A joint mission of the European Centre for Disease Prevention and Control (ECDC) and World Health Organization Regional Office for Europe (WHO/Europe) to Romania has recommended immediate resumption of BCG (Bacille Calmette–Guérin) vaccination against tuberculosis in infants in the country.
The new BCG vaccination programme announced by the Romanian Ministry of Health 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.
BCG vaccination was suspended by the Romanian authorities on 22 November as a precautionary measure following increased reports of enlarged lymph nodes in some children who had received the vaccine.
The Romanian Minister of Health asked ECDC and WHO/Europe to analyse the observed adverse effects in order to assess the safety profile of the BCG vaccine currently in use (produced by the Statums Serum Institut (SSI) in Denmark).
During the four-day investigation, the team – comprising experts in vaccine programmes and safety, tuberculosis, and communication – met with national authorities, experts and healthcare workers, visited hospitals’ neonatal wards and tuberculosis departments analysing BCG vaccine safety.
ECDC and WHO/Europe will ensure continuous support, including revision and implementation of a national protocol to manage adverse events following immunisation with BCG vaccine.
BCG vaccination in Romania
In the last decade BCG vaccination halved the number of tuberculosis cases in children under 14 years in Romania. For every million children under the age of five years vaccinated with BCG vaccine, over 350 severe tuberculosis cases are avoided.
The BCG-SSI vaccine has been used since 1931 to prevent TB and is distributed worldwide. It holds marketing authorisations in 46 countries and is prequalified by WHO.
Press conference presentation by Romanian Ministry of Health - 30 November 2012 (in Romanian)
The WHO/Europe and ECDC joint expert team reviewing immunization records in neonatal ward of the Bucur Hospital in Bucharest, Romania. From left: Dr. Kari Johansen, vaccine programme and safety specialist, ECDC; Dr. Victor Olsavszky, head of country office in Romania; Dr Patricia Vermeer de Bondt, vaccine safety specialist, WHO temporary advisor; and a nurse working in the hospital. Copyright WHO/C.Salvi