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EMA approved monkeypox vaccine

The European Medicines Agency (EMA) said today it has approved the use of a smallpox vaccine in humans to expand its use against the spread of monkeypox, which could mark the WHO’s highest alert level.

The EMA’s green light comes as the world awaits the results of experts after a meeting yesterday, Thursday, of the WHO’s emergency committee, whose director-general said he was concerned by the rise in the number of monkeypox cases around the world. .

The Imvanex vaccine, from the Danish company Bavarian Nordic, has been approved in the EU since 2013 for the prevention of smallpox. It was approved against monkeypox because of the similarity between this virus and the smallpox virus.

WHO director-general Tedros Adhanom Ghebreyesus said yesterday he was “concerned” by the rise in the number of monkeypox cases as he opened a meeting of the emergency committee, asking for expert advice. The head of the WHO is responsible for declaring a public health emergency of international concern, the health organization’s highest level of alert, based on the committee’s recommendations.

The situation has worsened in recent weeks with more than 15,300 cases already recorded in 71 countries, according to the latest figures from the US health authorities (CDC), the most up-to-date.

At the first meeting on June 23, the majority of experts had recommended to Tedros Adhanom Ghebreyesus not to declare a public health emergency of international concern.

The EMA based its recommendation on evidence from several animal studies that showed protection against monkeypox virus in non-human primates vaccinated with Imvanex.

“The safety profile of the medicine is favorable, with mild to moderate side effects, and the Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of the medicine outweigh the risks,” the EMA said in a statement.

Bavarian Nordic Pharmaceuticals, the only maker of an approved monkeypox vaccine, said on Tuesday it had received an order for 1.5 million doses, most of which will be delivered in 2023, from an unnamed European country. , as the US ordered an additional 2.5 million doses.

Source: Capital

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