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WHO- Vaccine response to the avian influenza A(H7N9) outbreak - step 1: development and distribution of candidate vaccine viruses
2 May 2013
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Release of candidate vaccine viruses
Candidate vaccine viruses are usually released to interested manufacturers after a series of characterization and safety tests have been completed1.
However, discussion with experts aimed at enhancing vaccine production readiness has led to a consensus that permits the expedited release of reassortant candidate vaccine viruses before the completion of all safety testing and characterization of the viruses. Specifically, a potential candidate vaccine virus can be released to a recipient if:
? The reassortant virus has passed the following tests satisfactorily:
o sequencing of the HA gene
o chicken embryo survival testing
? The recipient has BSL3 facilities and appropriate import permit if needed
should be noted that a virus that has passed the two safety tests described above, will still require handling at a biosafety level equivalent to that applicable for wild-type viruses (BSL-3 at laboratory scale, BSL-3 enhanced for large scale work). Furthermore, without antigenic characterization by one-way and two-way HI tests, no assessment of the antigenic appropriateness of a potential CVV can be given, and use of such potential CVVs is conducted at the manufacturer?s own risk.
A guidance document describing the required biosafety tests for CVVs derived from avian influenza A(H7N9) will be published on the WHO website shortly.
WHO will provide updates on the development and testing of potential CVVs on its website at: http://www.who.int/influenza/vaccines/virus/en/
Receipt of candidate vaccine viruses
In order to request potential reassortant candidate vaccine viruses of A(H7N9), vaccine manufactures, research institutes and other interested bodies should send an email to WHO CCs and ERLs of GISRS as listed at: http://www.who.int/influenza/gisrs_l...en/index.html; in particular, at this stage of development of CVVs, the WHO CC at CDC US (rvd6@cdc.gov) and the WHO ERL at NIBSC UK (Othmar.Engelhardt@nibsc. org), as well as the WHO CC at CCDC China (xinli@cnic.org.cn), the WHO CC at NIID Japan (nobusawa@nih.go.jp) and the WHO ERL at CBER/FDA, US (Zhiping.ye@fda.hhs.gov ) which are expecting to have potential reassortant candidate vaccine viruses of A(H7N9) available shortly.
To receive fully characterized and safety tested reassortant and wild type candidate vaccine viruses of A(H7N9), requests should be sent to WHO CCs and ERLs of GISRS as listed at: http://www.who.int/influenza/gisrs_l.../en/index.html.
A(H7N9) viruses, including reassortant candidate vaccine viruses, are considered PIP Biological Materials and are being shared under the PIP Framework (http://www.who.int/influenza/resourc.../en/index.html).
For general
see further information:
2 May 2013
Clip:
Release of candidate vaccine viruses
Candidate vaccine viruses are usually released to interested manufacturers after a series of characterization and safety tests have been completed1.
However, discussion with experts aimed at enhancing vaccine production readiness has led to a consensus that permits the expedited release of reassortant candidate vaccine viruses before the completion of all safety testing and characterization of the viruses. Specifically, a potential candidate vaccine virus can be released to a recipient if:
? The reassortant virus has passed the following tests satisfactorily:
o sequencing of the HA gene
o chicken embryo survival testing
? The recipient has BSL3 facilities and appropriate import permit if needed
should be noted that a virus that has passed the two safety tests described above, will still require handling at a biosafety level equivalent to that applicable for wild-type viruses (BSL-3 at laboratory scale, BSL-3 enhanced for large scale work). Furthermore, without antigenic characterization by one-way and two-way HI tests, no assessment of the antigenic appropriateness of a potential CVV can be given, and use of such potential CVVs is conducted at the manufacturer?s own risk.
A guidance document describing the required biosafety tests for CVVs derived from avian influenza A(H7N9) will be published on the WHO website shortly.
WHO will provide updates on the development and testing of potential CVVs on its website at: http://www.who.int/influenza/vaccines/virus/en/
Receipt of candidate vaccine viruses
In order to request potential reassortant candidate vaccine viruses of A(H7N9), vaccine manufactures, research institutes and other interested bodies should send an email to WHO CCs and ERLs of GISRS as listed at: http://www.who.int/influenza/gisrs_l...en/index.html; in particular, at this stage of development of CVVs, the WHO CC at CDC US (rvd6@cdc.gov) and the WHO ERL at NIBSC UK (Othmar.Engelhardt@nibsc. org), as well as the WHO CC at CCDC China (xinli@cnic.org.cn), the WHO CC at NIID Japan (nobusawa@nih.go.jp) and the WHO ERL at CBER/FDA, US (Zhiping.ye@fda.hhs.gov ) which are expecting to have potential reassortant candidate vaccine viruses of A(H7N9) available shortly.
To receive fully characterized and safety tested reassortant and wild type candidate vaccine viruses of A(H7N9), requests should be sent to WHO CCs and ERLs of GISRS as listed at: http://www.who.int/influenza/gisrs_l.../en/index.html.
A(H7N9) viruses, including reassortant candidate vaccine viruses, are considered PIP Biological Materials and are being shared under the PIP Framework (http://www.who.int/influenza/resourc.../en/index.html).
For general
see further information:
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