FDA makes first-ever approval of monkeypox vaccine

Sept. 25, 2019

The FDA has given the greenlight to a Danish drugmaker’s new monkeypox vaccine.

The landmark approval is the first vaccine OK’d for monkeypox, a rare viral zoonotic disease that is similar to smallpox and can be fatal. Although monkeypox chiefly affects people living near tropical rainforests in central and west Africa, the U.S. experienced an outbreak of the disease in 2003 — the first ever recorded outside of Africa.

The vaccine, called Jynneos and developed by Bavarian Nordic, will also receive a “priority review voucher” to accelerate future approval for other indications.

Read the Reuters report.