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

WASHINGTON – The shortage of vaccines to combat a rapidly growing monkeypox epidemic was caused in part by the fact that the Department of Health and Human Services did not demand in advance that the mass stocks of the vaccine it already possessed be bottled for distribution, according to several administration officials familiar with the matter.

When the federal government placed its orders, the Danish vaccine manufacturer, Bavarian Nordic, had booked other customers and hadn’t been able to do the job for months, officials said, even though the federal government had invested well beyond. $ 1 billion in vaccine development

The government is 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 delivery, of half a million doses, until October. Most of the other 5.5 million doses ordered by the United States are not expected to be delivered until next year, according to the federal health agency.

To expedite deliveries, the government is rushing to find another company to take care of some of the bottling, capping and labeling of the bulk frozen vaccine that is stored in large plastic bags at Bavarian Nordic’s headquarters outside. Copenhagen. Because that final manufacturing step, known as filling and finishing, is highly specialized, experts estimate that another company will take at least three months to prepare. Negotiations are underway with Grand River Aseptic Manufacturing, a Michigan factory that has helped produce Covid-19 vaccines, to bottle 2.5 million of the doses now ordered, hoping to reduce calendar months, according to people familiar with the situation.

Health and human services officials miscalculated the need so badly that on May 23 they allowed Bavarian Nordic to deliver some 215,000 fully finished doses that the federal government had already bought in European countries instead of keeping them for the United States.

At the time, the nation only had eight confirmed cases of monkeypox, agency officials said. And he could not have used those doses immediately because the Food and Drug Administration had not yet certified the facility where the vaccine, Jynneos, was poured into the vials.

But now it might. Some states are trying to extend doses by giving recipients only a two-dose injection of the vaccine. California, Illinois and New York have declared health emergencies. In New York City, all available slots for a monkeypox vaccine are taken.

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 hampered by the “same kind of bureaucratic delays, oversights and falls of ball that we made during the Covid pandemic “.

The obstacles to filling and finishing vials follow other missteps that have a limited vaccine supply. The United States once had around 20 million doses in a national supply, but failed to replenish them when they expired, leaving the supply dwindling to almost zero. He had 372,000 doses ready for use in Denmark, but waited weeks after the first case was identified in mid-May before requesting delivery of most of those doses. Another approximately 786,000 doses were withheld from an FDA inspection of the manufacturer’s new filling and finishing facility, but have now been shipped.

The government also owns the equivalent of approximately 16.5 million doses of bulk vaccine manufactured and stored by Bavarian Nordic. But when the health agency ordered the administration of 500,000 doses on June 10, other countries with outbreaks had submitted their orders and the first 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 – announced on July 1 and July 15 – most of them could only be delivered next year.

Mr. Gostin, who now heads 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 “start a fire.” under federal health agencies. The White House announced Tuesday that Robert Fenton, administrator of the Federal Emergency Management Agency, and Dr. Demetre Daskalakis, a CDC official, will lead the response.

Mr. Gostin said the nation’s public health agencies have been “a bit asleep behind the wheel on this” and the new coordinators should help “unlock all barriers to the procurement and distribution of vaccines and drugs, which is was deeply frustrating. “

Two senior federal officials, who asked for anonymity to speak frankly, said Mr. Biden is upset by the vaccine shortage. His administration has often touted his success in providing hundreds of millions of coronavirus vaccinations to Americans and is criticized that lack of foresight and management has left gay men – the main risk group for monkeypox. -not protected.

Some critics blame a leadership failure at the Department of Health and Human Services, saying the department’s secretary, Xavier Becerra, has taken a straightforward approach to an increasingly serious situation. Its 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 purchase vaccines, tests and treatments to protect against highly contagious viruses, bioterrorism. and other risks.

At a monkeypox press conference last week, Mr. Becerra said his department is doing everything it can to ensure that “we not only keep up with this virus, but we put an end to this epidemic.” He noted that he recently elevated the agency’s Office of Strategic Preparedness and Response so that he can respond more quickly to public health emergencies.

Sarah Lovenheim, its spokesperson, said in a statement: “Our response is accelerated to meet the evolving needs on the ground and will continue to accelerate. We will use all possible levers to continue allocating doses ahead of schedule, as much as possible ”.

So far, according to the CDC, 6,326 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 case count is widely regarded as an underestimate. Not only are the tests limited, but public health officials like Dr. Joseph Kanter, Louisiana’s top medical officer, have said that monkeypox can be difficult to diagnose. “It can be a lone injury or two, so if it’s not on a doctor’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 played an important role in the early stages of the Covid pandemic. As the pandemic escalated, the sheer torrent of cases overwhelmed the ability of health officials to contact people who may have been infected with someone who tested positive for the coronavirus. Once Covid vaccines became available, they became the cornerstone of the administration’s response to the pandemic.

Until early June, health and human services officials seemed adamant that the United States had more than enough stock 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, largely thanks to support from the federal government, which passed the $ 1 billion mark in 2014 and is now approaching $ 2 billion. Dawn O’Connell, assistant secretary of the federal health agency 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 plan in 2021 that now bottles 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 stock of another effective smallpox vaccine. No FDA inspections were scheduled until after the monkeypox outbreak and it didn’t end until July 27.

In early June, health and human services officials decided to essentially lend around 215,000 finished doses of the vaccine to the Bavarian Nordic region so that the company could supply them to European countries that were suffering from outbreaks.

“It made no sense while we waited for the FDA to complete the inspection – which is coming – that we sit on doses that our international colleagues in Europe could actually use,” Ms O’Connell said on June 10. the government is trying to reschedule the delivery of those doses for the end of the year, a company spokesperson said.

The final step of putting the liquid vaccine into vials represents a substantial share of the vaccine manufacturing cost. Some federal officials say the health department was slow to submit orders for that job because BARDA officials said they were short of funds.

When the demand for vaccines became a protest, however, the agency found the money to pay for five million more doses to administer. Officials are now considering transferring half of the job to another company that may be able to finish and fill doses more than twice as fast.

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

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

Kitty Bennett contributed to the research.