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Monkeypox: This is the vaccine recommended by EU regulator | 5 facts
After the drug regulator's recommendations, all eyes are on the decision of the EU's executive arm, the European Commission, which gives formal approval based on the EMA's recommendation.
The European Union drug regulator on Friday recommended the smallpox vaccine 'Imvanex', made by Bavarian Nordic, be authorised against monkeypox - a rare viral disease - once occurring in central and west Africa - now spreading across several countries, including India. The European Medicines Agency (EMA) said its recommendation was based on animal studies that suggest the vaccine protects non-human primates from monkeypox.
After the drug regulator's recommendations, all eyes are on the decision of the EU's executive arm, the European Commission, which gives formal approval based on the EMA's recommendation.
The EMA, in a statement, said: "To confirm the effectiveness of the vaccine against monkeypox, the company will collect data from an observational study that will be carried out during the ongoing monkeypox outbreak in Europe."
Also read | Study shows 95% monkeypox cases via sexual activity, WHO holds meet | 5 points
Of the total cases of monkeypox reported worldwide (15,000), nearly 70% of them have surfaced in Europe, affecting over 30 countries across the continent. Meanwhile, Kerala reported India's third case of monkeypox in a man who had returned from UAE. This was also the third case from the state.
Here are the 5 points on the vaccine:
>The drug regulator said the vaccine's safety profile was “favourable”, adding the benefits of its use outweighed the risks, noting mostly mild to moderate side effects.
>The vaccine, which is sold as Jynneos in the United States, has already been cleared for use against monkeypox by American regulators.
>The release stated that doses of the vaccine are "extremely limited" as most of the world's supply has already been bought by Britain, Canada, the EU and the US among other countries. Not a single dose has gone to Africa, where a more severe version of monkeypox has killed dozens of people.
>The health agency - in a release - also said Imvanex vaccine prepares the body to defend itself against infection with the variola (smallpox), monkeypox and vaccinia viruses. Because of the similarity between the virus in this vaccine and these viruses, antibodies produced against it are expected to protect against monkeypox, smallpox and vaccinia, it added.
>In addition to the use for the prevention of monkeypox, the EMA has recommended authorising Imvanex to protect people against disease caused by the vaccinia virus, which leads to symptoms similar to, but milder than those of smallpox.
(With AP inputs)
