Coronavirus Vaccine Update | Oxford vaccine may get approval for emergency use in India in next few days: Reports
New Delhi | Jagran News Desk: The coronavirus vaccine developed by Oxford University and AstraZeneca is likely to get approved for emergency use in India in next few days as the updated data submitted by Serum Institute of India (SII) appears "satisfactory", Times of India quoted government sources as saying.
The Central Drugs Standard Control Organisation (CDSCO) is likely to approve the vaccine for emergency use as soon as the evluation of data is complete and will not wait for approval from UK's Medicines and Healthcare products Regulatory Agency (MHRA), the report added.
“We can take our regulatory decisions independently. The company has submitted the same data here from clinical trials in the UK and Brazil and rolling reviews are going on. The updated information shared by Serum Institute also appears satisfactory. We are hopeful that based on regulatory assessment, the vaccine will be approved in a day or two,” Times of India quoted a senior official as saying.
Meanwhile, a Hindustan Times report quoted government sources saying that the CDSCO is likely to meet sometime this week to examine the application for approval submitted by the Serum Institute.
"The subject expert committee is likely to be convened this week to go through the application. Since Pfizer had also sought a fresh date to present its case on its EUA application of its anti-Covid-19 vaccine, the committee is likely to give them time the same date," Hindustan Times quoted an official as saying.
Alongside, the MHRA is also considering the data and it is possible that it may grant approval for emergency use, which will provide an added advantage in receiving the regulatory approval in India.
AstraZeneca's chief executive, Pascal Soriot, said Sunday that new data will show the vaccine is as effective as the Pfizer and Moderna jabs that have already been approved, protecting 95 per cent of patients, and is “100 per cent effective” in preventing severe illness requiring hospital treatment.
He said that it "should be" effective against the new highly transmissible variant of the deadly virus, which put England under complete lockdown again after its rapid spread was detected.
In the first trials of the Oxford vaccine, it was found to be 62 per cent effective overall, though one group accidentally given a half-dose first was 90 per cent protected.
Posted By: Abhinav Gupta