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Supplies and Logistics

Q and A: Update on BCG vaccine market – February 2016

Summary: In 2015, a global supply shortage of 16.5 million dose was experienced for BCG vaccines. However the supply outlook for 2016-2018 is no longer constrained and is considered to be sufficient to meet all country requirements.

Background:
BCG vaccine demand through UNICEF during 2015 increased from 123 million doses to reach 152.2 million doses. Increased country requirements including from some large middle-income countries (MICs) that typically self-procure, and country buffer stock replenishments, accounted for the increase. To meet growing demand, UNICEF secured and awarded three manufacturers additional supply of 38.3 million doses which increased the total 2015 awarded supply through UNICEF to 135.7 million doses, with a 16.5 million dose shortfall.

What were the implications for countries affected by the 2015 BCG vaccine shortage and how did UNICEF manage the shortage?
While countries drew from their in-country buffer stocks of vaccine, available vaccine was apportioned in smaller shipment sizes to countries to support programmes requirements. WHO and UNICEF provided detailed global guidance on how vaccines should be prioritized – if necessary – based on programmatic guidance. As a result, the crisis was successfully managed.

• For further information, please see the Q&A that was released in 2015 on the subject: http://www.unicef.org/supply/index_82351.html

• Also, WHO and UNICEF guidance on country prioritization: http://www.who.int/immunization/diseases/tuberculosis/BCG-country-prioritization.pdf?ua=1

How did UNICEF manage to get to the point of now being able to meet the demand for 2016-2018?
At this point, all manufacturers who supply the global market through UNICEF (except SSI) have resumed normal production and supply. Additionally, there was parallel work by WHO and UNICEF to encourage an additional BCG manufacturer to achieve WHO pre-qualification for their vaccine. As a result, in November 2015 additional quantities were available on the market and the temporary reduced vaccine availability was overcome.

UNICEF concluded its 2016-2018 BCG vaccine tender in September and awarded four manufacturers three-year long-term arrangements (LTAs) to supply 400 million doses. The allocated awards will improve vaccine supply security to meet demand and secure diversified sources of affordable and flexible supply.

The increase in total 2016 supply availability from existing manufacturers, together with supply from a new WHO prequalified vaccine, indicates total supply is sufficient to meet both suppressed 2015 demand carried over to 2016, as well as total forecast demand through 2016-2018.

The outlook for 2016 is that we expect to be able to meet countries annual needs and be in a position to start rebuilding stocks in UNICEF supplied countries. Most UNICEF supplied countries accept receiving vaccines from several manufacturers, as long as the vaccines are WHO pre-qualified. This provides operational flexibility.

• The list of WHO pre-qualified vaccines, including for BCG, can be found here: http://www.who.int/immunization_standards/vaccine_quality/PQ_vaccine_list_en/en/

• For further information, please see the December 2015 Bacillus Calmette-Guérin Vaccine Supply and Demand Update: http://www.unicef.org/supply/files/BCG_Supply_Status_December_2015.pdf


 

 

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