Viral Disease

FDA Approves Emergency Authorization of Monkeypox Vaccine

08/25/2022

The US Food and Drug Administration (FDA) has authorized emergency use of the JYNNEOS vaccine through intradermal injection in the effort to stop the spread of the monkeypox virus in the United States.1

This Modified Vaccinia Ankara (MVA) vaccine was approved by the FDA in 2019 for the prevention of both monkeypox and smallpox in adults aged 18 years and older that were at high risk for the diseases, to be administered by subcutaneous injection. 

This new method of administration is authorized for use in individuals aged 18 years and older who are considered at high risk for contracting monkeypox. Additionally, the emergency authorization allows for use of the vaccine in individuals aged 18 years and younger that are at high risk of the infection, to be administered by subcutaneous injection. With the authorization, the FDA increased the total number of doses for use by five-fold.  

On August 4, 2002, President Joe Biden declared the monkeypox infection outbreak as a public health emergency in the United States.2

“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,” said FDA Commissioner Robert M. Califf, MD in a press release. “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.” 

JYNNEOS is administered in 2 doses beneath the skin at 4 weeks apart for both subcutaneous and intradermal injections. However, a fraction of the vaccine dose is to be administered intradermally.

In 2015, a clinical study of the MVA vaccine demonstrated that the intradermal method of administering the vaccine produced a similar immune response to subcutaneous administration when both were compared.

Based on results from the 2015 clinical study, administration of the vaccine intradermally resulted in more redness, firmness, itchiness, and swelling at the injection site when compared with subcutaneously administering the dose, but resulted in less pain.

 

—Jessica Ganga

References:

  1. Monkeypox update: FDA authorizes emergency use of JYNNEOS vaccine to increase vaccine supply. News Release. US Food & Drug Administration; August 9, 2022. Accessed August 25, 2022. www.fda.gov/news-events/press-announcements/monkeypox-update-fda-authorizes-emergency-use-jynneos-vaccine-increase-vaccine-supply
  2. Biden-Harris administration bolsters monkeypox response; HHS secretary Becerra declares public health emergency. News release. US Department of Health & Human Services; August 4, 2022. Accessed August 25, 2022. www.hhs.gov/about/news/2022/08/04/biden-harris-administration-bolsters-monkeypox-response-hhs-secretary-becerra-declares-public-health-emergency.html