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Who position on h5n1 vaccines for human use

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  • Who position on h5n1 vaccines for human use

    1) [AVIAN INFLUENZA, PANDEMIC PREPAREDNESS, VACCINES, WHO, UPDATES] Meeting of the immunization Strategic Advisory Group of Experts, November 2007 ? conclusions and recommendations (Excerpts)

    The Strategic Advisory Group of Experts (SAGE) on immunization reports to the Director-General of WHO on issues ranging from vaccine research and development, to immunization delivery.

    Its purview extends beyond childhood immunization to all vaccine-preventable diseases. SAGE met on 6?9 November 2007 in Geneva, Switzerland.
    (...)

    Potential uses of WHO H5N1 vaccine stockpile and H5N1 vaccine


    In May 2007, the World Health Assembly requested that WHO develop a stockpile of infl uenza A (H5N1) vaccine.


    Plans by WHO to develop this stockpile have been supported by a pledge of 50 million vaccine doses made by GlaxoSmithKline Biologicals, which is under negotiation, and pledges of unspecified amounts of vaccine by 3 other companies.

    Several other H5N1 vaccines are under development by additional companies, and the regulatory approval of some H5N1 vaccines is anticipated in the near future.

    In 2 separate WHO consultations held in October 2007, safety and immunogenicity data were reviewed as were the critical technical parameters of this stockpile.


    The establishment of an H5N1 vaccine stockpile by WHO
    provides an important new opportunity for mitigating the impact of an H5N1 pandemic.

    However, from the outset, it has been clear that WHO?s stockpile will not be sufficient to meet most national needs for vaccine if an H5N1 pandemic occurs.

    Therefore, countries must develop and continue to update comprehensive, operational pandemic preparedness plans and, if vaccines are considered to be a national priority in those plans, explore other additional avenues for accessing H5N1 vaccines.

    In this regard, WHO?s work with manufacturers to increase the production capacity and supplies of H5N1 vaccines at affordable prices is urgent.

    Although the stockpile will increase access by countries to H5N1 vaccine, the supplies should not be considered a substitute for pandemic preparedness plans.


    SAGE reviewed current evidence on H5N1 vaccines with regard to safety and immunogenicity.

    Based on this review, SAGE found no data indicating undue safety concerns related to these vaccines over seasonal influenza vaccines but noted that larger studies are needed to assess the incidence of rare reactions.

    Data on vaccination in children are needed.

    Data were reassuring about cross-reactivity against heterologous strains; long-term studies on immune responses to boosting will be important.

    Agreement on standard immunological criteria and standard reagents for assessing H5N1 vaccine immunogenicity are needed to improve comparisons of
    clinical trials of different vaccines.


    SAGE made the following recommendations.
    1. WHO should continue to urgently develop the H5N1 vaccine stockpile and develop associated procurement,
    management, governance, regulatory and distribution procedures, as well as procuring necessary ancillary supplies such as syringes and needles.

    In doing so, WHO should also address the logistic aspects and long-term sustainability of the stockpile.


    2. National pandemic preparedness plans, many of which were developed before the availability of H5N1 vaccines, should be updated to enable countries to receive and efficiently deploy H5N1 vaccines from the stockpile.


    3. There should be 2 uses of the stockpiled vaccine.
    * For the first use, up to 50 million vaccine doses, or enough to vaccinate up to 25 million people, should be maintained to complement other interventions used in any operation to try to contain the earliest detected outbreak of H5N1 virus infections in which sustained human-to-human transmission of the H5N1 virus is identified and which is considered by WHO and the affected country to have the potential to initiate an influenza pandemic.

    The containment protocol, which is updated periodically as concepts evolve and new developments appear, is available online.9

    The estimated maximum amount of vaccine required to support such an intervention has been based on preliminary and unpublished modelling work.

    However, SAGE recognizes that the actual amount needed may vary depending on specific circumstances, and estimates might change based on future information.

    The decision to release stockpiled vaccine should be made jointly by the country in which the outbreak is located and WHO.

    Any country is eligible to receive stockpiled vaccine for this purpose because a pandemic could start anywhere, and its containment or delay to spread is in the interest of the country and global community.


    * For the second use, SAGE recommends that WHO work towards stockpiling as many as 100 million additional doses of the H5N1 vaccine.

    If there were sustained human-to-human transmission of the H5N1 virus, this stockpiled vaccine and any other stockpiled vaccine that had not been used for containment should be equitably distributed to low-income and middleincome countries to help maintain those services considered most essential by them.

    The amount provided to each country should be proportional to the size of the country?s population.

    The release of vaccine from the stockpile for this purpose should be made by WHO according to the International Health Regulations (2005) and based on an assessment of the circumstances that pertain at that time.


    SAGE also considered other possible uses of H5N1 vaccine but recognized the limitations of current knowledge and did not make further recommendations.

    However, at a later date SAGE will review issues such as the use of H5N1 vaccines in non-pandemic periods for populations who might benefit.

    Meanwhile, SAGE encourages continued vigorous research on H5N1 and other candidate pandemic vaccines, including long-term studies on vaccine stability, and further work to better define the potential risks and benefits of the other possible uses of
    H5N1 vaccine.

    Finally, SAGE is aware there are long-term resource implications of these recommendations and that countries and industry will need to support WHO to develop and maintain the WHO H5N1 vaccine stockpile.

    (9) See http://www.who.int/csr/disease/avian...ftprotocol/en/.

    Weekly epidemiological record - 4 JANUARY 2008, 83nd YEAR / 4 JANVIER 2008, 83e ANN?E - No. 1, 2008, 83, 1?16 - http://www.who.int/wer
    -


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  • #2
    Re: :.:WHO POSITION ON H5N1 VACCINES FOR HUMAN USE:.:

    "* For the second use, SAGE recommends that WHO work towards stockpiling as many as 100 million additional doses of the H5N1 vaccine.

    If there were sustained human-to-human transmission of the H5N1 virus, this stockpiled vaccine and any other stockpiled vaccine that had not been used for containment should be equitably distributed to low-income and middleincome countries to help maintain those services considered most essential by them.

    The amount provided to each country should be proportional to the size of the country’s population.

    The release of vaccine from the stockpile for this purpose should be made by WHO according to the International Health Regulations (2005) and based on an assessment of the circumstances that pertain at that time."

    100 milion doses versus ~5(6) bilion cit. => only for 2% of citizens

    "terrific reccomendation"

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