• Covishield, Covaxin approved
• The vaccines are 110 percent safe: Drug Controller General of India 
• Both vaccines to be administered in two doses
• Can be stored in normal refrigerator

New Delhi: It is indeed a red-letter day for India today as two vaccines for COVID-19 produced by Pune-based Serum Institute’s Covishield and Bharat Biotech’s Covaxin, received emergency approval from the country’s drug regulator this morning. 

Drug Controller General of India (DCGI) V.G. Somani said both firms submitted data on their trial runs and both have been granted permission for “restricted use.” “We’ll never approve anything if there is slightest of safety concern. The vaccines are 110 percent safe. Some side effects like mild fever, pain and allergy are common for every vaccine,” Somani said, addressing a news conference in New Delhi. 

Somani also said that both Covishield and Covaxin have to be administered in two doses and all the three vaccines — third being one by Zydus Cadila which has been issued permission to begin phase 3 trial — have to be stored at 2-8- degree Celsius. 

Incidentally, the Phase II clinical trials for Covishield were conducted at JSS Medical College and Hospital in Mysuru in August this year. In Karnataka, JSS Hospital was the only institute that was selected for the clinical trials. 

Hailing the scientific community, Prime Minister Narendra Modi tweeted, “It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India. This shows the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion.”

“We reiterate our gratitude to doctors, medical staff, scientists, Police personnel, sanitation workers and all Corona warriors for the outstanding work done, that too in adverse circumstances. We will remain eternally grateful to them for saving many lives,” another tweet from PM Modi read. 

Pune-based Serum Institute, the Drug Controller said, has submitted safety, immunogenicity and efficacy data of over 73,000 participants and found 70.42 percent efficacy.  The firm is conducting Phase 2 and Phase 3 trials on 1,600 participants in India. They submitted data of trials abroad also. Recommendation was made for restricted use and the trials will continue, Somani added.

Bharat Biotech’s Covaxin is conducting trials in collaboration with the Indian Council of Medical Research, the Drug Controller said. Phase I and Phase II trials were conducted in around 800 subjects and the results demonstrated that the vaccine is safe and provides a robust immune response.  The Phase III trial was initiated in India in 25,800 volunteers and till date, 22,500 participants have been vaccinated.

After adequate examination, the Central Drugs Standard controller (CDSCO) has decided to accept the recommendations of the expert committee and accordingly vaccines of SII and Bharat Biotech for restricted use in emergency situations, said Somani.

He added that the subject expert committee of the CDSCO consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine, among others.

“The Subject Expert Committee (SEC) has reviewed the data on safety and immunogenicity of the vaccine and recommended for grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains. The clinical trial on-going within the country by the firm will continue,” the Health Ministry said in a statement.

“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,” Serum Institute chief Adar Poonawalla tweeted.