MONDAY, Dec. 16, 2002 (HealthDayNews) -- A combination vaccine that protects children against diphtheria, tetanus, whooping cough, polio and diseases that stem from the Hepatitis B virus has been approved by the U.S. Food and Drug Administration.
The Pediatrix vaccine, produced by SmithKline Beecham, includes inoculations that are already available in the United States as separate vaccines, the agency says. But Pediatrix cuts down the number of shots needed in some cases from 9 to 3. The doses are recommended for infants at ages 2 months, 4 months and 6 months.
Side effects were similar to those from the separate vaccines, including pain, redness, swelling and fever. In clinical trials, incidence of fever was greater among those who received the combination vaccine than among recipients of the individual inoculations.
Pediatrix should not be given to infants less than 6 weeks old, the FDA says.
Here is the FDA Talk Paper announcing the approval. For more information about childhood vaccination, visit the U.S. Centers for Disease Control and Prevention.
