The Promising Covid-19 Treatment Provides Commissioning for Vaccine Distribution |

(CNN)-Antibody therapy designed to prevent Coronavirus It may be available as early as this fall, but only to a small fraction of the millions of Americans who may benefit from treatment.

Companies are already testing Monoclonal antibody therapy-An antibody created in the lab to target Covid-19-is intended for humans. Clinical trials are determining whether antibodies can prevent people from getting infected, and whether treatment can stop the worst symptoms of coronavirus when a patient becomes infected.

There is no guarantee that they will work.

If they prove to be valid, they may be available to Americans months ago. Vaccine is ready.. But according to the pharmaceutical company, the first distribution will probably be left to the federal government. Extensive testing,distribution Personal protective equipment And dispensing other drugs like lemdesibir to fight coronaviruses has already warned.

“This will be a trial run for vaccine allocation,” Representative Illinois Democratic Party member Bill Foster said he had called on the government’s accountability department to step up monitoring and periodically update its therapeutic drug manufacturing process. .. “The battle for this monoclonal antibody could happen two months from now, or sooner.”

It is not clear who will decide where the initial antibody dose will go. And the Trump administration’s record is full of unequal distribution and claims of political support.

Foster, a member of the House of Coronavirus Subcommittee, said, “The poor people can’t get enough therapeutic antibody therapies in overcrowded hospitals, and the wealthy people get a preventive dose by signing up Imagine a nightmare scenario where you could die because you can’t do it. For the week, you’ll stay in Presidential Suite in Malaago.” “There is little public confidence in Jared Kushner, Donald Trump, and the White House to ensure a fair distribution of emergency care.”

Pharmaceutical companies claim to be committed to ensuring that their products reach the patients who need them most. Meanwhile, senior government officials say they are still planning manufacturing and distribution plans.

Huge demand

Pharmaceutical companies and policy makers envision a huge demand for antibody therapies. They could be a life saver in stopping the spread of coronaviruses among nursing home staff and patients experiencing catastrophic mortality. It also limits the worst effects of the virus before the patient is wrapped up in the ventilator and can even be used prophylactically if the front line worker or family is infected with the coronavirus.

But even in the best of scenarios-even if such antibody treatments prove to be effective-probably only hundreds of thousands of times will be available initially. The initial supply is expected to be far below the tens of millions of Americans who could benefit from treatment.

In the United States, more than 60 million antibody therapies were needed the following year to fight all Americans hospitalized with coronavirus at home or to make contact with someone at home, according to research by researchers at Duke University. It will be.

“We won’t have enough capacity to handle these well, so vaccines should ultimately be the broadest solution for the entire population,” said one of the companies currently managing humans. Dr. Len Schleifer, CEO of Regeneron said. One of the only companies to contract with the US government for testing monoclonal antibodies and this type of treatment. “We need to direct these antibodies to where they can do their best, given that they work.”

Public-Private Partnership Working on Manufacturing Vaccines, Drugs, and Trials to Fight Coronavirus Under Operation Warp Speed-The Federal Government has begun stockpiling vaccines and related supplies. It imposed on a panel of scientists and health professionals to decide which Americans should be vaccinated first.

However, the federal government does not buy potential drugs in the same way as preordering vaccines. This is because it is difficult to buy a remedy because there are so many medicines still being tested.

Dr. Janet Woodcock, an employee of the Food and Drug Administration who heads the development of the “Warp Speed ​​Strategy” drug, said at a recent media briefing that “advanced drug purchases will be delayed.” “You have to choose the most promising agents. You can’t buy a pre-purchase of 600 different agents.”

US health professionals were particularly optimistic about the potential efficacy of monoclonal antibody therapy. This is because the medical industry has already used such treatments to treat illnesses such as HIV, asthma, Ebola, and some types of cancer.

“I know that the monoclonal antibody cocktail worked for Ebola if I had to choose, so I think I’m doing a lot for them,” said the director of the National Institutes of Health. Dr. Francis Collins told Congress last month. “There are various reasons to think that this is also a type of virus.”

Scientists looked at early coronavirus patients to find out what antibodies they made to fight the virus. Then, in the lab, they mimicked these antibodies to create a monoclonal therapy. Treatment is not as long-lived as a vaccine and can decline after a month or two. However, they are effective immediately, helping to temporarily protect vulnerable populations and help sick patients avoid the worst of the virus.

“How do you assign this?”

Companies like Regeneron and Eli Lilly are already starting to increase production in the hope that antibody therapies will be effective. We are also discussing pools of manufacturing resources with others in the industry if one or more treatments are effective and government approved.

But expanding production is no easy task, and the federal government, unlike vaccines, isn’t making any kind of investment in drug manufacturing capacity.

“Obviously, we strive to make as many doses as possible available to as many people as possible,” Woodcock said at a briefing in July, with limited manufacturing capacity for monoclonal antibody therapies worldwide. I pointed out that there is. “We, [Operation Warp Speed] Those who actually monitor the whole field and see what we can do. “

Added to the supply challenge: The most effective dose size to fight the virus, and the effective dose size to prevent infection is unclear. Patients with illnesses who try to kill the illness will need more than those who try to prevent the infection.

Regeneron believes that it may administer tens of thousands of therapeutic doses or hundreds of thousands of prophylactic doses per month. Eli Lilly plans to administer approximately 100,000 doses this year.

Where those doses go is probably a matter for the federal government.

“The big challenge at that point is to make sure that the drugs are carefully distributed and used in a way that allows them to make the most of their limited supply,” said Adam, co-author of Duke Research. Crotch estimates the need for the tens of millions of doses mentioned.

Another co-author of the Duke’s study, Martáwosiska, said she wanted to keep hospitals and other institutions from being overwhelmed by the temptation to exhaust more than they needed. I am.

“You really have to say what someone really needs, and how do you assign this?” Wosyska said. “Everyone has the motive to just stockpile”

Operation Warpspeed “is focused on developing, manufacturing, and distributing safe and effective vaccines and therapies approved by the FDA, not on policy,” Woodcock said in a written response to a question from CNN. Stated. “The missing COVID-19 measures allocation is a policy decision made by subject matter experts who receive input from outside parties, including medical ethicists.”

Woodcock, the government Distribution of lemdecivir early this yearThis resulted in doses not being delivered in some hospitals and overdosed in others. “All efforts will be made to ensure maximum transparency,” Woodcock said, adding that the Centers for Disease Control and Prevention and the Department of Defense are working on plans to distribute vaccines and medicines.

Pharmaceutical companies don’t know how the government can allocate their products, but executives have promised to ensure fair distribution and focus on the most vulnerable. I argue that

“I don’t think we’ll have the auction market where the people we can pay the most for are going to access it,” said Schreiffer of Regeneron.

“We are committed to equitable distribution of drugs. This should not include patient payability, social status or political ties.” Eli Lilly’s Skovronsky said. If necessary”

Skoblonsky said he hopes the government has learned some lessons from the previous distribution’s fumble.

“I’ve seen allocations of something else during this pandemic…tests, PPE, masks, ventilators, all of which are controversial,” he said.

However, removing the fear of treatment being given to the highest bidder or the most politically relevant person, it remains to determine which of the most vulnerable Americans deserve the first dose. There are still early trade-offs.

“We are very much at risk between nursing home people and a very large personal risk between the first responders who are potential spreaders of this disease. How do you split the allocation?” Rep. Foster said. “Both groups have a very strong moral view of the first doses of therapeutics and vaccines.”

Hope for a nursing home

Managing antibody therapy is also an issue. Pharmaceutical companies are considering injecting the drug via IV or via a syringe similar to insulin injection for prophylactic administration.

This is easy enough to do in a hospital. However, the housing for the elderly, devastated by high infection and mortality during the pandemic, is not well equipped. They are not rich in pharmacies or IVs and do not have enough staff to provide infusions to all patients.

Eli Lilly summons reinforcements to discontinue clinical trials at the Symphony Care Network facility in the Midwest.

The company has set up an RV that is equipped as a mobile pharmacy. We dispatched a truck full of infusions and equipment for infusions. We also provided staff to initiate IV, manage infusions, and follow up on patients.

“We need to address all these logistical factors,” said Dr. Alexander Stemer, an infectious disease expert and co-chairman of the Symphony’s Covid-19 Task Force.

This week, the network of care homes identified the first outbreak and began explaining details of the clinical trial to patients and staff. Many people have already registered.

“If Covid-19 is a 1,000-page textbook, we’re on page 5, and we’re learning about this disease every day,” said Infectious Disease Expert and Symphony’s Covid-19 Task Force. Said Dr. Alexander Stemer, co-chair of. .. “The good thing about this study is that it gives patients and staff the hope that they may be receiving treatments they can help.”

There has been widespread agreement among experts, pharmaceutical companies and policy makers that effective antibody therapy can be a boon, especially for nursing homes.

“The feeling of destiny, fear and death taking place in these places is heartbreaking, so it would be great if we could change that,” said Eli Lilly’s Scoblonksy. “Then we turn our way down to other groups that are also vulnerable.”