The National Health Surveillance Agency (Anvisa) approved, on Thursday (25), the importation and use of the Jynneos vaccine against monkeypox in Brazil. The unanimous decision of the agency’s collegiate board waives the registration of the immunizer for use in the country.
The vaccine should arrive in Brazil from September, according to the Ministry of Health. According to Minister Marcelo Queiroga, priority will be given to health professionals who are at greater risk of exposure, such as those who work directly in the handling of virus samples and in the treatment of people diagnosed with the disease.
The MVA-BN vaccine, also called Jynneos, Imvamune or Imvanex, is produced by the Danish company Bavarian Nordic, being one of the main immunizers marketed and already in use in parts of Europe and the United States in the current outbreak of the disease that affects more than 90 countries.
About the Jyneos vaccine
Considered third generation, the Jyneos vaccine has an improved safety profile and is less capable of causing adverse reactions. The formulation uses attenuated strains of the modified vaccinia virus of the Ankara strain, which is related to the smallpox virus.
The immunizer is intended for adults aged 18 years and over, with a recommended schedule of two doses to be administered four weeks apart. The vaccine has a validity period of up to 60 months when stored between -60 and -40°C.
The US Centers for Disease Control and Prevention (CDC) says there is currently no data available on the clinical effectiveness of the vaccine.
“Because there are limitations in our knowledge of the vaccine’s effectiveness in the current outbreak, vaccinated people should continue to take steps to protect themselves from infection by avoiding close, skin-to-skin contact, including intimate contact, with someone who has monkeypox,” he says. the CDC.
international approval
The Bavarian Nordic immunizer was licensed by the Food and Drug Administration (FDA), an agency similar to Anvisa in the United States, for the prevention of monkeypox virus infection.
The vaccine has been approved in the European Union since 2013 for the prevention of smallpox. In July, the European Medicines Agency (EMA) Committee for Human Medicines (CHMP) recommended extending the vaccine’s indication to include protecting adults against monkeypox.
In the US, the CDC recommends that MVA-BN doses should be prioritized for those people who are at risk for serious adverse events with ACAM2000 or severe monkeypox disease (such as people with HIV or other immunocompromised conditions). .
What does the WHO say about vaccination
The World Health Organization (WHO) states that mass vaccination against monkeypox is neither necessary nor recommended at this time. The updated guidelines on immunization against the disease were published in a guide released on Wednesday (24).
The WHO recommends preventive vaccination for people who may have been exposed those who have had contact with confirmed cases, preferably within four days of exposure to prevent the onset of the disease.
Primary preventive vaccination is recommended by the WHO for people at high risk of exposure including, but not limited to, gay or bisexual men who have sex with men or people with multiple sexual partners, healthcare workers at risk, laboratory staff working with orthopoxvirus, who perform diagnostic tests for monkeypox, and people who may be at risk, according to the policy of each country.
WHO recommends that vaccination programs should be supported by thorough surveillance and contact tracing and accompanied by a strong information campaign. In addition, decisions about the use of smallpox or smallpox vaccines must be based on a thorough assessment of the risks and benefits on a case-by-case basis.
Source: CNN Brasil
