WASHINGTON — A shortage of vaccines to combat a rapidly growing monkeypox outbreak will cause the Department of Health and Human Services to bottle large stocks of vaccines it already has for distribution, according to multiple administration officials. That was one of the reasons we didn’t ask for it early on. Familiar with the matter.
By the time the federal government placed the order, Bavarian Nordic, the vaccine’s Denmark-based manufacturer, had other customers booked and had been unable to work for months, officials said. – Vaccine development, even if the federal government invests more than $1 billion.
The government is currently distributing about 1.1 million doses, less than a third of the 3.5 million doses currently estimated by health officials to fight the outbreak. The next delivery of 500,000 doses he can’t expect until October. Most of the other 5.5 million doses ordered by the US aren’t expected to be delivered until next year, according to the federal health agency.
To speed up deliveries, the government is seeking another company to take over some of the bottling, capping and labeling of frozen bulk vaccines stored in large plastic bags at Bavarian Nordic’s headquarters outside Copenhagen. . Its final manufacturing stage, known as filling and finishing, is so highly specialized that experts estimate it would take another company at least three months to get it ready. At the Michigan plant, he is in ongoing negotiations with Grand River Aseptic Manufacturing, which has helped produce the Covid-19 vaccine, according to people familiar with the situation, and is bottling the current order of 2.5 million doses. I hope we can cut it a few months earlier than planned.
Health and social services officials said on May 23 that Bavarian Nordic had been allowed to deliver about 215,000 fully-finished products purchased to European countries instead of being stored by the federal government for the United States, thus eliminating the need. was calculated incorrectly.
Officials said there were only eight confirmed monkeypox cases in the country at the time. And the Food and Drug Administration had not yet certified the vaccine factory, so those doses could not have been used immediately. Jinneoswas poured into a vial.
But now it is possible. Some states are trying to expand the dose by having the vaccinated person receive only one of her two doses of vaccine. California, Illinois and New York have declared public health emergencies. New York City will take all available slots for monkeypox vaccination.
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 was “the same kind of bureaucratic delays and forgetfulness and ballrooms that we had.” is hindered by dropping the During the Covid pandemic.
Vial filling and finishing failures follow other failures that limit vaccine supplies.America used to About 20 million times It was in the national stockpile but could not be replenished when it expired and the supply was nearly depleted. Denmark had 372,000 doses on hand, but waited several weeks after the first case was confirmed in mid-May before requesting delivery of most of those doses. Delayed by FDA inspection of contractor’s new filling and finishing plant, shipping now.
The government also has the equivalent of approximately 16.5 million doses of bulk vaccine manufactured and stockpiled by Bavarian Nordic. But by the time health officials ordered his 500,000 doses to be put in vials on June 10, other countries with outbreaks had submitted their own orders, with the fastest deliveries. The day he was in October.
Another order of 110,000 doses soon followed for European countries. Bulk could only be delivered next year when the US placed two additional orders for his 2.5 million doses on July 1 and July 15, respectively.
Gostin, who is now the director of the O’Neill Institute of National and International Health Law at Georgetown University, said President Biden’s decision to appoint two new monkeypox response coordinators was under the federal health agency. Predicted that it would help “light the fire”. The White House announced Tuesday that Federal Emergency Management Agency administrator Robert Fenton and CDC official Dr. Demetre Dascalakis will lead the response.
Gostin said the country’s public health officials are “somewhat asleep on this issue” and that the new coordinator will “help unblock all obstacles to the procurement and delivery of vaccines and medicines.” It was supposed to be, and this was very frustrating.”
Two senior federal officials, who requested anonymity to speak candidly, said Mr. Biden was shaken by the vaccine shortage. His administration has often touted its success in delivering hundreds of millions of coronavirus injections to Americans, a lack of foresight and control that protected gay men, a major risk group for monkeypox. It is plagued by criticism that it is not.
Some critics have blamed the failure of the Ministry of Health and Human Services leadership, saying that the ministry’s secretary, Xavier Becerra, is taking a no-interference approach to an increasingly dire situation. The division oversees both the CDC and the Food and Drug Administration, as well as biomedical advanced research and development to help develop and purchase vaccines, tests, and treatments to protect against highly contagious viruses, bioterrorism, and other hazards. It also operates a station (BARDA). .
At a press conference on monkeypox last week, Becerra said his department was doing everything it could to ensure “not just staying ahead of this virus, but ending this outbreak.” He said he recently elevated the agency’s Office of Strategic Preparedness and Response so it can respond more quickly to public health emergencies.
The agency’s chief spokeswoman, Sarah Lovenheim, said in a statement: Use whatever means possible to keep doses assigned as far ahead of the timeline as possible. ”
So far, according to the CDC, Monkeypox 6,326 cases reported. For now, the virus is spreading almost exclusively among gay and bisexual men, and those with multiple or anonymous partners are believed to be particularly at risk. more Americans have died from Covid-19, but no one in the United States has died from monkeypox, he said.
Official case numbers are widely believed to be underestimated. Not only are tests limited, but public health officials like Louisiana’s chief medical officer, Dr. Joseph Cantor, say monkeypox can be difficult to diagnose. It could be one or two isolated lesions, so if it’s not on a clinician’s radar, it could be missed,” he said.
With the dose too low, health officials clearly plan to rely heavily on the “test and trace” strategy emphasized in the early stages of the Covid pandemic. As the pandemic escalated, the surge in cases overwhelmed health officials’ ability 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 pandemic response.
By early June, officials at the Department of Health and Human Services seemed firmly convinced that the United States had an adequate supply of the monkeypox vaccine (called Jynneos).
Bavarian Nordic was able to develop a vaccine that also works against smallpox, thanks to federal aid that exceeded $1 billion in 2014 and is now approaching $2 billion. Her Dawn O’Connell, undersecretary for preparedness and response at the Federal Health Service, told reporters in early June:
The company will open a new filling and finishing plant with a $75 million investment in 2021 and is now bottling between 200,000 and 300,000 doses per week. At the time, the United States was counting on Gineos to protect against smallpox, not monkeypox, and the government had a large stockpile of another effective smallpox vaccine. FDA inspections were not scheduled until after the monkeypox outbreak and were not completed until July 27.
In early June, health and welfare officials agreed in principle to lend Bavarian Nordic about 215,000 doses of the finished vaccine, allowing the company to supply them to European countries that were struggling with the epidemic.
On June 10, O’Connell said, “While we waited for the FDA to complete its inspections, it didn’t make sense for our international colleagues in Europe to sit at doses that could actually be used.” Officials said the government is looking to reschedule delivery of these doses later this year.
The final step of filling liquid vaccines into vials is a significant portion of vaccine manufacturing costs. Some federal officials say the health ministry was slow to submit an order for the work because BARDA officials claimed it lacked funding.
But when demand for the vaccine erupted in protest, officials found they needed to put money in vials to pay for another 5 million doses. Authorities are now considering moving half the work to another company.
Some experts say it can take six to nine months for plants to be ready to handle vaccines like Gynneos, which contain live virus in a weakened state. Carlo de Notaristefani, who oversaw the federal government’s coronavirus vaccine production until last year, said such factories would require high “biological safety levels”, including fully enclosed and isolated production lines. He said he had to work in
But he and other experts said it was possible to streamline the transfer of the Bavarian Nordic process so that another plant could be ready in about three months. said Bavarian Nordic had agreed to pay $10 million for the cost of such a transfer after federal officials said they had no budget.
Kitty Bennett Contributed to research.