01 February 2007

Vaccines are a critical intervention for preventing influenza and reducing its health consequences during a pandemic. Since 2004, WHO has been working with various partners to find ways to improve and promote the development and production of pandemic vaccines in order to make such vaccines available rapidly and in as large a quantity as possible.

As part of this activity, WHO, in collaboration with the World Organisation for Animal Health (OIE), has been exploring how to expedite the availability of a pandemic influenza vaccine by making pandemic vaccine viruses, required for the production of pandemic influenza vaccines, available to vaccine producers earlier than is currently the practice. Following an analysis of biosafety risks, WHO and OIE have agreed that if the pandemic preparedness alert phase reaches level 4 or above, pandemic influenza vaccine viruses that have been developed using reverse genetics by WHO Collaborating Centres, can be made available to vaccine manufacturers prior to the completion of all subsequent in vivo safety tests, including chicken and ferret tests.

It is anticipated that this accelerated procedure will reduce the time required to develop pandemic vaccines by approximately 14 days.

The revised procedure described above will be implemented only on the following conditions:

that WHO pandemic preparedness level is at phase 4 or above;

that any vaccine virus released to vaccine manufacturers prior to the completion of all in vivo safety tests will be classified as an infectious substance according to the International Air Transport Association (IATA) agreed definitions1 and will remain so until WHO announces that all relevant tests have been completed by the WHO Collaborating Centre; and

that the receipt of any virus classified as an infectious substance will be subject to compliance with;

All national import and export regulations concerning IATA classified infectious substances;

All relevant IATA regulations on shipping infectious substances;

All national biosafety guidance in dealing with infectious substances.

WHO will announce the availability from a WHO Collaborating Centre of any reverse genetic pandemic vaccine virus for vaccine development and will also announce the completion of subsequent in vivo safety tests. Member States wishing to receive such vaccine viruses are encouraged to make the necessary arrangements in advance with customs authorities, courier companies, national regulatory agencies and all other relevant national author