Indian vaccine manufacturer Serum Institute of India and Bharat Biotech failed to receive an emergency use authorisation (EAU) licence for their Covid-19 vaccines from the Drugs Controller General of India on Wednesday with the regulator seeking more data from the two companies on the clinical trials carried out so far.
While Hyderabad-based Bharat Biotech is conducting a three-phase clinical trial -- the third phase involves testing the vaccine's efficacy on 26,000 individuals -- for its indigenous shot, Pune-based Serum Institute has been asked to undertake a phase-2/3 bridging study on 1,600 persons to examine the vaccine's safety and immune responses on Indians since the efficacy of the original vaccine is being tested in multiple trials abroad. SII vaccine is the same as the AstraZeneca-Oxford University one.
Though none of the Indian trials have been completed, the two companies applied for the emergency use authorisation earlier this week after pharmaceutical giant Pfizer made a similar application before the DCGI seeking an EAU licence. Pfizer also sought a waiver from the clinical trial requirements.
While considering the SII application, the regulator asked for updated safety data of phase-2/3 clinical trials in India, immunogenicity data from the clinical trial in the UK and India, along with the outcome of the assessment of the UK regulator –- the Medicines and Healthcare products Regulatory Agency.
As for the Hyderabad-based company, the expert panel formed by the regulator suggested that the firm should present the safety and efficacy data from the ongoing phase-3 clinical trial for further consideration of the EAU application.
None of the EAU applications has been rejected, health ministry sources said. The Pfizer case was not considered as the company sought more time to make its presentation.
As many as nine vaccines are in various stages of clinical evaluation in India at the moment.