August 17, 2022 – The HHS announced that it is making up to 442,000 doses of the JYNNEOS vaccine available for states and jurisdictions to order under an accelerated Phase 3 of the National Vaccine Strategy (NVS) to combat the current monkeypox outbreak.
Under the original timeline for Phase 3, doses were to be made available for ordering in three segments released on July 29, August 15, and later in August. In light of the recent Food and Drug Administration (FDA) Emergency Use Authorization (EUA) and revised dosing guidelines from the Centers for Disease Control and Prevention (CDC), HHS is able to make both segments two and three available for ordering today—double the number of doses as originally anticipated.
Under the FDA EUA for JYNNEOS, the vaccine may be injected intradermally (in the upper skin layer) for individuals 18 years of age and older who are determined to be at high risk for monkeypox infection – a change that increases doses by up to five-fold. States and jurisdictions can now access additional doses from the federal government through the NVS earlier than projected and expand use of vaccine they have already received. The intradermal method of injecting the vaccine is safe and produces a similar immune response to the subcutaneous method (underneath the skin).
The EUA for the JYNNEOS vaccine allows health care providers to inject the vaccine intradermally for individuals 18 years of age and older who are determined to be at high risk for monkeypox infection. A full intradermal dose requires only 0.1mL of vaccine to elicit similar immunogenicity obtained with a 0.5mL subcutaneous dose without compromising the level of immune response achieved or the safety of the vaccine, which means that up to five people can now receive a full dose using just a single vial of vaccine.
It is critical to note that while this approach will extend the U.S. supply of JYNNEOS, vaccinated individuals will not receive “partial” doses. They will receive a full dose of vaccine for intradermal administration producing a similar level of immunologic response as a full dose for subcutaneous administration. Equally important to note is that protection conferred by the JYNNEOS vaccine requires two doses given 28 days apart – whether administered via the subcutaneous or intradermal routes. Persons under 18 years of age and some adults for whom intradermal administration is not recommended will continue to receive JYNNEOS administered via subcutaneous injection of 0.5mL.
In addition to accelerating access to doses under Phase 3, today’s action paves the way for launching Phase 4 of the NVS later this month – also faster than anticipated. HHS is working with all jurisdictions to determine how many JYNNEOS vials deployed to date are still available for use that potentially may yield up to five doses each. This will inform specifics of Phase 4 which, based on the increased number of doses in each unused vial, will likely include significant coverage of the entire at-risk population eligible for vaccination.