BRASILIA, Aug 27 (NNN-MERCOPRESS) — Brazil’s National Health Surveillance Agency (Anvisa) cleared the Health Ministry to import and use the Jynneos / Imvanex vaccine and the drug Tecovirimat, both against monkeypox.
The vaccine known as Jynneos in the United States or Imvanex in countries under the European Medicines Agency (EMA) is a smallpox vaccine and monkeypox, modified vaccinia virus, Ankara strain, it was explained. It is manufactured by the Bavarian Nordic laboratory in Denmark and Germany.
“The immunizer is intended for adults 18 years of age and older and has a shelf life of up to 60 months when stored at -60°C to -40°C. The temporary and 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 agency explained.
In her vote, rapporteur Meiruze Freitas pointed out that monkeypox is caused by a virus similar to smallpox and that, therefore, the vaccine is expected to prevent or reduce the severity of infection by the disease. She stressed the need for monitoring studies to confirm the effectiveness of the product.
Anvisa’s decision was based on the US Food and Drug Administration (FDA) assessment report for the Jynneos vaccine, on data released by the EMA and on reports from the UK National Health Service (NHS), as well as on the package insert, labeling statements and other documents submitted by the Brazilian Ministry of Health.
“The documentation forwarded by the Ministry of Health is the same made available by the FDA, and the imported product must correspond to the same characteristics of the application evaluated by Anvisa,” explained the agency.
In Brazil, there is still no submission of a vaccine clinical trial protocol to be conducted nationwide, and no protocol or even a vaccine already registered within Anvisa to be against monkeypox.
Regarding the antiviral drug, Anvisa stressed the authorization applied to Tecovirimat, packaged in a concentration of 200 mg, in pharmaceutical form hard capsule, oral use, with a shelf life of 84 months and indicated for the treatment of diseases caused by Orthopoxvirus in adults, adolescents, and children with a minimum weight of 13 kg.
“The product to be imported is the same one authorized in the United States for the company Siga Technologies, manufactured by Catalent Pharma Solutions, located in Winchester, Kentucky, in the United States,” Anvisa said.
The temporary and exceptional waiver applies only to the Ministry of Health and will be valid for six months, provided it is not expressly revoked by Anvisa. Director Meiruze Freitas highlighted, in her vote, that the agency’s previous knowledge about the drug, the result of communication and interaction with the authorities that evaluated the product, allowed the quick conclusion of the process.
She also said that access to the drug can save lives and control the damage of monkeypox, especially for patients at higher risk. As in the case of the vaccine against the disease, in Brazil, to date, there is no clinical trial protocol submission for the drug to be conducted nationally, nor is there a protocol submitted or even a drug already registered by Anvisa with the indication of treatment for monkeypox.
