Brazil’s National Health Surveillance Agency (Anvisa) approved the registration exemption for the Health Ministry to import and use the Bavarian Nordic vaccine and the drug Tecovirimat.
The vaccine developed by Bavarian Nordic is manufactured in Denmark and Germany, while Tecovirimat, which has already gone on sale in the U.S., is manufactured by the multinational Catalent Pharma Solutions.
The vaccine developed by Bavarian Nordic is manufactured in Denmark and Germany, while Tecovirimat, which has already gone on sale in the U.S., is manufactured by the multinational Catalent Pharma Solutions.
The authorization of the vaccine, called Jynneos in the U.S. and Imvanex in Europe, is “temporary and exceptional.” The Health Ministry is the only authority that can import the vaccine for six months. The vaccine is intended for adults 18 years of age and older.
Tecovirimat is a capsule administered orally. This product is indicated to treat diseases caused by Orthopoxvirus in adults, adolescents, and children of at least 13 kilograms of weight.
The move is a requirement for the use in Brazil of 50 000 doses of the vaccine being negotiated by the country’s Health Ministry with the Pan American Health Organization (PAHO).
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