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February 26, 2015 3:18 pm ET

Merck (NYSE: MRK), known as MSD outside the United States and Canada,
announced today that the U.S. Centers for Disease Control and
Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP)
voted to include GARDASIL^®9 (Human Papillomavirus 9-valent
Vaccine, Recombinant) in the recommendations for use of HPV vaccines.
GARDASIL 9 has been added to the routine recommendations for vaccination
of 11- and 12- year-old females and males. The vaccination series can be
started at age nine. Vaccination is also recommended for females aged 13
to 26 and for males aged 13 to 21 who have not been vaccinated
previously or have not completed the 3-dose series. GARDASIL 9 is not
approved by the U.S. Food and Drug Administration (FDA) for use in males
16 years of age and above.

GARDASIL 9 was approved by the FDA in December 2014 for use in girls and
young women 9 to 26 years of age for the prevention of cervical, vulvar,
vaginal, and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52 and
58, pre-cancerous or dysplastic lesions caused by HPV types 6, 11, 16,
18, 31, 33, 45, 52, and 58, and genital warts caused by HPV types 6 and
11. GARDASIL 9 is also approved for use in boys 9 to 15 years of age for
the prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52
and 58, precancerous or dysplastic lesions caused by HPV types 6, 11,
16, 18, 31, 33, 45, 52 and 58, and genital warts caused by HPV types 6
and 11. GARDASIL 9 is contraindicated in individuals with
hypersensitivity, including severe allergic reactions to yeast, or after
a previous dose of GARDASIL 9 or GARDASIL^® [Human
Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine,
Recombinant].

“The CDC has made increasing HPV vaccination rates a public health
priority,” said Jacques Cholat, M.D., president, Merck Vaccines, “and
today’s recommendation for GARDASIL 9 is an important milestone in the
shared effort to help further reduce the burden of HPV-related cancers
and diseases.”

The ACIP also recommends that if vaccination providers do not know or do
not have available the HPV vaccine previously administered, or are in
settings transitioning to GARDASIL 9, for protection against HPV 16 and
18 any HPV vaccine may be used to continue or complete the series for
females; GARDASIL or GARDASIL 9 may be used to continue or complete the
series for males. As stated in the Prescribing Information for GARDASIL
9, studies using a mixed regimen of HPV vaccines to assess
interchangeability were not performed for GARDASIL 9.

Due to the condensed meeting, the ACIP noted that vaccination with
GARDASIL 9 in prior HPV vaccine recipients will be considered as a
future policy discussion and vote at the June 2015 meeting. Efficacy of
GARDASIL 9 in preventing infection and disease related to HPV types 31,
33, 45, 52, and 58, in individuals previously vaccinated with GARDASIL
[Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine,
Recombinant] has not been assessed.

GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) added
to CDC’s Vaccines for Children program

During today’s meeting, the ACIP also voted to include GARDASIL 9 in the
CDC’s Vaccines for Children (VFC) program for both boys and girls.

Since 1994, the VFC program has provided vaccines to children through
the age of 18 who are Medicaid-eligible, uninsured, underinsured¹,
American Indian or Alaska Native. After the ACIP has made a
recommendation for the use of a given vaccine, the Committee votes on
whether the vaccine should be included in the VFC program. Eligible
children may receive recommended vaccines through VFC once the CDC
contracts for the purchase of the vaccine have been completed.

GARDASIL 9 is also available through Merck’s patient assistance program
for vaccines. Through this program, Merck will provide free vaccines to
adults who are uninsured and who are unable to afford vaccines. More
information can be found at www.MerckHelps.com.

About the ACIP

The ACIP develops written recommendations for the routine administration
of vaccines to children and adults, along with schedules regarding the
appropriate dosage and dosing frequency, and contraindications
applicable to the vaccines. The Committee, which consists of 15 experts
in immunization and related fields, provides advice to assist the CDC
and the nation in reducing the incidence of diseases that may be
prevented with vaccines and to increase the safe usage of vaccines and
related biological products. The ACIP recommendations do not result in
requirements for vaccine administration by individual states or coverage
by insurance companies. However, state health authorities and private
insurers typically follow the Committee’s guidance.

Details of the ACIP recommendations for GARDASIL 9 will be available
from the CDC. The recommendations are under review by the director of
the CDC and the Department of Health and Human Services and will become
official when published in the CDC’s Morbidity and Mortality
Weekly Report.

Important Information about GARDASIL 9 (Human Papillomavirus
9-valent Vaccine, Recombinant)

GARDASIL 9 does not eliminate the necessity for women to continue to
undergo recommended cervical cancer screening.

Recipients of GARDASIL 9 should not discontinue anal cancer screening if
it has been recommended by a health care provider.

GARDASIL 9 has not been demonstrated to provide protection against
disease from vaccine HPV types to which a person has previously been
exposed through sexual activity.

GARDASIL 9 has not been demonstrated to protect against diseases due to
HPV types other than 6, 11, 16, 18, 31, 33, 45, 52, and 58.

GARDASIL 9 is not a treatment for external genital lesions; cervical,
vulvar, vaginal, and anal cancers; or cervical intraepithelial neoplasia
(CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial
neoplasia (VaIN), or anal intraepithelial neoplasia (AIN).

Not all vulvar, vaginal, and anal cancers are caused by HPV, and
GARDASIL 9 protects only against those vulvar, vaginal, and anal cancers
caused by HPV 16, 18, 31, 33, 45, 52 and 58.

Vaccination with GARDASIL 9 may not result in protection in all vaccine
recipients.

Select Safety Information for GARDASIL 9

GARDASIL 9 is contraindicated in individuals with hypersensitivity,
including severe allergic reactions to yeast, or after a previous dose
of GARDASIL 9 or GARDASIL [Human Papillomavirus Quadrivalent (Types 6,
11, 16, and 18) Vaccine, Recombinant].

Because vaccinees may develop syncope, sometimes resulting in falling
with injury, observation for 15 minutes after administration is
recommended. Syncope, sometimes associated with tonic-clonic movements
and other seizure-like activity, has been reported following HPV
vaccination. When syncope is associated with tonic-clonic movements, the
activity is usually transient and typically responds to restoring
cerebral perfusion by maintaining a supine or Trendelenburg position.

Safety and effectiveness of GARDASIL 9 have not been established in
pregnant women.

The most common (≥10%) local and systemic adverse reactions in females
16 through 26 years of age were injection-site pain, swelling, erythema,
and headache. The most common (≥10%) local and systemic reactions in
boys 9 through 15 years of age were injection-site pain, swelling, and
erythema.

Dosage and administration for GARDASIL 9 (Human Papillomavirus
9-valent Vaccine, Recombinant)

GARDASIL 9 should be administered intramuscularly in the deltoid region
of the upper arm or in the higher anterolateral area of the thigh at the
following schedule: 0, 2 months, 6 months.

About Merck

Today’s Merck is a global healthcare leader working to help the world be
well. Merck is known as MSD outside the United States and Canada.
Through our prescription medicines, vaccines, biologic therapies and
animal health products, we work with customers and operate in more than
140 countries to deliver innovative health solutions. We also
demonstrate our commitment to increasing access to healthcare through
far-reaching policies, programs and partnerships. For more information,
visit www.merck.com
and connect with us on Twitter,
Facebook
and YouTube.

Forward-Looking Statement

This news release includes “forward-looking statements” within the
meaning of the safe harbor provisions of the United States Private
Securities Litigation Reform Act of 1995. These statements are based
upon the current beliefs and expectations of Merck’s management and are
subject to significant risks and uncertainties. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.

Risks and uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including interest
rate and currency exchange rate fluctuations; the impact of
pharmaceutical industry regulation and health care legislation in the
United States and internationally; global trends toward health care cost
containment; technological advances, new products and patents attained
by competitors; challenges inherent in new product development,
including obtaining regulatory approval; Merck’s ability to accurately
predict future market conditions; manufacturing difficulties or delays;
financial instability of international economies and sovereign risk;
dependence on the effectiveness of Merck’s patents and other protections
for innovative products; the exposure to litigation, including patent
litigation, and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise. Additional factors that could cause results to differ
materially from those described in the forward-looking statements can be
found in Merck’s 2013 Annual Report on Form 10-K and the company’s other
filings with the SEC available at the SEC’s Internet site (www.sec.gov).

Please see Prescribing Information for GARDASIL®9 (Human
Papillomavirus 9-valent Vaccine, Recombinant) at http://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_pi.pdf.
The Patient Product Information for GARDASIL®9 is also available at http://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_ppi.pdf.

¹ Underinsured children receive VFC vaccines at Federally
Qualified Health Centers.

GARDASIL^®9 and GARDASIL^® are
registered trademarks of Merck & Co., Inc., Whitehouse Station, N.J.,
U.S.A.

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Media:
Pamela Eisele, 267-305-3558
Deb Wambold, 215-652-2913
Investor:
Justin Holko, 908-740-1879
Amy Klug, 908-740-1898