A plasma shot could prevent coronavirus. But feds and makers won’t act

dandyfopp

A plasma shot could prevent coronavirus. But feds and makers won’t act, scientists say

https://www.latimes.com/science/story/2020-07-10/injection-prevent-coronavirus-feds-manufacturers-fail-to-act


JULY 10, 2020

6 AM


It might be the next best thing to a coronavirus vaccine.


Scientists have devised a way to use the antibody-rich blood plasma of COVID-19 survivors for an upper-arm injection that they say could inoculate people against the virus for months.


Using technology that’s been proven effective in preventing other diseases such as hepatitis A, the injections would be administered to high-risk healthcare workers, nursing home patients, or even at public drive-through sites — potentially protecting millions of lives, the doctors and other experts say.


The two scientists who spearheaded the proposal — an 83-year-old shingles researcher and his counterpart, an HIV gene therapy expert — have garnered widespread support from leading blood and immunology specialists, including those at the center of the nation’s COVID-19 plasma research.


But the idea exists only on paper. Federal officials have twice rejected requests to discuss the proposal, and pharmaceutical companies — even acknowledging the likely efficacy of the plan — have declined to design or manufacture the shots, according to a Times investigation. The lack of interest in launching development of immunity shots comes amid heightened scrutiny of the federal government’s sluggish pandemic response.


There is little disagreement that the idea holds promise; the dispute is over the timing. Federal health officials and industry groups say the development of plasma-based therapies should focus on treating people who are already sick, not on preventing infections in those who are still healthy.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, said an upper-arm injection that would function like a vaccine “is a very attractive concept.”


However, he said, scientists should first demonstrate that the coronavirus antibodies that are currently delivered to patients intravenously in hospital wards across the country actually work. “Once you show the efficacy, then the obvious next step is to convert it into an intramuscular” shot.


But scientists who question the delay argue that the immunity shots are easy to scale up and should enter clinical trials immediately. They say that until there’s a vaccine, the shots offer the only plausible method for preventing potentially millions of infections at a critical moment in the pandemic.


“Beyond being a lost opportunity, this is a real head-scratcher,” said Dr. Michael Joyner, a Mayo Clinic researcher who leads a program sponsored by the Food and Drug Administration to capitalize on coronavirus antibodies from COVID-19 survivors. “It seems obvious.”


The use of so-called convalescent plasma has already become widespread. More than 28,000 patients have already received the IV treatment, and preliminary data suggest that the method is safe. Researchers are also looking at whether the IV drip products would prevent new infections from taking root.


The antibodies in plasma can be concentrated and delivered to patients through a type of drug called immune globulin, or IG, which can be given through either an IV drip or a shot. IG shots have for decades been used to prevent an array of diseases; the IG shot that prevents hepatitis A was first licensed in 1944. They are available to treat patients who have recently been exposed to hepatitis B, tetanus, varicella and rabies.


Yet for the coronavirus, manufacturers are only developing an intravenous solution of IG.

Joyner told The Times that 600 COVID-19 survivors donating their plasma each day could, depending on donation volumes and concentrations, generate up to 5,000 IG shots. With millions of probable survivors in the United States, he said, capacity isn’t a problem.


Plasma companies said they’ve focused their efforts on an intervention for the sickest patients. Grifols, for example, said it has not developed a shot because it is pursuing a federally supported IV formula “to treat patients already infected with a serious case of COVID-19,” but the company acknowledged that an antibody injection would be a good choice for prevention.


Advocates for the immunity shots say businesses are reluctant to invest in a product that could soon be replaced by a vaccine, so the government should offer financial incentives to offset that risk.


Billions of federal dollars are already being spent on vaccine research through Operation Warp Speed, and funding for an IG shot that could serve as a bridge to a vaccine would come with a relatively modest price tag, they say.


“Antibodies are the most precious resource on the planet right now, next to air. We have the industry, the technology, and the know-how to produce a proven product,” said Patrick Schmidt, the chief executive of FFF Enterprises, a major distributor of IG products in the United States.

“The amount of money and resources going into a vaccine, with no guarantee it will work — this could have saved lives by now.”


:

The proposal for an injection approach to coronavirus prevention came from an immunization researcher who drew his inspiration from history.


Dr. Michael Oxman knew that, even during the 1918 flu pandemic, the blood of recovered patients appeared to help treat others. Since then, convalescent plasma has been used to fight measles and severe acute respiratory syndrome, or SARS, among other diseases.


Like other doctors, Oxman surmised that, for a limited time, the blood coursing through the veins of coronavirus survivors probably contains immune-rich antibodies that could prevent — or help treat — an infection.


On March 27, he and Dr. John Zaia, the director of City of Hope’s Center for Gene Therapy, submitted a proposal to the federal Biomedical Advanced Research and Development Authority, or BARDA, urging the rollout of IG shots for first responders and members of other high-risk groups.


The agency granted $12.5 million to Grifols and $14.5 million to Emergent BioSolutions to produce plasma-based COVID-19 medicines in IV form drips, among more than 50 different biomedical partnerships to fight the pandemic. But the immunity shot proposal was rejected.


The pair followed up with a detailed proposal to conduct a clinical trial at UC San Diego. They believed injectable 5-milliliter vials of IG could be given quickly by minimally trained healthcare workers, offering at least two months of immunity to doctors and nurses, as well as residents of nursing homes, college dormitories and military submarines.


The submission was backed by four other infectious disease researchers and statisticians, but it was also rejected, records show.


A spokeswoman for BARDA told The Times that the agency had received thousands of submissions, and that “while we are interested in the potential of [IG] for treatment and prevention, we are focused intently on treatments for hospitalized patients to save lives.”


The strategy baffled Oxman and Zaia, who said the IG shots are a far more efficient delivery system that can potentially reach many more people.


What’s more, prophylactic shots would probably require far fewer antibodies than IV treatments, Joyner said. With IG shots, plasma donations could possibly go twice — or even five times — as far, he said.


If a second wave of the virus were to arrive before an effective vaccine, that stockpile would be all the more essential.


Oxman started focusing his attention on the key players in the industry — the manufacturers who dominate the development of plasma drugs. He held weekly phone calls with Schmidt, the distributor; together, the two tried to persuade seven companies to produce the shots themselves and bring them to health agencies for testing. They were unsuccessful.


Takeda and CSL Behring, two large companies who co-lead the new CoVIg-19 Plasma Alliance to develop an IG product for IV drips, said their efforts are trained on the sickest. The IV formula “represents the fastest path to reach patients, assuming the trial is successful,” said Julie Kim, the head of the plasma-derived therapies business unit at Takeda.


Financial calculations may be another factor for companies. Intravenous plasma products are traditionally the main economic driver for the industry, supply experts said, in part because vaccines have replaced many short-term immunity shots over the years. The money-making antibodies are also far more diluted in intravenous drugs than in injectable ones, which boosts profit margins.


“They charge a fortune off of intravenous drugs in the hospital. They don’t want to devote the manufacturing plant to something that won’t make oodles of money,” said one infectious disease expert, who has advocated for coronavirus IG shots but asked not to be publicly identified.


Researchers also said industry executives have little incentive to produce the immunity shots for the coronavirus, given the possibility that a longer-lasting vaccine could replace it within a year.


Representatives for CSL, Takeda and Grifols all challenged that assertion.

“The choice of one delivery method or another has no connection with the potential financial or pricing implications,” a Grifols spokesman told The Times.


Throughout May, researchers and doctors at Yale, Harvard, Johns Hopkins, Duke and four University of California schools sent a barrage of letters to dozens of lawmakers. They held virtual meetings with health policy directors on Capitol Hill, but say they have heard no follow-up to date.


Dr. Arturo Casadevall, the chair of the National COVID-19 Convalescent Plasma Project, said he spoke to FDA officials who told him they do not instruct companies on what to produce. Casadevall told The Times that the leaders of the national project were “very supportive of the need to develop” an IG shot rapidly and that he believed it would be “very helpful in stemming the epidemic.”


Joyner, of the Mayo Clinic, said there are probably 10 million to 20 million people in the U.S. carrying coronavirus antibodies — and the number keeps climbing. If just 2% of them were to donate a standard 800 milliliters of plasma on three separate occasions, their plasma alone could generate millions of IG shots for high-risk Americans.


“At a hot-spot meatpacking plant, or at a mobile unit in the parking lot outside a mall — trust me, you can get the plasma,” Joyner said. “This is not a biological problem nor a technology problem. It’s a back-of-the-envelope intelligence problem.”


The antibody injections, for now, do not appear to be a high priority for the government or the industry.


Grifols, on April 28 — the same day that the U.S. topped 1 million confirmed coronavirus cases — made a major product announcement that would “expand its leadership in disease treatment with immunoglobulins.”


The product was a new vial for IG shots — to treat rabies.

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Comments (23)
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kadefol

So why isn't the government acting on this? The increasing virus numbers and economic shutdowns are not helping the GOP one bit. If they put a rush on this treatment, the economy could be back on its feet in a matter of a few months and the problem could be managed until there is a viable vaccine. Seems like a perfect interim solution.

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jerzeegirl (FL zone 9B)(9b)

A good solution at least for the poor health care workers who are working their butts off and are totally at risk.

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Lars(Z11a (coastal L.A.) and Z9a (desert))

<Advocates for the immunity shots say businesses are reluctant to invest
in a product that could soon be replaced by a vaccine, so the government
should offer financial incentives to offset that risk.>

The government is not interested in spending money on something that will soon be obsolete, even if it does save a few lives - those lives are not worth the money.

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kadefol

^^ That may be the reason, especially since many of those lives are pesky SS and Medicare recipients who are a drain on resources in the GOP's eyes.

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maifleur03

This is a temporary thing and not a long term solution. The antibodies fade. It does not make any difference if they are from plasma or from having the virus. There is not enough plasma for the current need much less to be giving it to people because they want it. I would prefer that what supply is available to be used to keep the ones giving care safer.

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leona_2008

Saving lives is not a priority of the trump administration.

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jmm1837

The feds and the big drug companies are putting all the money into a vaccine. Big profits to be made, even if it takes a few years and a lot of deaths along the way. I hope the Brits or the Germans or the Chinese get there first.

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Izzy Mn(4)

Only people that have higher amount of antibodies would qualify to donate to make a difference. I've also read one person per three recipients. Also, doesn't that leave the person with less antibodies that could help them fight off a possible reinfection. They are probably struggling with recovery as it is and would not do well if reinfected. Plus, it's their choice to donate, maybe even the criteria for donations. Maybe they want to hold off to do a direct donation to family or loved one who could need it, or someone who really needs it rather than wants and has the $ to pay.


Talking about donations. I just found out my brother has O- blood, a universal donor, only about 8% have it. He has been donating more blood lately. He gets calls to come in at times. But he can only receive O- blood. They did test for virus, it was negative.

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nancy_in_venice_ca Sunset 24 z10

They believed injectable 5-milliliter vials of IG could be given quickly by minimally trained healthcare workers, offering at least two months of immunity to doctors and nurses, as well as residents of nursing homes, college dormitories and military submarines.

Add the lack of immunity shots to the lacking PPE for healthcare workers -- those who are, and have been, putting their own lives at risk to treat Covid victims are simply not that important to Team Trump.

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jmm1837

Just remember, blood, complete with antibodies, is a renewable resource so what you donate today you can donate again a few days or weeks from now. And given the numbers who've had covid, there should be quite a few potential donors.

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Zalco/bring back Sophie!

I hope the Btits or the Germans or the Chinese get there first.


Well the PRC have already gifted us with this plague. I for one could do without any more from them in the health department, thank you very much.

Have the Australians enjoyed the threats coming from Beijing wrt Covid?


https://www.reuters.com/article/us-health-coronavirus-australia-china/australia-rejects-chinese-economic-coercion-threat-amid-planned-coronavirus-probe-idUSKCN2290Z6

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jmm1837

Nope, we're paying dearly for it with sanctions being imposed and a propaganda war going on. But science is science and I don't really care who gets there first. The Chinese seem to be well advanced on that front.

I'm just a little bad-tempered at the moment about recent US behavior when it comes to drugs. Our drug licencing body, the TGA, has just approved Remdesivir for therapeutic use in some cases - fortunately, we don't have many at the moment but we're going through a nasty spike and need every vial we can get. We managed to get a small supply of the drug early on, but the US has now basically grabbed the whole global supply, so it will be difficult getting more. Everyone understands that the company producing it is American, and America has to do what's in the interest of Americans, but countries that participated in the clinical trials to get the drug approved are more than a bit put off by the fact that they now can't get access to the drug itself. When it comes to something like this, there's usually more international cooperation.

https://www.abc.net.au/news/2020-07-11/remdesivir-approved-by-tga-coronavirus-covid-19-australia/12446036


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elvis

Big profits to be made, even if it takes a few years and a lot of deaths along the way. I hope the Brits or the Germans or the Chinese get there first.

It doesn't matter who "gets there first". I tend to agree with Zalco wrt PRC, however.

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HamiltonGardener

As far as I understand, the Chinese are the only ones developing attenuated virus vaccines. So, I’m guessing it’s likely the Chinese will “get there” first, but it will take them longer to get their vaccines out in large enough quantities. The first one to have large numbers of doses out the door for the world to use... I’m betting on the Oxford vaccine, but I don’t know how long the approval process will take to get governments comfortable with its safety.



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adoptedbyhounds

Add the lack of immunity shots to the lacking PPE for healthcare workers -- those who are, and have been, putting their own lives at risk to treat Covid victims are simply not that important to Team Trump.

Nope. It was NOT President Trump warning it was dangerous to try to save patients with Hydroxychloroquine before clinical trials were completed. Those warnings came from the hysteria driven left.

It was President Trump who encouraged our government bureaucracies to streamline their approval processes so that Hydrochloroquine, already being used successfully off label by doctors in the field, could be widely used as a therapy for covid19 patients, What he got instead, were political attacks for daring to mention a cheap, 60 year old drug that doctors already knew was effective. Some mocked him for "prescribing" the drug. Politicians stood between doctors and patients, even threatening doctors who dared to use it. Lots of MSM hit pieces against the drug. There was even a murder in which a woman claimed (and some here believed it!) that she and her husband willingly drank fish tank cleaner because Trump mentioned a drug the cleaner contained.

Today, we see another promising idea shot down by bureaucrats protecting their turf. Politicians get big bucks from pharmaceutical companies that are already working on a different therapy. Companies understandably don't want to lose their investments of time and money. Agencies like the FDA and CDC have enormous power, yet work at a snail's pace. Not good when the virus is killing at warp speed.

The left wanted slow, and it's getting it.

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jmm1837

Trump wanted Hydroxychloroquine licenced without any substantive proof that it worked, and without any consideration of risk. Guess what: there is still no solid proof that it works, and one major study that it is too risky. This is not coming from the "hysterical left" - this is coming from actual scientists. You do not skip steps in the safety protocols when trying to deal with a health problem, because if you get it wrong people die. You cannot speed up science because you want a quick fix coming into an election.

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adoptedbyhounds

"You do not skip steps in the safety protocols when trying to deal with a
health problem, because if you get it wrong people die.
"

And now hydrochloroquine critics come face to face with their own argument.

A plasma shot could prevent coronavirus. But feds and makers won’t act, scientists say.

"You do not skip steps in the safety protocols when trying to deal with a
health problem, because if you get it wrong people die.
"

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Lulu Smith

Still not proven, being tested. Here's a comment from a Mayo doctor:

"The effectiveness of convalescent plasma therapy in treating COVID-19 patients has yet to be established in clinical trials, but Joyner said he’s optimistic. An initial study has already shown the treatmentto be safe for COVID-19 patients."

https://www.nbcnews.com/news/us-news/covid-19-mitzvah-orthodox-jews-donate-blood-plasma-thousands-n1232656

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jmm1837

It's being tested for heavens sake. The problem is the lack of funding for the studies: it's all going into the vaccine basket. And the vaccine is of course being run through the proper protocols.

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adoptedbyhounds

"It's being tested for heavens sake. The problem is the lack of funding for the studies,."

The article said the feds won't act.

You say it is being tested.

You didn't mention who is doing the testing, nor did you say how they're able to do that with no funding.

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jmm1837

Convalescent plasma therapy is being trialled in a number of countries.


https://www.ecdc.europa.eu/en/covid-19/latest-evidence/vaccines-and-treatment


Not sure about it as a preventative, but the other trials will certainly assess safety, which is the first issue. Then comes efficacy.

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Izzy Mn(4)

I don't see this as being more than a treatment for someone who has it, last ditch effort. First you have to have a recovered person who is willing and medically able to donate. Matching blood types ( I think they need matching) Also, there has been some data that immunity could last as little as 2 weeks, but they just don't know yet.

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