European Medicines Agency pandemic influenza preparedness

Warning about the possible sale of fake medicines via Internet


The European Medicines Agency and National Competent Authorities in the Member States warn that criminal groups may take advantage of the current outbreak of the A/H1N1 influenza virus to sell fake, adulterated or unauthorised antiviral medication or vaccines via the Internet.

Members of the public who buy counterfeit or illicit copies of these medicines may be putting their own health, or that of their families, at risk.

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European Medicines Agency updates on A/H1N1 influenza virus

Outbreak of novel influenza virus A/H1N1 ('swine flu')

In April 2009 an outbreak of novel influenza virus A/H1N1 occurred in Mexico. Cases of infection in people have also been reported in the United States, some European Union Member States and other countries. The novel virus contains a new and unique combination of genetic material found in other H1N1 influenza viruses that typically affect humans, pigs and birds.

The European Medicines Agency is liaising with the European Commission, the European Centre for Disease Prevention and Control (ECDC), EU Member State authorities and the World Health Organization on the development of the A/H1N1 swine influenza situation in Europe. This includes facilitating the development and assessment of vaccines that will protect people against the novel virus, as well as improving the availability of effective treatments.

See EMEA pandemic influenza preparedness for information on the Agency’s role in such situations.

Update on 31 July 2009

European Medicines Agency recommends updating the product information for Tamiflu

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted recommendations to update the product information for Tamiflu with more information on the medicine’s use in children over 6 months of age and in pregnant and breastfeeding women.

  • For children aged from 6-12 months, the CHMP has concluded that during an influenza pandemic the benefits of the use of Tamiflu outweigh the risks and recommended the extension of the currently approved indication to include this population. The recommended dose to treat this age group is 3 mg per kg body weight twice daily for 5 days.
  • For pregnant and breastfeeding women, the CHMP recommended the use of Tamiflu for treatment and post-exposure prophylaxis.

The CHMP’s recommendations have been forwarded to the European Commission for the adoption of a decision. The updated product information in all EU languages for Tamiflu will be published shortly.

For more information on the recommended changes to the product information in English please see here.

More information about Tamiflu is available in the European Public Assessment Report for Tamiflu: http://www.ema.europa.eu/humandocs/Humans/EPAR/tamiflu/tamiflu.htm

For information on the CHMP’s guidance on the use of Tamiflu (oseltamivir) in children under 6 months of age and the use of Relenza (zanamivir) in pregnant and breastfeeding women in the case of a declared influenza A/H1N1 pandemic, please see:

Press release
Q&A
Opinion & Assessment report

 

Update on 28 July 2009

Relenza to be distributed with Rotacap/Rotahaler inhalation device during influenza pandemic

Member States of the European Union have assessed an application from the marketing authorisation holder to temporarily distribute Relenza (zanamivir) with a Rotacap/Rotahaler inhalation device instead of the authorised diskhaler. The distribution of an additional device is intended as a temporary measure during the H1N1 pandemic, because production capacity of Relenza with the approved diskhaler cannot meet the current increased demand for the medicine.

Relenza is an antiviral medicine belonging to a class of medicines called 'neuraminidase inhibitors', which also includes Tamiflu (oseltamivir), to which the A/H1N1 influenza virus ('swine flu') currently spreading around the world has shown susceptibility.

The temporary distribution of an additional device for the use of Relenza was proposed by the marketing authorisation holder to the Medical Products Agency (MPA) of Sweden, which is the reference Member State for Relenza. Following a review of the provided documentation, the MPA is recommending temporary distribution of Relenza with Rotacap/Rotahaler.

The CMD(h) has coordinated the procedure with help from the reference Member State, but it is up to the National Competent Authorities to decide whether the national distribution and use of the Relenza Rotacap/Rotahaler can be temporarily authorised during the pandemic taking into account the assessment report and recommendation by the reference Member State.

Relenza is currently authorised in all European Economic Area countries (the 27 European Union countries, plus Iceland, Liechtenstein and Norway) to treat or prevent influenza in adults and children from the age of five years onwards.

See the CMD(h) meeting report for more information

Update on 24 July 2009

Press release European Medicines Agency review of pandemic vaccines underway

The European Medicines Agency has started to receive data on H1N1 pandemic vaccines and the review began in July, with the commitment from the Committee for Medicinal Products for Human Use, to fast-track the review of data as vaccine manufacturers make them available.

Given the public health threat posed by the current pandemic, the Agency’s goal is to ensure data submitted to support marketing authorisations for vaccines are reviewed as early as possible, before the beginning of the Northern hemisphere flu season, expected in September. At present the Committee (or CHMP) is reviewing data relating to manufacture of vaccines. Additional clinical trials in adults and children are currently being initiated by the vaccine manufacturers and the results will be reviewed in the coming months as they become available.

For further information, see:
- Full press release
- Questions and answers

Update on 8 July 2009

Revised recommendations for pharmacovigilance plans for pandemic-influenza vaccines

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted revised recommendations for pharmacovigilance plans included in risk-management plans submitted as part of marketing-authorisation applications for pandemic-influenza vaccines.

The recommendations have been updated following the recent outbreak of the novel H1N1 influenza virus. They were adopted by the CHMP following discussions between the Pharmacovigilance Working Party, the Vaccine Working Party, the European Vaccine Manufacturers association and individual vaccine manufacturers.

The revised document is available here: CHMP recommendations for the Pharmacovigilance Plan as part of the Risk Management Plan to be submitted with the Marketing Authorisation Application for a Pandemic Influenza Vaccine (EMEA/359381/2009)

Update on 6 July 2009

Standard paediatric investigation plan adopted for pandemic-influenza vaccines

The European Medicines Agency (EMEA) and its Paediatric Committee (PDCO) have adopted guidance on a standard set of data that applicants should include in their application for a paediatric investigation plan (PIP) for a pandemic influenza vaccine, when submitted during an emergency situation (World Health Organization phase 5 or 6).

Manufacturers and marketing-authorisation holders are encouraged to anticipate and submit a request for a PIP and a waiver, or a request for modification of an existing, agreed PIP as early as possible.

See further details in the guidance document: EMEA/PDCO standard paediatric investigation plan for non-adjuvanted or adjuvanted pandemic influenza vaccines during a pandemic

Update on 12 June 2009

EMEA in ongoing discussions with vaccine manufacturers

The European Medicines Agency (EMEA) is in continuous dialogue with vaccine manufacturers and European and international regulators to discuss scientific and regulatory issues relating to the development and approval of vaccines. These include necessary requirements for clinical and non-clinical data to support the authorisation of influenza A/H1N1 vaccines, as well as strain recommendations for use in vaccine manufacture.

See further details in the press release: WHO declares influenza pandemic – European Medicines Agency initiates crisis-management plan

Update on 11 June 2009, at 18.15 UK time

WHO declares A/H1N1 influenza pandemic

The World Health Organization (WHO) has raised its pandemic alert level for the A/H1N1 influenza virus to phase 6.

The European Medicines Agency (EMEA) has a Pandemic influenza crisis-management plan in place, and has been working towards the implementation of this plan since the outbreak of the virus in April 2009.

The Agency continues to work with its European Union and international partners on a series of initiatives to facilitate the availability of anti-virals and vaccines for use in an influenza pandemic situation.

Update on 11 June 2009

Revised EU recommendation for composition of influenza vaccine

The European Medicines Agency has revised the EU recommendation for the composition of A/H1N1 influenza vaccine to add a further strain to the list of recommended production strains.

For full details, see:
EU recommendation for the emergent novel H1N1 influenza vaccine composition (EMEA/CHMP/BWP/340831/2009 Rev. 1)

Update on 5 June 2009

EU recommendation for composition of influenza vaccine established

The European Medicines Agency, acting through its Biologics Working Party's Influenza Working Group, has endorsed the recommendation established by the World Health Organization (WHO) for the composition of the vaccines to be prepared for use in humans against the novel influenza A (H1N1) virus.

For full details, see:
EU recommendation for the emergent novel H1N1 influenza vaccine composition (EMEA/CHMP/BWP/340831/2009)

Update on 3 June 2009

Extension of shelf-life for Relenza

The Member States of the European Union have approved the extension of the shelf-life of Relenza (zanamivir), oral inhalation powder, from five years to seven years. This decision is based on experimental data that show Relenza can safely be used for an additional two years.

The extension was proposed by the marketing authorisation holder to the Medical Products Agency (MPA) of Sweden, which is the reference Member State for Relenza, and agreed by other Member States via the mutual recognition procedure.

The Coordination Group for Mutual Recognition and Decentralised Procedures – Human, CMD(h), recommends that Relenza that is already on the market or in people's homes may — in the event of an influenza pandemic being officially declared by the World Health Organisation (WHO) — be used for up to two years after its current expiry date. Patients who have Relenza that has recently expired should not throw it away, as it might be needed during a declared influenza pandemic.

Relenza is an antiviral medicine belonging to a class of medicines called 'neuraminidase inhibitors', which also includes Tamiflu (oseltamivir), to which the A/H1N1 influenza virus ('swine flu') currently spreading around the world has shown susceptibility.

Relenza is currently authorised in all European Economic Area countries (the 27 European Union countries, plus Iceland, Liechtenstein and Norway) to treat or prevent influenza in adults and children from the age of five years onwards

See the CMD(h) meeting report announcing the approval of the extension of shelf-life of Relenza.

See also the EMEA's Questions and answers on the use of antiviral medicines in case of novel influenza A/H1N1 pandemic, which includes information on the use of Relenza by pregnant and breastfeeding women.

Update on 29 May 2009

Follow-up recommendations on use of antiviral medicines in the event of an influenza A/H1N1 pandemic

The Committee has adopted a set of follow-up recommendations to its guidance on the use of Tamiflu (oseltamivir) in children under one year of age and the use of Tamiflu and Relenza (zanamivir) in pregnant and breastfeeding women in the case of a declared influenza A/H1N1.

The detailed follow-up recommendations are available here.

Update on 8 May 2009

Guidance on use of antiviral medicines in the event of an influenza A/H1N1 pandemic

The European Medicines Agency has given guidance on the use of Tamiflu (oseltamivir) in children under one year of age and the use of Tamiflu and Relenza (zanamivir) in pregnant and breastfeeding women in the case of a declared influenza A/H1N1 pandemic.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that during an officially declared influenza A/H1N1 pandemic the benefits of the use of Tamiflu in children under one year old outweigh its risks. If the medicine is prescribed to these children, the recommended dosage is 2 to 3 mg per kilogram body weight.

For pregnant and breastfeeding women, the CHMP concluded that both Tamiflu and Relenza could be used during an Influenza A/H1N1 pandemic.

For more information see:
Press release
Q&A
Opinion & Assessment report

Recommendations on extension of shelf life for Tamiflu

The European Medicines Agency has recommended that the shelf life of Tamiflu capsules should be extended from five to seven years. Once formally approved by the European Commission, this will apply to all newly manufactured Tamiflu capsules.

In view of the recent outbreak of the novel influenza A/H1N1 virus, the Agency has also reviewed ways to use Tamiflu capsules in case of a shortage. The Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended that Tamiflu capsules that are already on the market may be used for up to two more years after their current expiry date during a declared pandemic. Patients who have Tamiflu capsules that have recently expired should not throw them away because they might be needed during a novel influenza A/H1N1 pandemic.

For more information see:
Press release
Q&A
Opinion & Assessment report

Update on 30 April 2009, at 19.30 UK time

European Medicines Agency prepares for approval of pandemic vaccines

The European Medicines Agency, together with its partners in the EU Member States, the European Commission, the European Centre for Disease Prevention and Control (ECDC), the World Health Organization (WHO) and the European Directorate for the Quality of medicines and healthcare (EDQM) met today with vaccine manufacturers. The purpose of the meeting was to share information on the novel influenza virus and discuss regulatory and scientific issues concerning the development and eventual approval of vaccines for use in a pandemic situation.

A press release with more information is available here.

Update on 30 April 2009, at 08.30 UK time

WHO pandemic alert now at phase 5

The World Health Organization (WHO) today increased the pandemic alert level from phase 4 to phase 5, in response to the ongoing development of the novel virus outbreak. There are six alert levels, with level 6 representing a pandemic situation.

According to the WHO, the current phase 5 "is characterized by human-to-human spread of the virus into at least two countries in one WHO region. While most countries will not be affected at this stage, the declaration of Phase 5 is a strong signal that a pandemic is imminent and that the time to finalize the organization, communication, and implementation of the planned mitigation measures is short."

See the World Health Organization website for further details on pandemic alert phases

Update on 29 April 2009

WHO alert level

Although an influenza pandemic has not been declared, the World Health Organization (WHO) increased the pandemic alert from level 3 to level 4 on 27 April 2009 in response to this outbreak. There are six alert levels, with level 6 representing a pandemic situation.

For more information on the WHO pandemic alert levels, see the World Health Organization’s website here.

Meeting with vaccine manufacturers

No vaccines are currently available for this novel virus. However, the Agency is liaising with vaccine manufacturers on the production of vaccines using already approved mock-up vaccines, and is hosting a meeting with vaccine manufacturers and influenza experts from across the EU on 30 April 2009.

Antiviral medicines

Among the antiviral medicines that are authorised in the EU for use in an influenza outbreak, the neuraminidase inhibitors Tamiflu (oseltamivir) and Relenza (zanamivir) have shown effectiveness against the novel virus.

  • Tamiflu is a centrally authorised medicine (i.e. authorised for use in all countries of the European Union, as well as in Iceland, Liechtenstein and Norway) for the treatment and prevention of influenza. The European public assessment report for Tamiflu can be found here.
  • Relenza (zanamivir) is authorised in all 27 EU Member States for the treatment of influenza. The reference Member State for Relenza is Sweden. Further information on Relenza is available in the summary of product characteristics and the patient information leaflet.

The M2 inhibitors amantadine and rimantadine do not appear to be effective against the novel virus strain.