Brazil’s drug authority Anvisa on Thursday (Aug 25) unanimously decided not to require registration for the Health Ministry to import and use the Jynneos/Imvanex vaccine and antiviral Tecovirimat, both against monkeypox.
Vaccine
Regarding the vaccine, the authorization concerns Jynneos or Imvanex—two of the names used to refer to the Modified Vaccinia Ankara vaccine, against both smallpox and monkeypox, in the US and Europe respectively. The shot is produced by Bavarian Nordic A/S in Denmark and Germany.
“The inoculation is intended for adults 18 years of age or older and has a shelf life of up to 60 months when stored between -60°C to -40°C. The temporary, exceptional waiver applies only to the Ministry of Health and will be valid for six months, provided it is not expressly revoked by Anvisa,” the watchdog stated.
In her vote, director Meiruze Freitas pointed out that monkeypox is caused by a virus similar to that of smallpox and therefore the vaccine is expected to prevent or reduce the severity of infection. Nevertheless, she underscored the need for monitoring studies to confirm the effectiveness of the product.
The move was based on the US Food and Drug Administration’s assessment for the Jynneos vaccine, the public information published by the European Medicines Agency, and the UK National Health Service, as well as the package insert, label, and other documents submitted by the ministry.
Antiviral
On the authorization of the antiviral, the national drug regulator pointed out it applies to Tecovirimat 200 mg, in its hard capsule form, for oral use, with a shelf life of 84 months, indicated for the treatment of diseases caused by the Orthopoxvirus in adults, adolescents, and children weighing at least 13 kg.
“The product to be imported is the same as the one authorized in the US for company Siga Technologies, manufactured by Catalent Pharma Solutions, in Winchester, Kentucky,” Anvisa’s statement reads.
Here also, the waiver applies only to the Ministry of Health and will be valid for six months, unless expressly revoked by Anvisa.
