Hundreds of thousands of expired US monkeypox vaccines still viable, tests reveal – POLITICO

Four hundred thousand doses of the monkeypox vaccine that had expired and were destined for destruction have been tested from US stockpiles and found to still be viable, the chief executive of vaccine maker Bavarian Nordic told POLITICO.

The Danish firm is carrying out tests, at the request of the United States, on some of the 28 million doses that expired around two years ago, Bavarian Nordic boss Paul Chaplin said in an exclusive interview. So far the news is good. Younger batches of expired doses remain of good quality with vaccine levels at sufficient concentrations. Testing is ongoing, but up to 1 million doses could pass from the batches being analyzed, Chaplin said.

The news comes as countries struggle to secure enough doses of the only licensed monkeypox vaccine to protect those most at risk from the painful viral infection, which is endemic in parts of Africa but has spread. around the world over the past four months, primarily among gay and bisexual communities. The United States, despite a long-standing partnership with the company to develop and stock the shot, was taken aback.

There is now an “ongoing dialogue” with the US Food and Drug Administration (FDA) about how to extend the shelf life of these batches to allow the Biden administration to distribute them, Chaplin said.

With US demand for the vaccine, called Jynneos, far exceeding supply, the FDA authorized a dose-saving approach for the emergency, stretching five doses from one with a shallower injection technique. The European Medicines Agency also recommended this approach on Friday. However, Bavarian Nordic has not publicly endorsed this technique – although Chaplin co-authored a small study on the method in 2015.

In a sign that these differences were coming to a head, The Washington Post reported this week that Chaplin had threatened to terminate the long-running U.S. vaccine supply contract over the decision to save doses, jeopardizing up to 13 million bulk doses. in Denmark and already owned by the United States

Chaplin declined to comment on these “rumors” but stressed that the contract was still in place.

He also dismissed media reports that Bavarian Nordic was at odds with the Biomedical Advanced Research and Development Authority (BARDA), the US government department that signed contracts with the Danish company, the first in 2007, to develop and get the vaccine. “Of course, we approach it from different angles, but [our relationship] is excellent, and it’s collaborative. And there is a lot of confidence and conviction on both sides,” added Chaplin.

One million doses will be delivered to the United States this year out of an order of 5.5 million of that volume, he said, the rest will arrive in the first quarter of 2023. The next shipment will be delivered in September, then shipments monthly until the end of the year, he says.

The company has also brought in its US manufacturing partner GRAM, which will put 2.5 million of the 5.5 million doses into vials. That facility is expected to be operational by mid-November following an accelerated technology transfer, Chaplin said, which began “in good faith” before the contract was signed this week. This process normally takes nine to 12 months; with the help of the US government, they are trying to complete it in three, he said.

A series of unfortunate events

Although dose savings, future shipments, and the ability to use officially expired doses are helping to expand the U.S. immunization program, supplies still fall far short of planned national stock and the needs of gay and bisexual communities. More than 14,000 cases had been recorded in the United States as of Friday.

This huge shortfall is the result of a catalog of unfortunate events, dating back to a US strategic shift to a new freeze-dried formula that would have a much longer shelf life.

One Million Doses of Bavarian Nordic’s Monkeypox Vaccine Will Be Delivered to US This Year | Mario Tama/Getty Images

“The 28 million doses we delivered… everyone knew they were expiring,” Chaplin said. “We knew there would be a gap.”

When the doses expired, there was no way at that time to make the freeze-dried version of the vaccine. The original plan was to use an existing Bavarian Nordic manufacturing partner, Germany’s IDT, but that collaboration fell through several years ago, he explained.

Bavarian Nordic then came up with another plan: in 2019 it offered to build its own facility in Denmark. The United States accepted.

Unable to complete

Over the years, the United States has ordered between 11 and 13 million doses of vaccine in bulk, a figure that can only be determined once converted into doses. This bulk, stored in Copenhagen, can either be transformed into frozen or freeze-dried liquid vaccine, at the request of the United States.

While the new freeze-dried product manufacturing facility has now been built, plans to bring it online have been derailed by the monkeypox outbreak. The focus is now on fast order processing, using the standard frozen liquid solution.

However, the company’s ability to convert bulk to frozen liquid doses has also been blocked. Indeed, the company agreed with the FDA to delay an inspection of this facility to coincide with an inspection when the freeze-dried facility would also be ready for evaluation.

This was “before anyone suspected there was going to be an outbreak of monkeypox,” Chaplin said, pointing out that if they hadn’t delayed “they could have [inspected] Last year.”

This meant the company could not release 1 million doses produced there to support a regulatory submission in the United States, and no further volumes could be filled into vials after the monkeypox outbreak emerged.

In early May, when the outbreak was detected, those plans changed. Both the FDA and the European Medicines Agency accelerated their inspections of the company’s new fill-and-finish facility, allowing manufacturing to start in late July. It also triggered the release of the one million doses filled there last year.

The company also resumed bulk vaccine manufacturing from the first week of August at a production facility that has been closed for expansion since last fall.

And there could be more. “We are in talks with several different potential contractors or other companies who could help us and Jynneos fill-finish,” Chaplin said.

Budget constraints

US decisions not to replenish expired stocks of the millions of bulk doses in Denmark also put the country in the position it finds itself in today. US officials said budget constraints impacted those decisions.

Although the United States has its largest portion in Denmark, there is an additional cost for requesting orders to be fulfilled and completed. “The larger the volume, the lower the price, and the smaller the volume, the higher the price,” Chaplin said, adding, “The greater part of the price per dose is, however, the volume.”

Until the Danish company ended its partnership with IDT – which carried out its last vaccine production in 2020 – the doses could have been requested to be filled and delivered by the United States.

But the United States never had the money to request the millions of doses that experts thought were needed, US officials told POLITICO.

“Budget constraints aside – I’m sure that was one of them – but strategically they wanted to move away from the liquid formulation and switch to a freeze-dried formulation because of the longer shelf life and ease of expedition,” Chaplin said. .

The strategy made sense. Spend a comparable amount to store vaccines that last much longer – eight years and counting based on current data, versus three years with the liquid formulation. But the timing, in hindsight, couldn’t have been worse.

“Freeze-dried activities have been pushed back,” Chaplin said. Since the outbreak, the company has focused its efforts on getting its expanded bulk vaccine facility back into service and advancing regulatory inspections of its new fill and finish site.

“Making Jynneos Liquid [is] everything we plan to do until the end of the year, and to be honest, the beginning of next year. We also plan to do only liquid filling for Jynneos,” Chaplin said.

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