Anvisa (National Health Surveillance Agency) authorized this Monday (29) the immediate and emergency use of 24,000 kits for laboratory diagnosis of monkeypox. The agency is still evaluating the application for definitive registration of the product.
With the release of supplies, the Ministry of Health intends to supply the Central Public Health Laboratories —which are public— and accelerate the diagnosis of the disease. Currently, only eight laboratories perform molecular biology analysis across the country.
The collegiate board of Anvisa considered, among other points, the large number of dammed exams awaiting investigation; “the risk associated with delay in diagnosis with regard to the spread of the disease in the country”; and the fact that there are no registered commercial tests.
“It is noteworthy that, currently, in the country, eight Reference Laboratories are technically structured for the diagnosis of monkeypox, by molecular biology, which have been shown to be limited in their ability to meet the growing demand, generating a number of requests for tests dammed up” , the agency said in a statement.
To date, there is no commercial test for the diagnosis of monkeypox registered with Anvisa. Therefore, both public and private laboratories have used their own methodology to analyze the material. The practice is recognized and regulated by the agency.
The request for release of molecular kits was presented to Anvisa on the 10th jointly by the Health Surveillance Secretariat of the Ministry of Health and Fiocruz (Fundação Oswaldo Cruz).
According to the balance sheet closed by the ministry on Saturday (27), Brazil has 4,493 confirmed cases of monkeypox and is investigating another 4,860.
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.
On Friday (26), Anvisa authorized the importation of a vaccine against monkeypox and the drug Tecovirimat, used to treat the disease. Last week, Brazil received 12 units of the antiviral, donated by the manufacturer.
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.
Monkeypox is a disease caused by a virus and spread mainly by contact with skin lesions of infected people. Another form of transmission is by respiratory droplets, such as coughing and sneezing. In this case, very close and prolonged contact is necessary.
Symptoms of the disease include sudden onset of injury or soreness (one or more) anywhere on the body, headache, fever or chills, muscle aches, tiredness, lumps in the neck, armpit, or groin. The guidance in case of suspicion is to immediately seek the nearest health unit for diagnosis.
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