'Covaxin', the indigenously-developed coronavirus disease (COVID-19) vaccine by the Hyderabad-based pharmaceutical firm Bharat Biotech, has now been granted permission by India's top drug regulator to conduct vaccine trials on children above the age of 12.
The development comes a day after Covaxin received approval from The Drugs Controller General of India (DCGI) to for restricted emergency use in the country, paving the way for a massive inoculation drive.
While granting the emergency use approval, the DCGI clarified the age requirements for active immunisation trials in a document.
According to reports, the 'Covaxin' indigenous shot has been approved for those above the age of 12, while the Oxford-AstraZeneca COVID-19 vaccine, manufactured by the Pune-based Serum Institute of India (SII) under the name 'Covishield', has been approved for those above the age of 18.
Meanwhile, All India Institute of Medical Sciences (AIIMS) director Dr Randeep Guleria on Sunday clarified that the approval of 'Covaxin' is for an emergency situation. It's different from 'emergency use authorisation' which has been granted to SII's 'Covishield'.
Questions were raised yesterday on the approval given to Bharat Biotech whose Phase III trial is pending and more data was sought from the biotech company by the Indian drug regulatory body.
The AIIMS director said the DGCI's approval clearly says it is only for an emergency situation keeping in mind the circulating variant strain.
"At the same time, they have to continue the trials and collect more data. Once that data comes in, we would be more confident, as far the safety and efficacy are concerned," he stated.
He said that in the beginning SII's vaccine will be used by the government, as it already has 50 million doses available which would be given to around three crore people and gradually built on it.
"By that time Bharat Biotech data would also be available. It is important to understand that we are trying to take care of any possible situation. With the UK reporting a huge surge in the number of cases such as per day, and a huge increase in the number of deaths, India's concern that benefits which have been achieved in the last ten months such as the decline in the number of cases, decrease in mortality, should certainly not get displaced," Dr Guleria said.
He further informed that in the UK, due to an increase in the number of cases, the UK government has delayed the administration of the second dose of the Pfizer vaccine.
"Because of the increase in the number of COVID cases, UK has actually changed the timeline of administering the vaccine which is used there. The second dose which was to be given on the 28th day, they are now giving it after 12 weeks. They want to vaccinate as many people as possible with just the first dose. It will give them some protection and decrease the number of cases. So, if a similar situation were to arise in India, we will be pro-active rather than being caught off guard," he added.
India has reported 29 cases of the UK strain of Coronavirus to date.
(With inputs from agencies)