Amid concerns raised by various quarters regarding the efficacy of the Covaxin indigenously developed by Bharat Biotech that is yet to complete phase 3 trial, the DCGI said it will be used in restricted cases and was approved “in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains”.
“We’ll never approve anything if there is slightest of safety concern.
“The vaccines are 110 per cent safe. Some side effects like mild fever, pain and allergy are common for every vaccine.
“It is absolute rubbish that people may become impotent,” he said at a Press conference here.
However, the doctors and research experts were not convinced as they termed it ‘a dangerous step’ given that details of Stage 3 clinical trials were yet not available.
They argued that the problem is that the Government in its eagerness to promote ‘vocal for local’ notion has bypassed key parts of the standard drug and vaccine-development protocol and have questioned DCGI’s claims that “it is 110 per cent safe”.
Experts also warned that the decision may lead to distrust among people regarding vaccines and that it may become difficult for the Union Government to defend it in the international fora.
Dr Rahul Bhargava, Director (Institute of Blood Disorder and Bone Marrow Transplant) Fortis Hospital, Gurgaon said that the Government is trying to modify the protocols related to phase three trials.
“We could have given go ahead to the vaccine developed by the Pfizer and Serum Institute of India as they have conducted needed studies. Biotech is still undergoing requisite trial and giving go ahead on the basis of present data can be harmful for the people.”
“Completely unaware of any data on efficacy of Bharat Biotech vaccine,” Dr Gagandeep Kang, an infectious disease expert told a news channel adding that it will be a stretch to say the vaccine will work against the UK strain of Covid. Her statement came even as AIMS Director Dr Randeep Guleria said that Covaxin can be used as a backup.
The All India Drug Action Network (AIDAN) called for withdrawal of nod to the Covaxin. “In light of the intense concerns arising from the absence of efficacy data and hence the limited regulatory review of the vaccine candidate, the implications of public rollout of an untested product, and lack of transparency we urge the DCGI to reconsider the recommendations of the SEC in granting the REU approval to Covaxin,” it said.
The only data for humans, available through publication pre-prints, are for safety and immunogenicity from Phase 1 and Phase 2 trials, across a total of 755 participants. In the interest of transparency it will be in the fitness of things that the trial data on the basis of which decisions have been taken by the SEC are immediately made public.
It is also not clear under which provisions of the extant law the SEC has recommended for grant of REU approval and in “clinical trial mode” at that, AIDAN said.
“The hypothesis being propagated that the whole virion inactivated vaccine is likely to be effective against mutations of the virus is not being supported by any efficacy from the trial because no data have as yet been generated in the Phase 3 trial. Yet this appears to have been used to justify the totally non-sequitur decision which has no basis in the science of rational vaccine development”, it said.
Dr Randeep Guleria, who is also member of the national task force on the coronavirus management in the country, said “in an emergency situation when there is a sudden increase in cases and we need to vaccinate, Bharat Biotech vaccine will be used. It can also be used as a backup when we are not sure how efficacious the Serum Institute vaccine is going to be.”
“Approval clearly says ‘emergency situation’ keeping in mind the circulating variant strains and at the same time, they have to continue the trial and get the data in. Once that data comes in, we will be more confident as far as safety and efficacy is concerned,” he said.