[Texto original em inglês]

The World Health Organization posted on WHO biological website (http://www.who.int/biologicals/en/) the first round public related to Recommendations to assure the quality, safety and efficacy of hepatitis E vaccines. The new recommendations are available at http://www.who.int/biologicals/vaccines/HEP_E_VACCINES_Recommendations_draft_1_public_consultation.pdf?ua=1.

A comment form on hepatitis E vaccines is downloadable from the website next to the document until 12 February 2018.

The current draft recommendations was prepared based on the discussion and consensus reached by the experts from regulators, industry and academia, in the working group meeting in May 2017 and subsequent review and comments of a initial draft by the working group participants over past months.

WHO are seeking for your critical review and comments/suggestions on this document for further development and improvement. Please would you send your comments or comments from your colleagues who are involved in regulation or responsible for manufacturing and quality control of hepatitis E vaccines by using the “comment form” on the web by 12 February 2018 to leid@who.int . Your comments will be reviewed by an informal consultation and incorporated into next version of the Recommendations as appropriate. Finally the Recommendations will be submitted to ECBS for review and adoption in its meeting in October 2018.

Source: Dianliang LEI PhD, Scientist Technologies, Standards and Norms, Essential Medicines and Health Products, World Health Organization. Email: leid@who.int