GIFT OF LIFE: Antibody Research vs The WHO Threatens

A lifesaving quest to harvest the plasma of Covid survivors
On April 1, Rabbi Leib Kelemen, a well-known author and rosh kollel in Jerusalem, sent out a podcast. Imagine, he told his listeners, a scene in which all the negative news coverage of chareidi Jews was suddenly replaced by images of chareidi Covid-19 survivors lining up in multitudes to give potentially life-saving convalescent blood plasma to those still battling the virus. Little did he know that the wheels were already turning that would bring his vision to pass.

If I Find a Donor
The story, which has the makings of a Hollywood thriller and which is far from over, begins with apparent serendipity. On March 29, Covid-19 patient Rabbi Mordechai Swiatycki of Monsey was taken to Westchester Medical Center, where his medical condition declined rapidly and he was placed on a respirator. At one point, the German-born infectious disease specialist overseeing Rabbi Swiatycki’s case, Dr. Bettina Knoll, began reviewing all the possible treatments with his son Abba.

She mentioned a number of possible medications, but also said she wished that she could try using convalescent blood plasma drawn from those who had recovered from the virus. Unfortunately, she said, there were no donors.

Abba asked what would happen if he could find a donor. Even though Dr. Knoll did not initially receive a favorable response from her supervisors to his suggestion, the seed had been planted in Abba Swiatycki’s mind.

On April 4, Abba contacted Rebbetzin Abby Fink of the Young Israel of New Rochelle, whose shul became the center of the first major outbreak of COVID-19 virus in New York State, when a shul member returned from a trip abroad and did not realize that he was infected. Rebbetzin Fink gave him the name of another man, Mordechai Serle of Flatbush, who had been searching for convalescent plasma for his hospitalized father-in-law. She informed Abba that Mordy Serle had found a donor. (Both Serle’s father-in-law, Reb Dovid Shurin, and Abba Swiatycki’s father recovered. The former never received the blood plasma that that a member of the New Rochelle community volunteered to give; the latter eventually received the convalescent plasma, but only after being removed from the ventilator.)

The two fortyish executives — Serle a partner in a law firm and Swiatycki a senior officer in a real estate development company — hit it off, however, and they decided to pool their efforts to see whether they could bring the convalescent plasma to more people in desperate need.

They didn’t have much medical background, but they possessed energy, creativity, a burning drive to get things done. Soon they would be commanding a national effort, to be named the Yitzchak Lebovitz Covid Plasma Initiative, to provide potentially lifesaving plasma to Covid patients.

By Motzaei Shabbos, April 5, the two had created a website covidplasmasavealife.com to register potential donors of convalescent plasma — i.e., all those who tested positive for Covid-19 virus and have been symptom-free for at least 14 days.

The entry of the first names in their data bank came about in a particularly poignant fashion. The family of Reb Meir Greenberg of Monsey were searching for convalescent plasma and had sought donors through one of the popular Orthodox websites for their critically ill father. At 2:00 a.m. in the morning on April 6, Abba Swiatycki received a call from one of the daughters; she sent him the names of all the people who’d offered to donate plasma to her father. Only later did Abba learn that she’d called him only moments after her father’s passing.

When Serle and Swiatycki first put up their website, the only hospital in the New York metropolitan area actively seeking convalescent plasma donors was Mt. Sinai in Manhattan. Playing a leading role in that campaign was a Monsey-based chassidishe importer of shoes, Chaim Lebovits, who has developed a volunteer sideline guiding individual patients with medical problems requiring the highest level of medical expertise. In the course of his activities, Lebovits had developed a close relationship with Dr. Jeffrey Bander, a cardiologist at Mt. Sinai Hospital.

Both Swiatycki and Serle had already been in contact with Lebovits, in the course of their search for convalescent plasma for their loved ones. Now he became the guide for his slightly younger colleagues and connected them with crucial contacts around the country, chief among them Dr. Shmuel Shoham, a native Israeli, now at Johns Hopkins University Medical Center in Baltimore; and Dr. Michael Joyner of the Mayo Clinic in Rochester, Minnesota.

The Angel and the Sword
Those contacts became crucial when the Mayo Clinic was appointed by the Food and Drug Administration (FDA) as the lead research institution for the FDA’s Expanded Access Program (EAP). The Mayo Clinic had already been joined in a voluntary association with over 50 other leading academic institutions, including Johns Hopkins, on research on convalescent plasma.

This is far from the first effort to harness plasma to fight infection. The technique was employed in the 1918 Spanish flu pandemic and again against the H1N1 flu in 2009–2010. Of most direct relevance to the COVID-19 pandemic, it was used to combat two previous coronaviruses: SARS in 2003 and MERS in 2012.

But the FDA’s approval of Early Access Program for convalescent plasma, under the Mayo Clinic’s auspices, had the potential to make the technique much more widespread and accessible. Until then hospitals could only gain permission to use convalescent plasma under a cumbersome procedure on a case-by-case basis, and usually only when the patient was critically ill. And past experience shows that it is more likely to be effective at an earlier stage of illness.

Under the EAP, any hospital that complies with the Mayo Clinic protocols and appoints a senior investigator to oversee the clinical trials is able to use transfusions of convalescent plasma. Nevertheless, in a video issued on April 2, Dr. Joyner predicted no more than a “trickle” of cases using the therapy in the week to come, and pointed out that the logistics involved are extremely complex.

Though Dr. Joyner did not specify the nature of those logistical complexities, they are threefold. The first is securing an adequate supply of donors. The second is finding enough machines to draw the blood plasma. Few hospitals have their own machines, and the 70-minute process of extracting the blood plasma and restoring the donor’s blood, along with the preliminary intake makes for a two-hour process per extraction. Then there is the logistical nightmare of making sure that all the slots on the available machines are taken and do not go unused. Finally, hospitals must be convinced to join the EAP. Like most large bureaucracies, their natural tendency is to continue doing what they have been doing and to avoid rapid changes in procedures.

Dr. Joyner, early on, came to view the chareidi community as a major ally. Because the community was so hard hit by the COVID-19 virus, it constituted a huge reservoir of potential donors. In addition, he knew the community’s ability to mobilize once it identifies a goal. As Chaim Lebovits likes to say of himself, “How did a chassid with lange peyos get to the point where he can reach the top expert in any medical field within half an hour? It’s because my entire education was in Yiddish, and my English is so weak. I never learned the words, ‘I can’t’ or ‘No.’ ”

On Erev Pesach, Chaim was having difficulty convincing a particular hospital to try convalescent plasma on one of his “clients.” After consulting his rav, he arranged a conference call on Yom Tov with the head of the hospital and Dr. Joyner. On another occasion, Dr. Joyner called Lebovits on Erev Shabbos, and told him that he needed eleven donors in Brooklyn, Minnesota before the weekend. Reb Chaim, who wasn’t previously aware of the existence of a Brooklyn in Minnesota, reached out to his connections in the Minneapolis suburb of St. Louis Park. An hour before Shabbos, eleven chassidim showed up at the blood center in Brooklyn Center, Minnesota.

After the successful conclusion of the Yom Tov phone call, Dr. Joyner told Reb Chaim, “I’m named after the archangel Michael, but I need a sword. You [i.e., your community] will be my sword.”

ABSTRACT: Effectiveness of convalescent plasma therapy 

in severe COVID-19 patients

Blood that Heals
Serle, Swiatycki, and Lebovits decided early on to follow a decentralized approach to compiling donor lists. In addition to their website, separate individuals and organizations in Crown Heights, Williamsburg, Monsey, Kiryas Yoel, Lakewood, and northern New Jersey have run their own donor campaigns. Already on April 1, Agudath Israel of America sent out a donor registration request to its membership.

Within two weeks, approximately 5,000 recovered coronavirus victims have signed up, out of an estimated potential donor pool of around 40,000. Each donor provides enough plasma at one session to benefit three patients (though where the patient does not respond to the first transfusion — perhaps because it is low in the necessary antibodies — a second unit is often given). Each donor can provide plasma every seven days.

The existing donors are already sufficient to cover every current slot for donations. The response of the chareidi community must further be put into the context of parallel efforts to enlist secular donors. This week, the ad hoc save-a-life campaign has secured 120 slots at two Delaware blood centers. Prior to Shabbos, the two sites had only two donors lined up. Similarly, a Pennsylvania blood center that services twenty-nine hospitals, with which negotiations have commenced, has only nine units of convalescent plasma on hand, representing at the most three donors.

The next bottleneck to be tackled was the shortage of machines capable of extracting the vital blood plasma containing antibodies to COVID-19. Maimonides Medical Center in Boro Park is one of the few hospitals close to a Jewish population center with the machine necessary to extract blood plasma. But, at present, it has only one such machine, and generally services no more than five donors daily.

Monsey businessman Leizer Sheiner and his Williamsburg counterpart Leizer Kestenbaum — both clients of Mordechai Serle — have been working closely with Maimonides to increase its collection and storage capacity by purchasing more tubing and collection bags, and hopefully, in the not-too-distant future, a second machine to extract convalescent plasma.

The big breakthrough, however, came when the group succeeded in bringing New York Blood Center (NYBC), one of the world’s largest blood centers, with affiliates across the United States, into the convalescent plasma project. NYBC has the capacity to extract hundreds of units of blood plasma daily.

One of the keys to clinching the deal was Mordy Serle’s undertaking to Dr. Beth Shaz, NYBC’s Chief Medical and Scientific Officer, that his group would handle all the paperwork connected to new donors and assist with the scheduling of donors. That work was done by data analyst Adam Kahn and a team of volunteers headed by Pam Sher, and including Henya and Dovi Grossman, Aliza Rubinstein, and Nosson Swiatycki.

Get Them on Board
But no matter how many donors are available and how many plasma extraction machines are humming, there is no benefit unless hospitals are on board with trying the convalescent blood therapy. The trio of askanim took on that responsibility as well.

Mt. Sinai had long been running clinical trials and was eager to partner with the Mayo Clinic from the start. At the initiative of Chaskie Rosenberg of Boro Park Hatzolah, Serle, Lebovits, and Swiaticki spoke by phone with Dr. Patrick Borgen of Maimonides Medical Center, and the hospital moved with great alacrity to join the EAP within two hours. Westchester Medical Center (WMC), which had already some experience using the convalescent plasma with a few individual patients also joined quickly. Dr. Elliot (Ari) Levine, an Orthodox cardiologist at WMC, has since taken a lead in handling inventory and allocation issues between NYBC and the various participating hospitals.

Other hospitals needed a bit more of a push, or at least education in the contours of the Mayo Clinic trials. Memorial Sloan Kettering, for instance, was not aware that the trials were not limited to critically ill patients.

As with compiling the donor lists, the ad hoc group has employed a decentralized approach to enrolling hospitals in the EAP clinical trials. Liba Lederer and Yehudah Kaszirer of the Lakewood Bikur Cholim, for instance, have been negotiating with hospitals in the Philadelphia and central New Jersey area, and other Orthodox groups are working with hospitals in northern New Jersey.

Still, just before Shabbos Chol HaMoed Pesach, Mordy Serle received a call from Dr. Shaz that she had 400 units of convalescent plasma in store and no takers. That Shabbos, Mrs. Serle delivered a baby girl at 11:30 a.m. Less than a quarter-hour after the birth, she told her husband that he had to do something about the missed opportunity represented by those 400 units, and while still in the delivery room, he began work on convening a conference call that afternoon.

When the conference call commenced, it included Dr. Joyner of the Mayo Clinic, Dr. Shoham of John Hopkins, Dr. Benjamin Chen and Dr. Jeffrey Bander of Mt. Sinai, representatives of ten New York metropolitan area hospitals — all of them serving significant Jewish populations — and most of the major Orthodox activists in the save-a-life group. All of the latter were acting under strict rabbinical guidance. The group heard a presentation by Dr. Chen and Dr. Bander on the extremely promising results from Mt. Sinai’s clinical trials to date, which was crucial to convincing some of the hospitals to become more active in using convalescent plasma. Then Dr. Joyner and Dr. Shoham answered all questions about the operation of the EAP. The former was able to allay concerns about any dangers arising from the transfusion of the blood plasma.

“Get the Chassidim”
Just two weeks since the launch of their website, the working group has given a major boost to use of a highly promising therapy for COVID-19 patients, and one that also has the potential to be used as a prophylactic for health care workers, who are the most exposed to the virus. There is still room for substantial expansion of the use of convalescent plasma in the New York metropolitan area. The donor base is already there, as the save-a-life initiative proves.

And the success of the program has created its own momentum, as more organizations seek to join in. The American Red Cross and Vitalent, a non-profit blood center, have announced that they are making available additional machines for the extraction of blood plasma. Meanwhile, the FDA has approved an antibody level test for recovered conronavirus victims, and the Mayo Clinic has committed to producing 1,000 tests a day, with the capacity to increase that to 20,000 if necessary. (These tests are crucial, as at present it is estimated that about five percent of plasma donors do not have high enough levels of antibodies for their plasma to be therapeutic, but until now, there has been no test for antibody levels.)

Not only can the model be expanded, but it can be duplicated around the country, particularly in areas hard hit by the coronavirus to date. Agudath Israel of America has already briefed all its regional directors on the program, and they are eager to work with hospitals in their areas. That has already happened with Sinai Hospital in Baltimore joining the Mayo Clinic protocols.

In addition, the group’s efforts have already had an impact in Israel. Chaim Lebovits relates with relish the discussion in a conference call between himself and Dr. Joyner and Dr. Shoham and a senior Magen David Adom (MDA) official in Israel. The MDA official’s main question concerned, “Where do you find the donors?” Dr. Shoham answered him in fluent Hebrew, “What’s your problem? Do what we did! Get the chassidim. You have plenty of chassidim.” The next day, the MDA official called back to say that they had successfully followed Dr. Shoham’s advice.

Indeed, there have been multiple calls from communal leaders in Israel, where there are fewer regulatory barriers to trying the convalescent blood therapy, for chareidim who have recovered from the COVID-19 virus to donate blood plasma. The Badatz-Eidah Hachareidis issued a proclamation that it is the highest priority for coronavirus surivors to donate blood. Similarly, Rabbi Elimelech Firer, the founder of Ezra L’Marpeh and considered one of the world’s greatest medical experts, appealed for donations of blood plasma and established a special hotline for those seeking to donate.

Public and Private
Not surprisingly, the story of a chareidi initiative at the forefront of research on what could become a game-changing therapy in battle against the coronavirus has attracted widespread media attention from outlets such as the Wall Street Journal, CNN, and Fox News.

But Mordechai Serle, Abba Swiatycki, and Chaim Lebovits — who, incidentally, have still not met one another in person — are focused not on media reviews but on saving more lives.

At all times, they have acted in accord with clear rabbinic guidelines, primarily from Rabbi Yisroel Reisman, a rosh yeshiva in Yeshiva Torah Vodaath and one of Flatbush’s most prominent shul rabbanim. He, in turn, has been in ongoing consultation with Rav Reuven Feinstein, on the one hand, and with leading infectious disease specialists to assess the potential benefit from convalescent plasma, on the other.

During World War II, Rav Dessler proclaimed that when Jews are being slaughtered, there is no more private life. The trio of askanim can attest to the truth of his words. During one conference call, Reb Chaim Lebovits told his colleagues that he had to get off the phone for a quarter of an hour for the levayah of his brother. And then, despite his personal mourning, he got back on the line.

As Easy as Drawing Blood?
As scientists are scrambling for vaccines, drugs, and other treatments against COVID-19, doctors have begun reexamining a century-old treatment for infections: infusion of blood plasma teeming with immune molecules, extracted from recovered donors.

Convalescent plasma therapy — which was used during the 1918 Spanish flu pandemic and against other infections before modern cures came along — harnesses antibodies found in the blood of people who have recovered from an infection (hence the term convalescent therapy), to treat patients who are infected. In this therapy, blood is drawn from a person who has recovered from the disease and the serum is separated and screened for antibodies — proteins produced by the immune system when the body is attacked by a pathogen.

These antibodies continue to float in the recovered person’s blood, primarily in the plasma — the clear, straw-colored liquid part of the blood — for months or even years.

The process for donating plasma is similar to donating blood. Plasma donors are hooked up to a small device that removes plasma while simultaneously returning red blood cells, white blood cells, platelets, and other blood components to the body with a saline solution to replace the withdrawn plasma. While regular blood donation takes less than half an hour, source plasma donation takes between one and three hours. But unlike regular blood donation in which donors have to wait for red blood cells to replenish between donations, which takes up to eight weeks, plasma can be donated in some cases as often as twice a week. (Originally featured in Mishpacha, Issue 807

History of Antibody Plasma Use

• 33 sick Israelis treated with antibodies from recovered COVID-19 patients
• Head of Israel’s blood service is cautiously optimistic of results timesofisrael
• Israel's MDA to treat coronavirus patients with new 'passive vaccine’. This assumes that those who have recovered from COVID-19 have developed special anti-virus proteins or antibodies in their plasma, which could therefore help sick patients cope with the disease. JPost
• SEE ALSO: Before Vaccines, Doctors ‘Borrowed’ Antibodies from Recovered Patients to Save Lives.  Doctors first tried injecting patients with blood plasma in the early 1900s. The method has been used against diphtheria, the 1918 flu pandemic, measles and Ebola.

How does one understand the Miracle of an Antibody Plasma Treatment vs. a COVID-19 ReInfection (of the 30 'ongoing' mutations of this deadly disease)?

Is this why the WHO came out with this veiled threat?

MEANWHILE:  WHO says recovered COVID-19 carriers may not be immune to second infection
arutzsheva: WHO Says No Evidence Shows That Having COVID Prevents A Second Infection “There is no evidence yet that people who have had Covid-19 will not get a second infection,” WHO said in a scientific brief published Friday.  YWN: The UN health agency said in a scientific brief published on Saturday that more research is needed. It said that ‘at this point in the pandemic, there is not enough evidence about the effectiveness of antibody-mediated immunity to guarantee the accuracy of an ‘immunity passport’ or ‘risk-free certificate’.’