U.S. authorizes monkeypox vaccine injection method to increase supply
2022.08.10 00:49
2/2
An employee of the vaccine company Bavarian Nordic works in a laboratory of the company in Martinsried near Munich, Germany, May 24, 2022. The company, headquartered in Denmark, is the only one in the world to have approval for a smallpox vaccine called J
2/2
(Reuters) -The U.S. drug regulator on Tuesday authorized Bavarian Nordic’s Jynneos vaccine for emergency use through intradermal injection for adults at high risk of monkeypox infection to increase supply to combat the outbreak.
The authorization from the Food and Drug Administration (FDA) will increase the total number of doses available for use by up to five-fold.
The regulator’s authorization comes after the United States as well as the World Health Organization declared monkeypox a public health emergency to bolster the response against the outbreak.
“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://
So far, 80 countries where the virus is not endemic have reported 26,500 cases of monkeypox, according to a Reuters tally.
Jynneos was approved in 2019 for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection and is administered beneath the skin or subcutaneously as two doses.
The FDA authorization on Tuesday allows for a fraction of the Jynneos dose to be administered between the layers of the skin, or intradermally, in those aged 18 years and older determined to be at high risk of monkeypox infection.
Two doses of the vaccine given four weeks apart will still be needed, the agency said.
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.
The administration of the vaccine requires a different type of needle than the current shot administration and is similar to the tuberculin skin tests (or PPD (NASDAQ:PPD)) or intradermal allergy tests.
The Biden administration said it was launching efforts to train health care workers and providers on how to administer the Jynneos vaccine intradermally, after making the decision to allow the FDA Commissioner to grant emergency use authorizations for monkeypox vaccines.
So far, the administration has made more than 1.1 million doses of the vaccine available to order and has shipped more than 620,000 doses, the U.S. Department of Health and Human Services said in a statement.
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.
