ECDC and WHO recommend resumption of TB vaccination program in Romania
The Romanian Ministry of Health temporarily suspended immunization with the vaccine on November 22 as a precautionary measure. There were reports of enlarged lymph nodes in children following administration of vaccines produced by the State Serum Institute of Denmark.
The joint ECDC/WHO mission arrived in Romania on November 26 to assess the safety profile of the BCG vaccine. The team analyzed vaccine safety, vaccine administration practices, public BCG vaccine perception, and the frequency, severity and treatment of vaccine reactions.
The mission concluded that restarting the BCG vaccination with the SSI strain in infants was safe and urgent. The vaccination program will resume with additional elements, including strengthening a risk management plan, reinforcing close monitoring of adverse events and creating a communication plan for health care workers with the public.
The BCG vaccine cut the number of Romanian childhood TB cases in half in the last decade. By vaccinating one million children under the age of five, the organizations predict more than 350 severe TB cases are avoided.
BCG Vaccine SSI has been used since 1931 for the prevention of TB. The company has marketing authorizations in 46 countries.