FOI release

Freedom of Information on adverse event report data for Boostrix-IPV vaccine (Pertussis/whooping cough) in pregnant women (FOI 22/003)

Published 31 May 2022

FOI 22/003

28th January 2022

Dear,

Adverse event report data for Boostrix-IPV vaccine (Pertussis/whooping cough) in pregnant women

Thank you for your email dated 1st January 2022 where you requested the following:

“I would like to kindly request adverse event report data for Boostrix-IPV vaccine (Pertussis/whooping cough) in pregnant women (or all cases of adverse events for that vaccine if pregnancy status cannot be determined) since 2012. The data can be provided in a raw form (reported cases in cvs/xls) as long as the column headers indicate the column content.”

Further to your request I can confirm that we have received a total of 130 UK spontaneous suspected adverse drug reaction (ADR) reports of pertussis vaccine (dTaP/IPV) use in pregnant patients between 01/01/2012 and 06/01/2022, inclusive. Of these 130 reports, 40 specifically report the brand as Boostrix-IPV. Please see the attached Vaccine Analysis Print (VAP) for a breakdown of the reported reactions within the 130 reports and refer to the enclosed information sheet for guidelines on how to interpret the VAP.

When considering the provided spontaneous 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://products.mhra.gov.uk/

You may be interested to know that 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 via the 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 UK Health Security Agency (UKHSA) (previously 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

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 DivisionFOI 22/003

28th January 2022

Dear,

Adverse event report data for Boostrix-IPV vaccine (Pertussis/whooping cough) in pregnant women

Thank you for your email dated 1st January 2022 where you requested the following:

“I would like to kindly request adverse event report data for Boostrix-IPV vaccine (Pertussis/whooping cough) in pregnant women (or all cases of adverse events for that vaccine if pregnancy status cannot be determined) since 2012. The data can be provided in a raw form (reported cases in cvs/xls) as long as the column headers indicate the column content.”

Further to your request I can confirm that we have received a total of 130 UK spontaneous suspected adverse drug reaction (ADR) reports of pertussis vaccine (dTaP/IPV) use in pregnant patients between 01/01/2012 and 06/01/2022, inclusive. Of these 130 reports, 40 specifically report the brand as Boostrix-IPV. Please see the attached Vaccine Analysis Print (VAP) for a breakdown of the reported reactions within the 130 reports and refer to the enclosed information sheet for guidelines on how to interpret the VAP.

When considering the provided spontaneous 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://products.mhra.gov.uk/

You may be interested to know that 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 via the 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 UK Health Security Agency (UKHSA) (previously 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

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