FOI release

Freedom of Information request (FOI 22/652)

Published 17 January 2024

FOI 22/652

24th October 2022

Dear

Thank you for your email of 27 April 2022 where you requested information on the package leaflet of the COVID-19 vaccine AstraZeneca. Please accept our apologies for the delay in responding to your request.

As you may be aware, this MHRA is responsible for ensuring that all medicinal products authorised in the UK meet acceptable standards of safety, quality and efficacy. The COVID-19 vaccines used in the UK vaccination programme were approved following a rigorous review of the safety, quality and effectiveness of the vaccines by the MHRA and the Government’s independent advisory body, the Commission on Human Medicines (CHM). The MHRA concluded that the COVID-19 vaccines were safe and effective and that the benefits of the vaccines outweigh any risk.

However, no medicine or vaccine is completely risk-free and hence the MHRA continually monitors the safety of the COVID 19 vaccines through a comprehensive safety monitoring strategy the details of which has been published online: https://www.gov.uk/government/publications/report-of-the-commission-on-human-medicines-expert-working-group-on-covid-19-vaccine-safety-surveillance. This monitoring strategy is proactive and based on a wide range of information sources, with a dedicated team of scientists continually reviewing information to look for safety issues or any unexpected, rare events.

One of these information sources is reports received through the Yellow Card Scheme which the MHRA operates on behalf of the Commission on Human Medicines (CHM). The scheme collects and monitors information on suspected safety concerns or incidents involving vaccines, medicines, medical devices, and e-cigarettes. The scheme relies on voluntary reporting of suspected adverse incidents by healthcare professionals and members of the public (patients, users, or carers). The purpose of the scheme is to provide an early warning that the safety of a product may require further investigation.

In order to provide information on the Yellow Card reports received on the COVID 19 vaccines, the MHRA regularly publishes a report summarising the suspected adverse reactions reported via the Yellow Card scheme: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions

The latest versions of the package leaflet for the COVID-19 vaccine AstraZeneca (for both vaccine supplied under Regulation 174 and vaccine supplied under the conditional marketing authorisation) can be found here:

Regulatory approval of COVID-19 Vaccine AstraZeneca - GOV.UK (www.gov.uk).The webpage also lists the dates that updates were made to the information in the package leaflet since the first version of the leaflet, dated December 2020.

You also asked, in relation to section 4 of the patient leaflet, how the frequency of ‘very rare (may affect up to 1 in 10,000 people) was determined. When describing side effects to medicines or vaccines in the product information, a frequency is estimated based on available data, whether this is from clinical trials or postmarketing data (eg the Yellow Card scheme). The categories are as follows:

• Very common (may affect more than 1 in 10 people)

• Common (may affect up to 1 in 10 people)

• Uncommon (may affect up to 1 in 100 people)

• Rare (may affect up to 1 in 1,000 people)

• Very rare (may affect up to 1 in 10,000 people)

• Not known (cannot be estimated from the available data): this usually refers to events detected in the postmarketing period, when the number of patients exposed is not known.

The events listed as very rare in section 4 of the version of the AstraZeneca vaccine patient leaflet dated 26 January 2022: extremely rare blood clots in combination with low levels of platelets and Guillain Barre syndrome, were both detected as possible side effects associated with the AstraZenenca COVID-19 vaccine from spontaneous reporting schemes in the UK and in other countries. However, as described in the MHRA’s report summarising safety data for the COVID-19 vaccines, by combining data on the number of people vaccinated with the numbers of Yellow Card reports received for these events, we were able to estimate that the frequency of the events was more in the region of 1 per 100,000, which is far less common than 1 in 10,000 or very rare. However the classification system for frequency used in the product information does not include a category for rarer events than 1 in 10,000.

Once again, we apologise for the delay in responding to you, and hope this information is helpful.

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 of this response; and can be addressed to this email address.

Yours sincerely,

FOI Team,