The United States could have gotten more doses of the monkeypox vaccine this year

The United States could have gotten more doses of the monkeypox vaccine this year

WASHINGTON — Vaccine shortages to combat the rapidly growing outbreak of monkeypox were in part because the Department of Health and Human Services failed early on to demand that a large stockpile of the vaccine it already had for distribution, according to several administration officials. familiar with the matter.

Officials said that by the time the federal government placed its orders, the vaccine manufacturer in Denmark, Bavaria Nordic, had booked other customers and had not been able to do the work for several months — even though the federal government had invested more than $1 billion in developing the vaccine. .

The government is now distributing about 1.1 million doses, less than a third of the 3.5 million that health officials now estimate are needed to combat the outbreak. It does not expect the next delivery of half a million doses until October. According to the Federal Health Agency, most of the other 5.5 million doses ordered by the United States are not scheduled for delivery until next year.

To speed up deliveries, the government is scrambling to find another company to take over some of the packaging, covering and labeling of the frozen frozen vaccines that are stored in large plastic bags at Bavaria Nordic’s headquarters outside Copenhagen. Since the final manufacturing stage, known as the filling and finishing stage, is highly specialized, experts estimate that 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 pack 2.5 million doses now on order, and hopefully, cut months off the schedule, according to people familiar with the situation.

Health and Human Services officials miscalculated the need so much that on May 23 in the northern state of Bavaria they allowed the delivery of about 215,000 fully-equipped doses that the federal government had already purchased to European countries rather than keep them for the United States.

At the time, agency officials said, there were only eight confirmed cases of monkeypox in the country. And she couldn’t use those potions right away because the Food and Drug Administration had yet to certify the plant where the vaccine, Jynneos, was poured into vials.

But it can now. Some states try to extend doses by giving recipients only one injection of the two-dose vaccine. California, Illinois and New York states have declared public health emergencies. In New York City, every available slot for monkeypox vaccine is taken.

Lawrence O. said. Justin, 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 bogged down by “the same kinds of bureaucratic delays, forgetfulness and dropping the ball as we did during the Covid pandemic.”

Barriers to filling and finishing vials follow other missteps in which vaccine supplies were limited. The United States once had about 20 million doses in a national stockpile but failed to replenish them as they expired, leaving supplies dwindling to almost nothing. She had 372,000 doses ready to go to Denmark, but she waited weeks after the first case was identified in mid-May before ordering most of those doses to be delivered. Nearly 786,000 more doses have been put on hold through FDA inspection of the manufacturer’s new filling and finishing plant but are now shipped.

The government also owns the equivalent of about 16.5 million doses of bulk vaccines produced and stockpiled by Bavaria Nordic. But by the time the health agency ordered 500,000 doses on June 10, other outbreak countries had made their own requests and the earliest delivery date was October.

Soon another request for 110,000 doses for European countries followed. When the US returned with two additional orders of 2.5 million doses each on July 1 and July 15, the bulk could only be delivered next year.

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

Mr. Justin said the country’s public health agencies have been “kind of asleep leading the way on this” and the new coordinators should help “remove all obstacles to the procurement and delivery of vaccines and medicines, which has been very frustrating”.

Two senior federal officials, who requested anonymity in order to speak frankly, said Biden is upset about the lack of a vaccine. His administration has long touted its success in delivering hundreds of millions of coronavirus shots to Americans, and has been shocked by criticism that a lack of insight and management has left gay men – the main monkeypox vulnerable group – unprotected.

Some critics blame the administration’s leadership failure, saying the department’s secretary, Xavier Becerra, has taken a laissez-faire approach to an increasingly dangerous situation. His division 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 procure vaccines, tests, and treatments to protect against highly contagious viruses, bioterrorism, and other risks.

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

“Our response has accelerated to meet evolving needs on the ground, and will continue to accelerate. We will use every lever possible to continue allocating doses ahead of schedules, as much as possible,” his spokeswoman Sarah Loevenheim said in a statement.

To date, according to the Centers for Disease Control and Prevention, 6,326 cases of monkeypox have been reported. Currently, the virus is almost completely prevalent among gay and bisexual men, and those with multiple or anonymous partners are considered particularly vulnerable. 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 number is widely considered an underestimate. Not only has testing limited, but public health officials such as Dr. Joseph Kanter, Louisiana’s chief medical officer, said diagnosing monkeypox could be difficult. “It could be one or two solitary lesions, so if you’re not on the doctor’s radar,” he said, “it can be missed.”

With very low doses, health officials appear to be planning to rely heavily on the “test and trace” strategy that emerged largely in the early stages of the Covid pandemic. As the pandemic escalates, the massive avalanche of cases has overwhelmed health officials’ ability to contact people who may have been infected by someone who tested positive for the coronavirus. Once the Covid vaccines were available, they became the cornerstone of the administration’s response to the pandemic.

During early June, Health and Human Services officials seemed quite convinced that the United States had more than enough supplies of the monkeypox vaccine, called Genus, to handle what appeared to be a small number of cases.

Northern Bavaria has been able to develop the vaccine, which also works against smallpox, thanks in large part to federal government support, which topped $1 billion in 2014 and is now heading toward $2 billion. “The world has genus because we’ve invested in it,” Dawn O’Connell, the federal health assistant secretary for preparedness and response, told reporters in early June.

The company opened a new $75 million filling and finishing plant in 2021 that now packages up to 200,000 to 300,000 doses per week. At the time, the United States relied on Jynneos for protection against smallpox, not monkeypox, and the government had a large stockpile of another effective smallpox vaccine. The FDA screening date was not set until after the monkeypox outbreak, and it wasn’t over until July 27.

In early June, Health and Human Services officials agreed to loan back about 215,000 final doses of the vaccine to northern Bavaria so the company could supply it to European countries that were experiencing an outbreak.

“It didn’t make sense while we were waiting for the FDA to get the screening done – and it’s coming – that we’re sitting on doses that our international colleagues in Europe could actually use,” Ms O’Connell said on June 10. A company spokesperson said the government is trying to reschedule delivery of those doses for later this year.

The final stage of placing the liquid vaccine in vials represents a significant share of the vaccine production cost. Some federal officials say the Health Department has been slow to submit its orders for this work because officials at BARDA have said they are short of funds.

When the demand for vaccines became a cry, the agency found the funds to pay an additional five million doses to be mobilized. Officials are now considering moving half of the work to another company that might be able to finish and fill doses more than twice as fast.

Some experts say it could take six to nine months for a plant to prepare to handle a vaccine like Genus, which contains live virus in a weakened state. Carlo de Notaristefani, who oversaw manufacturing of the coronavirus vaccine for the federal government until last year, said such factories should operate at a high “biological safety level”, including a completely closed and separate manufacturing line.

But he and other experts said it should be possible to simplify the relocation of the North Bavarian operation so that another plant could be ready in about three months. A company spokesman said Bavarian firm Nordic had agreed to pay $10 million of the cost of the transfer after federal officials said they did not have the budget to do so.

Kitty Bennett Contribute to research.

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