Swine flu vaccines

Report a suspected side effect with a flu vaccine (Pandemrix made by GSK or Celvapan made by Baxter)
(opens in a new window)

 

What's new

10 December 2009: Department of Health advises a change in Pandemrix dosage for healthy children aged over six months Pandemrix patient information leaflet updated The Joint Committee on Vaccination and Immunisation (JCVI) (external link) has reviewed data on the immune responses to Pandemrix in children aged over six months, as well as reactogenicity data and Health Protection Agency (HPA) (external link) studies. They have advised that healthy children aged over six months should have just one dose of Pandemrix (half an adult dose) unless the child is immunosuppressed or has an immune deficiency (as specified in the Green Book [external link]). Children over six months who are being vaccinated because they are in the priority groups for phase one, should also have one dose unless they have a similar immune condition. We expect the licence for Pandemrix to change shortly to permit one or two doses according to national advice. For further information please see: European Medicines Agency website (external link) Department of Health (H1N1) swine flu influenza: phase two of the vaccination programme; children over 6 months and under 5 years (external link) 4 December 2009: European Medicines Agency (EMEA) advises of risk of fever in young children following vaccination with Pandemrix The EMEA has warned that young children may experience fever after their second dose of the pandemic influenza vaccine Pandemrix. Health professionals and parents should monitor the temperature of children following vaccination and, if necessary, take measures to lower the fever. We will publish updated prescribing information shortly. European Medicines Agency advises of risk of fever in young children following vaccination with Pandemrix (external link)  Q&A on the risk of fever with Pandemrix in young children (external link)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The H1N1 swine flu vaccination programme was announced for the UK on 15 October 2009. Pandemrix, made by GlaxoSmithKline, and Celvapan, made by Baxter, will be used over the coming weeks and months to vaccinate people in the UK against H1N1 swine flu.

Information about the vaccination programme can be found on the Department of Health’s website:

Vaccination programme - Department of Health (external link)

The Department of Health has identified priority groups who will be first in line for vaccination against swine flu. These groups will include pregnant women, frontline health and social care workers, and everyone in at risk groups aged over six months. The specific clinical priority groups for vaccination against swine flu have been identified as:

1. individuals aged over six months and under 65 years in the current seasonal flu vaccine clinical at risk groups
2. all pregnant women
3. household contacts of immunocompromised individuals
4. people aged 65 and over in the current seasonal flu vaccine clinical at-risk groups.

Product information (patient information leaflets and Summaries of Product Characteristics)
The product information (patient information leaflets [PILs] and Summaries of Product Characteristics [SPCs]) for both Celvapan (Baxter) and Pandemrix (GSK) can be found on the European Medicines Agency website (external link).

Preparation of Pandemrix vaccine (GSK) - added 5 November 2009
Further to feedback received on the mixing of the two Pandemrix vials, we would like to clarify that it is important that the entire contents of the vial of adjuvant emulsion are added to the vial of antigen suspension. The Department of Health training video and the UK Health Departments' publication 'Immunisation against infectious disease' (The Green Book)(external link) advise to:

"...Check both vials for any foreign particles. Shake both vials. Then draw up all of the adjuvant emulsion into the syringe. Inject this into the vial containing the antigen suspension".

This point will be clarified as part of the continuing review and variations of the Pandemrix Summary of Product Characteristics (SPC) and patient information leaflet (PIL).

Provision of patient information leaflets (PILs)
Because new data from clinical trials are constantly emerging, the dosing instructions and other aspects of the prescribing information is subject to change in the coming months. For this reason, printed PILs may quickly be out-of-date and may cause confusion. For the first few vaccine batches, we have asked both companies not to provide the printed PILs as these are now out-of-date. As an interim measure, we are advising patients and healthcare professionals to download PILs from this section of the MHRA website. The Department of Health is also actively communicating the recommended dosage instructions as advised by the Joint Committee on Vaccination and Immunisation (JCVI) (external link).

We are currently in the process of agreeing the best mechanism for the companies to print and provide hard copies of the most up-to-date PILs with future vaccine batches.

Vaccine safety and monitoring suspected side effects
Pandemrix and Celvapan have been licensed for use throughout Europe following a thorough review of their manufacturing quality, the immunity they induce and their safety. This was based on information from clinical trials of prototype H5N1 (‘bird flu’) strain vaccines which have been studied over several years, as well as trials using the current H1N1 swine flu strain.

As with any vaccine, the swine flu vaccines will cause side effects in some people, although not everybody will have a side effect. The most common side effects will be injection site reactions (pain, swelling, and/or redness), headaches, dizziness, muscle aches, mild fever and fatigue. These side effects are mainly mild and last only two to three days. Some of these symptoms may be similar to a mild flu-like illness, although it should be stressed that the vaccines cannot cause swine flu itself.

Because clinical trials are relatively limited in size, very rare side effects might not be identified until the vaccines have been used on a wide scale in large numbers of people. The swine flu vaccines are not unique in this regard and this applies to any new medicine or vaccine. This is why the MHRA has in place robust systems for post-licensing safety monitoring.

The Yellow Card Scheme underpins safety monitoring in the UK. Through this Scheme, healthcare professionals and members of the public voluntarily submit reports of suspected side effects to the MHRA. Drug companies also submit such reports as part of their legal requirements. Safety scientists at theMHRA carefully evaluate 'signals' of suspected safety issues; it is important to point out that just because a Yellow Card has been sent it does not necessarily mean that the vaccine caused the reaction - it may be coincidental or due to an underlying medical condition.

As well as analysing Yellow Card data, the MHRA will review safety data from all available sources including those from other countries. The MHRA will use advice from independent experts, including that of the Commission on Human Medicines (CHM), in assessing any identified risks. We will also work closely with our European and international counterparts in such evaluation.

Weekly adverse drug reaction (ADR) summaries
The MHRA produces a weekly summary of all suspected side effects reported in the UK for the H1N1 vaccines during the swine flu pandemic. The summary will now be updated fortnightly, on a Thursday, and includes all side effects to Celvapan and Pandemrix reported up to previous report.

Information to help interpret the data on suspected side effects (186Kb)

4 February 2010: Weekly ADR summary (319Kb)
21 January 2010: Weekly ADR summary (315Kb)
14 January 2010: Weekly ADR summary (290Kb)
7 January 2010: Weekly ADR summary (291Kb)
31 December 2009: Weekly ADR summary (706Kb)
23 December 2009: Weekly ADR summary (16554Kb)
17 December: Weekly ADR summary (734Kb)
10 December 2009: Weekly ADR summary (365Kb)
3 December 2009: Weekly ADR summary  (557Kb) 
26 November 2009: Weekly ADR summary (523Kb)
19 November 2009: Weekly ADR summary (557Kb)
12 November 2009: Weekly ADR summary (191Kb)
5 November 2009: Weekly ADR summary (204Kb)

How to report suspected side effects to swine flu medicines
A special online version of the Yellow Card Scheme has been set up to receive reports of suspected adverse reactions to the swine flu vaccines (as well as antiviral medicines): the ‘Swine Flu Adverse Reaction (ADR) Portal’. This is accessed via http://swineflu.mhra.gov.uk or by using the red button at the top of this page, and provides a simple and, most importantlu, a quick way of getting this information into the MHRA’s safety monitoring system. For those without internet access, postal Yellow Card reports can still be submitted.

This Swine Flu ADR Portal allows the MHRA safety scientists to access suspected side effect reports in real-time which will allow us to identify any new risks as soon as they emerge.

If you think that you or somebody you know has experienced a suspected adverse drug reaction to the GSK Pandemrix vaccine or the Baxter Celvapan vaccine, please report it to us using the Swine Flu ADR Portal at:

http://swineflu.mhra.gov.uk/

You can also contact NHS Direct (for England and Northern Ireland), NHS 24 (for Scotland) or NHS Direct Wales (for Wales) for advice about side effects. Contact details are provided below.

• NHS Direct (external link)
  Tel: 0845 4647
• NHS 24 (Scotland) (external link)
  Tel: 08454 242424
• NHS Direct Wales (external link)
  Tel: 0845 4647