Clinical trials and assessment relating to the introduction of the Hep B vaccine to the UK infant immunisation schedule

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Dear The Joint Committee on Vaccination and Immunisation,

The Hepatitis B vaccine was added to the standard UK infant immunisation schedule from 2017 in the form of the 6-in-1 vaccine. Could you please provide documentation relating to the decision to add this vaccine, as follows:

- Clinical trials conducted to assess the short and long term safety of administering the Hepatitis B vaccine to infants under 16 weeks old
- The rationale and assessment of this decision including all minutes of relevant meetings

Could you also please provide statistics on the adverse effects documented since the introduction of this vaccine to the UK infant immunisation schedule?

Yours faithfully,

Ms Neethling

FOI, The Joint Committee on Vaccination and Immunisation

Dear Ms Neethling,

We acknowledge receipt of your email and request for information, which will be treated as a request for information under statutory access legislation.

Please note that requests under the Freedom of Information Act and the Environmental Information Regulations (EIRs) will receive a response within 20 working days from the day following the date of receipt of your request.

If the request is for your personal data (i.e. a Subject Access Request) under the Data Protection Act, then we will respond  within one month of the receipt of the request.
Public Accountability Unit
Public Health England
[email address]
Tel: 020 8327 6920 
www.gov.uk/phe   Follow us on Twitter @PHE uk

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FOI, The Joint Committee on Vaccination and Immunisation

1 Attachment

Dear Ms Neethling,

Please find attached Public Health England's response to your request.

Kind regards,

FOI Team

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