Today, the White House National Monkeypox Response team announced a series of actions the Biden-Harris Administration is taking to further accelerate its response to the monkeypox (MPV) outbreak and mitigate the spread of the virus. Since the first case was confirmed in the United States, the Administration has led a whole-of-government response to make tests, vaccines, and treatments more widely available to communities across the country and has worked with the LGBTQI+ community to provide information and resources directly to communities most at risk of contracting the virus.
To date, the Biden-Harris Administration has delivered nearly 1 million doses of JYNNEOS vaccine to jurisdictions - the largest JYNNEOS MPV vaccine program in the world. Last week, the Food and Drug Administration (FDA) announced the Emergency Use Authorization of the JYNNEOS vaccine to be administered intradermally in individuals 18 years of age and older determined to be at high risk of MPV, without compromising the level of immune response achieved or the safety of the vaccine. The action means that each vial of vaccine can be used for up to five doses, since the appropriate dose for intradermal administration is 0.1mL versus 0.5mL required per dose administered subcutaneously. Paired with that announcement, the Centers for Disease Control and Prevention (CDC) released a robust set of resources and tools to help jurisdictions train providers and health care professionals on how to administer the vaccine intradermally.
In less than ten days following FDA's EUA on intradermal administration, some of the country's largest counties have transitioned completely to intradermal administration of the JYNNEOS vaccine for eligible adults, including Los Angeles County, California, and Fulton County, Georgia. The increased availability of vaccine doses has also enabled more jurisdictions to offer second doses to eligible individuals, as the JYNNEOS vaccine is administered as two doses, four weeks apart for maximum protection
The Biden-Harris Administration has also significantly increased availability and convenience of orthopoxvirus tests, expanding capacity of tests from 6,000 tests per week to 80,000 tests per week. Additionally, the Administration has taken a number of steps to make TPOXX, a treatment for MPV, more accessible to prescribe, and today's announcements build on those actions.
To increase availability of vaccines, tests, and treatments, and protect communities most at risk of contracting the virus:
HHS to make 1.8 million doses of vaccine available for ordering beginning Monday.
Earlier this week, the Department of Health and Human Services (HHS) allocated and began distributing another 442,000 doses of vaccine to jurisdictions across the country. The announcement was the first allocation of vaccine following FDA's EUA allowing for intradermal administration of the JYNNEOS vaccine, so the 442,000 doses reflect the number of total doses that could be available through intradermal administration.
Today, HHS is announcing that it has accelerated Phase 4 of its National Vaccine Strategy and will be making an additional 1.8 million doses available for ordering starting Monday, August 22. Jurisdictions that are adopting the intradermal administration of vaccine and have used 90% of their current supply of vaccine will be able to order additional doses.
The Administration is making these doses available ahead of schedule to encourage rapid distribution of vaccine to individuals at high risk of contracting the virus, particularly gay, bisexual, and other men who have sex with men. The Administration is also encouraging intradermal administration of vaccine and providing technical assistance, support, and resources to jurisdictions in the process of adopting and expanding intradermal administration.
The Administration is making more vaccines available for jurisdictions hosting large LGBTQI+ events.
HHS is launching a pilot program to provide additional vaccine allocations to state and local health departments in jurisdictions that are hosting large events that attract gay, bisexual, and other men who have sex with men in the coming weeks and months. The pilot program is setting aside 50,000 doses of vaccine from the Strategic National Stockpile (SNS) that jurisdictions can request to order on top of their existing vaccine allocations and supply. The number of additional doses made available to a jurisdiction will be based on the size and nature of the event, and the ability to reach attendees at highest risk for MPV.
In addition to making more vaccine doses available, the CDC is offering assistance and support to jurisdictions to prepare for these large events, including helping develop vaccine and testing strategies to be stood up in and around these events, developing tools for information-gathering from event participants, and providing messaging and communications resources on vaccines, testing, and strategies to reduce one's risk of contracting the virus. CDC is also working with jurisdictions to quickly adopt the intradermal administration of JYNNEOS vaccine so more doses can be administered at these events to more people.
The Administration has already started working with North Carolina, Georgia, and Louisiana health departments to prepare for large LGBTQI+ gatherings in those states in the coming days and weeks. For example, the Administration worked with North Carolina to develop a plan to administer vaccines during the Charlotte Pride Festival & Parade on August 20th and 21st. The Administration will support North Carolina with up to 2,000 additional doses by replenishing their stock of vaccine with the number of doses administered during these events. Those doses are in addition to the more than 18,000 doses North Carolina has already received through its existing allocations.
ASPR is making 50,000 courses of TPOXX available to jurisdictions for prepositioning to facilitate timely access to TPOXX for eligible patients.
The Biden-Harris Administration will make available 50,000 patient courses of TPOXX to jurisdictions next week - nearly five times more courses than confirmed cases in the United States - to make the treatment more readily available for providers and patients. Jurisdictions will be allocated courses of TPOXX using formula based 75% on the number of cases in their jurisdiction and 25% on the number of individuals who are at the highest risk of contracting the virus, including individuals who are living with HIV or who could benefit from HIV pre-exposure prophylaxis. This allocation is in addition to over 20,000 courses ASPR has already deployed to jurisdictions from the SNS.
Since TPOXX was approved under the FDA's Animal Rule for the treatment of smallpox based on efficacy data in animals and safety data in healthy human volunteers – in the absence of clinical studies in patients with MPV – it is important that this drug be used judiciously in accordance with the Expanded Access protocol and applicable treatment guidelines.
