Decision on emergency authorisation for SII, Bharat Biotech’s COVID-19 vaccines deferred

Both manufacturers have been asked for more data before a final decision can be reached
Decision on emergency authorisation for SII, Bharat Biotech’s COVID-19 vaccines deferred

The novel coronavirus disease (COVID-19) vaccine candidates of Serum Institute of India (SII) and Bharat Biotech Intl Ltd were not recommended for emergency use authorisation (EUA) by the Subject Expert Committee (SEC) of the Drug Controller General of India (DCGI) December 9. 

The SEC comprises experts of various domains. The DCGI takes a final call on the basis of the recommendation of the SEC. The SEC has asked for more data from both vaccine manufacturers to give its final decision.

The government immediately termed as “fake”, some media reports that the vaccines had been “rejected”. 

According to details released later, SII — the manufacturer of the Oxford-Astrazeneca vaccine in India — has been asked to furnish in the next review:

  1. The updated data for safety and adequacy data of trials in India 
  2. Data in immunogenicity (the ability of a vaccine to produce an immune response) from interim Phase 3 results in the UK and the one ongoing in India
  3. The outcome of the assessment of AstraZeneca’s application before the UK regulator for emergency approval

Bharat Biotech has was asked for interim results of phase-3 trial data, which have just begun. The Hyderabad-based firm had sought emergency approval on the basis of the earlier phases generated out of clinical trials in India. 

Pfizer Inc had also applied for EUA in India. However, its representatives were not present in the meeting December 9.

Where vaccine candidates stand

All big COVID-19 vaccine manufacturers — Moderna Inc, AstraZeneca plc and Pfizer — have applied for emergency situations on the basis of interim results of phase 3.

Bharat Biotech, the Hyderabad-based firm has just started the phase 3 trial for its vaccine —Covaxin — which is an inactivated virus vaccine. The Indian Council of Medical Research is the secondary sponsor. 

“How can we give interim results when we have just begun the last phase?” a Bharat Biotech official told DTE earlier in the day.

SII’s vaccine — Covishield — is AstraZeneca / Oxford University’s vaccine candidate being manufactured in India. Sources in the DCGI said it was also waiting for the results of the applications that AstraZeneca had put to the UK drugs regulator for EUA.

The interim data of AstraZeneca’s vaccine has shown safety and also 70 per cent efficacy. SII is also conducting its own phase 3 trial on Covishield in India from which, any interim data is yet to come out. 

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