Searching for more data for emergency approval will not impact the launch of COVID-19 vaccine: center

Currently, six vaccines are undergoing clinical trials in India, the center said. (Representative)

New Delhi:

Applications from Bharat Biotech, Serum Institute and Pfizer requesting emergency use authorizations for their COVID-19 vaccines are being examined, the center said on Tuesday, stating that the Comptroller General of Medicines of India (DCGI) seeking more data from these companies does not will have an impact on the vaccine launch schedule.

These applications submitted to the DGCI are being examined by the subject matter expert committee on COVID-19 of the Central Organization for the Control of Drug Standards (CDSCO) for authorization of emergency use, said Dr. VK Paul, NITI Aayog member (health).

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

“Applications are being reviewed 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 is ongoing, “he said.

“I would like to mention that when we talk about these processes, we are not talking about a single individual or three people. They are scientists, epidemiologists, doctors, scientists, pharmacologists, biologists. They make the decision based on science.” , said Mr. Paul said.

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

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 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, Mr 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,” he said.

Regarding the development of the vaccine, said Mr. Paul, this week, DCGI granted the authorization to conduct human phase 1 and 2 clinical trials of 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, will be able to be maintained in a normal cold chain condition in a normal refrigerator. This is an important thing,” he said. he said.

He said at the moment, six vaccines are undergoing clinical trials in India. These are one developed by Bharat Biotech in collaboration with ICMR, the second by Zydus Cadila, the third by Gennova, the Oxford vaccine, whose study 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 Gamaleya National Center in Russia and the sixth manufactured by Biological E Ltd, Hyderabad, in collaboration with MIT, USA, Biological E.