FOI release

Freedom of Information request on the COVID-19 vaccines and pregnancy (FOI 21/885)

Published 20 January 2022

26th August 2021

FOI 21/885

Dear

Thank you for your email dated August 4th regarding the Yellow Card reports of ‘abortion spontaneous’ on the COVID ADR Summary publication Vaccine Analysis Prints.

In parent-child reports, if the foetus dies before 24 weeks with no other reactions reported, miscarriage (or ectopic pregnancy – if reported) is classified as the Adverse Drug Reaction (ADR) with the mother as the patient. As per our classification guidelines, the reaction will not be recorded as fatal as the parent is the patient. However, if the baby dies after 24 weeks gestation then the baby is considered the patient and stillbirth would be classified as the reaction with a fatal outcome. This guidance is in line with the NHS timelines for miscarriage and stillbirth; Stillbirth - NHS (www.nhs.uk).

The MHRA use a standardised dictionary when classifying ADR reports. MedDRA (Medical Dictionary for Regulatory Activities) is a clinically validated international medical terminology dictionary. Terms are categorised together into groups of similar terms, to aid with data analysis. This grouping takes place at 5 levels, with the highest-level grouping of System Organ Class (SOC) covering whole organs or body systems, and lower levels within each SOC such as Preferred Terms (PT) and finally into Lowest Level Terms (LLT) covering smaller groups of more closely related events. The COVID-19 Vaccine Analysis Prints show reactions at the PT level; the LLT ‘miscarriage’ maps to the PT ‘abortion spontaneous’. Cases are classified according to what is reported by healthcare professionals and patients. Therefore, if a miscarriage is reported without any information on gestation period, the ADR miscarriage will be recorded in the report without a fatal outcome and published in the COVID-19 Vaccine Analysis Prints. All cases are routinely followed up for further details including gestation period.

Regarding the ADRs ‘foetal death’ and ‘stillbirth’ - thank you for highlighting these inconsistencies and please be assured that we regularly reclassify cases that are incorrect and will do so in these instances.

When considering spontaneous data it is important to be aware of the following:

• A report of a suspected ADR to the Yellow Card scheme does not necessarily mean that it was caused by the vaccine, only that the reporter has a suspicion it may have. Underlying or previously undiagnosed illness unrelated to vaccination can also be factors in such reports. The relative number and nature of reports should therefore not be used to compare the safety of the different vaccines.

• All reports are kept under continual review in order to identify possible new risks. For a medicine or vaccine to be considered safe, the expected benefits will be greater than the risk of having harmful reactions. It is important to note that most people take medicines and vaccines without having any serious side effects.

A list of the recognised adverse effects of COVID-19 vaccines is provided in the information for healthcare professionals and the recipient information. These can be found on the Coronavirus Yellow Card reporting site. Further details on Yellow Cards reported in relation to COVID-19 vaccinations is available in our summary of Yellow Card reporting.

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