The US could get many more doses of monkeypox vaccine this year

WASHINGTON. The lack of vaccines to deal with the rapidly growing monkeypox outbreak was partly because the Department of Health and Human Services did not early on require large stocks of the vaccine it already had to be bottled for distribution, several administration officials said. familiar with the matter.

By the time the federal government placed its orders, Denmark-based vaccine manufacturer Bavarian Nordic had registered other customers and, officials said, had been unable to complete work for several months, even though the federal government had invested more than $1 billion for a vaccine. vaccine development.

The government is currently distributing about 1.1 million doses, less than a third of the 3.5 million that health professionals estimate are needed to control the outbreak. The next shipment, or half a million doses, is not expected until October. Most of the remaining 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 shipments, the government is scrambling to find another firm to take over some of the bottling, capping and labeling of the frozen vaccine, which is stored in large plastic bags at the Bavarian Nordic headquarters near Copenhagen. Because this final stage of production, known as filling and finishing, is highly specialized, experts estimate it would take another company at least three months to get ready. Discussions are underway with Grand River Aseptic Manufacturing, a Michigan plant that helped make Covid-19 vaccines, to bottle 2.5 million doses of those ordered now, which will hopefully shorten the schedule, according to people familiar with the situation. for several months.

Health and human services officials miscalculated the need so much that on May 23 they allowed Bavarian Nordic to ship about 215,000 fully-formulated doses, which the federal government had already purchased, to European countries instead of storing them for the United States.

There were only eight confirmed cases of monkeypox in the country at the time, the agency said. And they couldn’t use those doses immediately because the FDA hadn’t yet certified the plant that made the vaccine. Jinneospoured into vials.

But now he could. Some states are trying to increase doses by giving recipients only one shot of the two-dose vaccine. California, Illinois and New York have public health emergency declared. In New York, every available monkeypox vaccination site is full.

Lawrence O. Gostin, a former Centers for Disease Control and Prevention adviser who consulted with the White House about monkeypox, said the government’s response was hampered by “the same red tape, forgetfulness, and ball abandonment that we did.” during the Covid pandemic.”

Obstacles to filling and completing vials arise from other errors that limit vaccine supplies. The United States once had about 20 million doses in the national reserve, but failed to replenish if they expired, then the supply was reduced to almost zero. In Denmark, 372,000 doses were ready to ship. but waited a week after the first case was identified in mid-May, before requesting delivery of most of those doses. Approximately 786,000 more doses were delayed as a result of an FDA inspection of the manufacturer’s new bottling and finishing plant, but sent now.

The government also owns the equivalent of about 16.5 million doses of the bulk vaccine produced and stocked by Bavarian Nordic. But by the time the health agency ordered the 500,000-dose vials on June 10, other countries with outbreaks had submitted their own orders, and the earliest delivery date was in October.

Another order for 110,000 doses for European countries soon followed. When the United States returned with two more orders of 2.5 million doses each on July 1 and July 15, most could not be delivered until the following year.

mr. Gostin, who now leads the Institute of National and Global Health Law named after. O’Neill at Georgetown University, predicted that President Biden’s decision to appoint two new monkeypox response coordinators would help “ignite the fire” in federal health agencies. White House announced on Tuesday that Robert Fenton, administrator of the Federal Emergency Management Agency, and Dr. Demetre Daskalakis, spokesman for the CDC, will lead the response.

mr. Gostin said the national public health agencies are “kind of asleep at the wheel” and the new coordinators should help “unblock all the barriers to vaccine and drug procurement and delivery, which is very disappointing.”

Two senior federal officials, who requested anonymity in order to speak frankly, said Mr. Biden is frustrated by the lack of a vaccine. His administration has frequently touted its success by giving Americans hundreds of millions of coronavirus shots and has been stung by criticism that a lack of foresight and management has left gays, the main risk group for monkeypox, unprotected.

Some critics blame the failure on the leadership of the Department of Health and Human Services, saying department secretary Xavier Becerra has taken a hands-off stance in an increasingly serious situation. His department not only oversees both the CDC and the Food and Drug Administration, but also manages the Biomedical Advanced Research and Development Administration, or BARDA, which helps develop and procure vaccines, tests, and treatments to protect against highly contagious viruses. , bioterrorism and other dangers. .

During a press conference on monkeypox last week, Mr. Becerra said his department is doing everything it can to “not only get us ahead of this virus, but end this outbreak.” He noted that he recently elevated The Agency’s Office of Strategic Preparedness and Response so that it can respond more quickly to public health emergencies.

Sarah Lowenheim, chief spokesperson for the department, said in a statement: “Our response has accelerated to meet the growing needs on the ground and it will continue to accelerate. We will use every leverage we can to continue distributing doses as early as possible.”

So far, according to the CDC, 6326 cases of monkeypox have been reported. For now, 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 a million Americans have died from Covid-19, no one in the United States has died from monkeypox.

The official number of cases is considered an underestimate. Not only is testing limited, but public health officials such as Dr. Joseph Kanter, a senior Louisiana medical official, said monkeypox is difficult to diagnose. “It could be one or two solitary lesions, so if it’s not in the clinician’s field of vision,” he said, “it can be missed.”

Due to too few doses, health officials appear to be planning to rely heavily on the “test and trace” strategy that was widely used in the early stages of the Covid pandemic. As the pandemic escalated, the flood of cases made it impossible for 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.

In early June, health and human services officials were convinced that there was more than enough monkeypox vaccine called Jynneos in the United States to deal with several cases.

Bavarian Nordic was able to develop a vaccine that also works against smallpox thanks in large part to federal government support that topped $1 billion in 2014 and is now approaching $2 billion. Dawn O’Connell, the federal health agency’s assistant secretary for preparedness and response, told reporters in early June, “There are Jynneos in the world because we’ve invested in it.”

In 2021, the company opened a new $75 million bottling and finishing facility, which is now bottling 200,000 to 300,000 doses per week. At the time, the United States was counting on Jynneos to protect against smallpox, not monkeypox, and the government had a large supply of another effective smallpox vaccine. No FDA review was scheduled until the end of the monkeypox outbreak and was not completed until July 27th.

In early June, officials from the Department of Health and Human Services agreed to loan about 215,000 pre-packaged vaccine doses to Bavarian Nordic so the firm could ship them to European countries hit by outbreaks.

“While we waited for the FDA to conduct an inspection – which is coming soon – it didn’t make sense to sit on doses that our international counterparts in Europe could actually use,” Ms said. O’Connell said June 10. The government is now trying to move the delivery of those doses to the end of this year, a company spokesman said.

The final stage of bottling a liquid vaccine into vials represents a significant proportion of the cost of producing a vaccine. Some federal officials say the health department was slow to place orders for the work because BARDA officials said they were short of funds.

However, when the demand for vaccines became hype, the agency found the money to pay for another five million doses in vials. Officials are now considering outsourcing half of the work to another firm that could possibly finish and fill doses more than twice as fast.

Some experts say it could take six to nine months for the plant to get ready to work with a vaccine like Jynneos, which contains the live virus in a weakened state. Carlo de Notaristefani, who until last year oversaw the production of a coronavirus vaccine for the federal government, said such plants would need to operate at a high “biosecurity level” including a completely enclosed, isolated production line.

But he and other experts said it should be possible to simplify the transfer of the process to Bavarian Nordic so that another plant could be ready in about three months. A company spokesman said Bavarian Nordic agreed to pay the $10 million cost of such a transfer after federal officials said they didn’t have the budget for it.

Kitty Bennett contributed to research.