Officials at the Centers for Disease Control and Prevention met last week to discuss the latest developments in the fight against pneumonia.
They had the chance to prevent tens of thousands of deaths from the disease each year simply by recommending a new vaccine for routine delivery to adults. Unfortunately, they passed on the opportunity. That’s inexcusable. The CDC should reconsider its inaction and approve the new vaccine immediately.
Late last year, the federal Food and Drug Administration approved Prevnar 13, a vaccine that targets pneumonia-causing Streptococcus pneumoniae bacteria, for use in people over the age of 50. According to Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, pneumococcal pneumonia sends some 300,000 adults in that age group to the hospital each year.
It kills more than 25,000 Americans annually, according to a study from researchers at the University of Pittsburgh and the CDC. Recognizing that the vaccine could effectively prevent these hospitalizations and deaths, the drug regulator employed its “accelerated approval pathway,” which permits earlier approval of treatments for serious and life-threatening illnesses.
But a thumbs up from the FDA is not enough to get the vaccine into doctors’ hands and patients’ bodies. The CDC’s Advisory Committee on Immunization Practices has the final word on vaccines in this country.
The ACIP formulates America’s adult-immunization schedule. If the committee doesn’t recommend that a vaccine be placed on the schedule, then public and private payers like Medicare and private insurers are unlikely to pay for the treatment, no matter how effective it is.
Recommending Prevnar 13 for the vaccination schedule should be little more than a formality, but for some reason, the ACIP declined to schedule a vote on the matter at its February meeting.
Prevnar represents an improvement over Pneumovax (PPV), the only other vaccine against pneumococcal bacteria approved for administration to adults older than 50.
The FDA found that Prevnar “induced antibody levels that were either comparable to or higher than the levels induced” by PPV.
According to the joint University of Pittsburgh/CDC study, if Prevnar were recommended, 10.6 percent of all hospitalized pneumonia cases would be prevented in healthy 50-year-olds in the first year.
The vaccine is safe, too. It’s been tested in 6,000 people over the age of 50, and the side effects aren’t much different than those for any other vaccine: pain or swelling at the injection site, fatigue, headache, chills, and loss of appetite. And there’s currently an additional trial for another 85,000 people underway to confirm the vaccine’s clinical benefit.
Prevnar 13 is already approved for use among children younger than five years of age. If it’s safe and effective enough for our society’s youngest members, why wouldn’t it be for our oldest, too?
Given all this evidence, the scholars at the University of Pittsburgh and the CDC have unsurprisingly concluded that Prevnar 13 “strategies are highly cost-effective for 50-year-old cohorts compared to the present adult PPV recommendations” for fighting pneumococcal bacteria.
The ACIP only meets three times a year, and since the body failed to recommend Prevnar this month, seniors will have to wait until June for the committee to reconsider and it may not even be on the agenda then. In the interim, thousands of preventable cases of pneumonia would no doubt take root — and people would needlessly suffer, or even worse, die.
Rarely can public health officials save the lives of thousands of people with a mere administrative maneuver. But by adding Prevnar 13 to the adult-immunization schedule, ACIP can do just that.
The committee should give this new vaccine the thumbs up without hesitation.