CDC recommends expanded use of Pfizer vaccine
An advisory committee for the Centers for Disease Control and Prevention voted on Wednesday to recommended expanded use of Pfizer Inc's Prevnar 13 vaccine to include adults 19 and older with compromised immune systems due to conditions such as HIV infection, cancer and advanced kidney disease.
The Advisory Committee on Immunization Practices (ACIP) favored the expanded use by a vote of 14-0 with one abstention, the CDC said.
Prevnar 13, one of Pfizer's most important products, prevents pneumococcal pneumonia or invasive disease. Wall Street analysts, on average, have forecast Prevnar 13 sales will reach $6.75 billion by 2016. The company reported sales of $941 million in the first quarter.
"While we view this (recommendation) as an incremental positive, we think the Street expected a positive outcome," ISI Group analyst Mark Schoenebaum said in a research note.
Pfizer shares were off 9 cents at $22.62 in midday trading on the New York Stock Exchange.
Prevnar 13 was initially approved by the U.S. Food and Drug Administration in 2010 for the prevention of invasive pneumococcal disease caused by the 13 serotypes included in the vaccine in infants and children from 6 weeks through 5 years old.
The FDA in December approved Prevnar 13 for adults age 50 and older. ACIP has not yet recommended the vaccine for that patient population.
"We are committed to continuing discussions with the ACIP with the aim of expanding the recommendations to include all adults 50 years of age and older - a population rapidly increasing in the United States and at risk for developing vaccine-type pneumococcal pneumonia and invasive disease," Pfizer said in a statement.
Pfizer is expecting data next year from a Prevnar 13 trial of more than 84,000 subjects 65 and older to determine if the vaccine is effective in preventing the first episode of community-acquired pneumonia caused by the 13 pneumococcal serotypes in the vaccine.
ACIP is likely awaiting results from that trial, called CAPITA, before making a recommendation for the vaccine's use in older adults.
"The key event for Prevnar 13 remains the data readout in 2013 from the CAPITA adult outcomes study," Schoenebaum said.
The vaccine is not approved for those between the ages of 6 and 49.