War and disease have marched arm in arm for centuries. As World War II raged in Europe, the US military recognised that infectious disease was as formidable an enemy as any they would encounter on the battlefield. The US set up the Influenza Vaccine Commission to protect its soldiers from a repeat of the Spanish flu more than two decades ago.
Scientists took up the vaccine human trials on soldiers with war-time urgency. They completed the trials within a year, with full government backing, according to experts.
Could the Covid crisis do for the coronavirus vaccine what the war did for the flu vaccine?
“The world needs to come together and fast-track processes. I believe we can have the vaccine within a year. We already have the ‘proof of principle’ for the vaccine.
The trials have to move at a fast pace,” said Jacob John, virologist and former Indian Council of Medical Research chief.
There are over a 100 vaccines for Covid-19 currently undergoing research around the globe. Never has the world seen any vaccine being developed in less than five years, except the mumps vaccine, which took four years. The flu vaccine, too, involved years of laboratory research before the Commission was set up.
With Covid-19, scientists are hoping to accomplish a never-before feat. Some including the UK’s Oxford-AstraZeneca, Moderna, and China’s Sinovac Biotech are entering the stage of large-scale trials next month.
“We will be able to develop a vaccine, but it has to follow all the vaccine development steps... the minimum time we would need is at least 18-24 months, provided all the necessary facilities are made available,” said E Sreekumar, chief scientific officer, Rajiv Gandhi Centre for Biotechnology.
According to virologists, there are four phases in developing a vaccine. In the first phase, the researchers conduct a clinical trial, where very small doses are given to a small group of individuals.
In the second, healthy volunteers are injected with the vaccine. The purpose is not to look at the effectiveness but for side effects, studying the dosage and the quantity of antibodies that an individual develops. It helps assess what the body does to the drug and vice versa.
In the third phase, the individuals are given the vaccine and monitored over a period of time. During this phase, they may catch Covid-19, but may show only mild symptoms due to presence of antibodies.
“There are ethical considerations. Because you’ve given a vaccine to someone, are you going to challenge them with coronavirus to see if the immune system shuts it out?” asks Satyanarayana Mysore, head, Department of Interventional Pulmonology, Manipal Hospitals. In the fourth phase, which is achieved only after safety and efficacy have been shown in the previous stages, scientists monitor for five-six months after the vaccine is given to see if there are any remote side effects and whether a booster dosage is required. This entire exercise can take at least four-five years.
There are four categories of vaccines which are under development: the mRNA vaccine, which uses the genetic component of the virus itself, the standard vaccine using a weak version of the virus, third uses some other virus’ backbone, and last is the one where protein of the virus is made in the lab.
“The challenge in my view is that we should not cut corners... ‘Do no harm’ is the dictum in medicine. In doing a greater good, we should not be causing irreversible harm,” said Mysore, who’s also a member of Karnataka’s Covid taskforce.
In the past, there have been casualties with the use of diphtheria and the polio accine, experts say. “Vaccination is the safest way to develop herd immunity,” added Mysore.
Vaccines for Covid itself may have to be redeveloped if the virus mutates. “I’m pinning hopes that Moderna will come up with the vaccine... Who is going to get on the moon first is the question. But, will they get on there fast and return safely is equally important,” said Mysore.
The Pune-based Serum Institute of India has partnered University of Oxford, one of the strong contenders for the vaccine, to ramp up trials and vaccine development. India is also part of a global consortium to ensure there is equity of access and risk mitigation since many countries will stockpile vaccines in advance.
However, experts say the level of global cooperation that should be happening eludes the Covid crisis. They cite the rift between the World Health Organization (WHO) and the US as a roadblock. “At the time of swine flu, everybody looked up to the WHO for guidance which took absolute leadership... They have goofed up very badly in this pandemic,” added John.
He said by not leading from the front, WHO has made countries feel they have to fend for themselves. “Each country has to make the same mistake that other countries did... That social cohesiveness was broken, unfortunately, not by the virus but by the fear of the virus and the self preservation instinct that every country has,” John added.
Next: Equal access poses final trial for Covid vaccines
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