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By Simone Grizzo Bösenberg

September 6, 2022

Brazilian National Health Surveillance Agency authorizes exceptional drug and vaccine use against Monkeypox by the Ministry of Health

The Ministry of Health (MH) sent Brazilian National Health Surveillance Agency (Anvisa) a request for exemption from the sanitary registration, on an exceptional and temporary basis, of the drug Tecovirimat concentration 200 mg, capsule, oral use, for the treatment of Monkeypox, due to the public health emergency of international importance. The drug will be acquired by the MH by donation from the company SIGA Technologies and is manufactured by Catalent Pharma Solutions, located in the United States.

The MH also forwarded, together with its request, the assessment reports from the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) of the drug Tecovirimat SIGA, the package insert, as well as the labeling words. In addition, the MH forwarded to ANVISA the summary opinion of authorization for use from the EMA, certificate of batch quality control analysis, inspection report of the production site issued by the FDA, instructions for use of the drug and related scientific articles. It is important to note that Tecovirimat was evaluated both by the regulatory authorities of the United States and Europe (FDA and EMA – agencies considered as reference by ANVISA) and received authorization to be used in the respective target populations of each country.

In the US, the drug Tecovirimat (trade name TPOXX) from the company SIGA Technologies has been approved since 2018 for the treatment of adult and child patients with smallpox disease caused by the smallpox virus. However, to date, the FDA has not evaluated the safety and efficacy aspects of Tecovirimat for the treatment of Monkeypox, but the US Centers for Disease Control and Prevention (CDC) maintains an expanded access protocol for new investigational drugs, which allows the use of the drug TPOXX (Tecovirimat) for the primary or early empirical treatment of non-pox orthopoxvirus infections, including Monkeypox, in adults and children of all ages.

In Europe, the EMA granted, in January 2022, a marketing authorization for Tecovirimat SIGA valid throughout the European Union for the treatment of smallpox, Monkeypox and cowpox. The European Agency indicated that Tecovirimat is effective in reducing mortality caused by smallpox, Monkeypox and cowpox, based on animal studies. This drug has been evaluated in uninfected people, but its side effects are expected to be similar in infected people and are considered acceptable. The EMA has therefore indicated that the benefits of Tecovirimat SIGA are greater than its risks and it can be authorized for use in the European Union.

In Brazil, so far, there is no submission of a clinical trial protocol on a drug to be conducted nationally, and there is also no protocol submitted or even a drug already registered by ANVISA with the indication of Monkeypox treatment.

In view of this international scenario, the Collegiate Board of ANVISA unanimously approved the request for exemption from sanitary registration, so that the MH imports and uses the aforementioned drug in Brazil.

It is important to note that the temporary and exceptional exemption applies only to the Ministry of Health and will be valid for six months, and may be expressly revoked by ANVISA.

Jynneos and/or Imvanex vaccines

In addition, ANVISA also analyzed the request for exemption, also on an exceptional and temporary basis, from the sanitary registration of the Jynneos and/or Imvanex vaccines, manufactured by the companies Bavarian Nordic A/S and IDT Biologika GmbH, which must be acquired by the Ministry of Health for the prevention of Monkeypox. The MH forwarded the necessary documentation to ANVISA, such as pharmaceutical form, concentration, route of administration, indication, dosage, target population, proof of approval of the drug or vaccine in at least one of the international authorities trusted by ANVISA (FDA, EMA, MHRA/UK, Health Canada, PMDA/MHLW/Japan or WHO), scientific literature publications, among others.

The Imvanex vaccine has been approved in the European Union since 2013 for the prevention of smallpox. However, the EMA’s Committee on Human Medicines (CHMP) recommended extending the smallpox vaccine indication to include protection of adults against Monkeypox. In the US, the FDA issued an emergency authorization use for Jynneos (same vaccine, but with a different trade name in the US).

As informed by ANVISA itself, so far no vaccine developer has submitted a request for conducting clinical trials, registration or authorization with the Agency, so there is no registered or authorized vaccine in Brazil with the Monkeypox prevention indication. However, the above vaccine is one of those approved by authorities considered a reference by ANVISA.

Regarding the vaccine, the Collegiate Board also unanimously approved the request for exemption from the sanitary registration, on an exceptional and temporary basis, of vaccines to be acquired by the MH for immunization against Monkeypox. The validity of the exemption from registration is also six months, provided it is not expressly revoked by ANVISA.

The basis for the two requests sent by the MH is RDC nº 747/2022, approved at the 15th  Extraordinary Public Meeting of the Collegiate Board of ANVISA, which authorized the exceptional and temporary waiver of registration and on the requirements for exceptional authorization of import of medicines and vaccines purchased by the MH for the prevention or treatment of Monkeypox, due to the public health emergency of international importance, declared by the WHO on July 23, 2022. Furthermore, this Resolution applies to medicines and vaccines purchased by the MH for prevention or treatment of Monkeypox intended for SUS (Brazilian Unified Health System) and that meet the conditions established in this Resolution.

If you would like to be informed of further developments in this matter and/or need any assistance or clarification, please do not hesitate to contact us at email: mail@kasznarleonardos.com.

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