Women, newborns, children, and adolescents: life-saving momentum after a slow start
Scaling up new vaccines
Over a 20-year period, several new vaccines had been licensed for use in children, including vaccines that protect against pneumococcus and rotavirus infections, leading causes of childhood deaths from pneumonia and diarrhoea. Though prequalified by WHO, the vaccines were initially not being utilized in developing countries where the vast majority of deaths from pneumonia and diarrhoea occur. Historically, new vaccines have taken from 10 to 15 years to gradually trickle into the immunization programmes of developing countries. Again, no one wanted to wait. Everyone looked to WHO for guidance.
WHO issues authoritative position papers on vaccines, published in its Weekly Epidemiological Record, when new data on safety, efficacy, benefits or dosing schedules emerge, especially from studies conducted in resource-constrained settings, or when new products are licensed. These position papers shape Gavi policies and are also widely used by the managers of immunization programmes everywhere, but especially in the developing world, to align their strategies with the latest technical evidence and recommendations from WHO. In preparing the position papers, WHO scientists draw heavily on the Strategic Advisory Group of Experts on immunization.
The introduction of the new rotavirus vaccines in wealthy countries rapidly cut in half the number of hospital admissions of children with acute gastroenteritis. However, high rates of undernutrition and co-infections with other enteric pathogens raised doubts about whether similar positive outcomes could be expected in developing parts of Africa and South Asia. In its first position paper on rotavirus vaccines, issued in 2007, WHO was not prepared to recommend the inclusion of rotavirus vaccines in the national immunization programmes of these countries.
That position changed following the completion of studies in developing countries where sanitation was poor, mortality from diarrhoeal disease was high, and maternal infections with HIV were widespread. In 2013, a new position paper on rotavirus vaccines was issued in response to additional evidence on vaccines, their safety, and the duration of protection. WHO recommended that rotavirus vaccines should be included in all national immunization programmes and considered a priority, particularly in countries in Africa and South Asia with high mortality associated with gastroenteritis caused by rotavirus infection. In those countries, WHO further recommended that vaccination be part of a comprehensive package of prevention and treatment interventions.
"Introduction of the new vaccines was a show of solidarity and a willingness to innovate."
Dr Chan, WHO Director-General
Similar procedures were followed in 2012 when WHO issued a position paper on the new pneumococcal conjugate vaccines, protective against 10 and 13 common serotypes of Streptococcus pneumoniae. The position paper concluded that the new conjugate vaccines were safe and efficacious and represented significant progress in the fight against pneumococcal morbidity and mortality, especially in the developing world. WHO therefore recommended the inclusion of the vaccines in childhood immunization programmes worldwide. In developing countries, WHO recommended that vaccination be viewed as complementary to the use of other measures to control pneumonia.
A cornerstone objective of Gavi is to accelerate the introduction of new vaccines. By 2015, 19 countries had added rotavirus vaccines to their routine immunization schedules with GAVI support. By the end of 2015, more than 36 million children had been immunized with the vaccines. Beginning in 2010, GAVI supported rollout of the new pneumococcal vaccines in more than 50 countries. By the end of 2015, WHO estimated that nearly 80 million children had been protected. Thanks to these efforts, children in the world’s poorest countries were receiving the world’s best vaccines simultaneously with children in rich countries.
Introduction of the new vaccines was a show of solidarity and a willingness to innovate . Through the mechanism of an advance market commitment, the governments of Italy, the United Kingdom, Canada, the Russian Federation, and Norway, further supported by the Bill and Melinda Gates Foundation, contributed $1.5 billion to stimulate manufacturing of the pneumococcal conjugate vaccines for the developing country market. The mechanism was innovative but the signal was straightforward: if companies invest in expanded manufacturing capacity, the money will be there to purchase the products. The advance market commitment mechanism brought a substantial reduction in the price of the pneumococcal vaccines for use in the poorest countries. It also encouraged new manufacturers, including those in developing countries, to invest in the development of vaccines, potentially contributing to further price reductions in the long term.