Overview:
The first doses of the vaccine against monkeypox destined for Brazil has been approved by Anvisa and its dispensation applies only to the Ministry of Health and will be valid for six months.
Introduction:
The National Health Surveillance Agency (Anvisa) approved the release for use of the Jynneos/Imvanex vaccine against monkeypox and the drug tecovirimat to treat the disease in Brazil. To grant the approvals, the agency reviewed data from the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).
The temporary and exceptional waiver applies only to the Ministry of Health and will be valid for six months, provided it is not expressly revoked by Anvisa.
Anvisa authorizations:
Tecovirimat: concentration 200 mg, in the pharmaceutical form hard capsule, oral use, shelf life 84 months and indicated for the treatment of diseases caused by Orthopoxviruses in adults, adolescents and children weighing at least 13 kg.
Jynneos/Imvanex vaccine: Immunizer from the company Bavarian Nordic A/S is manufactured in Denmark and Germany. The vaccine is intended for adults 18 years of age and older and has a shelf life of up to 60 months when stored at -60 to -40°C.
Anvisa: Infection Control in Brazil:
Anvisa-Brasil expected that the smallpox vaccine and drug will prevent or reduce the severity of Monkeypox infection. However, he stressed the need for monitoring studies to be conducted to confirm the effectiveness of the vaccine for the prevention of Monkeypox.
Learn More: Monkey Sickness x Vaccinesx Medication
Need Regulatory Affairs in Brazil or USA ? contact us!
References
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.