In May 1796, Jenner took fluid from a cowpox blister on the hand of Sarah Nelmes, a cowpox patient, and scratched it onto the skin of a healthy 8-year-old James Phipps. Phipps got a fever, which soon subsided, but did not contract cowpox. Later, Jenner used fluid from a smallpox blister on Phipps, with the same result: no smallpox infection.
The technique was called variolation; it had been used and practised for decades before Jenner in India, China, parts of Africa and Turkey.
Jenner, a country doctor, then tried it on numerous others, in controlled and repeatable fashion: essentially, he conducted a ‘clinical trial’. He published the results of 18th century clinical trial as “An Inquiry into the Causes and Effects of the Variolae Vaccine”.
By today’s standards, Jenner’s ‘clinical trial’ is controversial, raising ethical questions about informed consent.
But then, it also enabled mass vaccination, the most cost effective and efficacious medical intervention.
Since then, we’ve made progress in ethics and scientific method too. Clinical trials, vaccines and drugs are subject to a very rigorous discovery and approvals process.
That said, the speed at which the Covid-19 vaccine was approved has generated another controversy.
Vaccines take about 10–15 years to perfect and be approved. So, it seems impossible to have approved vaccines for a pandemic in 10 months (the fastest one developed — for mumps — took four years)!
But wait, did you know that Coronaviruses are not a recent phenomenon?
Scientists have been studying the coronaviruses that cause the common cold for more than 50 years; in 1965, a group of British scientists isolated a new type of virus in tissue culture; it was similar to a virus that had been discovered in 1930s that infected chickens with bronchitis (remember the Avian flu virus?).
Hundreds of coronaviruses circulate among pigs, bats, camels, and cats. Seven made the jump from animals to humans, of which four cause mild symptoms, mostly the common cold. Three are much more serious, causing serious illness and death. SARS (severe acute respiratory syndrome) appeared in 2002 and disappeared in 2004, and MERS (Middle East respiratory syndrome) appeared in 2012. The third is Covid-19.
With a blueprint available from the past…
It took just 10 days after the first cases were reported in Wuhan, China to uncover the viral sequence of SARS-COV-2, or Covid-19. Thank advances in genomic science and technology that helped decode its genomic sequence. Researchers working together globally on creating a vaccine for the coronavirus family accelerated their efforts. In early April 2020, 74 countries had volunteered to be part of the Solidarity Trial, a global clinical trial and WHO initiative to create Covid-19 vaccines.
A 2018 study in The Lancet Global Health estimated the costs of early development and initial clinical trials in the range of $31–68 million.
Large scale clinical trials increase costs and accelerated development compounds them, so government funding becomes important. The US effort — ‘Operation Warp Speed’ — is a government-funded collaboration with multiple partners, the Centre for Diseases Control (CDC) and the National Institutes of Health (NIH).
The European Commission has also funded several vaccine candidates; it has contributed to a pool of $8 billion for Covid-19 research.
Our government, in the Union Budget for 2021–22, has committed almost $5 billion (Rs 35,000 crore) for vaccinating about one third of the population, or roughly 300 million people.
Globally, 6 vaccines have been approved — Pfizer and Moderna (US), Sinopharm (China), Gamaleya (Russia), AstraZeneca (the UK) and Bharat Biotech (India). There are currently 37 more in Phase 1 (tested for safety and dosage), 27 in Phase 2 (expanded safety trials) and 20 in Phase 3 (large-scale efficacy testing).
Can a controversy attract that kind of money?
In recent weeks, there have been headlines about new and emerging variants of Covid-19 that are harder to treat and have higher mortality rates. Scientists are trying to develop a vaccine that could protect people from all its forms and variants: a pan-virus vaccine. Attempts to create a similar vaccine for all variants of influenza failed; governments were unwilling to fund the development of a pan-virus vaccine, but Covid-19 has changed all that.
When you look back at the history of most technological breakthroughs, there has almost always been controversy over the impact they are going to have. It is be no different for the Covid-19 vaccines. But that’s not cause for anxiety or hesitation, but for the celebration of medical science.
So, let’s pay attention to the science instead of fanning the fires with controversies.