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SII applies for govt approval for AstraZeneca-Oxford COVID vaccine

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Adar Poonawalla-led Serum Institute of India has become the first Indian company to apply for emergency use authorisation (EUA) for the COVID-19 vaccine developed by AstraZeneca and the University of Oxford.

The development comes on the heels of US-based vaccine giant Pfizer’s Indian arm approaching the Drugs Controller General of India (DCGI) for EUA for its coronavirus vaccine. Notably, Pfizer has already secured EUA from the UK and Bahrain regulators.

The third-phase clinical trial of the Oxford COVID-19 vaccine—Covishield—is being conducted by the SII, co-sponsored by the Indian Council of Medical Research (ICMR), in various parts of the country in addition to clinical studies being carried out by Oxford-AstraZeneca in the UK and Brazil.

Based on phase two and three clinical trial results, the SII with the help of the ICMR will pursue early availability of the vaccine for India, the country’s apex health research body had said last month. According to the ICMR, the SII has already manufactured 40 million doses of the vaccine under the at-risk manufacturing and stockpiling license it obtained from the DCGI.

Vaccine effective, claims SII

Official sources, citing the SII application said, the firm has stated that data from four clinical studies, two in the UK and one each in Brazil and India, shows that Covishield is highly effective against symptomatic and most importantly against severe COVID-19 infections.

The results are in line with other coronavirus vaccines and because of the huge disease burden, Covishield is predicted to alleviate substantial COVID-19 mortality and morbidity, the firm is learnt to have said.

Also Read: India’s COVID-19 tally crosses 96.77 lakh

“In terms of safety, Covishield was well tolerated with respect to solicited adverse events and was not associated with an increased number of SAEs and deaths. A majority of solicited reactions were mild in severity and resolved without any sequelae. Therefore, Covishield is safe and well-tolerated and can be used effectively for prevention of Covid-19 in the targeted population. Thus, the benefit to risk ratio strongly supports the widespread use of Covishield,” a source said quoting the application.

The SII has also submitted 12 batches of the vaccine to the Central Drugs Laboratory (CDL) in Kasauli for testing, a source said.

Aatmanirbhar Bharat

“In line with our philosophy we assure you that for COVID-19 vaccines also, we are committed to making our country ‘aatmanirbhar’ (self-reliant) and fulfilling our prime minister’s clarion call of ‘vocal for local’ and ‘making in India’ for the world,” stated the application signed by Prakash Kumar Singh, Additional Director, Government and Regulatory Affairs at Serum Institute of India (SII).

In view of all these facts and unmet medical needs in the interest of the public at large to save millions of people in the country and across the globe, early availability of a vaccine against COVID-19 is a necessity, the application further stated.

“So, in the national interest, we request you to grant us emergency use authorisation of Covishield based on our application and in view of immediate need for a safe, effective, programmatically suitable and affordable vaccine for our country,” the application read.

According to sources, this vaccine is logistically feasible for distribution in the country’s urban and rural regions as it can be stored at two to eight degrees Celsius, which is an ideal temperature for being kept in cold storages in the country.

96.77 lakh COVID-19 cases

The health ministry on Monday informed that 32,981 fresh cases of COVID-19 have been reported in India in the past 24 hours. The addition of the fresh cases has taken the COVID-19 case tally to 96.77 lakh.

So far, the biggest single-day surge of 97,894 COVID-19 cases was reported in India on September 17. The second-highest surge of 97,570 COVID-19 cases was recorded on September 12. It is followed by 96,551 cases reported on September 11.

Notably, India has already surpassed Brazil in terms of cases. It is now the second-worst hit nation due to the coronavirus pandemic after the US.

Also, 391 COVID-19 related deaths were reported by the ministry during this period. The addition of the fresh fatalities has taken India’s death toll due to the deadly virus to 1,40,573.

 

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