The decision is considered immediate and emergency for the diagnosis of the disease; Brazil already has more than 4 thousand infected
Anvisa (National Health Surveillance Agency) authorized on Monday (29) the immediate and emergency use of 24,000 molecular kits for the monkey pox diagnosisor monkeypox. The tests are produced by the Bio-Manguinhos/Fiocruz Institute and are still being analyzed for registration approval by the agency.
The authorization was granted after a joint request by the Health Surveillance Secretariat, the Ministry of Health (SVS/MS), and the Bio-Manguinhos/Fiocruz Institute. For the decision, the Collegiate Board of Anvisa took into account, among several factors, the current emergency epidemiological situation of monkeypox in Brazil and the limitation of the laboratory response capacity to the disease.
Brazil is the third country with the most cases
So far, the country has more than 4,000 cases of the disease, with two confirmed deaths in Minas Gerais and Rio de Janeiro. Currently, Brazil is the third country with the highest number of infected people in the world, behind only the United States, which has 14,500 cases, and Spain, with 5,700 infected, according to the World Health Organization. .
Read more: How does the test to detect monkeypox work?
In addition, Anvisa also took into account, for authorization, the number of exams held back awaiting analysis and the risk associated with delayed diagnoses. The agency also noted that there are still no commercial tests or kits for registered diagnostics approved by the regulatory body.
“Currently, the protocols that have been used in the country for the diagnosis of monkeypox, both in public and private laboratories, have been based on their own methodologies developed by clinical laboratories, called in-house methodologies. This practice is recognized and regulated by Anvisa through Resolution (RDC) 302/2005,” said Anvisa in a statement.
Currently, Brazil has eight reference laboratories for the diagnosis of monkeypox, by molecular biology, but that are not meeting the demand. As a result, there are many requests for exams dammed up, which can delay the count of cases of monkeypox in Brazil and jeopardize the containment of the disease in the country.
Know more: Monkey pox: see infection risk activities
Something similar happened at the beginning of the COVID-19 pandemic, in March 2020, when the queue of exams to be analyzed reached 25 thousand throughout Brazil.
In addition, with the authorization of the emergency use of tests, the Ministry of Health will be able to decentralize testing to the Network of Central Public Health Laboratories (Lacen) in the states and reduce the time to release the results to patients.
Monkeypox vaccine and drug also approved
Last Thursday (25), Anvisa also released the registration waiver for import and use of the Jynneos/Imvanex vaccine and the drug Tecovirimat for monkeypox. Authorizations are also of an exceptional and temporary nature and are granted only to the Ministry of Health.
The authorized immunizers are Jynneons (USA) or Imvanex (EMA) which, despite having different names, are the same product. The drug approved by Anvisa is Tecovirimat 200 mg, in the pharmaceutical form of hard capsule for oral use.
Read more: Monkeypox: Health recommends masks for pregnant women
According to the Ministry of Health, the vaccine should first be provided to health professionals and people close to those infected with monkeypox. In relation to the antiviral, the first “contemplated” will be people with more serious cases of the disease, according to the minister of health Marcelo Queiroga.
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