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Above the rise of Merck’s Gardasil vaccine, a specter is looming

Merck & Co.’s HPV vaccine Gardasil drove its vaccine business growth in the fourth quarter, bringing in $542 million of the unit’s about $700 million.

The results beat Wall Street expectations by nearly $90 million and made Gardasil and the newer, more expensive Gardasil 9 among a handful of top Merck MRK, +3.35% products with year-over-year growth in the latest quarter.

But Gardasil also has an ax hanging over it: a Centers for Disease Control and Prevention recommendation that teenagers ages 15 and under need only two doses of the three-dose regimen.

The two-dose regimen should have a “rapid transition” this year, Chief Financial Officer Robert Davis said on the company’s earnings call, and “that will have a negative impact on sales in the U.S.

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