influenza pandemic (Phase 6 of the WHO Preparedness Plan) (Day 0)

(5) In November 2001 the Commission organised a symposium on the preparedness for influenza pandemics in humans.

In case of a pandemic situation with respect to human diseases other than the human influenza virus, the first paragraph and Article 7 may be applied mutatis mutandis.

In case of a pandemic situation with respect to the human influenza virus, duly recognised by the World Health Organisation or by the Community in the framework of Decision 2119/98/EC of the European Parliament and of the Council(8), the Commission may exceptionally and temporarily consider the variation to the terms of the market authorisation for human influenza vaccines to be accepted after an application has been received and before the end of the procedure laid down in Article 7. Nevertheless, complete clinical safety and efficacy data can be submitted during this procedure.

PSUR submission during the influenza pandemic:

PSUR submission when Prepandrix is used during the influenza pandemic:

PSUR submission when Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is used during the influenza pandemic:

Celvapan can only be marketed when there is an official WHO/ EU declaration of an influenza pandemic, on the condition that the Marketing Authorisation Holder for Celvapan takes due account of the officially declared pandemic strain.

Daronrix can only be marketed when there is an official WHO/ EU declaration of an influenza pandemic, on the condition that the Marketing Authorisation Holder for Daronrix takes due account of the officially declared pandemic strain.

Focetria can only be marketed when there is an official WHO/ EU declaration of an influenza pandemic, on the condition that the Marketing Authorisation Holder for Focetria takes due account of the officially declared pandemic strain.

Pandemrix can only be marketed when there is an official WHO/ EU declaration of an influenza pandemic, on the condition that the Marketing Authorisation Holder for Pandemrix takes due account of the officially declared pandemic strain.

Focetria is a vaccine against a pandemic influenza (flu).

Prophylaxis of influenza in an officially declared pandemic situation.

Pandemic influenza vaccine should be used in accordance with official guidance.

Pandemrix suspension for emulsion for injection Pandemic influenza vaccine (H5N1)

Whole virion influenza vaccine, inactivated containing antigen of pandemic strain*:

Whole virion influenza vaccine, inactivated, containing antigen of pandemic strain*:

36 Focetria does not contain live virus particles and so it cannot cause Pandemic influenza.

It has to be used for the prophylaxis of influenza in an officially declared pandemic situation.

Pandemrix is a vaccine for use in adults aged 18 to 60 years to prevent pandemic influenza (flu).

Whole virion influenza vaccine of pandemic strain, inactivated, containing antigen* equivalent to:

Daronrix, suspension for injection. Pandemic influenza vaccine (whole virion, inactivated, adjuvanted)

A need for this type of meeting may emerge, for example, in the event of a pandemic-influenza outbreak.

Pandemic influenza vaccine should be used in accordance with Official Guidance (see sections 4.2 and 5.1).

Pandemic influenza vaccine should be used in accordance with official guidance (see sections 4.2 and 5.1).

CELVAPAN suspension for injection Pandemic influenza vaccine (whole virion, Vero cell derived, inactivated)

Daronrix, suspension for injection. Pandemic influenza vaccine (whole virion, inactivated, adjuvanted) I. M.

Pandemic flu is a type of influenza that occurs at intervals that vary from less than 10 years to many decades.

CELVAPAN suspension for injection (whole virion, Vero cell derived, inactivated) Pandemic influenza vaccine I. M.

Daronrix is a vaccine used in adults aged 18 to 60 years to prevent influenza (flu) in an officially declared pandemic.

Daronrix, suspension for injection in pre-filled syringe Pandemic influenza vaccine (whole virion, inactivated, adjuvanted)

Daronrix, suspension for injection in multidose container Pandemic influenza vaccine (whole virion, inactivated, adjuvanted)

Focetria suspension for injection in pre-filled syringe Pandemic influenza vaccine (surface antigen, inactivated, adjuvanted)

Focetria injection Pandemic Influenza Vaccine (surface antigen, inactivated, adjuvanted) I. M. injection into the deltoid muscle

It is intended to be given before or during the next influenza (flu) pandemic to prevent flu caused by the H5N1 type of the virus.

Pandemrix suspension and emulsion for emulsion for injection Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)

Therefore, for pregnant women, administration of the pandemic influenza vaccine is recommended, irrespective of their stage of pregnancy.

CELVAPAN is a vaccine used in adults of 18 years of age and older. It is used to prevent influenza (flu) in an officially declared pandemic.

Pandemic flu is a type of influenza that occurs every few decades and which spreads rapidly to affect most countries and regions around the world.

The CHMP decided that Celvapan’ s benefits are greater than its risks for the prophylaxis of influenza in an officially declared pandemic situation.

In consequence, as soon as the pandemic is declared (Phase 6 of the WHO global Influenza preparedness plan) and the pandemic vaccine is used, the MAH shall submit periodic safety update reports with periodicity and format defined as follows:

The CHMP decided that Pandemrix’ s benefits are greater than its risks for the prophylaxis of influenza in an officially declared pandemic situation.

These viral proteins are prepared from the strain of influenza virus that complies with the WHO recommendations and EU decision in an officially declared Pandemic situation.

The Committee for Medicinal Products for Human Use (CHMP) decided that Focetria’ s benefits are greater than its risks for the prophylaxis of influenza in an officially declared pandemic situation.

From the clinical trials with the pandemic vaccine, most of the reactions were mild in nature, of short duration and qualitatively similar to those induced by conventional seasonal influenza vaccines.

The Committee for Medicinal Products for Human Use (CHMP) decided that Tamiflu’ s benefits are greater than its risks for the treatment and prevention of influenza, as an additional method in case of a pandemic or when flu vaccines are not effective against the influenza virus causing the seasonal epidemic.

The aim is to promote good practices in vaccinology priority setting, strategic planning and decision-making (based on scientific evidence and rationale) in childhood immunisation policies and in preparedness strategies (such as pre-event vaccinations or stockpiling), for serious health threats such as pandemic influenza and bioterrorism.

In case of a pandemic situation with respect to the human influenza virus, duly recognised by the World Health Organisation or by the Community in the framework of Decision No 2119/98/EC of the European Parliament and of the Council(8), competent authorities may exceptionally and temporarily consider the variation to the terms of the marketing authorisation for human influenza vaccines to be accepted after an application has been received and before the end of the procedure laid down in Article 7.