FDA issues Jynneos EUA to stretch monkeypox vaccine supply

Regulatory NewsRegulatory News | 09 August 2022 |  By 

Jynneos monkeypox vaccine. (Source: HHS)

The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Bavarian Nordic's monkeypox vaccine Jynneos to be administered to adults intradermally. The move is meant to significantly increase the availability of the vaccine because it requires much smaller doses compared to being injected subcutaneously.
Immediately after Health and Human Services (HHS) Secretary Xavier Becerra issued a determination under Section 564 of the Federal Food, Drug and Cosmetic Act (FD&C Act) to give FDA Commissioner Robert Califf EUA authority, the agency announced the vaccine could be administered in smaller doses between the skin, rather than under it, to those 18 and older. The move will allow authorities to stretch out the number of available doses to five times the number that would be available if the vaccine were to be given exclusively through subcutaneous 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," said Califf in an agency statement. "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."
The Biden Administration declared monkeypox a public health emergency (PHE) on 4 August but immediately warned that there aren’t enough vaccines to go around. So far, the two vaccines that are being administered for monkeypox are Jynneos and ACAM2000 which were initially developed for smallpox.
Jynneos is a modified vaccinia Ankara (MVA) vaccine and was approved in 2019 to prevent smallpox in immunocompromised adults, as well as monkeypox. While the vaccine was initially given in two doses four weeks apart underneath the skin, a 2015 clinical study found that it was just as effective when administered intradermally in lower doses.
HHS notes that to date it has allowed more than 1.1 million doses of Jynneos vaccines on the market and of those more than 620,000 doses have already shipped. The department also says it has made the ACAM2000 vaccine and the smallpox antiviral drug TPOXX available to treat monkeypox patients while ramping up monkeypox diagnostics to 80,000 rapid tests a week.
“Today’s action will allow FDA to exercise additional authorities that may increase availability of vaccines to prevent monkeypox while continuing to ensure the vaccine meets high standards for safety, effectiveness and manufacturing quality,” said Becerra after issuing the 564 determination which came after it was requested by HHS Assistant Secretary for Preparedness and Response Dawn O’Connell.


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