Covid-19 Vaccine Adverse Events and Deaths

Jessica Waddington made this Freedom of Information request to Medicines and Healthcare Products Regulatory Agency

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Jessica Waddington

Dear Medicines and Healthcare products Regulatory Agency,

In light of the fact that the U.K. population, wether vulnerable or not, are being asked to take one of the Covid-19 vaccines, it is reasonable to say that the public has the right to access post- vaccination outcomes and data, including all adverse events and deaths, and which age and health categories these events are attributed to.

Numerous deaths after vaccination have already been recorded globally, as have thousands of adverse events. This information constitutes the backbone of informed consent and is of particular relevance given that clinical trials of Covid-19 vaccines marketed in this country have not been completed and that at least two of the vaccines consist of new technologies never before used on the human population.

Under the Freedom of Information Act, I would like to request access to post Covid-19 reported vaccine outcomes.

I look forward to hearing from you soonest.

Yours faithfully,
Jessica Waddington

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 21/054

Dear Jessica Waddington,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 18 January 2021.

I confirm that your request is now being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.

If you need to contact us again about this request, please quote the reference number above.

Kind Regards,


MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Jessica Waddington,

In response to your request for information about adverse reactions (ADR) to Covid-19 vaccines, I can confirm that the MHRA does hold this data.

We intend to publish details of all suspected reactions reported in association with available COVID-19 vaccines, along with our assessment of the data on a regular basis. This is to provide reassurance in the ongoing benefit and risk assessment of available vaccines.

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) and the information you have asked for is therefore exempt from disclosure.

Section 22 is a qualified exemption which means we have considered whether there is a greater public interest in releasing the information requested or withholding it. We recognise there is strong interest in seeing this data and accept it should not be withheld. We believe that the public interest will be best served by accompanying the publication of the data with an analysis to aid its interpretation which is currently under preparation.

We will send you a link to the ADR data report once it has been published.

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

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 you receive this response and addressed to: [MHRA request email]

Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices

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 Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU Telephone 0203 080 6000

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Amanda Johnstone left an annotation ()

Dear Jessica

I have been chasing this data from the MHRA since 22 December 2020 and they have been saying all along that they will be publishing the C-19 vaccine ADR's in the near future, yet here we are and still nothing has been published.

There is clearly no transparency whatsoever and quite frankly I am disgusted in them.

Regards

Amanda

Jessica Waddington

Dear Medicines and Healthcare products Regulatory Agency,

Re: FOI 21/054 Internal Review

Thank you for your reply.

In response, I again ask for access to the raw original data detailing the following information, as it has been received and recorded by the MHRA:
1. Adverse reactions recorded of all peoples having received any one of the three Covid vaccinations
2. Deaths recorded of any persons after receiving any one of the three Covid vaccinations
3. Further information detailing age and any other relevant information (such as whether the persons receiving vaccinations had specific immunological issues or other conditions), as it has been recorded, if these details have been recorded.

If details in point 3 have not been recorded, I am happy to wait for analysis here, but points 1 and 2 are essential to my request.

With almost 7 million people having been vaccinated in this country to date, it is in the public’s best interest and it is their right to know the outcomes of these vaccinations before this data has been “analysed” or altered in any way. Altering the data before publishing it may result in this data being presented in a fashion that pertains to the government’s intended interest, rather than the public’s. With clinical trials incomplete and much that is yet unknown about how these vaccines affect human beings, alongside the immense pressure the government is putting on the population to take these vaccines, it could be considered a crime to withhold the direct and immediate outcomes of these vaccines from the public.

I understand this information has been requested of you in December 2020 and it is wholly unacceptable and irresponsible of the MHRA to withhold this information as it is critically important and relevant for the public to have access to it.

Under the FOIA, I will remind you of these disclosures:
“If the request is for a document that contains exempt information, the authority still has to communicate all the disclosable information in that document to the requester.

Under Section 11(1) of the Act, the requester can express a preference for the means by which the information is communicated to them.

Where an authority has agreed to comply with a requester’s preference to inspect a document under Section 11(1)(b), it should provide them with access to the original document, where practicable.”

My request is to see the raw, unanalysed data as it has been recorded by MHRA, with utmost urgency, as it is in the public’s best interest and it is our right.

I look forward to hearing from you.

Yours faithfully,

Jessica Waddington

Katie Greenwood left an annotation ()

I have made a similar request also and they keep fobbing me off.

Deaths increasing sharply in carehomes since vaccinations started there.

I urgently request to see a report from the £1.5 million spent on an AI tool to help compile them the adverse effects.

Katie G

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

FOI 21/054

Dear Jessica Waddington,

Thank you for your email of the 16th January where you have asked “Under the Freedom of Information Act, I would like to request access to post Covid-19 reported vaccine outcomes.?”

We confirm we have published the data and this is available to view at the following link of our website page below.

https://www.gov.uk/government/publicatio...

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

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 you receive this response and addressed to: [MHRA request email]

Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices

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

Kind Regards,

MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade
Canary Wharf
London E14 4PU
Telephone 020 3080 6000

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