MONDAY, June 23, 2008 (HealthDay News) -- The U.S. Food and Drug Administration has approved Sanofi Pasteur's Pentacel combination vaccine for children, the company said Monday.
Approved as a four-dose series at 2, 4, 6 and 15 to 18 months of age, it protects against diphtheria, tetanus, whooping cough (pertussis), polio, and influenza type B. Use of the vaccine could reduce the number of injections children get before they are 18 months old by as many as one-third -- from 23 shots to 16, Sanofi said in a statement.
The vaccine was clinically tested among more than 5,000 children. Adverse reactions included injection site redness, swelling, fever, fussiness, and crying.
The vaccine should not be administered to infants who developed Guillain-Barré syndrome after a prior tetanus vaccine, or if a serious adverse reaction was noted after a prior whooping cough vaccine, the company said.
The FDA has more information about this approval.