The Drugs Controller General of India has given its go-ahead for conducting Phase-1 human clinical trial of 'antisera', a potential treatment COVID-19. ICMR officials revealed on October 6, 2020 that antisera, which was developed by injecting inactivated SARS-CoV-2 in horses and can be a potential treatment for COVID-19.
- The 'antisera' has been developed by the Indian Council of Medical Research (ICMR) in collaboration with a Hyderabad-based bio-pharmaceutical firm- Biological E Limited.
- ICMR Director General Dr. Balram Bhargava said during a press briefing that ICMR has developed a horse antisera with Biological E and they have now got clearance for conducting clinical trials for that.
What is Antisera?
- Antisera are blood serum raised in animals, which is high in antibodies against specific antigens and are injected in humans to help kickstart the immune system to fight specific infections.
- The ICMR along with Hyderabad-based Biological E Limited has jointly developed highly purified equine antisera for prophylaxis and treatment of COVID-19. The study has been posted on the Research Square platform.
- The study provides evidence of the potential of generating highly purified F(ab')2 from equines against SARS-CoV-2 that can demonstrate consistent and high neutralisation activity.
- The in-vivo testing for efficacy of this indigenously developed, the cost-effective product is expected to pave the way for clinical evaluation.
- The product may also prove to be an efficient alternative to convalescent plasma treatment of COVID-19 patients.
- Such measures have been used in the past for controlling several viral and bacterial infections.
- However, 'antisera' is yet to undergo human clinical trials to establish safety and efficacy.
- Ten healthy horses were immunised with inactivated SARS-CoV-2 as a part of the study and after 21 days of immunisation, the plasma samples were tested. The results indicated the presence of SARS-CoV-2 specific IgG antibodies in the plasma samples.
- The ICMR stated in a tweet that although plasma recovered from patients experiencing COVID-19 could serve a similar purpose, the profile of antibodies, their efficacy and concentration keep varying, making it an unreliable clinical tool for patient management.
- The tweet further read that the standardisation 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.