Hadassah Medical Center in partnership with the Israeli biotechnology company Kamada Ltd. in Jerusalem, Israel treated its first COVID-19 patient with what it described as a “passive vaccine.”1 Reportedly, a young female suffering from several underlying medical conditions, who had been hospitalized for several weeks and intubated, was passively vaccinated by injecting antibodies from a person who had recovered from COVID-19.2
What Is a “Passive Vaccine”?
According to The Jerusalem Post, passive vaccination is also known as immunoglobulin therapy or transfusion of convalescent plasma. For example, tetanus immune globulin is used to prevent tetanus infection (also known as lockjaw), which gives passive protection that lasts long enough until the patient’s body can produce its own antibodies against tetanus.3
Active vaccination to prevent a viral infection occurs when a person is injected with a live, attenuated or inactivated virus, which manipulates the immune system into thinking the patient has had the infectious disease and vaccine strain antibodies and artificial immunity are produced.4
First Hospital in the World to Administer Immunoglobulin G
At the beginning of the COVID-19 pandemic, Hadassah Medical Center began collecting plasma rich with antibodies from coronavirus patients who had recovered from the infection with the goal of producing a treatment for severely ill COVID-19 patients.5 The plasma collected from the recovered patients was processed by Kamada, Ltd. to produce an IgG-based antibody treatment for coronavirus patients in severe conditions.6
The first dose of the “passive vaccine” was provided to a young woman with a pre-existing medical condition whose computerized tomography (CT) scan showed white lungs, an indication that she was critically ill with the infection. All of the known treatments for coronavirus, including the use of an extracorporeal membrane oxygenation (ECMO) machine, had not improved her condition.7
Several hours after she received the immunoglobulin, it was observed that the patient’s condition stabilized, leading physicians to become cautiously optimistic.8
Kamada Announces Compassionate Use for Its IgG Therapy for COVID-19
In June 2020, Kamada completed manufacturing its first batch of a plasma-derived IgG product for COVID-19 utilizing the company’s proprietary IgG platform technology. Additional production is ongoing and the first vials are now available for compassionate use in Israel.9 Compassionate drug use is the use of a new, unapproved drug to treat a seriously ill patient when no other treatments are available.10
Kamada To Expand Its IgG Therapy to the United States
In order to expand its clinical development program to the U.S., Kamada, with the support of Kedrion Biopharma based in New Jersey, intends to conduct a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) in order to obtain FDA’s approval of the proposed clinical development program.11
Kedrion is currently collecting COVID-19 convalescent plasma from U.S. recovered patients that will be used by Kamada to manufacture additional vials of the product. Kedrion is collecting the plasma through its plasma business unit, KEDPLASMA, at 23 FDA approved centers across the U.S.12
1 Jaffe-Hoffman M. Hadassah treats COVID-19 patient with new concentrated passive vaccine. The Jerusalem Post June 24, 2020.
3 Mayo Clinic. Tetanus Immune Globulin. Feb. 1, 2020.
5 Stern A. Hadassah Hospital First in World to Test Passive Coronavirus Vaccine. Hamodia June 24, 2020.
9 Globe Newswire. Kamada Announces Availability of its Plasma-Derived Hyperimmune IgG Therapy for Coronavirus Disease (COVID-19) for Compassionate Use Treatment in Israel. BioSpace June 17, 2020.
10 U.S. Food and Drug Administration. Expanded Access. Apr. 27, 2020.
11 See Footnote 8.