Can anything be better than starting the year with a cure to the virus that ravaged the entire world’s previous year? Therefore, in the first week of 2021; the Indian prime minister, Mr Narendra Modi, hailed; “a decisive turning point to strengthen a spirited fight!” on the approval indigenous COVID vaccine.

But the abrupt announcement came as a shock to the most, proposing a question; have India rushed in approving it’s homegrown COVID vaccine? And what is wrong with the India-made vaccine that is raising such a hesitancy amongst the vaccine-expert committees?

India’s indigenous COVID vaccine

On Sunday, 3 January 2021, India’s drug regulator flagged greenlight for the emergency usage of two indigenous vaccines, AstraZeneca Oxford jab and Covaxin; saying “restricted use in an emergency in the public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strains.”

Both the vaccines were manufactured in India, one by the Serum Institute of India and the other by Bharat Biotech. The controversy arose on the government-backed vaccine, Covaxin which is being developed by Bharat Biotech; a vaccine-developer company with more than 24 years of experience in the field; supplying vaccine in 123 countries around the globe.

The AstraZeneca-Oxford vaccine developed by the Serum Institute of India (SII) is out of the uncertainty because it is approved after phase three trial in Brazil and the United Kingdom. The UK became the first country to roll-out this vaccine, in the wake of surging cases of the new strain.

Covaxine is still under the third phase of a clinical trial, making the vaccine risky for dosage. Every vaccine has to go under four phases of a clinical trial; which ensures that the vaccine can provide immunity against the virus and doesn’t indicate any harmful side-effects in the receiver’s body. Though the manufacturing company claims to publish the report of the phase-3 trial by February; but that doesn’t make the vaccine any safe for people getting it before the reports, say experts.

Dr Krishna Ella, Chairman of Bharat Biotech, defends the obligations, saying; in case of a health crisis, India’s laws on clinical trial allows drug usage after it clarifies phase two trial; which Covaxin have. According to him, 24,000 participants are vaccinated for the third phase of the trial, and soon they will have the efficacy data.

Obligations on Covaxin, by Bharat Biotech

India is a major powerhouse of vaccine production, making more than 60% of the world’s vaccine. Bharat Biotech is also a well-known vaccine-maker whose clinical trials are running on about 700,000 participants from 20 countries. The firms have a stockpile of 20 million doses and by the end of the year aims to produce an estimate of 700 million doses.

By the sudden approval of Covaxin, experts, started obligating the decision to be taken in a rush. The drug is accused of ignoring the guidelines of the Central Drugs Standard Control Organisation (CDSCO). All India Drug Action Network, a patient’s right groups said, “it was baffled to understand the scientific logic”. Questions are raised on the vaccine’s efficacy and how the government can start vaccinating without accurate data.

Dr Shahidi Jameel, a renowned virologist, said to BBC, “Since there is no data for the third phase of trials, we don’t know how efficacious this vaccine is. We know it is safe, going by the limited phase two trials. What if we roll out a vaccine with unknown efficacy and later find it to be only 50% efficacious? Would it be fair to people who received it?”

The obligations have also taken political facet with the opposition accusing the ruling elite of the rushed decision on social media:

The Indian Ministry of Health and Family Welfare has planned to vaccinate about one-fourth of the country by August. In the vaccination project, the vaccine developed by SII is expected to play a significant part, whereas Covaxine, for now, will only be used as “backup”; say National Task Force of COVID-19.

Assurance of the indigenous COVID vaccine

Amongst the roaring obligations and uncertainty about the vaccine; Prof Paul Griffin, director of infectious diseases and microbiologist, University of Queensland, says emergency approval of vaccine without complete clinical reports is not unusual. According to him, if the previous trial stages’ data give promising results, then the vaccine can be used under urgent circumstances but in a targeted way.

On the other hand, the administration has declared that the vaccine would only be regulated in “clinical trial mode”. Dr Ella also assured that the manufacturing firm would closely monitor the vaccine recipients after dosage until the clinical trial report is released. He also claims that nothing to worry about, saying “our vaccine is 200% safe”.

The Covaxine is already being ordered in millions of doses from countries worldwide, and many are expecting the first batch of the jab in January; Reuters report. The uncertainty over the vaccine will only end after the third phase trial’s statements come in light.