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Supplies and Logistics

UNICEF information to countries on constrained BCG vaccine market

Summary:  Communication between UNICEF and countries that depend on UNICEF-procured commodities is essential when items supporting health programmes are in short supply.
In 2015, 180 million doses of BCG vaccines are projected to be required for countries relying on UNICEF procurement to ensure sustainability of their EPI programmes. However, only 107 million doses are expected to be available from manufacturers. UNICEF is working with partners, suppliers and governments to address the constrained market and its impact on children. Because UNICEF procures only vaccines that have been prequalified by the World Health Organization (WHO), there has been a concentrated effort to encourage existing suppliers to become prequalified.
At the moment, all prequalified BCG vaccine procured through UNICEF has been allocated to requesting countries; these are being shipped in quantities to avoid stock-outs and countries may have to rely on their buffer stocks.   Without the prequalification of BCG vaccine from additional manufacturers, supply constraints are expected to persist into 2016. UNICEF will continue to follow up on the status of prequalification of BCG vaccine from an additional manufacturer that may help to close a part of the 2015 supply gap. 
Achieving vaccine security is the goal of UNICEF’s vaccine procurement strategy. A sustainable, uninterrupted supply of affordable BCG vaccine of assured quality is dependent on many factors which UNICEF, along with other international health partners and organizations, works hard to influence positively. An expanded supplier base and countries’ own efforts to reduce wastage will likely be the biggest factors in alleviating the current shortage, and UNICEF and WHO are working with partners and governments to support enabling these changes. Guidelines on BCG country prioritisation can be found here.
What is BCG vaccine?
Bacille de Calmette et Guérin (BCG) vaccine is used against tuberculosis (TB). The World Health Organization (WHO) recommends that BCG be given to all children living in highly endemic countries as well as to infants and children at particular risk of TB exposure in otherwise low-endemic areas. A single dose of BCG vaccine given to neonates is one intervention that has contributed to a reduction in the burden of TB, and demonstrates the importance of immunization. Information about the BCG vaccine is described in WHO’s position paper:  http://www.who.int/wer/2004/en/wer7904.pdf?ua=1.

Has demand for UNICEF-procured BCG vaccine changed over time?
In the past, the demand for UNICEF-procured BCG vaccine has been relatively stable at around 120 million doses annually. However, over the past three years more and more countries that had procured their own BCG vaccines have turned to UNICEF for help because of the difficulty in accessing global supplies. In 2015, UNICEF was requested to procure 180 million doses for 70 countries.  
Why can’t UNICEF simply buy more BCG vaccine?
UNICEF procures BCG vaccines from suppliers whose vaccines have been prequalified by WHO. Prequalification assures UNICEF that the vaccine meets WHO-prescribed international standards for quality and safety.  Over the past three years, there has been a decline in global availability of BCG vaccine. The main reasons are:

  • The number of suppliers with prequalified vaccine is very limited. There are currently only four suppliers of prequalified BCG vaccine.
  • A number of suppliers who did not have prequalified BCG vaccine have exited the market, leading to an increased demand from the remaining global suppliers.Some suppliers of prequalified vaccines have experienced manufacturing problems that have reduced quantities of vaccines produced by 50 to 80 percent. 

What is UNICEF doing to overcome the shortage of BCG vaccine supply?
UNICEF uses multiple strategies to find solutions to overcome constrained markets. In the case of BCG vaccine:

  • UNICEF is working very closely with prequalified manufacturers to procure any remaining stocks and to encourage increased production. Through existing manufacturers, an additional seven million doses have been sourced for 2015
  • UNICEF has approached other manufacturers in the global market who produce BCG vaccine but do not have WHO prequalification in order to identify any excess production capacity which could potentially be accessed by self-procuring countries. Unfortunately there has been very limited availability found.
  • Suppliers of BCG vaccine that have not been prequalified as yet are being encouraged to seek prequalification and a new manufacturer is expected to have its BCG vaccine WHO-prequalified in 2015.
  • UNICEF is also working with WHO to prioritise the distribution of available vaccines to children who are most vulnerable to the disease.
  • UNICEF is making several smaller shipments which are scheduled to arrive in time to avoid stock out in countries. 
  • Advocacy by UNICEF and health partners is focusing on countries to reduce wastage where possible, and for more suppliers to enter the market by seeking prequalification of BCG vaccines or for existing suppliers to scale up capacity. 

Where can national health authorities get more information on their current BCG vaccine orders?
National health procurement authorities who have ordered BCG vaccines through UNICEF in 2015 should contact their UNICEF Health or Procurement Services focal point in the relevant Country Office for more specific information on the status of shipments. UNICEF market analyses of supply and demand are available on: https://www.unicef.org/supply/index_70361.html
When will the BCG vaccine supply be stabilised?
UNICEF expects the period of market constraint to continue into 2016. However, the anticipated prequalification of additional vaccines from a new supplier may mean that UNICEF will be able to help countries close some of their 2015 supply gap. 



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