Dr George Jacob
Kochi, July 25, 2020: The world has been at the mercy of SARS CoV-2 since late December 2019. Originating in the wet markets of China’s Wuhan through an inter-species transfer from bat to man, the virus managed to escape from its cage and become at its destructive best.
It has had the entire world between its powerful jaws. It still is at it. The mayhem unleashed had an initially somnolent and reluctant WHO wake up to declare it a pandemic.
Thousands continue to take ill and perish. Amid the whimper of the sick and labored breathes of their stretched care-givers can be heard cries for a vaccine. It represents the cry of the panicky sick and vulnerable healthcare providers – a medical world running helter-skelter for some semblance of defense against the marauder.
But the vaccine is no genie to spring out of a bottle on the shelf of some laboratory. This genie has to go through numerous stages before it matures into a full-fledged one to take birth as an efficacious vaccine.
The stages are exploratory stage, pre-clinical stage, submission of IND (Investigational New Drug) application, clinical stage, which itself need to go through I, II and III phases. The ‘genie’s developer after Phase III then applies for approval and licensure from bodies like FDA in the USA and ICMR in India.
One such genie-ChAdOx1nCoV-19, jointly developed by Oxford University and Pharma giant AstraXeneca seem to be attired and ready to leap out of the bottle, having shown promise in Phase III, as claimed by the journal lancet.
Closer home, India’s Bharat Biotech India is being arm-twisted by the ICMR to let out its ‘genie’-Covaxin by August 15.
Why August 15? ICMR head Balram Bhargava on July 2 asked all 12 trial sites of dubious standards to develop the vaccine by August 15. He probably wants the ICMR ‘bottle’ uncorked by the camera-happy prime Minister to let out the genie on the ramparts of the Red Fort, when addresses the nation on Indian Independence Day!
The showman premier will not have that video-op get past him! But Covaxin has only gained approval for phases I and II of mandatory trials. Dressing it up in a month could be disastrous. Bioethics experts have already expressed reservation of letting out a half-done ‘genie.’
It has to be used on humans, and not on animals once it collects its license. It would be foolhardy to rush through vaccine production. Historically, the gestation period of a vaccine has been 10 years. It has been so since Edward Jenner developed the smallpox vaccine in 1796.
Irrespective of the bottle from which a genie against SARS CoV-2 armed with license emerges, efficacy of the same will be weighed against the following facts:
• Initial results of Phase III of developing the Oxford ‘genie’ seem not to confer uniform long-term immunity on tested subjects.
• Vaccines have failed to halt the march of Covid-19’s lesser cousins, SARS and MERS
• Reports of reinfection with the virus have been reported from various regions as the pandemic rages.
• SARS CoV-2 is prone to mutation like any other virus, and its natural history varies widely within regions even in the tiny Indian state of Kerala, from where this is being penned. Every vaccine that has been developed has had to pass through a long period of uncertainty. It has had to wait till the confidence of men and women in white- those habitual nay-sayers, stubborn conformists and adamant conservatives is won for wider use. Remember, they were the ones who drive Jenner to lunacy before he developed the smallpox vaccine! The world will only be too happy to accept any vaccine, which has completed all phases of proper development, unhurried from any investigator. Away from the rigors of the mad competition the world is now witnessing, to develop one, and one which will render mankind immune to SARS CoV-2 for considerable time.