Biden admin snafu leaves 1 million monkeypox doses in Denmark

A top Biden administration official tried to beat away mounting criticism from public health activists Thursday that the White House is letting red tape snarl delivery of 1 million monkeypox vaccine doses — which are currently stuck at the manufacturing plant in Denmark.

It was the first appearance by the federal government’s pandemic response chief in New York City since local LGBTQ organizers sent the June 28 letter to the White House revealing the existence of massive supply sidelined by red tape.

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.

NYC Health Commissioner Dr. Ashwin Vasan (center) announced that more doses of the monkeypox vaccine are on its way to New York City.
Gregory P. Mango

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.”

The FDA did not immediately respond to questions.

Panjabi’s answer did not dispute key contentions in the letter about the number of shots, the FDA’s failure to inspect as required or that the FDA currently accepts EU certifications for other products and is already considering expanding the policy to cover vaccines.

And the response infuriated one of the authors of the letter, James Krellenstein, who called the White House honcho’s statements were “bulls–t.”

“That’s bullshit and they’re covering up,” retorted Krellenstein, a longtime activist who co-founded a group, PrEP4All, which successfully pushed officials to expand access to medications that prevent HIV. “They’re not being transparent about what’s going on.

A view outside MedRite Urgent Care
The FDA is refusing to import the doses as they have yet to inspect the plant.
Noam Galai/Getty Images

“Why were the Europeans able to inspect this plant a year ago, ensuring these doses can be used in Europe and the Biden Administration didn’t do the same,” he added. “The FDA is making a judgment that they’d rather let gay people remain unvaccinated for weeks and weeks and weeks than trust the European certification process.”

The fury over the doses stuck in Denmark is the latest headache to beset the monkeypox vaccine rollout in New York City — which is attempting to stem a tide of infections that has grown to 141 cases on Thursday, up from 111 on Tuesday.

New York City has received just 7,000 doses from the federal government amid the national vaccine shortage. Meanwhile, the city Department of Health and Mental Hygiene’s appointment booking system has failed to keep up with the high demand for the shots — most recently on Wednesday.

MedRite, the DOHMH vendor running the system, issued an apology late Wednesday night.

“MedRite’s system for Monkeypox vaccination appointments is now functioning. Apologies to those who attempted to register for the vaccine today,” the company tweeted. “We will continue to administer the vaccine as it is made available and thank the City [of New York] for their trust.”

A photo taken on July 13, 2020 shows the headquarters of Danish biotechnology company Bavarian Nordic in Hellerup
The vaccine doses are currently stuck at the Denmark facility.
Ritzau Scanpix/AFP via Getty Images

Spokesmen for DOHMH were not able to immediately provide details about its contract with MedRite, including the budget for the program.

Records filed with the City Record show MedRite receiving just one contract in recent years, which has ballooned to $36 million from $5 million for work related to the coronavirus vaccination.

The mounting frustrations left health officials and Mayor Eric Adams on the defensive, pushing back against comparisons to New York’s struggles during the early days of the coronavirus vaccine, which was beset by computer glitches and supply shortages.

“Each morning we get forecasts on monkeypox and we are managing this issue,” Hizzoner told reporters after an unrelated event in Brooklyn on Thursday. “We are taking it seriously, we are not just ignoring it.”

– Additional reporting by Jack Morphet and Sam Raskin


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