Romania: Officials recommend resuming the use of BCG vaccine

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After a temporary suspension of the use of the bacille Calmette–Guérin (BCG) vaccination by Romanian health officials ten days ago, UN and European health agencies are recommending the “immediate resumption” of the BCG vaccine program,according to a World Health Organization (WHO) Regional Office for Europe news release Nov. 30.Out of an abundance of precaution, the Romanian Ministry of Health suspended the use of BCG vaccine after several reports of enlarged lymph nodes in some children who had received the vaccine on Nov. 22.The BCG vaccine was produced by the State Serum Institute (SSI) of Denmark.The new BCG vaccination program, when implemented, was announced by the Romanian Ministry of Health and will include:

• strengthening the risk management plan including guidelines for vaccine administration, follow up and treatment of adverse events;
• reinforcing close monitoring of adverse events to detect them early and enable rapid and appropriate action;
• developing a communication plan for healthcare workers and for the public.

A joint WHO/European Centres for Disease Prevention and Control mission, requested by the Minister of Health, arrived in Romania 26 November and determined that restarting BCG vaccination with the SSI strain in infants was both safe and urgent.Bacille Calmette Guerin (BCG) is the most widely used vaccination in the world. BCG is made of a live, weakened strain of Mycobacterium bovis, (a cousin of Mycobacterium tuberculosis, the TB bacteria). It was developed in the 1930's and it remains the only vaccination available against tuberculosis today.It is used because it is effective in reducing the likelihood and severity of TB in infants and young children. That is especially important in areas of the world where TB is highly prevalent, and the chances of an infant or young child becoming exposed to an infectious case are high.In countries with high rates of TB, BCG is often given to infants at the time of birth because it helps prevent the more serious forms of TB disease from developing in children. In some countries BCG is given to the same person several times during childhood and early adult life, in an effort to maintain an immunity to TB.Investigational Multi-Drug Resistant Tuberculosis Drug Bedaquiline Gets Backing From FDA PanelAccording to the WHO, during the last decade, BCG vaccination has halved the number of TB cases in children under 14 years in Romania. For every million children aged under 5 years with BCG vaccination, over 350 severe TB cases are avoided.For more infectious disease news and information, visit and “like” the Infectious Disease News Facebook page