The expert committee of CDSCO met on 30/12, 01/01 and 02/01 to deliberate on accelerated approval of vaccines. Recommendations made on each day have been officially published.
π£ In this thread, we take a look at the timeline of events that lead to the approval. Must read.
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π£ In this thread, we take a look at the timeline of events that lead to the approval. Must read.
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30th December:
#Covaxin: Bharat Biotech presents status of Phase 3 trials and updated safety data.
π£ Committee recommends that updated safety and EFFICACY data of Phase 3 trials have to be presented for further consideration.
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#Covaxin: Bharat Biotech presents status of Phase 3 trials and updated safety data.
π£ Committee recommends that updated safety and EFFICACY data of Phase 3 trials have to be presented for further consideration.
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30th December:
#Covishield: SII presents safety and efficacy data of Phase 2/3 trials from UK, Brazil, SA along with data from ongoing Indian trials. SII mentions that UK has provided EUA.
π£ Committee asks for complete details of UK approval to be submitted.
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#Covishield: SII presents safety and efficacy data of Phase 2/3 trials from UK, Brazil, SA along with data from ongoing Indian trials. SII mentions that UK has provided EUA.
π£ Committee asks for complete details of UK approval to be submitted.
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1st January:
#Covaxin: Bharat Biotech presents data from Phase 1,2 trials as well as ongoing Phase 3. Efficacy yet to be demonstrated.
π£ Committee asks for Phase 3 recruitment to be expedited and present Phase 3 efficacy data for consideration for emergency use approval.
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#Covaxin: Bharat Biotech presents data from Phase 1,2 trials as well as ongoing Phase 3. Efficacy yet to be demonstrated.
π£ Committee asks for Phase 3 recruitment to be expedited and present Phase 3 efficacy data for consideration for emergency use approval.
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1st January:
#Covishield: SII presents details of UK approval.
π£ Committee reviews data and notes that the safety/immunogenicity data of India trials is comparable to overseas trials.
Decides to recommend for restricted emergency use.
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#Covishield: SII presents details of UK approval.
π£ Committee reviews data and notes that the safety/immunogenicity data of India trials is comparable to overseas trials.
Decides to recommend for restricted emergency use.
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Conditions of #Covishield restricted approval:
β Approved for >= 18 years of age.
β 2 doses, 4 to 6 weeks apart.
β SII should submit details of of ongoing Phase 3 studies.
β Safety data to be submitted every 15 days for first 2 months.
β Submit risk management plan.
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β Approved for >= 18 years of age.
β 2 doses, 4 to 6 weeks apart.
β SII should submit details of of ongoing Phase 3 studies.
β Safety data to be submitted every 15 days for first 2 months.
β Submit risk management plan.
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2nd January:
#Covaxin: Bharat Biotech presents data. Requests for approval in light of new mutated strain.
π£ Committee recommends for emergency use in clinical trial mode as a precaution, to have more vaccine options in light of mutant strains.
Phase 3 to continue.
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#Covaxin: Bharat Biotech presents data. Requests for approval in light of new mutated strain.
π£ Committee recommends for emergency use in clinical trial mode as a precaution, to have more vaccine options in light of mutant strains.
Phase 3 to continue.
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In summary:
β Approval for Covishield provided on 01/01 after reviewing UK approval and trial data globally and in India.
β #Covaxin: In the meetings held on 30/12 and 01/01, SEC had asked for Phase 3 efficacy data to be presented for approval considerations.
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β Approval for Covishield provided on 01/01 after reviewing UK approval and trial data globally and in India.
β #Covaxin: In the meetings held on 30/12 and 01/01, SEC had asked for Phase 3 efficacy data to be presented for approval considerations.
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In the meeting on 02/01, SEC decides to recommend Covaxin for emergency approval in clinical trial mode, without efficacy data from Ph 3 trials.
Reason given being to have more vaccine options in light of mutated strains. Clarification of clinical trial mode not provided.
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Reason given being to have more vaccine options in light of mutated strains. Clarification of clinical trial mode not provided.
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The detailed recommendation documents of SEC by date can be found here:
cdsco.gov.in/opencms/opencmβ¦
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cdsco.gov.in/opencms/opencmβ¦
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