- The FDA broadened the indication for Pfizer’s pneumococcal pneumonia vaccine, Prevnar 13, to include adults aged 18 through 49, the company announced Tuesday.
- The broadened indication secures the drug’s title as the only “pneumococcal vaccine approved across the lifespan.” Previously, the vaccine was only approved for adults over 50 and children 6 weeks to 17 years old. An earlier version of the Prevnar vaccine was approved to treat infants 2 to 15 months old.
- The Prevnar family of vaccines is Pfizer’s top-selling drug, generating $6.25 billion in 2015 sales. Pfizer competes with Merck’s Pneumovax 23 ($542 million in 2015) in the adult market.
Young children and older adults may be at the highest risk of pneumococcal pneumonia infection, but the broadened indication represents a great opportunity for Pfizer.
The Centers for Disease Control and Prevention (CDC) has been driving a public health campaign to encourage at-risk adults to be vaccinated in order to prevent infection.
Certain adults between the ages of 18 and 49 face increased risks, especially if they are immune-compromised, smoke or have a chronic disease. The CDC reports 67 million at-risk adults remain unvaccinated.
In addition, the CDC reports 900,000 people are infected with the disease each year, and 5% to 7% of those infected die as a result. In children under five, the disease is responsible for 15% of all deaths. However, 95% of all deaths from pneumococcal pneumonia are in adults.
The expanded indication should help strengthen Prevnar sales and further expand its lead over rival Merck.