Last week, a rare media interview given by the Trump administration’s “Vaccine Czar” offered a brief glimpse into the inner workings of the extremely secretive Operation Warp Speed (OWS), the Trump administration’s “public-private partnership” for delivering a COVID-19 vaccine to 300 million Americans by next January. What was revealed should deeply unsettle all Americans.
During an interview with the Wall Street Journal published last Friday, the “captain” of OWS, career Big Pharma executive Moncef Slaoui, confirmed that the millions of Americans who are set to receive the project’s COVID-19 vaccine will be monitored via “incredibly precise … tracking systems” that will “ensure that patients each get two doses of the same vaccine and to monitor them for adverse health effects.” Slaoui also noted that tech giants Google and Oracle have been contracted as part of this “tracking system” but did not specify their exact roles beyond helping to “collect and track vaccine data.”
The day before the Wall Street Journal interview was published, the New York Times published a separate interview with Slaoui where he referred to this “tracking system” as a “very active pharmacovigilance surveillance system.” During a previous interview with the journal Science in early September, Slaoui had referred to this system only as “a very active pharmacovigilance system” that would “make sure that when the vaccines are introduced that we’ll absolutely continue to assess their safety.” Slaoui has only recently tacked on the words “tracking” and “surveillance” to his description of this system during his relatively rare media interviews.
While Slaoui himself was short on specifics regarding this “pharmacovigilance surveillance system,” the few official documents from OWS that have been publicly released offer some details about what this system may look like and how long it is expected to “track” the vital signs and whereabouts of Americans who receive a Warp Speed vaccine.
Two official OWS documents released in mid-September state that vaccine recipients — expected to include a majority of the U.S. population — would be monitored for twenty-four months after the first dose of a COVID-19 vaccine is administered and that this would be done by a “pharmacovigilance system.”
In the OWS document entitled “From the Factory to the Frontlines,” the Department of Health and Human Services (HHS) and the Department of Defense (DOD) stated that, because Warp Speed vaccine candidates use new unlicensed vaccine production methods that “have limited previous data on safety in humans … the long-term safety of these vaccines will be carefully assessed using pharmacovigilance surveillance and Phase 4 (post-licensure) clinical trials.”
The key objective of pharmacovigilance is to determine each vaccine’s performance in real-life scenarios, to study efficacy, and to discover any infrequent and rare side effects not identified in clinical trials. OWS will also use pharmacovigilance analytics, which serves as one of the instruments for the continuous monitoring of pharmacovigilance data. Robust analytical tools will be used to leverage large amounts of data and the benefits of using such data across the value chain, including regulatory obligations.
In addition, Moncef Slaoui and OWS’s vaccine coordinator, Matt Hepburn, formerly a program manager at the Pentagon’s controversial Defense Advanced Research Projects Agency, had previously published an article in the New England Journal of Medicine that stated that “because some technologies have limited previous data on safety in humans, the long-term safety of these vaccines will be carefully assessed using pharmacovigilance surveillance strategies.”
The use of pharmacovigilance on those who receive the vaccine is also mentioned in the official Warp Speed “infographic,” which states that monitoring will be done in cooperation with the Food and Drug Administration (FDA) and the Centers for Disease Control and Protection (CDC) and will involve “24 month post-trial monitoring for adverse effects.”
In a separate part of that same document, OWS describes one of its “four key tenets” as “traceability,” which has three goals: to “confirm which of the approved vaccines were administered regardless of location (private/public)”; to send a “reminder to return for second dose”; and to “administer the correct second dose.”
Regarding a COVID-19 vaccine requiring more than one dose, a CDC document associated with OWS states:
For most COVID-19 vaccine products, two doses of vaccine, separated by 21 or 28 days, will be needed. Because different COVID-19 vaccine products will not be interchangeable, a vaccine recipient’s second dose must be from the same manufacturer as their first dose. Second-dose reminders for vaccine recipients will be critical to ensure compliance with vaccine dosing intervals and achieve optimal vaccine effectiveness.
The CDC document also references a document published in August by the Johns Hopkins Center for Health Security, associated with the Event 201 and Dark Winter simulations, as informing its COVID-19 vaccination strategy. The Johns Hopkins paper, which counts Dark Winter co-organizer Thomas Inglesby as one of its authors, argues that existing “passive reporting” systems managed by the CDC and FDA should be retooled to create “an active safety surveillance system directed by the CDC that monitors all [COVID-19] vaccine recipients — perhaps by short message service or other electronic mechanisms.”
Despite the claims in these documents that the “pharmacovigilance surveillance system” would intimately involve the FDA, top FDA officials stated in September that they were barred from attending OWS meetings and told reporters they could not explain the operation’s organization or when or with what frequency its leadership meets. The FDA officials did state, however, that they “are still allowed to interact with companies developing products for OWS,” STAT reported.
In addition, the FDA has apparently “set up a firewall between the vast majority of staff and the initiative [Operation Warp Speed]” that appears to drastically limit the number of FDA officials with any knowledge of or involvement in Warp Speed. The FDA’s director of the Center for Drug Evaluation and Research, Janet Woodcock, is the only FDA official listed as having any direct involvement in OWS and appears to be personally managing this “firewall” at the FDA. Woodcock describes herself as a long-time advocate for the use of “big data” in the evaluation of drug and vaccine safety and has been intimately involved in FDA precursors to the coming Warp Speed “pharmacovigilance surveillance system” known as Sentinel and PRISM, both of which are discussed later in this report.
Woodcock is currently on a temporary leave of absence from her role as the director of the Center for Drug Evaluation and Research, which allows her to focus her complete attention on overseeing aspects of OWS on behalf of the FDA’s Office of the Commissioner. Her temporary replacement at the FDA, Patrizia Cavazzoni, is “very aligned with Janet and where the agency is going,” according to media reports. Cavazzoni is a former executive at Pfizer, one of the companies producing a vaccine for OWS. That vaccine is set to begin testing in children as young as 12 years old.
The extreme secrecy of OWS has affected not only the FDA but also the CDC, as a CDC expert panel normally involved in developing the government’s vaccine distribution strategies was “stonewalled” by Matt Hepburn, OWS’s vaccine coordinator, who bluntly refused to answer several of the panel’s “pointed questions” about the highly secretive operation.
More secret contracts
While Moncef Slaoui and Warp Speed documents provide few details regarding what this “tracking system” would entail, Slaoui did note in his recent interview with the Wall Street Journal that tech giants Google and Oracle had been contracted to “collect and track vaccine data” as part of this system. Neither Google nor Oracle, however, has announced receipt of a contract related to OWS, and the DOD and HHS, similarly, have yet to announce the awarding of any Warp Speed contract to either Google or Oracle. In addition, searches on the U.S. government’s Federal Register and on the official website for federally awarded contracts came up empty for any contract awarded to Google or Oracle that would apply to any such “pharmacovigilance” system or any other aspect of Operation Warp Speed.
Given my previous reporting on the use of a nongovernment intermediary for awarding OWS contracts to vaccine companies, it seems likely that Warp Speed contracts awarded to Google and Oracle were made using a similar mechanism. In an Oct. 6 report for The Last American Vagabond, I noted that $6 billion in Warp Speed contracts awarded to vaccine companies were made through Advanced Technology International (ATI), a government contractor that works mainly with the military and surveillance technology companies and whose parent company has strong ties to the CIA and the 2001 Dark Winter simulation. HHS, which is supposedly overseeing OWS, claimed to have “no record” of at least one of those contracts. Only one Warp Speed vaccine contract, which did not involve ATI and was awarded directly by HHS’s Biomedical Advanced Research and Development Authority, was recently obtained by KEI Online. Major parts of the contract, however, including the section on intellectual property rights, were redacted in their entirety.
If the Warp Speed contracts that have been awarded to Google and Oracle are anything like the Warp Speed contracts awarded to most of its participating vaccine companies, then those contracts grant those companies diminished federal oversight and exemptions from federal laws and regulations designed to protect taxpayer interests in the pursuit of the work stipulated in the contract. It also makes them essentially immune to Freedom of Information Act requests. Yet, in contrast to the unacknowledged Google and Oracle contracts, vaccine companies have publicly disclosed that they received OWS contracts, just not the terms or details of those contracts. This suggests that the Google and Oracle contracts are even more secretive.
A major conflict of interest worth noting is Google’s ownership of YouTube, which recently banned on its massive multimedia platform all “misinformation” related to concerns about a future COVID-19 vaccine. With Google now formally part of OWS, it seems likely that any concerns about OWS’s extreme secrecy and the conflicts of interest of many of its members (particularly Moncef Slaoui and Matt Hepburn) as well as any concerns about Warp Speed vaccine safety, allocation and/or distribution may be labeled “COVID-19 vaccine misinformation” and removed from YouTube.
From the NSA to the FDA: the new PRISM
Though the nature of this coming surveillance system for COVID-19 vaccine recipients has yet to be fully detailed by Warp Speed or the tech companies the operation has contracted, OWS documents and existing infrastructure at the FDA offer a clue as to what this system could entail.
For instance, the Warp Speed document “From the Factory to the Frontlines” notes that the pharmacovigilance system will be a new system created exclusively for OWS that will be “buil[t] off of existing IT [information technology] infrastructure” and will fill any “gaps with new IT solutions.” It then notes that “the COVID-19 vaccination program requires significant enhancement of the IT that will support enhancements and data exchange that are critical for a multi-dose candidate to ensure proper administration of a potential second dose.” The document also states that all data related to the OWS vaccine distribution effort “will be reported into a common IT infrastructure that will support analysis and reporting,” adding that this “IT infrastructure will support partners with a broad range of tools for record-keeping, data on who is being vaccinated, and reminders for second doses.”
Though some Warp Speed documents hint as to the existing IT systems that will serve as the foundation for this new tracking system, arguably the most likely candidate is the FDA-managed Sentinel Initiative, which was established in 2009 during the H1N1 Swine flu pandemic. Like OWS itself, Sentinel is a public-private partnership and involves the FDA, private business, and academia.
According to its website, Sentinel’s “main goal is to improve how FDA evaluates the safety and performance of medical products” through big data, with an additional focus on “learning more about potential side effects.” Media reports describe Sentinel as “an electronic surveillance system that aggregates data from electronic medical records, claims and registries that voluntarily participate and allows the agency to track the safety of marketed drugs, biologics and medical devices.”
One of Sentinel’s main proponents at the FDA is Janet Woodcock, who has aggressively worked to expand the program as director of the FDA’s Center for Drug Evaluation and Research, with a focus on Sentinel’s use in “post-market effectiveness studies.” As previously mentioned, Woodcock is the only FDA official listed among the ninety or so “leaders” of OWS, most of whom are part of the U.S. military and lack any health-care or vaccine-production experience.
Woodcock’s temporary replacement at the FDA, Patrizia Cavazzoni, is also very active in efforts to expand Sentinel. STAT reported earlier this year that Cavazzoni previously “served on the sterling committee of I-MEDS, an FDA-industry partnership which allows drug makers to pay for use of the FDA’s real-world data system known as Sentinel to complete certain safety studies more quickly.”
Sentinel has a series of “collaborating partners” that “provide healthcare data and scientific, technical, and organizational expertise” to the initiative. These collaborating partners include intelligence contractor Booz Allen Hamilton, tech giant IBM, and major U.S. health insurance companies such as Aetna and Blue Cross Blue Shield, among many others. In addition, Sentinel’s Innovation Center, which it describes as the program’s “test bed to identify, develop, and evaluate innovative methods,” is partnered with Amazon, General Dynamics, and Microsoft. Sentinel also has a Community Building and Outreach Center, which is managed by Deloitte consulting, one of the largest consultancy firms in the world that is known for seeking to fill its ranks with former CIA officials.
The Sentinel system’s specific surveillance program aimed at monitoring vaccine effectiveness is known as the Post-licensure Rapid Immunization Safety Monitoring Program, better known as PRISM. Sentinel’s PRISM was “developed to monitor vaccine safety, but [to date] has never been used to assess vaccine effectiveness.” PRISM was initially launched alongside the Sentinel Initiative itself in 2009 “in response to the need to monitor the safety of the H1N1 influenza vaccine” after it was licensed, marketed, and administered. Yet, as previously mentioned, PRISM has yet to be used to assess the effectiveness of any vaccine while quietly expanding for nearly a decade, which implies that the stakeholders in the Sentinel Initiative have a plan to implement this “safety surveillance system” at some point.
The name PRISM may remind readers of the National Security Agency (NSA) program of the same name that became well known throughout the United States following the Edward Snowden revelations. Given this association, it is worth noting that the NSA, as well as the Department of Homeland Security (DHS), are now officially part of Operation Warp Speed and appear to be playing a role in the development of Warp Speed’s “pharmacovigilance surveillance system.” The addition of the NSA and the DHS to the initiative, of course, greatly increases the involvement of U.S. intelligence agencies in the operation, which itself is “dominated” by the military and sorely lacking in civilian public health officials.
CyberScoop first reported in early September that members of the NSA’s Cybersecurity Directorate were involved in OWS, with their role — as well as that of DHS — being framed mainly as offering “cybersecurity advice” to the initiative. However, the NSA and DHS are also offering “guidance” and “services” to both the other federal agencies involved in Warp Speed as well as OWS contractors, which now include Google and Oracle.
Google is well known for its cozy relationship with the NSA, including its PRISM program, and they have also backed NSA-supported legislation that would make it easier to surveil Americans without a warrant. Similarly, Oracle is a longtime NSA contractor and also has ties to the CIA dating back to its earliest days as a company, not unlike Google. Notably, Oracle and Google remain locked in a major legal battle over copyright issues that is set to be heard by the Supreme Court in the coming weeks and is expected to have major ramifications for the tech industry.
The public health panopticon
In the aftermath of the 9/11 attacks, the U.S. military attempted to institute a surveillance program so invasive that Congress defunded it just months after its creation due to public outrage. Known as Total Information Awareness (TIA), the program sought to develop an all-seeing surveillance apparatus managed by the Pentagon’s DARPA and officially argued that invasive surveillance of the entire U.S. population was necessary to prevent terrorist attacks, bioterrorism events, and even naturally occurring disease outbreaks before they could take place.
Before it was disbanded, TIA sought to collect Americans’ medical records; fingerprints; gait, facial, and iris biometric data; drug prescriptions; and even DNA in addition to citizens’ financial, travel, and media-consumption habits. TIA, not unlike OWS, was a “public-private partnership” managed by the DOD and partnered with the NSA, the CIA, and other intelligence agencies as well as the private sector and academia.
Also like Warp Speed, TIA officially justified its invasive surveillance goals by claiming that its initiatives would rescue Americans from the “invisible enemy” of faceless terrorists abroad and ensure citizens’ safety, security, and health. Today, Warp Speed officially takes aim at a new type of “invisible enemy” — a microbe invisible to the naked human eye.
In the years after 9/11, the public pushback against TIA was fierce. The American Civil Liberties Union (ACLU) claimed at the time that the surveillance effort would “kill privacy in America” because “every aspect of our lives would be catalogued,” while mainstream media outlets warned that TIA was “fighting terror by terrifying U.S. citizens.” Despite Congress officially defunding the program, it later emerged that TIA was never actually shut down, with its various programs having been covertly divided among the web of military and intelligence agencies that comprise the U.S. national security state.
Unlike in years past, TIA’s apparent successor, OWS, has received no pushback from mainstream media outlets or advocacy organizations, with many of these same entities now placing blind faith in the secretive initiative and lionizing it as the “only way” to resolve the COVID-19 pandemic crisis.
The national security state has carefully learned from and studied its past failures, while many Americans, in contrast, continue to place their trust in the very agencies and government entities that have lied the country into multiple wars, tortured and maimed countless civilians abroad, produced a series of failed states in order to plunder their resources, and are currently facilitating the pillaging of the American economy by Wall Street and the Federal Reserve under the guise of “relief.”
Allowing these same entities to surveil and track a majority of Americans and to use the country’s population as guinea pigs for unlicensed, understudied, and experimental vaccine technologies is a clear recipe for disaster. At the same time, it would also enable a surveillance panopticon so dystopian and far reaching that Americans stand to lose not only their few remaining civil liberties but even sovereignty over their own bodies.
The total-surveillance agenda that began with TIA and that has been resurrected through Warp Speed predated COVID-19 by decades. Its architects and proponents have worked to justify these extreme and invasive surveillance programs by marketing this agenda as the “solution” to whatever Americans are most afraid of at any given time. It has very little to do with “public health” and everything to do with total control.
Published with permission by The Last American Vagabond.