Recommendations of the SEC meeting to examine COVID-19 related proposal under accelerated approval process made in its 169th meeting held on 29.07.2021 at CDSCO, HQ New Delhi:
Agenda File Name & Drug Firm Name Recommendation No Name, Strength New Drug Division 1. M//s Zuventus In light of the earlier recommendation of the Healthcare SEC (COVID) meeting held on 24.06.2021 Limited. the firm presented the interim Analysis report (Clinical Trial-Phase-III) of 105 patients seeking for emergency approval of ND/CT-21/20/23164 Aviptadil Injection before the committee.
Aviptadil Injection The committee noted that clinical trial of the 150 ug/10ml. drug is ongoing in the other countries.
After detailed deliberation, the committee recommended that the firm should complete the clinical trial and present the data as per protocol including the details of all patients who have not been able to complete the trial. 2. CSIR-CDRI The applicant presented the data of Phase III clinical trial before committee. Lucknow The committee observed that results in moderate Covid-19 cases were not statistically significant. However, there are encouraging results in respect of certain end point in mild asymptomatic Covid-19 ND/CT/20/000046 patients. But, the sample size of mild patients was not adequate for considering emergency Umifenovir approval of the drug.
After detailed deliberation, the committee recommended that the applicant should conduct a large Phase III Clinical trial in statistically significant number of mild Covid-19 patients and accordingly, submit the protocol for further consideration by the committee. Biological Division
3. BIO/CT/21/000089 M/s Biological E The firm presented its proposal for grant of Limited permission to conduct Phase II/III clinical Covid-19 vaccine trial of Covid-19 vaccine containing SARS- containing SARS- CoV-2 Receptor Binding Domain of SARS- CoV-2 Receptor CoV-2 in age group of 5 years to 17 years Binding Domain of along with interim safety and immunogenicity data (after dose 1) from the
COVID-19 SEC meeting 29.07.2021 Agenda File Name & Drug Firm Name Recommendation No Name, Strength SARS-CoV-2 ongoing Phase-II/III clinical trial in adults with revised composition .
The committee noted that the vaccine is under Phase II/III clinical trial in age group ≥ 18 years of age and full safety and immunogenicity data is not ready for assessment.
After detailed deliberation, the committee recommended that
1. Safety & immunogenicity data from Phase II part of the Phase II/III clinical trial in adults to be submitted to CDSCO.
2. The clinical trial protocol should be revised as follows:
i. The study design should be revised to be a double blind, placebo controlled non-inferiority study and the non- inferiority margin should be as per WHO guidelines.
ii. The safety data of the first 100 participants in the age group of 12-18 years should be got evaluated by the DSMB and the results submitted to CDSCO before proceeding to phase-III part.
Accordingly, the firm should submit the revised clinical trial protocol along with data for further review by the committee.
4. COVAXIN & M/s Bharat Biotech The firm presented its proposal for grant of Adenoviral Intranasal International Limited, approval for conduct of Phase II/III clinical COVID-19 vaccine Hyderabad trial of COVAXIN & Adenoviral Intranasal (BBV154) COVID-19 vaccine (BBV154) along with the clinical trial protocol.
After detailed deliberation, the committee recommended for grant of permission for conduct of the proposed clinical trial removing the word “Interchangeability” from the study title.
Accordingly, the firm should submit revised
COVID-19 SEC meeting 29.07.2021 Agenda File Name & Drug Firm Name Recommendation No Name, Strength clinical trial protocol to CDSCO for approval.
5. BIO/CT/21/00009 M/s CMC Vellore The firm presented its proposal for grant of approval for conduct of Phase IV clinical trial of Mixing of COVID vaccines study of COVAXIN & COVAXIN & COVISHIELD along with the COVISHIELD clinical trial protocol.
Phase IV clinical trial After detailed deliberation, the committee recommended for grant of permission for conduct of the Phase IV clinical trial.
6. Ad26.CoV2.S viral M/s Johnson & The firm has informed that they are Johnson withdrawing their proposal.
Subsequent New Drug Division
7. SND/CT/21/000044 The firm presented the proposal of Phase- II/III Clinical Trial protocol for Remdesivir Remdesivir powder M/s. Lupin limited Powder for inhalation. for inhalation After detailed deliberation the committee recommended that the firm should conduct Phase-II Clinical trial. Accordingly, the firm should revise CT protocol with respect to study design, sample size, inclusion and exclusion criteria, efficacy endpoint, SOC standardization etc. and submit the same for further consideration by the committee.
COVID-19 SEC meeting 29.07.2021