The state of ongoing vaccine trials

A senior journalist states some vital facts about vaccine development in the history of human civilization and lends an in-depth perspective about the situation in context to the much awaited COVID-19 vaccine

Throughout history, nothing has killed more human beings than the viruses, bacteria and parasites that cause diseases. Not natural disasters, like earthquakes or volcanoes, not event war but the novel coronavirus disease (COVID-19) that emerged from Wuhan has turned into a mass killer. The COVID-19, declared by World Health Organization (WHO) as a pandemic on 11.03.20, has infected a little over 4,06,51,472 people and killed a little more than 11,22,997. On the other hand about 3,03,56, 801 people have recovered in 215 countries and territories across the world and 2 international conveyances till 05:19 GMT on October 21 as per worldometre.
Chinese virologist Dr Li-Meng Yan, assigned to investigate 'new pneumonia' in Wuhan, was the whistleblower through her stunning disclosure with scientific evidence that COVID-19 was created in a government controlled laboratory in Wuhan, the original epicentre of the global outbreak. Dr Yan had contacted a famous Chinese YouTuber in the US and exposed this fact. According to her the Chinese Government was just covering the virus and its human to human transmission already existed. "Sars-CoV-2 is a 'high mutant virus' that will become an outbreak soon and the Wuhan seafood market projected as intermediate hosts of the virus is just a 'smokescreen', she had stated several months ago.
"I decided to report it to my supervisor, who is also a WHO consultant. There was no response from the WHO and my supervisor. Everyone warned me not to cross the right line and maintain silence or else I would be made to disappear," she stated, before being allegedly forced to flee from Hong Kong to the US over safety concerns. Incidentally on 11.09.2019, she had highlighted her research on COVID-19 and the challenges she was facing in the course of an interview on a British talk show 'Loose Women' from a secret location. "This virus is not from nature. It originated from China Military Institute that discovered and owned some bad coronavirus, like CC45 and ZXC41, whose lab modification becomes a novel virus," she had added.
Human beings have benefited from vaccines for more than two centuries. Yet the pathway to effective vaccines has been neither neat nor direct as reflected by history of vaccines and immunization, beginning with Edward Jenner's creation of the world's first vaccine for smallpox in the 1790s, according to Alexandra Minna Steran and Howard Markel.
Dr Jenner, who hailed from Gloucestershire in England, had administered the world's first vaccine for smallpox. His 12 experiments since the 1770's published in a volume - Inquiry into the Causes and Effects of the Variolae Vaccine has laid the foundation for modern vaccinology. New vaccines by scientists were developed after more than 80 years due to bacteriological revolution, beginning in 1880s.
The vaccines developed so far include vaccines for Cholera, Dengue, Diphtheria, Hepatitis A, Hepatitis B, Hepatitis E, Influenza, Japanese encephalitis, Malaria, Measles, Meningococcal meningitis, Mumps, Pertussism, Rabies, Rotavirus, Rubella, Tetanus, TB, Typhoid, Varicella, Yellow Fever etc.
Today there is a global competition among scientists to invent COVID-19 drug and vaccine. However, the scientists have specific challenges.
The pathway to effective vaccines in human history has been neither neat nor direct
Replicating ability: "The pathogens are self-replicating. This sets them apart from the other major threats to humanity. When the virus infects, it makes the host a cellular factory to manufacture more viruses. The bacteria is capable of replicating on its own in the right environment," writes Bryan Walsh, an authority on viruses and vaccine development.
Representative image
Image: Representative image
The pathophysiology of the coronavirus disease is complex and mostly unknown. Therefore, identifying the molecular mechanisms that promote progression of the disease is critical as recent studies have reported transcriptomic profiles of cells, tissues and fluids from infected patients that mainly demonstrated activation of humoral immunity, dysregulated type I and III interferon expression, intense innate immune responses and inflammatory signaling.
Clinical trials for a new vaccine are on in many countries. There were 321 vaccine candidates in development in October 2020, a 2.5 fold increase since April. However, no candidate has completed clinical trials and efficacy. In October, some 42 vaccine candidates were in the stage of clinical research, including 33 in Phase-I-II trials and 9 in Phase-II-III trials.
The WHO, Coalition for Epidemic Preparedness Innovations (CEPI), and Gates Foundation have committed funds while a WHO telethon on 04.05.20 received US $8.1 billion (by way of pledges) from 40 countries to support rapid development of vaccines. The WHO also announced deployment of an international 'Solidarity trial' for simultaneous evaluation of several vaccine candidates reaching Phase-II-III clinical trials.
Globally, there are 230-odd initiatives in the vaccine race with 130 companies in a reasonably advanced stage. Of this, around 10 have already started clinical trials. In India (which is a major supplier of vaccines globally) several MNCs are talking to local manufacturers to see if their vaccines can be made here.
Coalition for Epidemic Preparedness Innovations (Cepi) vice-chair Gagandeep Kang has stated that there is reason to be optimistic as data emerging from clinical trials says a vaccine is feasible. Pune-based Serum Institute of India (SII) had begun Phase-II clinical trial of vaccine (Covishield) on healthy Indian adults on 25.08.20. The SII has partnered with a British-Swedish pharma company AstraZeneca for manufacturing the vaccine candidate, developed by the University of Oxford. 
Billionaire philanthropist Bill Gates, in his virtual address at the Grand Challenges Annual Meeting had said that COVID-19 vaccines shall be available by the summer of 2021 and this will be the fastest vaccine to be ever developed in human history.
India's research and manufacturing capabilities will play an important role in the fight against COVID-19, Gates said, adding that India is 'very inspiring' as it has taken several steps to improve the health of its people in the last two decades. "And now, India's research and manufacturing will be critical to fighting COVID-19, especially when it comes to making vaccines at large scale," he said. According to India's Union Health Minister, Harsh Vardhan the target for India is to make 30 crore shots available by June 2021.
Incidentally, India's largest vaccine trial (on 464 patients from 39 hospitals) in August, which was an initiative of Indian Council of Medical Research (ICMR) was not successful. Thus, scientists have been working with a hope against hope to make a vaccine.



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