Anvisa (National Health Surveillance Agency) received a request from the Ministry of Health, this Tuesday (23), for analysis of the vaccine against monkeypox.
The request follows the new model approved by the regulatory agency, with no registration required.
Anvisa’s collegiate board approved this Friday (19) the waiver of registration for imports of medicines and vaccines intended for the prevention or treatment of smallpox in monkeys.
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.
Anvisa waives the registration of vaccines and medicines approved by the WHO (World Health Organization) the FDA (Food and Drug Administration) of the United States, EMA (European Medicines Agency), in addition to the regulatory agencies of the United Kingdom, Japan and the United Kingdom. Canada.
The Ministry of Health made the request for the Jynneos vaccine, from the manufacturer Bavarian Nordic, which has already been evaluated by foreign regulatory authorities equivalent to Anvisa.
The FDA approved Jynneos in 2019 with an indication for smallpox and monkeypox. In Europe, the same vaccine is also approved.
“In this analysis, Anvisa will confirm that the essential characteristics of the vaccine are the same as those approved by the AREE [autoridades reguladoras estrangeiras]such as: manufacturer, concentration, pharmaceutical form, indications, contraindications, dosage, target population, route of administration and mode of use, among other information”, said Anvisa, in a note.
The request for exemption from registration will be evaluated by Anvisa’s technical areas and the decision must take place within seven business days.
In Brazil, so far, there is no medicine or vaccine registered with the indication of treatment or prevention of the disease.
The WHO considers monkeypox a public health emergency of international importance.
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