No compromise on pandemic vaccine safety in the pursuit of quick delivery

WHO European governing body discusses challenges of pandemic influenza vaccine development

Copenhagen, 15 September 2009

Pressure to meet demands for pandemic (H1N1) 2009 vaccine must not compromise safety standards, WHO experts stressed today. Addressing health decision-makers from across the WHO European Region at WHO’s European governing body meeting, they underlined the need to ensure delivery of the pandemic vaccine to high-risk groups in the Region. Measures to prepare for and respond to a possible second wave of the pandemic in the coming months were also discussed.

According to the latest WHO European survey, out of a total population of over 890 million in the 53 countries of the WHO European Region, about 700 million people live in countries that either have advanced purchase agreements with vaccine manufacturers or local production capacity. That leaves 190 million people outside the system and over half are in countries that rely on WHO support for their vaccine stockpiles.

A large number of potential vaccine manufacturers around the world are capable of producing the pandemic vaccine and most of them are located in the European Region – latest reports suggest up to 70% of global vaccine production could be located in the Region. It could take several months, however, before the vaccine is available to most of the world.

Dr Margaret Chan, WHO Director-General, stressed the importance of getting the right message across: “Streamlining the vaccine development regulatory process is good. Fast-tracking vaccine pre-qualification is also important. We want to do our job as quickly as possible. But, when we say that we fast-track things, it means that we streamline the bureaucratic process; there is no question that we would compromise on the quality and safety of vaccines.”

Experts stressed that regulatory procedures are in place to license pandemic vaccines. Procedures for expediting regulatory approval are rigorous and do not compromise safety or quality controls. Influenza vaccines have been used for over 60 years and have an established safety record in all age groups. While some adverse reactions have been reported, they have been rare.

“In the months ahead, we are going to face a large number of problems that we must anticipate if we are to take the right decisions. These have to do with the priority groups to receive the first doses of the vaccine, including health personnel, pregnant women, people with chronic diseases, especially respiratory ones, and obese people,” said Dr Marc Danzon, WHO Regional Director for Europe. “And we will have to think about the messages to give to the “worried well”, people who are not in priority groups but who will want to be vaccinated while there are not enough doses available. The same problem will be faced at global level, between those countries that can purchase large amounts of vaccine and those who will be excluded from this market. Questions of solidarity and equity become even more acute in times of crisis.”

WHO is currently in discussion with vaccine manufacturers, development banks and donors to see how to make vaccines available to low- and middle-income countries as early as possible. To date, a pledge to donate 150 million doses of pandemic vaccine has been made through WHO.

A number of other urgent pandemic issues were raised during the meeting, such as growing demands on health services: visits to emergency departments in many countries more than doubled in the pandemic period compared with influenza season. Other issues discussed included priority groups for vaccination beyond health care workers, pandemic versus seasonal vaccine, the lag time between the declaration of the pandemic and the availability of vaccines (4–6 months), the gap between potential demand and the anticipated supply of vaccines (94 million doses per week), and equity of access.

WHO European pandemic experts are available for interviews on topics discussed at the meeting. Requests should be sent to Ms Liuba Negru, Press and Media Relations Officer.

For more information, contact:

Press information:

Ms Liuba Negru
Press and Media Relations Officer
WHO Regional Office for Europe
Scherfigsvej 8, DK-2100 Copenhagen Ø, Denmark
Tel.: +45 39 17 13 44. Fax: +45 39 17 18 80
E-mail: LNE@euro.who.int