India approves Oxford University and AstraZeneca Covid-19 vaccine

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The panel recommended granting conditional approval for the Serum Institute of India's Corona vaccine Covishield.

The Drugs Controller General of India has yet to formally announce the approval.

Covishield is expected to get more use in India as it can be stored and transported under normal refrigeration while the Pfizer shot needs ultra low temperatures for storage. It has been developed jointly by Oxford University and pharma company AstraZeneca.

While considering Bharat Biotech's application, the SEC noted that the ongoing clinical trial is a large one with 25,800 subjects of which 22,000 have been enrolled, including subjects with comorbid conditions, which has demonstrated safety till date but efficacy is yet to be demonstrated. Pfizer had applied for regulatory approval for its vaccine on December 4 but they have not presented any data to the government so far and asked for more time.

Slaoui also voiced hope for approval in the first half of February of the Janssen vaccine by Johnson & Johnson, which in contrast to the initially approved vaccines comes in a single dose.

Meanwhile, the Union Health Ministry will conduct a dry run for COVID-19 vaccination across all states and union territories (UTs) on Saturday "to test the linkages between planning and implementation and to identify the challenges".

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The state data uses a seven-day average and two-week delay, meaning the latest figures are for the week starting December 13. Go to www.douglaspublichealthnetwork.org for more local information on COVID-19.

While it is unclear how soon DCGI Dr V G Somani will take the final call on approving Covishield, regulatory processes during the pandemic, especially for Covid-19 medicines and vaccines, have been fast-tracked considering the urgency of the situation.

India plans to vaccinate 30 crore people in the next six-eight months.

From installing freezers to setting up cold chain equipment, arrangements are being made at a Delhi government hospital for storing the vaccine, whenever it arrives.

"Therefore, there were differences between the comprehensive multi-country data we reviewed and the protection rate data previously evaluated by the UAE and Bahrain", Global Times quoted Yang as saying in a report published on Thursday.

Serum Institute of India (SII) is partnering with AstraZeneca to manufacture Covishield.

Serum Institute has pegged an approximate cost of Rs 200-225 per dose, and the expenses of the 1st 10 crore doses will be borne by PM Care fund. "We are unclear if SII has submitted the interim safety and immunogenicity data for all participants which is critical for the assessment of the vaccine candidate in an Indian population and the goal of the bridging study", the group has stated in the letter.

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