Anvisa director defends partnership between countries to accelerate production of monkeypox vaccine

Rapporteur for the release of the vaccine against monkeypox at Anvisa (National Health Surveillance Agency), director Meiruze Freitas told the Sheet this Friday (26) that countries need to work together and think of a strategy to rapidly increase the production of the immunizer.

On Thursday (25), the agency authorized the Ministry of Health to import the vaccine from the Bavarian Nordic laboratory, already approved in other countries, given the scenario of an international public health emergency. The decision also applies to the antiviral Tecovirimat, which will be used in critically ill patients.

“Countries need to prepare more and more and work together to face emerging and re-emerging diseases, facilitating the development of immunobiologicals, vaccines… It is necessary to work together so that the data evaluated in one country is used by another country. Data must be transparent, accessible,” he said.

The director of Anvisa also assesses that, in addition to the vaccine, the population needs to have access to the greatest amount of information, mainly on the ways of transmission of smallpox from monkeys. “I think that, today, the additional measure is information. Clear, objective information, in easily accessible language”, she says.

“What we realize is that essential hygiene measures remain for any infectious disease, and that goes for this disease as well. Experts are still debating whether there is a need for more restrictive measures, but we have not yet seen this in other countries .”

Understand what is known about monkeypox vaccination

Which vaccine will be used in Brazil?

Anvisa authorized the import and use of the non-replicating virus vaccine manufactured by the Bavarian Nordic A/S laboratory in Denmark. Despite being the same product, the immunizer is called Jynneos in the United States and Imvanex in Europe.

The immunizer was initially developed to control smallpox, but it has also shown efficacy against monkeypox. “Due to the similarities of the viruses and the studies carried out in animals, it was realized that this vaccine may also have a good response against monkeypox. The authorities extended its use considering the data evaluated”, says Freitas.

Who will receive the vaccine?

Anvisa released the application of the immunizing agent in adults aged 18 years and over, without restrictions. The Ministry of Health states, however, that, at this time, the vaccine will only be intended for health professionals who handle samples collected from patients and people who have had direct contact with patients.

Are there any vaccines approved for children in the country?

Not. Meiruze Freitas says, however, that new data may emerge. “I would say that the moment is very uncertain. Today, what we have in the reports is the indication of use for people over 18 years old, but this can also be malleable, depending on the data that emerge.”

How many doses were purchased?

The Ministry of Health purchased 50,000 doses of the vaccine through PAHO (Pan American Health Organization), an arm of the WHO (World Health Organization) in the Americas. The entity is coordinating the purchase from the manufacturer, globally, to facilitate access to the vaccine in countries with confirmed cases of the disease. The ministry says it is still in talks to acquire more doses.

When will vaccination start in Brazil?

The Ministry of Health expects to receive 20,000 of the 50,000 doses purchased in September and the remainder in October. The folder did not say when it intends to start vaccinating the target audience.

What can lead to the revocation of vaccine release?

Meiruze Freitas explains that the Ministry of Health is obliged to monitor people’s reaction to the vaccine and to report any problems. “We are talking about a product that, initially, was developed to be used almost in conditions of a rare disease. There were not so many people exposed to this product. Now, with monkeypox, the world started to have more people exposed. As more people are exposed to the product [a vacina]we can check if there will be any unknown or serious adverse reaction that forces us to perform an intervention.”

Anvisa’s release is valid for six months. What happens next?

The director of Anvisa says that if no company requests the definitive registration of a vaccine or authorization for emergency use within six months, the Ministry of Health can submit a request to Anvisa for an extension of the deadline. “The Ministry will present us with a report on the monitoring of the product in Brazil. Did it show efficiency? Did it reduce the number of cases? Was it safe? Did we not have adverse, unknown or risk reactions? If the epidemiological scenario remains the same, Anvisa may extend the deadline”, he explains.

Can someone who has had monkeypox get the vaccine?

Meiruze Freitas states that “the logic is to think so”. “There is not much information about this. At first, it is believed that those who had monkeypox have natural immunity for a period, but it is not yet known for how long. Back then, those who had smallpox later also had the smallpox vaccine. So, it is not possible to say that those who had monkeypox are exempt from the need to take the vaccine. We will still have to follow up.”

Can anyone who had the smallpox vaccine in the past get it now?

“There is no impediment. By logic, also using the same principle of reasonableness, it is believed that those who took the smallpox vaccine in the past would also have cross-protection [para varíola dos macacos], but we don’t know for how long. What is striking is that most people infected initially are under 40 years old. And these people under the age of 40 were born at a time when smallpox was eradicated, so they weren’t vaccinated. We would have to have a study to say that this actually happens, but there is a strong indication.”