Panacea Biotec starts supply of second component of Sputnik V in India

Panacea Biotec Ltd has supplied the first shipment of the second component of the Sputnik V coronavirus vaccine that is developed by the Russian Direct Investment Fund. Panacea said this is the first batch of the second component – human adenovirus serotype 5 - produced and supplied by it in India.

The batch will be distributed in India through Dr. Reddy’s Laboratories, a partner of RDIF and Panacea Biotec.

Doses of the second component have been manufactured at Panacea Biotec’s facility in Himachal Pradesh. The company had received necessary clearance from the Central Drug Laboratories (CDL), Kasauli on 31 August.

Full-scale production of Spuntik V started at Panacea Biotec’s facilities this summer. The facilities comply with good manufacturing practices (GMP) standards and are prequalified by World Health Organization (WHO).

To date, Sputnik V has been authorized in 70 countries with a total population of over 4 billion people.

“Panacea Biotec is pleased to have successfully produced and dispatched the first batch of Component II (Ad5) of Sputnik V vaccine. More batches are currently under production at our manufacturing facility in Himachal Pradesh,” said Rajesh Jain, managing director of Panacea Biotec.

Efficacy of Sputnik V is 97.6% based on the analysis of data on the coronavirus infection rate among those in Russia vaccinated with both components of Sputnik V from December 5, 2020 to March 31, 2021.

Sputnik V makes use of heterogeneous boosting (two different vectors for the two shots in a course of vaccination among COVID vaccines). This approach provides for immunity with a longer duration than vaccines using the same delivery mechanism for both shots.

Manufacturing the Russian vaccine is complex as it uses two different human adenoviral vectors – Ad26 and Ad5 for the first and second doses, respectively. The vaccine is administered in two doses 21 days apart. The Ad5 is used as a heterologous booster, which is critical to the efficacy of the vaccine.

The fund said that the safety, efficacy and lack of negative long-term effects of adenoviral vaccines have been proven by more than 250 clinical studies over two decades. There are no strong allergies caused by Sputnik V, the firm said.