The Drugs Controller General of India has given a nod for conducting Phase-1 human clinical trial for an “antisera” that was developed by injecting inactivated SARS-CoV-2 in horses and can be a potential treatment for COVID-19, ICMR officials said on Tuesday.
Indian Council of Medical Research (ICMR) in collaboration with a Hyderabad-based bio-pharmaceutical company has developed ‘antisera’. The pre-print version of the study regarding the development of the equine antisera has been posted on the Research Square platform.
According to a study, 10 healthy horses were immunized with inactivated SARS-CoV-2 and after 21 days of immunization, plasma samples were tested. The results of the plasma samples indicated the presence of SARS-CoV-2 specific IgG antibodies were detected in ELISA with neutralizing capacity.
ICMR Director-General Dr. Balram Bhargava on Tuesday said at a press briefing, “With Biological E Limited we have developed a horse ‘antisera’ and we have just got clearance for conducting clinical trials for that.” But it is yet to undergo human clinical trials to establish safety and efficacy.
Following a cue from it, we have developed horse serum, for which we have got clearance for clinical trial – DG, ICMR pic.twitter.com/Qxqgi3pwCX
— #IndiaFightsCorona (@COVIDNewsByMIB) October 6, 2020
What Exactly Are Antisera?
Antisera are a native serum that contains specific immunoglobulin, which has prophylactic or therapeutic action when administered to people suffering from viral or bacterial diseases. This is prepared by injecting antigens or venoms into healthy animals like horses.
Once injected, the animals produce antibodies which are normally associated with a globulin fraction serum. While a certain degree of antibodies is produced and the blood is taken from the animal and plasma is processed to produce specific antisera.
Antisera Can increase the Immune System
According to ICMR’s earlier tweet, they said that antisera are blood serum high in antibodies against specific antigens and are injected in humans to help kickstart the immune system to fight specific infections.
The ICMR and Biological E Limited, Hyderabad, has developed highly purified antisera (raised in animals) for prophylaxis and treatment of COVID-19.
The study also indicates the evidence of the potential of generating highly purified F (ab’) 2 from equines against SARS-CoV-2 that can demonstrate consistent and high neutralization activity.
Further, in-vivo testing for efficacy was found that this is indigenously developed and is a cost-effective product that will pave the way to clinical evaluation.
Additionally, being a donor independent method, this may prove as an efficient alternative to convalescent plasma for the treatment of COVID-19 patients. Earlier, such measures were used for controlling several viral and bacterial infections.
Experts say Antisera May Be More Effective than Antibodies
Antisera are a serum that contains antibodies. These antibodies are obtained by immunizing animals and are used to provide immunity to specific diseases.
According to ICMR, although, plasma helped patients to recover from experiencing COVID-19 could serve a similar purpose; the profile of antibodies, their efficacy, and concentration keep varying from one patient to another and therefore, makes it an unreliable clinical tool for patient management.
Standardization achievable through equine sera-based treatment modality thus stands out as yet another remarkable public health initiative supported by ICMR in the time of COVID-19.