Brazil facilitates registration of monkeypox vaccine and drugs

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Brazilian health regulator Anvisa approved a new regulatory framework to speed up the approval of monkeypox vaccines and drugs. The country already had such mechanisms to expedite processes related to Covid vaccines, but which are not valid for other diseases.

Under the new rules, the Health Ministry will be allowed to request Anvisa to waive the registration requirement for monkeypox vaccine and drug imports when they are approved by at least one reputable foreign body, such as the World Health Organization or the U.S. Food and Drug Administration.

Anvisa must reply to these requests in up to seven business days, but board member Meiruze Freitas said in a press conference that she thinks responses will be quicker.

At the end of July, Health Surveillance Secretary Arnaldo Medeiros said the Health Ministry ordered 50,000 doses of a monkeypox vaccine through a partnership with the Pan-American Health Organization. Shots are expected to arrive in September and November.

The government-ordered vaccine is produced by Danish pharmaceutical Bavarian Nordic — and is the same being supplied to the U.S. and the European Union. Ms. Freitas does not expect Bavarian Nordic itself to seek approval in Brazil. “Everybody [in the world] is seeking those [monkeypox] products,” she added.