FOI release

Freedom of Information request on the Vaccine Analysis Prints for Flucelvax Tetra and Supemtek brands of the influenza vaccine (FOI 22/016)

Published 31 May 2022

FOI 22/016

31st January 2022

Dear,

Thank you for your email dated 6 January 2022 where you asked for the following:

I am mainly interested in Flucelvax Tetra and Supemtek brands of the influenza vaccine. If you could please send over the Vaccine Analysis Prints for these two?

Further to your request please find attached a Vaccine Analysis Print (VAP) for the Flucelvax Tetra vaccine. The print contains information on all the UK spontaneous suspected Adverse Drug Reaction (ADR) reports received through the Yellow Card scheme up to and including 23/01/2022 in association with Flucelvax Tetra. During this time period, we received 678 UK spontaneous suspected Yellow Card reports associated specifically with the Flucelvax Tetra vaccine which contained a total of 1811 adverse reactions.

Also attached is a VAP for Flublok which is the US version that was used for the expanded flu vaccination programme last season prior to Supemtek being available for use. During the same time period we have received 176 UK spontaneous suspected Yellow Card reports associated specifically with the Flublok vaccine which contained 585 adverse reactions. Please find attached a guidance sheet which provides you with further information on how to interpret the prints.

We have also received a total of 4 UK spontaneous suspected Yellow Card reports associated specifically with the Supemtek vaccine. Due to the small number of reports a VAP for Supemtek vaccine has not been included in this response. However, you maybe interested to know that these 4 reports contained a total of 9 adverse reactions, which included rashes, pruritis, abdominal pain, muscle rigidity and vaccination site pain. Most of which are listed as undesirable effects in section 4.8 of the Summary of Product Characteristics (SPC).

Please be aware, the majority of adverse reactions received for Flucelvax, Flublok and Supemtek relate to local and systemic reactogenicity. As per the VAPs you will note during this time period we have not received any reports associated with Toxic Epidermal Necrolysis (TEN) or Stevens-Johnson Syndrome (SJS) with any of these vaccines.

Please note, as it is possible for one report to contain multiple ADRs, the number of ADRs is greater than the number of individual reports. It is also important to note that the information provided within this response will only include reports where the reporter has specifically stated the particular brands of interest. We do routinely follow up to ask for brand information where its hasn’t been originally provided but do not always receive this information, please bare this in mind when interpreting this data.

When considering the attached spontaneous 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 medicine, 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.

The MHRA continuously monitors the safety of vaccines through a variety of pharmacovigilance processes including the Yellow Card scheme. As part of our signal detection processes all adverse reaction reports received by the Yellow Card Scheme are individually assessed and cumulative information reviewed at regular intervals. Vaccines encompass a wide variety of products with different indications, different ingredients, and different mechanisms of action and as such safety for each vaccine is considered individually rather than as a group. If appropriate, regulatory action would be taken if any serious risks were confirmed.

As the data does not necessarily refer to proven side effects, you should refer to the product information which can be found here: https://www.medicines.org.uk/emc/ for details on the possible side effects of each vaccine.

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 22/016

31st January 2022

Dear,

Thank you for your email dated 6 January 2022 where you asked for the following:

I am mainly interested in Flucelvax Tetra and Supemtek brands of the influenza vaccine. If you could please send over the Vaccine Analysis Prints for these two?

Further to your request please find attached a Vaccine Analysis Print (VAP) for the Flucelvax Tetra vaccine. The print contains information on all the UK spontaneous suspected Adverse Drug Reaction (ADR) reports received through the Yellow Card scheme up to and including 23/01/2022 in association with Flucelvax Tetra. During this time period, we received 678 UK spontaneous suspected Yellow Card reports associated specifically with the Flucelvax Tetra vaccine which contained a total of 1811 adverse reactions.

Also attached is a VAP for Flublok which is the US version that was used for the expanded flu vaccination programme last season prior to Supemtek being available for use. During the same time period we have received 176 UK spontaneous suspected Yellow Card reports associated specifically with the Flublok vaccine which contained 585 adverse reactions. Please find attached a guidance sheet which provides you with further information on how to interpret the prints.

We have also received a total of 4 UK spontaneous suspected Yellow Card reports associated specifically with the Supemtek vaccine. Due to the small number of reports a VAP for Supemtek vaccine has not been included in this response. However, you maybe interested to know that these 4 reports contained a total of 9 adverse reactions, which included rashes, pruritis, abdominal pain, muscle rigidity and vaccination site pain. Most of which are listed as undesirable effects in section 4.8 of the Summary of Product Characteristics (SPC).

Please be aware, the majority of adverse reactions received for Flucelvax, Flublok and Supemtek relate to local and systemic reactogenicity. As per the VAPs you will note during this time period we have not received any reports associated with Toxic Epidermal Necrolysis (TEN) or Stevens-Johnson Syndrome (SJS) with any of these vaccines.

Please note, as it is possible for one report to contain multiple ADRs, the number of ADRs is greater than the number of individual reports. It is also important to note that the information provided within this response will only include reports where the reporter has specifically stated the particular brands of interest. We do routinely follow up to ask for brand information where its hasn’t been originally provided but do not always receive this information, please bare this in mind when interpreting this data.

When considering the attached spontaneous 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 medicine, 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.

The MHRA continuously monitors the safety of vaccines through a variety of pharmacovigilance processes including the Yellow Card scheme. As part of our signal detection processes all adverse reaction reports received by the Yellow Card Scheme are individually assessed and cumulative information reviewed at regular intervals. Vaccines encompass a wide variety of products with different indications, different ingredients, and different mechanisms of action and as such safety for each vaccine is considered individually rather than as a group. If appropriate, regulatory action would be taken if any serious risks were confirmed.

As the data does not necessarily refer to proven side effects, you should refer to the product information which can be found here: https://www.medicines.org.uk/emc/ for details on the possible side effects of each vaccine.

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