How the US is letting 20 million doses of monkeypox vaccine expire

Less than a decade ago, the United States had about 20 million doses of a new smallpox vaccine—also effective against monkeypox—in refrigerators in a national stockpile.

Such massive amounts of a vaccine, known today as Jynneos, could slow the spread of monkeypox after it first appeared in the United States more than two months ago. Instead, the supply, known as the Strategic National Stockpile, contained only 2,400 usable doses in mid-May, enough to fully immunize only 1,200 people.

The rest of the doses have expired.

Now, about 10 weeks into the outbreak, high-risk people who want to get vaccinated have not been able to find a dose and may not be able to find a dose for months.

The chain of events that dwindled the now critical vaccine stock to nearly nothing in the United States is only now emerging.

At several points, federal officials chose not to quickly renew doses when they expired, and instead poured money into developing a lyophilized version of the vaccine that would significantly increase its three-year shelf life.

As a lyophilized vaccine has been awaited approval by the Food and Drug Administration over the past decade, the United States has purchased massive quantities of a raw vaccine product, which has not yet been packaged in vials.

Incomplete vaccines remain stored in large plastic bags outside Copenhagen, at the headquarters of the small Danish biotech company Bavarian Nordic, which developed Jynneos and remains its sole producer.

For nearly 20 years, the US government has helped fund the company’s vaccine development, clinical trial, and manufacturing process, at a cost that crossed the $1 billion mark by 2014 and is headed toward $2 billion. Despite this, the United States now finds itself unable to purchase enough doses to quickly launch a massive vaccination campaign for those most at risk: men who have sex with men and, in particular, those with multiple partners.

One reason for the US stockpile of Jynneos is that the federal officials who oversee them have not viewed monkeypox, which has a relatively low mortality rate, is as big of a problem, or at least as theirs. They were focusing on the most dangerous and deadly scenarios, such as a bioterrorist attack involving smallpox or anthrax.

Dr. Gary Desbrow, director of the Biomedical Advanced Research and Development Authority, or BARDA, the federal agency that has supported the development of Jynneos and other drugs and vaccines to protect against epidemics, bioterrorism and other risks. “Our plans were to fight smallpox.”

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

“We were specifically asked to obtain smallpox vaccines, based on the identification of a physical threat that simply did not exist for monkeypox, specifically,” a spokeswoman for Health and Human Services said in a statement. “Today, as we are now in position to respond to the public health threat, we are working quickly around the clock to accelerate the number of doses available.”

The limited supply of available Jynneos shows that a new approach is needed to prepare for biological threats and pandemics, said a former federal official, Dr. Ali S. Khan, who until 2014 ran the CDC office that manages the stockpile. . “I want people to know how bad this situation is given the amount of money and resources that have been put into it,” he said.

In the wake of the September 11, 2001 terrorist attacks and subsequent anthrax letter attacks, the United States government redoubled its efforts to prepare for future threats. Smallpox was one of the obvious dangers, with a death rate of 30 percent. Although the virus was declared eradicated in 1980, lab samples existed, and there had long been concerns that a foreign country or terrorist group might be arming it.

In the years after 9/11, the United States stockpiled more than 100 million doses of smallpox vaccines — copies of the vaccine that killed the virus. With names like Dryvax and ACAM2000, they use a live virus that reproduces and can have serious side effects, including heart inflammation in about six out of 1,000 recipients. One or two people are expected to die out of every million vaccinated.

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

In 2010, the company delivered more than two million doses of the new smallpox vaccine to the Strategic National Stockpile, the company reports. By 2013, Northern Bavaria had delivered 20 million doses, according to the company’s annual report as well as US documents.

The vaccine came in vials in frozen liquid form, for three years at a temperature that the US government had stored: 20 degrees Celsius below zero, a little cooler than the freezer in the kitchen.

The new vaccine, called at the time Imvamune, not Jynneos, was never intended to replace a much larger stockpile of smallpox vaccines from older generations, but rather is offered to those at greater risk of complications from older vaccines and their member families, according to a public report. 2014 issued by the US Department of Health and Human Services. This included people with conditions ranging from eczema to HIV, pregnant women and infants.

Some federal health officials were skeptical. Jynneos asks for two shots—not ideal in the event of a biological attack—not one. And while traditional smallpox vaccines can have serious complications, that would be less of a concern if the country faced a smallpox outbreak.

But executives in northern Bavaria told shareholders that the long-term US plan was to stockpile enough Jynneos vaccine to immunize all 66 million eligible people in at-risk households.

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

With 20 million doses of Jynneos starting to expire, the United States ordered another eight million, which were shipped to the country’s stockpile in 2015, according to Bavaria Nordic and US Health and Human Services staff. This was supposed to be a “bridge” until the freeze-dried version came out, according to a federal planning agency made up primarily of Health and Human Services staff.

The former federal official, Dr. Ali S. Khan, who ran the CDC office that ran the stockpile until 2014, “frustrated at why it took so long to get a lyophilized lotion to keep for longer.”

But the eight million doses were the last big shipment for years. From 2015 onwards, the US has instead placed orders for hundreds of millions of dollars of bulk vaccine products — a raw vaccine that is stored in large bags, which will be converted into freeze-dried doses once the company has perfected the process and received FDA approval. (FDA) necessary.

By 2017, all 2799,370 doses in the Jynneos National Stockpile had expired, although the United States still had a huge stockpile of other smallpox vaccines.

Nicole Lowery, who oversaw the stockpile during her eight-year tenure as the Assistant Secretary for Preparedness and Response within Health and Human Services under President Barack Obama.

Both Jynneos and ancient stockpiled smallpox vaccines, such as ACAM2000, are Good options as a smallpox vaccine. Federal officials expect ACAM2000 to protect against monkeypox and have shipped doses to local health authorities for use, but its more severe side effects make many clinicians uncomfortable with its use in a mass monkeypox vaccination campaign.

The goal of producing a lyophilized vaccine took longer than expected, in part because of the slow Food and Drug Administration review process. In recent years, the northern state of Bavaria has also made an expansion that will eventually delay the delivery of vaccine doses.

Northern Bavaria has long relied on outside companies for the final stages of the production process, such as filling actual bottles. This is common, so much so that HHS has invested in “fill and finish” companies to reduce suffocation risks during the pandemic.

By 2017, the company had plans to build its own “fully finished” facility, which would make its vaccine production “more profitable than we’ve seen in the past,” according to Bavaria Nordic CEO Paul Chaplin, with government funding. America is part of this expansion.

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

The rest was filled at the new finish filling facility in Bavaria Nordic, which was commissioned in 2021.

But the Food and Drug Administration had not inspected the facility at the time the monkeypox outbreak began and those doses were deemed unusable until the inspection. As a result, the bulk of the 1.4 million dose order remained in Denmark until last month, when Food and Drug Administration inspectors arrived.

Now, the US government has asked Northern Bavaria to start sending out as many doses as possible, ignoring the goal of a freeze-dried formula for the time being.

But US officials say it could be months before the company can make millions of additional doses of the bulk vaccine supply that the United States has been paying northern Bavaria countries for years to stock.

With very little Jynneos on hand to contain an outbreak of monkeypox, federal officials are taking a fresh look at expired doses, which are still on hand. Health and Human Services officials sent samples to northern Bavaria for testing.

Officials say it is “highly unlikely” that they will still be able to survive. But if that was the case, the Strategic Response and Preparedness Department, a division within HHS, said it would provide it to “response”.

Sheryl Jay Stolberg Contribute to the preparation of reports.

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