Why every nation is in hurry to release COVID-19 drug/vaccine despite many concerns?

by Kamal Pratap Singh, kamal9871@gmail.com

Despite various questions about effectiveness, safety and availability there seems a hurry to release COVID treatment by individuals, scientists, organizations and Nations. There are numerous examples of failures like Solidarity trial candidates – remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon, AstraZeneca’s Calquence, Novartis’ Ilaris, Sanofi & Regeneron’s Kevzara, Eli Lilly antibody drug, Roche’s Actemra, Glenmark’s Favipiravir, Biocon’s Itolizumab, Patanjali’s Coronil and many many more. In this article we are discussing how the organizations came up with magical treatment and how these products were criticized and soon vanished from the news headlines, even though there was urgent need of treatment. We will also take a look at the aspects of pharma profiteering and lobbying, based on the many reports that signifies pharma/healthcare profiteering and lobbying that was aimed at financial gains in this COVID pandemic.

In a CBS interview, Fauci first suggested that the British regulators had failed to scrutinise the data carefully enough and had waved the vaccine through. Later he apologized for casting doubt over UK’s approval of Pfizer vaccine. Source: https://www.firstpost.com

Bullet points
– Several drugs have been given approval without any concrete studies and have been challenged
– Death rate is not significant and it is lowest in a densely country populated like India
– People have come out without any measure but transmission has not seen
– Many countries like new Zealand and Australia have reduced their COVID-19 transmission to zero without any drug/vaccine

There are many aspects to see how all this is working but let’s first take a look that what and how different COVID treatments came into picture and how they progressed or vanished.

COVID 19 drugs approved till now (Major ones)
On March 13, 2020 for the first time news reports appeared about China’s National Medical Products Administration had approved Fujifilm’s Favilavir (Favipiravir), an anti-viral drug as a treatment against coronavirus. This was the first time too when scientific but non-evidence based headline came into prevalence. The drug was touted as the first approved coronavirus drug, while clinical trials were still ongoing in Shenzhen, Guangdong province, when subjects involving 70 patients reportedly showed treatment efficacy with very little side effects but no effects on disease were discovered. (Source: https://www.hospimedica.com/covid-19/articles/294781247/fujifilms-antiviral-becomes-first-approved-drug-to-treat-coronavirus-in-china.html)
In March, the US president used a press conference to promote the use of hydroxychloroquine(HCQ), a common existing anti-malaria drug, to treat COVID-19, saying: “I sure as hell think we ought to give it a try.” Trump was influenced by a widely publicized study in France where 40 coronavirus patients were given HCQ, with more than half experiencing the clearing of their airways within three to six days. (https://www.statnews.com/2020/03/20/trump-coronavirus-drug-just-a-feeling/)

The first French scientist Didier Raoult who proposed HCQ was heavily criticized several times for this act (https://www.sciencemag.org/news/2020/03/insane-many-scientists-lament-trump-s-embrace-risky-malaria-drugs-coronavirus).

At the same time Food and Drug Administration (FDA) provided hydroxychloroquine with an “emergency use authorization” to use on coronavirus patients in some circumstances. Some experts in India too have criticised the endorsement of HCQ by India’s top health research body for use on COVID-19 patients and healthcare workers without proper evidence that proves the drug’s ability to reduce the viral load (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31180-6/fulltext). Now it has been proved that HCQ do not provide any better experience in COVID-19 patients. (https://www.nejm.org/doi/full/10.1056/NEJMoa2023184)

Another most popular earliest drug Gilead’s antiviral drug Remdesivir, intravenously administered in hospitals, was declared to be the first treatment to show improvement in COVID-19 trials. On around 1st May it was approved for emergency use in severely-ill patients in the United States, India and South Korea, and has received full approval in Japan even after drug failed its first randomised clinical trial according to draft documents published by the World Health Organization. Now various studies have published showing no effect on COVID patients (https://www.nejm.org/doi/full/10.1056/NEJMoa2023184)

On March 30, 2020 French pharmaceutical company Sanofi and Regeneron initiated trials around the world to determine whether Kevzara (repurposed) has the potential to play a role in addressing the COVID-19 global health crisis.  In October report were published about its failure, the drug typically used for rheumatoid arthritis have produced adverse reactions in some patients, including pneumonia and even death.

In most hurry Moderna’s researchers rush to test coronavirus vaccine in people without knowing how well it works in animals “I don’t think proving this in an animal model is on the critical path to getting this to a clinical trial,” said Tal Zaks, chief medical officer at Moderna, a Cambridge, Mass.-based biotech that has produced a COVID-19 vaccine candidate mRNA-1273 at record speed. He told STAT that scientists at the National Institutes of Health are “working on nonclinical research in parallel.” Meanwhile, the clinical trial started recruiting healthy participants in the first week of March. However, the vaccine by Moderna and Vaccine Research Center could start phase one clinical trials in April.(https://www.statnews.com/2020/03/11/researchers-rush-to-start-moderna-coronavirus-vaccine-trial-without-usual-animal-testing/)

US biopharma company Altimmune, a clinical stage biopharmaceutical company announced that it is working on an intranasal coronavirus vaccine, which is being developed based on a vaccine technology platform similar to NasoVAX, the influenza vaccine developed by Altimmune. There is no update since then about their product and any results of clinical trial. (https://clinicaltrials.gov/ct2/show/NCT04442230)

On April 10, 2020, the U.S. Food and Drug Administration issued an emergency use authorization for a blood purification system to treat patients 18 years of age or older with confirmed Coronavirus Disease 2019 (COVID-19) admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure. (https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-blood-purification-device-treat-covid-19)

On April 3, 2020 Bharat Biotech and the US-based FluGen along with virologists at the University of Wisconsin-Madison began the development and testing of a unique vaccine against covid-19 called CoroFlu Speaking to Business Today- a newspaper, Chairman and Managing Director of Bharat Biotech Krishna M Ella said a lot depends on the approval process. “If the government acts fast on it and treats it as a national emergency, it should be possible to get the vaccine out in about eight months. (https://www.thehindu.com/sci-tech/science/bharat-biotech-set-to-develop-and-test-vaccine-for-covid-19/article31244845.ece).

Krishna Ella believes the process could be faster in India as CoroFlu is being built on the backbone of FluGen’s flu vaccine candidate known as M2SR. “M2SR is proven in phase 2 human challenge studies, so it can fastrack the project,” he said. No news of any further developments of CoroFlu came afterwards but another candidate of Bharat Biotech secured regulatory approval from the DCGI to advance its COVID-19 vaccine candidate, COVAXIN, into human clinical trials.

Before this Bharat Biotech said it is leading a project to develop human monoclonal antibodies as therapy for COVID-19 infections. The project was sanctioned by the Council of Scientific and Industrial Research (CSIR) under its flagship programme, New Millennium Indian Technology Leadership Initiative. https://www.financialexpress.com/industry/bharat-biotech-to-lead-monoclonal-antibodies-project-for-covid-19-therapy/1953143/ This project was a collaboration between NCCS, Pune; IIT, Indore, and PredOmix Technologies but no progress has seen so far for antibody technology or any vaccine out of this. https://www.financialexpress.com/industry/bharat-biotech-to-lead-monoclonal-antibodies-project-for-covid-19-therapy/1953143/

In an article by The Lancet published on April 30, Bacille Calmette-Guérin vaccine (BCG) was proposed as COVID-19 cure. It wrote, in addition to its specific effect against tuberculosis, the BCG vaccine has beneficial nonspecific (off-target) effects on the immune system that protect against a wide range of other infections and are used routinely to treat bladder cancer. This has led to the suggestion that vaccination with BCG might have a role in protecting health-care workers and other vulnerable individuals against severe coronavirus disease 2019 (COVID-19). No fresh report was seen which connects COVID-19 and BCG.

The two big international multidrug trials were launched one after another to see if the combination of drugs can prove to be effective against COVID-19. The first trial was launched on 23 April 2020 by WHO and called “Solidarity Trial” for COVID-19 treatments, it was officially launched in Indonesia. The Indian Council for Medical Research (ICMR) has also fast tracked the roll out of the global ‘Solidarity Trial’ launched by the WHO to help find an effective treatment for COVID-19. Nine hospitals were given approval to conduct randomised controlled clinical trials under the WHO’s ‘Solidarity Trial’ to find an effective treatment. The drugs/therapies to be investigated through the study were:

Low-dose Dexamethasone
Colchicine
Tocilizumab
Convalescent plasma
REGN-COV2
Aspirin

According to a Nature Biotechnology article published on 11 May 2020 which called it the world’s biggest trial of drugs to treat COVID-19 patients was set up in the UK (https://www.nature.com/articles/s41587-020-0528-x ).
The study was jointly funded between UK Research and Innovation (UKRI) and the NIHR – and is sponsored by University of Oxford. The Recovery trial has recruited over 5,000 patients in 165 NHS hospitals. The drugs/therapies to be investigated through the study were:

Lopinavir-Ritonavir (commonly used to treat HIV)
Low-dose Dexamethasone (now only recruiting children)
Azithromycin (a commonly used antibiotic)
Hydroxychloroquine (an antimalarial drug)
Tocilizumab (an anti-inflammatory treatment given by injection)
REGN-COV2
Convalescent plasma

 

TABLE 1: Drugs which gain popularity during COVID-19 pandemic

S.No.	Drug/therapy	Company	Status as on	Source
1	Calquence		Failed in Phase II, 12 Nov	https://www.fiercepharma.com/pharma/az-s-calquence-fails-covid-19-study-hospitalized-patients-joining-list-repurposed-drugs-have
2	Favilavir (Favipiravir)	Glenmark	Ongoing, Phase III trial, 24th November	https://www.clinicaltrialsarena.com/news/glenmark-favipiravir-covid-19/
3	Hydroxychloroquine with Ivermectin	Didier Raoult, Donald Trump	failed	https://www.nejm.org/doi/full/10.1056/NEJMoa2023184
4	Remdesivir	Gilead’s	failed	https://www.nejm.org/doi/full/10.1056/NEJMoa2023184
5	Disinfectants	Donald Trump	failed	Due to general sense of people
6	Kevzara	Sanofi and Regeneron	failed	https://in.reuters.com/article/us-health-coronavirus-sanofi/sanofi-says-kevzara-drug-fails-as-possible-covid-19-treatment-idINKBN25S3R4
7	mRNA-1273	Moderna and Pfizer	No result posted yet	https://clinicaltrials.gov/ct2/show/NCT04283461
8	NasoVAX	Altimmune	No result posted	https://clinicaltrials.gov/ct2/show/NCT04442230
9	blood purification system	USFDA	No result posted	https://clinicaltrials.gov/ct2/show/NCT04478539
10	CoroFlu	Bharat Biotech and FluGen	No result posted	NONE
11	human monoclonal antibodies	Bharat Biotech/OTHERS	No result posted	https://clinicaltrials.gov/ct2/show/NCT04354766
12	Covaxin	Bharat Biotech	Ongoing	NONE
13	ChAdOx1 nCoV-19	Oxford University	No result posted	https://clinicaltrials.gov/ct2/show/NCT04536051
14	AZD1222	Oxford/AstraZeneca	No result posted	https://clinicaltrials.gov/ct2/show/NCT04516746
15	Convalescent plasma	Max Healthcare	Failed	DOI: 10.1056/NEJMoa2031304
16	BCG	OTHER	No result posted	https://www.clinicaltrials.gov/ct2/show/NCT04347876
17	Solidarity Trial – Dexamethasone, Colchicine, Tocilizumab, Convalescent plasma, REGN-COV2, Aspirin	WHO	Failed	https://www.nejm.org/doi/full/10.1056/NEJMoa2023184
18	Recovery trial – Lopinavir and Ritonavir, Dexamethasone, Azithromycin, Hydroxychloroquine, Tocilizumab, REGN-COV2, Convalescent plasma	UK	Failed	https://www.recoverytrial.net/results
19	Ivermectin and Doxycycline	Bangladesh	No result posted	https://clinicaltrials.gov/ct2/show/NCT04551755
20	Coronil	Patanjali Ayurveda	Failed	https://www.newindianexpress.com/nation/2020/jul/15/did-coronil-violate-clinical-trial-norms–doctors-experts-seek-mci-intervention-2170133.html
21	Itolizumab	Biocon	Failed	https://science.thewire.in/health/icmr-balram-bhargava-biocon-kiran-mazumdar-shaw-itolizumab-mortality-phase-2-trials/

 

On May 30, doctors in Bangladesh declared that the combination of Ivermectin and Doxycycline is an effective treatment against COVID-19, with patients recovering within four days. Ivermectin is an anti-parasite drug, while doxycycline is an antibiotic. Subsequently, Max Hospital registered a trial to study the effectiveness of Ivermectin with ‘standard of care treatment versus standard of care treatment for COVID-19 cases’. Another trial, registered by the Department of Medicine of Lady Hardinge Medical College in Delhi studied the effects of anti-malarial drug hydroxychloroquine, ciclesonide, a drug used to treat asthma, and Ivermectin in the treatment of moderate COVID-19 illness.

Later WHO provided advisory that Antibiotics work only against bacteria, not viruses. COVID-19 is caused by a virus, and therefore antibiotics should not be used for prevention or treatment. (https://www.who.int/emergencies/diseases/novel-coronavirus-2019/advice-for-public/myth-busters?gclid=EAIaIQobChMIhe6un7PP7QIVrINLBR1_GwSEEAAYASAAEgKqtPD_BwE#antibiotics)

In India, on June 30, Patanjali Ayurveda released a drug named Coronil without any approval of ICMR and claimed in big sponsored news & ads that “We have prepared the first Ayurvedic-clinically controlled, research, evidence and trial based medicine for COVID-19. We conducted a clinical case study and clinical controlled trial, and found 69% patients recovered in 3 days and 100% patients recovered in 7 days and it treats Coronavirus”. Several media houses kept running news for days in favour of coronil but later due to public outrage Patanjali and Baba Ramdev with his allies Balakrishnan retracted from their statement and claims and released a statement that the coronil just boost their immunity which will help people fight diseases like coronavirus, it has not made or shipped any medicine called ‘Corona Kit’. It also denied claims of calling the new medicine a “cure” for coronavirus, however a full video is available to see what he has said. https://www.youtube.com/watch?v=q8ko7kKboy0

On Jul 13 2020, Bengaluru based biotech major Biocon announced that its drug Itolizumab priced at Rs 8,000 per vial, which will hit the market as ALZUMAb, has received permission from the Drugs Controller General of India for use in moderate to severe COVID-19 patients. “It is the first novel biological therapy to be approved by the DCGI for treating patients with moderate to severe Covid-19 complications,” the executive chairperson of the company Kiran Mazumdar Shaw said at a press conference. Itolizumab, drew sharp scrutiny. The critics pointed to the small size of the clinical trial enrolling a total of only 30 hospitalised COVID-19 patients , exemption of Phase-3 trial, use of the drug as off-label for COVID-19, and making claims to the press before data is published in a peer-reviewed journal. Later, ICMR Director-General Balram Bhargava said there is not enough evidence from clinical trials that the drugs Itolizumab and Tocilizumab reduce mortality in COVID-19 patients. (https://www.newindianexpress.com/nation/2020/jul/25/covid-19-task-force-not-in-favour-of-itolizumab-for-treatment-says-evidence-inconclusive-2174698.html)

On 19 Jul 2020, DCGI pulls up Glenmark for false claims, first over trials result and overpricing of COVID-19 drug FabiFlu (Favipiravir). It said that it has been mentioned in representation that Glenmark drug is effective in co-morbid conditions like hypertension, diabetes, whereas in reality, as per protocol summary, this trial was not designed to assess the FabiFlu in co-morbid conditions.” Lok Nayak Hospital in Delhi, India had barred the use of Favipiravir in its hospital due to certain side-effects like loss of appetite, nausea and potential risk to liver, and cardiac functioning. (https://www.nationalheraldindia.com/india/delhis-ln-hospital-to-discontinue-anti-viral-drug-favipiravir-for-covid-19-treatment)

What’s next in COVID-19 treatment regime?
There are now hundreds of candidates ready to launch in the market. All these news are floating around but none of them has shown any magical effect on patients like any drug does. There are many existing players in the market like Pfizer, Bharat Biotech and Serum Institute India who are front runner in India whereas Pfizer is leading the world after grabbing support from two countries.

Before going further it is also to be shown that all these statements were followed by high profile deals among different govt and private organizations but none of the vaccine and its manufacturers have shown any immediate safe effect.

So we have seen how different individuals and organization laid emphasis on the need of treatment without studying the importance and safety. Thanks to scientific watchdogs like RETRACTION WATCH and ELIZABETH BIK that these miraculous drugs could not pull out money of pocket of general public or could save lives of them by boycotting these respective fake studies. TABLE 2.

TABLE 2. Retracted COVID-19 Studies related to COVID treatment and prevention
(Source: Retraction Watch)

S.No.	Retracted COVID-19 Studies	Intervention Questioned
1.	“Effectiveness of Surgical and Cotton Masks in Blocking SARS–CoV-2: A Controlled Comparison in 4 Patients,” published on April 6, 2020 in the Annals of Internal Medicine, retracted on June 1, 2020.	Masks
2.	“Hydroxychloroquine plus azithromycin: a potential interest in reducing in-hospital morbidity due to COVID-19 pneumonia (HI-ZY-COVID)?” preprint published on medRxiv, May 11, 2020, withdrawn on May 20, 2020. Our coverage here.	Hydroxychloroquine and azithromycin
3.	“Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis,” published in The Lancet on May 22, 2020, subjected to an expression of concern on June 2 ,and retracted on June 4.	Hydroxychloroquine
4.	“Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19,” published in the New England Journal of Medicine on May 1, 2020, subjected to an expression of concern on June 2, and retracted on June 4.	ACE inhibitors
5.	“Corona Virus Killed by Sound Vibrations Produced by Thali or Ghanti: A Potential Hypothesis,” published in Journal of Molecular Pharmaceuticals and Regulatory Affairs, dates of publication and retraction unknown.	Sound Vibrations: Thali or Ghanti
6.	“COVID-19 Emergency Responders in FDA’s Center for Drug Evaluation and Research,” published sometime after April 6, 2020 in Journal of the American Pharmacists Association, date of retraction unknown.	Other
7.	“Ivermectin in COVID-19 Related Critical Illness,” posted in April 2020 on SSRN, retracted sometime in May. Reporting from The Scientist here.	Ivermectin
8.	“Usefulness of Ivermectin in COVID-19 Illness,” posted on April 19, 2020 on SSRN, retracted sometime thereafter.
9.	Patterns of COVID-19 Mortality and Vitamin D: An Indonesian Study, published on SSRN on April 30, 2020. Retraction date unknown. (Hat tip to HealthNerd)	Vitamin D
10.	“Chloroquine or hydroxychloroquine for COVID-19: why might they be hazardous?” published in The Lancet May 22, 2020, retracted and replaced July 9, 2020. Our coverage here.	hydroxychloroquine
11.	“Treatment Response to Hydroxychloroquine, Lopinavir/Ritonavir, and Antibiotics for Moderate COVID 19: A First Report on the Pharmacological Outcomes from South Korea” medRxiv preprint posted May 18, 2020, and withdrawn June 14, 2020.	Hydroxychloroquine, Lopinavir/Ritonavir, and Antibiotics
12.	“SARS-CoV-2 was Unexpectedly Deadlier than Push-scooters: Could Hydroxychloroquine be the Unique Solution?” published on August 15, 2020 in Asian Journal of Medicine and Health, retracted August 16, 2020. Our coverage here.	Hydroxychloroquine
13.	“Decrease in Hospitalizations for COVID-19 after Mask Mandates in 1083 U.S. Counties,” medRxiv preprint posted on October 23, 2020 and withdrawn on November 4, 2020.	Mask

 

 

Now the questions arise as why everyone wants to push a vaccine in the market when the transmission has slowed down and this can be seen worldwide for ex; the political rallies of Trump and BJP govt in India and farmers’ protest when many individuals could be seen to avoid social distancing and preventive measures like masks. Though they can be accounted for the violation of emergency protocols but the science that comes out from this cannot be avoided. This science shows us that the transmission is not occurring either because virus has lost its virulence or it has become common like all other viruses that exist around us from centuries.

A regular update of data on COVID-19 deaths by the Centers for Disease Control and Prevention has prompted a groundswell of claims that only a fraction of people have actually died directly from the novel coronavirus. The report stated, “For 6% of deaths, COVID-19 was the only cause mentioned. For deaths with conditions or causes in addition to COVID-19, on average, there were 2.6 additional conditions or causes per death.” (https://www.usatoday.com/story/news/factcheck/2020/09/01/fact-check-cdcs-data-covid-19-deaths-used-misleading-claims/5681686002/)

So what can be the possible reason(s) for a Coronavirus push?
The reasons are aided by a confluence of many factors. A new method of developing vaccines was already waiting to be tested (for MERS), with the coronavirus a perfect target. Sky-high infection rates accelerated the pace of clinical trials, the most time-consuming part of the process. And the governments were willing to spend whatever it takes, eliminating financial risks and bureaucratic roadblocks and allowing mass production to begin even before the trials were done.

Healthcare profiteering and Pharma Lobbying
This biological pandemic has not only skyrocketed the share of companies which were/are providing COVID Healthcare solution but also attracting huge funding from public and private organizations.

Firstly, government promoted sanitizers and masks with a lot of enthusiasm, later when people got habitual of sanitizers, pharma companies raised and almost doubled and tripled the price of sanitizers in the market, lot of fake sanitizers also arrived in the market to fulfil the demand and need. Allmed Medical Products Co. makes just about any kind of gauze product imaginable. It also produces surgical masks, and its export-quality products were much sought-after in China those days. Chairman Cui Jinhai, who founded the company based in Hubei province at the epicenter of the coronavirus outbreak, is leading the way among tycoons in China’s medical and biotech industries who have added more $17 billion in stake value even as global markets plunge, according to the Bloomberg Billionaires Index. Shares of Guangzhou Wondfo Biotech Co., a developer of rapid-test kits and antibody tests, have gained more than 40% this year, making president Li Wenmei and his wife Wang Jihua a billionaire couple. Wang is the chairman. (https://www.msn.com/en-in/money/news/the-coronavirus-is-creating-new-medical-and-biotech-billionaires/ar-BB118uzT)

The Global Pharma Lobby around the world are making multiple announcements for development of their vaccines and have been running into a rat race of manufacturing the drugs/vaccine as well as its human trials, but the facts behind this rat race of making fool of the common man and digging out the money from the common man’s pocket in the name of Vaccine and saving their life from this Global Pandemic is far more different from what is shown. People have become so much annoyed, frustrated, irritated with the loss of life, money, job, health & lockdown and its overall impact on the economy that they are now ready to buy anything and everything in the name of safety and to end this all.

According to researchers’ team from Brigham Young University in Provo, Utah found that companies making drugs and vaccines for COVID-19, accounted for one-fourth of all lobbying funds in the first quarter of 2020. (https://www.dailymail.co.uk/health/article-8620057/Big-Pharma-spent-nearly-250-million-lobby-lawmakers-amid-coronavirus-pandemic.html)

For the study, published in the Journal of General Internal Medicine, the team looked at lobbying expenditures in the fourth quarter of 2019 and the first quarter of 2020. Results showed that lobbying spending hit $248.4 million between January 1 and March 31, and 357 new lobbyist registrations were filed during this period. Researchers found the biggest increases came from the pharmaceutical industry, making up 16 of the top 30 healthcare organizations in lobbyist spending.

Illinois-based AbbVie Inc’s spending soared by 155 percent whole Novartis International AG, based in Switzerland, increased its lobbyist spending by 259 percent this year over last year. Biogen Inc, headquartered in Cambridge, Massachusetts, increased its lobbyist spending by 344 percent.

London-based AstraZeneca Plc spent $780,000. The U.S. government committed as much as $1.2 billion to Astra in May to help make the potential vaccine it’s developing with the University of Oxford.

Moderna Inc. spent a company record $70,000 on lobbying in the second quarter, up from the $10,000 it spent in the same period a year ago. The Cambridge, Massachusetts-based biotech firm has also surged in trading this year and received backing from Operation Warp Speed.

Novavax Inc. disclosed lobbying the White House and Vice President Mike Pence’s office through an outside lobbying consultant, Faegre Drinker Biddle & Reath LLP. Among its lobbyists at the firm were former Republican Representative Luke Messer, who succeeded Pence in the House of Representatives when the latter became Indiana’s governor. The company had no products on the market but announced on July 7 it would receive $1.6 billion from the U.S. for its vaccine development process, the largest amount yet from Operation Warp Speed. Those funds will allow Novavax to conduct advanced human studies and establish manufacturing to deliver 100 million doses as soon as late 2020, the company stated at that time.

Abbott Laboratories, which has received emergency use authorization from the U.S. for both virus tests and antibody tests, spent $930,000, up 16% from the previous year. The company has been selling tests at a clip, although it has tried to counter concern about the false negative rate on one of its offerings.

Corporate Europe Observatory had also uncovered dozens of documents via freedom of information requests – including minutes from weekly calls between pharma and the Commission held during the pandemic – which reveal how the industry is putting profit before an effective pandemic response. The pharmaceutical industry initially used its special access to lobby against joint procurement of treatments in Europe, a tool intended to avoid member states competing for drugs and thus driving up prices. It has also used arguments that pit rich countries against each other (whilst leaving the ones with limited resources behind) to win lucrative advance purchase agreements for potential new vaccines, without the needed public interest conditions in place.

Another study at around 21st July 2020 in the Mint found that Gilead Sciences Inc. reported $1.26 million in lobbying spending in the three months ending June 30, 2020, according to a disclosures with the U.S. Congress. That was up 17% from a year ago and came as U.S. officials in May issued an emergency use authorization for Gilead’s remdesivir as a treatment for Covid-19 after a trial found it speed recovery by about four days in hospitalized patients. Gilead donated remdesivir to hospitals through June, but the company announced at the close of that month its plans to charge $390 a vial, or $2,340 for a five-day regimen, for direct government purchases by the U.S. or other developed countries.

South Africa and India have lodged a proposal at the World Trade Organization -WTO to suspend international patent laws for an extended period, allowing countries to produce their own versions of patented medicines, treatments and protective equipment without being held to ransom by the corporations which own those patents. Despite gaining broad support from around the world, Big Pharma howled in protest. Pfizer called it “nonsense”. British companies working on coronavirus treatments, AstraZeneca and GSK, refused to participate, backed by the British government which tried to water down the proposals. (https://www.aljazeera.com/opinions/2020/10/18/big-pharma-is-not-going-to-help-the-world-defeat-covid-19)

It is evident from the above statements that how much money can be involved in this whole pandemic. On vaccines only, Tedros said, $4.3 billion is needed immediately to lay the groundwork for mass procurement and delivery of vaccines and a further $23.9 billion is required for 2021. That total, Tedros said, is less than one-half of 1 percent of the $11 trillion in stimulus packages announced so far by the Group of 20, the world’s richest countries.

Politicization of vaccine
The politicization of vaccines, not just in the case of COVID-19 but also with regard to measles and many other diseases, is a key problem of public health where social science is essential for understanding the problem of persuasion,” said Saad B. Omer, director of the Yale Institute for Global Health and a co-author of the study which measured the effects of the timing of a vaccine approval relative to the U.S. elections and the influence of vaccine endorsements by President Donald Trump, U.S. Speaker of the House Nancy Pelosi, and Dr. Anthony Fauci. (https://news.yale.edu/2020/10/27/politics-affect-public-buy-covid-19-vaccine-study-shows)

The rumours are highly demanding that even presidents have to come forward to say that vaccine is not politicised, President-elect Joe Biden sought to instill public confidence in a coronavirus vaccine that could soon be available, insisting that its safety and effectiveness is being evaluated without political influence amid reports that President Donald Trump’s administration was pressuring the Food and Drug Administration for emergency authorization. (https://edition.cnn.com/2020/12/11/politics/joe-biden-coronavirus-vaccine/index.html)

The COVID-19 vaccine, nowhere on the horizon, was in the eye of a political storm, with the BJP promised to provide free shots to the over 10 crore population of Bihar as part of its election manifesto, and the Opposition deriding this as ‘vaccine politics’. On the heels of the BJP, one of its supporters, the AIADMK government in Tamil Nadu, offered to administer the vaccine to all, again free of cost. The announcement created a political storm. (https://www.theweek.in/news/india/2020/10/25/first-promised-in-bihar-a-non-existent-covid-vaccine-sparks-political-melee-across-india.html)

Conclusion:

Though it is not open in a country like India but US reports have shown that Pharma companies have spent their dollars on lobbying. Similarly huge funding was given to many companies for COVID-19 purposes. Still many pharma companies are trying to get funding, to get their products approved through various regulatory agencies and also govt contracts to supply vaccine. And lastly, the various political and otherwise gathering have provided an excellent research ground to show that Coronavirus transmission is not occurring now. The so-called vaccines claimed by pharma lobby around the world would provide with the active immunity against the disease, but as per one report of WHO and several mainstream media houses around the world, it has been observed that there are several cases where a person who has been infected by Coronavirus COVID-19 diseases once has been re-infected again even after getting treated and getting healthy. In other words, a person can be infected with coronavirus COVID-19 disease again and again no matter how strong his immunity has been developed. If this point is taken into the consideration, even if the global pharma lobby is successful in making the vaccine, it will not be as successful in preventing the COVID-19 disease as claimed by the large pharma companies around the world and the patients have to take vaccine more than once or everytime. In light of above statements now it is duty of everyone to think about what we need or what don’t.

Note: These are author’s personal views, Biotech Express and its Editors are not responsible for any of the content of this article. This article does not endorse any treatment for COVID-19.

Read December 2020 issue of Biotech Express magazine for full article.