US Strands 17M Monkeypox Vax Doses In Red Tape

The New York Daily News reports:

Nearly 17 million doses of monkeypox vaccine are collecting dust at a manufacturing plant in Denmark instead of being shipped to the U.S. due to a bureaucratic delay, White House officials confirmed Friday, as New Yorkers lined up in droves to get ahold of a shot from the city’s short supply.

About 6,000 monkeypox doses arrived in the city earlier this week, but the local Health Department and a third-party vendor, MedRite, bungled administering the shots, with reports of New Yorkers having their appointments canceled at the last minute due to flagging supply.

The city’s flubbed rollout has put a spotlight on the millions of U.S.-owned monkeypox doses stuck in Denmark — a dilemma that was first highlighted in a letter sent recently to President Biden’s administration by public health groups Prep4ALL and Partners In Health.

The New York Post reports:



The US government spent at least $2 billion developing and manufacturing the vaccine for the national stockpile, the June 28 letter states, but the Food and Drug Administration has refused to import the shots after it failed to inspect the plant — and then refused to accept the inspection results from European Union’s regulatory arm, which deemed the facility safe.

“Let me just set the facts straight on this one because I think there’s been some reporting that’s not completely captured the facts,” said Dr. Raj Panjabi, the senior director of the White House National Security Council leading pandemic preparedness.

The FDA “by policy” would not accept EU sign-off — or “reciprocity” — for “any vaccine,” Panjabi claimed. He added that the FDA had “expedited” inspections by “several months to make sure we have those vaccines here as quickly as possible.”