Covid vaccine adverse events

Melissa Smith made this Rhyddid Gwybodaeth request to Medicines and Healthcare Products Regulatory Agency

Automatic anti-spam measures are in place for this older request. Please let us know if a further response is expected or if you are having trouble responding.

Roedd y cais yn llwyddiannus.

Dear Medicines and Healthcare products Regulatory Agency,

While we applaud your decision to set up a dedicated Yellow Card scheme for Covid-19 vaccines (https://coronavirus-yellowcard.mhra.gov....) that have been authorised for emergency use, we have been unable to find any public disclosure of the adverse event report data being collated by the MHRA.

Given that the vaccines are experimental and only a very small number of people in Phase 3 trials for the experimental vaccines have also been exposed to SARS-CoV-2 in the community, it is imperative that all data are shared to allow individuals the right to informed consent for covid-19 vaccination.

On this basis, could you please provide:

1. All available reported adverse events associated with Covid-19 vaccination, including the nature and severity of the event, the body or organ system(s) involved, the vaccine involved, and the dosage delivered prior to the reported event.

2. All available data known to the MHRA, including from post-marketing surveillance, on vaccine-induced enhancement of infection or antibody-dependent enhancement (ADE).

3. All information linked to any communication strategy the MHRA is currently using or planning to use, to ensure all available data on ADE is captured from the public and health professionals during post-marketing surveillance.

Finally, can you please inform me if the MHRA is planning to place covid-19 vaccine adverse event reports from the Yellow Card scheme in the public domain, and if so, when.

Thank you in anticipation of an urgent response.

Yours faithfully,

Melissa Smith

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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References

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 21/013

Dear Melissa Smith,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 6 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, London E14 4PU
Telephone 0203 080 6000

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Gadawodd Amanda Johnstone anodiad ()

Dear Melissa

I e-mailed the MHRA YCST on 22 December 2020 essentially asking them the same thing.

They advised me that they will be publishing weekly C-19 vaccine ADR reports some time in the future yet could not specify a date.

Either they are incompetent or hiding something.

Regards
Amanda Johnstone

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

FOI 21/013

Dear Melissa Smith,

Thank you for your email dated 6th January 2021 where you requested information about adverse drug reactions (ADR) to Covid-19 vaccines, I can confirm that the MHRA does hold this data.

We will publish details of all suspected reactions reported in association with available COVID-19 vaccines in the near future, along with our assessment of the data on a regular basis. This is to provide transparent and clear information about the ongoing benefit and risk assessment of available vaccines.

As we plan to publish the data in the near future including narrative assessment of the data and any issues identified, 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 exempt from earlier disclosure.

We are pleased there is strong interest in seeing this important data; we consider that this is best met by publishing the finalised data with an analysis to aid its interpretation.

As above, we expect that this will be published in the near future and when it is, we will send you the link to both the data and our assessment.

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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Gadawodd Amanda Johnstone anodiad ()

Dear Melissa

It seems the MHRA hasn't changed their story since 22 December 2020 and we are now into February 2021.

They are criminals.

Regards
Amanda

Gadawodd Melissa Smith anodiad ()

Hi Amanda

We're disappointed with the outcome as you can imagine. We were hoping that the MHRA would release information.I'm sure there are many others with a similar interest. It's a shame they don't give a timeline for release.

It's one of the reasons the team at ANH International are calling for transparency around vaccines.

Thanks for taking an interest in the request.

Best wishes
Melissa

Gadawodd Amanda Johnstone anodiad ()

Yes Melissa, there have been at least another six FOI requests submitted to the MHRA and I have just emailed them, the Deputy Chair of the MHRA Board and the Minister who oversees them again today twice.

Gadawodd Lauren anodiad ()

Gadawodd Melissa Smith anodiad ()

Many thanks Lauren. Here's a link to the MHRA's data release - https://www.gov.uk/government/publicatio...

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

FOI 21/013

Dear Melissa Smith,

Thank you for your email.

Further to our response of 3rd February 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

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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