New Delhi: Some healthcare experts Monday questioned the government’s assertion that Bharat Biotech’s COVID-19 vaccine Covaxin can target mutated coronavirus strains. The healthcare experts asked for the scientific basis for the claim and for the vaccine’s safety and efficacy.
India’s drugs regulator Sunday granted emergency use approval to Oxford-AstraZeneca’s ‘Covishield’. It also granted approval to the indigenously developed Covaxin. The permission to use Covaxin was given even though not enough data on the latter’s efficacy and safety was available. Hence a debate has been triggered in India over the approval to Covaxin.
Noted virologist Shahid Jameel said he does not believe that eventually Covaxin would turn out to be safe. He also stated that it will not show more than 70 per cent efficacy.
“I say this based on the platform, which is widely used. Bharat Biotech’s own track record of successfully making inactivated viral vaccines is a pointed to the fact,” Jameel said. He also said his concerns are based on the processes adopted for approving the vaccine.
“If approval requires both safety and efficacy data for a representative population, phase 2 safety and immunogenicity do not fulfill that criteria,” Jameel pointed out.
Also read: Bharat Biotech gets permission to manufacture ‘Covaxin’ for sale
“That is why we conduct a phase 3. It is the closest you get to a population. Where is that data? Vaccines are not drugs. They are given to healthy people. They are prevention not a treatment. Both safety and efficacy is required,” the virologist asserted.
Indian Council of Medical Research (ICMR) Director General Dr Balram Bhargava had Sunday said Covaxin is based on an inactivated whole virus. So ii has potential to target mutated coronavirus strains including the UK-variant. That was one of the major reasons for giving it a conditional nod. He, however, had also said no clear data regarding the efficacy of the vaccine is available so far.
All India Institute of Medical Sciences (AIIMS) director Randeep Guleria Monday said Bharat Biotech’s vaccine has been given approval only in emergency situations as a backup. “If there is a surge in cases then we may need larger doses of vaccine then we may go with Bharat Biotech’s vaccine. The vaccine is more of a backup,” he said.
Guleria also rejected claims of fast-tracking the process.
“None of the clinical trials was fast tracked in terms of safety and efficacy. Fast tracking was done in taking regulatory approval which generally takes a long time while going from one phase to the other,” he informed.
All India Drugs Action Network (AIDAN) also questioned the claim that Covaxin can work better against the UK strain of the virus. It has been said that the new strain is more transmissible.
“It is not clear if there is any scientific basis to claim that Covaxin will be effective in the context of infection by mutant strains when its efficacy has not been established and is currently unknown against any strain of the virus,” AIDAN said in a statement.
“The claim 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 has been generated as yet in the Phase 3 trial,” it added.
