DCGI seeking more data for acute authorization will not affect timeline for vaccine launch: Center

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Applications from Bharat Biotech, Serum Institute and Pfizer seeking emergency authorization for use of their COVID-19 vaccines are being examined, the Center said on Tuesday claiming that drug regulator DCGI seeking more data from these companies will not affect the timing.

These requests submitted with the General Controller of Drugs of India are being examined by CDSCO’s COVID-19 departmental committee on licensing use authorization, said VK Paul, a member of NITI Aayog (health).

“This situation has been taken into account before, as it is an urgent authorization. There should be more than reasonable satisfaction about the safety, immunogenicity and effectiveness of the vaccine,” he told reporters when asked about DCGI seeking more information from the companies. by grant. of urgent use authorization to their vaccines.

“The applications are being examined on a scientific basis, using the scientific frameworks, global frameworks and ensuring that the vaccine is safe, immunogenic appropriately and effective in reducing the incidence of COVID-19 disease in humans. This independent process is ongoing.

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

Speaking of an adverse event after immunization (AEFI), Paul said, whenever a new drug or vaccine is introduced in the country, it is a phase 4 stage of clinical trial, which is also known as post-marketing surveillance.

Vaccine manufacturers during this phase monitor and track the effects of the vaccine systematically after it has been passed.

“If a vaccine or two comes after obtaining an urgent use authorization, you have to trust completely that the vaccine is scientifically proven, compliant with global standards, safe and effective,” he said.

Responding to a question from AEFI about COVID-19 vaccine, Paul reported, “This is an adult vaccine. Our AEFI system was aimed at children and women and those vaccinations happen in a certain way, starting from hospitals and then into the communities. But when we deals with adults, some practical aspects need to be addressed.

“Secondly, these vaccinations are on many new platforms that bring complexity. Furthermore, if authorized use is given, it requires more responsibility.
Lastly there are always new aspects, side effects, situations that need to be remembered. Above all, a lot of beneficiaries and target groups have to be treated for a short period in a mission mode, ”he said.

“Therefore, it is necessary to build on the standard principles of AEFI and make it specific to the fuller dimension of the requirements of this particular set of vaccines.”

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

“An important part of this vaccine is different from the Pfizer vaccine or others, this vaccine, if it exists, will be storable in normal cold chain conditions in a normal refrigerator. This is a big deal,” he said.

He said six vaccines are currently undergoing clinical trials in India. These are developed by Bharat Biotech in collaboration with ICMR; due to Zydus Cadila; the third of Gennova; Oxford vaccine, tested by Serum Institute of India; Vaccine against Sputnik V manufactured by Dr. Reddy’s Lab, Hyderabad in collaboration with the Russian National Center Gamaleya; and the sixth manufactured by Biological E Ltd, Hyderabad, in collaboration with MIT, USA.
Biology E.

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