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References

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1. https://www.gov.uk/government/collection...

Our Ref: FOI 21/311

Dear Gavin Roberts,

RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 28^th March 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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FOI 21/311

Dear Mr Roberts,

Thank you for your email.

With regards to your questions:

Please could you inform the public of the minimum timescales you have in
place of the current Covid vaccines to be able to complete your strict 
Phase 4 safety long term?

How long will you be monitoring births and of the vaccinated for
defects/stillborns/ miscarriage etc and also how old do you consider will
the next generation be when you will officially licence the use of these
vaccines for the long term?

There is no minimum timescale for assessing the long-term safety of any
vaccine.

The MHRA continuously monitors the safety of vaccines through a variety of
pharmacovigilance processes including the Yellow Card scheme. The MHRA,
together with independent expert advice from the Commission on Human
Medicines (CHM), is responsible for ensuring that the overall balance of
benefits in terms of effectiveness, and risks of medicines and vaccines is
positive at the time of licensing and remains so thereafter. Further
information about the MHRA’s pharmacovigilance strategy can be found here:
[1]https://www.gov.uk/government/publicatio...

Whilst an acceptable level of information has been received to provide
assurance that appropriate standards of quality, safety and efficacy have
been met for authorisation of the COVID-19 vaccines, patients included in
the clinical trials for COVID-19 vaccines continue to be followed up for
at least a year to gather further safety and efficacy data and MHRA will
continue to receive data from the companies as it becomes available.

If you disagree with how we have interpreted the Freedom of Information
Act 2000 with regards to your request, you can ask for an internal review.
It will be carried out by a senior member of the Agency who was not
involved with the original decision. Internal review requests should be
submitted within two months of the date you receive this response and
addressed to: [2][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.

After that, if you remain dissatisfied, you may write to the Information
Commissioner at; The Information Commissioner’s Office Wycliffe House
Water Lane Wilmslow Cheshire

SK9 5AF

They will make a decision on whether or not we have interpreted the FOIA
correctly in handling your request.

Yours sincerely

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU.

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