US has 17M monkeypox vaccine doses in Denmark as NYC scrambles – New York Daily News

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.

The viral disease, which is spreading across the world, primarily among men who have sex with men, causes blister-like rashes, fever and other symptoms. There are no known U.S. monkeypox deaths, and public health experts have stressed that the virus is less transmissible than COVID-19 — but that hasn’t quelled anxiety in New York City, which has emerged as an early epicenter, with 160 of the country’s roughly 700 cases reported here as of Friday.

[ EXPLAINER: What is monkeypox and should New Yorkers be worried? ]

“What I don’t understand is if vaccines are scarce and we know it’s affecting gay men, like why isn’t my doctor calling me?” Adrianao Jimenez, 37, a gay telehealth worker, told the Daily News earlier this week. “Do better. Make the vaccine available to everyone. I know I have to go get mine.”

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 letter, signed by the two group’s top executives, states that a senior federal public health official informed them that the U.S. Food and Drug Administration has not conducted a “timely inspection” of the Bavarian Nordic facility outside of Copenhagen where the vaccine supply is being stored.

As a result, the plant’s good standing certification with the U.S. has lapsed, and none of the doses can be delivered until the FDA conducts a new inspection — even though 1 million shots are already vialed, labeled and ready for delivery, the federal official told the executives, James Krellenstein and Garrett Wilkinson, according to their letter.

Krellenstein and Wilkinson contended there’s a way around the FDA snag.

The European Union’s Medicines Agency certified the Bavarian Nordic facility a year ago, and the duo said Biden could override the FDA’s authority and rely on the EU agency’s green light in order to get the doses to the states immediately.

“We must not allow the same failures of vaccine production and distribution that hampered the global COVID-19 response cause us to fail to contain the current monkeypox outbreak,” they wrote.

On top of the 1 million ready-to-deliver monkeypox shots, the U.S. has enough vaccine substance at the Danish facility to produce some 15.8 million more doses, according to the letter. However, Krellenstein and Wilkinson said the federal government only has a contract for putting about 500,000 of those doses into vials, and urged the Biden administration to secure commitments for the rest.

A Biden administration official did not dispute the stockpiles detailed by Krellenstein and Wilkinson, but dismissed the idea that the president could override the FDA and said: “no vaccines of any kind” can be distributed in the U.S. solely based on the EU agency’s say-so.

“The FDA is the gold standard and has an obligation to ensure only products that meet its standards for the American people, including its vaccines, are available here,” the official said. “The FDA is also an independent regulatory agency and keeping it independent is a priority for the administration on all issues.”

The official said FDA regulators are actively working to “expedite” inspections at the Bavarian Nordic plant “without sacrificing their rigorous quality control process.” He would not provide a timeline for when the inspection process will be completed, and neither would the FDA.

Nationwide, the Biden administration has distributed about 200,000 doses of monkeypox vaccine in the last 10 days, according to federal officials.

Dan Goldman, a Democratic candidate for New York’s 10th congressional district, said that’s far too slow and called on Biden to accept the EU certification for the Danish shots.

“The botched rollout and inadequate monkeypox vaccine supply is completely unacceptable and has put the health and safety of New Yorkers at risk,” Goldman said. “We have been dealing with a global public health emergency for the past two years and have seemingly learned nothing from our mistakes. New Yorkers deserve for their government to anticipate problems and properly address them.”

[ 75% of NYC monkeypox cases are in Manhattan, thousands of vaccine doses secured, officials say ]

Monkeypox is not a new medical phenomenon.

The virus got its name after first being detected in research monkeys in the 1950s, and outbreaks have occurred sporadically since then, primarily in Africa. Vaccines against the virus have existed for decades.

What’s unusual about the current outbreak is that cases have cropped up across the world, mostly in gay and bisexual men. Still, monkeypox can infect anyone, as it spreads most commonly through saliva and direct physical contact.

“There is stigma around it because it’s only affecting gay guys, but I just hope people are careful because just because the fire started here doesn’t mean it won’t spread,” said Jamison Monella, 27, who works at Pieces, a popular gay bar in the Greenwich Village. “I just want everyone to be careful.”

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