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SEC recommends J&J to conduct clinical study on its Covid-19 vaccine subject to conditions

Gireesh Babu, New Delhi
Saturday, October 9, 2021, 08:00 Hrs  [IST]

The Subject Expert Committee (SEC) of Central Drugs Standard Control Organisation (CDSCO) has recommended grant of permission to Johnson & Johnson to conduct clinical trials on its Covid-19 vaccine candidate Ad26, subject to certain conditions.

A meeting of the SEC held on October 1, said that the company presented justification on various conditions of clinical trial permissions recommended by the Committee, in the light of an earlier meeting held in August.

After detailed deliberation, the committee reiterated the previous recommendations, which recommended grant of permission to conduct the proposed study with certain conditions.

The conditions include that 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.

The firm should actively monitor the adverse events including MIS-C (multi-system inflammatory syndrome), post vaccine dose one and two for 42 days to three months under the primary endpoint.

The firm should use only the ICMR approved kits for rapid serological tests for anti-SARS-CoV-2 antibodies, it added.

The company, on July 13, 2021, presented the proposal for phase II/III clinical study protocol with amendment, before the SEC. The Committee, in a meeting held on August 26 and 27, recommended 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 should be initiated.

It has also recommended that the company should enroll a separate cohort for sero-positives in Part II of the study.

The objective of the study is to evaluate the safety, reactogenicity, and immunogenicity of different dose levels of the drug candidate. Administered as a one- or two dose regimen in healthy adolescents from 12 to 17 years inclusive.

The vaccine was approved by the CDSCO for restricted use in emergency situations in India on August 7, which enabled Johnson & Johnson to import the single dose drug for use in populations over 18 years.

Biological E Limited also received approval from the drug regulator on August 18, to manufacture the vaccine in India, as per an agreement between Johnson & Johnson and the company.

WHO, which has added the vaccine to the list of safe and effective emergency tools against Covid-19 in March, this year, said that 28 days after inoculation Janssen Ad26.CoV2.S was found to have an efficacy of 85.4% against severe disease and 93.1 % against hospitalization. A single dose of Janssen Ad26.COV2.S was found in clinical trials to have an efficacy of 66.9% against symptomatic moderate and severe SARS-CoV-2 infection.

 

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