FDA Approves GlaxoSmithKline's New Combination Vaccine For Children

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Main Category: Immune System / Vaccines
Also Included In: Pediatrics / Children's Health;  Pharma Industry / Biotech Industry
Article Date: 25 Jun 2008 - 11:00 PDT

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The US Food and Drug Administration (FDA) announced yesterday that it had given approval for the first new combination vaccine for protecting 4 to 6 year old children against diphtheria, tetanus, pertussis and polio diseases in one shot, made by GlaxoSmithKline (GSK).

The vaccine is branded as the trademarked name KINRIX, and its official long name is Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine.

It is approved for use with children who have already received GSK's Infanrix or Pediarix combination vaccines. Infanrix covers DPT, diphtheria, tetanus and pertussis (whooping cough), and Pediarix covers DPT, hepatitis B and polio.

Health experts tend to recommend combination vaccines because they reduce the number of shots children receive in a single visit.

On Monday, Sanofi Pasteur, part of French drugmaker Sanofi-Aventis SA, announced that the FDA had granted a license for its new 5-in-1 vaccine for use with children under 5 to protect them against diptheria, tetanus, pertussis, polio and Hib disease.

Assistant Clinical Professor of Pediatrics, University of California, San Diego School of Medicine, Dr William P. Hitchcock said in a press statement that:

"Children 4 to 6 years-old can receive five or more vaccinations in a single visit, which can be stressful for parents and vaccinators."

Reducing the number of vaccine shots a child receives in a visit, combination vaccines like KINRIX may help families meet CDC recommendations and school vaccination requirements, he added.

According to GSK, clinical trial results on KINRIX showed that it offers similar protection to the separate vaccines for Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) and Inactivated Poliovirus (IPV), and it has a similar safety profile.

The Phase III trial of KINRIX was the final confirmation. This comprised a randomized controlled study involving 3,156 US children aged from 4 to 6 years who were vaccinated with KINRIX at the same time as receiving their second dose of measles, mumps and rubella (MMR) vaccine (US licensed M-M-RII).

All the children had already received four doses of DTaP (INFANRIX) and three doses of IPV (IPOL).

Director for US Clinical Research and Development/Medical Affairs at GlaxoSmithKline, Dr Wayde M Weston, said that KINRIX contains the same DTaP and IPV ingredients as INFANRIX and PEDIARIX, two vaccines that doctors in the US have used for many years.

"With the introduction of KINRIX," said Weston, "eligible 4 to 6 year-olds can receive protection against four serious diseases with one less shot."

Sources: GSK press release, Associated Press.

Written by: Catharine Paddock, PhD


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