Freedom of Information request about COVID-19 vaccines and Phase 4 safety long term, and monitoring births (FOI-21-311)
Published 28 May 2021
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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: https://www.gov.uk/government/publications/report-of-the-commission-on-human-medicines-expert-working-group-on-covid-19-vaccine-safety-surveillance/report-of-the-commission-on-human-medicines-expert-working-group-on-covid-19-vaccine-safety-surveillance
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.
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Yours sincerely
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU.