Monkeypox vaccine: FDA authorizes change in how vaccine is given, in order to stretch supply
2 years, 7 months ago

Monkeypox vaccine: FDA authorizes change in how vaccine is given, in order to stretch supply

CNN  

CNN — The US Food and Drug Administration issued an emergency use authorization Tuesday that allows health-care providers to change how the Jynneos monkeypox vaccine is administered, stretching out the supply amid high demand. “I think we’re going to see that we will likely still run out of vaccines before we run out of arms,” Dr. Demetre Daskalakis, the White House’s assistant national response coordinator, said Tuesday. By increasing the number of available doses, more individuals who want to be vaccinated against monkeypox will now have the opportunity to do so.” He added at a briefing Tuesday, “we encourage jurisdictions to utilize alternative dosing method as quickly as possible, and we’ll be your partner in this step every step of the way.” The move comes less than a week after the Biden administration declared monkeypox a public health emergency, which gives the FDA and other government health agencies more flexibility to fight the spread of the virus. “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.” Prevention remains important The CDC is launching an outreach program to ease the transition to the new strategy, expanding its education and information efforts for public health officials and health care providers. “There is no traditional assessment of this vaccine … because there weren’t smallpox cases, and the monkeypox outbreaks before this were not large enough to really do a clinical trial,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said Tuesday.

History of this topic

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2 years, 8 months ago
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2 years, 8 months ago
EU drug regulator recommends clearing vaccine for monkeypox
2 years, 8 months ago

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