India's Drugs Controller General of India (DCGI) on Sunday gave final approval to two Covid-19 vaccines, paving the way for a huge inoculation program to stem the pandemic in the second worst-hit country. Lauding the development, All India Institute Of Medical Science (AIIMS) director Randeep Guleria said "it is a great day for the country and a good way to start the new year." He also said that indigenously developed Covaxin - one of the two vaccines approved - can be used as backup.
"It's a great day for our country and it's a very good way to start the new year. Both the vaccines are made in India. They are cost-effective & easy to administer. We should, in a very short period, start rolling out vaccines," said Guleria.
He also said that vaccines go through various stages to make sure it's safe. "All data is critically looked at by experts after which vaccine is approved," the AIIMS director further added.
The DCGI gave approval for the emergency use of two Covid-19 vaccines, one developed by AstraZeneca and Oxford University and the other by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV).
He said that the vaccine developed by Bharat Biotech will be used as backup. "In an emergency situation when there is a sudden increase in cases & we need to vaccinate, Bharat Biotech vaccine will be used. It can also be used as a backup when we're not sure how efficacious the Serum Institute vaccine is going to be," said Guleria.
"Initially, Serum Institute vaccine will be given. They already have 50 million doses available & they'll be able to give that in the initial phase where we'll vaccinate around 3 Cr ppl. Gradually,we'll build on it & by the time Bharat Biotech data will also be available," he added.
The nod marks the first vaccine approvals for India, which after the United States, has recorded the most infections of the coronavirus disease.
The DCGI granted the approval on the basis of recommendations of a Covid-19 Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO). "After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and accordingly, vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situations," DCGI Dr V G Somani told the media on Sunday.
Both of the vaccines are two-dose regimen and need 2-8 degrees Celsius storing temperature which make them more cost-effective in comparison to the other vaccine being developed by the US-based pharma giant Pfizer with its German partner BioNTech.
The country is now expected to start the immunisation drive within days and targeting to inoculate 300 million people. In the first phase of vaccination drive, frontline workers including doctors and people working in the healthcare sector will get the shots first. It will be free of cost for the first six to eight months of the drive.