The Biden administration announced it will expand access to monkeypox vaccines in a new “enhanced” national strategy to combat the outbreak, which includes the deployment of 296,000 vaccine doses over the coming weeks, and potentially 1.6 million vaccine doses over the coming months.
The plan seeks to “expand vaccination for individuals at risk and make testing more convenient for healthcare providers and patients across the country,” the White House said in a statement on June 28.
Under the strategy, the Department of Health and Human Services (HHS) will immediately allocate 56,000 doses of the two-dose Jynneos vaccine, which are currently in the national stockpile, to states and territories across the United States.
“States will be offered an equitable allotment based on cases and proportion of the population at risk for severe disease from monkeypox, and the federal government will partner with state, local, and territorial governments in deploying the vaccines,” the White House announced.
The move is a major step up from the 9,000 doses of the Jynneos vaccine that HHS has so far deployed from the national stockpile to the 32 states and jurisdictions that requested the vaccine.
HHS will also allocate another 240,000 doses in the coming weeks “to a broader population of individuals at risk,” as more doses are received from the manufacturer. This would bring the total number of vaccines to be distributed over the coming weeks to 296,000.
The White House said HHS will hold another 60,000 vaccines in reserve.
HHS Secretary Xavier Becerra said in a statement that the new strategy allows the government to “maximize the supply of currently available vaccines and reach those who are most vulnerable to the current outbreak.”
The announcement on June 28 comes as monkeypox vaccination appointments at sites in New York City and Washington, D.C., were maxed and ran out of Jynneos vaccine doses within 24 hours of opening on June 27.
The Centers for Disease Control and Prevention (CDC) has documented 306 confirmed cases in the United States.
Tiered Distribution Strategy
HHS said the vaccine “will be allocated using a four-tier distribution strategy that prioritizes jurisdictions with the highest case rates of monkeypox.”
“Within each tier, doses of JYNNEOS will be allocated based on the number of individuals at risk for monkeypox who also have pre-existing conditions, like HIV,” the department stated.
Up until now, monkeypox vaccines have been provided only to people who have had confirmed exposure to a monkeypox case. The Advisory Committee on Immunization Practices (ACIP) from the CDC now recommends that vaccines will be made available to people with “confirmed monkeypox exposures and presumed exposures.”
“This includes those who had close physical contact with someone diagnosed with monkeypox, those who know their sexual partner was diagnosed with monkeypox, and men who have sex with men who have recently had multiple sex partners in a venue where there was known to be monkeypox or in an area where monkeypox is spreading,” HHS said in a statement.
The Jynneos vaccine can be used even after a person is exposed to monkeypox; the vaccine is taken ideally within two weeks of possible exposure. A person is considered most protected from the disease two weeks after taking their second dose, which is administered 28 days after the first dose.
1.6 Million Doses of Jynneos Vaccine
The Food and Drug Administration (FDA) in September 2019 approved the Jynneos for the prevention of smallpox and monkeypox disease in people aged 18 and over, and stated at the time that it was the only currently FDA-approved vaccine as prophylaxis for monkeypox.
HHS said it expects over 750,000 doses of the Jynneos vaccine to be made available over the summer, and another 500,000 doses to be released throughout the fall, amounting to a combined 1.6 million additional doses over the coming months.
States and jurisdictions can also request the ACAM2000 vaccine which is “in much greater supply, but due to significant side effects is not recommended for everyone,” HHS noted on June 28.
ACAM2000, made by Emergent BioSolutions, was approved by the FDA in 2007 to prevent smallpox, but it can also be used to prevent monkeypox, according to CDC recommendations.
The White House noted that the ACAM2000 vaccine “cannot be provided to individuals who are immunocompromised or who have heart disease.”