The collegiate board of Anvisa (National Health Surveillance Agency) approved this Friday (19) the waiver of registration for the importation of medicines and vaccines intended for the prevention or treatment of monkeypox.
The rule, of an exceptional and temporary nature, allows the Ministry of Health to ask the regulatory agency for the measure for drugs that have already been approved by international authorities.
The model is similar to that adopted for Covid-19 vaccine imports via the Covax Facility.
According to the rapporteur Meiruze Sousa Freitas, after approval of the drug or vaccine registration waiver, the subsequent import processes will be evaluated and deliberated on a priority basis.
The WHO (World Health Organization) considers monkeypox a public health emergency of international importance.
In Brazil, so far, there is no medicine or vaccine registered with the indication of treatment or prevention of the disease.
There is already a vaccine approved in other countries. The FDA (Food and Drug Administration) has the Jynneos vaccine approved in the United States since 2019 with an indication for smallpox and monkeypox, as the disease is also known. In Europe, the same vaccine is also approved.
So far, 13 deaths have been recorded in the world, four in Nigeria, two in Spain, two in the Republic of Central Africa, one in India, one in Ghana, one in Ecuador, one in Brazil and one in Peru, which is still under investigation.
The Ministry of Health confirmed the first death associated with monkeypox in Brazil in July this year. The patient was a 41-year-old man from Minas Gerais, who had comorbidities and low immunity.
According to the folder, the cause of death was septic shock, an infection that was aggravated by the virus, also known by the English name “monkeypox”.
On Monday (15), the Minister of Health, Marcelo Queiroga, said that the situation in Brazil still does not require the government to declare a public health emergency of national importance.
“At this moment, there are no requirements for Espin (public health emergency of national importance), because most of the cases are in the state of São Paulo, and there is even the possibility of a public health emergency of importance regional, but the secretary [de Saúde] did not speak of it. So, when the need arises, the minister is here,” Queiroga said at a press conference in BrasÃlia.
The minister mentioned the request for recognition of a public health emergency for the entire country made by Conass (National Council of Health Secretaries) last week, but reiterated that there is no need for the measure.
On Wednesday (17), the WHO stressed that the available vaccines against monkeypox are safe, but said that data on the effectiveness of immunizations are lacking.
“We knew from the beginning that vaccines would not be a silver bullet,” said Rosamund Lewis, the organization’s technical lead. Even so, research already indicates some effectiveness in stopping the evolution of the disease, in addition to the importance of adopting other preventive measures.
One of them is to decrease the number of partners, since most infections are occurring during sexual intercourse. Avoiding agglomerations where skin-to-skin contact occurs and isolating suspicious people with a confirmed diagnosis of the disease are other measures.
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