The hunt for more monkeypox antiviral

THE BIG IDEA

RAMPING UP SUPPLY — The maker of an antiviral drug that’s shown promise for treating monkeypox is discussing with the U.S. government how to ramp up its production as dozens of countries now seek orders — and as, this morning, it announced $13 million in new orders.

As the WHO meets today to discuss whether monkeypox rises to the level of being a public health emergency of international concern, vaccines and treatments — including antivirals — could see even higher demand and take on greater importance around the world than usual.

Siga, the small company that makes the antiviral tecovirimat, has been talking with Biden administration officials about expanding manufacturing capacities, including possibly opening a second manufacturing site, CEO Phillip Gomez told Global Pulse.

The discussions with the Biomedical Advanced Research and Development Authority, Strategic National Stockpile and Department of Defense of expanded manufacturing come as monkeypox outbreaks grow and demand goes global — another signal of the scramble to prepare for the virus.

Siga regularly meets with officials in HHS, discussing how to meet the growing demand. HHS officials declined to comment on any potential discussions with public partners.

“We work with them on a weekly basis as we are developing — and just got approval for — an intravenous formulation, a pediatric formulation,” Gomez said. “Certainly, we talk with people in the administration as well about long-range implications and planning.”

Though the drug isn’t approved for monkeypox in the U.S. (as it is in Europe), it’s available under expanded access for investigational new drugs.

Current supplies

The drug’s global supply is relatively small at this point and only known to be stockpiled in two countries: the U.S. and Canada. The U.S. signed a contract with Siga years ago to maintain 1.7 million courses in its reserves, and the Department of Defense recently purchased $7.5 million of the drug. Canada planned to store 50,000 courses in its stockpile when it was first set up in 2019.

Thursday morning, Siga announced $13 million in new orders for the drug, mostly from new customers. In March, a country in the Asia-Pacific region purchased $3 million of the treatment to be delivered this year.

And now, many more countries are talking with the company about inking a deal.

“I think everyone’s reassessing,” Gomez said. “We’re working with many of those countries to work through how to respond to the current monkeypox demand.”

When tecovirimat could be used

Though data about tecovirimat’s use in monkeypox patients is relatively sparse, the drug is FDA-approved for smallpox and could have unique advantages in treating monkeypox infections, studies in primates have shown.

The ability to use the drug later in an infection could be particularly useful as testing can take multiple days to confirm monkeypox infections.

Researchers are studying tecovirimat for use alongside third-generation vaccines. The National Institutes of Health is working to set up more studies in Africa on the drug’s use for monkeypox, Gomez said.

Expanding manufacturing

Since 2020, Siga has produced about 360,000 courses annually — but that amount could increase significantly in the coming months.

“We probably [could] do a multiple like, you know, twice that, but we haven't looked at larger volumes yet to see if we can do well over that,” Gomez said.

Manufacturing, a four-step process based in the U.S., can ordinarily take more than a year to finish the drug — though Siga has some inventory available and has started the process for future orders to cut down the time to delivery.

“We are in a very different place than a drug that we may be trying to develop and scale up during an outbreak,” Gomez said, also noting the drug has already passed regulatory hurdles as a smallpox treatment. “Depending on the outbreak, I think it’s months away. I don’t think it's on the order, certainly, of years away.”

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IN THE SPOTLIGHT

KEEPING GLOBAL HEALTH ON THE G-7 AGENDAThe leaders of the Group of Seven countries will gather at their annual meeting in Germany on Sunday, with the pandemic vying for attention with the global food crisis, inflation concerns and the war in Ukraine.

The leaders of Canada, France, Germany, Italy, Japan, the U.K., the U.S. and the European Union will discuss the pandemic and how to strengthen preparedness and response and improve the global health architecture ata Monday midday session.

Bruce Aylward, senior adviser to the World Health Organization director-general, hopes the G-7 members that haven’t yet done their fair share in the pandemic response — all except Canada and Germany — will promise to up funding for the global response, which would help increase Covid testing and vaccination rates. The Access to Covid-19 Tools (ACT) Accelerator, a partnership of United Nations agencies and other organizations coordinating the global response, still needs$13 billion this year, mostly for buying tests.

“The Global Fund has not been able to take any new [Covid tests] orders since last November or even earlier than that because they simply haven’t gotten the financing,” Aylward told Global Pulse. As a result, testing rates have dropped by 70 to 90 percent in low- and middle-income countries, from what was already a low level, he said.

“This is where the world is saying ‘the most important thing is for us to find these viruses.’ Seriously? You’re not behaving that way,” Aylward said.

First in Pulse: Former officials ask for Global Fund money — Former Senate Majority Leaders Tom Daschle (D-S.D.) and Bill Frist (R-Tenn.), as well as former German health minister Hermann Gröhe, among others, are asking G-7 countries to increase their contribution to the Global Fund by 30 percent in a letter to G-7 leaders shared with Global Pulse.

The organization seeks to fundraise $18 billion for the next three years at a U.S.-hosted event in New York City in late September.

The U.S. has committed $6 billion, which means others must also step up their contributions.

The $18 billion would “save 20 million lives, avert more than 450 million infections or cases of HIV/AIDS, tuberculosis, and malaria, and rebuild vital frontline health services that will help detect and stop the next pandemic,” the former lawmakers write.

GLOBAL PULSE NUMBER

AROUND THE WORLD

MONKEYPOX VACCINES FOR THE UNEXPOSED — Some gay and bisexual men at high risk of contracting monkeypox should get vaccinated, even if they haven’t been exposed to the virus, the U.K. Health Security Agency announced Tuesday.

That’s a significant escalation to stop the virus’ spread, with more people now encouraged to get the vaccine beyond those who believe they’ve been directly exposed.

Its risks are similar to those of HIV, including men with a recent history of multiple partners or a recent bacterial sexually transmitted disease.

POLIO DETECTED IN LONDON SEWAGE— Vaccine-derived poliovirus was detected in London sewage samples collected between February and May, POLITICO’s Sarah-Taïssir Bencharif reports — leading health officials to declare a “national incident.”

The detection of related samples taken from North and East London, announced Wednesday by the U.K. Health Security Agency, kicked off an investigation into the possibility of spread between humans.

No cases of paralysis have been reported, and officials said the risk to the public is low, especially for those fully vaccinated against polio. Still, officials advise catching up on polio vaccination if needed.

U.S. ROLLS OUT COVID VACCINE DONATIONS FOR KIDS— The U.S has begun shipping pediatric Covid-19 vaccine doses around the world, encouraging countries to expand vaccination efforts to children.

With the COVAX vaccine facility, USAID recently delivered more than 300,000 doses to Mongolia and over 2 million to Nepal, the agency said. It comes after the U.S. pledged to expand the types of vaccine doses it donates to include booster and pediatric shots.

PICTURE OF THE WEEK

WHAT WE'RE CLICKING

Health Policy Watch: The fuss over who should declare public health emergencies in Africa.

Financial Times: We need vaccines and investment to tip the scales against malaria, writes Kenya’s President Uhuru Kenyatta.

The Guardian: ‘Women are treated like walking incubators’: Malta’s fight for abortion.