Pfizer Inc.’s Prevnar 13 vaccine for a bacterial infection that causes pneumonia won approval for use in adults 50 and older, a population that may add almost $2 billion to sales in 2015.
The Food and Drug Administration cleared the shot that will compete with Merck & Co.’s vaccine, which was approved almost 30 years ago, the agency said today in a statement.
The FDA weighed approval on the condition New York-based Pfizer studies the vaccine further to prove it protects against pneumococcal pneumonia. About 300,000 U.S. adults 50 and older are hospitalized with the infections each year, said Karen Midthun, director of FDA’s Center for Biologics Evaluation and Research.
“Pneumococcal disease is a substantial cause of illness and death,” Midthun said in the statement. “Today’s approval provides an additional vaccine for preventing pneumococcal pneumonia and invasive disease in this age group.”
Prevnar 13, approved in the U.S. last year for children 6 weeks to 5 years old, generated $2.82 billion the first nine months of 2011, according to the regulatory filings from Pfizer, the world’s biggest drugmaker. The vaccine may generate $5.9 billion by 2015, with adult use contributing $1.8 billion, said Catherine Arnold, an analyst with Credit Suisse Group AG in New York, in a note to investors.
“The FDA approval of Prevnar 13 for these adults offers the potential to contribute to the health of millions of aging Americans,” Ian Read, Pfizer’s chairman and chief executive officer, said today in an e-mail.
An FDA staff report released Nov. 14 determined the vaccine was safe and effective in adults who received Pneumovax 23 from Whitehouse Station, New Jersey-based Merck and in those never immunized. Pfizer started an 85,000-subject trial in the Netherlands to confirm the vaccine’s effectiveness in staving off pneumococcal pneumonia, the agency said today.
Pfizer hasn’t determined how long the shot will last and is studying a five-year duration as part of the Netherlands trial, said Peter Paradiso, of Pfizer’s vaccine development unit, in an interview.
Pfizer declined less than 1 percent to $21.64 at the close in New York. The shares gained 24 percent this year.
Merck’s Pneumovax 23 had $276 million in sales in the first nine months of this year, according to company filings.
Insurance coverage for Prevnar 13 will depend on whether the Centers for Disease Control and Prevention’s vaccines panel recommends Pfizer’s shot for those 50 and older. The 2010 health law requires coverage of vaccines recommended by the panel without a co-payment or deductible cost to patients.
Merck’s vaccine is recommended for people 65 and older and for people 2 years and older at high risk for pneumonia, such as those with sickle cell disease, HIV infection and other conditions that compromise the immune system, according to the CDC. It is also recommended for adults 19 to 64 who smoke, have asthma or live in nursing homes or long-term care facilities.