report https://www.gov.uk/government/publications/covid-19-vaccine-surveillance-report ). Public Health England (PHE) estimates that 60,000 deaths and 22,057,000 infections have been prevented as a result of the COVID-19 vaccination programme, up to 23 July. This is based on modelling analysis from PHE and Cambridge University’s MRC Biostatistics Unit (see https://www.gov.uk/government/publications/covid-19-vaccine-surveillance-report ).

6) Its deaths are not certified as Covid-deaths, and its future number of deaths is not aimed to realise the zero carbon-dioxide (CO2) output in 2050 or the depopulation agenda of Bill Gates, the World Economic Forum, the WHO, and UN. MHRA does not recognise or have information concerning any aim “to realise the zero carbon-dioxide (CO2) output in 2050 or the depopulation agenda of Bill Gates, the World Economic Forum, the WHO and the UN” and to suggest that we would authorise any vaccine to realise such ambitions is utterly offensive and wrong.

7) Its risk-benefit analysis has been published to fulfil MHRA duty to facilitate an informed consent. The assessment of all the vaccines that have been performed by the MHRA and the European Medicines Agency (EMA) have been published on our respective websites for information of how we authorised these vaccines.

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

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

Yours sincerely

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU