White House officials confirmed Friday that the federal government has nearly 17 million doses of monkeypox vaccine stockpiled at a manufacturing facility in Denmark, as New York City struggles to make do with a limited supply of shots after emerging as the U.S. epicenter for the viral disease.
Prep4ALL and Partners In Health recently sent a letter to President Biden’s administration highlighting the U.S.-owned doses in Denmark, of which about 1 million are vialed, labeled, packaged, and prepared for delivery.
The heads of the two organizations, James Krellenstein and Garrett Wilkinson, stated in the letter that they were informed by a senior federal public health official that the 1 million packaged doses would not be shipped to the United States because the Food and Drug Administration had not carried out a “timely inspection” of the Bavarian Nordic facility where the shots are being stored.
The doses cannot be delivered until the FDA conducts a new inspection, the federal official informed Krellenstein and Wilkinson, according to their letter. As a result, the plant’s good standing certification with the U.S. has expired.
However, the team claimed there was a workaround for the FDA’s red tape.
The Bavarian Nordic facility was accredited by the European Union’s Medicines Agency a year ago, and according to Krellenstein and Wilkinson, Biden could disregard FDA regulations and use the EU agency’s approval to distribute the doses right away.
The failure to produce and distribute vaccines effectively during the global COVID-19 response must not be allowed to prevent us from successfully containing the current monkeypox outbreak, they emphasized in their letter.
The United States has enough vaccine material at the facility in Denmark to produce an additional 15.8 million doses of monkeypox vaccine in addition to the packaged doses. The federal government only has a contract for completing about 500,000 of those doses, according to Krellenstein and Wilkinson.
Despite denying that the president could override the FDA, a Biden administration official said on Friday that “no vaccines of any kind” could be distributed in the U.S. based solely on the directive of the EU agency. The official did not contest the stockpiles described by Krellenstein and Wilkinson.
The official stated, “The FDA is the gold standard and has an obligation to ensure that only products that meet its standards are available here for the American people, including its vaccines.” The administration places a high priority on maintaining the FDA’s independence because it is a separate regulatory body.
In order to “expedite” inspections at the Bavarian Nordic plant and speed up the process “by months without sacrificing their rigorous quality control process,” the official said, the FDA is actively working to do so. When asked for an estimated completion date for the inspection process, he refused to say, and the FDA did not immediately respond to a request for comment.
The symptoms of monkeypox, which primarily affects men who have sex with other men, include fever, blister-like rashes, and other symptoms. Public health professionals have emphasized that there are no documented cases of monkeypox deaths in the United States and that the virus seems to be less deadly and contagious than COVID-19.
What is monkeypox, and should New Yorkers be concerned? [EXPLAINER]
Monkeypox vaccine availability is becoming a serious problem in New York City, where as of Thursday, 141 of the nation’s approximately 600 cases had been reported.
The city’s Health Department and a third-party vendor botched the rollout of the approximately 6,000 doses that arrived earlier this week, with reports of New Yorkers having their appointments canceled at the last minute due to a lack of supply.
[Officials say that thousands of vaccine doses have been secured, and that 75% of NYC monkeypox cases are in Manhattan.]
Democratic candidate for the 10th Congressional District of New York, Dan Goldman, slammed the federal government and Mayor Adams’ administration over the vaccine error and urged Biden to accept the EU certification for the shots given in Denmark.
The health and safety of New Yorkers are now at risk because of the botched rollout and insufficient supply of monkeypox vaccine, according to a statement from Goldman. “For the past two years, we have been coping with a global public health emergency, and it would appear that we haven’t learned anything from our mistakes. The people of New York deserve from their government that it foresees issues and effectively addresses them.
