COVID-19: India may get vaccine nod for emergency use by year-end

India is likely to have a COVID19 vaccine approved for emergency use before December ends as Central Drugs Standard Control Organizations CDSCO expert panel is set 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 IANSThe sources said that the approval may come after the goahead from the Subject Expert Committee which is likely to meet by the end of this weekThey also strongly indicated that the approval may come first for Adar Poonawallas SII vaccine cThe sources said that the Punebased SIIs vaccine candidate has an edge over Pfizers because of its low cost effective logistics and easy storageHowever no official confirmation came from the CDSCOPfizer and BioNTechs mRNAbased coronavirus vaccine requires a minus 70 degrees Celsius temperature for long term storage while SIIs Covishield developed from the master seed of AstrazenecaOxford Universitys Covid vaccine ChAdOx1 nCoV2019 can be stored in the domestic fridge at temperature not difficult to maintain 2 to 8 degrees CelsiusIANS had reported on Tuesday that SII has submitted additional data required by the Drug Controller General of India DCGI for determining the safety and immunogenicity for CovishieldIf SII receives approval then India could be the first country to give regulatory approval to AstraZenecas vaccine even as the medicine regulator of the UK Medicines and Healthcare products Regulatory Agency MHRA continues to examine data from the trialsThe US pharma giant Pfizer whose vaccine has been authorised in the US the UK 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 earlierA day ago the European Commission EC granted PfizerBioNTechs Covid19 vaccine a conditional marketing authorisation CMA under the new name ComirnatyPfizer was the first to apply for the EUA in India on December 5 followed by Punebased SII on December 6 Bharat Biotech sought EUA for its Covid vaccine Covaxin on December 7While Pfizer sought more time from the Subject Expert Committee SEC as its experts were busy and could not present their case on December 9 the SEC had asked SII and Bharat Biotech to furnish further safety and efficacy data in order to receive the EUA for their Covid vaccinesThe SEC had asked SII to submit an updated safety data of Phase 2 and 3 clinical trials in the country immunogenicity is the ability of a foreign substance such as an antigen to provoke an immune response in the body of a human or other animal data from the clinical trial in the UK and India along with the outcome of the assessment of the UKs Medicines and Healthcare products Regulatory Agency MHRA for grant of the EUAThe SEC had asked 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 UK and India along with the outcome of the assessment of the UKs Medicines and Healthcare products Regulatory Agency MHRA for grant of EUAMeanwhile it has recommended Bharat Biotech to present the safety and efficacy data from the ongoing Phase 3 clinical trials in the country for further considerationThis story has been sourced from a third party syndicated feed agencies Midday accepts no responsibility or liability for its dependability trustworthiness reliability and data of the text Midday managementmiddaycom reserves the sole right to alter delete or remove without notice the content in its absolute discretion for any reason whatsoever