Serum Institute of India has submitted an application for emergency use authorization (EUA) from Drugs Controller General of India (DCGI). Adar Poonawalla-headed Pune-based drugmaker has become the second company after Pfizer-BioNTech to apply for EUA in India for Covid-19 vaccine. However, the Serum Institute of India’s Covidshield is the first Covid-19 vaccine candidate, which’s being undergoing trial in India, to seek emergency approval.
CEO and Owner of Serum Institute of India Adar Poonawalla on Monday tweeted saying that his company has applied for EUA for the “first made-in-India” vaccine. He said the Serum Institute of India kept its promise of submitting an application for EUA before the end of 2020. Poonawalla has thanked the Government of India and Prime Minister Narendra Modi and said that Covishield will save “countless lives”.
As promised, before the end of 2020, @SerumInstIndia has applied for emergency use authorisation for the first made-in-India vaccine, COVISHIELD. This will save countless lives, and I thank the Government of India and Sri @narendramodi ji for their invaluable support.
— Adar Poonawalla (@adarpoonawalla) December 7, 2020
Serum Institute of India has been conducting phase 3 human trials of Oxford-AstraZeneca’s Covid-19 vaccine AZD1222 as Covishield vaccine. So far, Oxford-AstraZeneca’s AZD1222 has not received EUA from any other country in the world.
Covishield price, availability in India
Last week, PM Modi during a video conference with leaders of all-party on the COVID-19 situation assured that the elusive Coronavirus vaccine will be ready in India within a few weeks. AIIMS Delhi-Director Dr. Randeep Guleria had also said that Indian regulatory authorities would provide EUA to the covid-19 vaccine by the end of December or early January.
Earlier, Poonawalla revealed that the Covishield vaccine would cost Rs 500 to Rs 600 but the Government of India would get it in around Rs 225 to Rs 300. However, Poonawalla, later said that the final decision regarding the pricing of Covishield in India was not taken.
Covidshield Covid-19 vaccine can be stored at temperatures between 2 degrees celsius and 8 degrees celsius.
Oxford-AstraZeneca’s Covid-19 vaccine Covishield efficacy rate
In November, Oxford-AstraZeneca published interim results for its Covid-19 vaccine AZD1222. In the interim results, it was said that the covid-19 vaccine could be 90 per cent effective when given as a half dose but full dose efficacy rate was declared as 70 per cent. Soon after the announcement, controversy erupted over the dosage error during the human trial. However, this efficacy data did not contain results from the Serum Institute of India’s late-stage clinical trials of Covishield in India.
According to a PTI report, Covishield has been described as well-tolerated. The Covid-19 vaccine candidate is effective in preventing Covid-19 in the “targeted population”, said the PTI report. Notably, on August 2, the Serum Institute of India received the nod from the DCGI regarding conducting Phase 2 and Phase 3 human trials of Covishield. On November 28, PM Modi visited the Serum Institute of India’s plant in Pune.