The Drug Controller General of India (DCGI) the head department of the Central Drugs Standard Control Organization (CDSO) on Sunday approved Covishield by Oxford University – Astrazeneca – Serum Institute of India and Covaxin developed by Bharat Biotech – Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV) against Covid-19 for restricted emergency use. The approval of Covaxin, which has not yet completed the third phase of the trial, has come into criticism within India. “Bharat Biotech received DCGI approval for Phase 3 clinical trials in 26,000 participants in over 25 centres across India,” writes Bharat Biotech on its website.
Covaxin is an inactivated vaccine, which means it is developed by inactivating or killing the Disease-causing microorganism. The pathogen is unable to replicate but the immune system remains intact.
Opposition members and experts have raised the questions over the approval of Bharat Biotech Covaxin without data from phase 3 trials. Even the publication of phase II trial data is still undergoing the peer review process. To make matters worse concerned officials have released incomprehensible statements. Dr Randeep Guleria, All India Institute of Medical Sciences (AIIMS) Director claimed “In an emergency situation when there is a sudden increase in cases & we need to vaccinate, Bharat Biotech vaccine will be used. It can also be used as a backup when we’re not sure how efficacious the Serum Institute vaccine is going to be.” “Vaccines are 110 % safe. Some side effects like mild fever, pain & allergy are common for every vaccine. It (that people may get impotent) is absolute rubbish,” said VG Somani, DCGI.
The government has responded with the usual individual attacks on the opposition members, hiding behind technicalities and terming it strategic and of national interest. Among the sea of explanations, only one weak yet difficult to understand defence stood out by Union health minister Harsh Vardhan. “For those spreading rumours let it be known that EUA for COVAXIN is differently conditional – in clinical trial mode. EUA for COVAXIN is different from COVISHIELD because its use will be in clinical trial mode. All COVAXIN recipients to be tracked, monitored as if they’re in trial. COVAXIN approval is ‘Monitored Approval’ with strict follow-up & rolling review This approval ensures India has an additional vaccine shield in its arsenal especially against potential mutant strains in a dynamic pandemic situation – A strategic decision for our vaccine security,” he tweeted.
The claim of Phase 3 clinical trials with 26,000 participants is also a suspect. As per Bharat Biotech press release on 22 December 2020, “Bharat Biotech has announced successful recruitment of 13,000 volunteers and continued progress towards achieving the goal of 26,000 participants for Phase-3 clinical trial of COVAXIN across multiple sites in India.”
Irrespective of Modi Government’s propaganda needs for claiming Indian prowess in the development of COVID-19 vaccine, Bharat Biotech is reputed company holding more than 140 global patents, product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 116 countries and WHO Pre-qualifications. The company has built a world-class vaccine & bio-therapeutics products, research & product development infrastructure, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution. It has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika and the world’s first tetanus-toxoid conjugated vaccine for Typhoid. It is also the largest Rabies vaccine producer in the world after the acquisition of Chiron Behring (CHIRORAB) in 2019.