SII, Bharat Biotech engage in war of words: A look at controversies surrounding vaccines cleared by DCGI

The year 2021 has begun with an unseemly verbal duel between vaccine makers in India, with the heads of Serum Institute of India and Bharat Biotech making public allegations against each other. On 3 January, SII chief Adar Poonawalla said in an interview to NDTV that only vaccines of Pfizer, Moderna and Oxford-AstraZeneca have proven efficacy, and that other vaccine candidates, including Bharat Biotech’s Covaxin, are “safe, just like water.” (In India, Serum Institute is manufacturing vaccines developed by Oxford-AstraZeneca.) In response, Bharat Biotech chairman Krishna Ella alleged that AstraZeneca was giving paracetamol to volunteers to suppress adverse reactions. This war of words took place after the Drug Controller General of India announced the approval of the Covaxin and Covishield vaccines for restricted use in an emergency situation in a media interaction. DCGI chief VG Somani, however, did not answer questions from the media. Controversies surrounding vaccines Shortly after the DCGI’s announcement, some Congress leaders and activists questioned why Bharat Biotech’s vaccine was approved without it having completed Phase 3 trials.

Interestingly, an official government statement has said that permission has been granted to Bharat Biotech’s Covaxin “for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode…” This would suggest that people who receive the Covaxin shot will be treated as being part of the clinical train. Such a scenario would lead to a number of ethical questions. As noted by an article in The Wire , “If so, will the consent forms specify this? Will there be a control group? What will the data from this trial be used for? Will the rights normally afforded to clinical-trial participants also be afforded to those who consent to receive Covaxin or Covishield?” Further, it is also not clear why the phrase " in public interest as an abundant precaution" is mentioned only for Bharat Biotech and not for Oxford-AstraZeneca. One possibility is, as AIIMS director Randeep Guleria noted , that Bharat Biotech’s vaccine is a “backup for emergency situation, which may happen if there is a sudden surge in cases or reinfection.”

On Monday, Bharat Biotech’s chairman Krishna Ella sought to address some of these concerns in a press conference. “It hurts us as scientists…. we work 24 hours. Do we deserve this bashing?” he told media persons. Ella further said that Bharat Biotech has published details from its trials in five peer-reviewed journals, according to Business Standard. He also claimed that Covaxin has only 15 percent side effects, the lowest among its global peers. Further, taking a dig at Oxford-AstraZeneca’s vaccine, he said, “The Oxford-AstraZeneca vaccine has 60 percent side effects despite them giving 4 grams of paracetamol to their subjects to suppress these side effects. We have not given any paracetamol to our volunteers. We wanted the adverse effects (fever, pain, etc) to be reported and even then our side effects are around 15 percent only.” There have also been other troubling questions surrounding the Oxford-AstraZeneca vaccine, which is being marketed as Covishield in India. In November, a volunteer from Chennai reported neurological problems after receiving the vaccine and sued SII for Rs 5 crore. In response, SII filed a defamation suit against him for Rs 100 crore and claimed that the volunteer’s illness had nothing to do with the trial. Several experts have opined that engaging with the volunteer instead of filing a defamation suit against him would have been a better course of action. AstraZeneca and Oxford faced questions in November about their analysis — which looks at data from a total of 23,000 people in separate trials with differing protocols — after releasing an overview of the results. These centred on the smaller group who were given an initial half dose because of a mistake. The study showed the vaccine had an efficacy of 62 percent for those given two full doses, and of 90 percent in those given a half than a full dose. However, an AFP report quoted Simon Clarke, Associate Professor in Cellular Microbiology at the University of Reading, as saying that the smaller group did not contain any older participants (age 55 or over). “It remains possible that if the regulators allowed the vaccine to be used in this manner, the most at risk group may not be protected,” he noted.