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(Adds FDA comment in fourth paragraph.)
Nov. 16 (Bloomberg) -- Pfizer Inc.’s Prevnar 13 vaccine for a bacterial infection that causes pneumonia won the backing of a U.S. advisory panel today for use in adults 50 and older, a population that may add almost $2 billion to sales in 2015.
Advisers to the Food and Drug Administration at a meeting today in Silver Spring, Maryland voted 14-1 that the shot was safe and effective for adults in producing an immune response against the pneumococcal bacteria. The FDA doesn’t have to follow the panel’s recommendations.
The FDA is expected to decide on approval of Prevnar 13 in adults 50 and older by Jan. 2. The agency is weighing approval on the condition that Pfizer studies the vaccine further to prove it protects against pneumococcal pneumonia. Pfizer started an 85,000-subject trial in the Netherlands to confirm the vaccine’s effectiveness in staving off the infection.
“We are very optimistic that this trial is going to show the data that you want to see,” Marion Gruber, the FDA’s acting director of vaccine research and review, said during the panel meeting. She said the agency expects results from the study in 2013.
Prevnar 13, approved in the U.S. last year for children six weeks to 5 years old, generated $2.82 billion the first nine months of 2011, according to the New York-based drugmaker’s regulatory filings. 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 an Oct. 21 investment note.
An FDA staff report released Nov. 14 determined the vaccine was safe and effective in adults who received Merck & Co.’s older vaccine approved almost 30 years ago and in those never immunized. The report found no major side effects, though limitations included the size of the safety database, which may be too small to detect some rare adverse events, the report said.
FDA considers the protection of adults from pneumococcal pneumonia a “meaningful therapeutic benefit over existing treatments,” according to the report.
Pneumococcal pneumonia accounts for 175,000 hospitalizations each year in the U.S. and more than 6,000 deaths, according to the National Foundation for Infectious Diseases.
Pfizer conducted clinical studies that showed the vaccine likely will be associated with better protection than Whitehouse Station, New Jersey-based Merck’s Pneumovax 23 against pneumococcal pneumonia, Emilio Emini, Pfizer’s chief scientific officer for vaccine research, said in a telephone interview.
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.
Merck’s Pneumovax 23 brought in $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 Prevnar 13 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 ages 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 years old who smoke, have asthma or live in nursing homes or long-term care facilities.
--Editors: Angela Zimm, Bruce Rule
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