WHO and ECDC recommend immediate resumption of BCG vaccination programme against tuberculosis in Romania

WHO/Cristiana Salvi

Mission members reviewing immunization records in the neonatal ward of Bucur Hospital, Bucharest, Romania

A joint mission of WHO/Europe and the European Centre for Disease Prevention and Control (ECDC) to Romania has recommended immediate resumption of bacille Calmette–Guérin (BCG) vaccination against tuberculosis (TB) in the country.

The Ministry of Health temporarily suspended BCG vaccination on 22 November as a precautionary measure, following increased reports of enlarged lymph nodes in children after administration of the vaccine produced by the State Serum Institute (SSI) of Denmark.

The BCG vaccination programme will resume with additional elements, taking account of the mission’s findings. These 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; and
  • developing a communication plan for health care workers and the public.

In 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.

About the mission

The joint WHO/ECDC mission, requested by the Minister of Health, arrived in Romania 26 November and comprised vaccination, safety, TB and communication experts. It assessed the safety profile of the BCG vaccine in use by analysing the observed adverse effects.

During the four-day investigation, the team met with national authorities, experts and health care workers and visited hospitals’ neonatal wards and TB departments. It analysed:

  • BCG vaccine safety
  • vaccine administration practices
  • the severity, frequency and treatment of vaccine reactions
  • the public’s perception of BCG vaccine.

It concluded that restarting BCG vaccination with the SSI strain in infants was both safe and urgent.

BCG Vaccine SSI has been used since 1931 to prevent TB and is distributed worldwide. It holds marketing authorizations in 46 countries and is prequalified by WHO.

WHO/Europe and ECDC will provide continuous support, including to the revision and implementation of a national protocol to manage adverse events following immunization with BCG vaccine.