Lagatar24 Desk
Pune, Sept.28: The Novavax Covid-19 vaccine will now be tested on children aged seven to eleven years by the Serum Institute of India (SII). Earlier this year, the business began testing on children aged 12 to 17. India’s medicines authority approved the vaccine maker’s request to expand the experiment to include children aged seven to eleven years old on Tuesday.
Candidates aged seven and up were allowed to enroll by the Subject Expert Committee (SEC), which advises the Central Drugs Standard Control Organisation (CDSCO). The expert group recommended in July that SII should be granted permission to conduct phase 2 and 3 trials of Covovax, the Novavax candidate.
The trials will be undertaken on children aged two to seventeen, with clearances for different age groups coming in later stages. The trials would involve approximately 920 youngsters of various ages. The next stage of the studies would focus on youngsters aged two and up. The blinded, randomised, placebo-controlled research will evaluate the Novavax candidate’s immunogenicity, tolerability, and safety in a paediatric group.
The Novavax contender, Covovax, is believed to have a 90% effectiveness rate, however, it has yet to be licenced for use anywhere.
SII’s CEO, Adar Poonawalla, announced a few days ago that the company has begun paediatrics studies, with a minimum timeline of three to four months. Covovax (the SII-manufactured Novavax vaccine) could be approved for use in children as early as January or February.
In India, Zydus Cadila’s DNA Covid-19 vaccine has been approved for emergency use so far, for children aged 12 and over.