Expert panel allows adolescent trials of J&J vaccine with riders

SEC asks J&J to monitor adverse events closely for next three months

The subject expert committee (SEC) advising the Central Drugs Stan­dard Control Orga­nisation (CDSCO) has allowed US pharma major Johnson & Johnson (J&J) to conduct clinical trials on adolescents for its two-dose Covid-19 vaccine, albeit with some conditions.

The firm had on August 17 sought approval from the CDSCO to conduct trials on children aged 12-17 years.

The SEC said after “detailed deliberations”, the committee recommended granting of permission to conduct the proposed study with some conditions — the firm should submit interim safety data from part 1 (28 days after vaccination) of the study before the committee and only after its review, the second part of the study may be initiated.

Moreover, the SEC has asked the company to “closely monitor” the adverse events, including Multi­system inflammatory syndrome in children (MIS-C), post-vaccine dose 1 and 2 for 42 days to 3 months under the primary end-point.

An email sent to the company rema­ined unanswered till the time of going to press.

J&J had started trials globally for a two-dose regimen of its vaccine last year. In April this year, the firm expanded the study to include adolescents in the 12-17 age bracket.

In August, J&J got an emergency use authorisation (EUA) from the Indian drug regulator for its single-shot Covid-19 vaccine. Phase 3 clinical trial (ENSEMBLE trial) had demonstrated that the J&J single-shot vaccine was 85 per cent effective in preventing severe disease across all regions studied, and showed protection against Covid-19-related hospitalisation and death, beginning 28 days after vaccination.

Studies have shown that the J&J vaccine has 66 per cent efficacy against moderate to severe Covid disease, and about 85 per cent efficacy in severe cases.

As for seeking permission to conduct trials on adolescents, J&J had said in August, “Johnson & Johnson is committed to facilitating global equitable access to its Covid-19 vaccine and recognise the unmet needs of children.”

To achieve herd immunity, vaccine trials must be done on children, it had said. “To ultimately achieve herd immunity, it is imperative that Covid-19 vaccine clinical trials continue to move forward, and we remain deeply committed to the critical work needed to make our Covid-19 vaccine equitably accessible for all age groups,” the spokesperson had said.

J&J has an Indian manufacturing partner — Hyder­abad-based Biological E.

Meanwhile, Bharat Biotech has submitted data from its clinical trials on children aged two years and above to the drug regulator this month.

Zydus Cadila has got approval for use among those aged over 12 for its DNA vaccine. Serum Institute of India has started trials on children seven years and above recently for the Novavax vaccine.