A logo is pictured outside a WHO building during an Executive Board meeting in Geneva
Brussels:
A program led by the World Health Organization to deliver COVID-19 drugs to poor countries is betting on experimental monoclonal antibody treatments and steroids, but is avoiding Gilead’s successful remdesivir therapy, according to an internal document.
The WHO draft document, seen by Reuters and dated October 30, indicates that the priorities are to secure monoclonal antibodies in a tight market and to stimulate the purchase and distribution of the cheap dexamethasone steroid, which it already has. reserved nearly 3 million treatments for poorer countries.
Monoclonal antibodies are made copies of antibodies created by the body to fight infection.
The document, which for the first time describes how the program would spend donor money, does not cite remdesivir as a priority drug – a significant omission because the antiviral is the only other drug approved alongside dexamethasone in the world. for the treatment of COVID-19.
Gilead Science, the U.S. company that developed remdesivir, said the WHO program had not funded its COVID-19 trials and never contacted the company about a possible inclusion of the drug in its wallet.
The drug supply system is one of the four pillars of the so-called ACT Accelerator, a WHO-led project that also aims to secure COVID-19 vaccines, diagnostics and protective equipment for countries in need. poorer by raising over $ 38 billion at the start. from 2022.
“The immediate priorities for the (therapeutic) pillar are to step up efforts on monoclonal antibodies while increasing the use of dexamethasone,” says the WHO document, still subject to change and expected to be released on Friday or next week.
The drug supply program, co-led by the Wellcome Trust, a charity, and Unitaid, a health partnership hosted by the WHO, urgently needs $ 6.1 billion, including $ 750 million of ‘by February, out of a total demand of $ 7.2 billion.
More than half of the urgently needed money would be used to procure and distribute monoclonal antibodies, the document said, indicating that these therapeutics could have a “revolutionary” impact but that they are rare.
No monoclonal antibody drug has yet been approved against COVID-19, but the WHO program has already invested in research into the new technology and secured the production capacity of a Fujifilm plant Diosynth Biotechnologies in Denmark.
Fujifilm was not immediately available for comment.
The program wants to spend $ 320 million to produce antibodies at this facility, the document says, estimating that this would be enough to secure at least 4 million courses of antibodies assuming high-end purchase costs of $ 80 per course. .
A spokesperson for Unitaid, speaking on behalf of the program’s co-leaders, confirmed that it wanted to raise and invest $ 320 million in securing monoclonal antibodies, but declined to comment on potential trade deals citing confidential agreements.
An additional $ 110 million would be used for regulatory approval and other market readiness procedures for monoclonal antibodies in poorer countries, the document said, while $ 220 million would fund clinical trials of antibodies. monoclonal and COVID-19 drug projects in poorer countries.
Among the companies developing monoclonal antibodies against COVID-19 are US pharmaceutical giant Eli Lilly, Swiss company Novartis and US company Regeneron, whose antibodies were administered with remdesivir to US President Donald Trump in October when he tested positive for the coronavirus.
Eli Lilly has already agreed to produce antibodies at the Fujifilm plant from April and make them available “affordably” in poorer countries, a company spokeswoman said.
Lilly’s drug is being tested and is seeking emergency clearance in the United States.
A US government-led trial of the drug was suspended in mid-October for safety concerns, but further trials are continuing. Despite the suspension, the U.S. administration said last week it had sealed a $ 375 million supply deal.
It is not known how and if the WHO program will raise the necessary funds for the provision of antibodies and other projects.
Regeneron and Novartis were not immediately available for comment.
Remdesivir? No thanks
Despite lack of funds, WHO’s drug supply program wants to “transform the treatment landscape,” the document says, and distribute hundreds of millions of COVID-19 courses to poorer countries here 2022.
Besides monoclonal antibodies and dexamethasone, he also plans to develop and secure experimental drugs, including new antivirals and reused drugs.
The program wants to spend an additional $ 100 million to strike deals with manufacturers of unspecified drugs from mid-2021, the document says, and plans to invest an additional $ 4.4 billion next year to secure it. drugs showing positive results in clinical trials.
The Unitaid spokeswoman said that among the reused therapies, dexamethasone and its alternative, hydrocortisone, showed the most promise.
Remdesivir, also known as Veklury, is also a reused antiviral that was initially tested against Ebola.
Unitaid confirmed that the program did not purchase or fund remdesivir. He did not say whether he could purchase the drug in the future or why remdesivir was not among the priority treatments in the document.
Remdesivir has been approved in dozens of countries around the world to treat COVID-19. However, preliminary results from a major WHO-sponsored trial revealed in October that the antiviral had little or no benefit for COVID-19 patients, contradicting previous positive trials.
Governments continue to buy it, however, with Germany announcing this week the purchase of more than 150,000 doses for the next six months.
(Except for the title, this story was not edited by GalacticGaming staff and is posted from a syndicated feed.)
