Pfizer has received European approval to expand the use of its pneumococcal conjugate vaccine Prevenar 13 to adults aged 18 to 49 years for the prevention of invasive pneumococcal disease, according to a company statement.
The vaccine, which protects against 13 strains of Streptococcus pneumoniae, is approved in the European Union (EU), the United States, and elsewhere for use in infants, young children, and adolescents aged 6 weeks to 17 years, as well as adults 50 years of age and older.
"Prevenar 13 is now the only pneumococcal vaccine in the EU that offers protection against invasive disease from infancy through adulthood." the company said in the statement.
The European Commission's decision to expand use of the vaccine to 18- to 49-year-olds followed the submission and review of data from an open-label phase 3 trial of the vaccine in healthy adults in this age group, the company said.
The study, which met all primary and secondary objectives, showed that the vaccine is at least as immunogenic in this age group as it is in adults aged 60 to 64 years, as measured 1 month after vaccination. Prevenar 13 showed a favorable safety profile and was generally well-tolerated.
"Adults aged 18 to 49 years with certain underlying medical conditions may benefit in particular from vaccination with Prevenar 13 because of an increased risk of pneumococcal disease," said Luis Jodar, PhD, vice president of the Vaccines Global Medicines Development Group at Pfizer.
Prevenar 13 (known as Prevnar 13 in the United States, Canada, and Taiwan) is now approved in more than 120 countries worldwide for use in infants and young children, as well as in more than 80 countries for use in adults 50 years of age and older.
But not approved for scheduling in the United States (beyond patients who are immunocompromised or over age 65). What’s wrong with this picture?
On the last working day of the year (December 30, 2011), the FDA approved Prevnar 13 (a pneumococcal 13-valent conjugate vaccine) for people ages 50 years and older to prevent pneumonia and invasive disease caused by the bacterium, Streptococcus pneumoniae. In fact, the new use for Prevnar 13 was approved under the agency’s accelerated approval pathway, which allows for earlier approval of treatments for serious and life-threatening illnesses.
(The Centers for Disease Control and Prevention reports that 5,000 adults die from pneumonia every year.)
And to drive home the importance of this action, the FDA issued a press statement on the approval before heading home for the long weekend:
“According to recent information for the United States, it is estimated that approximately 300,000 adults 50 years of age and older are hospitalized yearly because of pneumococcal pneumonia,” said Karen Midthun, M.D., director of FDA’s Center for Biologics Evaluation and Research. “Pneumococcal disease is a substantial cause of illness and death. Today’s approval provides an additional vaccine for preventing pneumococcal pneumonia and invasive disease in this age group.”
Not so fast.
Although it’s quite a high hurdle to have a vaccine approved by the FDA (and appropriately so), it’s not the final hurdle in getting it to patients. That final hurdle resides with the Centers for Disease Control’s Advisory Committee on Immunization Practices (ACIP).
ACIP’s charge is to “provide advice and guidance to the Secretary, HHS, the Assistant Secretary for Health, and the Director, CDC, regarding the most appropriate selection of vaccines and related agents for effective control of vaccine-preventable diseases in the civilian population.”
The ACIP meets three times a year, and during these meetings newly licensed vaccines are discussed and a vote is taken to include (or not include) the new vaccine on the adult immunization schedule. ACIP’s recommendations become a basis for reimbursement by public and private payers who will pay for vaccinations that are part of the committee’s recommendation -- but generally not otherwise. The CDC schedule plays an important gatekeeper role for vaccines that goes well beyond the scope of FDA approval. Vaccines approved by the FDA but not appearing on the CDC routine vaccination schedule are likely to gain little traction because of a lack of guidance to providers on how to use the vaccine -- and lack of payer coverage.
In other words, minus a positive ACIP recommendation, a disease that is responsible for approximately 200,000 emergency room visits a year will continue to harass patients and haunt our healthcare system. Minus a positive ACIP vote, new and potentially life-saving vaccines are redlined and another nail is hammered into the coffin of innovation.
The need for this patient population exists. The vaccine is safe and effective. Without a recommendation the vaccine will not be available to a large swath of Americans. It’s time for ACIP to call the question.
The battle against the “dangerous idiots” of vaccine denial is dangerous enough, we must avoid the equally daunting danger of … inertia