Vaccine regs amended

Executive Summary

To make clinical testing requirement more flexible and consistent with current scientific knowledge for measles virus vaccine live, mumps virus vaccine live and rubella virus vaccine live, FDA announced in a Nov. 16 Federal Register notice. The amendment, which becomes effective on Dec. 16, removes the consecutive lot requirement for clinical trials; eliminates requirement for prescribed lot tests to allow alternative testing; is changed to allow alternative routes of vaccine administration; and amended to allow mumps vaccine safety test only on chick embryo kidneys, not liver. According to the amendment, rubella virus may now be propagated in cell culture lines other than duck embryo cell cultures, and rabbit renal cultures. Additional standards for measles and smallpox vaccines have been dropped.