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Safety assessments and clinical trials of Hepatitis B vaccine for infants

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Dear Medicines and Healthcare products Regulatory Agency,

The Hepatitis B vaccine was added to the UK standard 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 behind this decision - this may include minutes of meetings, for example with the Joint Committee on Vaccination and Immunisation (JCVI)

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

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Dear Enquirer,
 
Thank you for your enquiry to the Medicines and Healthcare products
Regulatory Agency. This automated response confirms that we have received
your email and that it will be dealt with as quickly as possible.
 
You can expect a reply from us within a few days for a straightforward
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of 18 working days; or 20 working days if your request is a Freedom of
Information request; one month if you are making a request for access to
your personal data under the General Data Protection Regulation 2018.
 
Our website contains a wealth of information which may assist with your
enquiry. Some of our popular pages are:
 
Clinical trials of medicines and Clinical investigation for a medical
device:

[1]https://www.gov.uk/medicines-medical-dev...
       
Manufacturer’s and wholesale dealer’s licences:

[2]https://www.gov.uk/apply-for-manufacture...
 
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[3]https://www.gov.uk/register-as-a-manufac...
 
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Kind regards
 
The Customer Services Team
Communications division
 
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone: 020 3080 6000
Email: [8][MHRA request email]
Stay connected: [9]mhra.gov.uk/stayconnected
 
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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Our Ref: FOI 19/322

Dear Ms Neethling,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 17 July 2019.

I confirm that your request is now being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.

If you need to contact us again about this request, please quote the reference number above.

Kind Regards,

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone: 020 3080 6000
Email: [MHRA request email]
Stay connected: mhra.gov.uk/stayconnected

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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

6 Attachments

FOI 19/322

Dear Ms Neethling,

Thank you for your email.

Please find attached the response and attachments to your FOI request.

Kind Regards

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone: 020 3080 6000
Email: [MHRA request email]
Stay connected

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Dear MHRA Customer Services,

Thank you very much for this comprehensive information. Much appreciated.

There is some information missing - clinical trials and safety assessments on the long term impacts of administering Hepatitis B vaccine to infants under 16 weeks. The studies cited in the scientific discussion only looked at reactions up to a few days following vaccination. I don't believe this is adequate, especially given the extremely miniscule chance of an infant contracting Hepatitis B in the UK.

Additionally, the only rationale for introducing this vaccine to the UK schedule is because the WHO suggested it? Given the extremely miniscule risk of a not-at-risk infant contracting Hepatitis B in this country, you would hope that the impact of adding more vaccines to the schedule would be considered at greater length, especially given the complete lack of understanding of the long term impacts of these vaccines on infants. Could you please comment on this?

Could you also please confirm who conducted the clinical trials? The manufacturer themselves, or an independent third party?

Yours sincerely,

Ms Neethling

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Dear Enquirer,
 
Thank you for your enquiry to the Medicines and Healthcare products
Regulatory Agency. This automated response confirms that we have received
your email and that it will be dealt with as quickly as possible.
 
You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer.  We endeavour to
respond to requests within the Department of Health’s target response time
of 18 working days; or 20 working days if your request is a Freedom of
Information request; one month if you are making a request for access to
your personal data under the General Data Protection Regulation 2018.
 
Our website contains a wealth of information which may assist with your
enquiry. Some of our popular pages are:
 
Clinical trials of medicines and Clinical investigation for a medical
device:

[1]https://www.gov.uk/medicines-medical-dev...
       
Manufacturer’s and wholesale dealer’s licences:

[2]https://www.gov.uk/apply-for-manufacture...
 
Registration of medical devices, opticians and dental laboratories:

[3]https://www.gov.uk/register-as-a-manufac...
 
Reporting a problem with a medicine or medical device:

[4]https://www.gov.uk/report-problem-medici...
 
Deciding if your product is a medicine or a medical device:

[5]https://www.gov.uk/decide-if-your-produc...
 
Reporting a counterfeit medical product:
 
[6]https://yellowcard.mhra.gov.uk/counterfe...
 
We are continuously looking to make improvements to the service offered by
our Customer Services team, so if you have any feedback please don’t
hesitate to get in touch with us either on the number below or by
completing the form at the link below:
[7]https://www.surveymonkey.com/s/MHRACusto...
 
If you have not heard from us after 18 working days then please contact us
on 020 3080 6000.
 
Kind regards
 
The Customer Services Team
Communications division
 
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone: 020 3080 6000
Email: [8][MHRA request email]
Stay connected: [9]mhra.gov.uk/stayconnected
 
All emails are retained by the Agency in a secure area together with the
Agency’s response, for eight years in accordance with our Retention and
Disposal Schedule. Our privacy notice can be found [10]here.
 
Please note this is an automated reply; please do not respond to this
message.
 
 

show quoted sections

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Our Ref: FOI 19/388
       
Dear Ms Neethling,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
        
Thank you for your enquiry below which we received on 13 August 2019.
       
I confirm that your request is now being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt. 

If you need to contact us again about this request, please quote the reference number above.
        
Kind Regards,

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone: 020 3080 6000
Email: [MHRA request email]
Stay connected: mhra.gov.uk/stayconnected

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FOILicensing, Medicines and Healthcare products Regulatory Agency

Dear Ms Neethling

Many thanks for your information request dated 13th August 2019 where you
asked for further information regarding the administration of Hepatitis B
vaccine to infants under 16 weeks, in particular the rationale for its
introduction, clinical trials and safety assessments on the long-term
impacts of its use, and who carried out the clinical trials. We are
pleased to be able to provide you with the following information.

 

The clinical trials that supported the initial licensure of Infanrix Hexa
was undertaken by the manufacturer, GlaxoSmithKline. Beyond the duration
of follow-up in the clinical trials, long-term safety has been evaluated
through global post-marketing surveillance, undertaken by public health
authorities as well as the manufacturer, over a period of 20 years. Since
its first authorisation in 2000, Infanrix Hexa has been authorised for use
in more than 80 countries, with more than 40 million children vaccinated
worldwide. The possible side effects of Infanrix Hexa as established in
the clinical trials and identified from evidence collected during this
period of post-marketing surveillance are described in the product
information, which can be viewed on-line at
[1]https://www.medicines.org.uk/emc/product....

 

With regard to the rationale for the introduction of Infanrix Hexa into
the immunisation schedule, this decision was taken by Public Health
England (PHE), with advice from the JCVI, based on the burden of hepatitis
B in the UK and cost-effectiveness of the vaccine. Our previous response
included a reference to the JCVI minutes. As immunisation policy is not
within the remit of MHRA, we recommend that you contact PHE for any
further clarification of the immunisation policy. Please see the link
below.

[2]https://www.gov.uk/guidance/contacts-phe...

 

If you have a query regarding this FOI, please reply to this email.

Kind regards

FOI Licensing

 

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We don't know whether the most recent response to this request contains information or not – if you are Ms Neethling please sign in and let everyone know.