JnJ gets CDSCO panel nod for COVID vaccine study in 12-17 year old

New Delhi: In order to achieve the unmet medical need in the treatment of COVID-19, the Subject Expert Committee (SEC) functional under the Central Drug Standard Organization (CDSCO) has granted the American-based pharma major Johnson & Johnson (J&J) permission to conduct a study of its Ad26.COV2.S vaccine in India on children in the 12-17 age group.

However, the approval is subject to several 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 completion of review, the Part II study should  be initiated.

This came after the US-based pharmaceutical giant Johnson and Johnson presented the proposal for Phase II/III clinical study protocol no. VAC31518COV3006, Amendment 1, dated 13 July2021 before the committee.

Earlier, the Medical Dialogues Team had reported that pharma major Johnson & Johnson (J&J) had applied to the Central Drugs Standard Control Organisation (CDSCO) for permission to conduct a vaccine trial of the Covid-19 single shot Janssen vaccine in India on children of 12-17 age group.

Earlier, the Union Health Minister Mansukh Mandaviya had tweeted about the Emergency Use Authorisation being given to Johnson & Johnson.

Mandaviya had tweeted, "India expands its vaccine basket! Johnson and Johnson's single-dose COVID-19 vaccine is given approval for Emergency Use in India. Now India has 5 EUA vaccines. This will further boost our nation's collective fight against COVID19."

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.

Now, in continuation, the SEC committee  at its 178th meeting to examine COVID-19 related proposals under the accelerated approval process, held on 26.08.2021 and 27.08.2021 at CDSCO, thoroughly examined the Johnson and Johnson's proposal for Phase II/III clinical study protocol no. VAC31518COV3006, Amendment 1,dated 13 July2021.

The committee 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. 

After detailed deliberation, the committee recommended the grant of permission to conduct the study with the following conditions:

1) The firm should submit the interim safety and efficacy data from Part I of the study before the Committee (along with IDMC report) and only after its review the Part II study be initiated.

2) The firm should actively monitor the adverse events (AEs) including Multisystem inflammatory syndrome in children (MIS-C), post vaccine dose 1 and 2 for 42 day to 3 months under the primary endpoint.

3) The firm should use only the Indian Council of Medical Research (ICMR) approved kits for rapid serological test for antiSARS-CoV-2 antibody.

4) The firm should enrol a separate cohort of sero-positives in Part II of the study.