Volume 7: Medicines and Cosmetics
Annex 4 to Chapter 6: Human vaccines that did not comply with the 1989 CSM/VPC guidelines

Vaccine	Compliance with guidelines	Estimated stocks of non-complying vaccines			BSEWG advice
		10 Jan. 1990	31 May 1990	31 Oct. 1990	10 Jan. 1990	4 July 1990	31 Oct. 1990
Measles	Serum - changed to NZ source mid-1990.	to Sept. 1990	3 months' supply(ie, to Sept. 1990).		For vaccines generally - benefits of vaccine programme outweighs risk.	No specific advice as source changed and stocks only to Sept. 1990.
MMR (unlicensed)	Peptone - switched to non-UK source Sept. 1990.	to Dec. 1990	184,029 doses.			Should only be granted a licence if complies with guidelines.
Tuberculin PPD	Glycerol beef broth - eliminated from production second half of 1990.	to Sept. 1991	18 months' supply (ie, to Dec. 1991).		Company should be asked to move over to the new product and replace stocks as soon as feasible.	Replacement of stocks should be encouraged as quickly as practicable.
DTP	Media - changed to non-UK source Sept. 1990. Media produced prior to change-over was incorporated in final product until December 1990.	Adsorbed: to June 1990. Unadsorbed: to May 1991.	for supply through to 1992/93.	Adsorbed: to between June 1991 and Dec. 1991. Unadsorbed: to between Sept. 1992 and Dec. 1994.	Replacement of unadsorbed with adsorbed should ensure former is replaced earlier than 1991.	Meeting to be held with the company to discuss future plans and bring forward time for exhaustion of stocks.	Explore whether the unadsorbed vaccines should be replaced with batches that complied with the guidelines, especially for stock-out date beyond 1991.