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Pfizer, others will have to conduct clinical trials of COVID-19 vaccine in India for approval

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Pfizer and BioNTech will have to conduct local clinical trials for securing emergency use authorisation for its COVID-19 vaccine, the government has said. The head of the government task force on COVID-19 vaccine, Dr. VK Paul, said that local clinical trials are a pre-condition for seeking emergency use authorisation.

Notably, Pfizer and BioNTech have applied to the Indian drug regulator for emergency use authorisation. However, the government is yet to provide the same. The vaccine has been already approved by the US and UK and has been already given to thousands of people. The World Health Organisation has also approved the vaccine, which means that poor countries with weaker regulatory systems can approve the vaccine.

High efficacy, high cost of Pfizer vaccine

Interestingly, the vaccine developed by Pfizer has one of the best efficacy rates in clinical trials—close to 95%. However, the problem lies in its cost and logistical issues. Each dose of the double-dose vaccine costs around $19-20. Also, the vaccine needs to be stored at ultra-low temperatures of minus 70 degrees Celsius, which requires robust and expensive infrastructure.

Vaccines approved by India

The Indian drug regulator has approved low-cost vaccines manufactured by the Serum Institute of India and Bharat Biotech. Notably, the Pune-based Serum Institute is manufacturing the vaccine developed by AstraZeneca and the University of Oxford.

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However, the vaccine had run into controversy in the past over the manner in which the efficacy percentage was derived by AstraZeneca. On the other hand, the vaccine manufactured by Bharat Biotech is yet to complete its phase 3 trial and the government had to face severe criticism from the Opposition for approving it sans the mandatory phase 3 trial.

Over 1.05 cr COVID-19 cases

The health ministry on Thursday informed that 16,946 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 past 1.05 crore.

Also, 198 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 1,51,727.

Of the over 1.05 crore coronavirus cases reported so far, over 2.13 lakh are active cases of the virus. It is above 2 per cent of the total caseload. Interestingly, over 1.01 crore cases have recovered from the viral infection so far.

 

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