FDA Emergency Use Authorization allows for alternative dosing regimen; increases JYNNEOS supply by up to five-fold
Combatting the monkeypox outbreak is a top priority of the Biden-Harris Administration. Today, as part of the Administration’s comprehensive effort to mitigate the spread of monkeypox, the Administration announced that it has taken action to increase the number of vaccine doses available by up to five times through an alternative dosing regimen. The Food and Drug Administration (FDA) today announced it is granting Emergency Use Authorization (EUA) for the JYNNEOS vaccine to be administered intradermally. Because intradermal administration requires a smaller dose, this change allows the number of available doses to increase by as much as five-fold while continuing to ensure the vaccine meets high standards for safety and quality.
The White House National Monkeypox Response team today outlined its plan to implement this approach and ensure providers and public health officials put the alternative dosing regimen into practice.
Today’s announcements include:
The Department of Health and Human Services (HHS) announced a Section 564 declaration, allowing FDA to use its authority to allow health care providers to administer up to five times the number of vaccine doses per vial of JYNNEOS vaccine.
Following last week’s public health emergency declaration, today HHS Secretary Xavier Becerra issued a determination under the Section 564 declaration of the Food, Drug, and Cosmetic Act that allows for emergency use authorization of vaccines to prevent monkeypox and prevent severe disease from the virus. This action paves the way for the federal government to get up to five times the amount of doses administered out of a single vial of the JYNNEOS vaccine.
HHS Assistant Secretary for Preparedness and Response Dawn O’Connell requested that the Secretary issue the Section 564 determination and last week’s public health emergency declaration. This declaration allows HHS to take emergency measures based on the information currently available about the monkeypox virus.
FDA subsequently granted Emergency Use Authorization for the JYNNEOS vaccine to be administered intradermally – enabling the current vaccine supply to increase five-fold without sacrificing safety and quality.
Today, the FDA issued an Emergency Use Authorization allowing healthcare providers to use an alternative dosing regimen of the JYNNEOS Vaccine to expand the total number of doses available for use by up to five-fold. The EUA now allows for 0.1ml of the JYNNEOS vaccine to be administered between layers of the skin (intradermally), as opposed to 0.5ml of the vaccine that is administered under the skin (subcutaneously). Data from a 2015 clinical study of the JYNNEOS vaccine prior to its approval, published in a peer-reviewed journal, demonstrated that a fifth of the dose, when given intradermally on the same two-dose schedule as currently administered, produced an immune response that was similar to subcutaneous dosing – meaning individuals in both groups responded to vaccination in a similar way. Additionally, data shows the intradermal administration of other vaccines such as influenza and hepatitis B, is safe and effective for immunocompromised individuals, such as people with HIV. JYNNEOS has been tested in individuals with immunocompromising conditions and has found to be safe and effective in the trials that were performed to support approval. Two doses of the vaccine given 28 days apart will still be needed. Individuals who received their first dose subcutaneously can receive their second dose intradermally or subcutaneously.
The administration requires a different type of needle than the current vaccine administration, similar to the administration for a tuberculin skin tests (or PPD) or intradermal allergy tests. As part of the Administration’s comprehensive monkeypox response effort, the Centers for Disease Control (CDC) will conduct trainings and outreach to clinicians, public health officials, providers, and patients to make sure jurisdictions can effectively administer the vaccine using this alternative dosing regimen.
The FDA also authorized use of the vaccine, using the standard dosing route, in individuals younger than 18 years of age determined to be at high risk of monkeypox infection.
The White House National Monkeypox Outbreak Response team will oversee the prompt and coordinated implementation of this strategy by HHS, CDC, FDA, and state and local health officials.
Since the start of the outbreak, HHS has distributed more than 670,000 JYNNEOS vaccines to states and jurisdictions from the Strategic National Stockpile (SNS). In addition, the SNS is preparing to distribute approximately 400,000 additional vials to states and jurisdictions as part of the next phase of the national vaccine strategy. Jurisdictions that administer 90% of their current vaccine supply may request additional doses sooner. Because of today’s announcement, the 400,000 vials of vaccine in the SNS’s inventory that have been allocated but not yet distributed hold the potential to provide up to 2 million doses using intradermal administration. Additionally, vaccines that have been received by jurisdictions, but not yet administered, are eligible for intradermal administration.
In order to quickly and effectively implement this approach to increase JYNNEOS vaccine dose supply five-fold, the Biden-Harris Administration is launching a robust effort to train health care workers and providers on how to administer the JYNNEOS vaccine intradermally.
Intradermal administration of vaccine is currently used by providers across the country, particularly when administering tuberculosis skin tests (in the forearm) and intradermal allergy tests, and providers currently have the supplies needed to administer the vaccine in this way. Nonetheless, the Administration will actively engage providers and clinicians to ensure they are prepared to use this approach for most adults who need JYNNEOS vaccine.
CDC is releasing interim clinical guidance and a Dear Colleague Letter from FDA to public health officials, and will be hosting trainings and webinars to support the transition to intradermal administration.
The Centers for Disease Control and Prevention is launching a robust plan to communicate with and train public health professionals and providers to quickly implement the intradermal vaccine administration strategy.
Beginning today, the CDC is releasing:
- Interim clinical considerations on its website, with relevant guidance on how to administer the JYNNEOS vaccine intradermally. The “Interim Clinical Considerations for Use of JYNNEOS and ACAM2000 Vaccines during the 2022 US Monkeypox Outbreak” document includes an overview of monkeypox vaccines, vaccination strategies and post-exposure prophylaxis, and planning considerations for health departments including health equity. In addition, it provides interim guidance for use of JYNNEOS or ACAM2000 vaccines, including the schedule and dosing regimens that can be considered, dosing intervals, vaccine administration, evidence quality, pre- and post-vaccination counseling, and contraindications and precautions.
- Supporting documents including FAQs for providers and the general public about monkeypox vaccines
- Related resources for providersincluding template standing orders and preparation and administration summary documents.
- A video to help train health care providers and medical professionals immediately on intradermal vaccine administration.
- CDC is making experts and clinicians available this afternoon to answer questions on intradermal administration.
- CDC also plans to communicate with tens of thousands of public health officials and healthcare providers through a Clinical Outreach and Communications Activity (COCA), and will hold webinars and training sessions online and on the ground in communities where the outbreak is most severe.
Vaccines will continue to be shipped as 0.5ml vials, and HHS will be reviewing existing allocations and future vaccine distribution timelines to reflect the increased number of doses now available.
Vaccine vials shipped from the supplier, the SNS, and jurisdictions will continue to be shipped as 0.5ml vials, from which healthcare providers can withdraw 0.5ml for a single subcutaneous dose or 0.1ml for an intradermal dose.
Currently, the SNS has approximately 400,000 vials of JYNNEOS ready for distribution, totaling up to 2 million doses if administered by the intradermal route. Jurisdictions can order additional vaccine supply starting on August 15th or when they have used 90% of their current vaccine allotment. Jurisdictions can also continue to administer the vaccine subcutaneously while they are training medical professionals on the alternative dosing regimen for administration of the vaccine, and for individuals who still need the standard subcutaneous regimen, like children and adolescents.
In light of today’s announcements and the anticipated increase in JYNNEOS vaccine supply, CDC and ASPR are reviewing the current allocation and distribution timeline for vaccines. The goal of revised allocation or distribution strategies will be to ensure jurisdictions have sufficient vaccine supply to implement a two-dose strategy using intradermal application, and to ensure that jurisdictions aren’t receiving more vaccine than they can store or use in a given time period .
ASPR will proceed with procurement of 5.5 million vials of vaccine, totaling over 25 million additional doses that will be available in the United States.
Even with the alternative vaccine administration, the Administration for Strategic Preparedness and Response (ASPR) will proceed with its procurement of 5.5 million vials of vaccine, which, factoring in the alternative dosing regimen, represents as much as 25 million doses that will become in the United States, in addition to current vaccine supply.
The Biden-Harris Administration will also continue to work to accelerate vaccine production and distribution. Last week, the Administration announced that 150,000 vials – totaling up to 750,000 doses administered intradermally – will arrive in the United States and be available for distribution in September, two months earlier than originally planned.
Today’s announcement is part of the Biden-Harris Administration’s comprehensive strategy to combat the monkeypox outbreak and protect those at risk of contracting the virus. Since the first known cases in the United States, the Administration has developed a robust and agile strategy to expand and accelerate the production and distribution of vaccines, increased testing capacity from 6,000 tests per week to 80,000 tests per week, made treatments more accessible, and communicated on an ongoing basis with public health officials, state and local leaders, and individuals most impacted by the virus to date, including the LGBTQI+ community.