Monkeypox Vaccine Maker Warns of FDA Dosing and Administration Change
In private, the company that manufactures the only monkeypox vaccine approved by the Food and Drug Administration expressed concerns to the Biden administration about the FDA’s plans to dilute a vial’s dose into five doses and change the way the shot is administered.The CEO of Bavarian Nordic, Paul Chaplin, wrote of his concerns to the Department of Health and Human Services in a letter obtained by the Washington Post Tuesday, the paper reports.“Bavarian Nordic...is dedicated to assisting Governments around the globe to control the current monkeypox outbreak and is fully supportive of dose-sparing approaches, such as delaying the second vaccination,” Chaplin wrote. “However, we do have some reservations on the [new injection] approach, due to the very limited safety data available..., the higher [rates of expected adverse reactions] compared to the JYNNEOS standard dose and route..., and the fact that there was a relatively high percentage of subjects...that failed to receive the second vaccination during a controlled clinical study.”The letter continues, “We have been made aware of some additional analysis of the [intradermal] study data, but essentially this does not change the overall picture that the [intradermal] administration results in increased [adverse reactions] compared to [the current route of administration] and this may have a negative impact on vaccine uptake and coverage.”For the manufacturer to present valid data concerning its product and untested protocols, Chaplin urges the administration to gather data from the rollout of the government’s new dosage and administration option.“It is our understanding that it is the United States Government position that there is no time to prepare or conduct such a.
