Sputnik V Receives Emergency Approval, Other Vaccines To Follow

The Russian vaccine will be manufactured by Dt. Reddy's Laboratories while other foreign manufacturers will have to conduct bridging studies

The National Expert Group on Vaccine Administration for COVID-19 on Tuesday announced that the Centre will fast-track emergency approvals for foreign COVID-19 vaccines that have already received approval by medical regulators along with WHO. This announcement came on the day India announced its third approved COVID-19 vaccine.

The Drugs Controller General of India (DCGI) approved Sputnik V, produced by Russia's Gamaleya National Research Institute of Epidemiology and Microbiology for emergency use authorization (EUA) in India on Tuesday making it the third vaccine to receive EUA. This vaccine will be manufactured by Dr. Reddy's Laboratories from Hyderabad, who approached the DCGI to manufacture and distribute the vaccine in the country.

Sputnik Vaccine Approval

Found to have a 91.6% efficacy against SARS-CoV-2, the vaccine funded by the Russian Direct Investment Fund (RDIF) received a lot of criticism when the country approved the vaccine even when its Phase III trials were underway.

The vaccine instead of using one vector uses two different adenoviral vectors for both the vaccine dosages. Just like AstraZeneca uses an adenoviral vector that causes common colds among humans, Sputnik scientifically known as Gam-COVID-Vac combined vector vaccine uses two of them.

While the first vector (rAd26-) is administered through the first shot, the second vector (rAd25-) is given through the second dose after 21 days. According to the RDIF, the vaccine uses two different vectors to boost the immune response as well as reduces the risk of the immune system developing resistance to the initial vector. The vaccine has to be stored at -18°C in its liquid form and between 2-8°C if freeze-dried, thus not requiring any additional cold-chain infrastructure if kept refrigerated.

Dr. Reddy's conducted Phase III trials across the country to check the safety and immunogenicity of the vaccine. Comparing the interim results of the Phase III results submitted by the manufacturer with the results of the clinical trials in Russia, the Subject Expert Committee comprising of pulmonologists, immunologists, microbiologists, pharmacologists, and others approved the vaccine for restricted emergency use authorization in the country.

Along with Dr. Reddy's, five other pharmaceutical companies will also be manufacturing the vaccine according to deals signed with the RDIF. They are Gland Pharma, Hetero Biopharma, Virchow Biotech, Panacea Biotec and Stelis Biopharma. All of these manufacturers together will be able to produce 600 million doses in a year.

This is the third vaccine to be approved by the DCGI along with Covishield and Covaxin but has the highest efficacy rate from all three. The government is yet to release the standard operating procedure for the distribution of Sputnik, its price, and also how many doses it plans to procure. So far, there have been no reports of adverse events linked to this vaccine.

The Russian vaccine has so far been approved in 55 countries and RDIF plans to sell it at less than $10 per shot.

Other Foreign Vaccines To Follow

Other vaccines that have received emergency approval for restricted use are the ones approved by USFDA (US), EMA (EU), UK MHRA, PMDA Japan or which are listed in WHO (Emergency Use Listing). Instead of conducting large scale clinical trials, they will conduct post approval parallel bridging studies in which they will check if the results in India are similar to results in other countries. The bridging studies which are equivalent to Phase II/III will be conducted once the vaccines are approved.

Furthermore, before starting large scale vaccination, the first 100 beneficiaries will be observed for seven days to assess if there are any adverse effects.

This implies that COVID-19 vaccines manufactured by Pfizer, Johnson & Johnson, and Moderna could be fast-tracked if they decide to approach the DCGI for approval. When asked if the Chinese vaccines would be a part of the provisions, Health Secretary Mr. Rajesh Bhushan stated that all vaccines which are approved by either US, EU, UK, or Japan will be included in these trials.


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