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As the world pins its hopes on the will and skill of scientists, the Covid vaccine race has also exposed the dirty underbelly of the pharma business where the lure of big money influences and often overrides greater common good. Here’s a report.

According to The Lancet, one of the oldest and most prominent medical journals, the first symptoms of the Covid-19 pandemic were reported on December 1, 2019, from Wuhan in China. By early 2021, the pandemic spread across the world, paralyzing normal life and collective well-being, and wrecking economies. One year old, the Covid-19 has now about 6.4 crore confirmed cases and it has claimed 15 lakh lives, show the World Health Organization statistics. 

There is consensus among the WHO and the governments that an effective vaccine is our best bet against Covid-19. It is no surprise hence that some 172 countries are in the race to develop a vaccine against Covid-19. The countries cooperate with scientists from research and pharmaceutical institutions to develop over 50 candidate vaccines for tackling the disease and restore normalcy. Although Russia announced in August that it successfully registered the world’s first Covid-19 vaccine, Sputnik-V, not everyone was in agreement. The critics are apprehensive about the claim due to the absence of data on Sputnik-V’s clinical trials. A group of international scientists also questioned the results of the vaccine published, saying some of the findings appeared improbable.

Also treading cautiously with the Russian vaccine is India, even though Moscow is open to giving the vaccine to its long-standing ally in Asia. All India Institute of Medical Sciences (AIIMS) director Randeep Guleria says the inoculation (vaccination) needs critical examinations to ensure its efficacy. Kiran Mazumdar-Shaw, promoter of the Indian pharma company Biocon, says more advanced Covid vaccine programmes are going on elsewhere. In the US, the $10.8 billion Operation Warp Speed is also placing big bets on the development of a Covid vaccine.  

As things stand now, the Covid-19 vaccine remains a work in progress and it is unlikely, dear reader, we are going to get one before May 2021. As the world pins all its hopes on the will and skill of scientists, the vaccine race has exposed the dirty underbelly of the pharma business where healthcare watchers say the lure of big money influences and often overrides greater common good. Many fear that the rush to approve vaccines and political pressure can adversely impact and deepen the current healthcare crisis. Various polls conducted in the US, where the largest number of coronavirus cases (1.4 crore) and deaths (2.7 lakh) reported, the public believe that the government-sponsored health institutions are now deeply compromised: 62% of Americans worry the US Food and Drug Administration will rush to approve vaccines without adequately assuring safety and effectiveness because of political pressure (KFF Health Tracking Poll) and only 21% definitely plan to get vaccinated while 49% probably or definitely will not (Pew Research Centre).

Covishield allegations

One such case, creating a shadow over the trials, has been reported from Chennai in India recently, where a 40-year-old volunteer alleged adverse reaction after taking the ‘Covishield’ vaccine during the trial. One of the prominent candidate vaccines in the world, ‘Covishield’, is under development at the Serum Institute of India’s (SII) Pune laboratory with a master seed from Oxford University and British-Swedish pharmaceutical giant AstraZeneca. The vaccine for SARS-CoV-2 (the virus that causes Covid-19) made in the UK is being tested in large efficacy trials in British Isles, Brazil, South Africa and the US. The Indian vaccine, funded by the SII and Indian Council for Medical Research (clinical trial site fees), is currently undergoing the Phase II and III trials. 

The Indian volunteer has sued the company for Rs 5 crore alleging that the vaccine triggered a bad reaction which includes neurological impairment and an inability to get back to life before being inoculated. That’s serious, if true. The volunteer has also demanded that the vaccine trial be immediately halted and all plans for its manufacture and distribution be suspended, failing which legal action would be taken. He was enrolled for the third phase of the human trial at the Sri Ramachandra Institute of Higher Education and Research, Chennai.

While the SII rejected the claims, the ICMR said that the Drugs Controller General of India and the ethics committee of the implementation site (SRIHER) would investigate the matter. The SII also threatened to seek damages of over Rs 100 crore from the complainant, terming the allegations as ‘malicious and misconceived’. The SII in a statement said that there is absolutely no correlation between the person’s medical condition and vaccine trial. “It is evident that the intention behind spreading of such malicious information in an oblique pecuniary motive,” the institute headed by Adar Poonawalla added. The SII is one of the largest vaccine manufacturers by the number of doses produced.

That said, the DCGI had on September 11 directed the SII to suspend any new recruitment in phase 2 and 3 clinical trials of the vaccine candidate till further orders in the backdrop of pharma giant AstraZeneca pausing the clinical trials in other countries because of “an unexplained illness” reported in a participant in the study. However, on September 15 it permitted the Institute to recommence the trial.

Dirty picture of Covid vaccine race

A recent article on The Guardian, titled ‘How the race for a Covid-19 vaccine is getting dirty’  Laura Spinney, the author of Pale Rider: The Spanish Flu of 1918 and How It Changed the World says that politics and profit seem to muddle the attempts to develop the Covid vaccine.  There are already allegations that Russia and China have tried to hack Covid research being conducted elsewhere. The UK’s National Cyber Security Centre (NCSC) said the hackers “almost certainly” operated as “part of Russian intelligence services”. Microsoft alleged Russia and North Korea sponsored hackers to steal Covid research.

Also Read: Hackers On Covid Vaccine Research

Scientists say science cannot be rushed. They suggest politicians should be patient. But pharmaceutical companies, obviously, see a goldmine in a potential vaccine. Last August, a computational biologist at Johns Hopkins University in Baltimore, the US, said a vaccine must first go to a wider pool of volunteers even before clinical trials formally end. This statement caused controversy. The biologist, Steven Salzberg, soon changed his stand as criticism mounted. But experts say this is just one of the many casualties of the vaccine rush. The biggest risk is that the public might lose trust in the vaccines and may not be ready to cooperate with agencies when a vaccine becomes ready. That’s a crisis. 

There are other ethical issues as well. For one, most pharma companies that take part in the vaccine race have seen their stock value going up in style, sparing some blips when vaccines trials took a dive. Even in India, the NIFTY Pharma Live Price Movement shows the values have doubled since April 2020. 

In the language of the market, “the pharma stocks have all moved far ahead of their fundamentals”. But many seem to be cashing in on the trend. For instance, to give a global example, the chairman and CEO of Pfizer Albert Bourla and Executive Vice President Susman Sally sold over 1.76 lakh shares of the company the day it announced the results of its Covid-19 vaccine trial. 

Activists say such trends are not healthy for the society given that it will demoralise scientists as well as the public at large and may end up jeopardizing future research. Considering that the Covid vaccine race has already impacted research into other drugs and vaccines, with Covid-19 claiming a lion’s share of the health R&D across the globe, maintaining a safe distance between profits, politics and purpose and hygiene of intent in the field of Covid-19 vaccine research is important.