Anvisa (National Health Surveillance Agency) authorized the importation of a vaccine against monkeypox and the drug Tecovirimat, an antiviral used to treat the disease. The approval took place this Thursday (25) in a unanimous decision of the collegiate board.
In both cases, the temporary exemption from registration has a period of six months, and can be revoked, and is valid only for the Ministry of Health – which, in practice, prevents private companies from importing and marketing the products.
The authorization applies to the vaccine from the Bavarian Nordic A/S company, manufactured in Denmark and Germany. Despite being the same product, the immunizer is called Jynneos in the United States and Imvanex in Europe.
The Ministry of Health had asked Anvisa to release the vaccine on Tuesday (23). Last week, the agency approved the rule that provides for the exemption of registration for the importation of medicines and vaccines intended for the prevention or treatment of monkeypox.
The federal government purchased 50,000 doses from PAHO (Pan American Health Organization) for the vaccination of specific groups, such as health professionals who deal directly with the virus in laboratories. The expectation is that 20 thousand doses arrive in the country in September and the rest in October.
According to Anvisa’s definition, the Bavarian Nordic vaccine should only be applied to adults aged 18 or over. The shelf life is 60 months when stored under appropriate conditions.
The antiviral Tecovirimat can be used with a concentration of 200 mg in the treatment of adults and children weighing at least 13 kg. The drug is for oral use.
Brazil will initially receive a small donation from PAHO, for only 50 people. At the beginning of the month, the Minister of Health, Marcelo Queiroga, said that the antiviral will be intended for the most serious patients. “There are immunosuppressed patients, young, with lesions in more than 80% of the body,” he said at the time.
According to the balance sheet released by the ministry on Thursday, Brazil has 4,216 confirmed cases of monkeypox and is investigating another 4,858. On Wednesday (24), the ministry announced the first case in a domestic animal in the country, in Juiz de Fora (MG). This is a five month old puppy.
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