The United States Food and Drug Administration on Wednesday gave a nod to the Bavarian Nordic's plans to ramp up manufacturing of its Jynneos vaccine that is being used in efforts to stem a global outbreak of monkeypox.
The move comes as monkeypox cases surge globally forcing UN Health agency World Health Organisation (WHO) to designate it as a global Public Health Emergency- the highest alarm the agency can sound.
Earlier WHO had declared the Monkeypox virus spread as a pandemic.
“Today, the FDA is announcing it has approved a supplement to the biologics license for the JYNNEOS Vaccine, which is approved to prevent smallpox and monkeypox, to allow for additional manufacturing capabilities at one of the plants where the vaccine is made,” the US agency tweeted.
The inspection ‘were necessary work to help ensure the quality and safety of the vaccine’ said the US health agency said in view of the surging number of cases.
“With this supplement approval, those manufactured doses may now be further distributed and administered. Additional doses manufactured at this plant can help address the need for this vaccine moving forward,” FDA further informed.
Last month, the Biden administration unveiled a new plan to vaccinate eligible Americans against monkeypox, prioritizing those who have been exposed to the virus in states with the highest infection rates.
Hundreds of thousands of doses of the Jynneos vaccine from Bavarian Nordic A/S will be made available under the administration’s new plan through a tiered-allocation system, the US Department of Health and Human Services had said.
Unlike Covid-19, vaccination after monkeypox exposure can help significantly slow the spread of the virus and protect those who are most vulnerable, White House Covid Response Coordinator Ashish Jha had said on a call with media.
Meanwhile, the World Health Organisation (WHO) on Wednesday alerted that more than 18,000 cases of monkeypox reported globally from 78 countries, with the majority in Europe. Last week, the WHO declared the monkeypox outbreak a global health emergency.
WHO chief said, More than 18,000 cases have now been reported to WHO from 78 countries, with more than 70% of cases reported from Europe. “So far, five deaths have been reported, and about 10% of monkeypox cases are admitted to hospital to manage the pain caused by the disease."
(With inputs from agencies)
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