U.S. FDA authorizes Bavarian Nordic’s vaccine for emergency use against monkeypox

The U.S. drug regulator on Tuesday authorized Bavarian Nordic’s Jynneos vaccine for emergency use through intradermal injection in individuals aged 18 years and older who are determined to be at high risk of monkeypox infection.

The authorization from the Food and Drug Administration (FDA) will increase the total number of doses available for use by up to five-fold. It also allows individuals younger than 18 years to receive the vaccine by subcutaneous injection if they are determined to be at high risk of monkeypox infection.

“In recent weeks the monkeypox virus has continued to spread at a rate that has made it clear our current vaccine supply will not meet the current demand,” said FDA Commissioner Robert Califf. (https://bit.ly/3p7C9Ao)

The move follows the Biden administration’s decision on Tuesday to allow the FDA Commissioner to grant emergency use authorizations for monkeypox vaccines.

For those aged 18 years and older determined to be at high risk of monkeypox infection, the authorization allows for a fraction of the Jynneos dose to be administered between the layers of the skin.

Two doses of the vaccine given four weeks apart will still be needed, the agency said.

The United States declared monkeypox a public health emergency last week, in an effort to bolster its response to contain the outbreak.

Last month, the World Health Organization declared monkeypox a global public health emergency. So far, 80 countries where the virus is not endemic have reported 26,500 cases of monkeypox, according to a Reuters tally.

Britain will run out of monkeypox vaccines in about two to three weeks as the country has little more than 8,300 doses of vaccine left, the Financial Times reported on Tuesday.

(Reporting by Ankur Banerjee in Bengaluru; Editing by Aditya Soni)