Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:
(a) the parameters considered to approve the use of the vaccines - Covishield and Covaxin;
(b) whether the Government has taken any measures to publish the test results of Covishield and Covaxin from Phase II and Phase III trials;
(c) if so, the details thereof and the action taken thereon?
ANSWER
THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND
FAMILY WELFARE
(SHRI ASHWINI KUMAR CHOUBEY)
(a): Central Drugs Standards Control Organization (CDSCO) has granted permission to manufacture both Covishield and Covaxin as per New Drugs and Clinical Trials Rules, 2019 (ND & CT Rules 2019) under Drugs and Cosmetics Act, 1940.
Covaxin vaccine is being manufactured by M/s Bharat Biotech International Limited. The firm had submitted interim safety and immunogenicity data of Phase I and II clinical trials carried out in the country along with safety data including Serious Adverse Event (SAE) data of the ongoing Phase III clinical trial in the country. The data was reviewed by Central Drugs Standard Control Organisation (CDSCO) in consultation with Subject Expert Committee (SEC) comprising domain knowledge experts. The committee noted that this vaccine is Inactivated Whole Virion Corona Virus Vaccine having potential to target mutated corona virus strains. The data demonstrated a strong immune response (both antibody as well as T cell) and in-vitro viral neutralization. The ongoing clinical trial is a large trial on 25800 Indian subjects in which all 25800 subjects have already been enrolled. Moreover, the firm presented the safety and efficacy data from Non-human primate challenge study also to CDSCO, where the vaccine has been found to be safe and effective.
After detailed deliberations, the SEC recommended grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains.
Based on the recommendations of SEC, CDSCO has granted permission to M/s Bharat Biotech International Limited, Hyderabad to manufacture Covaxin vaccine for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode with various conditions/restrictions.
M/s Serum Institute of India Pvt., Ltd. Pune has submitted safety immunogenicity & efficacy data of phase II/III clinical trials of AstraZeneca vaccine carried out in UK, Brazil and South Africa along with the safety & immunogenicity data from the ongoing Phase II/III clinical trial in the country. The Subject Expert Committee (SEC) of CDSCO reviewed the proposal of restricted emergency use along with above details and the data received. The Medicines and Healthcare products Regulatory Agency (MHRA) approval for AstraZeneca vaccine on 30.12.2020 along with its conditions/restrictions was also reviewed by the committee.
The committee noted that the safety & immunogenicity data presented by the firm from the Indian study is comparable with that of the overseas clinical trial data.
Based on the recommendations of SEC, CDSCO granted permission to Serum Institute of India to manufacture COVISHIELD vaccine for restricted use in emergency situation with various conditions/restrictions.
(b) & (c): Under New Drugs and Clinical Trials Rules, 2019, it is not mandatory for publication of results of any clinical trial data by CDSCO. However, Summary of Product Characteristics (SmPC) & Prescribing Information for the COVISHIELD and COVAXIN are available in public domain which contains brief of clinical data. Further, clinical trial data in respect to phase I clinical trial results of COVAXIN of M/s Bharat Biotech & Phase I/II & Phase III clinical trial results of M/s AstraZeneca who is technical collaborator of COVISHIELD vaccine has been published in scientific journals and pre prints of Phase II clinical trial reports of COVAXIN of M/s Bharat Biotech are available at MedRxiv.