Serum Institute Receives Approval To Launch Covovax Trials On Children Aged 7-11

The Serum Institute of India (SII) this week has received permission to conduct phase 2 and 3 clinical trials of Covovax among children aged 7 to 11 years. It is the Indian version of the Covid-19 jab developed by the American biotechnology firm Novavax.

After Bharat Biotech's Covaxin and Zydus Cadila's ZyCoV-D, Covovax becomes the third Covid-19 vaccine to be tested in children in the country.

According to Hindustan Times, an unnamed source revealed that “Covovax has received the approval and the company [SII] can go ahead and recruit volunteers as per the set protocol”. As per another report by Business Standard, the news was confirmed by industry insiders.

Candidates aged seven and above were allowed to enrol by the Subject Expert Committee (SEC), which advises the Central Drugs Standard Control Organisation (CDSCO).

In March 2021, India's medicines authority gave the Puna-based vaccine manufacturers authorisation to test the vaccine on adults. SII was granted permission to conduct clinical studies in the 12 to 17 age group by the SEC in July and the trials are still going on.

The expert panel of the Central Drugs Standard Control Organization said: "After detailed deliberation, the committee recommended for allowing enrolment of subjects of 7 to 11 years of age group as per the protocol."

The trials would involve approximately 920 youngsters of various ages, while the next stage of the trials would focus on youngsters aged two and up.

The blinded, randomised, placebo-controlled study will evaluate the Novavax candidate's immunogenicity, tolerability and safety in a paediatric group.

However, Indian health officials have yet to approve the Covovax vaccine, which claimed to have a 90 per cent efficacy rate.

A few days ago, SII's CEO, Adar Poonawalla, announced that the Covishield makers had begun paediatrics trials, with three to four months being the minimal period.

However, according to reports, the SII-manufactured Novavax vaccine Covovax could be available for approval for use in children as early as January or February 2022.

As of now, in India, only Ahmedabad-based Zydus Cadila's DNA Covid-19 vaccine has received the green light for emergency use in adults and children aged 12 and above.

Meanwhile, the Covaxin makers, Hyderabad based Bharat Biotech, has completed the trial on children and now it is analysing data before presenting it to the Indian regulators. The trials have been conducted on children above the age of two.

Covaxin is safe for usage among infants, according to Bharat Biotech CMD Krishna Ella, while Zydus Cadila is yet to launch its vaccine.

As schools reopen across the country, India will need to vaccinate youngsters eventually. Currently, only people aged 18 and above are eligible for vaccinations as part of the national immunisation drive.