India approved two coronavirus vaccines for emergency use – Serum Institute of India’s Covishield vaccine and Bharat Biotech’s Covaxin vaccine, on 3rd January.
Drugs Controller General of India (DCGI) approved the vaccines based on the recommendations submitted by the Subject Expert Committee (SEC) for restricted use. The SEC includes experts from different fields such as immunology, pharmacology, pediatrics, microbiology and medicine.
DCGI said that the data submitted by the vaccine producers shows their vaccines are safe and effective.
Oxford-AstraZeneca’s COVID-19 vaccine Covishield is manufactured by Serum Institute of India. In Phase I clinical trials, the immunogenicity and efficacy of Covishield vaccine were tested on 23,745 overseas individuals and the vaccine was found to be 70% effective. After that, the vaccine was tested on 1600 individuals in Phase II and III clinical trials in India and the vaccine showed similar effectiveness.
COVID vaccine Covaxin is manufactured by Bharat Biotech in association with ICMR and NIV. Covaxin vaccine was tested in several animals such as mice, rats, rabbits, hamsters and Rhesus macaques. After that, Phase I and Phase II clinical trials were conducted on 800 individuals and the vaccine was found to safe and generated a strong immune response. In Phase III trial, the vaccine was tested on 22,500 of the 25,800 individuals and the vaccine was found to be safe.
Covishield and Covaxin vaccines are administered in two doses around 4-6 weeks apart and they are stored at 2° C to 8° C temperature making them easier to transport safely.
After the approval of the vaccine, Prime Minister Narendra Modi took to Twitter to congratulate India and hardworking scientists and called it a decisive turning point.
A decisive turning point to strengthen a spirited fight!
DCGI granting approval to vaccines of @SerumInstIndia and @BharatBiotech accelerates the road to a healthier and COVID-free nation.
Congratulations India.
Congratulations to our hardworking scientists and innovators.
— Narendra Modi (@narendramodi) January 3, 2021
Serum Institute of India’s CEO Adar Poonawalla thanked Prime Minister Narendra Modi and others for the support. He tweeted that COVISHIELD vaccine is approved, safe, effective and ready to roll-out in the coming weeks.
Happy new year, everyone! All the risks @SerumInstIndia took with stockpiling the vaccine, have finally paid off. COVISHIELD, India’s first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks. pic.twitter.com/TcKh4bZIKK
— Adar Poonawalla (@adarpoonawalla) January 3, 2021
Thank you Hon. Sri @narendramodi Ji, Hon. Sri @drharshvardhan Ji, @MoHFW_INDIA @ICMRDELHI @DBTIndia #DCGI_India @UniofOxford @AstraZeneca @gavi @GaviSeth @gatesfoundation and @BillGates for your support
— Adar Poonawalla (@adarpoonawalla) January 3, 2021
DCGI also gave the green light to Cadila Healthcare’s corona vaccine for Phase 3 clinical trials.
India has the second-highest number of COVID-19 cases in the world and it has recorded over 10.3 million and 150,000 deaths. Now, India is planning to immunize about 300 million people in 2021 and the priority will be given to health care workers, the emergency services, and people susceptible to infection.
India has also conducted a dry run of the Covid-19 vaccine to check all the steps of the vaccination process and to train the vaccinators.
