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Viruses and reagents

Status of development of candidate vaccine viruses and reagents

 

Candidate vaccine viruses being developed internationally

 

Candidate vaccine viruses are being developed by a number of laboratories as indicated by WHO .

A/California/7/2009 (egg isolate) – classical reassortment and reverse genetics

A/England/195/2009 (MDCK cell isolate) – reverse genetics

A/California/4/2009 (MDCK isolate) – reverse genetics

A/Texas/5/2009 (MDCK isolate) - reverse genetics

A/Ohio/7/2009 (MDCK isolate) - reverse genetics

A/New York/20/2009 (MDCK isolate) - reverse genetics

The candidate vaccine viruses currently available are listed below and are also indicated by WHO

 

Candidate influenza vaccine viruses

Parental H1N1 virus

Laboratory

NYMCX-179A conventional reassortant virus A/California/7/2009 NYMC, USA
NYMCX-181 conventional reassortant virus A/California/7/2009 NYMC, USA
NYMCX-181A conventional reassortant virus A/California/7/2009 NYMC, USA
IVR-153 conventional reassortant virus A/California/7/2009 CSL, Australia
IDCDC –RG15 reverse genetics virus A/Texas/5/2009 CDC, USA
CBER-RG2 reverse genetics virus A/California/04/2009 CBER, USA
NIBRG-121 reverse genetics virus A/California/7/2009 NIBSC, UK
NIBRG-121xp reverse genetics virus A/California/7/2009 NIBSC, UK
NIBRG-122 reverse genetics virus A/England/195/2009 NIBSC, UK

 

Candidate vaccine viruses available from NIBSC

Candidate influenza vaccine viruses 3

Parental H1N1 virus

NIBSC code

Availability

NIBRG-121 1 A/California/7/2009 09/122 Now
NIBRG-121xp 2 A/California/7/2009 09/268 Now
NYMCX-179A 1 A/California/7/2009 09/216 Now
NYMCX-181 2 A/California/7/2009 09/176 Now
NYMCX-181A 2 A/California/7/2009 09/178 Now
IVR-153 1 A/California/7/2009

09/236

Now
NIBRG-122 2 A/England/195/2009 09/130 Now

1 Safety tests have been completed and are reported by WHO

2 Safety tests are not needed as earlier tests of similar reassortants indicate that they are attenuated in ferrets, as described by WHO.

3 Large-scale work can be done under BSL-2 enhanced (pandemic influenza vaccines), or at BSL-2 if there is widespread pandemic (H1N1) 2009 virus infection locally and a comprehensive risk assessment has been agreed, as described by WHO

 

Reagents

Reagents for Single Radial Diffusion assay of Influenza A (H1N1)v virus vaccine will be developed by NIBSC and other Essential Regulatory Laboratories. As work progresses, new information will be made available.

 

Reagents for influenza vaccine standardisation

NIBSC code

Availability

A/California/7/2009 (NYMCX-179A) antigen (cell derived)

09/174 Now

A/California/7/2009 (NYMCX-179A) antigen (egg derived)

09/146 Now

A/California/7/2009 (NIBRG-121xp) antiserum

09/196 Now

A/California/7/2009 antiserum

09/152 Now

1 Maximum order 30 vials per manufacturing site

2 No restriction on number of vials ordered

 

Ordering candidate vaccine viruses from NIBSC

The conventional reassortants NYMCX-179A , NYMCX-181, NYMCX-181A and IVR-153 and the reverse genetics viruses NIBRG-121, NIBRG-122 and NIBRG-121xp may be ordered at standards@nibsc.hpa.org.uk

 

Viruses are free of charge (normally a maximum of two vials per recipient), but customers are expected to pay shipping and packaging costs. Reagents for Single Radial Diffusion assay are subject to the usual NIBSC handling charge of £60 per vial, plus shipping and packaging costs. Approved National Control Laboratories for human health are exempt from the £60 handling fee.

Importation of viruses and reagents

If you anticipate ordering any of these materials, we recommend that you contact your local regulatory authorities now and start the process of applying for import permits, as these can take some time to arrange.

 

Some countries make a distinction between import permits for commercial purposes where the material will be distributed and for research purposes where the material will be consumed within the importing organisation. We advise applying for a RESEARCH permit as the conditions applied will usually be less strict and thus help to avoid delays. You will have to give an undertaking that the materials will not be distributed outside of your organisation. This will usually minimise or even eliminate the import conditions