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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 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).
#Internacional | La #Anvisa liberó el uso de la vacuna Jynneos/Imvanex y el medicamento Tecovirimat contra la viruela del mono. Brasil va 4 mil 144 infectados y un fallecido. El Ministerio de Salud podrá importar y utilizar la vacuna y el medicamento en territorio nacional. pic.twitter.com/yBbg335sk8
The Anvisa released the use of the Jynneos/Imvanex vaccine and the drug Tecovirimat against monkeypox. Brazil has 4,144 infected and one deceased. The Ministry of Health may import and use the vaccine and medicine in national territory.
After the U.S. and Spain, Brazil, with more than 4 000 confirmed monkeypox cases, is the third most affected country in the world. So far, only one death has been reported in Brazilian territory.
This outbreak of monkeypox virus was declared an international health emergency by the World Health Organization (WHO) on July 23.