The company that makes the only monkeypox vaccine is almost out of stock

The company that makes the only monkeypox vaccine is almost out of stock

One of the most important tools for controlling the global monkeypox epidemic is built in an anonymous industrial area of ​​Kvistgård, a small forested village in Denmark about forty kilometers north of Copenhagen. Here, in fact, are the production plants of Bavarian Nordic, a biotechnology company that is also the only manufacturer of the most advanced vaccine against the disease. The vaccine - which in the United States is called Jynneos, in Canada Imvamune and in Europe is known as Imvanex - is the only one to have obtained approval from the European Medicines Agency (EMA) and the US Food and Drug Administration.

The problem is that Bavarian Nordic's manufacturing plants remained closed until recently and that currently most vaccine doses produced before closure are frozen in plastic bags and not yet usable. Meanwhile, the spread of monkeypox has been declared an international health emergency by the World Health Organization (WHO), with over 30,000 infected in 88 countries (and almost 600 in Italy alone), mostly attributable to skin-to-skin or sexual contact between men who have sex with men.

In the spring of 2022, Bavarian Nordic closed its Kvistgård manufacturing facility to focus on other vaccine products, including rabies and encephalitis vaccines. The company had planned to restart the plant in the third quarter of this year, but "it's reopening right now," says Thomas Duschek, communications manager at Bavarian Nordic. Duschek reports that the plant will be fully operational in approximately one month and will add a production line. The company is also considering switching to a 24-hour production run to meet demand, as well as postponing other vaccines to prioritize monkeypox vaccines.

Bavarian Nordic is also considering contracting with other companies to increase production. It has already entered into an agreement with a US company, whose name remains confidential. The problem here is that making the vaccine is a complex process, and it would take several months for another manufacturer to catch up. In Bavarian Nordic itself, Duschek believes it will take at least six months for new vaccines to start shipping.

Worldwide availability WHO estimates that there are approximately 16 million doses of the vaccine globally , which, according to the organization's estimates, should be sufficient to contain the epidemic. The main obstacle is that most of these vaccines are still in bulk form, which means that doses still need to be transferred from the frozen bags to the vials, a process known as fill and finish and that according to Bavarian Nordic will take several months. WHO is said to be in negotiations with other manufacturers that could help speed up the process. In the United States, the New York Times reported that the country's health authorities are negotiating with a Michigan facility that could contribute to the bottling of 2.5 million doses.

The other problem is that the most of these doses have already been purchased by the United States, although only a quarter of global cases have been detected on the American continent, with no deaths reported.

While possessing the majority of current stocks, however , the United States has failed to secure a steady supply of usable vaccines. For years the country has been accumulating doses to protect itself from smallpox, even in the event of a bioterrorism attack. In the past twenty years, the United States has purchased nearly 30 million doses. Nevertheless, most of the usable doses have in the meantime expired and have never been replaced, although the United States has in the meantime ordered many more (according to Bavarian Nordic, the United States has the equivalent of about 16.5 million doses. bulk, many of which were frozen while a vaccine freeze-drying method was being developed). When the monkeypox outbreak began, the United States had just 2,400 usable doses.

Outside the United States, the Health Emergency Preparedness and Response Authority (Hera) European Commission bought 160,000 doses for the European Union (EU). UK health authorities recently said they bought more than 100,000 doses of the vaccine, while Australia reports buying 450,000, of which 100,000 will arrive this year and the rest in 2023. The United States currently remains the country with the greater availability of the vaccine developed by the Danish company.

Other options and vaccination campaigns However, there are alternatives to the Bavarian Nordic vaccine. One of these is Acam2000, another vaccine that protects against smallpox which however has contraindications linked to some rare but serious side effects, which particularly affect pregnant women, newborns and immunocompromised people, such as those with HIV. which has a higher prevalence among men who have sex with other men. The administration, then, requires specific training. Nonetheless, some experts argue that this vaccine should be made available to people who choose to receive it with awareness of the risks, especially considering that the United States has a huge supply, about 100 million doses. A further option is a Japanese-developed smallpox vaccine, Lc16, which could also be used against monkeypox, although it is itself associated with some side effects. mass vaccination campaigns were needed. At first, ring vaccination campaigns were used, in which close contacts of infected people are vaccinated. WHO now recommends giving the vaccine to at-risk groups of the population, such as health care workers and men who have sex with other men.

While weighing the pros and cons of existing vaccines, WHO has appealed to countries that use vaccines to "collect and share critical data on their effectiveness". At the moment the picture remains rather confusing, as the available vaccines were originally developed for smallpox. In a press conference on July 27, WHO officials estimated that 5 to 10 million doses would be enough to keep the outbreak under control under the current strategy - fewer than currently available in bulk, but much more than the doses that could be given quickly at this time. Given the limited availability, there are discussions about whether a single dose of Bavarian Nordic's vaccine, or even an even smaller amount, may be sufficient (the vaccine was designed with two doses being administered).

Africa and inequality in distribution The first death due to monkeypox was recorded in Africa, which is the only continent where the virus is endemic and where no doses of the vaccine have arrived. In the past five years, outbreaks of the disease have been detected in parts of central and western Africa; to date, 75 people are suspected of having died from the virus across the continent, and cases are on the rise in Nigeria. However, the actual death toll is presumably higher, due to limited testing.

It was precisely the inequity in vaccine distribution that got us to where we are now. Despite loudly reporting recent outbreaks, African scientists have largely been ignored. "The lack of investment continues to haunt us," says Liz Breen, a lecturer at the University of Bradford in the UK and an expert on healthcare supply chains. The African Center for Disease Control and Prevention has called for the continent to have priority in the distribution of the vaccine: "If we are not safe, the rest of the world is not safe," said Ahmed Ogwell, acting director of the body.

WHO has urged countries that have vaccines to share them with those that do not. The organization announced in June that it will institute a vaccine-sharing program, but has since released little information on when and how this will happen.

Ultimately, supply depends on the pharmaceutical industry, which is driven mainly by financial incentives and not by a sense of moral duty. "I wouldn't be surprised if it turns out that this company will be churning out billionaires in two years' time," says Sridhar Venkatapuram, lecturer in global health and philosophy at King's College London. Bavarian Nordic's forecast revenue for the current year has already grown more than double, while the company's stock price has tripled. This means that to stem the epidemic the world depends on the production of a few companies: "God forbid that one of these companies goes bankrupt", adds Breen.

Also that in the coming months, vaccines will continue to be a rare commodity , especially in low-income countries. And if the epidemic cannot be controlled, there is a risk that the virus will spread and establish itself in new animal populations. What Covid-19 and now monkeypox demonstrate is that addressing epidemics as a national problem is simply not an effective method. The leaders of rich countries and international organizations must understand that "if there is an epidemic in some remote country, it could become your problem within a month or a week - explains Venkatapuram -. This concept just did not enter. in people's heads ".

This article originally appeared on UK.

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