The smallpox virus vaccine maker could increase doses by 8 million next year

When mpox first began spreading internationally in 2022, affected countries rushed to purchase some of the limited supply of smallpox virus vaccines being produced in the world. The Danish company Bavarian Nordic, maker of the Jynneos smallpox vaccine, faced the significant challenge of meeting demand with its supply.

This week’s announcement of a second public health emergency of international concern to address new and concerning outbreaks of mpox in Africa has put the company back in the spotlight. The World Health Organization released some projections about the amount of vaccine it thought Bavarian Scandinavian countries could produce (cited in a STAT story here), which were corrected quite quickly by the company itself.

STAT spoke to CEO Paul Chaplin on Thursday to ask what Bavarian Nordic can actually produce – if buyers place orders. So far, the only order the company has received is an order for 175,000 placed by the European Union’s Health Emergency Preparedness and Response Authority (HERA), which it is donating to the Africa Centers for Disease Control and Prevention. BN, as Chaplin calls the company, has supplemented this with a donation of 40,000 doses. The combined purchases and donations equal 215,000 doses, enough vaccine to vaccinate 107,500 people. Jynneos is administered in two doses.

The conversation has been lightly edited for length and clarity.

At the WHO press conference, someone from the agency wrote down some numbers, the doses you have on hand and the doses you can make in the coming year. I’ve read different numbers elsewhere. What is your inventory and your capacity?

I just want to put the situation into context. Before the 2022-2023 outbreak, we were producing to order because we had relatively few orders. While we managed to supply everyone who asked during the 2022-2023 outbreak, it was a bit of a struggle because we were out of stock.

But we have been working at maximum capacity since the end of 2022. And we’ve been building inventory for orders that we expected to come in this year, but also to have some peak capacity that we could leverage. take vaccine in bulk and restock quickly in case there is another outbreak or large order.

The WHO was right. We had just over 500,000 doses in stock that we could deploy immediately. But 215,000 of these have already been allocated through the HERA-Africa CDC-BN donation. So we still have 300,000 doses in stock.

We could produce another 2 million doses by the end of this year. And by the end of next year there will be a total of 10 million. So it’s all cumulative, not in addition.

So another 8 million next year? Not even another 8 million, more like another 7.5 million?

Around that. And that’s along with everything else we already produce.

Just to be clear, are those extra 8 million doses you could take next year committed to anyone at this point? Or are we talking about a potential 8 million doses that could be made if someone signs a contract?

The only doses that are now being used for the current African situation are the 215,000 doses. Everything else is available capacity that we can produce – when we receive orders.

What is the time frame between signing an order for part of that capacity and the delivery of doses?

The inventory we have now consists of doses. They come in vaccine vials, ready to use. Will ship tomorrow, if anyone orders.

We also have a bulk stock of vaccines, which will take a month or two to fill and release. So 2 million total by the end of the year is delivery.

If someone signs a contract and says, “Please use some of your capacity next year to supply me with 1 million doses,” how long would it take to fill that order?

If I don’t have an inventory of anything and someone says, “I want 1 million doses,” it’s going to be over a year from the time I start ordering the raw materials to the time the vaccine doses go out.

But we are working at our maximum capacity. So a lot of raw materials are arriving.

That’s why we decided as a company that we’re going to have an ongoing inventory so that we can respond more quickly because we knew it. Maybe we didn’t really expect the next outbreak to happen so soon after the last one, but we knew it was coming and we knew exactly what would happen.

It now feels a bit like we are at the beginning of the 2022 outbreak, we have the reported case in Sweden and we have the situation in Africa.

That’s why we have this rolling inventory, which puts us in a much better place now than we were in 2022, in the sense that if someone says, “Can you deliver 2 million doses by the end of the year?” the answer is yes.

Are you talking about prices per dose and whether there are price differences depending on who you sell to?

We don’t often talk about price. Price depends on volume and also on long-term commitment. So if we get a long-term commitment, we will give a discount and of course the bigger the volume, the more discount we can give.

We are aware of the price restrictions of certain organizations and we will do what we can. We like to be part of the solution, but we are only part of the solution. I think it is very important that everyone understands: this is an international problem. And we are part of the solution, but we are not the solution. And we rely on others to step up and try to address this situation all together.

Who are you talking about there? Governments? Gavi? UNICEF?

I think all the organizations you just mentioned are. Poorer countries will need financial help.

I think Covid and the latest mpox outbreak should have taught the international community a lesson: you can’t ignore an outbreak that isn’t outside your border for too long without realizing it will eventually come to your border.

The 2022-2023 outbreak came from Africa. There is now a larger outbreak of another clade in Africa. And if we don’t do anything about it, it’s only a matter of time.

Are you thinking about expanding production capacity? Or does the boom and bust nature of ordering put you off that idea? You can’t make things you don’t sell.

In 2022-2023, we actually had a dialogue – a serious dialogue – with several pharmaceutical companies, but also with contract manufacturers to expand production. And we actually brought on board a contract manufacturer in the US, which is part of our total capacity today.

But we were very, very close. And we even have contracts with companies that allow us to press the button to expand production at short notice. But third parties only want to take over business if they receive money. So again, this is all dictated by orders.