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Seventh GAVI Board Meeting, Stockholm, 11 March 2002

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Discussion

• The GAVI Board had previously granted the Indonesian application for birthdose hepB vaccine conditional approval with the following two conditions:
  
  
  • To provide a detailed plan of action for the proposed nation-wide expansion hepB birth dose vaccine for the first two implementing years;
  • To provide plans to strengthen the function of ICC.
    
    
• After reviewing the responses and information received by Indonesia to the above conditions, the IRC recommends approval for the application for birth dose hepB vaccine for 5 years. In addition, Indonesia has made a request for injection safety support, a request that the IRC recommends be resubmitted.
  
  
• Concern was expressed regarding reports that Biopharma is experiencing high wastage rates in filling Uniject (the brand name of Biopharma’s pre-filled monodose technology), which may be an indication that the technology is not completely ready for industrial use.  This will need to be monitored.

DECISIONS

The Board: 

8.1. Approved the recommendations of the IRC:  one year of support to Indonesia for a birth dose of pre-filled monodose hepatitis B vaccine.  The vaccine will be procured nationally at a price in 2002 of $0.80 per dose, at a total estimated cost for 2002 of $2,508,000, and a potential five-year commitment of $16 million.  The vaccine price will be re-negotiated after one year.

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