DCGI seeking more data for the granting of emergency use authorization will not have an impact on the vaccine launch schedule: Government

At this stage, vaccine manufacturers systematically monitor and monitor the effects of the vaccine after it has been passed.

Applications from Bharat Biotech, Serum Institute and Pfizer requesting emergency use authorizations for COVID-19 vaccines are being examined, the Center said on Tuesday, saying the DCGI drug regulator seeking more data from these companies will not impact the timing of launch of vaccines.

“These requests to the Comptroller General of Drugs of India are being examined by the CDSCO’s subjective COVID-19 expert committee for authorization for emergency use,” said Dr. VK Paul, a member of NITI Aayog (Health).

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“This situation has been taken into account in advance, as it is an emergency use permit. There should be more than reasonable satisfaction with the safety, immunogenicity and effectiveness of the vaccine, “he told reporters when asked about the DCGI requesting more information from companies for the emergency authorization of vaccines. their.

“Applications are being examined on a scientific basis, using scientific frameworks that are aligned globally and ensuring that the vaccine is safe, adequately immunogenic and effective in reducing the incidence of COVID-19 disease in humans. This independent process takes place.

Read also: Coronavirus | Bharat Biotech Covaxin COVID-19 vaccine enters phase 3 studies

“I would like to note that when we talk about these processes, it is not about an individual or three people. These are scientists, epidemiologists, clinicians, scientists, pharmacologists, biologists. They make the decision based on science, “said Paul.

Speaking about post-immunization adverse events (EFSA), Paul said every time a new drug or vaccine is introduced into the country, there is a stage 4 phase of the clinical trial, also known as post-market surveillance.

Also read: Phase 3 Covaxin studies at Bharat Biotech begin in the state

At this stage, vaccine manufacturers systematically monitor and monitor the effects of the vaccine after it has been passed.

“If a vaccine or two comes after obtaining an emergency use authorization, you should have full faith that the vaccine is scientifically proven, meets global standards, safe and effective,” he said.

Responding to a question about AEFI for the COVID-19 vaccine, Paul said: “This is an adult vaccine. Our AEFI system was intended for children and women, and these vaccinations take place in a certain way, starting with hospitals and then in communities. But when dealing with adults, certain practical issues need to be addressed.

“Secondly, these vaccinations are in several new platforms that bring complexity. Moreover, if an emergency use permit is granted, it requires more responsibility. Finally, there are always new aspects, side effects, situations that need to be taken into account. Above all, a large number of beneficiaries and target groups are to be addressed in a short period of time in a mission mode “, he said.

“Therefore, it needs to be based on the standard principles of AEFI and be specific to the fuller size of the requirements of this particular set of vaccines.”

Regarding the development of the vaccine, said Paul, this week, DCGI granted authorization to conduct human phase 1 and 2 clinical trials of the COVID-19 vaccine developed by Gennova Biopharmaceuticals Ltd in Pune, in collaboration with HDT, USA.

“An important part of this vaccine is different from the Pfizer vaccine or others, this vaccine, if it exists, can be maintained under normal cold chain conditions in a normal refrigerator. This is an important thing, “he said.

He said at the moment, six vaccines are undergoing clinical trials in India. These are the ones developed by Bharat Biotech in collaboration with ICMR; the second by Zydus Cadila; the third of Gennova; The Oxford vaccine, whose study is being conducted by the Serum Institute of India; The Sputnik V vaccine, which is manufactured by Dr. Reddy’s Lab, Hyderabad, in collaboration with the Gamaleya National Center in Russia; and the sixth produced by Biological E Ltd, Hyderabad, in collaboration with MIT, USA.

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