FOI release

Freedom of Information request on COVID-19 vaccines (FOI 21/729)

Published 29 December 2021

27th July 2021

FOI 21/729

Dear

Thank you for your emails dated 27th June 2021 and 8th July 2021 where you requested the below from the start of the vaccine rollout till the most recent available date:

• The number of yellow cards that have been reported from a postal code area beginning with BL1-BL9 and WN1-WN5, and from which how many resulted in a fatality
• A breakdown of the age of the patients and the reporter details
• A list of the reactions reported from the above-mentioned postal code areas and how many required hospital treatment
• How much the World Health Organisation (WHO) and the Bill and Melinda Gates Foundation have donated per year between 2010-2021
• When the Pfizer, AstraZeneca and Moderna filled for emergency use for currant mRNA-based vaccines, did the MHRA acknowledge that these are gene therapy-based (vaccines) as the FDA (Food and Drug Administration) perceives them as such.’?
• Do the MHRA medically consider these drugs/vaccines as gene therapy-based (vaccines)?
• Did the MHRA ever question or ask the drug manufacturer to clinically prove that the spike protein of SARS-COV-2, or the SPIKE proteins from the mRNA vaccines are NOT TOXIC to human?

With regards to your request, Table 1 displays the number of UK spontaneous suspected Adverse Drug Reaction (ADR) reports we have received associated with any COVID-19 vaccination as of 6th July, reported directly to the Yellow Card scheme with either a BL or WN postal area code as listed above. Please note that this information was extracted based on the postcode provided by the reporter.

Table 1: Total number of suspected Adverse Drug reaction (ADR) reports in association with a COVID-19 vaccine from a BL or WN postal code as of the 6th July 2021.

Postal code area	Number of reports	Number of fatal reports
BL	1346	8
WN	1190	22

It is important to bear in mind the following points when interpreting Yellow Card data:

• The data provided only includes ADR reports received directly from healthcare professionals or from patients, parents, and carers. Reports are also received by the MHRA from pharmaceutical companies who have a legal obligation to report serious suspected ADRs relating to their products. Reports sent to us by pharmaceutical companies are regarded as indirect reports meaning they have not been sent to us from members of the public or healthcare professionals. Such indirect reports from pharmaceutical companies will typically not include details of the reporter, to protect reporter confidentiality. We have therefore not included indirect reports.
• Please be aware, the reporting of a particular reaction does not necessarily mean that it has been caused by a vaccine. Many factors must be considered in assessing the relationship between a vaccine and suspected reaction including the possible contribution of other drugs being taken, and the underlying disease.
• Furthermore, the number of reports received should not be used as a basis for determining incidence of a reaction as neither the total number of reactions occurring, nor the number of patients using the drug is known.
• This information will only include reports where the reporter has provided the postcode. Please note that postcode is a mandatory field on the Coronavirus Yellow Card reporting site and therefore it is likely this information captures the majority of reports received for your specific request. Please note that reports received via other routes where postcode is not provided or where it is provided incorrectly are evaluated in the same way as all other reports received via the Yellow Card scheme.

We are unable to provide details on age and seriousness (e.g. hospitalisation) of reports as we intend to publish all suspected reactions reported in association with available COVID-19 vaccines in an interactive format as an interactive Drug Analysis Profiles (iDAPs), along with our ADR summary that is published each week. The use of iDAPs will enable users to view the data by categories of their choice such as age and seriousness of reports. As we plan to publish the data, we consider that your request is covered by Section 22 of the Freedom of Information Act (information intended for future publication). Unfortunately, we are unable to provide an exact date as to when iDAPs (interactive Drug Analysis Profiles) will be published. We recognise that there is strong interest in seeing this data and accept it should not be withheld indefinitely. Please be assured that we will send you the link to the iDAPs as soon as they are available.

A breakdown by reporter qualification, patient, parent, carer and healthcare professional of the number of directly reported UK spontaneous ADR reports received by the MHRA as of the 6th July 2021 in association with a COVID-19 vaccination from a BL or WN postal code is provided in, Table 2 and Table 3. In addition, please note it is possible for a report to have more than one reporter therefore the total number of reports will not equate to the total number of reporters.

Table 2: All UK, suspected spontaneous direct ADR reports from a BL postal code associated with a COVID-19 vaccination broken down by reporter qualification as of the 6th July 2021.

Reporter qualification	Number of reports
Patient, parent or carer	987
Healthcare professional	359

Table 3: All UK, suspected spontaneous direct ADR reports from a WN postal code associated with a COVID-19 vaccination broken down by reporter qualification as of the 6th July 2021

Reporter qualification	Number of reports
Patient, parent or carer	900
Healthcare professional	292

You also asked for a list of the ADRs as reported to us and how many complaints we have received regarding the COVID-19 vaccines nationwide. The MHRA’s role is to continually monitor safety during widespread use of a vaccine. 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 MHRA publishes a weekly summary of Yellow Card reports associated with the COVID-19 vaccines which can be found on this link. In this publication, you will find a breakdown of the number of ADR reports by brand where specified and country, as well as Vaccine Analysis Prints. The Vaccine Analysis Prints contains complete data for all spontaneous suspected adverse drug reactions (ADRs), or side effects, which have been reported in association with a COVID-19 vaccine via the Yellow Card Scheme. Please note we routinely review and update cases to ensure information is accurately captured on our database so published numbers may change over time.

In terms of the additional questions you asked, we have received grant funding from the Bill and Melinda Gates Foundation as well as other sources such as the European Commission, the Innovative Medicines Initiative and WHO. This funding has supported work to strengthen regulatory systems in other countries.

The majority of our income comes from the pharmaceutical industry through fees. For example, all Marketing Authorisation applicants have to pay a fee. The licensing of medicines is an independent, scientific process which is overseen by the Commission on Human Medicines (CHM).

The CHM is an independent body which advises on applications for marketing authorisations. This includes considering further representation against our provisional advice in respect of national applications; advises on the need for, and content of, risk management plans for new medicines; advises on the impact of new safety issues on the balance of risks and benefits of licensed medicines – e.g. adding warnings, restricting or suspending use of a medicine and advises the licensing authority on changes to legal status of marketing authorisations.

Please see the links below for further information.

https://www.gov.uk/government/news/mhra-awarded-over-980000-for-collaboration-with-the-bill-and-melinda-gates-foundation-and-the-world-health-organisation

The current level of grant funding received from the Gates Foundation amounts to approximately $3m. This covers a number of projects and the funding is spread across 3-4 financial years.

We are an executive agency of the Department of Health and Social Care. Our Annual report (link below) contains information on page 9 regarding our funding. If you require more details about the level of Government Funding, please refer to the financial statements in the Annual report.

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/902328/MHRA_Annual_Report_and_Accounts_2020.pdf

No COVID-19 vaccine would be approved until it has demonstrated safety, quality, and efficacy through a robust clinical trial programme, as determined by the MHRA, and unless the evidence supports its use.

The Public Assessment Reports that are published very clearly contain MHRA’s assessment of the authorised vaccines.

You may be aware of the data that would have been looked at and assessed as part of the authorisation process for each vaccine, as this is described in each Public Assessment Report in a lot of detail.

To confirm that harm from the spike proteins themselves on the vaccine recipient has not been observed in any of the clinical trials.

The temporary authorisations of the Pfizer/BioNTech, Oxford/AstraZeneca and Moderna vaccines was done through an expedited rolling review. A ‘rolling review’ can be used to complete the assessment of a promising medicine or vaccine during a public health emergency in the shortest time possible. This is done as the packages of data become available from ongoing studies on a staggered basis. The temporary authorisation under Regulation 174 permits the supply of identified vaccine batches, based on the safety, quality and efficacy data submitted to MHRA. These authorisations do not constitute a marketing authorisation.

All vaccines are tested through three phases of clinical trials to ensure they meet the gold standard. Phase 1 trials are with a small group of people to make sure there are no safety concerns and determines the appropriate dosage for the best immune response. Phase 2 trials are conducted on a larger group of people to check the vaccine works consistently and that the immune response is sufficient. Phase 3 trials test the vaccines on thousands of people for scientists to assess if the vaccine is producing immunity that will prevent disease. Usually, these phases are run in sequence, but in an effort to find a safe and effective Covid-19 vaccine as quickly as possible, once safety has been ascertained through Phase 1, Phases 2 and 3 are being run in parallel. Extensive checks and balances are required at every stage of the development of a vaccine, and this is no different for a Covid-19 vaccine. No stages in the vaccine development processes were bypassed.

The temporary authorisations for use of the COVID-19 vaccines in the UK followed a rigorous scientific assessment of all the available evidence of quality, safety and effectiveness by the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA expert scientists and clinicians reviewed data from the laboratory pre-clinical studies, clinical trials, manufacturing and quality controls, product sampling and testing of the final vaccine, and also considered the conditions for its safe supply and distribution. The decision was made with advice from the Commission on Human Medicines (CHM), the government’s independent expert scientific advisory body. Regarding the MHRA approval of the Pfizer/BioNTech and the Oxford/AstraZeneca COVID-19 vaccines, further information (including information for physicians and recipients of the vaccine, and Public Assessment Reports [PARs] for each vaccine) are available on the MHRA website. Links to these are provided below:

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

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

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

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

As with any vaccine or medicine, COVID-19 vaccines require continuous safety monitoring to ensure that the benefits in protecting people against COVID-19 outweigh any side effects or potential risks. This is a process known as safety monitoring (pharmacovigilance). This ensures that any potential medium and long-term safety issues are promptly and adequately evaluated. As part of our signal detection processes, all adverse reaction reports received are individually assessed and cumulative information reviewed at regular intervals. Be reassured that the MHRA is working in collaboration with partners in the health system to rapidly assess all available safety data in real time and communicate any emerging issues, as necessary.

A PAR is available for the assessment by MHRA of the Pfizer/BioNTech vaccine in adolescents, please refer to Annex 1 in the above-linked PAR for the Pfizer/BioNTech vaccine.

Please note that clinical data is routinely published by the EMA on their website, including clinical data received for the Pfizer, AstraZeneca and Moderna vaccines. A link to these is provided below:

https://clinicaldata.ema.europa.eu/web/cdp

Regarding your specific questions, MHRA does not consider these vaccines to be gene therapy-based vaccines. Regarding the toxicity of the spike proteins, the non-clinical and clinical assessments of the vaccines are available in the PARs for each vaccine, that have been provided above.

I hope the information provided is helpful, but if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division