Brazil currently has the third most cases of monkeypox in the world. Until August 20 of this year, 14,054 notifications were registered for the disease, with about 4,000 confirmed cases – according to the new update of the Epidemiological Bulletin made available by the Brazilian Ministry of Health.
It is in this epidemiological scenario and within the exponential growth in the number of cases that the Brazilian Ministry of Health set up a health emergency center to monitor and prepare a vaccination plan against monkeypox in the country.
In this context, on August 19, 2022, the Brazilian Health Regulatory Agency (“Anvisa”)’s Collegiate Board of Directors (or simply “DICOL”) met at the 13th Extraordinary Meeting to discuss:
- the proposal to open a regulatory process to provide for the exemption, on an exceptional and temporary basis, of the registration, as well as for the requirements for exceptional authorization of importation, of medicines and vaccines acquired by the Ministry of Health in the prevention and/or treatment of monkeypox due to the Public Health Emergency of International Concern (or simply “PHEIC”), and
- the proposal for a Resolution of the Anvisa’s Collegiate Board of Directors on the subject. Both remained unanimously approved at the end of the session.
Therefore, on August 25th at a DICOL meeting, the Agency approved two public health measures against the disease: (i) the exemption from registration and (ii) consequent release for import and use, for a period of 6 (six) months and applicable only to the Ministry of Health, (a) of tecovirimat medicine (i.e., also known as TPOXX and already authorized on the United States), aimed at treating the confirmed cases on Brazil through a partnership with the Pan American Health Organization (or simply “OPAS”), as well as (b) of the Jynneos/Imvanex vaccine, manufactured in Denmark and Germany by the company Bavarin Nordic A/S, which was already approved in the United States, Canada and the European Union.
These urgent regulatory measures take place on the context of a declaration made by the World Health Organization on July 23, 2022, in which monkeypox epidemic became a PHEIC.
Supporting data from the European Medicines Agency (or simply “EMA”) and from the Food and Drug Administration (or simply “FDA”) were analyzed for the approval of such health measures. By way of illustration, research published in the scientific journal “The Lancet Infections Disease” has pointed out that the antiviral showed promise in reducing the duration of symptoms – which can last from 2 to 4 weeks –, in addition to the period of time in which patients with monkeypox are able to infect other people.
Furthermore, it is clear that this time Anvisa soon sought to fit in with the equivalent foreign regulatory authorities – much faster, by the way, than in the context of Covid-19, in which the Public Health Emergency of National Importance (or simply “ESPIN”, in Portuguese) was only declared in February 2020 (i.e., more than 3 months after the first case was confirmed in the world).
Several governmental efforts have also been made in relation to the supply chain of tests for the diagnosis of monkeypox (i.e., by molecular or genetic sequencing).
With the aforementioned regulation and approvals, the Brazilian Ministry of Health may ask Anvisa to exempt medicines and vaccines that have already been approved in other countries from registration (i.e., like the TPOXX medicine and the Jynneos/Imvanex vaccine), provided that their conditions are the same as those of other regulatory agencies, in addition to adopting actions to ensure patient safety regarding the use of these supplies. In addition, the Ministry shall establish vulnerable and priority groups for vaccination and shall promote greater and better monitoring of imported products, in addition to managing guidelines for the notification of adverse events, technical complaints and guidelines for health services.
The new measures’ goal lies on the simplification and reduction of bureaucracy in the documentation for the process of importing medicines and vaccines against monkeypox, promoting greater speed and efficiency in the fight against the epidemic – since this way it is possible to control the spread of the disease in a faster way, as well as to facilitate the access of the Brazilian population to essential pharmaceutical products against it.
The Anvisa’s director, Meiruze Souza Freitas, stated in a very thoughtful way that the Agency may suspend the exemption from registration and/or the use of any product related to which safety issues are identified.
The approval of the new health measures is extremely important for the Brazilian society, and it is in line with the Anvisa’s institutional purpose of promoting the protection of the population’s health. At this rate, the outcome of the story can be, and will certainly be, different from what we saw a short time ago with Covid-19. After all, more lives will be saved thanks to a faster, more accurate and effective governmental decision-making process.