By Dr. George Jacob

Kochi: It is not even a year since SARS-CoV-2 infected humans and boiled over into a full-fledged pandemic. The first whining for a vaccine against the novel virus was heard even with the virus’ first baby steps over the Great Wall of China.

There was a virtual stampede by clueless healthcare providers and desperate nations outside laboratories expecting a messiah who will deliver humankind from Covid-19. They assumed that with dearth of pharmacological redemption from unrelenting grip of a determined virus, a vaccine would be the ‘messiah’, who could impress on the virus causing infection of the gravity of Small Pox and Spanish Flu pandemics to let go.

As viral statistics threatened to go through the roof, heads-of state arm-twisted reputed pharma companies. They upped into fifth gear and claimed success with vaccine discovery. It mimicked the proverbial ‘tiger there, tiger here’ situation. Politicians, especially those belonging to India’s governing alliance realized they had a new magic wand to wave at naïve countrymen.

They had yet another promise to blurt out through microphones at electoral rallies. Illiterate and gullible voters listened without understanding much. Without realizing consequences! Joining politicians were governments which had much to gain by jumping onto the vaccine bandwagon.

Compulsions were many. America’s Trump had an important presidential election to fight. India’s Modi had elections to many of her state legislatures lined up. Vaccine against the Corona virus seemed a new guaranteed vote-winner. Amidst the growing ruckus around the much sought-after vaccine stood skeptical healthcare providers and infectious-disease experts.

Skepticism that wasn’t misplaced in the face of numerous uncertainties of a relatively novel viral pandemic viz; reinfection, viral mutation, shelf-life of immunity-conferring antibodies, serious adverse events reported haphazardly during development of various vaccines by different competing pharmaceuticals, tendency among communities which claimed to have ‘flattened the viral curve’ to throw caution to the wind. Only to have viral graph assume verticality. With governments imposing lockdowns subsequently. Europe is an example.

The responsibility to restore sanity firmly rested with stretched pharmaceutical laboratories. The ball remained in their courts. They seemed to respond to the challenge admiringly.

Resultantly there is a long train of vaccines claiming to have passed prescribed phases of vaccine development on the conveyer belt rolling out of the pharmaceuticals.

Some of them are:
• Moderna. This nucleoside modified mRNA vaccine developed by Massachusetts-based Biotech company claims successful completion of Phase I trials. It has entered Phase III trials on 30,000 volunteers across the USA. The vaccine which claims up to 100% efficacy is expected to occupy pharmacy shelves by February/March 2021.
• AZD 1222. This recombinant Spike(S) protein of SARS CoV2 developed from weakened version of Common cold-causing Adenovirus from Chimpanzees claims 90% efficacy. This has entered phases II/III trials in India and England and phase IIII trials in Brazil, South Africa and US.
• BNT162b2. This vaccine produced by New York-based Pfizer and Germany’s BioNTech claiming more than 90% efficacy has entered phases II and III in US, Brazil and Germany. At the time of writing Britain has reportedly licensed the vaccine for human use from next week.
• Covaxin developed by India’s Bharat Biotech has secured permission for Phase III trial.
• Sinovac. Developed by China’s Sinovac Biotech has launched phase III trials in Brazil, Bangladesh, Indonesia and Turkey.
• Sinopharm is another Chinese vaccine undergoing phase III trials in UAE, Peru and Morocco.
• Sputnik V developed in Russia’s Gamaleya National Centre of Epidemiology and Microbiology claims over 90% efficacy.
• JNJ-78436735 a vaccine developed by Johnson and Johnson’s janssen Pharmaceuticals division is undergoing Phase III trials.
• Covishield. This vaccine is developed jointly by Oxford University and pharma giant AstraZeneca. Pune-based Serum Institute of India (SII) is involved in bulk production of Covishield in India, where it is undergoing phase III trials. The vaccine made headlines recently when a Chennai-based volunteer threatened to sue SII for Rs. 5 crores for causing ‘severe neurological adverse events’ after receiving the vaccine. A piqued SII rubbishing the volunteer’s charge subsequently filed Rs. 100 crore defamation suit against him.

And the list goes on. And so does uncertainties. Most of them only in Phase III trial claim over 90% efficacy.

Are Indians ready to receive the vaccine jab?

As things stand, the resounding answer is a ‘NO’. Loud, and clear.

This is because none of the vaccines which claims over 90% efficacy have completed phase III trials convincingly. Phase IV trials await completion of successful phase III trials before the vaccine is licensed for human use.

Moreover, serious adverse events, especially involving the nervous system have been reported in a number of vaccine candidates. Unless a larger phase IV trial rules out such adverse events, no vaccine ought to be marketed.
American lawyer, activist and author Robert.F.Kennedy Jr has gone to the extreme of accusing mRNA vaccines with altering the genetic material of volunteers, amounting to genetic manipulation- a crime by itself. An observation as grave as that deserve threadbare investigation.

Lastly, the vaccine has fallen into the hands of the politician willing to play dangerous ‘vaccine politics’. The vaccine has clearly fallen into wrong hands. People shouldn’t be martyred by ‘vaccine politics’.

Last but not the least, all vaccines against SARSCoV2 demand stringent cold chain requirements. Most of them require storage in temperatures around-20 0 C, or even lower sub-zero temperatures. Effective and time-tested cold chain exists in India for vaccines included in the Universal immunization Program. This is clearly inadequate for that against the corona Virus.
For the above reasons, I will refuse to receive a dose of the vaccine, as a healthcare provider myself, as things stand- Unclear, half-baked and expedited by politicians whose agenda is not victory over the pandemic but electoral gains.

(Doctor George Jacob is the Consultant Surgical Gastroenterologist, Lakeshore Hospital, Kochi, Kerala.)