In a significant advance, the Subject Matter Expert Committee (SEC) of the Central Medicines Control Organization (CDSCO) on Wednesday (December 30) did not award the US to the COVID-19 vaccine developed by Oxford-AstraZeneca for use in India. The SEC also declined to consider Pfizer and Bharat Biotech Pvt Limited’s request for emergency use authorization (US) saying that the vaccines developed by all of these companies will not receive authorization “yet” as more data is needed.
The SEC is scheduled to meet again on January 1 for talks on granting approval to a COVID-19 vaccine for emergency use in India.
It should be noted that the Pune-based Serum Institute of India (SII) had requested the US for the Oxford-AstraZeneca vaccine, which was approved for use in the UK on Wednesday. Bharat Biotech is known to have applied for the go-ahead for Covaxin, the indigenous vaccine from India.
“More time was requested on behalf of Pfizer. The SEC reviewed and analyzed the additional data and information submitted by SII and Bharat Biotech Pvt Ltd. Analysis of the additional data and information is ongoing. The SEC will meet again on January 1, ”the expert panel said in a statement.
Britain on Wednesday (December 30) approved the Oxford-Astrazeneca coronavirus vaccine for use against COVID-19. The UK government made the decision at a time when the country is battling a highly contagious new variant of COVID-19.
“The government today accepted the recommendation of the Medicines and Health Products Regulatory Agency (MHRA) to authorize the use of the COVID-19 vaccine from the University of Oxford / AstraZeneca,” the Health Ministry said.
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“The authorization recommends 2 doses administered with an interval of b / w 4 and 12 weeks. In clinical trials this regimen was shown to be safe and effective in preventing symptomatic COVID-19, without severe cases and without hospitalizations more than 14 days later of the second dose, “AstraZeneca said in a statement.
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