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Tuesday, 5 January 2021

India to kick-start Covid-19 vaccination drive with SII vaccine

  • India kicked off a nationwide vaccination drive against the new corona virus with the expert panel on Friday granting Emergency Use Authorisation (EUA) for the Oxford-AstraZenica vaccine being manufactured in India by Serum Institute of India (SII) and the health authorities following it up with a nationwide dry run of the vaccination dive on Saturday in select districts across the country.
  • The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) which met on Friday to decide on the Emergency Use Authorisation (EUA) request of new corona virus vaccines decided to give conditional nod for the Oxford-AstraZenica vaccine being manufactured in India by Serum Institute of India (SII). 
  • The committee asked Bharat Biotech to speed up recruitment for its phase 3 clinical trials and return with more data.
  • Pfizer and BioNTech had requested for more time to produce data and their application wasn't considered on Friday.
  • The expert panel is reported to have recommended that the prescribed dose of the Oxford-AstraZeneca vaccine be administered in two doses at a gap of 4 to 6 weeks. It's not clear yet what dosage has been given approval. 
  • A version of the Oxford University-AstraZeneca vaccine – already approved for use in UK – is being produced by the SII, it is called ‘Covishield’ and is “likely to be the first to be rolled out in India,” according to reports.
  • The Oxford vaccine is also affordable and easier to store.
  • SII has been asked to provide more safety and efficacy data from all its global trials as Phase three clinical trial data on Oxford vaccine from the UK and Brazil had thrown up differing efficacies based on dosages given. 
  • India’s drug control authority had also hinted on 31 December that a Covid vaccine may be approved soon. “Probably we will have a happy New Year with something in hand. That is what I can hint at,” Drugs Controller General Dr VG Somani said during a webinar.
  • Meanwhile, there are more vaccines in the running for emergency use. An IANS report said India currently has eight Covid-19 vaccine candidates, including three indigenous vaccines, under different stages of clinical trials, which could be ready for authorisation within months.
  • The objective of the dry run was to assess operational feasibility in the use of the vaccine in actual field environment, test the effectiveness of the linkages and identify the challenges and find the way forward prior to actual implementation, a press release by the government stated.
  • It will also focus on difficult terrains and regions with poor logistical support.
  • The government release also mentions that around 96,000 vaccinators have been trained for the eventual administering of the vaccine across states.The dry run in the states of Assam, Andhra Pradesh, Punjab, and Gujarat, was concluded on 29 December with all the partaking states expressing satisfaction regarding the operational approach and the aid of IT platforms to ensure smooth operations. Source: https://www.domain-b.com/
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