DRL will make Russian Covid vaccine for India

Firm to conduct phase 3 trials and seek Indian approvals

Sputnik V, the Russian vaccine for Covid-19, will be manufactured by Dr Reddy’s Laboratories Ltd in Hyderabad after clearance from regulatory authorities.

If the regulatory authorities in India approve of the vaccine, it can be made available in India by the end of 2020. There will be 100 million doses of the vaccine supplied to India.

G.V. Prasad, co-chairman and managing director of Dr Reddy’s Laboratories, said “The phase 1 and 2 results have shown promise and we will be conducting phase 3 trials in India to meet the requirements of Indian regulators.”

Sputnik V is based on an adenoviral vector platform and the phase 3 human trials are to be carried out by the country that takes the vaccine from Russia. Different populations in the world react differently to the vaccine. Hence each country will have to take it and experiment on their own.

In phase 1 and 2 trials carried out on primates, Syrian hamsters and transgenic mice, it was found to be 100 per cent protective. The phase 3 trials in Russia were carried out on 76 participants. of which most were men.

In these trials, according to the science journal Lancet on September 4, it

has been stated that there is no adverse reaction and the immune response was strong. It was found that the immunoglobulin produced was higher than those who have recovered from Covid-19. Antibody production was high and it

continued to be even after 14 days. The data states that it peaked in 28 days after the vaccine was given.

However, scientists have also pointed out errors in the data and state that it requires more accurate

assessment. The immune response is not directly proportional to the degree of protection. There is a need for more human trials on different populations before it is decided whether or not it will suit them.