Expert panel of the Central Droge Authority of India on Wednesday recommended that the Serum Institute of India(SII) should not allow children aged two to 17 years to carry out a phase 2/3 test of the Covovax vaccine Covid-19.
On Monday, SII requested a licence to conduct the Covovax trial on 920 children, 460 of them in groups of 12-17 and 2-11, in 10 sites, from the Drug Controller General of India (DCGI).
However, the Central Drugs Standard Control Organization Subject Expert Committee denied the permission to say, Covovax has not been approved in any country. The SII was requested before proceeding with child studies to submit safety/immunogenicity (Covovax) data from the oncoming clinical trial in adults.
Last month, Novavax announced NVX-Phase CoV2373’s III Phase 3 study showed 100% protection from moderate and severe diseases and 90.4% overall efficacy.
If approved, Covovax would have been the third vaccine to be tested on children in the country after Bharat Biotech’s Covaxin and Zydus Cadilla’s ZyCov-D.
Covovax is the third vaccine in this country to be tested on children following Bharat Covaxin Biotech and Zydus Cadilla’s ZyCov-D if approved.
The Pune-based company is committed to the production of NVX-CoV2373 under the Covovax brand name on location by the US biotechnology company Novax.
Covovax’s clinical trials started in India in March and Adar Poonawalla, Chief Executive Officer of SII, had previously stated that the vaccine would start in India for adults by September.
“Excited to witness the first batch of Covovax (developed by @Novavax) being manufactured this week at our facility in Pune. The vaccine has great potential to protect our future generations below the age of 18. Trials are ongoing. Well done team @seruminstindia!” he later said in a post on Twitter.
So far, four vaccines – Bharat Biotech’s Covaxin, the SII’s Covishield, Russia’s Sputnik V and the one manufactured by Moderna (sold unde the brand name ‘Spikevax’ int he US) – have been cleared by the Indian government.
In January, the SII began distributing the Covishield vaccine throughout the country. To manufacture the vaccine, it had formed a partnership with the University of Oxford and AstraZeneca.
