Giuseppe
Emeritus
[Source: World Health Organization, full PDF document: (LINK). Edited.]
Update of the development and availability of candidate vaccine viruses for avian influenza A(H7N9), 20 May 2013
Safety testing of two potential candidate vaccine virus (CVV) for avian influenza A(H7N9) virus, IDCDC-RG32A(1), developed by the WHO Collaborating Centre for Reference and Research on Influenza in the Centers for Disease Control and Prevention, US, and NIBRG-2681, developed by the WHO Essential Regulatory Laboratory (ERL) in the National Institute for Biological Standards and Control (NIBSC), UK, using reverse genetics technology, have been completed following the recommended safety testing regimen as described in the ?Update of WHO biosafety risk assessment and guidelines for the production and quality control of human influenza vaccines against avian influenza A(H7N9) virus?(2).
The resulting data have been reviewed by an expert group convened by WHO and have been found to be satisfactory. Therefore, it was concluded that the virus IDCDC-RG32A and NIBRG-268 are attenuated compared to a closely related wild-type A(H7N9) virus, A/Anhui/1/2013.
In view of the above, the potential candidate vaccine viruses IDCDC-RG32A and NIBRG-268 can now be handled under BSL-2 enhanced(3) containment.
The expert group also concluded that CVVs that have HA and NA genes with sequences that are identical or nearly identical to those of a reassortant virus, in this case the IDCDC-RG32A, that has already been assessed, would be exempted from full safety testing(2). Therefore, two other potential CVVs of A(H7N9), NIBRG-267, developed by the WHO ERL in NIBSC, UK; and CBER-RG4A, developed by the WHO ERL at the Center for Biologics Evaluation and Research, US, can now also be handled in the same conditions as recommended for IDCDC-RG32A: BSL-2 enhanced containment.
It should be noted that these are potential CVVs that have not yet been fully characterized antigenically.
The summary table of candidate vaccine viruses of influenza A(H7N9) is updated on the WHO website(4).
_________
1. http://www.who.int/entity/influenza/vaccines/virus/candidates_reagents/summary_a_h7n9_cvv_20130510.pdf
2. http://www.who.int/biologicals/areas/vaccines/influenza/biosafety_risk_assessment_10may2013.pdf
3. WHO biosafety risk assessment and guidelines for the production and quality control of human influenza pandemic vaccines, TRS No. 941, Annex 5 (2007), http://www.who.int/biologicals/publications/trs/areas/vaccines/influenza/Annex%205%20human%20pandemic%20influenza.pdf
4. http://www.who.int/influenza/vaccines/virus/candidates_reagents/summary_a_h7n9_cvv_20130520.pdf
-
-------
Update of the development and availability of candidate vaccine viruses for avian influenza A(H7N9), 20 May 2013
Safety testing of two potential candidate vaccine virus (CVV) for avian influenza A(H7N9) virus, IDCDC-RG32A(1), developed by the WHO Collaborating Centre for Reference and Research on Influenza in the Centers for Disease Control and Prevention, US, and NIBRG-2681, developed by the WHO Essential Regulatory Laboratory (ERL) in the National Institute for Biological Standards and Control (NIBSC), UK, using reverse genetics technology, have been completed following the recommended safety testing regimen as described in the ?Update of WHO biosafety risk assessment and guidelines for the production and quality control of human influenza vaccines against avian influenza A(H7N9) virus?(2).
The resulting data have been reviewed by an expert group convened by WHO and have been found to be satisfactory. Therefore, it was concluded that the virus IDCDC-RG32A and NIBRG-268 are attenuated compared to a closely related wild-type A(H7N9) virus, A/Anhui/1/2013.
In view of the above, the potential candidate vaccine viruses IDCDC-RG32A and NIBRG-268 can now be handled under BSL-2 enhanced(3) containment.
The expert group also concluded that CVVs that have HA and NA genes with sequences that are identical or nearly identical to those of a reassortant virus, in this case the IDCDC-RG32A, that has already been assessed, would be exempted from full safety testing(2). Therefore, two other potential CVVs of A(H7N9), NIBRG-267, developed by the WHO ERL in NIBSC, UK; and CBER-RG4A, developed by the WHO ERL at the Center for Biologics Evaluation and Research, US, can now also be handled in the same conditions as recommended for IDCDC-RG32A: BSL-2 enhanced containment.
It should be noted that these are potential CVVs that have not yet been fully characterized antigenically.
The summary table of candidate vaccine viruses of influenza A(H7N9) is updated on the WHO website(4).
_________
1. http://www.who.int/entity/influenza/vaccines/virus/candidates_reagents/summary_a_h7n9_cvv_20130510.pdf
2. http://www.who.int/biologicals/areas/vaccines/influenza/biosafety_risk_assessment_10may2013.pdf
3. WHO biosafety risk assessment and guidelines for the production and quality control of human influenza pandemic vaccines, TRS No. 941, Annex 5 (2007), http://www.who.int/biologicals/publications/trs/areas/vaccines/influenza/Annex%205%20human%20pandemic%20influenza.pdf
4. http://www.who.int/influenza/vaccines/virus/candidates_reagents/summary_a_h7n9_cvv_20130520.pdf
-
-------