US may have more doses of monkeypox vaccine this year

WASHINGTON — The vaccine shortage to combat the fast-growing epidemic of monkeypox is in part due to the Department of Health and Human Services’ early failure to demand that the bulk of the vaccine it possesses must be bottled for distribution, according to multiple administration officials familiar with the matter.

At the time of the federal government’s order, Denmark-based vaccine maker Bavarian Nordic had reservations for other customers and was unable to do the job for months, officials said – even though the federal government has invested more than $1 billion in vaccine development.

The government is currently distributing about 1.1 million doses, less than a third of the 3.5 million that health officials estimate are needed to fight the outbreak. It doesn’t expect the next delivery, with half a million doses, until October. According to the federal health agency, most of the other 5.5 million doses the US has ordered won’t be delivered until next year. .

To speed up delivery, the government is looking for another company to take over some of the bottling, capping and labeling of frozen bulk vaccines that are being stored in large plastic bags at the headquarters. Bavarian Nordic headquarters outside Copenhagen. Because the final production stage, known as fill and finish, is highly specialized, experts estimate it will take at least three months for another company to perfect. Negotiations are ongoing with Grand River Aseptic Manufacturing, a Michigan plant that has helped produce the Covid-19 vaccine, whose 2.5 million doses are currently on order, which will hopefully eliminate months of comparisons. with the plan, according to people familiar with the situation.

Health and Human Services officials had so miscalculated demand that on May 23, they allowed Bavarian Nordic to deliver approximately 215,000 fully completed doses of the drug the federal government had purchased to countries. Europe instead of keeping them for the United States.

Agency officials said at the time there were only eight confirmed cases of monkeypox in the country. And it can’t use those doses right away because the Food and Drug Administration has not yet certified the vaccine factory, Jynneoswas poured into the jar.

But it is possible now. Some states are trying to prolong the dose by giving recipients only one dose of the vaccine. California, Illinois, and New York have declare a public health emergency. In New York City, every site available for monkeypox vaccination is available.

Lawrence O. Gostin, a former adviser to the Centers for Disease Control and Prevention who consulted with the White House on monkeypox, said the government’s response has been tripped by ” bureaucratic delays and absent-mindedness like we did. during the Covid pandemic. “

Obstacles to the subsequent filling and completion of vials are other missteps that limit vaccine supply. The United States used to have about 20 million doses in the national stockpile but can’t add them when they expire, making the supply almost nonexistent. It already has 372,000 doses ready to go in Denmark but waited for weeks after the first case was identified in mid-May before requesting most of those doses. Another 786,000 doses were withheld by an FDA inspection of the manufacturer’s new finishing plant, but has been shipped now.

The government also owns about 16.5 million doses of the vaccine in bulk produced and stored by Bavarian Nordic. But by the time the health authorities ordered a bottle worth of 500,000 doses on June 10, other countries with the epidemic had already submitted their own orders and the earliest delivery date was October.

Another order for 110,000 doses to European countries soon followed. When the U.S. returns to two orders of 2.5 million doses each on July 1 and July 15, this bulk can only be delivered the following year.

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

Mr. Gostin said the nation’s public health authorities were “sleeping on this work,” and the new coordinators should help “to bypass all obstacles to procurement and supply.” vaccines and drugs, which have been deeply disappointing.”

Two senior federal officials, who requested anonymity to speak frankly, said Biden was upset by the vaccine shortage. His administration has often touted its success in delivering hundreds of millions of coronavirus shots to Americans, and has been sparked by criticism that a lack of foresight and regulation has driven gays and lesbians. Men – the main risk group for monkeypox – were not protected.

Some critics blamed the failure of leadership at the Department of Health and Human Services, saying that the department’s secretary, Xavier Becerra, took a strict approach to the increasingly dire situation. His division not only oversees both the CDC and the Food and Drug Administration, but also runs the Biomedical Advanced Research and Development Authority, or BARDA, which helps develop and procure vaccines, tests and treatments to protect against highly contagious viruses, bioterrorism and other hazards. .

During a press call about monkeypox last week, Mr Becerra said his department is doing all it can to ensure that “we are not only ahead of this virus, but we are also ending its spread.” this outbreak”. He noted that he was recent enhancement The agency’s Office of Strategic Preparedness and Response so it can respond more quickly to public health emergencies.

Sarah Lovenheim, his spokeswoman, said in a statement: “Our response has accelerated to meet real evolving demand, and it will continue to accelerate. We will use every lever we can to keep allocating drug doses ahead of time as possible.”

So far, according to the CDC, 6,326 cases of monkeypox reported. Currently, the virus is spreading almost exclusively among gay and bisexual men, and those with multiple or anonymous sex partners are considered particularly at risk. 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 count is considered an underestimate. Not only is testing limited, but public health officials like Dr. Joseph Kanter, the top health official in Louisiana, say monkeypox can be difficult to diagnose. “It could be a solitary lesion or two, so if it’s not on the clinician’s radar,” he says, it could be missed.

With so few doses, health officials clearly plan to rely heavily on the “test and trace” strategy that was heavily used in the early stages of the Covid pandemic. As the pandemic escalated, the sheer number of cases overwhelmed health officials’ ability to come into contact with people who might have been infected by someone who tested positive for the coronavirus. As Covid vaccines became available, they became the cornerstone of the administration’s pandemic response.

In early June, Health and Human Services officials were convinced that the United States had enough supplies of the monkeypox vaccine, known as Jynneos, to handle what appeared to be a handful of cases. .

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

The company opened a new $75 million finishing plant in 2021, currently bottling 200,000 to 300,000 doses per week. At the time, the United States was relying on Jynneos for protection against smallpox, not monkeypox, and the government had a large stockpile of other effective smallpox vaccines. No FDA inspection is scheduled until after the monkeypox outbreak, and it remains inconclusive until July 27.

In early June, Health and Human Services officials agreed to loan back approximately 215,000 doses of the completed vaccine to Bavarian Nordic so that the company could supply them to European countries experiencing outbreaks of the disease. .

“It makes no sense that while we wait for the FDA to complete the review – which is coming soon – we sit on the dosage that our international colleagues in Europe actually have,” said Ms. O’Connell. usable,” said Ms. O’Connell on June 10. Now. A company spokesman said the government is trying to reschedule the delivery of those doses by the end of the year.

The final stage of packing the liquid vaccine into a vial represents a significant portion of the cost of vaccine production. Some federal officials say the health department was slow to submit its order for that work because officials at BARDA thought they were short on funds.

However, when demand for the vaccine became vehemently opposed, the agency found it would have to pay for another five million doses to be packed in vials. Officials are now contemplating transferring half of the work to another company that can complete and fill dosages more than twice as fast.

Some experts say it can take six to nine months for a preparatory plant to process a vaccine like Jynneos, which contains a live virus in a weakened state. Carlo de Notaristefani, who oversaw production of a coronavirus vaccine for the federal government until last year, said that such plants must operate at a “high level of biosecurity”, including a production line. production is completely self-contained and isolated.

But he and other experts say it is possible to streamline the Bavarian Nordic process transfer so that another plant can be ready in about three months. A company spokesman said Bavarian Nordic had agreed to pay $10 million in such transfer costs after federal officials said they did not have the budget for this.

Kitty Bennett contribution research.

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