Serum Institute may start Covid-19 vaccine trials on kids in August

Pune-based Serum Institute of India (SII) is set to start paediatric clinical trials of US firm Novavax’s Covid-19 vaccine candidate this month, said sources in the know. Two Indian vaccine makers — Bharat Biotech (Covaxin) and Zydus Cadila (ZyCoV-D) — have already started trials on children.

Covovax, the Novavax candidate, is said to have close to 90 per cent efficacy, but is yet to be approved for use anywhere. This comes after an expert panel advising the Central Drugs Standard Control Organization recommended granting permission to SII for conducting phase 2 and 3 trials of Covovax in July.

SII will conduct trials on those aged between two to 17 years.

The trials would roughly cover 920 children divided in two groups — 2 to 11 years and 12 to 17 years — across 10 sites in India. The blinded, randomised, placebo-controlled study is aimed at testing the immunogenicity, tolerability and safety of the Novavax candidate on a paediatric cohort. “The trials will start in August,” said a source close to the development.

SII did not comment on the matter. But the Pune-based vaccine maker has already started production of Covovax vaccines.

Children’s shot at a vaccine

• Trials to be conducted on 920 children across 10 sites in India
• They will be divided into two groups — 2 to 11 years and 12 to 17 years
• SEC turned down SII proposal in June to start children trials
• In July it agreed to allow inclusion of a paediatric cohort
• SII said adult trials in India and worldwide have sufficient safety data