Bharat Biotech’s Covaxin trials for children underway; results expected by Sept: AIIMS chief

Bharat Biotech’s Covaxin trials for children are presently underway and the results are expected to be released by September, All India Institute of Medical Sciences (AIIMS) chief Dr. Randeep Guleria has said. Commenting on the development, the AIIMS chief said, “The vaccines for children should come out now because trials in India are already there in the vaccines which are available in India, Bharat Biotech trial is in the final phase by September we will have the data.”

The trial is conducted in three phases by segregating children into categories according to their age. The first trial was started in the age group of 12-18 years followed by the age group of 6-12 years and 2-6 years which are currently undergoing trials.

He further said that Zydus Cadila has included the data for children for their COVID-19 vaccine.

“Zydus Cadila vaccine has also included children and their data is already there. They have already applied for the emergency use authorization,” he said.

Zydus Cadila has concluded its trial for children between the age group of 12 to 18.

The Ahmedabad-based pharmaceutical firm had on July 1, requested emergency use approval for ZyCoV-D, its three-dose COVID shot – the world’s first Plasmid DNA vaccine.

It will, however, be a few more days before the country’s drug regulator Drugs Controller General of India (DCGI) gives it emergency use authorisation, as per sources.

Dr. Guleria also said, “In the coming few weeks or by September vaccines should be available for children. We should then start schools in a graded manner as we have been doing for 18-45 years age and that also will give more protection to the kid and more confidence to the public that children are safe.”

The Government of India has been holding discussions with COVID-19 vaccine manufacturers Moderna and Pfizer, for procuring their vaccine. However, there has been a delay over the same.

“There could be multiple reasons of delay. I think two or three things need to be kept in mind. One is collaboration and the understanding with the government on the doses. But they should also have that many doses to give because we must understand that these companies have pre-booked the order from many countries. Thus, they have obligation to give vaccines to those countries. Unless they fulfill the obligations, they cannot spare doses for other countries like India and other parts of the world. They have huge pre-booked doses,” explained the AIIMS chief.

India has been in discussions with the two firms on several issues including indemnity waiver.

Earlier, Dr. VK Paul, Member (Health), NITI Aayog had said, “We are holding discussions. It is a process of negotiation and dialogues. We are trying to get a solution on contractual and commitments issues. This process is ongoing.”

May need COVID-19 vaccine booster shots for emerging variants: AIIMS chief

With various mutations of the SARS-CoV-2 emerging in the near future, there might be a need for the country to adopt a booster dose with second-generation COVID-19 vaccines, Dr. Guleria said. 

“It seems that we probably need the booster dose of vaccines as with the passage of time the immunity tends to fall. There is waning immunity. We would like to have a booster dose that will cover for various emerging variants,” he said.

He further stated that the booster dose will be a second-generation vaccine.

“We will have second-generation vaccines which would be better in terms of the immunity they give, covering of the new variants and a having a better overall efficacy. Trails of booster vaccine shots are already going on. You will probably need a booster dose till the end of this year. But that’s only once the population is vaccinated, then the next step will be to administer a booster dose,” Dr. Guleria said.

(With inputs from ANI)

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