WHO Guidelines on the quality, safety and efficacy of Vi polysaccharide conjugate typhoid vaccine is now posted and available for review and comment.
The draft e-Guidelines (PDF) can be found here:
The Comment Form (MS Word) can be found here:
The deadline for comments is:
Comments should be sent to:
Mr Jinho Shin at shinj@who.int
Please also know that the following meeting is being planned to review and discuss this document:
· WHO Informal Consultation of WHO Guidelines on Quality, Safety and Efficacy of Typhoid Vi Capsular Polysaccharide Conjugate Vaccine WHO-HQ Geneva, 29 – 30 April 2013
Typhoid fever causes around 21 million cases and at least 200,000 deaths per year. Children are most at risk in typhoid-endemic countries such as India, Pakistan, Nepal and Bangladesh. Vaccination is an effective preventive intervention, especially when coupled with hand washing, household water treatment, and other preventive measures. To date, two safe and effective typhoid vaccines are available: the oral S. Typhi Ty21a vaccine and the injectable Vi polysaccharide (PS) vaccine. However, these vaccines require periodic revaccination and are not applicable for children under aged 2 years. Currently, several groups are developing Vi PS protein conjugate vaccines that are expected to be safe and effective in infancy or early childhood.
At present, there is no global written standard for regulatory evaluation and licensing of typhoid conjugate vaccines. The first working group met together in Jeju, Republic of Korea, 5-7 September 2012 to initiate the process of its development. Clinical data reviews took place in London 7-8 January 2013. The drafting group has prepared a guidelines document for consultation with experts in this field for the meeting.
The objective of the meeting is:
- To broadly consult and gather consensus with national regulatory authorities and national control laboratories, vaccine developers and manufacturers on proposed WHO guidelines on the quality, safety and efficacy of typhoid conjugate vaccines.
The expected outcome is:
The proposed WHO guidelines on the quality, safety and efficacy of typhoid conjugate vaccines to be submitted for adoption to the WHO Expert Committee on Biological Standardization (ECBS) at its meeting in October 2013.
The WHO contacts are:
When finalized and approved, the WHO Expert Committee on Biological Standardization (ECBS) report will complement already available WHO Technical Report Series ECBS reports on typhoid vaccines:
- Posted By IPA Admin Office on Date (MM/DD/YYYY) : 03/21/2013
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