The National Agency for Health Surveillance (ANVISA) closed on Thursday (13th) another batch of pentavalent vaccine from the Indian company Biologicals E. Limited. This is the second time in less than a month. Again, a suspended lot of pentavalent vaccine. According to him, he "got bad results in the aspect test."
“Appearance analysis” is an analysis of the regulatory body that checks the color, smell and characteristics of the product packaging. For example, it identifies any change in texture or the presence of particles.
Limited lots do not apply.
In a note sent G1Anvisa explained that the vaccine was not registered in Brazil, but “was imported by the Ministry of Health on an exceptional basis for use in the immunization program”, as provided for in resolution 203/2017.
This standard establishes criteria for products not registered in Brazil for import. This can happen in four situations:
- When there is no product in the national market or therapeutic alternatives registered with Anvisa;
- In cases of public health emergency of national or international importance;
- For immunobiological preparations that are part of the National Immunization Program, which are acquired by the Revolving Fund of the Pan American Health Organization (PAHO) or the World Health Organization (WHO);
- Donations from international multilateral organizations or official agencies of foreign cooperation.
Anvisa also clarified that the ban applies only to a specific lot, and not to all vaccines from the same manufacturer. Hanging lot number 220103417C, manufactured in April 2017 and valid until October 2019.
Prior to the closure of this report, Biologix E. Limited did not comment. A pharmaceutical company specializes in the manufacture of low-cost vaccines.
The pentavalent vaccine, as the name suggests, protects the patient from five diseases: diphtheria, tetanus, whooping cough, hemophilic influenza type B bacteria (responsible for nose and throat infections), and hepatitis B .