Brownstone Institute
Why the Secrecy Over Vaccine Contracts?
From the Brownstone Institute
Major international governments have signed multibillion-dollar legal contracts with drug companies in order to secure access to covid-19 vaccines.
But the drug companies and governments have refused to divulge details, saying the information is “commercial in confidence.”
In 2021, we got our first peek at contracts between Pfizer and various international countries after they were leaked to The Bureau of Investigative Journalism and US consumer group Public Citizen.
“The contracts offer a rare glimpse into the power one pharmaceutical corporation has gained to silence governments, throttle supply, shift risk and maximise profits in the worst public health crisis in a century,” said Zain Rizvi, author of the Public Citizen report.
Pfizer was accused of “bullying” governments during contract negotiations, asking some Latin American countries to put up sovereign assets, such as embassy buildings and military bases, as a guarantee against the cost of any future legal cases.
High court decision
Last month, a South African NGO called Health Justice Initiative won a high court challenge to gain access to all of South Africa’s covid-19 vaccine contracts.
Tony Nikolic, an Australian solicitor from law firm Ashley, Francina, Leonard & Associates, reviewed the Pfizer contract and says it reads like South Africa was “held to ransom” over the deal.
“It’s a one-sided contract. Pfizer gets all of the profits and none of the risks,” says Nikolic. “It’s akin to extortion, there’s absolutely no liability for the vaccine manufacturer in terms of injuries that may arise from their product.”
The South African government agreed to “indemnify, defend and hold harmless” Pfizer and all its affiliates from “any and all suits, claims, actions, demands, losses, damages, liabilities settlements, penalties, fines, costs and expenses” arising from the vaccine.
It also says the government will “create, dedicate, and maintain a no-fault compensation fund sufficient to undertake and completely fulfil the indemnification obligations….. for damage, injury, or harm arising out of, relating to, or resulting from the development, administration, or use of the vaccine.”
Nikolic says, “It’s like the manufacturers could ask for anything they wanted. There was such panic at the time and images in the media of people dying in the streets created a real sense of fear and insecurity around the world.”
The protection against liability is not only in place for the initial vaccine formulation, but for “any or all related strains, mutations, modifications or derivatives of the foregoing that are procured by Purchaser.”
“What this means,” explains Nikolic, “is that Pfizer can modify its vaccine to match whatever variants emerge, and still have all the same protections against liability. This is nothing more than a cash cow for Pfizer, they are privatising the profits, whilst socialising the costs.”
Pfizer charged the South African government $10 per dose, which is nearly 33 percent more than the $6.75 “cost price” it reportedly charged the African Union.
“In my view, this is why Pfizer wants the details kept secret, so that it can protect the various price differences between countries. It’s classic price gouging with a predatory twist, that is why procurement transparency is essential,” says Nikolic.
Long-term safety?
The contract states “the long-term effects and efficacy of the vaccine are not currently known and that there may be adverse effects of the Vaccine that are not currently known.”
Nikolic says this is in stark contrast to the public health messages at the time.
“We had politicians and key opinion leaders telling people that the vaccines were ‘safe and effective’ when the procurement contracts themselves did not make such claims,” says Nikolic.
“The contract clearly indicates that adverse effects were unknown at the time of signing. The burden of proof should never have been on the people to prove the vaccine was unsafe, it should have been on the manufacturer to prove the vaccine was safe,” he adds.
Nikolic has spent the last two years trying to access the procurement contracts signed by the Australian Government.
“Australians are still in the dark about what is contained within these contracts. We know it gave liability protection to the vaccine manufacturers like other countries, but that’s the extent of it,” says Nikolic.
“We need to know what our politicians knew at the time of signing the deal. And we need to know how much money we, the taxpayer, spent for a vaccine that turned out to be far less safe or effective than promised,’ he adds.
In a recent Australian Senate committee hearing, Queensland Senator Malcolm Roberts grilled Pfizer executives under oath about the indemnity clauses in its contract with the Australian government, but Pfizer refused to give details.
“The contents of Pfizer’s contract with the Australian Government remains confidential,” said Pfizer Australia’s medical director Krishan Thiru.
In 2021, Nikolic mounted a legal challenge against covid-19 vaccine mandates in the NSW Supreme Court where he tried to subpoena the Pfizer contract, but his request was blocked.
Undeterred, Nikolic submitted an FOI request to the Australian Department of Health.
The FOI request, however, was denied because the contracts “contain information that is confidential in nature” such as “trade secrets and commercially valuable information.” It stated:
“The documents contain commercial information regarding the procurement of vaccines to Australia. The documents contain information specifically relevant to the unique commercial arrangements between the department and third parties, including indicative prices, payment terms, professional indemnity, ongoing funding measures, manufacturing details and production measures.”
Nikolic says, “It’s unethical, potentially unlawful and immoral for them to argue that the right to preserve commercial confidence overrides the right for public safety, it just doesn’t make sense.”
He adds, “It just boggles the mind how governments just rolled over and entered into agreements with companies like Pfizer that have a long track record of breaching the False Claims Act resulting in billion-dollar criminal and civil liability.”
Reposted from the author’s Substack
Author
From the Brownstone Institute
A walk through a dozen convenience stores in Montgomery County, Pennsylvania, says a lot about how US nicotine policy actually works. Only about one in eight nicotine-pouch products for sale is legal. The rest are unauthorized—but they’re not all the same. Some are brightly branded, with uncertain ingredients, not approved by any Western regulator, and clearly aimed at impulse buyers. Others—like Sweden’s NOAT—are the opposite: muted, well-made, adult-oriented, and already approved for sale in Europe.
Yet in the United States, NOAT has been told to stop selling. In September 2025, the Food and Drug Administration (FDA) issued the company a warning letter for offering nicotine pouches without marketing authorization. That might make sense if the products were dangerous, but they appear to be among the safest on the market: mild flavors, low nicotine levels, and recyclable paper packaging. In Europe, regulators consider them acceptable. In America, they’re banned. The decision looks, at best, strange—and possibly arbitrary.
What the Market Shows
My October 2025 audit was straightforward. I visited twelve stores and recorded every distinct pouch product visible for sale at the counter. If the item matched one of the twenty ZYN products that the FDA authorized in January, it was counted as legal. Everything else was counted as illegal.
Two of the stores told me they had recently received FDA letters and had already removed most illegal stock. The other ten stores were still dominated by unauthorized products—more than 93 percent of what was on display. Across all twelve locations, about 12 percent of products were legal ZYN, and about 88 percent were not.
The illegal share wasn’t uniform. Many of the unauthorized products were clearly high-nicotine imports with flashy names like Loop, Velo, and Zimo. These products may be fine, but some are probably high in contaminants, and a few often with very high nicotine levels. Others were subdued, plainly meant for adult users. NOAT was a good example of that second group: simple packaging, oat-based filler, restrained flavoring, and branding that makes no effort to look “cool.” It’s the kind of product any regulator serious about harm reduction would welcome.
Enforcement Works
To the FDA’s credit, enforcement does make a difference. The two stores that received official letters quickly pulled their illegal stock. That mirrors the agency’s broader efforts this year: new import alerts to detain unauthorized tobacco products at the border (see also Import Alert 98-06), and hundreds of warning letters to retailers, importers, and distributors.
But effective enforcement can’t solve a supply problem. The list of legal nicotine-pouch products is still extremely short—only a narrow range of ZYN items. Adults who want more variety, or stores that want to meet that demand, inevitably turn to gray-market suppliers. The more limited the legal catalog, the more the illegal market thrives.
Why the NOAT Decision Appears Bizarre
The FDA’s own actions make the situation hard to explain. In January 2025, it authorized twenty ZYN products after finding that they contained far fewer harmful chemicals than cigarettes and could help adult smokers switch. That was progress. But nine months later, the FDA has approved nothing else—while sending a warning letter to NOAT, arguably the least youth-oriented pouch line in the world.
The outcome is bad for legal sellers and public health. ZYN is legal; a handful of clearly risky, high-nicotine imports continue to circulate; and a mild, adult-market brand that meets European safety and labeling rules is banned. Officially, NOAT’s problem is procedural—it lacks a marketing order. But in practical terms, the FDA is punishing the very design choices it claims to value: simplicity, low appeal to minors, and clean ingredients.
This approach also ignores the differences in actual risk. Studies consistently show that nicotine pouches have far fewer toxins than cigarettes and far less variability than many vapes. The biggest pouch concerns are uneven nicotine levels and occasional traces of tobacco-specific nitrosamines, depending on manufacturing quality. The serious contamination issues—heavy metals and inconsistent dosage—belong mostly to disposable vapes, particularly the flood of unregulated imports from China. Treating all “unauthorized” products as equally bad blurs those distinctions and undermines proportional enforcement.
A Better Balance: Enforce Upstream, Widen the Legal Path
My small Montgomery County survey suggests a simple formula for improvement.
First, keep enforcement targeted and focused on suppliers, not just clerks. Warning letters clearly change behavior at the store level, but the biggest impact will come from auditing distributors and importers, and stopping bad shipments before they reach retail shelves.
Second, make compliance easy. A single-page list of authorized nicotine-pouch products—currently the twenty approved ZYN items—should be posted in every store and attached to distributor invoices. Point-of-sale systems can block barcodes for anything not on the list, and retailers could affirm, once a year, that they stock only approved items.
Third, widen the legal lane. The FDA launched a pilot program in September 2025 to speed review of new pouch applications. That program should spell out exactly what evidence is needed—chemical data, toxicology, nicotine release rates, and behavioral studies—and make timely decisions. If products like NOAT meet those standards, they should be authorized quickly. Legal competition among adult-oriented brands will crowd out the sketchy imports far faster than enforcement alone.
The Bottom Line
Enforcement matters, and the data show it works—where it happens. But the legal market is too narrow to protect consumers or encourage innovation. The current regime leaves a few ZYN products as lonely legal islands in a sea of gray-market pouches that range from sensible to reckless.
The FDA’s treatment of NOAT stands out as a case study in inconsistency: a quiet, adult-focused brand approved in Europe yet effectively banned in the US, while flashier and riskier options continue to slip through. That’s not a public-health victory; it’s a missed opportunity.
If the goal is to help adult smokers move to lower-risk products while keeping youth use low, the path forward is clear: enforce smartly, make compliance easy, and give good products a fair shot. Right now, we’re doing the first part well—but failing at the second and third. It’s time to fix that.
Author
From the Brownstone Institute
Cigarettes kill nearly half a million Americans each year. Everyone knows it, including the Food and Drug Administration. Yet while the most lethal nicotine product remains on sale in every gas station, the FDA continues to block or delay far safer alternatives.
Nicotine pouches—small, smokeless packets tucked under the lip—deliver nicotine without burning tobacco. They eliminate the tar, carbon monoxide, and carcinogens that make cigarettes so deadly. The logic of harm reduction couldn’t be clearer: if smokers can get nicotine without smoke, millions of lives could be saved.
Sweden has already proven the point. Through widespread use of snus and nicotine pouches, the country has cut daily smoking to about 5 percent, the lowest rate in Europe. Lung-cancer deaths are less than half the continental average. This “Swedish Experience” shows that when adults are given safer options, they switch voluntarily—no prohibition required.
In the United States, however, the FDA’s tobacco division has turned this logic on its head. Since Congress gave it sweeping authority in 2009, the agency has demanded that every new product undergo a Premarket Tobacco Product Application, or PMTA, proving it is “appropriate for the protection of public health.” That sounds reasonable until you see how the process works.
Manufacturers must spend millions on speculative modeling about how their products might affect every segment of society—smokers, nonsmokers, youth, and future generations—before they can even reach the market. Unsurprisingly, almost all PMTAs have been denied or shelved. Reduced-risk products sit in limbo while Marlboros and Newports remain untouched.
Only this January did the agency relent slightly, authorizing 20 ZYN nicotine-pouch products made by Swedish Match, now owned by Philip Morris. The FDA admitted the obvious: “The data show that these specific products are appropriate for the protection of public health.” The toxic-chemical levels were far lower than in cigarettes, and adult smokers were more likely to switch than teens were to start.
The decision should have been a turning point. Instead, it exposed the double standard. Other pouch makers—especially smaller firms from Sweden and the US, such as NOAT—remain locked out of the legal market even when their products meet the same technical standards.
The FDA’s inaction has created a black market dominated by unregulated imports, many from China. According to my own research, roughly 85 percent of pouches now sold in convenience stores are technically illegal.
The agency claims that this heavy-handed approach protects kids. But youth pouch use in the US remains very low—about 1.5 percent of high-school students according to the latest National Youth Tobacco Survey—while nearly 30 million American adults still smoke. Denying safer products to millions of addicted adults because a tiny fraction of teens might experiment is the opposite of public-health logic.
There’s a better path. The FDA should base its decisions on science, not fear. If a product dramatically reduces exposure to harmful chemicals, meets strict packaging and marketing standards, and enforces Tobacco 21 age verification, it should be allowed on the market. Population-level effects can be monitored afterward through real-world data on switching and youth use. That’s how drug and vaccine regulation already works.
Sweden’s evidence shows the results of a pragmatic approach: a near-smoke-free society achieved through consumer choice, not coercion. The FDA’s own approval of ZYN proves that such products can meet its legal standard for protecting public health. The next step is consistency—apply the same rules to everyone.
Combustion, not nicotine, is the killer. Until the FDA acts on that simple truth, it will keep protecting the cigarette industry it was supposed to regulate.
Author
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