The applications of Bharat Biotech, Serum Institute and Pfizer seeking emergency use authorisation for their COVID-19 vaccines are being examined, the Centre said on Tuesday asserting that drug regulator DCGI seeking more data from these companies will not impact the vaccine-roll out timeline.
These applications filed with the Drugs Controller General of India are being examined by the subject expert committee on COVID-19 of CDSCO for emergency use authorisation, NITI Aayog member (health) Dr V K Paul said.
"This situation was factored-in from before as it is emergency use authorisation. There should be more than reasonable satisfaction about the safety, immunogenicity and effectiveness of the vaccine," he told reporters when asked about DCGI seeking more information from the companies for grant of emergency use authorisation to their vaccines.
"The applications are being examined on scientific basis, using the frameworks that are scientific, frameworks that are globally aligned and ensuring that the vaccine is safe, immunogenic adequately and effective in reducing the incidence of COVID-19 disease in people. This independent process is going on.
"I would like to note that when we talk about these processes, it is not one individual or three people. These are people who are scientists, epidemiologists, clinicians, scientists, pharamocologists, biologists. They take the decision based on science," Paul said.
Speaking about adverse event following immunisation (AEFI), Paul said whenever a new medicine or vaccine is introduced in the country, there is a phase 4 stage of clinical trial which is also known as post-marketing surveillance.
The 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 emergency use authorisation, you should have complete faith on the fact that the vaccine is scientifically proven, matches global standards, safe and effective," he said.
Replying to a query about AEFI for COVID-19 vaccine, Paul informed, "This is an adult vaccine. Our AEFI system was targeted to children and women and those vaccinations take place in a certain way, starting with hospitals and then into the communities. But when we deal with adults, certain practical aspects have to be tackled.
"Secondly, these vaccinations are in multiple new platforms that bring in complexity. Further, if emergency use authorisation is given, it calls for more responsibility.
Lastly, there are always new aspects, side-effects, situations that have to be kept in mind. Above all, a large number of beneficiaries and target-groups are to be tackled over a short period of time in a mission-mode," he said.
"Therefore, there is a need 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."
On vaccine development, Paul said, this week, the DCGI has granted clearance for conduct of the phase 1 and 2 human clinical trials of the COVID-19 vaccine developed by the Pune-based Gennova Biopharmaceuticals Ltd in collaboration with HDT, USA.
"Important part of this vaccine is unlike Pfizer's vaccine or others, this vaccine, if it comes into existence, will be maintainable at a normal cold chain conditions in a normal fridge. This is a big thing," he said.
He said at this point, six vaccines are undergoing clinical trials in India. These are one developed by Bharat Biotech in collaboration with ICMR; second by Zydus Cadila; third one by Gennova; Oxford vaccine, trial of which is conducted by Serum Institute of India; Sputnik V vaccine which is being manufactured by Dr Reddy's Lab, Hyderabad in collaboration with Russia's Gamaleya National Centre; and the sixth one manufactured by Biological E Ltd, Hyderabad, in collaboration with MIT, USA.