Freedom of Information request on the Hepatitis B vaccine (FOI 21/909)
Published 17 January 2022
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15th September 2021
FOI 21/909
Dear
Thank you for your FOI request dated 11 August 2021, where you requested the following information:
Related to the Hepatitis B vaccines Engerix-B and HBVaxPro/HBVaxDNA/HBVax-II/Recombivax or any other band name used by Merck for its monovalent Hepatitis B vaccine, for the time period 01/01/1986 to 01/01/2000:
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all minutes of pharmacovigilance committees;
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reports of pharmacovigilance investigations (expert panel reviews and any other relevant document including associated PSUR assessment reports) and any other relevant document related to safety updates for those products
Apologies for the delay in replying to you. Of the hepatitis B vaccines you mention, only Engerix B (manufactured by GlaxoSmithKline) and HBVaxPro (MSD) are authorised in the UK. The other products you mention are names of hepatitis B vaccines authorised in other countries and so we would not hold any information in relation to these products. However, we consider that retrieving the information that you have requested will take longer than 24 working hours to complete, as it involves searching multiple information sources over a period of 14 years. As such your request falls under Section 12 of the FOI Act, which specifies that a public authority may refuse requests where the cost of dealing with them would exceed the appropriate limit, which for central government is set at £600. This represents the estimated cost of one person spending 24 working hours in determining whether the department holds the information, locating, retrieving and extracting the information.
If, however, the request can be restricted, we will be happy to reconsider your FOI request.
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.
Kind regards,
FOI Team
Vigilance and Risk Management of Medicines Division
Medicines and Healthcare Products Regulatory Agency