Merck's Durham Site Receives U.S. FDA Licensure for Varicella Bulk
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to manufacture bulk varicella at the company's site in Durham, N.C., for use in Merck's vaccines to protect against chickenpox and shingles. The approval will enable the site to produce bulk varicella supply for the U.S. and help boost Merck's overall global supply capabilities.
In 2010, the site was approved to produce finished chickenpox vaccines. In the longer term, Merck plans for the site to produce bulk and finished product for other Merck childhood vaccines, and for the shingles vaccines as well.
"The licensure of the Durham varicella bulk facility marks a significant milestone for Merck and adds additional manufacturing capabilities to an already strong Merck vaccine network," said Willie Deese, president, Merck Manufacturing Division. "The Durham facility will help us meet the increasing global demand for our quality vaccines that enhance health care for millions around the world."
"Producing more of our chickenpox and shingles vaccines means we can help protect more children and adults against these diseases," said Julie Gerberding, M.D., president, Merck Vaccines. "This is an important step forward in our long-term strategy to reach more and more people around the world with Merck's vaccines."
Prior to this licensure, all global bulk supplies for Merck's varicella-containing vaccines were produced at the company's facility in West Point, Pa.
The Durham facility is part of Merck's more than $1 billion investment in its vaccine manufacturing capabilities over the past nine years. The company has also modernized and expanded vaccine operations at its facilities in West Point, and Elkton, Va., and built a new facility in Carlow,Ireland, which is scheduled to be licensed in 2014.
These combined investments demonstrate Merck's continuing commitment to providing high-quality vaccines to meet increasing global demand for these products.
The company broke ground for the Durham site in 2004. In 2008, Merck dedicated the facility in the memory of its most distinguished vaccine researcher, the late Maurice R. Hilleman, who developed vaccines for eight of the diseases for which vaccines are routinely recommended for children in the U.S. The Maurice R. Hilleman Center for Vaccine Manufacturing in Durham today employs 1,100 people.
"This is an exciting day for Merck colleagues, especially those here at the Durham facility," said John Howell, Durham plant manager, Merck. "All of our employees are dedicated and proud of what we do every day – getting vaccines and medicines to patients who need them – and this licensure is a critical step forward."
About VARIVAX® (Varicella Virus Vaccine Live)
VARIVAX is a vaccine indicated for active immunization for the prevention of varicella in individuals 12 months of age or older.
Each dose is approximately 0.5 mL after reconstitution and is administered by subcutaneous injection.
In children 12 months to 12 years of age, if a second dose is administered, there should be a minimum interval of three months between doses.
In adolescents greater than13 years of age and adults, two doses should be administered with a minimum interval of four weeks between doses.
Selected Safety Information for VARIVAX
Do not administer VARIVAX to individuals with: a history of severe allergic reaction to any component of the vaccine (including neomycin and gelatin) or to a previous dose of varicella vaccine; immunosuppressed or immunodeficient individuals, including those with a history of primary or acquired immunodeficiency states, leukemia, lymphoma or other malignant neoplasms affecting the bone marrow or lymphatic system, AIDS, or receiving immunosuppressive therapy; any febrile illness or active infection, untreated tuberculosis; or those who are pregnant.
Evaluate individuals for immune competence prior to administration of VARIVAX® (Varicella Virus Vaccine Live) if there is a family history of immunodeficiency. Avoid contact with high-risk individuals susceptible to varicella due to possible risk of transmission. Defer vaccination for >5 months following blood or plasma transfusions or administration of immune globulins. Avoid use of salicylates for six weeks following administration of VARIVAX to children and adolescents.
Frequently reported (>10 percent) adverse reactions in children ages 1 to 12 years who were monitored for 42 days include: fever >102.0°F (38.9°C) oral: 14.7 percent; injection-site complaints: 19.3 percent. Frequently reported (>10 percent) adverse reactions in adolescents and adults ages 13 years and older monitored for up to 42 days include: fever >100.0°F (37.8°C) oral: 10.2 percent; injection-site complaints: 24.4 percent. Other reported adverse reactions in all age groups include: varicella-like rash (injection site) and varicella-like rash (generalized).
In a clinical trial involving children who received two doses of VARIVAX three months apart, the incidence of injection-site clinical complaints (primarily erythema and swelling) observed in the first four days following vaccination was slightly higher post-dose two (overall incidence 25.4 percent) than post-dose one (overall incidence 21.7 percent), whereas the incidence of systemic clinical complaints in the 42-day follow-up period was lower post-dose two (66.3 percent) than post-dose one (85.8 percent).
The duration of protection from varicella infection after vaccination with VARIVAX is unknown.
Vaccination with VARIVAX may not result in protection of all healthy, susceptible children, adolescents, and adults.
About ZOSTAVAX® (Zoster Vaccine Live)
ZOSTAVAX is a live attenuated virus vaccine indicated for prevention of herpes zoster (shingles) in individuals 50 years of age and older. ZOSTAVAX is not indicated for the treatment of zoster or postherpetic neuralgia. ZOSTAVAX should not be used for prevention of primary varicella infection (Chickenpox).
Select Safety Information for ZOSTAVAX
Vaccination with ZOSTAVAX does not result in protection of all vaccine recipients.
ZOSTAVAX® (Zoster Vaccine Live) is contraindicated in: persons with a history of anaphylactic or anaphylactoid reaction to gelatin, neomycin, or any other component of the vaccine; persons with a history of primary or acquired immunodeficiencies; persons on immunosuppressive therapy; pregnant women or women of childbearing age.
A reduced immune response to ZOSTAVAX was observed in individuals who received concurrent administration of PNEUMOVAX 23® (Pneumococcal Vaccine Polyvalent) and ZOSTAVAX compared with individuals who received these vaccines four weeks apart. Consider administration of the two vaccines separated by at least four weeks.
Serious vaccine-related adverse reactions that have occurred following vaccination with ZOSTAVAX include asthma exacerbation and polymyalgia rheumatica. Other serious adverse events reported following vaccination with ZOSTAVAX include cardiovascular events (congestive heart failure, pulmonary edema). Common adverse reactions occurring in ≥1percent of vaccinated individuals during clinical trials include injection-site reactions (erythema, pain/tenderness, swelling, hematoma, pruritus, warmth) and headache.
Transmission of vaccine virus may occur between vaccinees and susceptible contacts.
Deferral should be considered in acute illness (for example, in the presence of fever) or in patients with active untreated tuberculosis.
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United Statesand Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care 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.
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; and 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 2012 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).
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VARIVAX® is a registered trademark of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.
ZOSTAVAX® is a registered trademark of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.
PNEUMOVAX 23® is a registered trademark of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.
Please see Prescribing Information for Zostavax at http://www.merck.com/product/usa/pi_circulars/z/zostavax/zostavax_pi2.pdf and Patient Product Information for Zostavax at http://www.merck.com/product/usa/pi_circulars/z/zostavax/zostavax_ppi.pdf.
Please see Prescribing Information for VARIVAX at http://www.merck.com/product/usa/pi_circulars/v/varivax/varivax_pi.pdf and Patient Product Information for VARIVAX at http://www.merck.com/product/usa/pi_circulars/v/varivax/varivax_ppi.pdf.
Colleen Lange, (215) 652-0212
Cheznee Johnson, (919) 884-4138
Carol Ferguson, (908) 423-4465