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NMRA’s vaccine verdict ‘soon’

21 Jan 2021

  • India submitted vaccine for clearance on Tuesday 

  • One more vaccine partially submitted by SPC

    By Hiranyada Dewasiri   The Oxford-AstraZeneca vaccine from India was submitted to the National Medicines Regulatory Authority (NMRA) for clearance, to be used in Sri Lanka on Tuesday (19), and the NMRA will “soon” announce its decision on this vaccine, The Morning learnt. Speaking to The Morning yesterday (20), NMRA Chief Executive Officer Dr. Kamal Jayasinghe said that the NMRA would release its verdict on this vaccine, possibly in as early as three days. “We will release the clearance results in two or three days, or very soon.” However, when queried, Dr. Jayasinghe refused to reveal the names of these vaccines. India announced that it will begin to supply vaccines under a grant assistance to Bhutan, the Maldives, Bangladesh, Nepal, Myanmar, and the Seychelles, yesterday. However, it was reported that India awaits the necessary regulatory clearance from Sri Lanka, Afghanistan, and Mauritius to begin the supply of vaccines to these countries. It was reported by foreign media that the vaccine being imported to these countries is the “Covidshield” vaccine produced in India from the Oxford-AstraZeneca master seed. Dr. Jayasinghe added that the documents necessary for the clearance of a second vaccine are yet to be received. “We have however received most of the documents for the second vaccine to be reviewed.” The NMRA clearance will not take the country’s storage facilities into consideration when reviewing a vaccine, Dr. Jayasinghe said. However, he said that the NMRA can take action if the necessary cold chains and storage temperatures are not maintained during import and distribution. Various health officials and Parliamentarians have been suggesting that the Oxford AstraZeneca Covid-19 vaccine, which can be stored between 2-8°C, would be brought to Sri Lanka. According to health officials, Sri Lanka’s vaccine storage facilities consist of 2-8°C standard vaccine-storing refrigerators. It is also reported that all vaccines produced in India against the coronavirus can be stored between 2-8°C temperatures. India recently granted emergency-use authorisation for two vaccines produced in India, namely, the Oxford-AstraZeneca’s “Covidshield”, and Bharat Biotech’s “Covaxin”. On Saturday (16), the nation started inoculating health workers in what is regarded as the world’s largest Covid-19 vaccination drive, with the ultimate aim of inoculating 300 million people. However, it was reported on Tuesday that nearly one-third of those invited to receive the vaccine at the launch of the nationwide drive failed to turn up. This came after the Government confirmed late on Monday (18) that two post-vaccination deaths had been reported, increasing the hesitancy challenge of delivering the vaccine in the world’s second most populous nation. When questioned whether the reported post-vaccine deaths in India will be taken into consideration when reviewing the vaccines, he said that “all things will be considered”. India is home to the world’s largest vaccine makers and has one of the biggest immunisation programmes.


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