FOI release

Freedom of Information request on the data presented weekly in MHRA's Summary of Yellow Card reporting in association with the COVID-19 vaccination campaign (FOI 21-694)

Published 29 December 2021

13th July 2021 FOI 21/694

Dear

Thank you of your email dated 14th June 2021, where you requested information relating to the data presented in our weekly Summary of Yellow Card reporting in association with the COVID-19 vaccination campaign.

Please find below the responses to each of your queries:

1. Do you have information on whether these events when they occur tend to be less severe when associated with a second dose or are they similar to when occurring after the 1st dose.

It is difficult to determine from the Yellow Card data whether the cases of thromboembolic events with low platelets occurring after the second dose of COVID-19 vaccine AstraZeneca are less severe. However, as per the MHRA’s most recent COVID-19 vaccine adverse drug reaction (ADR) publication, which includes reports received up to 30 June 2021, the incidence of these events after the first or unknown dose was 14.8 per million doses. The incidence rate following the second dose is 1.7 cases per million doses. While there is currently less follow up time following the second doses, the data do not indicate an increased risk of these events following the second dose of COVID-19 vaccine AstraZeneca. The advice is that anyone who did not have these side effects should come forward for their second dose when invited.

1. Do you have information on which age range the events occurred and the outcome, in your table no 5 it looks like 1st dose and 2nd dose are counted together and it is just the 2nd dose info I am looking for.

We can confirm that we do hold this information however as we intend to publish the data, we consider that 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 therefore exempt from disclosure.

Section 22 is a qualified exemption which means we have considered whether there is a greater public interest in releasing the information requested or withholding it. We recognise there is strong interest in seeing this data and accept it should not be withheld however wish to publish this information alongside appropriate context and assessment.

1. Do you also have information on how many people have received the vaccination in each age group range for the second dose.

The MHRA do not hold this data. Instead, this information falls within the remit of Public Health England (PHE), who are facilitating the delivery of the national COVID-19 vaccination programme. The following website may have some useful information for you regarding this information, or you may wish to contact PHE directly: Daily summary Coronavirus in the UK (data.gov.uk)

1. Do you have any information on how the people who had these events after the second dose responded to the first dose i.e. did they have severe side effects or react unusually in any way which might have indicated a future problem.

It is important to note that people may report side effects in different ways. Whilst reporters are able to submit information relating to both the first and second dose of the COVID-19 vaccinations within one Yellow Card report, this is not mandated. Reports may only include information relating to a single dose, and we are therefore not able to comment on the incidence or severity of suspected side effects following other doses. Analysis of the cases following the second dose of COVID-19 vaccine AstraZeneca does not indicate any pattern or identifiable risk factors in relation to ADRs following the first dose. Often, it is not stated on the Yellow Card report whether the individual experienced any ADRs following their first dose. We are continuing to closely monitor these data.

It is also important to note that the number of reports received via the Yellow Card scheme does not directly equate to the number of people who suffer adverse reactions and therefore cannot be used to determine the incidence of a reaction. When considering the spontaneous ADR data, it is important to be aware that a reported reaction does not necessarily mean it has been caused by the vaccine, only that the reporter had a suspicion it may have. The fact that symptoms occur after use of a vaccine, and are reported via the Yellow Card Scheme, does not in itself mean that they are proven to have been caused by the vaccine. Underlying or concurrent illnesses may be responsible and such events can also be coincidental. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular drug or vaccine and may be stimulated by promotion and publicity.

I hope the information provided is helpful, but 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, Vigilance and Risk Management of Medicines Division