As cases of the novel coronavirus continue to mount around the globe, one experimental treatment that has yielded positive results is the use of convalescent plasma. Based on the relatively simple theory that antibodies in the blood of recovered COVID patients could help others fight the virus, several nationwide efforts have been underway for months both to collect large quantities of plasma for delivery to the sick and to test the extent to which plasma can fight the epidemic.
A sea of anecdotal cases testifying to its ability to heal, backed by mounting scientific data, makes plasma an especially promising therapeutic option and possibly even a temporary source of preventive immunity as the future of the virus’ trajectory and hopes for an effective vaccine remain unknown.
A Helping Arm
In the early days of the outbreak in the New York area, stories abounded of struggles to procure plasma units for hospitalized patents, as the valuable commodity remained in short supply.
Through a mix of desperation, organizational skills and community cohesiveness, Orthodox Jewry ended up playing an essential role in bridging this vital gap.
“When corona was still blaring here, we started speaking to hospitals about giving plasma, and they were telling us that it’s not a proven method and that they’re too overwhelmed to have staff administer something on a trial basis; ‘It’s not worth it’,” said Rabbi Yehudah Kaszirer, director of Lev Rochel Bikur Cholim of Lakewood.
A point that emerged from these conversations was that hospitals were giving two units of blood from patients who had recovered from COVID-like symptoms, but had never been tested for antibodies. While only a half unit was technically needed for the treatment to have a good chance of helping a patient, without knowing if the virus-fighting elements were indeed there, the large dose was being given with the hope that enough antibodies would be present somewhere in the mix. The calculation made sense, but it made the process of giving plasma a longer one that required far more blood than hospitals could hope to have on hand.
“We said: We’re going to knock out that process for you so that you’ll have plasma that you know already has antibodies,” said Rabbi Kaszirer.
The idea was initially raised on a conference call with staff at the Mayo Clinic’s Convalescent Plasma Expanded Access Program. Through the involvement of Johns Hopkins physician Dr. Shmuel Shoam, the program’s team had only shortly before been put in contact with another Jewish group that would become the COVID Plasma Initiative, led by Chaim Mayer Lebovics, Abba Swiatycki and Mordechai Serle.
The exceptionally high levels of infection in the Orthodox community in late March and early April meant that it was a population filled with potential donors.
“We had been working with the FDA to get expanded access, but the problem was that in April there was not enough plasma. That was solved quickly by a lot of individuals who donated on their own, but in large part by the Orthodox community, who really stepped up to the plate and with their tight social cohesion were able to mobilize on a mass scale,” said Dr. Michael Joyner, a researcher who leads the Mayo Clinic’s plasma program. “For that we are eternally grateful to them.”
Within hours of the conference call, held shortly after Pesach, a blitz effort was made to get the word out to the Orthodox community that anyone who had recovered from COVID should come to get tested for antibodies as a first step in donating potentially life-saving plasma. Within 24 hours, they had filled 1,000 vials, which Rabbi Kaszirer accompanied on a late-night flight to the Mayo Clinic in Rochester, Minnesota. By noon that day, he was back in Lakewood and shortly thereafter got results from Dr. Joyner’s team.
“We let the people who were eligible know right away and had them on the chair to give plasma the next morning,” said Rabbi Kaszirer. Two days later, Lakewood’s Kimball Hospital got its first units of plasma for patients.
Based on the success of the operation, the Mayo Clinic gave the groups thousands more slots to use for testing on their equipment and dozens more such drives were launched in Orthodox centers around the country.
“The community of medical researchers is also kind of a cohesive tribal world, and we were very grateful that our community and theirs were able to find each other to help in this horrible situation,” said Dr. Joyner. He added that the business acumen of some of the organizers was also a skill that greatly helped advance his program’s goals.
“One of the positives — for lack of a better word — to come out of this is that there’s been cross-pollination between different groups, and the skill set that business minded people brought to this helped them organize and it helped us organize,” he said. “If we were able to accomplish so much with this community under so much pressure, we’d like to see how much more we could do other times when we have time to plan.”
With the strides the project has made, many hospitals across the country are now supplied with ample plasma to help eligible patents. Yet, shortages still have arisen in more recently hard-hit areas like Florida and Texas. As the pandemic has progressed, more hospitals have reached out to those involved in collecting antibody-rich plasma for help in seeing that supply keeps up with demand.
“It’s important for anybody looking at this project to understand that we are not directing this plasma to any specific patients; our mission is to make sure that every hospital we are in touch with has sufficient amounts of plasma to meet the needs they have,” said Rabbi Kaszirer.
Rabbi Kaszirer added that in his advocacy work in the medical world, the wide publicity that the campaign has garnered in the general media has produced a side benefit as well.
“Unfortunately, this has been a time when our community got bullied, for lack of a better term, for a lot of good and bad things that we did. We are never going to be able to explain ourselves or get out of such situations, because it’s a reality of galus, but on the other hand, if we can give something positive back that makes an impression, that in and of itself changes the way some medical professionals look at our patients.”
Stories of the effectiveness of convalescent plasma therapy abound, and with few effective means of treating severe COVID patients, many have pinned a great deal of hope on the method. Rabbi Kaszirer said that shortly after one hospital received its first delivery, a woman in her 90s was admitted with breathing problems and other serious symptoms. She was given a plasma transfusion and was released two days later.
“We’re very optimistic,” said Dr. Joyner. “This isn’t going to wipe [COVID] out, but we’re hopeful that it will buy us some time until additional therapies or a vaccine can be developed.”
More than 28,000 COVID patients in the United States have received plasma infusions, and testing has shown no significant risks.
Harnessing blood of recovered patients to help the sick is hardly a new concept and was used routinely from the late 19th century until around World War II, when the method was largely supplanted by vaccines and more effective medical treatments. It was a tool used to help the sick fight Spanish Flu during the epidemic of 1918-19, yielding mixed results.
Once antibody-containing blood is donated, plasma (the largest single component of blood, which contains red and white cells) can be removed and added to a drug called immune globulin (IG), which allows it to be delivered to patients intravenously.
Several studies of the method’s success in fighting COVID are ongoing, but some of the most recent results have produced data that randomized testing showed that plasma did little to improve the mortality of hospitalized patents. Dr. Joyner said that many of the studies that failed to show benefits had been stopped midway for a variety of reasons, and may be incomplete. He also said that numbers were likely affected by a phenomenon observed by many who have followed the use of plasma in hospitals — that it is highly effective in the earlier stages of disease, but far less so once patients become critical to the point of needing to be admitted to the ICU. This trend fed early disappointments early in the outbreak, when limited plasma supplies were reserved for the sickest patients.
Still, Dr. Joyner cautioned that while he was encouraged by many of the results he has seen, more testing is needed to label plasma transfusions a proven COVID therapy.
“It’s too soon to tell,” he said. “Part of the problem of being a research doctor is that the doctor in you wants to do whatever you think could heal people, but a researcher has to be objective and wait for proof on all sides. You have to learn to keep a foot in both worlds.”
A largely untried use of convalescent plasma, some researchers believe, holds even more hope for fighting the pandemic: delivering small amounts as injections of immunity to vulnerable populations such as the elderly and healthcare workers, and possibly even the general population.
The idea is regarded as safe, technically doable, and highly likely to be effective, with Dr. Anthony Fauci calling it “a very attractive concept.” Yet, the project has totally stalled, with the federal government unwilling to even consider it for approval and no movement from private industry to produce what would be needed to make preventive plasma injections available.
Dr. Michael Oxman, a Professor Emeritus of Medicine and Pathology at the University of California, is one of those championing the cause of creating and delivering plasma-based injections on a mass scale. After a career that has spanned over half a century and led to such developments as the shingles vaccine, he put aside his present projects to promote the concept.
“This pandemic is killing 1,000 people a day in the U.S.,” he said. “There are between four and 10 million people who have recovered from COVID, and many of them are altruistic; this is not an opportunity we can afford to waste.”
Adding that he would be willing to bet “what’s left of my retirement savings or my life” that the method would offer effective protection against contracting COVID, Dr. Oxman said that production of an intramuscular injection can be done quickly and would need a fraction of the amount of plasma that is necessary to fight virus in sick patients. Furthermore, he says that it can be delivered quickly by technicians with minimal training and need not tie up nurses.
Yet, the Biomedical Advanced Research and Development Authority (BARDA), the government’s department responsible for medical countermeasures such as vaccines, has denied his team an interview to even discuss the initiative. Undeterred, the 83-year-old Dr. Oxman is feverishly reaching out to elected officials and influential voices in government and the biomedical industry to promote the idea.
Even with an effective vaccine still likely at least a year away, there are several factors holding up the suggestion from gaining meaningful traction. First among them is a focus on using the existing plasma supply for sick patients in hospitals whose lives are presently at risk — an explanation given by BARDA in response to an inquiry by the Los Angeles Times. Approving the plan would likely put hospitals and blood banks in competition with those delivering the injections over plasma supplies.
Dr. Oxman said the reasoning was insufficient.
“As a physician I understand why treatment has to take priority, but under the circumstances it makes no sense to give it overwhelming priority,” he said.
There are other roadblocks as well. Dr. Fauci’s own endorsement was couched by a statement that use of plasma for preventive immunity should only be considered after its use for treating the sick has been conclusively proven.
Dr. Oxman added that manufacturers are reluctant to invest in producing an intramuscular injection when the intravenous dilutes delivered in hospitals they are focused on are far more profitable.
Even if the plan would be put into action, its effectiveness would likely be limited. As studies increasingly show that the antibodies produced by COVID fade after about three months, the shots could not provide immunity for longer than that, and would not give recipients any level of cellular immunity — which might last longer.
Still, the concept is one that has been used widely in the past to protect against other potentially dangerous illnesses. Dr. Oxman said that he was called on several times to deliver plasma from recovering shingles patients to immunize expectant mothers who had been exposed to chicken pox, a closely related disease.
In the short time frame available to use the shots to curb the pandemic’s spread, it would be close to impossible to provide decisive proof of its effectiveness; yet Dr. Oxman says that its safety, the historical track record of such methods, and the emergency nature of the present moment should override having to clear such a hurdle.
“There are manufacturers in the United States who could produce this very quickly,” he said. “We could get this to a lot of critical people over the next few months; all it would take is an executive order to move some of the plasma we have and to tell businesses to make it.”