Bharat Biotech’s Covaxin will only be used as backup till the completion of its phase 3 clinical trials: AIIMS Director

The development comes a day after the Drug Controller General of India (DGCI) gave emergency use approval to two Coronavirus vaccines- Oxford University-AstraZeneca’s vaccine manufactured by the Serum Institute and indigenous vaccine developed by the Hyderabad based Bharat Biotech. The cautious approach taken by the health authorities has been adopted in the wake of the absence of efficacy data from the third phase clinical trials of the vaccine. Moreover, the decision to approve the use of the Covishield vaccine has been taken on the basis of its immunogenicity(capability to generate immunity against virus) which was reported during the phase 1 and phase 2 clinical trials of the vaccine.

AIIMS Director Dr Randeep Guleria told the Indian Express that the Covaxin is like a back-up vaccine which will be used if there is a sharp increase in the number of cases and health authorities as of now would stick to the use of Covishield only. However, he added that once the clinical phase 3 data of Covaxin is out by next month, the indigenous vaccine might also be given the same approval for its widespread use among the population. Emphasising on the fact that the emergency use approval given to Bharat Biotech’s vaccine is different from that granted to Covishield, Dr Guleria said that the approval has been given to the company to stockpile the vaccine in case of its urgent need. He further said that in case the spike in the number of cases reported due to the new strain of Coronavirus turns out to be alarming then the health authorities would resort to using both the vaccines in order to stop the spread of the virus.

Dr Guleria further said that the approval granted to Covaxin was on the lines of approval granted to drugs like hydroxychloroquine and remdesvir for the treatment of Coronavirus. He added that subject to the condition that the vaccine is safe the health authorities would be able to use the vaccine without knowing the actual efficacy of the vaccine. The actual efficacy of the vaccine would only be ascertained after the phase 3 clinical trials have got completed.

Head of the ICMR Dr Balram Bhargava who worked in close collaboration with the Bharat Biotech told the Indian Express that no safety concerns have been reported in more than 22,500 participants who were administered the indigenous vaccine. He also said that the vaccine had also shown immunogenicity in the volunteers and none of the participants of phase 1 and phase 2 clinical trials had contracted the virus. Dr Bhargava further said that the indigenous vaccine which targets the whole virus instead of just its spike protein may turn out to be more beneficial in countering the new mutations in Coronavirus. However, both Dr Guleria and Dr Bhargava agreed that the picture would be clearer only after the final phase clinical data of Covaxin has been released by the next month.