FDA Approves Boostrix for Adults

FDA Approves GlaxoSmithKline Tetanus, Diphtheria, Whooping Cough Vaccine, Boostrix, for Adults

New Indication for Booster Vaccine Expands Disease Protection to Individuals Aged 10-64 Years

PHILADELPHIA, PA--(Marketwire - December 8, 2008) - GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has approved Boostrix [Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine, Adsorbed (Tdap)] for use in adults 19-64 years of age. Boostrix offers protection against tetanus, diphtheria and pertussis (whooping cough) to individuals 10-64 years of age -- the broadest age range for any Tdap vaccine. Boostrix was previously approved as a booster vaccine for preteens and teens.

"Whooping cough is a highly contagious respiratory disease that can be prevented through vaccination, yet, according to the Centers for Disease Control and Prevention (CDC), most adolescents and adults have not received the recommended booster shot," said Andrew C. Eisenberg MD, MHA, FAAFP, Associate Professor, Department of Public Health and Policy, Texas A&M School of Rural Public Health. "Boostrix can be given in place of one tetanus diphtheria (Td) booster for adolescents and adults, in accordance with the CDC recommendation for whooping cough protection."

The approval of Boostrix in adults was based on two clinical trials in which nearly 3,000 U.S. subjects 19-64 years of age were vaccinated with Boostrix. The data demonstrate the overall safety and immunogenicity of Boostrix in providing booster protection against tetanus, diphtheria and whooping cough in adults.

The CDC recommends a single Tdap vaccination for adults aged 19-64 years, in place of a Td booster if the last dose of the Td vaccine was received 10 or more years prior in individuals who have not already received a Tdap vaccine. This includes healthcare personnel who have direct patient contact, as well as adults younger than 65 years of age who have or anticipate having contact with infants younger than 12 months (e.g., parents, grandparents, childcare providers).

"This approval extends the whooping cough protection afforded by Boostrix in adolescents to adults 19-64, expanding options for adult Tdap vaccination," said Wayde M. Weston, Ph.D., Director, U.S. Clinical Research and Development/Medical Affairs, GlaxoSmithKline.

The approval of Boostrix in adults expands the GSK Vaccines portfolio, making it the only company in the country to offer a full line of vaccines to protect adults from pertussis, hepatitis A & B and flu.

About Pertussis (Whooping Cough)

Whooping cough, also known as pertussis, is a serious and highly contagious respiratory disease characterized by severe coughing fits. Whooping cough may lead to complications such as pneumonia or rib fracture in adolescents and adults. The illness may last for more than 100 days and can lead to lost time at work or school. Babies who have not received all of their shots for whooping cough are at risk of catching the illness. Preteens, teens and adults are often the source of infection for infants.

Whooping cough starts off like the common cold, and may include symptoms such as a runny nose, sneezing, mild fever and severe coughing fits. While more than 3,500 cases of whooping cough were reported in U.S. adults ages 20 years and older in 2007, many more cases may go unreported. In fact, it is estimated that over 600,000 cases occur in adults annually. According to the CDC's 2007 National Immunization Survey, an estimated 98 percent of adults aged 18-64 years reported that they have not received the whooping cough booster shot.

About Boostrix

Boostrix is approved as a booster vaccination for the prevention of tetanus, diphtheria and pertussis in individuals 10-64 years of age. Since 2005, more than 7.5 million doses of Boostrix have been distributed in the US to protect adolescents from whooping cough.

This press release contains general information about pertussis infection and the potential impact of vaccination. It also contains information about Boostrix which is presented separately. Approval of Boostrix for use in preventing tetanus, diphtheria and pertussis in adults 19-64 was based on immune response data and not on data concerning effect of vaccination with Boostrix on these diseases or outcomes of these diseases (such as pneumonia or rib fracture, nor of transmission of disease). For additional information about Boostrix, please see the complete Prescribing Information accompanying this material.

Important Safety Information

In clinical studies, common adverse events were injection-site reactions (pain, redness, swelling, or increase in arm circumference), headache, fatigue, and gastrointestinal symptoms. Severe allergic reaction after a previous dose of Boostrix or encephalopathy within 7 days of a previous pertussis antigen-containing vaccine is a contraindication. The decision to give Boostrix should be based on benefits and risks if Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior tetanus toxoid-containing vaccine, or if progressive or unstable neurologic disorders exist. Persons who experienced an Arthus-type hypersensitivity reaction following a previous dose of tetanus toxoid-containing vaccine should not receive Boostrix unless 10 years have elapsed. The prefilled syringes contain dry natural latex rubber that may cause allergic reactions.

GlaxoSmithKline: A Leader in Vaccines

GlaxoSmithKline Biologicals (GSK Biologicals) is a leading global vaccine manufacturer committed to preventing disease in people of all ages with innovative vaccines and delivery systems. The division, headquartered in Belgium, is active in vaccine research, development and production with more than 30 vaccines currently available globally and 20 more in development. In 2007 GSK Biologicals distributed 1.1 billion doses of vaccines -- an average of 3 million doses a day.

GlaxoSmithKline is one of the world's leading research-based pharmaceutical and health care companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit www.gsk.com.

Boostrix is a registered trademark of the GlaxoSmithKline group of companies.

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2007.


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Posted: December 2008

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Boostrix (tetanus, diphtheria, acellular pertussis vaccine (Tdap)) FDA Approval History

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