WHO recommendations on pandemic (H1N1) 2009 vaccines
13 JULY 2009 GENEVA -- On 7 July 2009, the Strategic Advisory Group of Experts (SAGE) on Immunization held an extraordinary meeting in Geneva to discuss issues and make recommendations related to vaccine for the pandemic (H1N1) 2009.
SAGE reviewed the current pandemic situation, the current status of seasonal vaccine production and potential A(H1N1) vaccine production capacity, and considered potential options for vaccine use.
The experts identified three different objectives that countries could adopt as part of their pandemic vaccination strategy:
protect the integrity of the health-care system and the country's critical infrastructure;
reduce morbidity and mortality; and
reduce transmission of the pandemic virus within communities.
Countries could use a variety of vaccine deployment strategies to reach these objectives but any strategy should reflect the country’s epidemiological situation, resources and ability to access vaccine, to implement vaccination campaigns in the targeted groups, and to use other non-vaccine mitigation measures.
Although the severity of the pandemic is currently considered to be moderate with most patients experiencing uncomplicated, self-limited illness, some groups such as pregnant women and persons with asthma and other chronic conditions such as morbid obesity appear to be at increased risk for severe disease and death from infection.
Since the spread of the pandemic virus is considered unstoppable, vaccine will be needed in all countries. SAGE emphasized the importance of striving to achieve equity among countries to access vaccines developed in response to the pandemic (H1N1) 2009
The following recommendations were provided to the WHO Director-General:
All countries should immunize their health-care workers as a first priority to protect the essential health infrastructure. As vaccines available initially will not be sufficient, a step-wise approach to vaccinate particular groups may be considered. SAGE suggested the following groups for consideration, noting that countries need to determine their order of priority based on country-specific conditions: pregnant women; those aged above 6 months with one of several chronic medical conditions; healthy young adults of 15 to 49 years of age; healthy children; healthy adults of 50 to 64 years of age; and healthy adults of 65 years of age and above.
Since new technologies are involved in the production of some pandemic vaccines, which have not yet been extensively evaluated for their safety in certain population groups, it is very important to implement post-marketing surveillance of the highest possible quality. In addition, rapid sharing of the results of immunogenicity and post-marketing safety and effectiveness studies among the international community will be essential for allowing countries to make necessary adjustments to their vaccination policies.
In view of the anticipated limited vaccine availability at global level and the potential need to protect against "drifted" strains of virus, SAGE recommended that promoting production and use of vaccines such as those that are formulated with oil-in-water adjuvants and live attenuated influenza vaccines was important.
As most of the production of the seasonal vaccine for the 2009-2010 influenza season in the northern hemisphere is almost complete and is therefore unlikely to affect production of pandemic vaccine, SAGE did not consider that there was a need to recommend a "switch" from seasonal to pandemic vaccine production.
WHO Director-General Dr Margaret Chan endorsed the above recommendations on 11 July 2009, recognizing that they were well adapted to the current pandemic situation. She also noted that the recommendations will need to be changed if and when new evidence become available.
SAGE was established by the WHO Director-General in 1999 as the principal advisory group to WHO for vaccines and immunization. It comprises 15 members who serve in their personal capacity and represent a broad range of disciplines from around the world in the fields such as epidemiology, public health, vaccinology, paediatrics, internal medicine, infectious diseases, immunology, drug regulation, programme management, immunization delivery, and health-care administration.
Additional participants in the SAGE meeting included members of the ad hoc policy advisory working group on influenza A(H1N1) vaccine, chairs of the regional technical advisory groups and external experts. Observers included industry representatives and regulators who did not take part in the recommendation process in order to avoid conflicts of interest
WHO/Europe outbreak updates
Nearly 10 000 confirmed cases of pandemic (H1N1) 2009 in the European Region
2 July 2009, 09:00 GMT 36 of the 53 Member States in the WHO European Region had reported a total of 9967 confirmed cases, including four fatal ones, of pandemic (H1N1) 2009 virus infection to WHO/Europe as of 09:00 GMT, on 2 July. Since the update of 26 June, Bosnia and Herzegovina and Lithuania have reported their first cases, and the number of reported cases in the Region has risen by 73%.
Latvia, Montenegro, Serbia and Slovenia report first cases of influenza A(H1N1)
26 June 2009, 06:00 GMT As of 06:00 GMT on 26 June, 34 of the 53 Member States in the WHO European Region had reported a total of 5763 confirmed cases, including a fatal one, of influenza A(H1N1) virus infection to WHO/Europe. The number of reported cases rose by 74% between 19 and 26 June.
Confirmed cases of influenza A(H1N1) virus in Europe continue to rise
19 June 2009, 06:00 GMTAs of 06:00 GMT on 19 June, 30 of the 53 Member States in the WHO European Region had reported to WHO/Europe a total of 3308 confirmed cases, including a fatal one, of influenza A(H1N1) virus infection. The number of reported cases rose by 83% from 11 to 19 June. Cases increased substantially in Germany, France, Israel, the Netherlands and the United Kingdom.
Over 2500 confirmed cases of influenza A(H1N1) in Europe
16 June 2009, 06:00 GMTAs of 06:00 GMT on 16 June, 30 of the 53 Member States in the WHO European Region had reported a total of 2572 cases of influenza A(H1N1) to WHO/Europe. On 14 June 2009, the United Kingdom confirmed the first fatal case of influenza A(H1N1) in Europe, also the first outside the Americas. A woman diagnosed with influenza A(H1N1) virus infection, and with underlying health conditions, died in hospital in Scotland, United Kingdom. The vast majority of individuals with the virus have presented with mild illness.
11 June 2009, 22:00 GMTSince the update of 5 June, Ukraine has reported a new laboratory-confirmed case of influenza A(H1N1). As of 22:00 GMT on 11 June, 30 of the 53 countries in the WHO European Region had reported a total of 1803 cases to WHO/Europe. The number of reported cases increased by 89% from 5 to 11 June. On 11 June, WHO raised the level of influenza A(H1N1) pandemic alert to phase 6. The pandemic is characterized as of moderate severity.
11 June 2009, 16:00 GMTToday WHO raised the level of influenza A(H1N1) pandemic alert to phase 6, as sustained community-level transmission of the virus is taking place in more than one region of the world. The pandemic is characterized as of moderate severity. Most of the cases have been mild, but even mild cases and the current level of severe cases could have a significant impact on health systems and society.
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