Day 2, 2021: India Gets The Second COVID-19 Vaccine, Covaxin!


On the second day of the New Year 2021 India has got the second COVID-19 vaccine, the totally home-developed Covaxin. The expert panel on vaccines or the Subject Expert Committee (SEC) of the Drugs Controller General of India (DCGI) has today approved Covaxin for restricted emergency use authorization in the country after a marathon meeting ranging over several hours. With the vaccination dry run or the mock inoculation trials starting across the country from today India now has two COVID-19 vaccines: Covishield, approved yesterday, has over 50 million doses ready while Covaxin is believed to have around 10 million doses ready as India prepares for the world’s largest vaccination drive for 300 million people in the first phase. However, no marketing rights have so far been given to any of them the as the Government of India is set to procure the vaccines to lead the mass vaccination drive. Vaccination for the health and frontline workers has already been made free by the Government. The Indian regulator DCGI has on hands now two vaccines to give the final approval to, anytime soon.

 

Covaxin vaccine is developed by Bharat Biotech of Hyderabad, a reputed drug manufacturer of India, in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). Not much information is available in the public domain about the making process, apart from the fact that it is an inactivated vaccine developed from the Indian strain of the Coronavirus. The efficacy rate is also not known like in the cases of all other approved vaccines. At the moment it is in the third phase of clinical human trials with only around half of the proposed 27,000 volunteers getting enrolled so far. However, as per the data of the second phase trials the two doses of the vaccine applied with a break of 28 days had yielded promising results of immunity against COVID-19 for at least three months.

 

The expert panel has, of course, made it mandatory for Bharat Biotech to go on making the data available to the DCGI as their trials progress, and there are several conditionalities involved too in the recommendation. But a sense of hurry cannot still be ruled out entirely, particularly in light of the fact that there was an official announcement earlier to make the fully indigenous vaccine ready for use by August 15, 2020 which was withdrawn immediately thence. However, the Indian regulator is known for its painstaking research and analysis of data before approving any drug or vaccine, and therefore, since the expert panel has indeed recommended Covaxin to the DCGI for approval it is almost assured that there are no safety concerns and with all the positives for the immunity data added to it. In any case, it is still early days as far as the final say on the effectiveness of all the vaccines is concerned, the world over, and that no vaccine can ever be cent percent efficacious. 

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