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 India’s General Controller of Medicines (DCGI) seeking more data from these companies is not will influence the timetable for expelling a vaccine.
These requests submitted to the DGCI are being examined by the COVID-19 departmental expert committee of Central Drug Standards Control Organization (CDSCO) for acute authorization, said NITI member Aayog (health) Dr VK Paul.
“This situation has been taken into account before, as it is about licensing use authorization. There should be more than reasonable satisfaction about the safety, immunogenicity and efficacy of the vaccine,” he told reporters when asked about DCGI seeking more information from the companies for giving emergency use authorize 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,” he said.
“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, “Mr. Paul said.
Speaking of an adverse event after immunization (AEFI), Mr Paul said whenever a new drug or vaccine is introduced in the country, there 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, Mr Paul reported, “This is an adult vaccine. Our AEFI system has been targeted at children and women and these vaccinations take place in a certain way, starting from hospitals and then into the communities. “But when we are dealing with adults, some practical aspects need to be addressed.”
“Secondly, these vaccines are in many new platforms that bring complexity. Furthermore, if a licensed use authorization is granted, it requires more responsibility. Ultimately, there are always new aspects, side effects, situations that need to be considered. of beneficiaries and target groups must be treated for a short period in a mission regime, ”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,” he said.
On vaccine development, Mr. 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, United States.
“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 one developed by Bharat Biotech in collaboration with ICMR, second by Zydus Cadila, third by Gennova, Oxford vaccine, which is being tested by Serum Institute of India, Research Institute of India, Sputnik V vaccine, manufactured by Dr. Reddy’s Lab, Hyderabad. cooperation with the Russian National Center Gamaleya and the sixth manufactured by Biological E Ltd, Hyderabad, in collaboration with MIT, USA, Biological E.