==The manufacturer of the only monkeypox the U.S. Food and Drug Administration (FDA)-approved vaccine has raised concerns with senior Biden administration health officials about their plan to split doses and change how injections are given , according to a new Washington Post report.
“We have some reservations…due to the very limited safety data available,” Bavarian Nordic CEO Paul Chaplin wrote in a statement. letter Secretary of Health and Human Services (HHS) Xavier Becerra and FDA Commissioner Robert Califf.
Chaplin added that it would be “prudent” to conduct further studies before revising the national monkeypox vaccination strategy and that his company has been “inundated with calls from U.S. government officials with questions and concerns” about how to implement the new vaccination plan.
In response, Biden administration officials acknowledged the concerns but said the new strategy would proceed as planned.
“We’ve had conversations with them about this, as has the FDA,” Becerra said.
“We wouldn’t have moved on if we didn’t think it was safe and effective, and if the FDA hadn’t dotted the I’s and crossed out the T’s,” he continued.
On Tuesday, the FDA issued a emergency use authorization that allows health care providers to divide Jynneos doses of monkeypox vaccine in hopes of inoculating up to five times as many people against the fast-spreading disease. CNN reported that the vaccine can now be offered to high-risk adults intradermally, or between the layers of the skin, rather than subcutaneously, or under the skin, as it has typically been administered. This will allow providers to get up to five doses from a standard single-dose vial.
“Over the past few weeks, the monkeypox virus has continued to spread at a rate that has made it clear that our current vaccine supply will not meet current demand,” Califf said. said in a report. “The FDA quickly explored other scientifically appropriate options to facilitate access to the vaccine for all affected individuals. By increasing the number of doses available, more people wishing to be vaccinated against monkeypox will now be able to do so.
The FDA’s decision came less than a week after the Biden administration declared monkeypox a public health emergency, which will help mobilize more resources and personnel to fight the emerging outbreak. has spread rapidly across the country over the past two months. There are currently more than 10,300 monkeypox infections in forty-nine states, according to the Centers for Disease Control and Prevention (CDC). On Wednesday alone, 1,391 new cases were reported nationwide, the largest one-day increase to date.
“We are still operating under a containment goal, although I know many states are starting to question whether we are moving more into a mitigation phase at this time, given that our case numbers continue to climb. increasing rapidly,” said Jennifer McQuiston, the CDC’s official. responsible for monkeypox, said on Tuesday, by CBS News.
Ethen Kim Lieser is a Washington State-based finance and technology editor who has held positions at Google, The Korea Herald, Lincoln Journal Star, AsianWeek, and Arirang TV. Follow him or contact him on LinkedIn.