The Biden-Harris administration has made a number of announcements to further speed up its reaction to the monkeypox (MPV) outbreak and stop the virus’s spread, according to the White House National Monkeypox Response team. Since the first case in the country was confirmed, the administration has led an all-government response to increase access to tests, vaccines, and treatments for communities nationwide. In addition, the administration has collaborated with the LGBTQI+ community to directly deliver resources and information to the communities most at risk of contracting the virus.
The Biden-Harris Administration currently maintains the largest JYNNEOS MPV vaccine programme in the world, having distributed approximately 1 million doses of the JYNNEOS vaccine to counties. The JYNNEOS vaccine was given emergency use authorization by the Food and Drug Administration (FDA) to be administered intradermally to anyone 18 years of age and older who were found to be at high risk of MPV, without compromising the amount of immune response attained or the vaccine’s safety. Due to the fact that the acceptable amount for intradermal administration is 0.1mL rather than the 0.5mL needed for each dose administered subcutaneously, the action allows each vial of vaccine to be utilised for up to five doses. Along with that announcement, the Centers for Disease Control and Prevention (CDC) produced a comprehensive set of tools and resources to assist jurisdictions in instructing healthcare professionals and providers on how to deliver the vaccine intradermally.
Some of the biggest counties in the nation, including Los Angeles County in California and Fulton County in Georgia, totally switched to intradermal injection of the JYNNEOS vaccination for eligible adults in less than ten days after the FDA’s EUA on the topic. Due to the JYNNEOS vaccine’s requirement for two doses given four weeks apart for optimum protection, more jurisdictions are now able to provide second doses to those who qualify.
The capacity of tests has expanded from 6,000 tests per week to 80,000 tests per week under the Biden-Harris Administration, greatly increasing accessibility and convenience. The Administration has also taken a number of steps to increase the accessibility of prescribing TPOXX, a medication for MPV, and today’s announcements build on those efforts.
To make more testing, treatments, and vaccines available and to safeguard areas where the virus is most likely to spread:
Beginning on Monday, 1.8 million doses of the vaccine will be available for purchase through HHS.
The Department of Health and Human Services (HHS) allocated and started dispensing an additional 442,000 doses of vaccine to jurisdictions across the nation earlier this week. The 442,000 doses reflect the total number of doses that might be made accessible through intradermal administration, as the announcement was the first distribution of vaccine after the FDA’s EUA permits for intradermal administration of the JYNNEOS vaccine.
Phase 4 of HHS’s National Vaccine Strategy has been expedited, and as of August 22nd, an additional 1.8 million doses will be made available for purchase. The ability to order more doses of the vaccine will be available to jurisdictions that are implementing the intradermal injection method and have utilised 90% of their current supply.
In order to encourage the speedy distribution of the vaccine to people who are most at risk of catching the virus, particularly homosexual, bisexual, and other males who have sex with men, the administration is making these doses available earlier than expected. The Administration also promotes intradermal vaccination administration and offers technical support, resources, and assistance to jurisdictions that are implementing and extending intradermal vaccination.
For counties holding significant LGBTQI+ events, the Administration is making more immunizations available.
In the coming weeks and months, HHS is initiating a pilot programme to give increased vaccination allocations to state and local health departments in areas that will be hosting major events that draw homosexual, bisexual, and other men who have sex with men. To supplement jurisdictions’ current vaccination allocations and supplies, the pilot initiative is reserving 50,000 doses of vaccine from the Strategic National Stockpile (SNS). In order to target guests who are most at risk for MPV, the size and nature of the event will determine how many additional doses will be made available to a jurisdiction.
In addition to increasing the number of vaccine doses available, the CDC is helping jurisdictions prepare for these significant events. This assistance and support includes developing vaccine and testing strategies to be put in place during and around these events, creating tools for gathering information from event attendees, and providing messaging and communications resources on vaccines, testing, and strategies to lower one’s risk of contracting the virus. In order to quickly deploy the intradermal administration of the JYNNEOS vaccine and provide more doses at these events to more people, the CDC is also collaborating with jurisdictions.
In order to get ready for sizable LGBTQI+ events that will take place in those states over the next few days and weeks, the Administration has already begun working with the health departments of Louisiana, Georgia, and Louisiana. For instance, the Administration collaborated with North Carolina to design a strategy for immunisation for the August 20th and 21st Charlotte Pride Festival & Parade. By replacing their supply of vaccine with the amount of doses given at these events, the administration will provide North Carolina with up to 2,000 extra doses. In addition to the more than 18,000 doses that North Carolina has already gotten through its current allocations, those doses are being added.
For prepositioning, ASPR is providing 50,000 courses of TPOXX to countries, enabling quick access to TPOXX for qualified patients.
To make the treatment more accessible for providers and patients, the Biden-Harris Administration will make 50,000 patient courses of TPOXX available to jurisdictions next week. This is almost five times as many courses as there have been confirmed cases in the United States. Courses of TPOXX will be distributed to jurisdictions according to a formula based on two factors: the number of cases in the jurisdiction and the number of people who are most at risk of catching the virus, including those who have HIV or who would benefit from HIV pre-exposure prophylaxis. This distribution is in addition to the more than 20,000 courses from the SNS that ASPR has already distributed to jurisdictions.
It is crucial that this medication be used carefully in accordance with the Expanded Access protocol and applicable treatment guidelines because 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.