The US Food and Drug Administration. (FDA, in English) approved an additional authorization for the use in the country of the doses of the vaccine against smallpox and monkeypox manufactured in a plant of the pharmaceutical Bavarian Nordic, in Denmark.
The FDA said that after completing the inspection process for that plant earlier this month, it concluded that Bavarian Nordic’s vaccine, called Jynneos, meets quality standards.
The US regulator added that it had previously facilitated the transport of those doses from the plant in Denmark to the US so that they could be ready to be distributed As soon as you give permission.
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There are two licensed monkeypox vaccines in the US, Jynneos and Acam2000, but supplies of the former have so far been quite limited in the country.
The Secretary of Health and Human Services (HHS, in English), Xavier Becerra, said in a statement that the FDA authorization “means that 786,000 doses (additional) vaccines will be available for use in the US.”
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The authorization comes amid criticism of health authorities by legislators and patient advocacy organizations in the US, who have denounced that the response to monkeypox is being slow and the vaccines insufficient.
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According to data from the Centers for Disease Control and Prevention (CDC), in the US there are currently 3,591 cases detected of monkeypox. Infections have been found in almost every state in the country, except in Montana, Wyoming, Alaska and Vermont.
The World Health Organization (WHO) declared an international health emergency, its highest alert level, due to the current outbreak of monkeypoxwhich already adds up to more than 16,000 cases (5 of them fatal) in 75 countries, many of them in Europe, where the disease was not endemic.
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