EMA accepts Pfizer app to expand Prevenar in adults
Sales of Pfizer's ($PFE) best-selling vaccine may soon be getting bigger. The European Medicines Agency (EMA) has accepted the company's application to expand the label on Prevenar 13 in adults to include the prevention of pneumonia caused by the 13 pneumococcal serotypes the vaccine contains.
The application is based on Pfizer's expansive CAPiTA trial, which revealed back in March that the vaccine cut first episodes of community-acquired pneumonia (CAP) by 46% and first episodes of non-invasive CAP by 45%. Those numbers impressed analysts, including BMO Capital Markets' Alex Arfaei. He predicted strong adult uptake outside the U.S., where smoking and other factors make populations more vulnerable to pneumococcal disease.
"Pneumococcal pneumonia continues to be a serious health problem, causing significant illness and mortality in older adults," Dr. Emilio A. Emini, Pfizer's SVP of vaccine R&D, said in a statement. "The results of the Community-Acquired Pneumonia Trial in Adults study underscore the potential benefits of Prevenar 13 in preventing disease in this age group."
|Dr. Emilio Emini, Pfizer's SVP of vaccine R&D|
Pfizer is also in search of a recommendation from the CDC's Advisory Committee on Immunization Practices (ACIP) when it comes to using the vaccine in adults. But that may be a longer shot: According to ISI Group analyst Mark Schoenebaum, immunizing adults may not be effective in the long term thanks to herd immunity, the committee figures.
But whether or not Pfizer wins those nods, its vaccine sales will soon be growing. Last week, it finally scored a deal to bulk up beyond the Prevnar franchise, agreeing to buy Baxter's ($BAX) marketed vaccines portfolio in a $635 million transaction.
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