hyderabad the development of covaxin wasnt a rush job under political pressure the union government asserted thursday jumping to the defence of the indigenous covid19 vaccine following reports in the us that it was rolled out despite discrepancies and its maker bharat biotech was coercedthe hyderabadbased pharma company clarified wednesday that it never was under any political pressure and no shortcuts were used eitherthe two core points of reports by usbased health news website stat the reports alleged that the indian regulator endorsed the vaccine despite discrepancies in a number of clinical trial participantson thursday bharat biotech pointed out that vaccines against ebola and monkey pox were approved abroad based on phase 1 and 2 clinical data and without phase 3 if such an approval was given by regulators in india there would be an uproar but the same people and organisations remain silent demonstrating hypocrisy it saidthe government called the us reports completely misleading fallacious and illinformed it said national regulator central drugs standard control organisation cdsco strictly followed prescribed norms in approving vaccines for emergency use authorization euait said cdscos subject expert committee sec comprising domain experts granted restricted eua to covaxin on january 1 and 2 2021 after reviewing data on safety and immunogenicity and an abundant precaution in clinical trial modethe stat reports stated questionable changes were made to the trial protocols to expedite the approval process they said phase 3 protocol was given the goahead while phase 2 trials were still underway and the final covaxin candidate dosage was selected without phase 2 datathe centre said secs nod for phase 3 trial was based on scientific data presented by bharat biotech and established practices it pointed out that the clinical trial mode condition was removed on march 11 2021 based on submissions from bharat biotech and assessment of the interim efficacy and safety data by secbharat biotech condemned the targeted narrative against covaxin put forth by select individuals and groups who have no expertise in vaccines or vaccinology they helped perpetuate misinformation and fake news throughout the pandemic and are unable to comprehend global product development and licensure pathwaysexplaining the skipping of trial stages the company said the decision to proceed to phase 3 trials was taken based on data from phase 1 studies and results from successful animal challenge trials the phase 2 studies were designed to determine if the lower dose of 3mcg would be effective instead of the 6mcg dose which would have doubled our manufacturing capacity in the interest of public health it was decided to proceed with the 6mcg dose for phase 3 trialsbharat biotech said it was undeterred by efforts to discredit its work it said when some people were busy spreading false information during the pandemicour diligent efforts have resulted in a universal covid19 vaccine for adults and children alike which can be administered repeatedly as booster doses without safety concerns it saidthe company said covaxin is one of the most studied covid19 vaccines worldwide covaxin was evaluated