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“Gaumutra” Vaccine: Against all odds

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If you have not guessed it already, I’m referring to Covaxin, India’s first fully indigenous Vaccine response to slay the demons let loose by the ‘once in a century’ global pandemic, Covid 19. “Gaumutra” Vaccine was a frequently used pejorative for Covaxin on social media(SM). Given that SM is prone to hyperbole and extreme responses, the crude name given to Covaxin was not surprising. But why was it called “gaumutra” vaccine is what fascinates me and pains me at the same time.

The name implies a half baked, no good Vaccine. A large part of mainstream print and TV media (MSM), though more nuanced in its criticism of Covaxin, was also essentially skeptical about Covaxin. Unfortunately, a section of Indian scientists and academicians too were skeptical about Covaxin. Objective criticism is good for science. It spurs scientists to course correct and improve. But in case of covaxin, most of the criticism from MSM and academia was not based on science but on a sense of disbelief.

How could India, a nation of also rans, produce a world class Vaccine, that too in quick time, almost simultaneously with its western counterparts. Their skepticism, however hard they tried to mask it, came to the fore with every article they wrote and every debate that they ran on TV. What should have been celebrated as an achievement of India’s medical science fraternity, was turned into a smear campaign. While the political opposition to Covaxin was understandable, the vehement opposition from MSM and a section of the scientific community was baffling, to say the least.

Covaxin, India’s indigenous Covid 19 vaccine, was developed by Bharat Biotech (BB) in collaboration with ICMR and National Institute of Virology (NIV), Pune. It was a wonderful example of a successful public private partnership.

Vaccine development is generally a long drawn and tedious process. On an average, vaccines take 10-15 years to develop. The record for the fastest developed Vaccine was held by Mumps vaccine in the pre covid era. It took 4 years to develop. In contrast Covaxin traveled from the drawing board into our bloodstream, or shall I say muscles, in less than nine months. Vaccine development is also a risky business, with no guarantees of success. Glaxo Smithkline’s MRNA vaccine was one of the early candidates supported under USA’s Covid 19 fast track vaccine development program, Operation Warp speed. But it failed at the early trial stages. German government supported vaccine, Curevac, failed in the third phase trials recently with a 47% reported efficacy (cutoff is 50%).

Covaxin’s successful journey was spectacular and nothing short of a fairy tale. India recorded its first Covid case in late Jan 2020, a Wuhan returnee in Kerala. WHO declared Covid 19 as a global pandemic in  Mar 11, 2020. India went into a nationwide lockdown in late Mar 2020. NIV-ICMR successfully isolated Sars Covid virus on Mar 13, 2020. India became the 5th country in the world to do so. ICMR-NIV entered into a PPP agreement with BB to try and develop India’s first indigenous Covid vaccine in Apr 2020. NIV transferred the virus to BB in May 2020. Dr Krishna Ella, founder of BB, mentioned in an interview that BB team had to travel from Hyderabad to Pune by road to receive the virus strain as it was lockdown time. 

Then began a scientific sprint, a race against time. Small animal trials were conducted in Jun-Aug 2020. Rhesus monkey trials were conducted almost in parallel in Jul-Aug 2020. Animal trials showed promising safety and immunogenicity data. It also established the vaccine’s ability to mount strong B and T cell response, giving ample confidence to proceed into human trials . Phase 1 and 2 trials were again carried almost in parallel in Jul- Oct 2020.

In Nov 2020, BB started what was then the largest phase 3 vaccine trials in India, carried out on 25,800 participants. Proud to report that this record has recently been broken by India’s 2nd indigenous Covid Vaccine, Zycov D, knocking at the approval doors, with phase 3 trials carried out on 30,000 volunteers. On Jan 3, 2021, Drugs Controller of India granted restricted approval to Covaxin. India started administering Covaxin as part of its Covid immunization program on Jan 16, 2021. Rest, as they say, is history.

Covaxin has been developed using a whole virion inactivated Vero cell derived platform. It’s an old and proven vaccine development platform. But the paint brush is as good as the hand that holds it. BB, a relatively new entrant among India’s vaccine makers, has carved a niche for itself with many patents and firsts to its credit. It introduced world’s first Zika virus vaccine. BB also introduced Rotovac, India’s first indigenous rotavirus vaccine.

Covaxin reported an interim efficacy of 81% and a final efficacy of 77.8%. While it’s efficacy might be lower than the current favorites, the  MRNA vaccines like Pfizer, where it scores over MRNA vaccines is in its broad based response to the virus.  In contrast, MRNA vaccines are designed for a pointed response to specific strains. No wonder that every time the virus mutates, the MRNA makers have to go back to the drawing board to tweak the vaccine, while Covaxin is effective against original strain, UK strain, Delta and Delta plus without requiring any changes in the original vaccine.

Its makers are fairly confident of its efficacy against future strains as well. Many studies across the globe r have established Covaxin’s efficacy against Delta and Delta plus variants while Pfizer is currently conducting fresh phase 3 trials of its modified version for Delta variant response.  Covaxin is “fill it, shut it, forget it” type vaccine.  In cricketing parlance, it’s an all rounder.  May not get you double hundreds or run through sides.  But an allrounder will give us enough runs and wickets when most needed.

A part of the opposition to Covaxin can be assumed to be sponsored by rival companies and countries. But its hard to believe that a large section of Indian “experts“ were not aware of the science and data behind Covaxin development. Yet they chose to consistently dismiss Covaxin as half baked, even when presented with genuine data at each stage. This was in sharp contrast to their kid gloves approach towards western vaccines. Covishield, developed by Oxford Astra Zeneca, was accepted without any murmurs, even though it faced blood clotting hurdles in several European countries.

For Pfizer and Moderna, the same set of experts were advocating blind acceptance even without a small scale bridging trial. It essentially reflected their lack of belief in Indian scientist’s abilities. It ultimately reflected their own paucity of self belief and a deep sense of inferiority complex. What should have been a celebration of India’s medical science achievement, was unfortunately turned into a smear campaign.

It was a real baptism by fire for India’s first indigenous Covid vaccine. But quality cannot be suppressed for too long. Covaxin is a good product and  I am pretty certain that it will pass all tests with flying colors.  But what worries me  is why do we need  a Dr Fauci to tell us that Covaxin is a good vaccine. A whole generation of Indians have almost been hypnotized to believe that they are inferiors and our country cannot build any world class product. While on one hand we celebrate Sundar Pichais and Satya Nadellas of this world, on the other hand we suffer from deep rooted inferiority complex.

We almost entirely credit their success to the western world’s education and work culture. We almost treat them as Americans while admiring their success, forgetting that their early education and intellect were shaped in India. We ignore another important factor behind their success. Their genes. They are children of their forefathers. They are no more or no less intelligent or enterprising than their forefathers. They could become world leaders because of the enabling environment that they got in the US. Their success gives me hope that if good educational system and work culture is provided to most of the bright kids in India, they can probably recreate the American dream and magic in India.

While most people blame the political class for all the ills that plague our country. However I don’t brood too much over it, because I am pretty certain that the political class will sooner or later improve the educational and business environment in India under public pressure. I am more worried about the fact that we Indians, with deep rooted self-doubts, may not be ready to dream and fly.

The starting step should be shedding of this inferiority complex and embracing self belief and “can do attitude” by us Indians. Even a baby leaves a walker and starts walking, though wobbly initially, only when it starts believing that it can walk without support. Great nations like US and Japan did not become developed in a day. It took decades. But the first part of the journey almost always starts with a few baby steps of self belief. All is not lost though. I see hope in the youth of today who unlike us, thanks to modern communication technology, is more exposed. Hence, they are more confident and self assured.

I ask the gen X of India, are you ready to take the baby steps of self belief before you and our great nation takes off into the skies of success and glory. India’s future trajectory is hidden in their answers.

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