Covaxin's data for children will be available after the Phase 2/3 trials are completed in September, according to Delhi AIIMS chief Dr. Randeep Guleria, and approval is expected in the same month.
New Delhi: According to Delhi AIIMS Chief Dr. Randeep Guleria, Covaxin, India's first indigenous COVID-19 vaccine will be available for children by September.
"Covaxin's data for children after completion of the Phase 2/3 trials will be available by September, and the approval is expected in the same month," Guleria said in an interview with a leading news agency.
Furthermore, he stated that if Pfizer-vaccine BioNTech's is approved in India, it could be one of the options available to children.
On Screening Children
On June 7th, the Delhi AIIMS began vaccine clinical trials on children aged 2 to 17. Bharat Biotech was granted permission by the Drugs Controller General of India (DCGI) on May 12th to begin phase 2-3 trials of Covaxin on children as young as two years old.
Meanwhile, Guleria previously warned that the third wave of COVID-19 could hit India in the next six to eight weeks if crowds are not controlled and rules are not followed.
"If Covid-appropriate behavior is not followed, the third wave can happen in six to eight weeks. We need to work aggressively to prevent another large wave till vaccination kicks in," he told a leading news agency.
The Subject Expert Committee (SEC) accepted and approved the phase 3 trial data of Covaxin, which showed 77.8% efficacy, on Tuesday (June 22), according to a leading news agency. This data will now be reviewed by the DCGI.
Guleria also stated that policymakers must now consider how to open schools in such a way that institutes do not become super-spreader events. "A holistic approach has to be taken," he said when asked about opening schools.
Calling children to school on alternate days and ensuring Covid-appropriate behavior would help in non-containment zones, he said.
"Open-air schooling would be a good way to avoid infection spread through India's climate may not permit it," he added.
What Sero Surveys Say
Despite the fact that sero surveys have shown that children produce antibodies, Dr. Guleria says he has no reason to believe that children will be the ones who suffer the most.
"When children also come for trials, we see anti-bodies in them," he said, that children in the country had been exposed to the infection and, despite not having been vaccinated, would have gained some natural protection.
Children have a high level of seropositivity, according to a study conducted by AIIMS (New Delhi) and the WHO. According to the preliminary findings of this study, the third wave of Covid infections may not affect children any more than the previous two waves.