WASHINGTON — A shortage of vaccines to cope with a rapidly growing monkeypox outbreak was partly because the Department of Health and Human Services failed to ask whether to distribute bulk stocks of already owned vaccines, according to several administration officials. to be bottled. 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 operate for months, officials said — even though the federal government had committed more than $1 billion. have invested. Vaccine development.
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 fight the outbreak. It doesn’t expect the next delivery of half a million doses, until October. According to the Federal Health Agency, the United States has ordered most of the other 5.5 million doses not to be distributed until next year.
To expedite deliveries, the government is scrambling to find another firm to handle some of the bottling, capping and labeling of frozen bulk vaccines being stored in large plastic bags at Bavarian Nordic’s headquarters outside Copenhagen . Because that final construction phase, known as fill and finish, is highly specialized, experts estimate it will take at least three months to be ready. Talks are underway with Grand River Aseptic Manufacturing, a Michigan factory that has helped produce the Covid-19 vaccines, which now have 2.5 million doses of bottles on order, expected by time. There would be months of shaving off the schedule.
Health and Human Services officials miscalculated the requirement so much that on 23 May, they allowed the Bavarian Nordic to deliver approximately 215,000 fully prepared doses, which the federal government had given to European countries instead of keeping them for the United States. Had already bought.
At the time, there were only eight confirmed cases of monkeypox in the country. And it couldn’t use those doses immediately because the Food and Drug Administration had not yet certified the plant where the vaccine, Jinios, was infused into the vials.
But now it can. Some states are trying to increase the dosage by giving recipients only one shot of the two-dose vaccine. California, Illinois and New York have declared public health emergencies. In New York City, every available slot for a monkeypox shot is taken.
Lawrence O. Gostin, a former adviser to the Centers for Disease Control and Prevention who has consulted with the White House about monkeypox, said the government’s response “has been hit by the same kinds of bureaucratic delays and amnesia and dropping the ball.” during the pandemic.”
Barriers to 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 failed to replenish them after they ran out, reducing the supply to almost nothing. Its 372,000 doses were ready to go to Denmark, but most of those doses waited weeks after the first case was identified in mid-May before requesting delivery. Another approximately 786,000 doses were withheld by FDA inspection of the manufacturer’s new fill-and-finish plant, but have now been shipped.
The government has the equivalent of about 16.5 million doses of the bulk vaccine produced and stored by Bavarian Nordic. But by the time the health agency ordered a vial of 500,000 doses on June 10, other countries with outbreaks had submitted their orders and the earliest delivery date was October.
A further order for 110,000 doses soon followed for European countries. When the United States returned with two more orders of 2.5 million doses – announced July 1 and July 15 – bulk could only be delivered 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 hire two new monkeypox response coordinators would “kindle the fires” under federal health agencies. ” will gain help in. The White House announced Tuesday that Federal Emergency Management Agency Administrator Robert Fenton and a CDC official, Dr. Demetre Daskalakis, will lead the response.
Mr. Gostin said the country’s public health agencies are asleep at the wheel, and that new coordinators must “help remove all barriers to the procurement and distribution of vaccines and medicines, which have been very disappointing.” Is.”
Two senior federal officials, who requested anonymity to speak frankly, said Biden is troubled by the lack of a vaccine. His administration has often touted its success in giving Americans hundreds of millions of coronavirus shots, and is baffled by criticism that a lack of foresight and management has left gay men – the major risk group for monkeypox – vulnerable.
Some critics accuse the Department of Health and Human Services of a leadership failure, saying the department’s secretary, Javier Becerra, has taken a hands-on approach to the increasingly dire 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 develops vaccines, tests, and treatments to protect against highly contagious viruses, bioterrorism, and other threats. Helps to buy and sell. ,
During a press call on monkeypox last week, Mr Becerra said his department was doing everything possible to ensure “we not only stay ahead of this virus but end this outbreak.” He noted that he had recently elevated the agency’s Office of Strategic Preparedness and Response so that it can respond more quickly to public health emergencies.
Her spokeswoman Sarah Lowenheim said in a statement: “Our response has been accelerated to meet emerging needs on the ground, and will continue to accelerate. We will do everything we can to continue to allocate doses as early as possible. “
According to the CDC, 6,326 cases of monkeypox have been reported so far. For now, the virus is spreading almost exclusively among gay and bisexual men, and those who have 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 of monkeypox.
The official case count is widely underestimated. Not only is testing limited, but Louisiana’s top medical official, Dr. Public health officials such as Joseph Kantor said monkeypox can be hard to diagnose. “It could be one or two solitary lesions, so if it’s not on a physician’s radar,” he said, it could be missed.
With very low doses, health officials are clearly planning to rely heavily on the “test and trace” strategy, which was very much the case in the early stages of the COVID pandemic. As the pandemic progressed, the sheer torrent of cases overwhelmed health officials’ ability to contact people who may have been infected from 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 firmly reassured that the United States had enough supplies of the monkeypox vaccine, called Geneos, to handle a handful of cases.
The Bavarian was able to develop the Nordic vaccine, which also works against smallpox, thanks largely to federal government support, which crossed $1 billion in 2014 and is now heading toward $2 billion. Don O’Connell, the federal health agency’s assistant secretary for preparedness and response, told reporters in early June: “The world has genos because we’ve invested in it.”
The company opened a new $75 million fill-and-finish plant in 2021 that is now bottling up to 200,000 to 300,000 doses a week. At the time, the United States was relying on genes, not monkeypox, to protect against smallpox, and the government had a large stockpile of a more effective smallpox vaccine. No FDA oversight was scheduled until after the monkeypox outbreak, and it didn’t end until July 27.
In early June, Health and Human Services officials agreed to mandatorily return about 215,000 ready-made doses of the vaccine to Bavarian Nordic, so that the firm could supply them to European countries that were hit by the outbreak.
Ms O’Connell said on 10 June: “While we were waiting for the FDA for inspection – which is coming – it didn’t make sense that we sit on doses that our international colleagues in Europe can actually use. Huh.” Now a spokesperson for the company said the government is looking to re-deliver those doses later this year.
The final stage of dispensing the liquid vaccine into vials accounts for a large part of the cost of vaccine production. Some federal officials say the health department was slow to submit its orders for that work because Barda officials argued they lacked funding.
When the demand for vaccines became an outcry, however, the agency found that the vial of money had gone to pay for five million more doses. Officials are now considering shifting half the work to another firm that may be able to carry out and fill doses more than twice as fast.
Some experts say it can take up to six to nine months for a plant to handle a vaccine like GenoS, which contains a live virus in a weakened state. Carlo di Notaristefani, who oversaw coronavirus vaccine manufacturing for the federal government until last year, said such factories must operate at a high “biological safety level”, including a fully enclosed, separate manufacturing line.
But he and other experts said it should be possible to streamline the transfer of the process to Bavarian Nordic so that another plant could be ready in about three months. A spokesman for the company said the Bavarian Nordic agreed to pay $10 million of the cost of such a transfer because federal officials said they did not have the budget for it.
Kitty Bennett Contributed to research.
(This story has not been edited by seemayo staff and is published from a rss feed)