The article “Pneumococcal Conjugate Vaccine for Young Children” in this issue of American Family Physician, presents evidence and recommendations for use of pneumococcal conjugate vaccine (PCV).1 In this editorial, we comment on the process used to make policy recommendations for the use of PCV.
The Advisory Committee on Immunization Practices (ACIP) formed a working group to develop recommendations for PCV use in children in the United States. The working group consisted of scientists from the Centers for Disease Control and Prevention (CDC), voting members from the ACIP, liaisons from professional organizations including the American Academy of Family Physicians (AAFP), and other physicians. The manufacturer, Lederle Laboratories, participated through conference calls.
Initially, the working group concentrated on the burdens of invasive disease, including age, risk-group–based incidence rates, serotypes, vaccine safety, immunogenicity and efficacy. Some participants strongly advocated for an explicit evidence-based approach. The data clearly showed a high incidence of invasive disease during the first two years of life, with decreasing rates thereafter. Unanimity was reached on the importance of vaccinating children younger than two years. However, the cut-off points for catch-up vaccination after two years of age were less clear because the data showed that as incidence rates for invasive disease dropped, the morbidity rate also dropped, and serotype distribution changed, which lowered protection against all serotypes.
The group discussed the best way to handle data showing that blacks, Alaskan natives and American Indians have higher incidence rates of pneumococcal disease than whites. A number of participants favored including these groups in high-risk groups for catch-up vaccination in the 24- to 59-month age group. Previous ACIP recommendations for use of pneumococcal polysaccharide vaccine called for vaccination of certain Alaskan native and American Indian groups.2
By the fall of 1999, cost data on pneumococcal disease became available but, because the exact vaccine cost was unknown, cost-effectiveness analyses were, at best, incomplete. Some group members argued for waiting until the vaccine cost was known so that more complete data about cost-effectiveness would be available, thereby possibly encouraging the manufacturer to set a reasonable price.
At the full ACIP meeting in October 1999, scientists from the CDC presented the data. The working group recommended vaccination of children younger than two years but was vague about catch-up vaccination of children older than two years. Other voting members from the ACIP saw an opportunity to further reduce disease incidence by increasing the age for catch-up vaccination to five years. Thus, a broader interim recommendation was made.
The National Medical Association (NMA) has taken the position that use of PCV has the potential to decrease the incidence of pneumococcal disease in U.S. children, particularly those younger than 36 months. It is also recognized by peer-reviewed research data that black, American Indian, Alaskan native and other minority-group children remain at greater risk for this disease beyond 36 months of age. Because of the significant epidemiologic findings derived from the data, the NMA asked the ACIP to strongly recommend use of PCV in all children disproportionately affected by this disease including, but not limited to, black, American Indian and Alaskan native children through 59 months of age.
The AAFP reviewed the data, including the incidence data by age and high-risk groups. The AAFP made the decision to recommend vaccination for children younger than two years and catch-up vaccination through 59 months of age for those in high-risk groups, including blacks, Alaskan natives and American Indians.
Some time after the ACIP meeting, the manufacturer released the list price of $58 per dose to the private sector, making it the most expensive routine infant vaccination series to date. This price is higher than the break-even price of $46 per dose, which means that, unlike other childhood vaccines, there is no cost savings to society in the private sector.3 PCV was approved for use in February 2000.
The American Academy of Pediatrics (AAP) developed recommendations, published in August 2000, using numerical cut points to define risk and assist in making recommendations.4
Concerns about consensus between the AAP, ACIP, AAFP and the public sector led to further discussions in the spring of 2000 about the approach used to develop the recommendations and cut points. The concerns included the feasibility of rapid catch-up vaccination and social equity because of budget constraints and the cost of PCV. The ACIP recommendations were published in October 2000.5
In the end, the ACIP recommended routine vaccination of children up to two years of age and catch-up vaccination for those in high-risk groups, such as those with sickle cell disease and human immunodeficiency virus infection who are between 24 and 59 months of age. No ethnic groups were included at the recommendation level, which was similar to the AAP's position. The ACIP suggested that use of PCV be considered in children in other xgroups, including Alaskan natives, American Indians and blacks. The vaccine was made available to eligible persons in these ethnic groups through the Vaccines for Children Program. The AAFP maintained its earlier position of catch-up vaccination through 59 months of age for children at high risk, including certain ethnic groups, which is consistent with the NMA position.6
Ultimately, decisions were made on the basis of a number of factors, with science being the primary issue. Harmonization, cost-effectiveness and feasibility were other factors.