Expert panel says no to Covovax's children trials in India
What's the story
A Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) has denied permission to Pune-based Serum Institute of India (SII) for conducting clinical trials of its second COVID-19 vaccine, Covovax, in children.
The panel rejected SII's request for allowing Phase 2/3 trials of Covovax—its version of American biotechnology company Novavax's COVID-19 vaccine candidate—among those aged two to 17 years.
Details
Novavax's vaccine has not been approved in any country: SEC
A government official familiar with the development said the SEC felt "more data needs to be examined on the vaccine's safety results in adults before it is allowed to be tested in children."
The expert panel also noted that Novavax's vaccine candidate "has not been approved in any country." In fact, it didn't receive regulatory approval even in its home country, the US.
License agreement
NVX-CoV2373 is a protein-based vaccine locally being manufactured by SII
To note, Novavax's vaccine candidate, NVX-CoV2373, is a protein-based COVID-19 vaccine that is locally being manufactured by the Serum Institute in India.
The American biotechnology company, in August 2020, announced a license agreement with the Pune-based vaccine maker for the development and commercialization of its vaccine candidate in low and middle-income countries, including India. The SII reportedly began the production of Covovax last week.
SII's application
SII sought DCGI's approval for trials in children
The SII reportedly submitted its application seeking permission for Phase 2/3 trials of Covovax in children aged two to 17 years to the Drugs Controller General of India (DCGI), which heads the CDSCO, on Monday.
The company proposed to conduct the trials on 920 children—460 subjects each in the 2-11 and 12-17 years age groups—at 10 trial sites across the country.
SII's plans
Covovax likely to be launched in India by September
To recall, SII CEO Adar Poonawalla, in March, informed that clinical trials of Covovax have commenced in India and later said it could be launched by September.
The vaccine manufacturer even hoped to begin trials in children by July but has now been denied permission for the same by the expert panel.
Notably, SII is also locally manufacturing Covishield—India's version of Oxford-AstraZeneca's COVID-19 vaccine.
Vaccines for children
COVAXIN, ZyCoV-D clinical trials for children underway
Once approved by the SEC on COVID-19, Covovax would become the third vaccine against the novel coronavirus to be tested among children in India after Hyderabad-based Bharat Biotech's COVAXIN and Ahmedabad-headquartered Zydus Cadila's ZyCoV-D.
Bharat Biotech got DCGI's permission for COVAXIN trials in children aged two to 18 years on May 11. Zydus Cadila is also testing ZyCoV-D in the 12-18 years age group.