HPV Vaccine

Summary

The request sought annual HPV vaccination statistics, consent procedures, and adverse reaction reporting data for the Isle of Man since 2008. The Department of Health and Social Care disclosed vaccination uptake rates from 2010 to 2016, clarified that Patient Information Leaflets are provided at the time of vaccination rather than beforehand, and explained that adverse reaction data is aggregated by the UK's MHRA and not returned to the local department.

Key Facts

• HPV vaccination was introduced into the routine schedule in 2010 using Cervarix, with Gardasil used from 2011 onwards.
• Patient Information Leaflets (PILs) are supplied with the vaccination, not prior to giving informed consent.
• Adverse effects are recorded via the MHRA Yellow Card scheme, but specific Isle of Man reports are not fed back to the local DHSC.
• Vaccination uptake rates for eligible girls ranged between 84.2% and 92.3% from 2010 to 2016.
• No vaccination data was provided for 2008 or 2009 as the program had not yet started.

Data Disclosed

• 2010
• 2011
• 2012
• 2013
• 2014
• 2015
• 2016
• 465
• 532
• 445
• 402
• 458
• 414
• 430
• 395
• 491
• 403
• 360
• 416
• 376
• 362
• 84.9%
• 92.3%
• 90.6%
• 89.6%
• 90.8%
• 84.2%

Original Request

1) Since 2008 and broken down by year, how many girls on Island have been HPV vaccinated by the use of either: a) Gardasil or b) Cervarix. 1b) What is the annual percentage of applicable girls who received HPV vaccination by year, since 2008? 2) Have all parents / guardians / potential vaccinated girls been supplied with a FULL copy of the HPV PIL (Patient Information Leaflet) listing expected adverse effects prior to giving ‘informed’ consent for HPV vaccination? 3) What is the DHSC process for recording adverse effects due to HPV vaccination?  4) How many adverse reactions in each year since 2008, have been recorded as notified by: a) a patient, b) a parent / guardian, c) school staff, d) health worker? Many thanks, Courtenay Heading

Data Tables (1)

Full Response Text

Department of Health and Social Care

Rheynn Slaynt as Kiarail y Theay

Page 1 of 3 FOIA/DHSC/rvsd/01

Chief Executive: Malcolm Couch Freedom of Information Team Department of Health & Social Care Chief Executive’s Office Crookall House Demesne Road Douglas Isle of Man, IM1 3QA Tel: Email: Website: Date: FOI Reference: (01624) 642621 foi.dhsc@gov.im www.gov.im/dhsc 29th January 2018 IM117-230i

Dear
REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2015 (“the Act”) Thank you for your request to the Department of Health and Social Care, dated 16th January 2018. Your request You asked for: Freedom of Information Request Regarding HPV Vaccination Harms 18th January 2018 Question 1 Since 2008 and broken down by year, how many girls on Island have been HPV vaccinated by the use of either: a) Gardasil or b) Cervarix. 1b) What is the annual percentage of applicable girls who received HPV vaccination by year, since 2008? Question 2 Have all parents / guardians / potential vaccinated girls been supplied with a FULL copy of the HPV PIL (Patient Information Leaflet) listing expected adverse effects prior to giving ‘informed’ consent for HPV vaccination? Question 3 What is the DHSC process for recording adverse effects due to HPV vaccination?
Question 4
How many adverse reactions in each year since 2008, have been recorded as notified by: a) a patient, b) a parent / guardian, c) school staff, d) health worker?

Response to your request We are pleased to be able to provide a response to your request with answers to your questions: Question 01: Since 2008 and broken down by year, how many girls on Island have been HPV vaccinated by the use of either: a) Gardasil or b) Cervarix. 1b) What is the annual percentage of applicable girls who received HPV vaccination by year, since 2008?

Page 2 of 3 FOIA/DHSC/rvsd/01 Please find the Department’s response to Question 01: Isle of Man HPV vaccination introduced into the routine vaccination schedule in 2010 with Cervarix vaccine, Gardasil vaccine has been used since 2011.

Question 02: Have all parents / guardians / potential vaccinated girls been supplied with a FULL copy of the HPV PIL (Patient Information Leaflet) listing expected adverse effects prior to giving ‘informed’ consent for HPV vaccination? Please find the Department’s response to Question 02: No, PILs are given with vaccination. Question 03: What is the DHSC process for recording adverse effects due to HPV vaccination?
Please find the Department’s response to Question 03: DHSC process is to participate in the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card scheme (details available here: https://yellowcard.mhra.gov.uk/). Question 04: How many adverse reactions in each year since 2008, have been recorded as notified by: a) a patient, b) a parent / guardian, c) school staff, d) health worker? Please find the Department’s response to Question 04: Anyone concerned that an adverse reaction may have occurred can report this online to the Yellow Card Scheme.
Reports from the Isle of Man are not fed back by MHRA to DHSC but are included in the aggregate statistics and analyses prepared by MHRA.

School Year 2010 2011 2012 2013 2014 2015 2016 Eligible Cohort 465 532 445 402 458 414 430 HPV Received 395 491 403 360 416 376 362 % HPV Received 84.9% 92.3% 90.6% 89.6% 90.8% 90.8% 84.2%

Page 3 of 3 FOIA/DHSC/rvsd/01 Your right to request a review

If you are unhappy with this response to your freedom of information request, you may ask us to carry out an internal review of the response, by completing a complaint form and submitting it electronically or by delivery/post to me at DHSC Freedom of Information Team, Department of Health and Social Care, Chief Executive’s Office, Crookall House, Demesne Road, Douglas, Isle of Man, IM1 3QA; Email: Foi.DHSC@gov.im. An electronic version of our complaint form can be found at www.gov.im/foireview.. If you would like a paper version of our complaint form to be sent to you by post, please contact me and I will be happy to arrange for this. Your review request should explain why you are dissatisfied with this response, and should be made as soon as practicable. We will respond as soon as the review has been concluded.

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Yours sincerely

Freedom of Information Team Department of Health and Social Care