DCGI seeking more data for granting emergency use authorisation won't impact timeline for vaccine roll-out: Govt

applications of Bharat Biotech, Serum Institute and Pfizer seeking emergency use authorisation for ir COVID-19 vaccines are being examined, Centre said on Tuesday asserting that drug regulator DCGI seeking more data from se companies will t impact vaccine-roll out timeline.

se applications filed with Drugs Controller General of India are being examined by 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. re should be more than reasonable satisfaction about safety, immugenicity and effectiveness of vaccine," he told reporters when asked about DCGI seeking more information from companies for grant of emergency use authorisation to ir vaccines.

" applications are being examined on scientific basis, using frameworks that are scientific, frameworks that are globally aligned and ensuring that vaccine is safe, immugenic adequately and effective in reducing incidence of COVID-19 disease in people.  This independent process is going on.   "I would like to te that when we talk about se processes, it is t one individual or three people. se are people who are scientists, epidemiologists, clinicians, scientists, pharamocologists, biologists. y take decision based on science," Paul said.

Speaking about adverse event following immunisation (AEFI), Paul said whenever a new medicine or vaccine is introduced in country, re is a phase 4 st of clinical trial which is also kwn as post-marketing surveillance.  vaccine manufacturers during this phase monitor and track effects of vaccine systematically after it has been passed.  "If a vaccine or two comes after obtaining emergency use authorisation, you should have complete faith on fact that 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 n into communities. But when we deal with adults, certain practical aspects have to be tackled.

"Secondly, se vaccinations are in multiple new platforms that bring in complexity. Furr, if emergency use authorisation is given, it calls for more responsibility. Lastly, re 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.  "refore, re is a need to build on standard principles of AEFI and make it specific to fuller dimension of requirements of this particular set of vaccines."    On vaccine development, Paul said, this week, DCGI has granted clearance for conduct of phase 1 and 2 human clinical trials of COVID-19 vaccine developed by Pune-based Genva  Biopharmaceuticals Ltd in collaboration with HDT, USA.

"Important part of this vaccine is unlike Pfizer's vaccine or ors, this vaccine, if it comes into existence, will be maintainable at a rmal cold chain conditions in a rmal fridge. This is a big thing," he said.

He said at this point, six vaccines are undergoing clinical trials in India. se are one developed by Bharat Biotech in collaboration with ICMR; second by Zydus Cadila; third one by Genva; 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 sixth one manufactured by Biological E Ltd, Hyderabad, in collaboration with MIT, USA.Biological E.