An antibody treatment designed to protect against coronavirus could be available as early as a few months — but only for a fraction of the millions of Americans who might benefit from the treatment. No Australian release has been confirmed.
Companies are already testing monoclonal antibody therapies — antibodies created in a lab to target COVID-19 — in humans.
The trials are determining whether the antibodies can prevent people from becoming infected and whether the treatments can stave off the worst symptoms of coronavirus when a patient does become infected.
But according to drug-makers, the initial distribution will most likely be left up to the federal government, whose shoddy track record on setting up widespread testing, distributing personal protective gear and dispensing other drugs such as remdesivir to fight coronavirus is already setting off alarms.
"This will be a test run for allocation of vaccines," Representative Bill Foster said.
Mr Foster is an Illinois Democrat who has asked the Government Accountability Office for enhanced oversight, and regular updates, on the therapeutic manufacturing process.
"This scramble for monoclonal antibodies could happen two months from now or even earlier."
It's not clear who will make the decisions about where the initial antibody doses go. And the Trump administration's record is littered with allegations of unfair distribution and political favoritism.
Mr Foster, a member of the House coronavirus subcommittee, imagines a potential nightmare scenario where "poor people are dying in overcrowded hospitals because they can't get the adequate doses of the curative antibody therapeutics, while rich people are getting preventative doses by signing up for the week stay at the presidential suite at Mar-a-Lago", he said.
"There's really very little public trust of Jared Kushner and Donald Trump and the White House to make a fair allocation of emergency medical treatments."
Drug-makers insist they're committed to making sure their products wind up with the patients who need them most. Government officials, meantime, say they're still working out their manufacturing and distribution plans.
They could also limit the worst effects of the virus, before patients wind up on ventilators, and be used preventatively for frontline workers or even their family members if a worker is exposed to someone with coronavirus.
But even in the best-case scenario — even if such an antibody treatment proves effective — there will likely be only a few hundred thousand doses initially available.
The early supply is expected to fall far short of the tens of millions of Americans who could potentially benefit from the treatment.
A study from researchers at Duke University determined the US would need more than 60 million doses of antibody therapies over the next year to treat every American hospitalised with coronavirus, fighting it at home or exposed to it by someone in their household.
"We won't have enough capacity to make enough of these," Dr Len Schleifer said.
Dr Schleifer is the chief executive of Regeneron, one of the companies currently running human trials of monoclonal antibodies and one of the only companies with a US government contract for this type of therapy.
"So, a vaccine ultimately has to be the broadest solution for the entire public.
"We'll have to direct these antibodies where we can do the most good, assuming that they work."
Under Operation Warp Speed, the public-private partnership working to produce vaccines, drugs and tests to fight coronavirus — the federal government has begun stockpiling vaccines and related supplies.
It has charged panels of scientists and medical experts with deciding which Americans should get inoculated first.
But the federal government isn't buying up potential drugs in the same way it's pre-ordering vaccines, partly because it's harder to stock up on therapeutics when there are so many still being tested.
"Advanced purchasing of therapeutics is going to be slower," Dr Janet Woodcock, a Food and Drug Administration official who leads therapeutics development for Operation Warp Speed, said in a recent media briefing.
"We have to select the most promising ones. We can't just buy advanced purchases of 600 different agents."
US health experts have been particularly optimistic about the odds of monoclonal antibody treatments being effective, in part because the healthcare industry already uses such therapies to treat illnesses like HIV, asthma, Ebola and some types of cancer.
"If I had to pick one, I think the monoclonal antibody cocktails have a lot going for them because we know they worked for Ebola," National Institutes of Health Director Dr Francis Collins told Congress last month.
"There's all kinds of reasons to think this is the kind of virus it should work for, too."
Scientists studied early coronavirus patients to determine what kind of antibodies they produced to fight off the virus. Then, they mimicked those antibodies in a lab setting to create monoclonal treatments.
The treatments aren't as long-lasting as vaccines and potentially wear off after a month or two. But they take effect quickly and are useful in temporarily protecting vulnerable populations or helping sick patients ward off the worst of the virus.
They're also conferring with others in the industry about pooling manufacturing resources if one or more treatments prove effective and are authorised by the government.
But it's no small feat to scale up production and the federal government has not made the kind of investment in manufacturing capacity for drugs as it has for vaccines.
"Obviously we are trying to get as many doses available as possible for as many people," Dr Woodcock said in a July briefing, noting that across the globe there's limited capacity to manufacture monoclonal antibody treatments.
"We have manufacturing experts in [Operation Warp Speed] who are really surveilling the whole field and seeing what we can do."
Adding to the supply challenge: it's not clear what dose size will work best to fight the virus and what dose size will be effective in preventing infection.
Sick patients trying to beat the disease will likely require a higher dosage than people trying to prevent infection.
Regeneron believes it can potentially make tens of thousands of treatment doses per month or hundreds of thousands of preventative doses. Eli Lilly expects to produce roughly 100,000 doses this year.
Where those doses go is a question that will most likely fall to the federal government.
"The big challenge at that point is going to be making sure that the drug is distributed thoughtfully and is used in the way we can make the best possible use of the limited supply," Adam Kroetsch, a co-author of the Duke study estimating the need for tens of millions of doses, said.
You can get up-to-date information from the Federal Government's Coronavirus Australia app, available on the App Store, Google Play and the Government's WhatsApp channel.
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| An antibody treatment designed to protect against coronavirus could be available as early as this fall |
Companies are already testing monoclonal antibody therapies — antibodies created in a lab to target COVID-19 — in humans.
 |
| People line up behind a health care worker at a mobile coronavirus testing site at the Charles Drew University of Medicine and Science in Los Angeles |
The trials are determining whether the antibodies can prevent people from becoming infected and whether the treatments can stave off the worst symptoms of coronavirus when a patient does become infected.
There's no guarantee they will work.
If they are proven effective, they could be available to Americans months before a vaccine is ready.But according to drug-makers, the initial distribution will most likely be left up to the federal government, whose shoddy track record on setting up widespread testing, distributing personal protective gear and dispensing other drugs such as remdesivir to fight coronavirus is already setting off alarms.
"This will be a test run for allocation of vaccines," Representative Bill Foster said.
 |
| Coronavirus infections among younger populations are skyrocketing |
Mr Foster is an Illinois Democrat who has asked the Government Accountability Office for enhanced oversight, and regular updates, on the therapeutic manufacturing process.
"This scramble for monoclonal antibodies could happen two months from now or even earlier."
It's not clear who will make the decisions about where the initial antibody doses go. And the Trump administration's record is littered with allegations of unfair distribution and political favoritism.
Mr Foster, a member of the House coronavirus subcommittee, imagines a potential nightmare scenario where "poor people are dying in overcrowded hospitals because they can't get the adequate doses of the curative antibody therapeutics, while rich people are getting preventative doses by signing up for the week stay at the presidential suite at Mar-a-Lago", he said.
"There's really very little public trust of Jared Kushner and Donald Trump and the White House to make a fair allocation of emergency medical treatments."
Drug-makers insist they're committed to making sure their products wind up with the patients who need them most. Government officials, meantime, say they're still working out their manufacturing and distribution plans.
Enormous demand
Drug-makers and policymakers alike envision enormous demand for antibody treatments. They could be a lifesaver in stopping the spread of coronavirus among staff and patients in nursing homes, which have seen devastating death rates.They could also limit the worst effects of the virus, before patients wind up on ventilators, and be used preventatively for frontline workers or even their family members if a worker is exposed to someone with coronavirus.
But even in the best-case scenario — even if such an antibody treatment proves effective — there will likely be only a few hundred thousand doses initially available.
The early supply is expected to fall far short of the tens of millions of Americans who could potentially benefit from the treatment.
A study from researchers at Duke University determined the US would need more than 60 million doses of antibody therapies over the next year to treat every American hospitalised with coronavirus, fighting it at home or exposed to it by someone in their household.
"We won't have enough capacity to make enough of these," Dr Len Schleifer said.
Dr Schleifer is the chief executive of Regeneron, one of the companies currently running human trials of monoclonal antibodies and one of the only companies with a US government contract for this type of therapy.
"So, a vaccine ultimately has to be the broadest solution for the entire public.
"We'll have to direct these antibodies where we can do the most good, assuming that they work."
Under Operation Warp Speed, the public-private partnership working to produce vaccines, drugs and tests to fight coronavirus — the federal government has begun stockpiling vaccines and related supplies.
It has charged panels of scientists and medical experts with deciding which Americans should get inoculated first.
But the federal government isn't buying up potential drugs in the same way it's pre-ordering vaccines, partly because it's harder to stock up on therapeutics when there are so many still being tested.
"Advanced purchasing of therapeutics is going to be slower," Dr Janet Woodcock, a Food and Drug Administration official who leads therapeutics development for Operation Warp Speed, said in a recent media briefing.
"We have to select the most promising ones. We can't just buy advanced purchases of 600 different agents."
US health experts have been particularly optimistic about the odds of monoclonal antibody treatments being effective, in part because the healthcare industry already uses such therapies to treat illnesses like HIV, asthma, Ebola and some types of cancer.
"If I had to pick one, I think the monoclonal antibody cocktails have a lot going for them because we know they worked for Ebola," National Institutes of Health Director Dr Francis Collins told Congress last month.
"There's all kinds of reasons to think this is the kind of virus it should work for, too."
Scientists studied early coronavirus patients to determine what kind of antibodies they produced to fight off the virus. Then, they mimicked those antibodies in a lab setting to create monoclonal treatments.
The treatments aren't as long-lasting as vaccines and potentially wear off after a month or two. But they take effect quickly and are useful in temporarily protecting vulnerable populations or helping sick patients ward off the worst of the virus.
'How do you allocate this?'
Companies like Regeneron and Eli Lilly have already started ramping up production in the hopes their antibody treatments will prove effective.They're also conferring with others in the industry about pooling manufacturing resources if one or more treatments prove effective and are authorised by the government.
But it's no small feat to scale up production and the federal government has not made the kind of investment in manufacturing capacity for drugs as it has for vaccines.
"Obviously we are trying to get as many doses available as possible for as many people," Dr Woodcock said in a July briefing, noting that across the globe there's limited capacity to manufacture monoclonal antibody treatments.
"We have manufacturing experts in [Operation Warp Speed] who are really surveilling the whole field and seeing what we can do."
Adding to the supply challenge: it's not clear what dose size will work best to fight the virus and what dose size will be effective in preventing infection.
Sick patients trying to beat the disease will likely require a higher dosage than people trying to prevent infection.
Regeneron believes it can potentially make tens of thousands of treatment doses per month or hundreds of thousands of preventative doses. Eli Lilly expects to produce roughly 100,000 doses this year.
Where those doses go is a question that will most likely fall to the federal government.
"The big challenge at that point is going to be making sure that the drug is distributed thoughtfully and is used in the way we can make the best possible use of the limited supply," Adam Kroetsch, a co-author of the Duke study estimating the need for tens of millions of doses, said.
You can get up-to-date information from the Federal Government's Coronavirus Australia app, available on the App Store, Google Play and the Government's WhatsApp channel.
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