WASHINGTON — A vaccine shortage to fight a rapidly growing monkeypox outbreak was caused in part because the Department of Health and Human Services failed to initially request that large stocks of the vaccine it already had be bottled for distribution, according to multiple officials at the administration familiar with the matter.
By the time the federal government placed its orders, the vaccine’s Denmark-based maker, Bavarian Nordic, had booked other customers and was unable to complete the work for months, officials said — even though the federal government had invested well over $1 billion dollars 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 now estimate are needed to fight the epidemic. He does not expect the next shipment of half a million doses until October. Most of the other 5.5 million doses ordered by the United States are not scheduled to be delivered until next year, according to the federal health agency.
To speed up supplies, the government is scrambling 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. Because this final production phase, known as fill and finish, is highly specialized, experts estimate that another company would need at least three months to prepare. Talks are continuing with Grand River Aseptic Manufacturing, a Michigan factory that has helped produce the Covid-19 vaccine, to bottle 2.5 million of the doses now on order, hoping to avoid months behind schedule, according to people familiar with the situation.
Health and Human Services officials so miscalculated the need that on May 23 they allowed Bavarian Nordic to ship about 215,000 fully prepared doses that the federal government had already bought to European countries instead of withholding them for the United States.
At the time, the nation had only eight confirmed cases of monkeypox, agency officials said. And he couldn’t use those doses right away because the Food and Drug Administration hadn’t yet certified the plant where the vaccine, Jynneos, was vialed.
But now he could. Some states are trying to extend the doses by giving recipients just one shot of the two-dose vaccine. California, Illinois and New York have declared public health emergencies. In New York, every available monkeypox vaccination slot is taken.
Lawrence O. Gostin, a former adviser at the Centers for Disease Control and Prevention who consulted with the White House on monkeypox, said the government’s response was hampered by “the same kinds of bureaucratic delays and forgetting and dropping the ball that we did during the Covid pandemic.”
Obstacles to filling and finishing vials follow other missteps that limit vaccine supplies. The United States once had about 20 million doses in a national stockpile, but was unable to replenish them as they expired, leaving the supply dwindling to almost nothing. It had 372,000 doses ready to ship to Denmark, but waited weeks after the first case was identified in mid-May before requesting the delivery of most of those doses. Another approximately 786,000 doses were held up by an FDA inspection of the manufacturer’s new filling and finishing plant, but have already been shipped.
The government also has the equivalent of about 16.5 million doses of mass vaccine produced and stored by Bavarian Nordic. But by the time the health agency ordered 500,000 doses to be packaged in vials on June 10, other countries with outbreaks had sent their own orders, and the earliest delivery date was October.
Another order for 110,000 doses for European nations soon followed. When the United States returned with two more orders of 2.5 million doses each on July 1 and July 15, the bulk could not be delivered until the following year.
Mr. 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” in federal health efforts. agencies. The White House announced Tuesday that Robert Fenton, an administrator at the Federal Emergency Management Agency, and Dr. Demetrius Daskalakis, a CDC official, will lead the response.
Mr Gostin said the nation’s public health agencies were “kind of asleep at the wheel on this” and the new coordinators needed to help “unblock all the barriers to the supply and delivery of vaccines and medicines, which is deeply disappointing”.
Two senior federal officials, who spoke on condition of anonymity to speak candidly, said Mr. Biden was upset about the vaccine shortage. His administration has often touted its success in getting hundreds of millions of coronavirus vaccines to Americans and has been stung by criticism that a lack of foresight and management has left gay men — the main risk group for monkeypox — unprotected.
Some critics have blamed a failure of leadership at the Department of Health and Human Services, saying the department’s secretary, Xavier Becerra, took a hands-off approach to an increasingly serious situation. His department 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 buy vaccines, tests and treatments to protect against highly contagious viruses, bioterrorism and other hazards.
During a press conference on monkeypox last week, Mr. Becerra said his department was doing everything possible to ensure that “we not only get ahead of this virus, but that we end this epidemic.” He noted that he recently upgraded the agency’s Office of Strategic Preparedness and Response to be able to 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 will continue to accelerate. We will use every lever possible to continue to distribute doses ahead of schedule as much as possible.”
So far, according to the CDC, 6,326 cases of monkeypox have been reported. 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 one million Americans have died from Covid-19, no one in the United States has died from monkeypox.
The official number of cases is widely believed to be an underestimate. Not only are tests limited, but public health officials like Dr. Joseph Kanter, Louisiana’s top medical officer, said monkeypox can be difficult to diagnose. “It can be one or two single lesions, so if it’s not on the 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 figured heavily in the early stages of the Covid pandemic. As the pandemic has escalated, the sheer flow of cases has hampered the ability of health officials to contact people who may have been infected by someone who tested positive for the coronavirus. Once Covid vaccines became available, they became the cornerstone of the administration’s response to the pandemic.
By early June, health and human services officials seemed firmly convinced that the United States had more than enough of the monkeypox vaccine, called Jynneos, to handle what appeared to be a handful of cases.
Bavarian Nordic was 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 moving toward $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 filling and finishing plant in 2021, which now bottles 200,000 to 300,000 cases a week. At the time, the United States relied on Jynneos to protect against smallpox, not monkeypox, and the government had a large supply of another effective smallpox vaccine. No FDA inspection was scheduled prior to the monkeypox outbreak, and it was not completed until July 27.
In early June, Health and Human Services officials agreed to return about 215,000 finished doses of the vaccine to Bavarian Nordic so the company could deliver them to European countries suffering from outbreaks.
“It didn’t make sense while we were waiting for the FDA to do the review – which is coming – to sit on doses that our international colleagues in Europe can actually use,” Ms O’Connell said on 10 June. the government is trying to delay the delivery of those doses until later this year, a company spokesman said.
The final step of putting the liquid vaccine into vials represents a significant part of the cost of vaccine production. Some federal officials say the health department has been slow to send out orders for the work because officials at BARDA say they don’t have enough funds.
But when demand for the vaccines sparked outrage, the agency found money to pay for another five million doses that needed to be cut. Officials are now considering outsourcing half the work to another firm that may be able to complete and fill doses more than twice as fast.
Some experts say it can take six to nine months for the plant to prepare to handle a vaccine like Jynneos, which contains live virus in a weakened state. Carlo de Notaristefani, who led the production of coronavirus vaccines for the federal government until last year, said such factories must operate at a high “biosafety level,” including a fully enclosed, segregated production line.
But he and other experts said it should be possible to streamline the transfer of…
Add Comment