The National Health Surveillance Agency (Anvisa) approved this Thursday (25) the waiver of registration for the Ministry of Health to import and use in Brazil the Jynneos / Imvanex vaccine for immunization against monkeypox.
In the decision, unanimously, the Board of Directors of the body approved the request of the Ministry of Health.
The authorization given by Anvisa is for the vaccine Jynneos (US) or Imvanex (EMA) which is an immunizing agent against smallpox and Monkeypox, a modified vaccinia virus, of the Ankara strain, which despite being the same product, has different names in the US and Europe.
The vaccine from the Bavarian Nordic A/S company is manufactured in Denmark and Germany.
The immunizer is intended for adults aged 18 years and over and has a shelf life of up to 60 months when stored between -60 to -40°C.
The temporary and exceptional exemption applies only to the Ministry of Health and will be valid for six months, provided it is not expressly revoked by Anvisa.
In her vote, Reporting Director Meiruze Freitas highlighted that Monkeypox is caused by a smallpox-like virus, therefore, the smallpox vaccine is expected to prevent or reduce the severity of Monkeypox infection.
However, Meiruze stressed the need to conduct monitoring studies to confirm the effectiveness of the vaccine for the prevention of Monkeypox.
*In update
Source: CNN Brasil