DCGI, which needs more data to issue emergency approval, does not affect the vaccine launch timeline: Govt

Vaccine manufacturers systematically monitor and track the effects of the vaccine at this stage after it has been adopted.

Bharat Biotech, Serum Institute and Pfizer’s applications for emergency approval for their COVID-19 vaccines are currently under review. The center said Tuesday that the drug regulator DCGI, which is demanding more data from these companies, will have no control over the schedule for the vaccine’s launch.

“These applications, filed with the Drugs Controller General of India, are being reviewed by CDSCO’s Committee of Experts on COVID-19 for emergency approval,” said Dr. VK Paul, member of the NITI Aayog (Health).

Also read: Coronavirus | Foreign envoys visit Bharat Biotech’s vaccine facility in Hyderabad

“This situation was taken into account from earlier, as it is an emergency permit. The safety, immunogenicity and efficacy of the vaccine should be more than reasonably satisfied, ”he told reporters when asked about DCGI to get more information from companies for emergency licensing of their vaccines.

“Applications will be studied on a scientific basis, using the scientific framework that is global in scope and ensures that the vaccine is safe, sufficiently immunogenic and effective to reduce the incidence of COVID-19 disease in humans.” This independent process takes place.

Also read: Coronavirus | Bharat Biotech’s COVID-19 vaccine Covaxin is entering phase 3 trials

“I would like to point out that these processes are not one or three people. These are people who are scientists, epidemiologists, clinicians, scientists, pharmocologists, and biologists. You make the decision based on science, ”Paul said.

Regarding Post-Immunization Adverse Events (AEFI), Paul said that every time a new drug or vaccine is launched in the country there is a Phase 4 phase of clinical study, also known as post-market surveillance.

Also Read: Bharat Biotech’s Covaxin Phase 3 Trials Begin In The State

Vaccine manufacturers systematically monitor and track the effects of the vaccine at this stage after it has been adopted.

“If a vaccine or two comes after you get emergency clearance, you should have full confidence that the vaccine is scientifically proven, meets global standards, is safe and effective,” he said.

When asked about AEFI for the COVID-19 vaccine, Paul replied, “This is an adult vaccine. Our AEFI system was targeted at children and women, and these vaccinations take place in specific ways, from hospitals to communities. However, when we deal with adults there are certain practical issues that need to be addressed.

Second, these vaccinations are on several new platforms that add complexity. When an emergency permit is given, more responsibility is required. After all, there are always new aspects, side effects and situations that need to be considered. Above all, a large number of beneficiaries and target groups should be approached in mission mode in a short time, ”he said.

“Hence there is a need to build on AEFI’s standard principles and tailor them specifically to the broader dimension of the requirements of this particular vaccine set.”

For vaccine development, said Paul, the DCGI this week approved the conduct of phase 1 and 2 clinical trials in humans with the COVID-19 vaccine, which is being carried out by Pune-based Gennova Biopharmaceuticals Ltd in collaboration with HDT, USA , were developed.

“An important part of this vaccine is different from Pfizers or any other vaccine. If this vaccine exists, it can be maintained in a normal refrigerator under normal cold chain conditions. It’s a big deal, ”he said.

At this point in time, six vaccines are in clinical trials in India. These were developed by Bharat Biotech in collaboration with ICMR. Second of Zydus Cadila; third from Gennova; Oxford vaccine, the study of which is being carried out by the Serum Institute of India; Sputnik V vaccine developed by Dr. Reddy’s Lab, Hyderabad, made in collaboration with Russia’s Gamaleya National Center; and the sixth, manufactured by Biological E Ltd, Hyderabad, in collaboration with MIT, USA. Biological E.

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