The United States could have received many more doses of monkeypox vaccine this year

The Department of Health and Human Services was slow to ask the manufacturer to turn the bulk vaccine the government already had into vials.

WASHINGTON — Shortages of vaccines to fight a fast-growing monkeypox epidemic were caused in part because the Department of Health and Human Services failed to ask very sooner than bulk supplies of the vaccine he already had would be bottled for distribution, according to several administration officials familiar with the matter.

By the time the federal government placed its orders, Danish vaccine maker Bavarian Nordic had booked other customers and was unable to get the job done for months, officials said — even though the federal government had invested well over a year. billion dollars in vaccine development.

The government is now distributing about 1.1 million doses, less than a third of the 3.5 million that health officials now estimate is needed to fight the outbreak. He does not expect the next delivery, of half a million doses, until October. Most of the remaining 5.5 million doses ordered by the United States are not expected to be delivered until next year, according to the federal health agency.

To speed up deliveries, the Government is working to find another company to take over some of the bottling, capping and labeling of the frozen bulk vaccine which is stored in large plastic bags at the headquarters of Bavarian Nordic outside Copenhagen. Since this final manufacturing phase, known as fill and finish, is highly specialized, experts estimate it will take another company at least three months to prepare. Negotiations are underway with Grand River Aseptic Manufacturing, a Michigan plant that helped produce Covid-19 vaccines, to bottle 2.5 million of the doses currently on order, hoping to squeeze months off the schedule, people say close to the situation.

Health and human services officials miscalculated the need so much that on May 23 they authorized Bavarian Nordic to deliver about 215,000 fully finished doses that the federal government had already purchased from European countries instead of withholding them for the United States.

At the time, the country only had eight confirmed cases of monkeypox, agency officials said. And he couldn't have used those doses right away because the Food and Drug Administration hadn't yet certified the factory where the vaccine, Jynneos, was poured into vials.

But he could now. Some states are trying to stretch the doses by giving recipients just one injection of the two-dose vaccine. California, Illinois and New York have declared public health emergencies. In New York, every available slot for a monkeypox vaccine is being taken.

Lawrence O. Gostin, a former adviser to the Centers for Disease Control and Prevention who has consulted the White House about monkeypox, said the government's response has been hampered by "the same kinds of bureaucratic delays, oversights and dropping the ball that we did during the Covid pandemic". p>

The obstacles to filling and finishing vials follow other missteps that have limited vaccine supplies. The United States once had some 20 million doses in a national stockpile, but failed to replenish them when they expired, leaving the supply dwindling to almost nothing. It had 372,000 doses ready to go to Denmark, but waited weeks after the first case was identified in mid-May before asking for most of those doses to be delivered. About 786,000 other doses were withheld by an F.D.A. inspection of the manufacturer's new fill and finish plant, but