Rigmarole of Vaccines

Farid Ahmad

19th August, 2020 11:57:23 printer

Rigmarole of Vaccines

Farid Ahmad

Once a lethal virus goes out of sight, it goes out of mind. The first strain of the coronavirus raged in Asia about two decades ago. There was an immediate effort to develop a vaccine against the pathogen. A decade later, a new strain of the same virus emerged in the Middle East after the dust of the first strain had settled. Again, a renewed enthusiasm for developing a vaccine surfaced. Now, nearly two decades from SARS outbreak, we are battling against another novel strain of the coronavirus known as Covid-19 that emerged from China's Wuhan. This tiny creature has, of course, well dwarfed the prior two coronavirus strains in its transmissibility and lethality. This novel pathogen has ultimately caused a global pandemic, disrupting society more suddenly than any previous pandemic outbreak, endemic disease or battle could. Once again, the researchers jumped into action to develop vaccines against the newest strain of the coronavirus.

Vaccine is the crown jewel that is born after labouring over the research by the scientists for years. And it functions as the protective shield against pandemics. Therefore, why we did not already have a vaccine against coronavirus? An inside look provides many causes as the answer of this question. Generally, when a pandemic subsides, the public loses interest. Funding and research for vaccines fall. Even the committed funds for research and development dry up or sometimes they are diverted to other projects. Thus, most labs working to develop a vaccine against the pathogen find it difficult to secure the level of support needed to accomplish the task. And the efforts to continue rapid development of vaccines inevitably ebb. Moreover, developing a safe and effective vaccine is a Herculean task and a monumental accomplishment. Many things can go wrong during the research. Always big hurdles stand between humanity and safe vaccines that show a degree of efficacy that would make it deployable. So, a vaccine cannot be brought to market in a hurry. It takes years to prove its effectiveness free from side effects.

In 2014, President of the Sabin Vaccine Institute Professor Peter Hotez and others wrote an article emphasising the urgent need for a vaccine targeting the strains of the coronavirus that caused SARS and MERS. In the article, Hotez wrote, “Waiting for a full-blown MERS epidemic, or even pandemic to occur, before even beginning vaccine development could result in the loss of many lives.” From his statement, it seems he knew enough to know that the world would be ill-prepared for inevitable future coronavirus pandemics. As Hotez predicted, the current outbreak is already on the track to be the deadliest coronavirus pandemic in history.

However, research information is never being thrown up by the researchers. Researchers have already sequenced the coronavirus genome. They have clear understanding of its molecular mechanisms and enough knowledge about its life cycle and how it invades the human respiratory systems. Therefore, they have had the off-the-shelf information necessary to begin developing a vaccine. For these reasons, Covid-19 vaccines have started cropping up, defying the long and tedious timeline required to develop a vaccine traditionally. There are currently over four dozen different vaccines awaiting clinical trials. Among them five vaccines are in final trials. Researchers are optimistic and promising to bring the vaccine in the market within a few months. Nearly all of these vaccines rely on the molecular understanding that was discovered during the outbreak of SARS and MERS.

Historically, vaccine developers used to grow live viruses in cells. These real, lab-grown viruses tend to be either weakened, inactivated, or stripped down to their benign parts before being introduced into a person’s body, where they triggered a protective immune response. Some institutions are following these traditional procedures for developing Covid-19 vaccines. But the new platforms that are leading currently to create vaccines are mRNA platforms. Here mRNA stands for ‘messenger RNA’. This is a type of molecule that can convert a DNA’s blueprint into an actual, functional protein molecule. Genes are at the centre of these new vaccine platforms. The mRNA platform is therefore designed to isolate a virus’s ‘gene of interest’. This particular gene codes for the protein that the immune system reacts to; thus, prints its genetic sequence, and then formulate it so that it can be injected into a person. Once injected, the idea is that the body’s cells will take up the mRNA and start making proteins that trigger a protective immune response. In short, modern vaccines are based on messenger RNA (mRNA) that carries the genetic material of the virus and teaches the body's immune system to fight the virus.  

The mRNA platform can produce vaccine quickly and in great volume. It abridges the usual ‘decade or more’ timeline for vaccine development to less than two years. But the problem is that the newer platforms that are generating the hype, hoopla and optimism are relatively untested, largely unproven. Therefore, these vaccines could come with new and unexpected risks.  A commercial vaccine has never been brought to market using these platforms. Hundreds of researchers throughout the world are exploring new and old sciences for Covid-19 vaccine development. They want as many shots on goal from as many different directions, so that they can eventually get a vaccine. Their initiatives to develop a vaccine correspond substantially to the shotgun approach that is out of many one, two or a few small grapeshot’s from a shot gun are sufficient to bring down a bird.

Vaccines, as a pharmaceutical product, are not particularly profitable. Vaccines are massively expensive to produce and involve a big financial risk. Even vaccines that got approval from the research and development section to move forward, often fail during clinical trials, forcing companies to abandon the projects. For pharmaceutical companies, vaccines often are simply a poor business model. A future vaccine that would have high efficacy against coronavirus will generally confer protection for the entire life of an individual if a dose of the vaccine is administered to him for one time. On the contrary, it is extremely profitable for pharmaceutical companies to put their efforts to produce and provide drug treatments for chronic conditions, where people take medicines on a daily basis for extended periods of time. For these reasons, many companies turn away from vaccine business. If history guides the present stakeholders, efforts to create a vaccine against coronavirus will unfortunately not continue with the same enthusiasm and support that are happening now as soon as the outbreak naturally subsides. Scientists should not let the history repeat itself.  The world infected with coronavirus needs a vaccine to be ready and available as soon as possible. To ensure that it happens, scientists are conducting research day and night. Many companies are working to produce vaccines taking massive financial support from the US government and others. Very recently, Russia has given astonishing news amid the positive news from the US and the UK. On August 12, 2020, President Putin said that Russia had become the world's first country to grant regulatory approval to a Covid-19 vaccine, a move hailed by Moscow as evidence of its scientific prowess. The Economic Times reports the breaking news under the caption ‘Russia registers the world's first coronavirus vaccine; Putin says his daughter was given a shot.’

While some prominent scientists are wondering about the speed of vaccine’s approval because of its incomplete final trial, commonly known as Phase III trial involving a large number of people as participants, the Moscow based Association of Clinical Trials Organisations (ACTO), a trade body representing the world's top drug makers in Russia, has urged the health ministry to postpone approval until that final trial had been successfully completed. ACTO has said there are high risks associated with registering a drug before that happens. But the Russian business conglomerate Sistema has said it expects to put it into mass production by the end of this year. The Russian vaccine developed by Moscow's Gamaleya Institute will be marketed under the trade name 'Sputnik V' on foreign markets. 'Sputnik V' will remind the whole world the historic ‘Sputnik moment’ of 1957 when the then Soviet Union launched the world's first satellite Sputnik 1. Many misdoubt that Moscow may be putting national prestige before safety. But Putin dismissed those concerns; rather he was bragging about Moscow's success during the announcement.

If anyone has already read the reports of The New York Times and BBC News regarding the hacking of vaccine data by Russian spies, he is supposed to be able to visualise the vaccine market scenario. Western Nations’ security services warned the concerned saying that the hackers have been targeting British, Canadian and American organisations racing to create coronavirus vaccines. On May 18, 2020, British Prime Minister Boris Johnson said that there might never be a vaccine for Covid-19 despite the huge global effort to develop one. On August 4, 2020, WHO has warned that a vaccine for coronavirus might never be found. WHO Director-General said at a virtual press conference that a "silver bullet" answer to the pandemic is far from guaranteed, despite scientists around the world pushing to develop one. He also added, ‘We all hope to have a number of effective vaccines that can help prevent people from infection. However, there's no silver bullet at the moment, and there might never be.’ On the other hand, Russia is saying that twenty countries, including India that has the largest vaccine producer in the world ‘Serum Institute of India (SII)’, have pre-ordered one billion doses of Sputnik V and that with foreign partners it would be able to produce 500 million doses a year in five countries.

However, news of a potential Covid-19 vaccine should be welcomed. Russia's groundbreaking and encouraging work should be hailed as the most revolutionary move towards successful production of a vaccine that can oust coronavirus from our planet. But safety must be the priority during this vaccine preparation. Hope Russia and other countries will adopt prudent approaches breaking their business jargon. And the innovators will ensure equitable access to their future vaccines. Billions of doses would be produced for the world population. People of low- and middle-income countries will not be neglected. Though first Cholera vaccines were developed throughout the decades (1880-1900), they were available globally on a large scale since the second world war. We now wish that the shipments and even-handed distribution of vaccines will be as quickly as possible across the world by advanced and efficient distribution network.

[The writer acknowledges different sources of information with gratitude.]


The author is Assistant Professor, Institute of Appropriate Technology, BUET and Reviewer, Advances in Economics and Business, HRPUB, USA.