FDA Approves Hiberix

FDA Approves GSK's Hib Vaccine, Hiberix

PHILADELPHIA, Aug. 19 /PRNewswire-FirstCall/ -- In response to a U.S. shortage of a vaccine to protect infants from Haemophilus influenzae type b (Hib), GlaxoSmithKline (NYSE:GSK) has received accelerated approval from the FDA (Food and Drug Administration) for Hiberix [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] as a booster dose in children 15 months through four years of age. Hib is an often severe and potentially deadly bacterial infection that can cause meningitis.

The Hib vaccine shortage began in 2007 when another vaccine manufacturer temporarily suspended manufacturing of its Hib containing vaccines. This led the CDC (Centers for Disease Control and Prevention) to recommend temporary deferral of the booster dose for healthy children not at increased risk for Hib disease. Earlier this summer, the CDC reinstated the routine Hib booster dose due to an increase in supply. However, supply was not sufficient to support a mass catch-up effort for the millions of children who did not receive the booster dose during the shortage. Hiberix will help restore supply so children who missed the booster dose can get caught-up. Additionally, children coming in for routine visits can receive the Hib booster shot on time.

"We are pleased that we were able to respond to this public health need," said Peter Lammers, Vice President, U.S. Vaccines, GlaxoSmithKline. "GSK was able to act swiftly to increase supply of Hib vaccine so that children can complete the vaccination schedule as recommended by the CDC."

The CDC recommends that children receive the complete Hib vaccination series. The series includes a booster dose in the second year of life, in addition to a complete primary series of immunization in infants.

"It is important for children to complete the series of recommended immunizations, including booster shots, to protect them against serious infectious diseases such as Hib," said Jerome Klein, MD, Professor of Pediatrics at Boston University School of Medicine, member of the Division of Pediatric Infectious Diseases at Boston Medical Center. "The approval and availability of an additional Hib vaccine, for the booster dose will make it possible for children to be fully immunized to prevent serious infectious diseases caused by Hib."

The review of Hiberix for the booster indication was conducted under accelerated approval regulations due to the shortage of Hib vaccine supply in the U.S. GSK submitted safety and efficacy information from clinical studies conducted outside the U.S. for this review. In those studies, a booster dose of Hiberix following primary series vaccination provided protective levels of antibodies against Hib bacteria, regardless of the priming vaccine that was used.

More than 54 million doses of Hiberix have been distributed outside the U.S. since the 1996 launch in Germany, and the vaccine is currently registered in nearly 100 countries.

  The vaccine is expected to be available within several weeks.

About Hiberix

Hiberix is indicated for active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b. Hiberix is approved for use in children 15 months through 4 years of age (prior to fifth birthday).

In clinical studies, adverse events in children receiving Hiberix included pain and redness at the injection site, fever, fussiness, loss of appetite, and restlessness. A severe allergic reaction (e.g. anaphylaxis) after a previous dose of any Hib or tetanus toxoid-containing vaccine or any component of Hiberix is a contraindication. If Guillain-Barre syndrome has occurred within six weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give Hiberix should be based on careful consideration of the potential benefits and possible risks. Vaccination with Hiberix may not protect 100% of susceptible individuals.

About Hib Disease

Hib disease is an often serious and potentially deadly infection caused by bacteria called Hib (Haemophilus influenzae type b). The most common type of invasive Hib disease is meningitis. Hib disease usually occurs in children under five years of age, and immunization is the best preventive measure against the disease. In the U.S., Hib occurs primarily in underimmunized children and among infants too young to have completed the primary immunization series. Due to routine use of the Hib conjugate vaccine since the late 1980's, the incidence of Hib disease in infants and young children in the U.S. has decreased by more than 99 percent.

GlaxoSmithKline Biologicals - GSK Biologicals, GlaxoSmithKline's vaccines business, is one of the world's leading vaccine companies and a leader in innovation. The company is active in the fields of vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development. Headquartered in Belgium, GSK Biologicals has 13 manufacturing sites strategically positioned around the globe. In 2008 GSK Biologicals distributed 1.1 billion doses of vaccines to 176 countries in both the developed and the developing world - an average of 3 million doses a day.

Through its accomplished and dedicated workforce, GSK Biologicals applies its expertise to discover innovative vaccines that contribute to the health and well-being of people of all generations around the world.

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit http://us.gsk.com/.

  Media Inquiries

  Jennifer Armstrong          (919) 483 2839

  Lisa Behrens                (919) 483 2839

  Jen Hill Baxter             (215) 751 7002

  Tom Curry                   (215) 751 5419

Video: http://www.prnewswire.com/mnr/hiberix/38399

Source: GlaxoSmithKline

CONTACT: Jennifer Armstrong, +1-919-483-2839, or Lisa Behrens,
+1-919-483-2839, or Jen Hill Baxter, +1-215-751-7002, or Tom Curry,
+1-215-751-5419

Web Site: http://us.gsk.com/
 

Posted: August 2009

Hiberix (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)) FDA Approval History

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