By the end of this month or early next month at least one covid-19 vaccine should get emergency authorisation: AIIMS Director

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AIIMS director Dr Randeep Guleria on Thursday pinned his hopes on the five Covid-19 vaccine candidates which are in advanced stages of clinical trial in India, stating they are logistically feasible for distribution in both urban and rural areas.

His assertion comes amid Pfizer-BioNTech’s anti-coronavirus vaccine getting emergency clearance in the UK, paving the way for mass vaccinations against the deadly novel coronavirus from as early as next week.

Dr Guleria expressed hope that by the end of this month or early next month, at least one of the five vaccines being locally-tested should get emergency use authorisation from the drug regulator to be administered to the public starting with priority groups.

According to sources, global pharma giant Pfizer had talks with the Indian government late August, but since then there has been no development.

During a briefing last month, NITI Aayog member (Health) Dr V K Paul, who also heads the National Expert Group on Vaccine Administration, said that sufficient doses of the Pfizer vaccine as required for the Indian population will not be available but the government is examining the possibilities and will work out a strategy (for its procurement and distribution) in case the vaccine gets regulatory approvals.

The requirement of extremely low temperature of -70 degree Celsius for storing the Covid-19 vaccine developed by Pfizer poses a big challenge for its delivery in a developing nation like India, especially in its smaller towns and rural areas where maintaining such cold chain facilities would be very difficult, Guleria said.

“Five vaccine candidates are in advanced stages of clinical trial in India and no significant serious adverse effects have been seen so far. Also, they are logistically feasible for distribution in a large country like India, both in its urban and rural parts.

“Hopefully, by the end of this month or early next month, at least one of them should get emergency authorisation from the Indian drug regulator for its distribution among Indian population,” he said.

The five vaccines are under different phases of clinical trials in India with the Serum Institute of India conducting phase-3 trial of the Oxford-Astrazeneca Covid-19 vaccine, while the indigenously developed vaccine by Bharat Biotech in collaboration with ICMR has already started the phase-3 clinical trial.

Another indigenously-developed vaccine by Zydus Cadila has also completed phase -2 clinical trial in the country.

Dr Reddy’s Laboratories and the Russian Direct Investment Fund (RDIF) on Tuesday announced the start of adaptive phase 2 and 3 clinical trials for Covid-19 vaccine Sputnik V in India.

Also, Biological E. Ltd has started early phase 1 and 2 human trials of its Covid-19 vaccine candidate.