Washington, D.C.—With monkeypox cases rising in the United States, and persistent issues with vaccine supply, the FDA issued an Emergency Use Authorization (EUA) for the Jynneos vaccine to allow healthcare providers to use the vaccine for adults who are determined to be at high risk for monkeypox infection.
That will increase the total number of doses available for use by up to fivefold, according to public health officials.
Based on the EUA, the vaccine also can be used in children and adolescents at high risk of monkeypox infection. For them, Jynneos is administered via subcutaneous injection, whereas the adult version is administered via intradermal injection.
"In recent weeks the monkeypox virus has continued to spread at a rate that has made it clear our current vaccine supply will not meet the current demand," stated FDA Commissioner Robert M. Califf, MD. "The FDA quickly explored other scientifically appropriate options to facilitate access to the vaccine for all impacted individuals. By increasing the number of available doses, more individuals who want to be vaccinated against monkeypox will now have the opportunity to do so."
A key pharmacy group is asking that federal health officials take another step to ensure that those who need vaccination can get it: Allow pharmacists to order and administer the vaccines. That was spelled out in a letter to the Department of Health and Human Services (HHS) Secretary, Xavier Becerra.
Tom Kraus, JD, vice president, government relations, ASHP, pointed out, "Pharmacists are well positioned to administer monkeypox vaccines for pre- and post-exposure prophylaxis of healthcare workers, patients, their close contacts, and populations at risk for severe disease from monkeypox virus (such as people with HIV or other immunocompromising conditions)."
Mr. Kraus advised, "To ensure timely access to vaccines for monkeypox, we recommend that HHS issue a Public Readiness and Emergency Preparedness (PREP) Act declaration to allow pharmacists to order and administer monkeypox vaccines," adding, "As the monkeypox outbreak continues to grow both domestically and globally, we urge you to act quickly so that pharmacists may order and administer vaccines to prevent monkeypox virus infection in vulnerable populations."
Jynneos, the Modified Vaccinia Ankara (MVA) vaccine, was approved in 2019 for the prevention of smallpox and monkeypox disease in adults aged 18 years and older determined to be at high risk for smallpox or monkeypox infection. The vaccine typically is administered subcutaneously as two doses, 4 weeks apart.
With the new EUA, a fraction of the Jynneos dose can be administered intradermally, with the two doses over 4 weeks still required.
"There are no data available to indicate that one dose of Jynneos will provide long-lasting protection, which will be needed to control the current monkeypox outbreak," the FDA noted.
An FDA press release cited a 2015 clinical study of the MVA vaccine to explain, "Individuals who received the vaccine intradermally received a lower volume (one-fifth) than individuals who received the vaccine subcutaneously. The results of this study demonstrated that intradermal administration produced a similar immune response to subcutaneous administration, meaning individuals in both groups responded to vaccination in a similar way."
It added that intradermal administration resulted in more redness, firmness, itchiness, and swelling at the injection site, however, less pain. It also calls the side effects "manageable."
Since Dr. Becerra's declaration of the monkeypox outbreak emerging as a public health emergency on August 9, 2022, the FDA has been allowed to issue an EUA to grant emergency use of unapproved vaccines or unapproved uses of approved vaccines.
In his letter, the Mr. Kraus states that CDC guidance calls for the monkeypox vaccine to be given within 4 days from the date of exposure for the best chance to prevent onset of the disease and within 14 days to reduce symptoms of the disease. "When patients access care from a pharmacist, directing the patient to another provider for vaccine administration would unnecessarily delay administration," he added. "To ensure pharmacists are able to expand access as vaccine supplies increase, we urge you to proactively authorize pharmacists to order and administer monkeypox vaccines."
In the letter, the ASHP also urges the HHS to proactively coordinate with payers—including Medicare and Medicaid—to ensure adequate reimbursement to support services provided by pharmacists, which has been an issue with some COVID-19 therapies.
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