Gennova dose gets nod, Covovax cleared for 7+
NEW DELHI: The Drugs Controller General of India (DCGI), the country’s drugs regulator, on Tuesday granted emergency use authorisation (EUA) to India’s first indigenously developed MRNA vaccine against Covid-19 manufactured by Pune-based Gennova Biopharmaceuticals.
Also on Tuesday, the drugs regulator granted EUA to Covid-19 vaccine Covovax for use in children aged 7-12 years, according to people familiar with the matter, making it the third dose to be cleared for children under 12 years in India.
Unlike other MRNA vaccines such as the ones developed by Moderna and Pfizer that need to be stored at sub-zero temperatures, Gennova’s vaccine remains stable between 2-8°C. The company had applied for EUA for its vaccine — GEMCOVAC-19 — to the drugs regulator in March this year.
Unlike conventional immunisation models, MRNA vaccines carry molecular instructions inside the host body to make the protein through a synthetic RNA of the virus. The host body then produces the viral protein that is recognised by the immune system, thereby making the body ready to fight against the disease. The advantage that MRNA technology offers against conventional approaches is that it allows for faster development and scale-up of production for vaccines.
Meanwhile, the announcement regarding Covovax comes four days after the central drugs standard control organisation (CDSCO)’S subject expert committee had recommended the vaccine, the second shot manufactured by Pune-based Serum
Institute of India (SII), for emergency use. As on Tuesday, India has approved the use of coronavirus vaccines in children aged 12 and above, although not all of the approved doses are being administered to these age groups. Covovax, developed by Us-based Novavax Inc, is being administered to those aged 14 years and above, Bharat Biotech’s Covaxin is given to those 15 and above, and Biological E’s Corbevax is administered to children in 12-14 age group.
SII sought approval in the form of two separate applications submitted on March 16 and June 1 with trial data of children aged 7-12 years and 2-7 years respectively. In its previous meeting on April 29 this year, the subject expert committee sought more data.
“Children run the risk of bringing home infection... Therefore, it is important to vaccinate them also. As for babies, I would say, there is no immediate need and cannot be priority at the moment,” said Dr Rahul Nagpal, director, department of paediatrics, Fortis Healthcare.