India: Expert panel recommends approval to Sputnik V vaccine

An Expert panel of the Central Drugs Standard Control Organisation (CDSCO) recently approved the Emergency Use of COVID-19 vaccine Sputnik-V. However, the Drugs Controller General of India (DGCI) is to take a final call on the recommendation. When approved, Sputnik will be the third COVID-19 vaccine to be available in India.

Sputnik V Vaccine

The Sputnik V is a Russian vaccine. The Dr Reddy’s Laboratories partnered with the Russian Direct Investment Fund to conduct clinical trials on the vaccine and for its distribution rights in India. The vaccine has proved 91.6% of efficacy during its phase 3 trials.

Emergency Use Authorisation

Currently, the vaccines COVAXIN of Bharat Biotech and COVISHIELD of AstraZeneca are under administration. They have been given Emergency Use Authorisation. Emergency Use Authorisation is an interim approval of vaccine.

The fastest approval for a vaccine until now took about four and a half years. This approval was for the mumps vaccine developed around 1960s. Therefore, to use vaccines in emergency situations as that of COVID-19, Emergency Use Authorisation is provided.

How is Emergency Use Authorisation granted in India?

A company seeking Emergency Use Authorisation must conduct local trials to prove that the vaccine is safe and effective on Indian population.

What are the risks with Emergency Use Approved Vaccines?

After every clinical trial, the vaccine is upgraded by nullifying its side effects and potential risks. In case of Emergency Use Authorisation, there is no time for these rigorous clinical trials.

The Emergency Use Authorised vaccines might have potential risks. The people should be informed about the extent of risks of the vaccine.

Other drugs that received Emergency Use Authorisation in India

The other drugs that received Emergency Use Authorisation in India are Favipiravir, Remdesivir and Itolizumab.




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