DCGI Seeking More Data for Emergency Use Authorization Will Not Affect Timing for Vaccine Launch: Govt

Vaccine manufacturers during this phase monitor and track the effects of the vaccine systematically after it is approved.

Applications from Bharat Biotech, Serum Institute, and Pfizer seeking emergency use authorization for their COVID-19 vaccines are under consideration, the Center said on Tuesday stating that drug regulator DCGI seeking more data from these companies will have no impact on the timing of the vaccine launch.

“These applications filed with the Drugs Controller General of India are being reviewed by CDSCO’s COVID-19 subject matter expert committee for emergency use authorization,” said NITI Aayog member Dr VK Paul. (health).

Read also: Coronavirus | Foreign correspondents visit Bharat Biotech, biological vaccine facilities in Hyderabad

“This situation has been considered earlier as it is an emergency use authorization. There should be more than reasonable satisfaction with the vaccine’s safety, immunogenicity and efficacy, “he told reporters when asked about the DCGI seeking more information from companies for granting emergency authorization for their vaccines. .

Applications are examined 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.

Read also: Coronavirus | Bharat Biotech’s COVID-19 Covaxin vaccine enters phase 3 trial

“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, ”Paul said.

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.

Also Read: Bharat Biotech’s Covaxin Phase 3 Studies Begin in the State

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 are authorized for emergency use, you should have complete confidence that the vaccine is scientifically proven, meets global standards, safe and effective,” he said.

Responding to a question about the AEFI for the COVID-19 vaccine, Paul informed: “This is an adult vaccine. Our AEFI system was aimed at children and women, and those vaccinations happen a certain way, starting in hospitals and then in communities. But when it comes to adults, some practicalities need to be addressed.

“Secondly, these vaccinations are on multiple new platforms that bring complexity. Also, if emergency use authorization is granted, more responsibility is required. Finally there are always new aspects, side effects, situations to be aware of. Above all, a large number 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 upon the standard principles of the AEFI and make them specific to the fullest dimension of the requirements of this particular set of vaccines.”

Regarding 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 partnership with HDT. , USA.

“An important part of this vaccine is different from the Pfizer 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; second by Zydus Cadila; third of Gennova; Oxford vaccine, the study of which is conducted by the Serum Institute of India; Sputnik V vaccine, produced by Dr Reddy’s Lab, Hyderabad in collaboration with the Russian national center Gamaleya; and the sixth produced by Biological E Ltd, Hyderabad, in collaboration with MIT, USA.

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