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 The Advisory Committee on Immunization Practices (ACIP), in a 13-2
vote, recommended that elderly patients take Pfizer's vaccine, even
if they had previously been vaccinated with Merck & Co's leading
Pneumovax vaccine.
But the panel, which provides medical advice to the U.S. Centers for
Disease Control and Prevention, expressed concern that the federal
Medicare insurance program for the elderly currently is unable to
cover Prevnar 13 for patients who have already taken Pneumovax.
A Medicare official, speaking to the panel in Atlanta, said his
agency would have to change its rules in order to qualify such
patients for reimbursement, and that its evaluation would likely
extend until January 2016.
Prevnar 13 and an older version of the vaccine known as Prevnar 7
have combined annual sales of almost $4.5 billion, making them
Pfizer's second-biggest franchise. Prevnar 13 is approved for
children 6 weeks through 17 years of age, and for adults 50 and
older.
Although used mainly to prevent infections in young children, data
in March from a large-scale trial showed Prevnar 13 was highly
effective in those 65 and older. Based on its brightened prospects
in the elderly, industry analysts raised their long-term sales
forecasts for the vaccine by as much as $3 billion a year.
But the forecasts hinged on a positive recommendation from ACIP,
whose endorsements doctors and insurers rely upon in deciding
whether to prescribe and reimburse vaccines.
"They (ACIP) are probably the most senior body in the United States
that makes recommendations for use of vaccines, and once they make a
recommendation, that is what insurers follow," said Susan Silbermann,
president of Pfizer Vaccines. She noted, however, that the director
of the Centers for Disease Control must ratify the advisory panel's
decision.
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The panel recommended that adults 65 years or older who have not
previously received either Prevnar or Pneumovax, or whose previous
vaccination history is unknown, should first receive a dose of
Prevnar 13, followed by a dose of Pneumovax.
Adults in that age range who have not previously received Prevnar
13, but have received Pneumovax, should receive a dose of Prevnar,
the panel recommended.
The panel also recommended that Prevnar 13 be re-evaluated in 2018,
and revised as needed. That is because far fewer people are expected
to be prone to infections after others are widely vaccinated - a
phenomenon known as herd immunity.
Pneumovax had global sales of $653 million in 2013, with 8 million
doses distributed in the United States. But many doctors have said
they consider the product minimally effective.
Pfizer shares were up 1.2 percent in after-hours trading, from their
closing price on Wednesday of $28.08.
(Reporting by Ransdell Pierson; editing by Gunna Dickson)
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