Pfizer's ($PFE) Prevenar 13 is already the world's best-selling vaccine, and it kept on rolling Tuesday with a European label expansion.
The European Medicines Agency (EMA) has approved the shot in adults for prevention of pneumonia caused by the 13 pneumococcal serotypes the vaccine contains. The green light comes on the back of Pfizer's CAPiTA trial, which showed that Prevenar cut first episodes of community-acquired pneumonia by 46% and first episodes of noninvasive CAP by 45%.
"We welcome the approval of this new indication for Prevenar 13 in the EU," Rene Reinert, Pfizer's VP of vaccines medical and scientific affairs, said in a statement. "… This is particularly important for older adults and those with medical conditions that may make them more vulnerable to this serious, debilitating and potentially deadly disease."
Some analysts, like BMO Capital Markets' Alex Arfaei, have predicted strong adult uptake for Prevenar outside the U.S., where smoking and other factors make populations more vulnerable to pneumococcal disease. Those revenues will build on the $4.46 billion the vaccine raked in for Pfizer in 2014.
But not everyone is happy with Prevenar's globe-leading revenue haul. Earlier this year, pressure from price critics prompted the company to sink the cost of the vaccine from $3.30 to $3.10 per dose. Still, medical charity Médecins Sans Frontières dubbed the move "inadequate" and reiterated requests that Pfizer and fellow pneumococcal vaccine maker GlaxoSmithKline ($GSK) make their jabs available at a three-dose cost of $5 per child in developing countries.
- read Pfizer's release
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