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ANVISA suspends manufacture of vaccine against tuberculosis

ANVISA suspends manufacture of vaccine against tuberculosis

Anvisa - Agência Nacional of Health Surveillance on Wednesday ordered the suspension of BCG and Immuno BCG vaccine production by the Ataulpho de Paiva Foundation in Rio de Janeiro. The company is the only one that produces these medications in the country and is also the supplier of SUS - Sistema Único de Saúde, manufacturing around 15 million doses per year.

The Agency has determined the suspension based on the result of the sanitary inspection investigation carried out in the manufacturing, between November 28 and 30 of this year. During the inspection, it was verified the non-compliance with Good Manufacturing Practices (GMP) requirements for the manufacture of injectable products. It was also observed that the processes used by the company in the identification of quality deviations and their causes are not efficient.

In previous inspections, Anvisa asked the BCG vaccine manufacturer for an action plan, which was presented on June 24 this year with the necessary adaptations to meet the Good Manufacturing Practices required for injectable products. This plan will be monitored by Anvisa and the Sanitary Surveillance of RJ.

BCG vaccine users

The company's BCG and Immuno BCG vaccines that are on the market have not been suspended and may continue to be used in health services. All lots of these vaccines are submitted to quality control tests by the National Institute of Health Quality Control (INCQS) before being released for consumption in the national market.

What is the BCG vaccine?

A vaccine is composed of the bacillus of Calmette & Guérin, obtained by the attenuation of Mycobacterium bovis, one of the bacteria that transmit the tuberculosis. It is considered mandatory and should be taken as soon as possible.

The National Immunization Program of the Ministry of Health currently recommends universal vaccination of children against tuberculosis. It is important that it be given to the newborn soon. If this is not possible, it should be given after the first month of life. It can be taken by children with positive HIV serology who do not have symptoms, or children of asymptomatic seropositive women.

In areas of high prevalence, children aged 6 to 7 should also be vaccinated on occasion if they do not have a complete vaccination schedule against tuberculosis. Similarly, it can be applied simultaneously with hepatitis B.


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(Health)