AIIMS Director clarifies nod to Covaxin is for emergency situation, not emergency use authorization

New Delhi: All India Institute of Medical Sciences (AIIMS) director Dr Randeep Guleria on Sunday clarified that approval of COVAXIN, Bharat Biotech's COVID-19 vaccine is for an emergency situation and not an emergency use authorization which is given to Serum Institute of India's COVISHIELD.

Speaking to ANI, Dr Guleria said Bharat Biotech was not given emergency use authorization because of the fact that more data is still needed for the approval.

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"If you look at the approval of COVAXIN, it says clearly that it is for an emergency situation and not emergency use authorisation that is given for Serum Institute. This is so because of the fact that more data is still needed. They have just given an emergency approval for emergency situation and that is keeping in mind the situation globally," the AIIMS director said.

Drugs Controller General of India (DCGI) granted permission for restricted use in an emergency situation to vaccines of Serum Institute of India and Bharat Biotech. However, questions were raised on approval given to Bharat Biotech whose phase III trial is pending and more data was sought from the biotech company by Indian drug regulatory body.

"We do not have an effective antiviral drug. What we have is vaccines so we must be pro-active and that is why in an emergency situation where there is suddenly an increase in the number of cases and we need to vaccinate a large number of people, the Bharat Biotech vaccine will be used," he said.

"Or when we have a situation where we are not sure how efficacious Serum Institute's vaccine is going to be then as a back up the Bharat Biotech vaccine can be used," Dr Guleria added.

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.

COVID-19 vaccines of Serum Institute of India and Bharat Biotech have been granted permission for restricted use in emergency situations, said Drugs Controller General of India (DCGI) on Sunday.

"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 situation and permission is being granted to M/s Cadila Healthcare for the conduct of the Phase III clinical trial," said VG Somani, DCGI, during a media briefing today. 

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