A man holds doses of the Imvanex vaccine, used to protect against the monkeypox virus, at the Edison Municipal Vaccination Center in Paris, France, July 27, 2022.
Alain Jocard | Pool | Reuters
The United States will provide 786,000 additional doses of monkeypox vaccine to local health departments “as soon as possible,” the country’s top health official said Wednesday.
Health and Human Services Secretary Xavier Becerra said the federal government will announce Thursday that more of the two-dose vaccine, called Ginneos, will be distributed to local health departments. The U.S. monkeypox vaccination campaign has hit major setbacks as demand for shots outstrips supply, leading to long lines at clinics and protests in some cities.
According to the Centers for Disease Control and Prevention, the US has reported more than 3,500 cases of monkeypox in 46 states, Washington, DC and Puerto Rico. The United States has the second-highest number of monkeypox cases in the world, after Spain.
The Jynneos vaccine is made by the Danish biotech company Bavarian Nordic. The FDA had to inspect and sign off on the Bavarian Nordic plant in Denmark to ensure that the staff met quality standards. The doses were shipped to the US, and the FDA reviewed them this month and can now be distributed to local authorities for use.
In a letter to the White House last week, House Democrats criticized the pace of FDA inspections and called on President Joe Biden to use executive authority to speed up delivery. The FDA began inspecting the facility in early July, two months after the global outbreak of monkeypox.
“It is not clear why the FDA delayed reviewing the stockpile needed for biodefense, and this failure cost the U.S. monkeypox response valuable time. Bureaucratic delays should not prevent us from obtaining the doses of vaccine we need now,” the spokesman said. The letter, signed by 48 other members of Congress, was written by Monday Jones and Jerrold Nadler of New York.
The FDA’s top vaccine representative, Dr. Peter Marks told reporters earlier this month that the agency and HHS had worked to expedite approval of the Bavarian Nordic facility after the first confirmed case of monkeypox in the United States.
House Democrats also called on the White House to declare a public health emergency and work with Congress to provide additional funding to fight the epidemic.
The US has sent more than 300,000 doses of the Ginneos vaccine to state and local health authorities since May, the Biden administration said. HHS also secured an additional 5 million doses for the US to be shipped by mid-2023.
The FDA approved the Jynneos vaccine in 2019 for people 18 years of age and older who are at high risk of getting mumps or chickenpox. Although monkeypox causes a milder illness, the viruses are in the same family. According to the CDC, there is no information on how effective vaccines are at preventing disease in the current outbreak.
Monkey pox is primarily spread through close physical contact during sex, and currently men who have sex with men are at the highest risk of infection. In the United States, 99% of monkeypox cases are men, and 98% of 309 patients who provided demographic information were men who had sex with men, according to the CDC.
According to the CDC, vaccination with Jynneos should be started within four days of exposure to monkeypox to have the best chance of preventing the onset of disease. Two doses are administered 28 days apart. If the vaccine is given between 4 and 14 days after exposure, the vaccines do not prevent the disease but may reduce symptoms.
The CDC recommends vaccination for people with confirmed or suspected monkeypox, as well as for people at high risk of exposure. The US also has more than 100 million doses of an older-generation smallpox vaccine called ACAM2000, which is effective in preventing monkeypox, but ACAM2000 can cause serious side effects. It is not recommended for people with weakened immune systems, including HIV-positive people, pregnant women, and people with eczema and skin conditions.