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

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 request early that bulk supplies of the vaccine it had already being bottled for distribution, according to several administration officials. familiar with the matter.

By the time the federal government placed its orders, Denmark-based vaccine maker Bavarian Nordic had booked other customers and couldn’t get the job done for months, officials said – even though the government federal government had invested well over a billion dollars in the development of the vaccine.

The government is currently 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 trying 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 shave months off the schedule, according to people close of the situation.

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

At the time, the country had only 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 it 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 taken.

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

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 requesting delivery of most of those doses. About 786,000 more doses were blocked by an FDA inspection of the manufacturer’s new fill-and-finish plant, but have now been shipped.

The government also has the equivalent of about 16.5 million bulk vaccine doses produced and stored by Bavarian Nordic. But by the time the health agency ordered 500,000 doses for injection on June 10, other countries with outbreaks had submitted their own orders and the first delivery date was October.

Another order for 110,000 doses for European countries soon followed. When the United States returned with two more orders for 2.5 million doses each on July 1 and 15, the bulk could not be delivered until the next year.

Gostin, who now directs the O’Neill Institute for National and Global Health Law at Georgetown University, predicted that President Biden’s decision to appoint two new monkeypox response coordinators would help ” light a fire” within the framework of the federal health agencies. The White House announced Tuesday that Robert Fenton, an administrator with the Federal Emergency Management Agency, and Dr. Demetre Daskalakis, a CDC official, will lead the response.

Gostin said the country’s public health agencies were “sort of asleep at the wheel about this” and that the new coordinators should help “unlock all the obstacles to the purchase and delivery of vaccines and medication, which has been deeply frustrating.”

Two senior federal officials, who requested anonymity in order to speak candidly, said Mr Biden was upset about the vaccine shortage. His administration has often touted its success in providing hundreds of millions of coronavirus vaccines to Americans, and is stung by criticism that a lack of foresight and management has left gay people – the main risk group for monkeypox – without protection.

Some critics blame a failure of leadership at the Department of Health and Human Services, saying department secretary Xavier Becerra has taken a hands-off approach to an increasingly dire situation. His department not only oversees the CDC and the Food and Drug Administration, but also directs the Biomedical Advanced Research and Development Authority, or BARDA, which helps develop and purchase vaccines, tests and treatments to protect against highly infectious viruses. contagious, bioterrorism and other dangers. .

During a monkeypox press call last week, Becerra said his department was doing everything in its power to ensure that “not only do we stay ahead of this virus, but that we end this epidemic”. He noted that he recently elevated the agency’s Office of Strategic Preparedness and Response so it can respond more quickly to public health emergencies.

Sarah Lovenheim, its spokeswoman, said in a statement: “Our response has accelerated to meet the changing needs on the ground, and it will continue to accelerate. We will use all possible levers to continue to allocate doses ahead of schedule, whenever possible. »

So far, according to the CDC, 6,326 cases of monkeypox have been reported. For now, the virus is spreading almost entirely among gay and bisexual men, and those with multiple or unnamed partners are considered particularly at risk. Mr Becerra noted that while more than a million Americans have died from Covid-19, no one in the United States has died from monkeypox.

The official case tally is widely believed to be an underestimate. Not only is testing limited, but public health officials like Dr. Joseph Kanter, Louisiana’s top medical official, have said monkeypox can be difficult to diagnose. “It can be one or two solitary lesions, so if it’s not on a clinician’s radar,” he said, it can be missed.

With too few doses, health officials apparently plan to rely heavily on the “test and trace” strategy that featured heavily in the early stages of the Covid pandemic. As the pandemic escalated, the torrent of cases overwhelmed health officials’ ability to contact people who might have been infected by someone who had tested positive for the coronavirus. Once Covid vaccines became available, they became the cornerstone of the administration’s pandemic response.

In early June, health and human services officials seemed firmly convinced that the United States had more than enough supplies of the monkeypox vaccine, called Jynneos, to treat what appeared to be a case handle.

Bavarian Nordic was able to develop the vaccine, which also works against smallpox, largely thanks to support from the federal government, which topped $1 billion in 2014 and is now approaching $2 billion. Dawn O’Connell, the federal health agency’s assistant secretary for preparedness and response, told reporters in early June: “The world has Jynneos because we invested in it.”

The company opened a new $75 million fill-and-finish plant in 2021 that now bottles up to 200,000 to 300,000 doses per week. At the time, the United States relied on Jynneos to protect against smallpox, not monkeypox, and the government had a large stockpile of another effective smallpox vaccine. No FDA inspections were scheduled before the monkeypox outbreak, and they didn’t end until July 27.

In early June, health and human services officials agreed to essentially loan about 215,000 finished doses of vaccine to Bavarian Nordic so the company could supply them to European countries that were suffering from outbreaks.

“It made no sense while we waited for the FDA to do the inspection – which is coming – that we would sit on doses that our international colleagues in Europe could actually use,” Ms O’Connell said on June 10. the government is trying to postpone delivery of those doses to the end of this year, a company spokesperson said.

The final step of putting the liquid vaccine into vials represents a substantial part of the cost of producing the vaccine. Some federal officials say the Department of Health was slow to submit its orders for this work because BARDA officials argued they lacked funds.

When demand for vaccines became an outcry, the agency found the money to pay for an additional five million doses to be injected. Officials are now considering transferring half of the work to another company that might be able to complete and fill the doses more than twice as fast.

Some experts say it can take up to six to nine months for a factory to prepare to handle a vaccine like Jynneos, which contains live virus in a weakened state. Carlo de Notaristefani, who oversaw the manufacture of coronavirus vaccines for the federal government until last year, said these factories must operate at a high “biosafety level”, including a fully-fledged manufacturing line. closed and separate.

But he and other experts said it should be possible to streamline the process transfer from Bavarian Nordic so that another plant could be ready in about three months. A company spokesperson said Bavarian Nordic agreed to pay $10 million of the cost of such a transfer after federal officials said they did not have the budget for it.

Kitty Bennett contributed to the research.

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