How the US allowed 20 million doses of monkeypox vaccine to run out – The Mercury News

Less than a decade ago, there were about 20 million doses of a new smallpox vaccine in the United States—also effective against monkeypox—sitting in the freezer at a national stockpix.

Such a large amount of the vaccine, known today as Genios, could have slowed the spread of monkeypox after it first emerged in the United States more than two months ago. Instead, the supply, known as the Strategic National Stockpile, had only 2,400 usable doses left in mid-May, enough to completely vaccinate only 1,200 people.

The rest of the dose had expired.

Now, about 10 weeks into the outbreak, high-risk people who want to get vaccinated are unable to find a dose and may not get one for months.

The chain of events that led the stockpile of the now-critical vaccine to almost nothing in the United States is only now emerging.

At several points federal officials opted not to refill quickly after the dose had expired, instead investing money in developing a freeze-dried version of the vaccine, which would have significantly increased its shelf life of three years.

Waiting for freeze-dried vaccines to be approved by the Food and Drug Administration dragged on over the past decade, with the United States purchasing large quantities of raw vaccine products that have not yet been filled into vials.

Incomplete vaccines are kept in large plastic bags outside Copenhagen, Denmark, headquartered in Bavarian Nordic, the small Danish biotech company that developed Genos and remains its sole manufacturer.

For nearly 20 years, the U.S. government has helped with the development of the company’s vaccine, clinical trials, and manufacturing process, which cost more than $1 billion as of 2014 and are headed toward $2 billion. Despite this, the United States now finds itself unable to obtain enough doses to launch a widespread vaccination campaign for those at highest risk: men who have sex with men, and in particular, those who have multiple partners. Huh.

One reason the US stockpile of Jynneos is dwindling is that federal officials overseeing it did not see monkeypox, which has a relatively low mortality rate, as a problem, or at least their problem. They focused on the most dangerous and deadly scenarios, such as bioterror attacks involving smallpox or anthrax.

“We have to prepare against many threats with a limited budget,” said Dr. Gary Disbrow, director of the Biomedical Advanced Research and Development Authority, or BARDA, the federal agency that has developed Zynos and other drugs and vaccines to protect against the pandemic. has supported development. , bioterrorism and other threats. “Our plan was for smallpox.”

Now, monkeypox has emerged as a serious public health threat. By the end of July, more than 5,000 cases had been reported in the United States, and about 1,300 in New York City.

“We were required to develop a vaccine for smallpox based on a determination of a physical hazard that did not exist specifically for monkeypox,” a Health and Human Services spokesperson said in a statement. “Today, now that we are in response mode to face a public health threat, we are working rapidly round the clock to accelerate the number of doses available.”

A former federal official, Dr Ali S Khan, who until 2014 ran the Office of Disease Control and Prevention, which managed the stock, said the limited supply of available Genios suggests that there is a potential for biological hazards and pandemic preparedness. A new approach is needed. , “I want people to know how bad it was considering the money and resources put into it,” he said.

Fears of 9/11 and Bioterrorism Attacks

Following the September 11, 2001, terrorist attacks and the subsequent anthrax letter attacks, the US government doubled its efforts to prepare against future threats. A clear threat was smallpox, which had a 30% mortality rate. Although the virus was declared eliminated in 1980, laboratory samples of it did exist, and there was long-standing concern that a foreign country or terrorist group might weaponise it.

In the years following September 11, the United States stockpiled more than 100 million doses of the smallpox vaccine—the version of the vaccine that wiped out the virus. With names like Dryvax and ACAM2000, they use a live virus that replicates and can have dangerous side effects, including heart inflammation in about six out of 1,000 recipients. One or two people are expected to die per lakh vaccinations.

After 2001, the United States sought an effective smallpox vaccine with fewer side effects. In 2003, it began pumping millions of dollars into Bavarian Nordic, a small company with a promising new smallpox vaccine.

In 2010, the company distributed more than 2 million doses of its new smallpox vaccine to the Strategic National Stockpile, the company reports. As of 2013, Bavarian Nordic had distributed 20 million doses, according to the company’s annual report as well as US documents.

The vaccine came in vials in liquid-frozen form, with a shelf life of three years at temperatures the US government stored them at: minus 20 degrees Celsius, slightly cooler than kitchen freezers.

The new vaccine, then known as Immune, not Genios, was never intended to replace the large stockpile of older generations of smallpox vaccines, but rather to people at high risk of complications from older vaccines and their families. was to be presented. According to a 2014 report from the US Department of Health and Human Services, Member. This included people with conditions ranging from eczema to HIV and pregnant women and infants.

Some federal health officials were skeptical. Jynneos required two shots—not ideal in the event of a bioterror attack—instead of one. And although traditional smallpox vaccines can have serious complications, it won’t be a cause for concern if the country does face an outbreak of smallpox.

But Bavarian Nordic officials told shareholders the long-term US plan was to stockpile enough Genos vaccine to vaccinate all 66 million eligible people in high-risk households.

In 2009, the company received a $95 million contract from the United States to develop freeze-dried formulations with a shelf life of five to 10 years.

According to Bavarian Nordic and US Health and Human Services personnel, as the 20 million GenoS doses began to run out, the United States ordered another 8 million, which were shipped to the nation’s stockpile in 2015. The order was to be “a bridge” until a freeze-dried version emerged, according to a federal planning body composed primarily of health and human services personnel.

Khan recalled “disappointment at why it was taking so long to obtain a freeze-dried preparation that could be kept for longer.”

But 8 million doses were the last substantial shipment for years. Since 2015, the United States has instead placed orders for a bulk vaccine product worth hundreds of millions of dollars – basically raw vaccines stored in large bags, which are converted into freeze-dried doses after the company completes the process. and the necessary FDA approval will be obtained. ,

As of 2017, the national Jynneos stockpile had exhausted all 27,993,370 doses, although it still had a large stockpile of other smallpox vaccines in the United States.

“In fairness, I’m not sure anyone in their right mind would have thought we needed more smallpox vaccines,” said Dr Nicole Lurie, who served as her assistant secretary for preparedness and response within Health. During the tenure of eight years, the stock was inspected. Human Services under President Barack Obama.

Jynneos and older stockpile vaccines, such as ACAM2000, are good options as smallpox vaccines. Federal officials hope that ACAM2000 protects against monkeypox and has sent doses to local health officials for use, but its harsh side effects make many doctors uncomfortable using it for large-scale monkeypox vaccination campaigns.

one delay after another

The freeze-dry vaccine production target has taken longer than expected, partly because of the slow FDA review process. In recent years the Bavarian Nordic also underwent an expansion that would eventually delay the delivery of vaccine doses.

The Bavarian Nordic had long relied on outside companies for the final stages of the production process, such as filling the actual vials. This is common, so much so that HHS has invested in “fill and finish” companies to reduce the risk of a bottleneck during a pandemic.

By 2017, the company had plans to build its own “fill-finish” facility that would make its vaccine production “more profitable than what we’ve seen in the past,” according to Paul Chaplin, CEO of Bavarian Nordic. The government is funding a portion of this expansion.

In early 2020, the United States placed an order from Bavarian Nordic for 1.4 million liquid-frozen doses, its first significant order for a product ready for use in years. Some of those doses – about 372,000 – were filled by a third-party contractor, and have until now been the main source of doses for the country’s monkeypox vaccination program.

The rest of the Bavarians were filled at Nordic’s new fill-finish facility, which got underway in 2021.

But the FDA had not inspected the facility until the monkeypox outbreak began and deemed those doses unusable until the inspection. As a result, the bulk of the 1.4 million-dose order sat in Denmark until last month, when FDA inspectors arrived.

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