POST 00869E : COMBINATION VACCINES, LYOPHILIZED VACCINES, DILUENTS AND VVMS

POST 00869E : COMBINATION VACCINES, LYOPHILIZED VACCINES, DILUENTS AND VVMS Follow-up on Posts 00847E, 00852E, 00855E, 00858E, 00860E and 00864E 26 December 2005 _____________________________________ Michel Zaffran (mailto:[email protected]) from WHO draws some conclusions from this discussion started by his message of 26 October. At the same time he answers questions asked by Anthony Battersby (mailto:[email protected]) from the United Kingdom, like this one raised by a reply to his query from a vaccine manufacturer, and published here in the first part of this message. _____________________________________ Below is GSKs response to my question about the suitability of keeping reconstituted Pentavalent vaccine. What is the basis for suggesting that Penta can be kept longer when it has been reconstituted? Anthony -------------Forwarded Message----------------- From: INTERNET:[email protected], INTERNET:[email protected] To: FBA Date: 12/12/2005 11:14 PM RE: Tritanrix-HB+Hib Enquiry Dear Anthony Battersby Thank you for your query regarding our product Tritanrix-HB+Hib* (diptheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type B vaccine). You requested information on the storage and stability of this product once it has been reconstituted. I hope that the following information is useful to you. Tritanrix-HB+Hib is not marketed in the UK, and therefore I am unable to make any specific recommendations for it use. However, it is marketed throughout Europe. Section 3.2.6 of the European Product Monograph states: "Tritanrix-HB+Hib is presented as a Tritarix-HB suspension in a monodose or two-dose glass vial. Upon storage, a white deposit and clear supernatant can be seen. Hib is presented as a white pellet in a monodose or two-dose glass vial. The shelf-life is indicated on the labels and packaging. The maximum shelf-life is 3 years. Tritanrix-HB+Hib should be stored at +2 C to +8 C. Freezing is contraindicated, and if the vial has been frozen, it should be discarded." "The final vaccine is prepared by reconstitution of the Hib pellet with the Tritanrix-HB suspension. The vial containing the reconstituted vaccine has to be shaken to obtain a homogenous turbid white suspension. Check for any particulate matter and discard if any is observed. After reconstitution, the vaccine should be used promptly. If left standing, a white deposit and clear supernatant may appear; shaking will restore homogeneity. Partially used two-dose vials can be stored for up to 24 hours at +22 C. However, according to WHO recommendations, the remaining vaccine must be discarded after the end of each immunization session, or after 6 hours from reconstitution, whichever comes first." It would be a clinical decision as to whether the vial is stored for the 24 hours after reconstitution. Kind regards Michael R Keegan BSc (Hons) HIV, Vaccines, Neurology and Critical Care Medical Information Advisor GlaxoSmithKline UK Ltd. -------------------------------- The traditional lyophilized vaccines (yellow fever, measles) do not contain preservatives because of the interaction of the preservative/thiomersal with the live attenuated organism. Hence the diluents for these vaccines have traditionally been some form of Water for Injection with no preservatives. Therefore, The WHO recommendations, on the use of multidose vials (MDVP) applied only to liquid bacterial vaccines which contained thiomersal (and met other of requirements as spelled out in the policy statement With the DTP HepB - Hib or DTP-Hib, we have a lyophilized vaccine (hib) which is not a live attenuated vaccine. It is a conjugated vaccine which is not incompatible a priori with thiomersal and therefore can be reconstituted and combined with DTP or DTP HepB (containing thiomersal) The question was raised some time back of whether we should take advantage of this situation and open the door to the application of the multi-dose vial policy to this new generation of vaccines. Some preliminary data of studies conducted in South Africa showed that it was probable that the policy could apply (i.e. the effect of the preservative would be such that an accidental contamination of the vial on the first day --- which of course should be avoided --- would not result in growth of the micro organism over time- the preservative would prevent this growth and even reduce the number of colonies). In other words the risk if not higher the second day than the first - hence the MDVP The consensus at that time however was that , it would be very confusing to the field to have some lyophilized vaccines for which the MDVP applies when all others must be discarded at the end of the session or after 6 hours which ever comes first. The message I sent requesting views on a possible change of practice, was trying to see whether the VVM was well enough established on the ground to help differentiate between the different types of lyophilized vaccines (those that must be discarded and those that could be kept according to the MDVP) . From the range of reactions we have received it appears clearly that this would be a very premature move Michel Michel Zaffran Coordinator, Access to Technologies Immunization, Vaccines and Biologicals WHO Family and Community Health ______________________________________________________________________________ ______________________________________________________________________________ Visit the TECHNET21 Website at http://www.technet21.org You will find instructions to subscribe, a direct access to archives, links to reference documents and other features. ______________________________________________________________________________ To UNSUBSCRIBE, send a message to : mailto:[email protected] Leave the subject area BLANK In the message body, write unsubscribe TECHNET21E ______________________________________________________________________________ The World Health Organization and UNICEF support TechNet21. The TechNet21 e-Forum is a communication/information tool for generation of ideas on how to improve immunization services. It is moderated by Claude Letarte and is hosted in cooperation with the Centre de coopération internationale en santé et développement, Québec, Canada (http://www.ccisd.org) ______________________________________________________________________________