U.S. Monkeypox Vaccine Supply Tops One Million Doses

Federal health officials announced that the United States has obtained 786,000 additional doses of the FDA-licensed monkeypox vaccine Jynneos for distribution to state health authorities in the coming weeks.

That action brings the total number of available Jynneos doses to 1.1 million, including 338,000 doses that have already been distributed, said Department of Health and Human Services (HHS) Secretary Xavier Becerra during a July 28 media briefing.

"Our goal is pretty straightforward," Becerra said. "Stay ahead of the virus and end this outbreak."

In addition to securing vaccine doses, the federal government has overseen the boosting of monkeypox testing capacity to between 60,000 and 80,000 tests per week, Becerra said. And approximately 10,000 Americans have received the antiviral therapy tecovirimat through an expanded access protocol administered by the Centers for Disease Control and Prevention (CDC).

"We have, in our Strategic National Stockpile, 1.7 million treatments available for Americans," Becerra added.

Jennifer McQuiston, deputy director of CDC's Division of High Consequence Pathogens and Pathology, said more than 20,000 monkeypox cases were reported worldwide through July 27, including more than 4,600 U.S. cases.

"We expect the number of reported cases are going to go up over the next several days and weeks," she warned. "CDC strongly encourages all healthcare providers to be on high alert for patients presenting with monkeypox symptoms and to test any patient for whom monkeypox is suspected."

McQuiston said the most commonly reported symptom of monkeypox is rash, which affects 99% of those infected with the orthopoxvirus. Other common symptoms include malaise, fever, swollen lymph nodes, chills, headache, and muscle pain.

According to CDC's latest data, the median age of people with monkeypox is 35 years, and 99% of cases involve people who were assigned the male sex at birth. McQuiston said the "vast majority" of cases have occurred in men who reported sexual contact with other men. So far, non-Hispanic whites account for 37% of U.S. cases, followed by Hispanics and Latinos (31%), non-Hispanic Blacks (27%), and Asian-Americans (4%).

Jynneos smallpox and monkeypox vaccine (live, nonreplicating) was licensed by the Food and Drug Administration in 2019. The vaccine is indicated for the prevention of smallpox and monkeypox disease in adults who are at high risk for infection. The product is manufactured by Bavarian Nordic A/S of Denmark.

According to the product's FDA-approved labeling, the recommended dosage is two 0.5-mL subcutaneous injections administered four weeks apart, preferably in the upper arm. v

CDC distributes the vaccine under an allocation formula that was recently revised to account for the total population of those at risk in a specific jurisdiction and the number of new cases reported in the jurisdiction since the last allocation.

"This update gives greater weight to prioritizing vaccine to areas with the greatest number of people at risk, which includes men who have sex with men, who have HIV, or who are eligible for HIV [pre-exposure prophylaxis], while still considering where we are seeing cases increase," McQuiston said.

Dawn O'Connell, administrator of the HHS Administration for Strategic Preparedness & Response, said the current allocation system will shift next week to the same centralized system that's used to order COVID-19 treatments.

O'Connell said the United States has authorized a total of 5.5 million doses to be manufactured from bulk vaccine product and could authorize 11.1 million more doses if Congress approves funding for the project.

The currently licensed formulation of Jynneos is supplied as a frozen suspension in packages of 20 single-dose vials, 0.5 mL each, that must be stored at -25 °C to -15 °C and protected from light. Each vial should be thawed to room temperature for administration.

A June 14 communication from the manufacturer states that unopened vials of the vaccine may be stored at 2-8 °C for up to 8 weeks from thawing.

Bavarian Nordic announced in May that it will supply a lyophilized formulation of the vaccine starting next year.

For additional information and tools for responding to the outbreak, visit ASHP's monkeypox resource page.