Experts body welcomes approval of indigenous vaccines

The DCGI approved Serum Institute of India's Covishield and Bharat Biotech's Covaxin for emergency use of January 3

The Organised Medicine Academic Guild (OMAG) has welcomed the decision of the Central Drugs Standard Control Organization (CDSCO) to grant licenses for two ‘Made in India’ Covid-19 vaccines saying that it marks the commencement of a new chapter in the fight against the pandemic.

The Subject Expert Committee (SEC) of CDSCO approved emergency use of Serum Institute of India's Covishield and Bharat Biotech's Covaxin today.

“We may recall that a similar permission was granted for use of a drug Bedaquiline for Multi-Drug Resistant Tuberculosis (MDR-TB) three years back,” the OMAG said.

Read | Wait for vaccine ends: Serum Institute of India, Bharat Biotech get DCGI nod for emergency use

“The entire 2020 were ravaged with Covid-19 pandemic bringing lives of people to almost standstill. Covid vaccine-mania went on for the last few months, but with the approval of these two Indian vaccines, a new chapter starts in the Covid-pandemic in India which will have cascading effects globally, especially for the developing nations. And hence, if 2020 was a ‘Covid-19 year’, then 2021 will be a ‘Covid-Vaccine’ year,” OMAG President Dr S Natarajan and Secretary General Dr Ishwar Gilada said.

Other vaccines in the pipeline awaiting regulators' nod include Pfizer’s mRNA, applied for restricted use and Russia's Sputnik V with Dr Reddy’s and Zydus-Cadila’s ZyCov-D; are in different stages of human trials.

After the laboratory and animal trials, the vaccine goes for human clinical trials in three phases. The first phase is conducted with 30-50 people, second has 300-500 people while the third phase has more than 3,000 participants to find gauge safety and efficiency. The third phase test is also double-blind, which means half the volunteers get the vaccine and the other half gets a placebo.

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“We had seen vaccine nationalism. Rich countries had pre-booked vaccines for their citizens, with the US booking six times more than its population! That initially meant no vaccine for the poor countries,” said Dr Gilada.

“If most of the vaccine produced is taken by these countries, what will happen to the developing and under-developed countries? Currently, the world, particularly the developing world, depends on India for healthcare, for medicines and several vaccines and it will be the same for Covid vaccines as well. Even today, 60 per cent of all the vaccines used globally are manufactured in India,” he added.