Mary Wilson
Well-known member
July 14, 2022, 5:19 PM CDT
By Benjamin Ryan and Aria Bendix
More than 1 million doses held up in Denmark
... But avoidable mistakes also slowed down the distribution of vaccines, according to some politicians and activists.
“The federal government should have ordered far more of this vaccine to stockpile,” said California state Sen. Scott Wiener. “It’s not surprising that we’re having a monkeypox problem. People have predicted this. This should not be shocking. And so now, the U.S. is having to scramble to order more.”
... Bavarian Nordic, which makes Jynneos, is prepared to ship 1.1. million doses to the U.S. But the Food and Drug Administration needed to inspect the company’s manufacturing facility before those doses could be released. That inspection was originally planned for later this year but the FDA moved it up in response to the monkeypox outbreak, said Rolf Sass Sørensen, vice president of investor relations and communications at Bavarian Nordic. The FDA finished inspecting the facility on Saturday, he said.
Even so, the agency hasn’t signed off on the doses yet, so none have been shipped, Sørensen said.
“It’s really up to the FDA,” he said. “We have had plenty of bought vaccine in storage.”
... Krellenstein urged the U.S. government in a letterin June to accept the European Medicines Agency’s signoff on the Bavarian Nordic facility. But the FDA told NBC News that it “takes the quality of vaccine manufacturing very seriously” and determined that it needs to conduct its own inspections of foreign facilities.
https://www.nbcnews.com/health/health-news/went-wrong-rollout-monkeypox-vaccine-rcna38017
By Benjamin Ryan and Aria Bendix
More than 1 million doses held up in Denmark
... But avoidable mistakes also slowed down the distribution of vaccines, according to some politicians and activists.
“The federal government should have ordered far more of this vaccine to stockpile,” said California state Sen. Scott Wiener. “It’s not surprising that we’re having a monkeypox problem. People have predicted this. This should not be shocking. And so now, the U.S. is having to scramble to order more.”
... Bavarian Nordic, which makes Jynneos, is prepared to ship 1.1. million doses to the U.S. But the Food and Drug Administration needed to inspect the company’s manufacturing facility before those doses could be released. That inspection was originally planned for later this year but the FDA moved it up in response to the monkeypox outbreak, said Rolf Sass Sørensen, vice president of investor relations and communications at Bavarian Nordic. The FDA finished inspecting the facility on Saturday, he said.
Even so, the agency hasn’t signed off on the doses yet, so none have been shipped, Sørensen said.
“It’s really up to the FDA,” he said. “We have had plenty of bought vaccine in storage.”
... Krellenstein urged the U.S. government in a letterin June to accept the European Medicines Agency’s signoff on the Bavarian Nordic facility. But the FDA told NBC News that it “takes the quality of vaccine manufacturing very seriously” and determined that it needs to conduct its own inspections of foreign facilities.
https://www.nbcnews.com/health/health-news/went-wrong-rollout-monkeypox-vaccine-rcna38017