Use only ICMR approved kits for rapid serological test: CDSCO panel tells JnJ on Ad26.COV2.S study

New Delhi: Reiterating the prior suggestion, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has opined the American-based pharma major Johnson and Johnson (JnJ) to conduct a study of its Ad26.COV2.S vaccine in India on children in the 12-17 age group, subject to specific restrictions.

This came after the firm presented justification for various conditions of clinical trial permission recommended by the committee.

However, after listening to the justifications, the committee has approved the waiving of one condition that states the firm should enroll a separate cohort for sero-positives in Part II of the study.

Johnson and Johnson's Ad26.COV2.S is a lead recombinant vaccine candidate that contains an adenovirus serotype 26 (Ad26) vector expressing a stabilised SARS-CoV-2 spike protein. The vaccine was created in collaboration with Johnson and Johnson (J&J), Janssen Pharmaceutical, and the Beth Israel Deaconess Medical Center.

Earlier, at the 178th SEC meeting to examine COVID-19 related proposals under the accelerated approval process, held on 26.08.2021 and 27.08.2021 at CDSCO, the US-based pharmaceutical giant Johnson & Johnson presented the proposal for Phase II/III clinical study protocol no. VAC31518COV3006, Amendment 1, dated July 13 2021 before the committee.

In response, the committee at that meeting noted that the safety profile from the pre-clinical and clinical trials in adults may justify the conduct of the trial.

Further, analysing the innovations vs. existing therapeutic options, the committee noted that the objective of the study is to evaluate the safety, reactogenicity, and immunogenicity of different dose levels of Ad26.COV2.S administered as a One-or Two-Dose Regimen in healthy adolescents from 12 to 17 years inclusive.

In addition to this, the committee considered the unmet medical need, as to date, there is no approved treatment for COVID-19. The trial drug may be an alternative treatment/prevention option for COVID-19 infection.

Accordingly, after detailed deliberation, at the 178th SEC meeting, the committee approved the study with a few conditions, including that the firm should submit the interim safety and efficacy data from Part I of the study before the Committee (along with the IDMC report) and only after its review, the Part II study be initiated.

In addition, the committee suggested that the firm actively monitor the adverse events (AEs), including Multisystem inflammatory syndrome in children (MIS-C), post vaccine dose 1 and 2 for 42 days to 3 months under the primary endpoint.

Further, the expert panel directed the firm to use only the Indian Council of Medical Research (ICMR) approved kits for rapid serological testing for anti-SARS-CoV-2 antibody.

In addition, the firm was instructed at a previous meeting that a separate cohort of sero-positives should be included in Part II of the trial.

However, in continuation with the above, at the 186th SEC meeting to examine COVID-19 related proposals under the accelerated approval process held on 01.10.2021 at CDSCO, the firm presented justification for various conditions of clinical trial permission recommended by the committee.

After detailed deliberation, the committee reiterated the previous recommendations and recommended for grant of permission to conduct the proposed study with the following conditions:

1) The firm should submit the interim safety data from Part I (28 days-post vaccination) of the study before the Committee and only after its review the Part II study may be initiated.

2) The firm should actively monitor the AEs, including MIS-C, post vaccine dose 1 and 2 for 42 days to 3 months under the primary endpoint.

3) The firm should use only the ICMR approved kits for rapid serological test for anti-SARS-CoV-2 antibody.