Immunization, Vaccines and Biologicals

Summary of the SAGE November 2013 meeting

WHO/C. Scudamore

While acknowledging the progress made in endemic countries to date – including the absence of type 3 wild poliovirus cases, the 40% decline in polio cases in endemic countries, and the absence of endemic virus in Afghanistan – the Strategic Advisory Group of Experts (SAGE) on immunization echoed the alarm of the Independent Monitoring Board that the insecurity and lack of access for vaccinators in large areas of northwest Pakistan and northeastern states in Nigeria now constituted the greatest risk to completing polio eradication.

This risk was compounded by the increasing international spread of the virus into the Horn of Africa and the Middle East in 2013, particularly into highly vulnerable areas such as south/central Somalia and Syria where vaccinator access and security were also severely compromised.

SAGE provided several recommendations to address the wild polio virus risks and in relation to IPV introduction globally in the context of the polio endgame, including:

  • countries introducing 1 dose of inactivated polio vaccine (IPV) into the routine immunization schedule should administer the dose at or after 14 weeks of age, in addition to the 3-4 doses of oral polio vaccine (OPV) in the primary vaccination series;
  • countries have flexibility to consider alternative schedules (e.g. earlier IPV administration) based on local conditions (e.g. documented risk of vaccine-associated paralytic poliomyelitis or VAPP prior to 4 months of age); and
  • to help accelerate eradication and reduce vulnerability, all polio endemic countries should establish a plan for IPV introduction by mid-2014 and other high-risk countries by end-2014.

SAGE endorsed the proposed strategy on IPV supply, financing and introduction including the tiering of countries based on the risk of circulating vaccine-derived poliovirus (cVDPV) emergence and spread.

SAGE discussed the first annual report on the implementation of the Decade of Vaccine (DoV) Global Vaccine Action Plan (GVAP). SAGE endorsed the following recommendations as the major areas of necessary focus: 1. Improving data quality, 2. Increasing immunization coverage, 3. Accelerating progress towards measles and rubella/CRS elimination, and 4. Enhancing country ownership of national programmes. This should allow the WG to prioritize the specific issues to focus on during the next few years.

SAGE expressed its grave concern around the current situation in Syria and its neighboring countries as reported by the Eastern Mediterranean region (EMR). Effectiveness of immunization campaigns to stop the spread of polio and measles were not able to achieve the envisaged level of immunization coverage. SAGE reemphasized the need for political intervention as well as financial and technical support to countries affected by the current crisis to sustain adequate health services. Coordinated involvement of partners was crucial to stabilize the situation; SAGE encouraged donors to provide additional funding to support and strengthen routine immunization and enable conduction of urgently required interventions such as high quality supplementary immunization activities.

SAGE also expressed deep concern about the mounting challenges being faced by in-country supply chain systems that are stretched to effectively manage existing vaccines and handle the surge of new ones to be introduced and wants to draw the attention of all partners on this issue and encourage greater investments and attention to strengthening immunization supply chain systems in-country.

SAGE concluded that the recommending bodies, including WHO, need to clearly quantify and communicate the favorable risk benefit ratio of maternal immunization, and to engage in a dialogue with regulators and manufacturers to review current regulatory practices against the evidence on risks and benefits and biological plausibility on product safety. SAGE requested the secretariat to develop a process and a plan to move this agenda forward creating alignment between data safety evidence, public health needs and regulatory processes.

SAGE recommended that no physical stockpile on H5N1 vaccine should be created in view of the Pandemic Influenza Preparedness Framework provisions, on condition that equity is considered and established when vaccine is distributed to low and middle income countries.

The meeting report will be published in the WHO Weekly Epidemiological Record on 3 January 2014.

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