More doses of monkeypox vaccine may be available in the US this year

WASHINGTON — A rapidly growing monkeypox vaccine shortage is caused in part by the Department of Health and Human Services’ inability to demand bottling for distribution of its bulk vaccine stockpile. familiar with the problem.

At the time of the federal government’s order, Denmark-based vaccine maker Bavaria Nordic had orders from other customers and could not make the work for months, government officials said – despite the federal government investing more than $1 billion. vaccine development.

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

To speed up deliveries, the government is trying to find another firm to take over some of the bottling, capping and labeling of the frozen bulk vaccine, which is stored in large plastic bags at Bavarian Nordic’s headquarters outside Copenhagen. The final production phase, called filling and finishing, is so specialized that experts estimate it would take at least three months for another company to prepare. Talks are underway with Grand River Aseptic Manufacturing, a factory in Michigan that helps produce Covid-19 vaccines, to bottle 2.5 million doses on order now, hopefully cutting several months off schedule, according to people familiar with the situation.

Health and Human Services officials misjudged the need so badly that on May 23, they authorized Bavaria’s Nordique to ship 215,000 complete doses that the federal government had purchased to European countries rather than to the United States.

According to representatives of the agency, at that time only eight cases of monkey disease were registered in the country. And it wouldn’t be able to use those doses right away because the Food and Drug Administration hasn’t certified the factory where the Jynneos vaccine is vialed.

But now it is possible. Some states are trying to extend the dose by giving recipients just one dose of the two-dose vaccine. Public health emergencies have been declared in California, Illinois and New York. All available slots are taken for monkeypox shots in New York.

Lawrence O., a former adviser to the Centers for Disease Control and Prevention who consulted with the White House on monkeypox. Gostin said the government’s response was “skewed by bureaucratic delays, forgetfulness, and the same kind of abandonment we did. During the Covid pandemic.”

The hurdles in filling and finishing vials follow other missteps that have limited vaccine supplies. The United States once had about 20 million doses in its national stockpile, but was unable to replenish them when they expired, reducing the supply to almost nothing. Denmark had 372,000 doses ready, but after the first case was identified in mid-May, it waited several weeks before being asked to provide most of those doses. Another 786,000 doses were held up by an FDA inspection of the manufacturer’s new filling and finishing plant, but have now been shipped.

The government also has the equivalent of 16.5 million doses of vaccine manufactured and stored by Bavarian Nordic. But by the time the health agency ordered the infusion of 500,000 doses on June 10, other countries had placed their orders and the earliest delivery date was October.

Another order for 110,000 doses for European countries followed soon after. The bulk may not be delivered until next year, when the United States returns with two more orders of 2.5 million doses each on July 1 and July 15.

Mr. Gostin, who now heads Georgetown University’s O’Neill Institute for National and Global Health Law, predicted that President Biden’s decision to appoint two new monkeypox coordinators would help “light a fire” among federal health agencies. The White House said Tuesday that Federal Emergency Management Agency Administrator Robert Fenton and Dr. Demeter Daskalakis of the CDC is leading the response.

Mr Gostin said the country’s public health authorities were “asleep at the wheel” and new co-ordinators should help “remove all barriers to the procurement and delivery of vaccines and medicines”.

Two senior federal officials, speaking on condition of anonymity, said Mr. Biden complains about the lack of vaccines. His administration has touted its success in delivering hundreds of millions of coronavirus shots to Americans, criticizing a lack of oversight and oversight that left gay men — the prime risk group for monkeypox — unprotected.

Some critics blame a failure of leadership at the Department of Health and Human Services, saying the department’s secretary, Xavier Becerra, overstepped an increasingly serious situation. His department not only oversees the CDC and the Food and Drug Administration, but also manages the Biomedical Advanced Research and Development Administration (BARDA), which helps develop and procure vaccines, tests, and treatments to protect against highly contagious viruses, bioterrorism, and other threats. .

During a press conference on monkeypox last week, Mr. Becerra said his department is doing everything it can “not only to prevent this virus, but to end this epidemic.” He noted that he recently upgraded the agency’s Strategic Preparedness and Response Division so it can respond more quickly to public health emergencies.

Its spokeswoman Sarah Lowenheim said in a statement: “Our response has accelerated to meet the evolving needs on the ground, and it will continue to accelerate. We will use all leverage to continue distributing doses as early as possible.”

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

The number of official cases is greatly underestimated. Not only is testing limited, but public health officials Dr. Joseph Canter, Louisiana’s chief medical officer, said monkeypox can be difficult to diagnose. “It could be one or two solitary lesions, so if it’s not on the clinician’s radar, it can be missed,” he said.

With very low doses, health officials apparently plan to rely on the “test and follow” strategy that was so important in the early stages of the Covid pandemic. As the pandemic has intensified, the influx of cases has eliminated the ability of health workers to contact people who have tested positive for the coronavirus. Once Covid vaccines became available, they became the backbone of the administration’s response to the pandemic.

In early June, Health and Human Services officials said they believed the monkey vaccine, known as Ginneos, was enough to handle a few cases in the United States.

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

The company opened a new $75 million filling and finishing plant in 2021, which is now pouring 200,000 to 300,000 doses per week. At the time, the United States was relying on Ginneos to protect against smallpox, not monkeypox, and the government had a large stockpile of another effective smallpox vaccine. The FDA review was not scheduled until after the monkeypox outbreak, and it was not finalized until July 27.

In early June, Health and Human Services officials agreed to return 215,000 finished doses of the vaccine to Bavarian Nordik so the firm can deliver them to European countries affected by the outbreak.

“It doesn’t make sense that we’re sitting on doses that our international counterparts in Europe can use while we wait for FDA review,” said Ms. O’Connell announced this on June 10. Now the government is trying to postpone the delivery of these doses until the end of this year, said a company representative.

The final step of putting the liquid vaccine into vials is a significant part of the cost of vaccine production. Some federal officials at BARDA said funds are running short.

As demand for the vaccines skyrocketed, the agency found the money to pay for another five million doses. Officials are now considering outsourcing half of the work to another firm, which can complete and fill doses twice as fast.

Some experts say it could take six to nine months to develop a vaccine like Jynneos, which contains live virus in a plant-attenuated state. Carlo de Notaristefani, who until last year oversaw the production of the coronavirus vaccine for the federal government, said such plants must operate at a “high level of biosecurity,” including a fully enclosed, segregated production line.

But he and other experts said it should be possible to streamline the Bavarian Nordic process, so another plant should be ready in three months. Bavarian Nordic agreed to pay $10 million of the cost of such a transfer after federal officials said there was no budget for it, a company spokesman said.

Kitty Bennett contributed to the research.

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