COVID-19: Concerns About COVAXIN Approval and Other Vaccines Under Development in India

India has granted emergency approval to two vaccines, one is the CoviShield, manufactured by the Serum Institute of India (SII) and the other developed by Bharat Biotech, COVAXIN. Covishield is the vaccine that was originally developed by Oxford and AstraZeneca and COVAXIN is India’s indigenous vaccine candidate.

In a statement, the Union Ministry of Health and Family Welfare was quoted to have said, “The SEC (subject expert committee) has recommended COVAXIN for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strains.”

The SEC was constituted by the Central Drugs Standard Control Organisation and gave the recommendation in favour of COVAXIN on January 2.

However, concerns have been raised about the approval of COVAXIN approval as the interim efficacy data of the phase 3 clinical trials is not known properly. Bharat Biotech has not produced any such data yet.

Commenting on the unavailability of efficacy data and the approval, Satyajit Rath, eminent immunologist associated with IISER Pune, told NewsClick, “The approval granted to the COVAXIN vaccine, in the apparent absence of any protective efficacy data at all, is deeply concerning. It dilutes the regulatory process enormously, and feeds anti-vaccine anxieties. Also, the peculiar wording of this conditional approval has not been explained; neither the reasons for it nor the practical implications have been made clear, adding to the confusion and mess.”

Interestingly, the Indian Council of Medical Research (ICMR) director Balram Bhargava said that COVAXIN will prove better against the new strain that has caused rapid infection in over 50,000 people in UK.

However, responding to ICMR DG’s claims, Rath said, “This claim that the COVAXIN vaccine might be more effective against the so-called 'UK variant' is nonsensical at this point of time. There is no evidence so far at all that this is the case. In fact, there is no evidence as yet that this vaccine protects against even the regular virus strain.”

Also read: COVID-19: People’s Science Network Raises Questions about Vaccine Politics

He added, “The Director-General, ICMR, seems to have said that he 'hopes' or 'thinks' that the COVAXIN 'vaccine' might be more effective against the so-called 'UK variant'. That is neither here nor there; we all hope for all sorts of things. If wishful thinking was to be the basis for regulatory approval, a century of carefully developed drug/vaccine regulatory processes would go out of the window. And since the DG-ICMR is a co-author on the publications reporting the development of this 'vaccine', there is clearly a degree of conflict of interest involved as well, so perhaps we should not pay too much attention to what he hopes about this vaccine candidate.”

Highlighting the rush for approval of the vaccine, Rath said, “The most generous interpretation is that this is driven by the sense that the more vaccines we have available to deploy, the better. This is right, of course, but should not come at the cost of a flagrant disregard for systematic regulatory processes. The less generous interpretation would be that ICMR, as a co-developer of this vaccine candidate, is trying hard to get quick credit. Again, if this is true it plays fast and loose with the integrity of regulatory processes.”

OTHER VACCINE CNDIDATES BEING DEVELOPED IN INDIA

Alongside, there are other vaccine candidates that are being manufactured and are under various stages of clinical trials. Some of these under clinical trials are listed below:

1. ZyCoV-D: This vaccine is being developed by Zydus Cadila on the DNA platform. Cadila is collaborating with the Department of Biotechnology for developing this vaccine. The candidate is going through phase III of clinical trials.

2. Sputnik V: This vaccine, developed by Russia’s Gamaleya Institute, is under phase 2 and 3 trials in India with collaboration with Dr. Reddy’s Laboratories.

3. Biological E Ltd. Vaccine: The Hyderabad-based company is developing a vaccine which is under preliminary stages of clinical trials. Biological E is in collaboration with Baylor College of Medicine in Houston and Dynavax Technology Corporation, an US based company. Their early trial results are expected to come out by February. 

4. NVX-Cov 2373: This candidate is under development by the SII in collaboration with Novavax, another US based company. 

5. HGCO 10: This vaccine is developed by the Pune-based company Gennova Biopharmaceuticals and it is also an mRNA vaccine like the ones developed by Pfizer and Moderna. Reportedly, the phase I clinical trials of this candidate is expected to start from January 2021.

Apart from these, there is another candidate vaccine developed by Aurobindo Pharma Ltd which is yet to reach clinical trial state and there is a second candidate developed by Bharat Biotech in collaboration with Thomas Jefferson University, US, which is also in the pre-clinical stage.

Also read: Pfizer, SII Seek Emergency Use Authorisation for Covid-19 Vaccines; What are India’s Prospects?