Covid vaccine: India ready, says Modi, as doubts linger


Prime Minister Narendra Modi on Monday said the world’s biggest Covid-19 vaccination program was set to begin in India, even as some experts questioned the green light by the Indian authorities to at least one of the two vaccines.

The Drugs Controller General of India (DCGI) on Sunday approved the Covid-19 vaccine developed by AstraZeneca and Oxford University, named Covishield in India and manufactured in that country by the Serum Institute of India.

Also allowed for ‘restricted emergency use’ was the indigenously developed Covaxin of Bharat Biotech in the country.

World’s biggest Covid-19 vaccination program set to begin in India. For this, the country is proud of the contributions of its scientists and technicians,” Modi was quoted as saying on Monday.

However, the expert panel of the Central Drugs Standard Control Organisation (CDSCO), whose recommendation the DCGI accepted, “approved both vaccines under limited evaluation data. The Serum Institute has no efficacy data on Covishield from India, while Covaxin’s efficacy is still under evaluation,” The Telegraph newspaper reported on Monday.

The terminology used for green-lighting the Covaxin — “clinical trial mode” — was also vague, other experts were quoted as saying in other Indian publications.

The All India Drug Action Network, a watchdog organization, said it was shocked at the restricted emergency use authorizations to both vaccines, and in a statement detailed the unanswered questions about the vaccines.

Prime Minister Modi’s ministers and party colleagues, however, blamed the Opposition for ‘fueling rumors.’

India’s health minister Dr Harsh Vardhan tweeted: “For those spreading rumours let it be known that EUA for COVAXIN is differently conditional – in clinical trial mode

EUA for COVAXIN is different from COVISHIELD because its use will be in clinical trial mode.

All COVAXIN recipients to be tracked,monitored as if they’re in trial”

In an interview with The Times of India, Dr Gagandeep Kang, the vice-chair of the board of Coalition for Epidemic Preparedness, a global partnership seeking to proactively develop vaccines, said she was “completely confused” by the approvals.

Either you are doing a clinical trial or you are not. I am completely confused,” she said.

Meanwhile, Russian Sputnik V vaccine makers have said that they are working with AstraZeneca to take the efficacy of the AstraZeneca vaccine to over 90 percent.

In a tweet, Sputnik V said: “As Indian regulator recommends for approval full-dose regimen of AstraZeneca’s vaccine with efficacy of 62.1 per cent based on phase 3 clinical data. Sputnik V is working on clinical trials with AZ to increase the efficacy of AZ vaccine to over 90 per cent”.

AstraZeneca is currently working with the Russians on the combination of their vaccine’s vector with that from Sputnik V (showing 91.4 percent efficacy as per Phase 3 final control point recorded last month), precisely to see if that could help boost its vaccine’s efficacy to over 90 percent as well.

While both vaccines use adenoviral vector technology, the AstraZeneca vaccine is based on a chimpanzee adenovirus (which is not the most popular technology among the vaccinated as recently conducted polls indicated that, given a choice, consumers prefer other technologies), the Sputnik V vaccine is based on a human adenovirus.

Unlike AstraZeneca, which uses one and the same component for both inoculations, the Russian vaccine uses two different ones in two separate inoculations.

Covishield and Covaxin have to be administered in two doses and can be stored at 2-8° Celsius (35.6-46.4°F).

The vaccines will be first offered to 10 million healthcare workers, along with 20 million frontline and essential workers and 270 million elderly, mostly above the age of 50 years with co-morbidities.

India will produce about 300 million doses of the Russian Sputnik V coronavirus vaccine in 2021, head of the Russian Direct Investment Fund (RDIF), Kirill Dmitriev, said in an interview with Rossiya 24 TV channel last month.

“In India, we have agreements with four large manufacturers. India will produce about 300 million doses or more of the vaccine for us next year,” Russian news agency Tass quoted him as saying.

In September 2020, Dr. Reddy’s Laboratories and RDIF entered into a partnership to conduct clinical trials of the Sputnik V vaccine and the rights for distribution of the first 100 million doses in India.

Dr Reddys and RDIF announced in December that they have commenced adaptive Phase 2 and 3 clinical trials for Sputnik V vaccine in India for Covid-19 after receiving the necessary clearance from the Central Drugs Laboratory, Kasauli.

On August 11, 2020, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world’s first registered vaccine against Covid-19 based on the human adenoviral vector platform.