Applications from Bharat Biotech, Serum Institute, and Pfizer seeking emergency use authorization for their COVID-19 vaccines are under consideration, the center said Tuesday, stating that the Drugs Controller General of India (DCGI) looking for more data from these companies will have no impact on the vaccine launch history.
These applications filed with the DGCI are being reviewed by the Central Drugs Standard Control Organization (CDSCO) COVID-19 subject matter expert committee for emergency use authorization, said Dr. VK Paul, member (health care ) of NITI Aayog.
“This situation has been considered earlier as it involves emergency use authorization. There should be more than reasonable satisfaction with the safety, immunogenicity and efficacy of the vaccine,” he told reporters when asked to DCGI which seeks more information from companies for granting emergency use authorization for their vaccines.
“Applications are reviewed on a scientific basis, using scientific frameworks, frameworks aligned globally and ensuring that the vaccine is safe, adequately immunogenic, and effective in reducing the incidence of COVID-19 disease in people. This independent process is ongoing. “he said.
“I would like to point out that when we talk about these processes, it is not one individual or three people. These are people who are scientists, epidemiologists, clinicians, scientists, pharmacologists, biologists. They make the decision based on science,” said Mr. Ha said Paul.
Speaking of post-immunization adverse events (AEFI), Paul said that whenever a new medicine or vaccine is introduced into the country, there is a phase 4 clinical trial, also known as post-marketing surveillance.
Vaccine manufacturers during this phase monitor and track the effects of the vaccine systematically after it is approved.
“If one or two vaccines arrive after you have been authorized for emergency use, you should have full confidence 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, Mr. Paul informed: “This is an adult vaccine. Our AEFI system was aimed at children and women and those vaccinations take place in a certain way, starting with hospitals and then in communities. But when it comes to adults, some practical aspects have to be addressed.
“Secondly, these vaccinations are in multiple new platforms that bring complexity. Also, if emergency use authorization is given, more responsibility is required. Finally, there are always new aspects, side effects, situations that need to be Kept in mind Above all, large numbers of beneficiaries and target groups need to be addressed in a short period of time in missionary mode, “he said.
“Therefore, it is necessary to build on the standard principles of AEFI and make them specific to the fullest dimension of the requirements of this particular set of vaccines,” he said.
On vaccine development, Paul said, DCGI this week granted permission to conduct Phase 1 and 2 human clinical trials of the COVID-19 vaccine developed by Gennova Biopharmaceuticals Ltd of Pune in collaboration with HDT, USA. .
“An important part of this vaccine is different from Pfizer’s vaccine or others, this vaccine, if it is produced, will be maintainable under normal cold chain conditions in a normal refrigerator. This is an important thing,” he said.
He said six vaccines are in clinical trials in India at this point. These are one developed by Bharat Biotech in collaboration with ICMR, the second by Zydus Cadila, the third by Gennova, Oxford vaccine, the study of which is conducted by the Serum Institute of India, the Sputnik V vaccine which is manufactured by Dr Reddy’s Lab, Hyderabad in collaboration with the Russian Gamaleya National Center and the sixth produced by Biological E Ltd, Hyderabad, in collaboration with MIT, USA, Biological E.