COVID-19 vaccine: 'India to have a happy year with something in hand'

As India awaits with bated breath for a silver bullet against coronavirus the Drug Controller General of India DCGI on Thursday hinted at the approval of vaccine and said the country will have a happy new year with something in handThe drug regulator is currently analysing the data submitted by Serum Institute of India which is manufacturing OxfordAstraZeneca vaccine and Bharat Biotech which is making indigenous vaccine in collaboration with ICMR The expert panel will convene a meeting on January 1 on thisThe industry and research organisation have stood the test of time It has been a very wonderful experience Probably we will have a happy new year with something in hand That is what I can hint at Drug Controller General of India DCGI VG Somani saidOn Wednesday the Subject Expert Committee SEC of the Central Drugs Standard Control Organisation CDSCO had met to consider the Emergency Use Authorisation EUA request of Pfizer Serum Institute of India and Bharat Biotech Private LimitedFurther time was however requested on behalf of Pfizer Additional data and information presented by SII and Bharat Biotech was then perused and analysed by the expert panel The analysis of the additional data and information is going on and it will convene again on January 1 the Centre had said in a statementAmericas Pfizer was the first one to apply for the accelerated approval on December 4 followed by Serum and Bharat Biotech who applied on December 6 and 7 respectively Pfizer had however requested more time to make a presentation before the committeeOn December 9 the Subject Expert Committee asked Serum Institute of India and Bharat Biotech to submit more data and information to get approvalThe expert panel had then recommended Serum to submit the outcome of the assessment of the UKMHRA for grant of emergency use approval the updated safety data of the Phase IIIII clinical trial and immunogenicity data from the clinical trial in the UK and IndiaBharat Biotech was recommended to present the safety and efficacy data from the ongoing Phase III clinical trial in the country for further considerationTheir applications were reviewed again on Wednesday hours after the UK accepted the recommendation of the Medicines and Healthcare Regulatory Agency MHRA to authorise Oxford UniversityAstraZenecas Covid19 vaccine named Covishield for emergency useThe authorisation was significant for India as the Punebased Serum Institute of India had tied up with the company to conduct clinical trials and manufacture vaccineThe Central government plans to vaccinate nearly 30 crore people in the first phase of drive It will be offered to one crore healthcare workers along with two crore frontline and essential workers and 27 crore elderly mostly above the age of 50 years with comorbiditiesAs many as eight Covid19 vaccine candidates are under different stages of clinical trials which could be ready for authorisation in near future including three indigenous vaccinesIt includes AstraZeneca and Oxford university developed and Serum Institute of India manufactured Covishield Covaxin by Bharat Biotech Limited ZyCoVD by Zydus Cadila and Russian vaccine candidate SputnikVThe list also contains NVXCoV2373 by SII HGCO19 by Geneva and two unlabelled vaccinesRecombinant Protein Antigen based vaccine by Biological E Limitedand Inactivated rabies vector platform by Bharat BiotechThis 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