Operation Warp Speed (OWS), a joint operation between U.S. Health and Human Services (HHS) and the Department of Defense, continues to be shrouded in secrecy, but little by little information is emerging that long-term monitoring of the U.S. public is part of the plan.
At face value, OWS is a public-private partnership tasked with producing therapeutics and a fast-tracked COVID-19 vaccine1 — 300 million doses' worth that are intended to be made available starting in January 2021.2
But it appears the involvement doesn't end there. Rather than just ensuring a vaccine is produced and made available for those who want it, Moncef Slaoui, the chief scientific adviser for Operation Warp Speed, dubbed the coronavirus vaccine czar,3 said in an interview with The Wall Street Journal that the rollout will include "incredibly precise … tracking systems."4,5
Their purpose? "To ensure that patients each get two doses of the same vaccine and to monitor them for adverse health effects."6 In an interview with The New York Times, Slaoui described it as a "very active pharmaco vigilance surveillance system."7
What Will the Vaccine Monitoring System Entail?
This is the No. 1 question, and one that hasn't been answered, at least not officially. "While Slaoui himself was short on specifics regarding this 'pharmacovigilance surveillance system,'" news outlet Humans Are Free reported, "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."8
One of the documents, titled "From the Factory to the Frontlines: The Operation Warp Speed Strategy for Distributing a COVID-19 Vaccine," was released by HHS.9It also mentions the use of pharmacovigilance surveillance along with Phase 4 (post-licensure) clinical trials in order to assess the vaccines' long-term safety, since "some technologies have limited previous data on safety in humans."10
The report, which lays out a strategy for distributing a COVID-19 vaccine, from allocation and distribution to administration and more, continues:11
"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. Pharmacovigilance provides timely information about the safety of each vaccine to patients, healthcare professionals, and the public, contributing to the protection of patients and the promotion of public health."
Similar language was reiterated in an October 2020 perspective article published in The New England Journal of Medicine (NEJM), written by Slaoui and Dr. Matthew Hepburn.12
Hepburn is a former program manager for the U.S. Defense Advanced Research Projects Agency (DARPA), where he oversaw the development of ProfusA,13 an implantable biosensor that allows a person's physiology to be examined at a distance via smartphone connectivity. ProfusA is also backed by Google, the largest data mining company in the world.
Writing in NEJM, the duo writes, "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."14
'Traceability' a Key Tenet of Operation Warp Speed
Humans Are Free also references an OWS infographic,15 which details the COVID-19 vaccine distribution and administration process. One of the four key tenets is "traceability," which includes confirming which of the approved vaccines were administered regardless of location (public or private), reminding recipients to return for a second dose and ensuring that the correct second dose is administered.
That word — pharmacovigilance — is used again, this time as a heading inferring that the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention will be involved in "24-month post trial monitoring for adverse effects/additional safety feature." Pharmacovigilance, also known as drug safety, generally refers to the collection, analysis, monitoring and prevention of adverse effects from medications and other therapies.16
Passive reporting systems for adverse events, like the Vaccines Adverse Event Reporting System, already exist and are managed by the FDA and CDC.
However, a report released by Johns Hopkins Bloomberg School of Public Health, Center for Health Security suggests that passive systems that rely on people to send in their experiences should be made into an "active safety surveillance system directed by the CDC that monitors all vaccine recipients — perhaps by short message service or other electronic mechanisms — with criteria based on the World Health Organization Global Vaccine Safety Initiative."17,18
What's more, according to Humans Are Free, "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."19 STAT News further reported:20
"The Food and Drug Administration, which is playing a critical role in the response to the pandemic, has virtually no visibility into OWS — but that's by design … The FDA has set up a firewall between the vast majority of staff and the initiative to separate any regulatory decisions from policy or budgetary decisions.
FDA officials are still allowed to interact with companies developing products for OWS, but they're barred from sitting in on discussions regarding other focuses of OWS, like procurement, investment or distribution."
Johns Hopkins Bloomberg School of Public Health, Center for Health Security, by the way, has ties to Event 201, a pandemic preparedness simulation for a "novel coronavirus" that took place in October 2019, along with Dark Winter, another simulation that took place in June 2001, which predicted major aspects of the subsequent 2001 anthrax attacks.
Hepburn also reportedly "ruffled feathers" during a June 2020 presentation to the CDC's Advisory Committee on Immunization Practices because he offered no data-rich slides, which are typically part of such presentations, and, STAT News reported, "Several members asked Hepburn pointed questions he pointedly did not answer."21