“Anarchic” vaccination or clinical trials?

BUENOS AIRES, Argentina — Vaccination against monkeypox can complement other public health measures aimed at containing the current outbreak in non-endemic countries. However, when it comes to the need to get vaccinated now, we need to “calm down”, according to officials and experts at a meeting hosted by Argentina’s health ministry. Another question to consider is whether doses should be given in clinical trials so that evidence can be accumulated, they said.

The vaccination that has started for some groups in other countries, such as the United States, Canada and the United Kingdom, is “anarchic” and completely illogical, according to Tomás Orduna, MD, head of the tropical medicine unit and travel medicine at the Hospital for Infectious Diseases Francisco Muñiz in Buenos Aires.

“There is a use because there is a demand from certain groups…For example, at the last International AIDS Conference in Montreal, there was a sense of anarchy with the way anyone who wanted to be vaccinated was vaccinated – and all this while there are severe restrictions when it comes to accessing vaccine supplies,” Orduna said. He made the remarks during a meeting with the Argentine Network of Science Journalism (RADPC), during which Medscape Spanish Edition took part.

Carla Vizzotti, MD, Argentine Minister of Health and former President of the Argentine Society of Vaccinology and Epidemiology (SAVE), confirmed that Argentina is one of 10 countries in the Americas that have notified the Pan American Organization of Health (PAHO) that it was interested in acquiring monkeypox vaccines through the PAHO Revolving Fund.

But “we must calm down”, she insisted. In response to a question from Medscape Spanish Editionsaid Vizzotti, “Argentina wants to know the availability to then go ahead and make decisions based on the recommendations.”

Prophylaxis before and after

On July 23, the Director General of the World Health Organization (WHO) declared the ongoing monkeypox outbreak a public health emergency of international concern. From temporary recommendations was: “Consider targeted use of second- or third-generation smallpox or monkeypox vaccines for post-exposure prophylaxis among contacts, including household, sexual and other contacts of community cases and health workers where it occurs. may have been a violation of protective equipment.”

The following recommendation was also made: “Consider the targeted use of vaccines for pre-exposure prophylaxis in people at risk of exposure; this may include health care workers at high risk of exposure, laboratory personnel working with orthopoxviruses, clinical laboratory personnel performing diagnostic tests for monkeypox, and communities at high risk of exposure or with behaviors to high risk, such as people who have multiple sex partners.”

The WHO also reported that modeling work carried out by the European Center for Disease Prevention and Control (ECDC) and the European Health Commission Emergency Preparedness and Response Authority (HERA) suggests that adding vaccination-related interventions can increase the chances of controlling the outbreak, with pre-exposure prophylaxis of people at high risk of exposure appearing to be the most effective strategy for using vaccines when contact tracing is less effective or impractical.

Nevertheless, the WHO Director-General recommended that states “make every effort to use existing or new monkeypox vaccines in collaborative clinical efficacy studies, using design methods and standardized data collection tools for clinical data and outcomes, to rapidly scale up evidence generation”. on efficacy and safety, collecting vaccine efficacy data (for example, such as comparing one- and two-dose vaccine regimens) and conducting vaccine efficacy studies.

In response to another Medscape Spanish editionTo questions from Juan Manuel Castelli, doctor of medicine, specialist in infectious diseases and undersecretary for health strategies of the Argentine Ministry of Health, clarified that these would be “tracking studies, traceability studies” . He went on to explain, “We need to trace nominal vaccination, assess the risk of exposure – particularly among healthcare workers – and assess what is happening in terms of presenting or not presenting with the disease.” “If there is an anarchic system in the administration of the vaccine,” he added, “it will also be difficult to monitor the results.”

Search for support

On Friday, August 5, there was an extraordinary session of the Directing Council during which Member States demand that PAHO/WHO Director Carissa F. Etienne, MBBS, continues to support them in implementing a coordinated response to deal with the monkeypox outbreak, including support for “equitable access to vaccines against monkeypox.

At the RADPC meeting, Etienne pointed out that there is currently only one third-generation monkeypox vaccine in the world – a non-replicating smallpox vaccine. It is made by a single manufacturer – the small Danish company Bavarian Nordic – and it is in high demand all over the world. She added that talks with the company have already begun.

“We have to be rational. The knowledge we have is very scarce, and what is even more scarce is the supply,” Orduna noted. “If we vaccinate, for example, healthcare workers who are very unlikely to be exposed to someone with a suspected or confirmed case of monkeypox, we are wasting the few doses we have.”

In the United States, the continued spread of monkeypox virus has been declared a public health emergency. On August 8, to stretch the country’s limited supply, authorities authorized the administration of a fifth of the usual dose of the Danish vaccine. Meanwhile, Brazil expects to receive 50,000 doses between September and October. By applying the same approach as the United States, they will be able to vaccinate not 25,000, but 125,000 people.

According to data on PAHO/WHO Dashboard on Monkeypox in the Region of the Americas, as of August 19, there were 19,603 confirmed cases. The United States had the most (13,451), followed by Brazil (3,359), Canada (1,112), Peru (891), Mexico (252) and Chile (189).

Orduna did not disclose any relevant financial relationship.

Follow Matías A. Loewy of Medscape Spanish Edition on Twitter @MLowey.

This article was translated from Medscape Spanish Edition.

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