Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and biologicals. Planning common next steps. A workshop Report.

This online workshop Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and biologicals. Planning common next steps was organized on October 14th, 2021, by the Animal Free Safety Assessment Collaboration (AFSA), the Humane Society International (HSI), the European Federation of Pharmaceutical Industries and Associations (EFPIA), in collaboration with the International Alliance of Biological Standardization (IABS). The workshop saw a participation of over a hundred representatives from international organizations, pharmaceutical industries and associations, and regulatory authorities of 28 countries.

WHO working group meeting to amend WHO Recommendations to assure the quality, safety and efficacy of live attenuated yellow fever vaccines.

The current WHO Recommendations to assure the quality, safety and efficacy of live attenuated yellow fever vaccines were adopted in 2010. This document recommends that vaccine virus master and working seed lots should be tested for viscerotropism, immunogenicity and neurovirulence in monkeys. A vaccine manufacturer has reported, recently, discrepancies on the clinical scoring of monkeys during assessment of working seed lots and suggested aligning neurotropism assessment of yellow fever vaccines virus seed lots with that of neurovirulence testing of polio vaccines virus seed lots.

Removal of the innocuity test from The International Pharmacopoeia and WHO recommendations for vaccines and biological products.

The innocuity test was indicated as a quality control test to release pharmaceutical and biological products to the market. The test was intended to detect possible extraneous toxic contaminants derived from the manufacturing processes of the product. The test was included in WHO Recommendations and Guidelines for vaccines, biotherapeutics and blood products and in some monographs on antibiotics in The International Pharmacopoeia.

WHO working group meeting to develop WHO Recommendations to assure the quality, safety and efficacy of enterovirus 71 vaccines.

Enterovirus A71 (EV71) is one of the major causative agents of hand, foot and mouth disease (HFMD), and is sometimes associated with severe central nervous system syndromes. Vaccines against EV71 infection have been developed or are in development in several countries and few have been licensed in China. In response to requests from some of these countries, WHO convened a working group meeting in Shanghai China from 11 to 12 September 2019 to develop WHO Recommendations to assure the quality, safety and efficacy of EV71 vaccines.

Acellular pertussis vaccines in China.

In China, whole-cell pertussis (Pw) vaccines were produced in the early 1960s and acellular pertussis (Pa) vaccines were introduced in 1995. Pa vaccines have now almost completely replaced Pw vaccines in the national immunization program. To strengthen the regulation of vaccines used in China, a vaccine lot release system was established in 2001 and Pa vaccines have been included in the system since 2006.

WHO Working Group on revision of the Manual of Laboratory Methods for Testing DTP Vaccines-Report of two meetings held on 20-21 July 2006 and 28-30 March 2007, Geneva, Switzerland.

This report reflects the discussion and conclusions of a WHO group of experts from National Regulatory Authorities (NRAs), National Control Laboratories (NCLs), vaccine industries and other relevant institutions involved in standardization and control of diphtheria, tetanus and pertussis vaccines (DTP), held on 20-21 July 2006 and 28-30 March 2007, in Geneva Switzerland for the revision of WHO Manual for quality control of DTP vaccines. Taking into account recent developments and standardization in quality control methods and the revision of WHO recommendations for D, T, P vaccines, and a need for updating the manual has been recognized. In these two meetings the current situation of quality control methods in terms of potency, safety and identity tests for DTP vaccines and statistical analysis of data were reviewed.

Standardization of regional reference for mamushi (Gloydius blomhoffii) antivenom in Japan, Korea, and China.

The mamushi (Gloydius blomhoffii) snakes that inhabit Japan, Korea, and China produce venoms with similar serological characters to each other. Individual domestic standard mamushi antivenoms have been used for national quality control (potency testing) of mamushi antivenom products in these countries, because of the lack of an international standard material authorized by the World Health Organization. This precludes comparison of the results of product potency testing among countries.