India is likely to have a Covid-19 vaccine approved for emergency use before December ends as Central Drugs Standard Control Organization's (CDSCO) expert panel is set to to review the applications of Serum Institute of India (SII) and Pfizer for the emergency use authorisation (EUA) of their candidates, multiple sources associated with the development told IANS.The data was submitted a few days ago to the Central Drugs Standard Control Organization, which would be reviewed by the Subject Expert Committee in a review meeting which is likely to take place by the end of this week, a top official of CDSCO confirmed to IANS.The official also informed that if the SEC finds the data presented by the Serum Institute of India satisfying, India may have the vaccine for Covid-19 by the end of December.V.K. Paul, member (health), NITI Aayog, and head of the national task force for Covid-19, also informed Dec. 22 that of the two companies which were asked for additional data to receive emergency use approval for their Covid vaccines for emergency use authorization, one has submitted them to the CDSCO.The SII, along with Bharat Biotech, had applied for the emergency authorization of their Covid-19 vaccines with the DCGI earlier this month.Covishield has been developed at the SII’s laboratory in Pune with a master seed from Oxford University/Astra Zeneca.Two vaccines candidates – Covishield by SII and Covaxin by Bharat Biotech – are in the third stage of clinical trials.
However, their applications were not approved as the SEC found inadequate safety and efficacy data of the vaccines in a review meeting held Dec. 9.The SEC had recommended the firms to furnish further safety and efficacy data in order to receive the EUA for their Covid vaccines.The SEC had asked the SII to submit an updated safety data of phase 2 and 3 clinical trials in the country, immunogenicity data from the clinical trial in the U.K. and India, along with the outcome of the assessment of the U.K.’s Medicines and Healthcare products Regulatory Agency for grant of EUA.Meanwhile, it had recommended Bharat Biotech to present the safety and efficacy data from the ongoing phase 3 clinical trials in the country for further consideration.CDSCO’s expert panel is also set to review the application of Pfizer for the emergency use authorization.Sources said that the SII’s vaccine candidate has an edge over Pfizer’s because of its low cost, effective logistics and easy storage.However, no official confirmation came from the CDSCO.Pfizer and BioNTech’s mRNA-based coronavirus vaccine requires a minus 70 degrees Celsius temperature for long term storage while SII’s Covishield, developed from the master seed of Astrazeneca/Oxford University’s Covid vaccine - ChAdOx1 nCoV-2019, can be stored in the domestic fridge at temperature not difficult to maintain - 2 to 8 degrees Celsius.Pfizer, whose vaccine has been authorized in the U.S., the U.K. and Canada, has written to the DCGI seeking a fresh date to present its case for the EUA of their vaccine candidate BNT162b2, after it failed to present its data before the reviewing committee of CDSCO earlier.