New Delhi: All India Institute of Medical Sciences (AIIMS) director Dr Randeep Singh Guleria today lauded the work done by Indian laboratories in making indigenous vaccines.
“The research has been done here and it’s truly from the scratch and it is Indian vaccine. It’s a great moment, especially because unlike past where we had to rely on importing various products like PPE or N95; now we have vaccines which are being manufactured in India itself. We do not have to rely on vaccines coming from outside. They are cost-effective and easy to administer between 2 to 8 degrees Centigrade,” he said. He also said that a vaccine has to go through various stages of study to make sure that it is safe for use.
“It is important to understand that when we look at any vaccine, safety is paramount and therefore a vaccine goes through various stages of studying to make sure that it is safe,” Dr Guleria stated in an interview with ANI.
The statement has come after India’s indigenous vaccines got consent from Drugs Controller General of India (DCGI) for rollout.
The procedure for the making of a vaccine starts with a study on small animals like mice and hamster to the big ones like monkeys. Once safety is ensured, the same is tried on humans.
“All the data are being critically looked at by the regulatory authorities and experts and then only a vaccine is given approval. At multiple levels, the safety is ensured and I do not think we should be concerned,” Dr Guleria said.
Phase I of the human trials work towards ensuring the safety and effectiveness of the vaccine. After that, the efficacy trial is carried out and then again to safety trials in phase II with a larger number of people. Then Phase III trials are carried out, post which regulatory authorities critically analyse the data and vaccine is given approval.
There are questions being raised on Covaxin of Bharat Biotech which is yet to go for Phase III trials. Dr Guleria responded, “Even as far as Bharat Biotech vaccine is a concern, it is on a traditional platform which has been used for other vaccines also. It is shown to be safe and they have robust data from Phase I and Phase II trials to show that it’s a safe vaccine.”
DCGI has today approved vaccines of Serum Institute of India and Bharat Biotech. There is a requirement of more data from the trials due to which they have been approved for restricted use in emergency situations.
Dr Guleria cautioned that people with disabilities and disorders have higher chances of developing the disease and may get missed out. A criterion is being made to prioritise such patients. He said the aim is to decrease mortality by vaccinating higher risk group and then start vaccinating enough number of people so that a good amount of people have immunity against the virus.
India is already preparing for universal immunisation programme for rolling out the vaccine. It will commence shortly as per the guidelines from experts. All this will help in bringing down the mortality and controlling the pandemic.
Also read: Covaxin approved as it’s more likely to act against mutant Covid strain, says ICMR chief