Swine flu information

 

This section provides an overview of the Agency’s preparations and contingency plans for swine flu and a pandemic situation.  You can find information on the antiviral medicines, Tamiflu and Relenza, and the swine flu vaccines, Pandemrix and Celvapan (including how to report suspected side effects), and contact details within the Agency for swine flu enquiries. We will be publishing a summary of changes to legislation and accompanying guidance.

On 11 June 2009, the World Health Organization (WHO) raised its alert to level 6, recognising that A(H1N1) swine flu has spread to pandemic levels around the globe. The vast majority of cases of swine flu in the UK have been mild with a number of more severe cases. The virus continues to spread within the UK.

The Agency has been working for some time on plans for working arrangements in the event of a flu pandemic.  The recent developments have brought these plans to a head and we are now putting certain measures in place to deal with the situation.

• We aim to continue to provide as full a service as possible throughout a flu pandemic.
• Our key priority is to ensure that people in the UK continue to get the medicines and medical devices they need during the pandemic period. We will monitor the safety of flu medicines and vaccines.
• We will maintain communication with our stakeholders and staff throughout the period.
• We are providing specific guidance and support to our staff.

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What's new

5 March 2010: Suspected adverse drug reaction (ADR) analysis: swine flu vaccines - H1N1 (Celvapan and Pandemrix) (300Kb)
The latest summary of all the suspected side effects to date which have been reported during the pandemic to the H1N1 vaccines, Celvapan and Pandemrix, has been added to the Swine flu vaccines section.

4 February 2010: Suspected adverse drug reaction (ADR) analysis: influenza antivirals - Tamiflu (oseltamivir) and Relenza (zanamivir) (240Kb)
The latest summary of all the suspected side effects to date which have been reported during the pandemic to Tamiflu and Relenza has been added to the Anitviral medicines section.

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:

The updated Pandemrix patient information leaflet (33Kb)

Department of Health: A (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) 

5 November: Preparation of Pandemrix vaccine (GSK)
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 (SmPC) and patient information leaflet (PIL).

23 October 2009: Tamiflu (oseltamivir) patient information leaflets have been amended
We have amended the UK versions of the patient information leaflet (PIL) to remove advice on using aspirin. The PIL differs slightly from the official PILs provided in packs of Tamiflu. The important advice is that children aged under 16 years should not be given aspirin. For those aged 16 and over, patients receiving Tamiflu may also take aspirin, especially if advised to do so by their healthcare professional.

22 October 2009: New swine flu vaccines section launched
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. Further information about these vaccines, including their safety and how to report suspected side effects, as well as product information, is available in our new section on swine flu vaccines.

20 October 2009: Patient information leaflets (PILs) for Pandemrix (GSK) and Celvapan (Baxter)
PILs for Pandemrix (GSK) and Celvapan (Baxter) have been added to the swine flu vaccination programme announcement above.

12 October 2009: MHRA statement on the supply and administration of repackaged H1N1v pandemic influenza vaccines under Patient Group Directions
For the purposes of Patient Group Directions, the supply and administration of vaccines in smaller packs produced by the repackaging of the authorised (licensed) H1N1v pandemic influenza vaccines Celvapan® (Baxter) and Pandemrix® (GSK) will be deemed, for the duration of the WHO declared pandemic, to be equivalent to vaccines in the original packs as placed on the market by the holders of the marketing authorisations.

This statement of equivalence is made on the condition that the repackaging is carried out by either licensed manufacturing sites under appropriate good manufacturing practice or under professional pharmaceutical supervision.

2 October 2009: European Medicines Agency (EMEA) recommends authorisation of Celvapan for use against pandemic influenza
Following the licensing of Focetria (Novartis) and Pandemrix (GlaxoSmithKline) on 29 September, the EMEA has recommended that a third pandemic-influenza vaccine, Celvapan (Baxter), be authorised by the European Commission for use in protecting EU citizens against 'swine flu'. The UK government already has a purchasing contract in place for Celvapan vaccine. A Commission decision is expected shortly. The details of the EMEA's recommendation can be viewed on its website:
› EMEA press release: European Medicines Agency recommends authorisation of additional vaccine for influenza pandemic (H1N1) 2009 (external link)

2 October 2009: European Commission approves Focetria and Pandemrix for use in the H1N1 influenza pandemic
On 29 September, the European Commission granted licences that will allow the influenza vaccines Focetria (Novartis) and Pandemrix (GlaxoSmithKline) to be used to vaccinate people against the virus causing the current H1N1 influenza pandemic. The Commission's decision follows the scientific recommendations adopted in respect of these vaccines by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on 24 September 2009.
› European Commission press release: Commission paves the way for vaccinations for influenza pandemic (H1N1) 2009 (external link)

25 September 2009: European Medicines Agency recommends authorisation of two vaccines for influenza pandemic (H1N1) 2009
Following the issue of a positive opinion by the Committee for Medicinal Products for Human Use (CHMP), the European Medicines Agency (EMEA) today recommended to the European Commission that marketing authorisations should be granted for two vaccines for protection against influenza A(H1N1) (‘swine flu’) for use within Europe, including the UK. The vaccines concerned are Focetria (Novartis) and Pandemrix (GlaxoSmithKline). The UK government already has a purchasing contract in place for Pandemrix vaccine. Before a full European Union-wide marketing authorisation for the vaccine is given, this recommendation must first be considered by the European Commission, who is expected to make its decision shortly. The details of the EMEA's recommendation can be viewed on their website:
› EMEA press release: European Medicines Agency recommends authorisation of two vaccines for influenza pandemic (H1N1) 2009 (external link)
› EMEA questions and answers on vaccines for the pandemic (H1N1) 2009 (‘swine flu’) (external link)

21 August 2009: Information on suspected side effects to Tamiflu and Relenza
The MHRA produces a weekly summary of all the suspected side effects to date which have been reported during the pandemic to Tamiflu and Relenza. The summary is updated each Thursday and includes all side effects to Tamiflu and Relenza reported up to the end of the previous week.

12 August 2009: Safety information on oseltamivir (Tamiflu) and zanamivir (Relenza) for pandemic swine influenza A/H1N1 (159Kb)
We have published an article in 'Drug Safety Update', our monthly newsletter for healthcare professionals, outlining some of the key facts on the safe use of Tamiflu and Relenza.

9 July 2009: MHRA contacts for swine or pandemic flu enquiries
This section provides details of who to contact in the Agency for swine or pandemic flu enquiries

7 July 2009: Letter to healthcare professionals: Swine flu - Reporting suspected adverse reactions to Tamiflu, Relenza and future Swine flu H1N1 vaccines
We have issued a letter to healthcare professionals about a new online system for reporting suspected adverse drug reactions (ADRs) to Tamiflu, Relenza and future Swine flu H1N1 vaccines.

7 July 2009: Antiviral medicines page launched
This page includes patient information leaflets and Summary of Product Characteristics for Tamiflu and Relenza, as well as how to report suspected side effects.

8 May 2009: MHRA authorises temporary distribution of unlicensed medicine
In accordance with Article 5(2) of Directive 2001/83/EC on the Community Code relating to Medicinal Products for Human Use, in response to the confirmed spread of influenza virus the Secretary of State for Health has temporarily authorised the distribution of unlicensed oseltamivir powder and an unlicensed oral liquid formulation of oseltamivir for administration to infants under 1 year of age in the prevention or treatment of influenza. The Medicines for Human Use (Marketing Authorisations etc) Regulations 1994 and the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 have been amended.

Further information on swine flu

National Pandemic Flu Service
A new self-care service which will give people with pandemic swine flu symptoms fast access to information and antivirals was launched on 23 July 2009:
› National Pandemic Flu Service (external link)

Swine flu information
For health information on swine flu:

• Residents of England, please go to www.nhs.uk  or www.direct.gov.uk/swineflu  or call the swine flu information line on 0800 1513513. 
• Residents of Scotland, please go to www.nhs24.com.
• Residents of Wales, please go to www.nhsdirect.wales.nhs.uk  or www.wales.gov.uk/health.
• Residents of Northern Ireland, please go to www.dhsspsni.gov.uk  or www.publichealth.hscni.net  or call the Northern Ireland Swine Flu Help Line on 0800 0514142.
  

For information on how to prepare your business for swine flu, please go to Business Link (external link).

• • For information specific to Scotland, go to Business Gateway (external link) or Highlands & Islands Enterprise (external link).
  • For information specific to Wales, go to Flexible Support for Business (external link).
  • For information specific to Northern Ireland, go to Invest Northern Ireland (external link).