COVID-19 Vaccine Wars

Vaccines play a vital role in public health. Few would argue with that. It’s also reasonable to assume that nearly all 7.8 billion citizens of the globe must have had at least one vaccine in their lifetime. Without vaccines, we would see countless polio-related disabilities around the world. The benefits of vaccines are fairly apparent, but they don’t come without risks.

 

As the world marked the first anniversary of the COVID-19 pandemic in March, a fresh scramble for vaccines was ramping up. Though multiple vaccine candidates have been up for consideration, the scarcity of doses is exposing grave inequality in healthcare provision around the world. But even if there were sufficient volumes to cover every person on the planet, we would still have to contend with vaccine hesitancy. To overcome vaccine hesitancy, as uSpiked had previously reported, we need to be truthful, avoiding even an ounce of falsehood.

 

About a year ago, US constitutional law professor Alan Dershowitz, known for being one of the lawyers who appeared for former US President Donald J Trump at his first impeachment hearing, opined that we should “believe science, but be sceptical of scientists”.

Prof. Dershowitz’s cautionary words were published in the early days of COVID-19 when little was known about the virus. At the time, our TV screens flickered with conflicting advice: Don’t touch your face!;  don’t stockpile face masks!;  no handshakes!;  no gatherings!;  face masks not necessary!
 

While the issue of face masks could be justified on the ground that governments across the world were seeking to preserve the few available masks for healthcare workers, some of the claims at the time just did not make sense. But as long as they seemed to be backed by some scientists, we simply accepted them. Most of the advisories have been adjusted somewhat as scientists get to understand the new deadly virus’ characteristics.

 

A year since the pandemic was declared we are now confronted with the issue of vaccines. In the wake of the devastation left behind by the virus, any remedy that could stem its rampant transmission, and the associated sufferings and deaths, would be welcome. As a series of vaccines become available, safety and efficacy should be paramount when acquiring them for populations.

 

The wealthier nations have cornered the vaccine production, leaving poorer nations to haggle over the leftovers.  When it comes to procurement, President Cyril Ramaphosa and his government have fallen short. While Ramaphosa started his fight against COVID-19 by prioritising science, that earlier resolve seems to have died off to be overtaken by political interests.

The forces stifling the Ramaphosa administration’s battle against the virus are evident in our daily lives, from people visiting shopping malls without face coverings to others protesting against lockdowns. And of cause, we cannot ignore patrons in bars drinking alcohol while yapping away.

 

 The need for the equitable distribution of vaccines, and the government’s loss of control of the process, has stirred action. In early February, trade union Solidarity and Afriforum threatened to approach the courts to break what they called the “government’s monopoly on vaccine purchase and distribution”  In essence, the two organizations intended to ask the courts to allow those who can afford to import the vaccines to do so; and probably sell them to consumers – independent of the government's rollout plans.

 

uSpiked’s initial inquiry into vaccine procurement was to understand the issue of liability indemnity being granted to pharmaceutical companies in regard to COVID-19 vaccines.  Being a new virus, mistakes are inevitable, but where they occur, policymakers need to promptly own up and correct the mistakes. The uSpiked Data Team wanted to understand why, if these vaccines are as safe as claimed by their manufacturers, were they seeking the liability indemnity?

 

The issue of indemnity has inarguably gone bonkers. The Bureau of Investigative Journalism reported how Pfizer, the first of the Big Pharma to release a vaccine, demanded of Latin American governments to sign over their countries' sovereign assets such as embassy buildings and military bases, as a guarantee against the cost of any future legal cases.

 

Locally, after the fiasco with AstraZeneca vaccines, President Ramaphosa's government was under immense pressure to do something. And, as if the stars were aligned in our favour, on February 27, the American Food and Drug Administration (FDA) green-lit Johnson & Johnson’s (J&J) COVID-19 vaccine (Ad26.COV2.S) for emergency use. The data presented to the FDA in the request for Emergency Use Authorization (EUA), showed the J&J vaccine to be safe and efficacious enough for authorisation. It prevented COVID-19 in 72% of cases in the United States and in 64% in South Africa, where a concerning variant (501.V2) was discovered on 18 December 2020. The J&J single jab was reported to have been 86% efficacy against severe forms of Covid-19 in the United States, and 82% against severe disease in South Africa 28 days after injection. But most importantly there were no COVID-19-related deaths.

 

At 64% (compared to about 40% efficacy for the annual flu vaccine) that should be good enough for the government to arrange procurement. But some information wasn’t clearly presented. There was a reference to geographical regions as opposed to variants. The way data was presented for South Africa did not make it clear which variant was being tested for.  The company claimed that South African participants in Phase 3 clinical trial were mainly exposed to variant 501.V2, discovered towards the tail-end of that clinical trial

 

In an attempt to understand the geographical data, uSpiked came across a report by South Africa's multi-award-winning investigative journalist, Mzilikazi wa Afrika, where he exposed a clinical trial that was being disguised as a vaccination rollout.

 

Since it was a clinical trial, why would a liability indemnity be needed, and to whom would it be granted? That’s how the two stories have merged.

 

Besides the record speed at which pharmaceutical companies have developed the vaccines (processes that previously took several years, being completed in under a year) there are other legitimate concerns at the involvement of Johnson & Johnson, a company that had never previously developed a vaccine. There are additional concerns arising from the fact that in the previous decade J&J was engulfed in a litany of legal action over its products.  There were also those troubling secret recalls of J&J products.

 

All those plus non-vaccine development experience could also have been responsible for the lack of significant market reaction last November when Aspen Holdings announced their agreement with Johnson & Johnson. Traders must have been asking; “What does J&J know about the development of vaccines.”

 

 

In a letter dated 8 February 2021, Prof. Glenda Elizabeth Gray, president and CEO of the South African Medical Research Council (SAMRC) requested authorisation from the South African Health Products Regulatory Authority (SAHPRA) to conduct what has been called “… COV3001 – Phase 3B Open-Label Study”.

 

This is simply an extended single product medical study since it would be unethical to include a placebo when the subject product already has some proven levels of acceptable efficacy and safety.

 

From available data, this medical study does not provide any clear outcome measures. The primary outcome measures for this single product medical study is buried between the dates of the February 8 letter and the FDA-published data of February 26.

 

Yet J&J, for some undisclosed reasons, adjusted the South African data upwards by seven percentage points. Considering that J&J informed the FDA that “both the initial and updated analysis are based on the database cut-off for the primary analysis (January 22, 2021)”. That was 18 days before Prof. Gray’s application for the medical study. Did someone involved with the J&J Phase III clinical trial misanalyse the data from South Africa? If so, what other data could have been misanalysed?

 

Besides the questionable dates, as already mentioned above, in the data presented to the FDA, J&J presented geographical data. For instance, J&J stated: "In South Africa, where the 20H/501Y.V2 variant (B.1.351 lineage) was the predominant strain (96.3% of sequenced cases thus far) …”.

 

“Predominant”  is the notable word in this data set; J&J could not cite what percentage of their 4,000 South African trial subjects were exposed to the now-world-infamous South African variant or how predominant the variant was before its discovery on 18 December.

 

Prof. Gray and her team at SAMRC must have been equally concerned, hence the application of 8 February 2021. Executives and scientists at J&J must have also realised this shortfall hence the need to undertake the expanded study.

Prof. Gray could not have just decided to make the application to SAHPRA without clearance from J&J. The data presented to the FDA did not specify exactly how many of the enrolled participants were exposed to the dreaded South African variant. But at least half of the 4,000 participants must have been on the J&J product.

 

The expanded medical study, (though not yet published at clinicaltrial.gov), appears intended to test the efficacy of the product against the South African variant. That is a line of thought that may appear far-fetched, but where else would one easily encounter the variant if not at our health facilities? Journalists are used to joining the dots. But we also realise that not all dots are joinable. We don’t suffer from apophenia – the psychotic tendency to see meaningful connections between unrelated things. But just as it’s easy to see a smiley face in a full moon, it’s also human to convincingly join dots that aren’t joinable.

 

In the SMRC's application to SAHPRA for the study, the stated primary objectives are: "To monitor the effectiveness of the single-dose AD26.COV2.S COVID-19 vaccine among healthcare workers as compared to the general unvaccinated population in South Africa …. To monitor hospitalisations or deaths in the cohort of healthcare workers …”.

 

The obvious question is: are healthcare workers different from the general public? What are scientists involved in the study trying to communicate? Could it be something like the vaccines are now being custom-designed for individual sectors?

 

J&J must have realised that the geographical presentations alone were not cutting it, hence the decision to file the Addendum. This is the same filing that increased the efficacy by seven percentage points. [from where did J&J extract those additional seven percents -Editor] Statistics provided by J&J support this hypothesis.  J&J stated to the FDA that “… preliminary sequence data confirm that approximately 94.5% (86/91 sequenced samples) of the COVID-19 cases that occurred in the study in South Africa were due to the SARS-COV-2 variant 20H/501Y.V2 …”.  At least the Addendum attempted to provide some clarity even if it wasn’t definitive.

 

In Prof. Gray's expanded trial, J&J is reportedly supplying (not donating) 500,000 doses of Ad26.COV2.S vaccines. According to reliable sources at SAHPRA, the regulator was caught in a complex web. Doses of the AstraZeneca vaccine that had been paid for by the government had arrived in the country eight days earlier, but the vaccine was just 22% efficacious against the South African variant, and although Prof. Gray’s submission provided the initial data of 57% efficacy for J&J vaccine, SAHPRA could not rely on these claims since the study had not been peer-reviewed.

 

But when FDA received and reviewed the same data plus what was contained in the Addendum by J&J on 26 February 2021, SAHPRA gave the green light for the expanded trial to proceed. This authorisation was a precious commodity for the administration of President Ramaphosa. With the AstraZeneca fiasco still fresh in the public’s mind, a medical study targeting 500,000 frontline health care workers with a seemingly effective vaccine could fit right into the national vaccines rollout programme.

 

Whoever advised the Presidency to stealthily interchange names did not appear to have been conversant with the workings of medical research. How could they expect that the targeted workers would not wonder why they have to sign an eleven-page Informed Consent Document? And why would J&J need to monitor for any infections for three to six months?

Without going into further details, undertaking such studies would not be a mere 15 minutes per subject, hence the slow uptakes we are witnessing. But the Presidency and National Department of Health did not expect the public to see through the veil. They simply appropriated the study and publicly appeared to own it as part of the rollout. Hence the interchangeability of the terms “rollout”, “trial” and “study”. Even the government news agency is yet to update its communication on the subject.

 

Prof. Linda-Gail Bekker, the study’s co-national principal investigator, told uSpiked in a telephone interview that they requested J&J to allow for the inclusion of President Ramaphosa in the study. That explains the shot received by the president. She further confirmed that Ramaphosa also signed the informed consent document.

 

The first public impression that the study was part of the national COVID-19 Vaccination Rollout Strategy, as published by the National Institute for Communicable Diseases, stuck until Mzilikazi wa Afrika exposed the fight within SAHPRA over what was happening.

 

The National Department of Health officials were immediately summoned to appear before the Parliamentary Portfolio Committee on Health to explain exactly what was happening with the vaccines.

 

During the virtual appearance before the committee on 5 March 2021, we saw what we have become accustomed to: “Don't criticise our people”. First, the Minister of Health Dr Zweli Mkhize found other more urgent matters to deal with in KwaZulu-Natal. Instead, Deputy Minister Dr Mathume Phaahla and Director-General Dr Sandile Buthelezi represented the department.

The explanation the health department provided for the J&J rollout/study/trial confusion was as messy as political processes could be. As the meeting got to a boil, ANC members of the committee, instead of letting the department officials respond to questions from opposition members, fired their salvos at their opposition colleagues. For instance, when Economic Freedom Fighters (EFF) member of the committee, Naledi Chirwa, sought to know why the department had been lying to the public, ANC members demanded that she stop accusing department officials of deceit. Chirwa was compelled to withdraw her “liars” comment. Ironically, she was allowed to continue with her questioning by simply replacing the word “liar” with “untruthful.  [If the department could substitute the word “trial” for “rollout”, why couldn't Chirwa replace the word “liar” with “untruthful”? – editor].

As the fights continued, an ANC member could be heard pleading for the protection of ‘our’ deputy health minister. Lest the chair forgot, the deputy minister is a member of their political party needing protection from opposition members.

 

The deputy minister proceeded to take credit for the decision by J&J to avail the 500,000 doses of the vaccine disregarding a decision earlier motivated by Prof. Gray for J&J to sponsor Phase 3B study by providing the 500,000 doses.

 

In their attempts to explain why the doses were arriving in dribs and drabs “their” deputy minister said they were the leftovers from various Phase 3 clinical trials J&J had conducted around the world. That’s not that close to the truth [-using a lie to explain a lie is pathetic -Editor]. The Phase 3 clinical trial was conducted in eight countries (US, South Africa and six Latin American countries) with fewer than 50,000 participants. Given the number of participants, why would J&J have designated more than 500,000 doses for the trial? Those seemingly unrelated dots appeared related once again. According to J&J’s the Phase 3 ENSEMBLE study enrolled 44,783 participants for a double-blind, placebo-controlled clinical trial. There are two big dots to be joined here:

1. At least half of the participants were given the placebo
2. The pharmaceutical giant further disclosed that 44% of the participants were in the United States

If these disclosures are to be believed, participants from seven other participating countries consisted of under 25,000 participants. How many of these were in the geographical region presented as South Africa? But most importantly, why did J&J designate more than 500,000 doses for the Phase 3 clinical trial that had only enrolled fewer than 50,000 subjects to generate such a large quantity of leftovers!  Corporations are known to be economical with the truth and it gets murkier when the information is being passed on via politicians with vested interests and in need to cover up their failures.

… technically and legally, this is an expanded research in terms of human trials …

Prof. Dershowitz’s warning to be sceptical of scientists again comes resurfaced.  In his opening remarks, Dr Phaahla implied that it was the department that had approached J&J for doses that had remained from the Phase 3 trial around the world. This is at odds with Prof Gray’s application.

 

According to the deputy minister “… technically and legally, this is an expanded research in terms of human trials …”. He further implied that the department had approached SAHPRA seeking registration of, and an emergency use authorisation for, the J&J vaccine. That statement, if true, appears to be a glaring conflict of interest. What role do politicians have in medical studies? Why would the department be performing the work of a product manufacturer? It’s the manufacturers or their agents that would normally make applications for registration of their products to the regulatory authorities. Is the government (the health department) acting as an agent for a private company?

 

Since it is a clinical trial, all costs are part of the manufacturer’s research and development budget. Why would J&J avail 500,000 doses, worth in excess of $5 million, for this additional study for a product that is not just in high demand but has already been accepted as efficacious in some parts of the world? Hence during this expanded study, the issue of liability indemnity would not arise. Prof. Linda-Gail Bekker informed uSpiked that the liability insurance J&J had secured for Phase 3 trials would still cover the 500,000 doses.

 

And as already noted above, President Ramaphosa, according to Prof. Bekker, signed the informed consent document and will also be monitored by the researchers as the study progresses. There is a national security element to this. Did the president surrender his data to be kept by J&J for up to 15 years and what elements of the records would be shared with affiliates and other third parties?

President Ramaphosa, being a trained lawyer, must have had a deeper understanding of what he was signing. But wouldn't we have rather had our president getting his jab free of any conditions!

The most topical issue whenever COVID-19 vaccines are discussed is liability indemnity, where manufacturers are provided with a legal shield against any consumers who may be injured or die due to the vaccines’ side effects or what is routinely referred to as “adverse events”.

 

Some wealthy countries have been granting indemnity like candies on Halloween night to Big Pharma as a condition for the supply of these possible life-saving products. Big Pharma is bullying some low-income countries into signing off all their sovereign assets as guarantees against future legal cases.

 

[Imagine it is early 2014 and you are an environment-conscious consumer. Your bank has just approved your request for motor vehicle finance. You pay a visit to the Ford dealership in Cape Town’s CBD. Then the sales agent introduces you to a brand-new Ford Kuga SUV 1.6-litre EcoBoost. The name makes it sound environmentally suitable SUV. And it looks classy enough. But as the agent hands you the paperwork for your signature, he lets it slip that should your new ride bursts into flames during the period of your ownership, Ford would not be liable. In other words, you'll be on your own. Under what circumstances would you proceed with the transaction? — Editor]

 

The liability indemnity being granted to manufacturers of COVID-19 vaccines is not a new thing. Our Team has traced its origin to 35 years ago in the U.S.A in a 1986 bill introduced in Congress amending the Public Health Service Act and enacting the National Childhood Vaccine Injury Act of 1986 that created the National Vaccine Injury Compensation Program (NVICP) vaccine manufacturers were granted the legal shield. That system is meant to work as our local Road Accident Fund.

 

Congressional records show that when the proposed bill was still at the committee stages, some Big Pharma executives and their lobbyists motivated Congress to provide liability indemnity to vaccine manufacturers with some arguing that vaccines are not medicines and should be treated simply as biological products. But the most striking disclosure was that “vaccines are unavoidably unsafe”.

 

This “unavoidability” issue was later confirmed by the US Supreme Court in a case that has been a matter of debate among American trial lawyers and academics. Big Pharma capitalised on the US government's weakness at the time. With threats of biological attacks coming from its enemies (real or just perceived), and the US government, lacking the capacity to develop antidotes against the on-coming pathogens was at the barrel of the private sector that insisted on being incentivised to continue with their private research on various pathogens and developments of antidotes including vaccines. Big Pharma extorted Congress to get the legal shield onto the statutes. If not granted, they threatened to shut down their research labs. And as the politicians were seeing American enemies circling with biological weaponry, they folded.

 

Whether those arguments were scientific or not, Congress passed Bill H.R.5184 creating the legislation that shielded vaccine manufacturers against legal liabilities. Not all countries have such laws in their books hence the pressure being applied on poor-to-middle income countries to sign off their assets. With such demands, how hard would it be to convince the vaccine hesitants that the vaccines are as safe as they are claimed to be? If they are truly safe, why can't their manufacturers stand by their products? Or what do they know about their products that they are not disclosing?

 

Regardless, Finance Minister Tito Mboweni in the previous months has been granting the demanded indemnity to manufacturers of vaccines. The weight of this finance ministry offered indemnity would be tested should there be cases of injuries related to the COVID-19 vaccines. uSpiked requested a copy of the liability indemnity agreement from the National Treasury, but in a single sentence, Minister Mboweni’s department told us to direct our query to the Department of Health. Since the indemnity was signed off by Mboweni, we shall be filing a PAIA request to the Treasury for the records in the coming days. The public has a right to know what kind of guarantees the minister placed on the table.

 

Asked for his opinion on blanket indemnity being offered to pharmaceutical companies by countries without statutes like the American one, a UK-based senior International corporate lawyer told uSpiked that “the prima facie view is that it seems wrong. Normally when a party contracts out of liability based on negligence, one could override it if there were severe cases of negligence. With the government offering indemnity in this way, a citizen’s right may be further limited. It’s as if manufacturers could mess up as they wish and still get paid for their products and suffer no consequences for injury/damage done”.

 

With American CDC reporting multiple cases of vaccine-related injuries, and with countries in the northern hemisphere reporting cases of AstraZeneca vaccine-related blood clots in recipients, it's just a matter of time before we see whether the liability indemnities being granted are worth the papers they are printed on. When the dust settles, how many nations would have lost their embassy buildings in major cities? We will hopefully still be here to report on it.

 

Locally, we consulted a team of Healthcare Attorneys with a leading South African law firm (whose identity we keep confidential) who generously directed us to some fundamental issues. In a legal opinion that has been echoed by other trial lawyers. The team doubted the effectiveness of the ministerial directive. Another local trial lawyer was even blunter on the subject “… neither ministerial nor presidential directives can override Common Law or any other enacted law for that matter. That is the responsibility of parliament or the Constitutional Court.  The most effective legislation is the Consumer Protection Act. Unless there is a legislative amendment to the two laws, vaccine manufacturers would have no legs to stand on. They would wave the indemnity all they want, but our courts would not give a hoot.”

 

The team of healthcare lawyers stated, “Manufacturers may be liable for product defects in terms of the Consumer Protection Act 68 of 2008 (“CPA”) and in terms of the common law, acquilian (or delictual) action. 

 

“In particular, section 61(1) of the CPA sets out the basis for statutory product liability in South Africa.  Section 61(1) of the CPA states as follows: 

the producer [which would include a manufacturer] or importer, distributor or retailer of any goods is liable for any harm, as described in subsection (5), caused wholly or partly as a consequence of—

(a) supplying any unsafe goods;

(b) a product failure, defect or hazard in any goods; or

(c)inadequate instructions or warnings provided to the consumer pertaining to any hazard arising from or associated with the use of any goods,

irrespective of whether the harm resulted from any negligence on the part of the producer, importer, distributor or retailer, as the case may be.” 

They concluded; “It is clear from section 61(1) that liability arising from section 61 is a strict liability – i.e. it is not fault-based.  Consequently, whether there was negligence or intent on the part of the ‘manufacturer’ is irrelevant.  A manufacturer will be liable if a consumer experiences harm as a result of the: (i) supply of unsafe goods; (ii) a product failure or hazard in any goods; or (iii) inadequate instructions or warnings provided to the consumer pertaining to any hazard arising from or associated with the use of any goods.”

 

They clarified that unless an amendment is effected on the relevant Section of the CPA to specifically cater for liability indemnity for COVID-19 Vaccines, or a stand-alone law is passed by parliament, “ individuals who suffer serious vaccine-related injuries would either use the CPA or common law to claim for the damages incurred from the manufacturer of the vaccine. The government however would incur the liability, save in the case of a manufacturing defect/failure of the vaccine to meet manufacturing specifications (in which case the manufacturer would remain liable)”

 

Without knowing the details of the legal opinion provided by the team of Healthcare attorneys, another local legal giant quipped “… there is currently nothing stopping my clients from suing COVID-19 vaccine manufacturers for related injuries. If their product is unsafe, we will see them in courts.” In a tongue-in-cheek comment, this legal giant told us, “when we sue for injuries, our clients would not expect payments in the forms of an embassy building in some countries.”

 

Putting all the data we have obtained together, it would appear that The National Treasury, with the power of a stroke of a pen is acting as the insurer of the biological products sold by Big Pharma.  The injured parties will still have to first deal with the manufactures in courts in event of injuries. And should any awards be granted, the manufacturers would then decide whether to evoke their insurance policy (government-provided liability indemnity) for reimbursement.

 

[As we were going into publication, we were still waiting for the final opinion of the larger-than-life godfather of South Africa’s class-action lawsuits, Attorney Jacques Theron. — Editor]

 

 That is why it is important to know the terms of Minister Tito Mboweni’s liability indemnity agreement with Pfizer and all others. Considering that the deal has been concluded and deliveries of vaccines are being made, (according to President Ramaphosa), The NDA signed with Pfizer has expired, we requested a copy of the Liability Indemnity Agreement from the National Treasury. In a single line response, the Treasury redirected us to the Department of Health.

 

Since it is public knowledge that the agreement pertaining to indemnity was with the National Treasury, and not the Department of Health, in the coming weeks, uSpiked will be filing PAIA request for these records.

 

According to a Cape Town-based political scientist, that agreement is worth nothing and the Big Pharma must be aware of it. “What do they have to lose?” she asked us, “They know their products are safe and expect no lawsuits. It is a futures game being played. They are just making the government a silent partner responsible for the distribution, an entity that runs the distribution on their behalf and pays to be a partner. It’s a sweetheart deal for both parties and even the citizens. In months terms, do we even know for how long we would remain protected by the vaccines? Let’s say it's annually, whom do you think that particular governments would call on first? … right the previous supplier.”

 

She further warned that personal Injury lawyers should not now start recruiting more staff in anticipation of vaccine-related injuries; very few may surface: “The Big Pharma must have done their homework and seen clearly that collecting from some government will not be an easier task and is more stressful. So to avoid the headaches, the manufacturers will just produce the safest possible products.” [who would buy an airbase at an auction anyway – editor]

 

See Editorial To Jab or Not to Jab

 

* Additional data acquisition and processing by Miguel García of San Francisco, California