Procedures for obtaining release of H5N1 sequences to the public domain

Information on the gene sequences of H5N1 viruses is important for vaccine development, the preparation of reagents used for diagnostic purposes, and monitoring for drug-resistant strains.

Sequence information on viruses collected over time and from different geographical areas can help track evolutionary changes in the virus and identify mutations. It is not, however, presently known which mutations affect the pathogenicity and transmissibility of the virus in humans and thus might signal an altered threat to human health. Epidemiological findings remain the most important alert to changes in the virus that indicate improved transmissibility among humans.

Currently, the genetic sequencing of H5N1 viruses is a product of collaborative work between national or other laboratories receiving specimens in countries with outbreaks and the international network of specialized H5 reference laboratories coordinated by WHO. WHO seeks permission from the country that provides the virus to place the sequence information in the public domain.

WHO believes that timely sharing of H5 virus sequence information is a critical step for improving the international response to the avian and pandemic influenza threat. In its coordinating role, WHO seeks to facilitate the timely release of sequence data to the public domain, such as the Los Alamos National Laboratory (LANL) Influenza Sequence Database and GenBank. Formal procedures exist by which the WHO reference laboratory initially informs the originating laboratory of sequence results and simultaneously requests permission to place these results in the public domain. In the event of a negative reply or no reply, WHO directly approaches the Ministry of Health in the originating country, requesting authorization to release sequence data.