Freedom of Information request on the Yellow Card reported side effects for the whooping cough vaccine during pregnanc and COVID-19 vaccines during pregnancy and in breastfeeding mothers (FOI 21-612)
Published 13 August 2021
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24th June 2021 FOI 21/612
Dear
Thank you for your email dated 25th May 2021 where you requested the following:
“the yellow card reported side effects for the whooping cough vaccine during pregnancy and also the Pfizer and Moderna C-19 vaccines during pregnancy and in breastfeeding mothers”
Further to your request we have received a total of 124 UK, spontaneous suspect adverse drug reaction (ADR) reports of pertussis vaccine (Repevax, DTPA IPV Vaccine and Boostrix) use in pregnant patients up to and including 03/05/2021. Please find the enclosed data containing tables 1-3 which includes a line listing for these reports, and aggregated patient age and sex.
The MHRA undertook a large epidemiological study to proactively monitor the safety of pertussis vaccine in pregnancy which is published here: https://www.bmj.com/content/349/bmj.g4219. Our analysis found no evidence of any risks to pregnancy. Rates of normal, healthy births, as well as any adverse outcomes, were similar to those seen in unvaccinated women.
Aside from our epidemiological study, we also continue to evaluate reports of suspected adverse reactions submitted Yellow Card scheme, as we do for all medicines and vaccines. We encourage such reporting to ensure we can continually appraise the safety of vaccines and medicines. In addition to the reassuring results from the epidemiological study mentioned above, we have not identified any safety concerns in relation to the administration of the pertussis vaccine in pregnancy from the Yellow Card reports received to date.
The following link will give you more information on pertussis vaccine use in Pregnancy. The link will direct you to the Public Health England website where you will find a factsheet and a leaflet. https://www.gov.uk/government/publications/resources-to-support-whooping-cough-vaccination
When considering the provided spontaneous Adverse Drug Reaction (ADR) data, it is important to be aware of the following points:
• A reported reaction does not necessarily mean it has been caused by the vaccine, only that the reporter had a suspicion it may have. Each year, millions of doses of routine vaccinations are given in the UK alone, and when any vaccine is administered to large numbers of people, some recipients will inevitably experience illness following vaccination. 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.
• 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 or compare the safety profile of different vaccines. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular drug, and may be stimulated by promotion and publicity about a drug. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time.
As this data does not represent a list of possible side effects from the pertussis vaccine, please refer to section 4 the product information, which can be found here: https://www.medicines.org.uk/emc/files/pil.5580.pdf
Regarding your request for adverse drug reaction data for the Pfizer BioNTech and Moderna COVID-19 vaccines, the MHRA is regularly publishing Yellow Card data associated with COVID-19 vaccinations. Yellow Card data for drugs is routinely published on the Yellow Card website, with vaccine data available on request. However, for COVID-19 vaccinations we are proactively publishing details of adverse drug reactions received, including MHRA assessment of the data to provide context. Please note this data is updated weekly. https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions
Extensive post-marketing experience of the use of the Pfizer BioNTech and Moderna vaccines in the USA have raised no safety concerns regarding their use in pregnancy. These data have been published in the medical literature. The JCVI has therefore advised that women who are pregnant should be offered vaccination at the same time as non-pregnant women, based on their age and clinical risk group. Reports of COVID-19 vaccine use in pregnancy broadly report similar reactions to those reported for non-pregnant individuals.
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