SII gets SEC approval for phase 3 clinical trial of Covovax as booster dose
Premium- SII put an application before DCGI seeking approval to conduct phase 3 clinical trials in India for Covovax
NEW DELHI: An expert committee of Drugs Controller General of India (DCGI) has granted permission to Serum Institute of India (SII)’s Covovax for conducting phase 3 clinical trials in India for the booster dose against covid-19 , according to people aware of the development.
Covovax is a SARS-CoV-2 RS protein (covid-19) recombinant spike Nanaoparticle Vaccine to fight against covid-19.
SII did not immediate reply to the query sent by Mint till the time of publishing this story.
Pune based pharmaceutical firm had put an application before DCGI seeking approval to conduct phase 3 clinical trials in India for Covovax as booster dose in adults who have been vaccinated either with Covishield or Covaxin. Prior to this, the country’s top drug regulator had given his nod for Covovax for restricted emergency use in adult population.
This comes in the backdrop of the Subject Expert Committee of Central Drugs Control Standard Organization (CDCSO) on Friday recommending Serum Institute of India Ltd’s covid-19 vaccine Covovax for emergency use authorization (EUA) for 12-17 year old, as reported by Mint earlier. The recommendation is yet to be approved by the DGCI. At present, only Bharat Biotech’s Covaxin is used to immunize teenagers between 15 and 18.
SII has been developing Covovax through a technology transfer protocol from Novavax, thats already been approved by the European medicines Agency for conditional marketing authorisation.
In December last year, the World Health Organization issued an emergency use listing to SII's version of US firm Novavax Inc's covid-19 vaccine, paving the way for the two companies to ship their doses for the COVAX program.
The Subject Expert Committee (SEC) of India’s drug controller has also recommended allowing Dr Reddy’s Laboratories to conduct phase 3 trials of Sputnik Light vaccine for covid-19 as a booster dose, as reported by Mint earlier. In September 2020, Hyderabad-based Dr Reddy’s Laboratories partnered Russian Direct Investment Fund (RDIF) for conducting clinical trials for Sputnik’s vaccine and for its distribution rights in India in the wake of covid-19 pandemic. Sputnik vaccines are being developed at Russia’s Gamaleya National Research Institute of Epidemiology and Microbiology and are based on the human adenoviral vector platform.
Last month, the apex drug regulator had also granted emergency use authorisation permission to Dr Reddy’s single-shot Sputnik Light vaccine in India under some regulatory provisions.
According to the Ministry of Health & Family Welfare, vaccination is the key tool to protect the most vulnerable population groups in the country from covid-19.
As on 6 March, India’s cumulative covid-19 vaccination coverage exceeds more than 178.83 crore. In the last 24 hours, over 26.19 lakh vaccine doses have been administered to the people across the country while 5,476 new covid cases have been reported.
With the third wave of covid-19 witnessing less severity of illnesses and lower number of deaths, the union government last week said it is “rational" to reopen schools, colleges, and other routine activities. At least 92% of deaths have occurred in unvaccinated individuals during the third wave of covid-19 in 2022 in India.
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