He also made it clear that the Covaxin vaccine will be administered to people under phase 3 trials and only after getting their prior consent.The Union Health Ministry has said that the centre and state governments were in a position to begin vaccination within 10 days of getting the approval from the regulator Drug Controller General of India (DCGI). The Ministry also said that the final approval to start the first phase of the vaccination drive will only be given by the central government, the Indian Express reported. The comments from the Health Ministry came days after the Drug Controller General of India (DCGI) granted emergency use approval to two Coronavirus vaccines in the country. The first vaccine has been developed by the Oxford University and AstraZeneca and manufactured by the Serum Institute of India while the second vaccine has been developed by the Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
As far as the operational challenges related to the vaccination drive are concerned, a total of 286 sessions sites in the country had already conducted a dry run of the vaccination drive one day before the vaccines were approved by the DGCI, the Union Health Secretary Rajesh Bhushan was quoted as saying. Bhushan said that the run helped in tackling operational challenges, checked the efficacy of the Co-WIN(software platform) on a larger scale and boosted the confidence of all the stakeholders concerned before the actual rollout of the vaccine.
On questions being raised about approval given to Bharat Biotech’s Covaxin before the completion of its phase 3 trials, the ICMR head Dr Balram Bhargava was quoted as saying that rules permitted the DGCI to grant emergency use approval to Covaxin on the basis of the data of its phase 2 clinical trials. Referring to the The New Drugs and Clinical Trials Rules which were formulated in March 2019, Dr Bhargava said that rules allowed the regulator to grant emergency use approval to a vaccine that had shown immunogenicity and safety in its phase 2 trials. He also made it clear that the Covaxin vaccine will be administered to people under phase 3 trials and only after getting their prior consent.
To assuage the concerns about the safety of the indigenous vaccine, Dr Bhargava said that the first dose of the vaccine had already been administered to more than 25,800 participants and about 5000 participants have also been given the second dose of the vaccine and none of the participants have reported any safety issues.
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