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SEC recommends permission to SII & Cadila Healthcare to conduct further studies on Covid-19 vaccines

Gireesh Babu, New Delhi
Wednesday, September 29, 2021, 08:00 Hrs  [IST]

The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has recommended allowing Serum Institute of India (SII) to initiate procedures to conduct clinical trials on its second Covid-19 vaccine in the country, among children in the age group of seven to 11. The Committee also granted permission to Cadila Healthcare to conduct the phase III clinical trial for the two dose schedule of its Covid-19 vaccine.

In a meeting held on September 23, the SEC said that SII presented the safety data of initial 100 participants of 12-17 years of age with seven days follow-up after first dose of SARS-CoV-2 rS protein nanoparticle vaccine with Matrix-M1 adjuvant along with the DSMB recommendations before the committee.

The protein nanoparticle vaccine has been developed by US-based pharmaceutical Novavax, named as Covovax, and is being developed in partnership with SII. The company has been expecting to launch the vaccine for adults in India by September, according to earlier reports. The partners have also submitted application with the World Health Organisation (WHO) for emergency use listing (EUL), earlier this month.

The grant of EUL by the WHO is a prerequisite for exports to numerous countries participating in the Covax programme, which was established to allocate and distribute vaccines equitably to participating countries and economies. Novavax has recently entered into a deal with the GAVI, the vaccine alliance, to provide vaccines to Covax programme, of which majority is to be made by Serum Institute.

In addition to the submission for WHO EUL, SII and Novavax has recently completed the submission of modules required by regulatory agencies in India, Indonesia and the Philippines for the initiation of review of the vaccine, including preclinical, clinical, and chemistry, manufacturing and controls (CMC) data.

The Vaccine candidate NVX-CoV2373 has demonstrated overall efficacy of 89.7 per cent according to the trials conducted by the company. The vaccine candidate is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes Covid-19 disease.

“After detailed deliberation, the committee recommended for allowing enrolment of subjects of 7 to 11 years of age group as per the protocol and the firm should submit the safety data of the first 100 participants before proceeding to further participants of lower age group,” said the SEC during the meeting held on September 23.

It may be noted that at present, out of the six vaccines approved by the Drug Controller General (India) in the country against Covid-19 pandemic, only Cadila Healthcare’s ZyCoV-D is the only jab that has been approved for use in children over 12 years old.

Meanwhile, Cadila Healthcare has submitted a revised clinical trial protocol for conduct of Phase II clinical trial of its recombinant vaccine 3 mg in two dose schedule, as per the recommendation of the SEC.

After detailed deliberation, the committee recommended grant of permission to conduct the phase III clinical trial subject to condition that volume of blood to be withdrawn in the paediatric cohort shall be as per National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, issued by ICMR.

The SEC has earlier approved the restricted use of the three dose regimen of ZyCoV-D is (on day 0, day 28 and day 56) in emergency situation in the age group of 12 years and above subject to condition that the firm should conduct phase 1/II and phase III clinical trials as per the protocol and submit the data for review by the Committee. It has also been conducting studies for 3mg (two dose regimen with day 0 and day 28).


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