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WHO calls for global audit of smallpox, monkeypox jabs and fair access

The World Health Organization has urged countries that have stockpiled doses of smallpox and monkeypox vaccines and treatments to engage in talks to fairly distribute the doses where they are now most needed.

Several countries have built up their own emergency supplies of vaccines to protect against possible future smallpox outbreaks. Smallpox, a virus in the same family as monkeypox but more deadly, has been eradicated since 1978. But some laboratories still store the virus for scientific reasons, spurring countries to retain vaccines for health security.

Around 200 cases of monkeypox have been reported in the last three weeks across 20 non-endemic countries including in Europe and North America, and cases are continuing to rise. Given the fast-changing and uncertain situation, the World Health Organization urged countries on Friday to audit their vaccine and drug supplies and to provide fair and needs-based distribution of such medical countermeasures.

The WHO plea comes as it has been revealed the European Union, through its Health Emergency Preparedness and Response Authority, HERA, has confirmed that it’s in talks to buy monkeypox vaccines and treatments for the bloc.

There are several types of vaccine for smallpox and one for monkeypox, and the WHO is keen to find out what global supplies are available.

“Some countries have a stockpile of the first generation of vaccine,” Sylvie Briand, the WHO’s director of epidemic and pandemic preparedness and prevention, told a briefing on Friday. “We don’t know exactly the number of doses that are available in the world and so that’s why we encourage countries to come to WHO and tell us: What are their stockpiles? What are the quantities available? And have they done potency testing on those vaccines? So that we have a better understanding of what are the resources currently in hand.”

The first-generation vaccine that was available for the smallpox eradication is known as LC16m8; second- and third-generation smallpox vaccines are known as Microgene and ACAM200, respectively; and more recently, the Modified Vaccinia Virus Ankara, or MVA vaccine, has come to market.

Only the MVA vaccine, called Imvanex and manufactured by Bavarian Nordic, has been approved for use for monkeypox — in the U.S. and Canada in 2019. In the EU, it only has the smallpox license; but countries are already using it off-label to protect high-risk close contacts of monkeypox cases.

In her slides, Briand also listed an additional vaccine called VACdelta6 from the Russian Federation, with an anticipated license this year. A WHO document from 2018, titled WHO Advisory Committee on Variola Virus Research, suggests that this vaccine is more effective and has fewer side effects than the earlier-generation jabs.

Given that there have been no cases of smallpox for decades and monkeypox is just starting to emerge in non-endemic countries, Rosamund Lewis, head of the smallpox secretariat that is part of the WHO Emergencies Program, pointed out that there is very limited data on the efficacy of any of these vaccines against monkeypox. Imvanex was authorized for use based on data from animal studies.

Lewis said that the WHO was currently assessing Bavarian Nordic’s vaccine for prequalification, which if approved, would allow it to be used under license in countries throughout the world. “That activity will need to be accelerated,” she said.

She underscored, however, that it is “a new product,” and the result of “decades of research on smallpox countermeasures.”  

“As far as we know, smallpox countermeasures may be protective against monkeypox,” she said. But there hasn’t been the opportunity to study it in clinical trials to demonstrate efficacy, she said.

Guidance from the WHO’s advisory group on smallpox and monkeypox vaccines says that there is “no need for mass vaccination,” she said.

The monkeypox virus is transmitted primarily by close physical contact, “and therefore contact tracing, investigation and isolation remain the primary modes of control for the time being,” she said.

Meanwhile, vaccination follows the 2013 guidance for all orthopoxvirus infections, she said. For preventive purposes, people who are at risk from an occupational perspective may wish to consider vaccination, including laboratory personnel, health workers, frontline health workers and or first responders.

There are still many unknowns about these unusual monkeypox outbreaks. So far, genetic sequencing has shown that the virus appears to be the same as the West African monkeypox virus, which is the milder of two types, with a mortality rate of 3 percent to 6 percent, Briand said.

Normally, any cases in non-endemic countries are traced back to travel to an endemic country and such cases are self-limiting. But most of the current outbreaks are not connected to travel. It’s not yet clear if these outbreaks seen all over Europe will also prove to be self-limiting and die down quickly, Briand said.

Meanwhile, research is under way to find out if these outbreaks are directly linked to cases in animals. As the name suggests, monkeypox is a zoonotic virus, meaning it’s an infectious disease that has jumped over from animals. But unlike the name suggests, it’s in fact mostly found in rodents.

What the WHO does not yet know is which animal species is responsible for providing the habitat for monkeypox. It’s working with other agencies specialized in animal health to provide more insights on the animal reservoir and the modes of transmission, which at present is known to be direct contact.

Briand’s plea to countries is to have clear communication with the public, to be alert to the risks, and to have an appropriate and needs-based response.

“Please work with WHO so that we can have a global response to this event and we are coordinated and we make sure that there is an equitable access to countermeasures based on public health needs,” Briand said.

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