FOI release

FOI 21/098 - FW: Further to FOI 21/010 - Freedom of information request - COVID19 Vaccine – Various Queries and Data

Published 24 March 2021

Thank you for your email.

Regarding the questions below:

If DATA and research is available can you please provide the list of known adverse reactions for someone who falls into the above categories?

Patients with mild to moderate, well-controlled comorbidities were included in clinical trials and no differences in the safety profile compared to those without comorbidities were identified. The list of adverse reactions associated with the vaccine can be found in the “Information for UK recipients on COVID 19 Vaccine AstraZeneca” document previously provided. This information is applicable to all vaccine recipients. Vaccination with either of the authorised vaccines is not contraindicated in the populations mentioned below.

Can you confirm or deny if someone who has received the vaccine and is tested using PCR testing within 7-28 days after receiving the vaccine, would they test positive or negative?

If someone takes a PCR test within 7 to 28 days of receiving the vaccine, that result would test negative unless they have also been infected with COVID-19 virus in that period.

Finally for those people who are 80 years plus and fall into these categories could the adverse reactions include death? possibly from anaphylaxis or similar?

All authorised vaccines are indicated for use in patients aged 80 and over. MHRA are proactively monitoring the safety of all approved COVID-19 vaccines for near real-time safety monitoring at population level. More than 13 million doses of COVID-19 vaccines have now been administered across the UK, most of which have been given to those most vulnerable. We expect the vaccines to have already prevented many deaths from COVID-related disease. Our surveillance does not suggest that the COVID-19 vaccines have contributed to any deaths.

Would you accept liability for this recommendation if harm should come to someone if they take the vaccine? If it is proven that the vaccine was part of chain of events leading to the harm of the person?

For information on indemnity/liability we advise you contact the Department of Health and Social Care (DHSC) with this request.

Web contact form - https://contactus.dh.gov.uk/?openform

Telephone: 020 7210 4850

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: info@mhra.gov.uk

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