Freedom of Information request on the adverse reactions reported relating to abortions following the COVID-19 vaccination (FOI 21/1069)
Published 27 April 2022
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5th October 2021
FOI 21/1069
Dear
Thank you for your email dated 21st September 2021, where you asked for the following information under the Freedom of Information Act:
The Yellow Card adverse reactions PDFs found here on the government website:
https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions contain reports and deaths within the category “Pregnancy Conditions.” Within the column “Total Reactions for Drug” there are reports relating to:
1) Abortion related conditions and complications
2) Abortions not specified as induced or spontaneous, and
3) Abortion spontaneous
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Are the reports within the above subcategories included in the “Total Fatal Outcome Reports” at the bottom of each PDF? For example, at the time of writing, there are a reported 309 abortions spontaneous for Pfizer. Are these 309 miscarriages included in the death count? If not, why not?
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Please could you also confirm what the MHRA considers as the difference between foetal death and abortion spontaneous. Why is foetal death recorded in the fatalities column but abortion spontaneous is not?
As you state, the MHRA had received 309 UK spontaneous suspected Adverse Drug Reaction (ADR) reports associated with a spontaneous abortion and the Pfizer/BioNTech COVID-19 vaccination between the 9th December 2020-8th September 2021.
To clarify, in the UK a spontaneous abortion (also called miscarriage) is defined as the spontaneous loss of a fetus before the 24th week of pregnancy. Pregnancy losses after the 24th week are defined as stillbirth or fetal death. Under UK law, loss of a baby in the uterus (namely, miscarriages or stillbirths) prior to 24 weeks of pregnancy are not counted as deaths. In line with this, miscarriages and related conditions prior to 24 weeks are not classified as fatal by MHRA and the event is considered to relate to the mother rather than the fetus, therefore this number would not be included in the total fatal count at the bottom of each Vaccine Analysis Print (VAP). However, any reports of fetal death or stillbirth are classed as a fatal event and will be included in the total fatal count.
Please note we routinely review and update cases to ensure information is accurately captured on our database so published numbers may change over time. Moreover, it is important to understand 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 or medicine and are reported via the Yellow Card scheme, does not in itself mean that they are proven to have been caused by it. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.
Sadly, miscarriage is estimated to occur in about 1 in 4 pregnancies in the UK (outside of the pandemic) and most occur in the first 12 weeks (first trimester) of pregnancy, so some miscarriages would be expected to occur following vaccination purely by chance. There is currently no pattern to suggest an elevated risk of miscarriage or stillbirth related to exposure to the COVID-19 vaccines in pregnancy. The MHRA takes each report seriously and continues to closely monitor reports of vaccine exposure in pregnancy. If any further data or evidence becomes available which suggests these vaccines are unsafe for use in pregnancy, this will be reviewed as soon as possible by our assessors and independent expert committee advisors, and any safety concerns identified will be communicated.
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