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,