Regulacje i polityka gospodarcza · 13.09.1996

Interim DTP/DTaP Vaccine Information Materials

On July 31, 1996, the Food and Drug Administration (FDA) licensed an acellular pertussis vaccine (combined with diphtheria and tetanus toxoids) (DTaP) for administration to infants as young as 2 months of age. This recent development necessitates a revision of the vaccine information statement entitled, ``Diphtheria, Tetanus, and Pertussis Vaccine: What you need to know before your child gets the vaccine,'' which was developed by HHS as required by the National Childhood Vaccine Injury Act of 1986. A separate notice is being published in the Federal Register to begin formal revision of the statement under the procedures mandated by 42 U.S.C. Sec. 300aa-26. Pending completion of the formal revision process to revise the vaccine information statement, CDC is distributing the following interim statement which includes the new information regarding an acellular pertussis vaccine combined with diphtheria and tetanus toxoids (DTaP), to replace the current diphtheria, tetanus, and pertussis statement. This will ensure that individuals receiving the vaccine will have accurate up-to-date information which recognizes the recent licensure of an acellular pertussis vaccine combined with diphth