COVID-19 Vaccines Tested in Clinical Trials, Despite Bogus Social Media Claims

SciCheck Digest

The COVID-19 vaccines were tested in large, randomized controlled trials before the Food and Drug Administration authorized them for emergency use. But a popular YouTube video spins a conspiracy theory that distorts legal codes to falsely claim otherwise.

How were safe and effective vaccines developed so rapidly?

How were safe and effective vaccines developed so rapidly?

The unprecedented speed of the COVID-19 vaccines was due to multiple factors.

Candidates for an mRNA vaccine — the technology used for the Pfizer/BioNTech and Moderna vaccines — can be quickly designed once scientists know the genetic sequence of the virus and which protein to target. Researchers already knew from past experience with SARS and MERS, which are other diseases caused by coronaviruses, that the spike protein the virus uses to enter cells was likely the right one.

Similarly, Johnson & Johnson has been researching adenovirus-based vaccines — the technology its COVID-19 vaccine uses — for many years in working on vaccines for HIV and Zika, and its Europe-approved Ebola vaccine.

The testing of the vaccines was also sped up by consolidating some of the early testing stages. Companies typically don’t want to proceed with expensive trials until there’s a sign the vaccine will work, but the government took on that financial risk in many cases.

The phase 3 randomized controlled clinical trials were also fast because high levels of disease transmission meant COVID-19 cases quickly accumulated among trial participants. And production capacity was sped along by starting manufacturing even before knowing whether the vaccines would be successful.

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Why were the vaccines authorized on an emergency basis, and how is that different from full approval?

Why were the vaccines authorized on an emergency basis, and how is that different from full approval?

The Food and Drug Administration expedited review of the vaccines because of the public health risks of the ongoing pandemic. All three vaccines in use in the U.S. were rolled out under an emergency use authorization, or EUA, which is typically less stringent than the full licensure, which is called a biologics license application, or BLA. However, the FDA added more rigorous requirements for a COVID-19 vaccine EUA.

Under a standard EUA, regulators must determine that the product “may be effective” and the “known and potential benefits outweigh the known and potential risks.” For these EUAs, the FDA went further and required “at least one well-designed Phase 3 clinical trial that demonstrates the vaccine’s safety and efficacy in a clear and compelling manner.” The agency also wanted to see at least two months of follow-up data on half or more of the participants, and said it expected vaccine companies to continue to collect data to pursue full approval.

The FDA granted full approval to the Pfizer/BioNTech COVID-19 vaccine for people 16 years of age and older on Aug. 23, 2021. The decision was based on additional data from the phase 3 clinical trials, in which more than half of participants were followed for at least four months after receiving a second dose, and a review of safety surveillance and manufacturing data, including inspections of production facilities. After a similar review, the agency fully approved the Moderna vaccine for people 18 years of age and older on Jan. 31, 2022.

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Full Story

All of the four COVID-19 vaccines available in the U.S. were tested in large, randomized controlled trials for safety and efficacy before the FDA granted them emergency use authorization and they were rolled out to the public.

Two of the vaccines are now fully approved: the Pfizer/BioNTech and Moderna shots. These are the vaccines the vast majority of vaccinated Americans have received.

As is standard in clinical trials, the volunteers in the COVID-19 vaccine trials were informed of the risks and benefits so they could decide whether to participate, or what is known as informed consent.

Yet a Jan. 7 YouTube video that racked up more than 300,000 views in its first three days falsely claims the trials were a sham. The video also incorrectly suggests the trial participants did not give informed consent.

“A bombshell new report shows that the Department of Defense — yes the pentagon — controlled the COVID-19 program from the very beginning, and everything we were told was political theater, basically to cover it up, right down to the FDA vaccine approval process,” says host Clayton Morris, at the start of the video. “It was all theater. That means that human beings were used as props.”

The 17-minute video is an episode of the YouTube show Redacted, which Morris co-hosts with his wife and which has previously trafficked in misinformation, including about COVID-19. Morris is a former “Fox & Friends” host and real estate investor who moved to Portugal following fraud allegations by former clients.

The video features Alexandra, or Sasha, Latypova, who is described as “a former executive of a pharmaceutical contract research organization.” She has previously made media appearances with organizations opposed to vaccines, such as Robert F. Kennedy Jr.’s Children’s Health Defense, and has written for the pseudoscientific website TrialSiteNews. 

In the Redacted interview, Latypova makes a series of false claims, many predicated on her misreading of government contracts and the legal code. Lawyers with expertise in the area told us the claims are bunk.

False Claim About ‘Theatrical’ Clinical Trials

Latypova kicks off her interview by claiming “the Department of Defense used very shady contracting practices and also used several laws that were put in place previously … to shield pharmaceutical companies, to not conduct, you know, proper clinical trials.”

“As a result, we have this theatrical performance called clinical trials, but they were actually not real,” she continues. “Based on the laws that are used here and then involved in this process, clinical trials are not required at all. And, and in fact they cannot be conducted.”

This is patently false. All of the vaccine clinical trials were very much real. Not only have thousands of Americans participated in these trials, some of whom have been interviewed for news stories, but there are reams of data from these trials that the FDA reviewed prior to issuing the emergency use authorizations and the approvals. 

These data were also reviewed by multiple independent review groups for the FDA and the Centers for Disease Control and Prevention in publicly accessible meetings, and the results were also published in peer-reviewed journals. The notion that these trials were not real strains credulity and requires conspiratorial thinking.

Latypova’s mischaracterization likely stems from her misreading of the laws governing emergency use authorizations, or EUAs. It’s true that an EUA, which can cover a variety of diagnostics, treatments or vaccines during an exceptional situation such as a pandemic, is different from a full approval — and does not necessarily require a clinical trial. 

However, the legal code specifically says that an EUA can consider data “from adequate and well-controlled clinical trials, if available.” And for the COVID-19 vaccines, the FDA made clear in guidance that clinical trials were required.

An October 2020 FDA guidance document states that for a COVID-19 vaccine “for which there is adequate manufacturing information to ensure its quality and consistency, issuance of an EUA would require a determination by FDA that the vaccine’s benefits outweigh its risks based on data from at least one well-designed Phase 3 clinical trial that demonstrates the vaccine’s safety and efficacy in a clear and compelling manner.”

“For vaccines (and new drugs like Paxlovid, which also received an EUA) the FDA always requires clinical trials,” Villanova University law professor Ana Santos Rutschman told us. “Technically, guidance is not binding,” she added, “but we’ve never seen FDA depart significantly from guidance it issues in any of these areas.”

And of course, trials were indeed performed for all of the vaccines that received an EUA, contrary to Latypova’s claim that they were fake.

“The difference between an EUA and other forms of regulation is that the standard for effectiveness is that ‘it is reasonable to believe’ that a product is effective,” Rutschman explained. “‘Reasonable to believe’ is a lower standard than the one required for full approval; this means that companies are able to submit clinical trial data to the FDA sooner than they normally would under the full approval pathway. But the clinical trials still have to be ok’ed by the FDA, which also reviews all the data generated during the trials, and keeps monitoring the product even after it is authorized under an EUA, as well as after full approval.”

“Sasha Latypova’s argument is a classic example of a causal fallacy,” Jacob S. Sherkow, a law professor at the University of Illinois Urbana-Champaign, told us. “Latypova assumes that because some clinical investigations are not required under an EUA, they could not have occurred.”

“It’s bogus as a matter of law, as a matter [of] logic, and a matter of fact,” he added.

False Informed Consent Claim

Another of Latypova’s false claims is the suggestion that informed consent wasn’t obtained in the COVID-19 vaccine trials. 

She cites the 21st Century Cures Act signed in 2016 by President Barack Obama, saying the law changed “the informed consent requirements, such that subjects don’t have to be necessarily informed of what’s going on if it’s deemed not in their best interest.”

Latypova proceeds to suggest that this is what happened in the COVID-19 vaccine trials. “They don’t have to inform the subjects what it is, they can use a lot of secrecy, they don’t have to run clinical trials, they’re not required, because these products cannot be investigational products, that’s what the law says,” she says, repeating her claim about the trials. “If they cannot be investigational products, then we don’t have any investigation, we don’t have any clinical trial subjects. So that’s how they’re pulling this off.”

“[I]t’s just nonsense,” Sherkow said. “There’s nothing in the CURES Act that says, ‘No informed consent for clinical trials.’”

Rutschman agreed, noting that the Cures Act allows for small modifications to informed consent in certain situations, but does not “do away with informed consent requirements.” 

Other scientists have published research analyzing the informed consent documents used in the COVID-19 vaccine trials. While the researchers concluded the forms should have been shorter and easier to read, it’s simply not true that such forms did not exist.

A COVID-19 vaccine is ready to be given to a volunteer in a phase 3 clinical trial in Hollywood, Florida, in August 2020. Photo by Chandan Khanna/AFP via Getty Images.

Latypova’s related legal claim about “investigational products” refers to a particular part of the legal code about EUAs (21 U.S. Code § 360bbb–3(k)) that states the use of an EUA product “shall not be considered to constitute a clinical investigation.” But Rutschman said Latypova’s interpretation of those words is “entirely incorrect.”

Rather than meaning that an EUA product cannot be studied in a clinical trial, as Latypova has incorrectly assumed, the law is saying that an EUA product still needs to be studied or continued to be studied in a clinical trial to receive full approval, Rutschman said. 

“The provision is saying this is a particular pathway to bring products to market during an emergency, but use of these products is not a clinical investigation; if you’re going to seek full approval you have to continue running trials even as you make the vaccines/drugs available under an EUA,” she explained.

Other Assorted Claims

Among Latypova’s numerous other false claims (we aren’t covering them all) is the suggestion that the pandemic was “planned” and that an unnamed “they” — presumably the government — want to relinquish control to the World Health Organization.

“The pre-planning goes [back] years,” Latypova says. “For example, there is pandemic enterprise. It’s a quasi-private, quasi-government enterprise that’s been set up in 2013 that involves 10 heads of federal agencies.” She calls the group a “cabal” and claims the majority of the efforts were focused on maintaining secrecy.

“It’s almost like they knew this was coming,” Morris interjects. “This is where we talk about conspiracy theories on the show. I mean, it’s all true.”

It’s unclear which entity Latypova has in mind. The most likely candidate is a group known as the Public Health Emergency Medical Countermeasures Enterprise. It’s primarily made up of officials in multiple agencies, but includes industry partners, and helps to coordinate the government’s response during public health emergencies. It was created in 2006.

In any case, it’s incorrect to suggest the COVID-19 pandemic was planned. Conspiracy theorists have made similar claims before, as we’ve written. The reality is that well before 2019, scientists and government officials had been concerned about pandemics, including those caused by coronaviruses. Trying to prepare for them is not evidence that they were orchestrated or planned.

Near the end of the video, Morris suggests that “they’re already planning the next one” — presumably referring to the government and the next pandemic — and Latypova agrees.

“The next important thing that they want to do is give up our sovereignty to WHO,” she says, referring to the International Health Regulations.

We’ve explained before that the WHO can make recommendations for countries to follow during global health emergencies, but the WHO doesn’t have authority over countries to force compliance.

It’s worth noting that while Latypova and Morris make much of the Department of Defense’s role in the COVID-19 vaccine program, there is nothing unusual about it.

“DoD is always very involved in vaccine R&D,” Rutschman said, noting that historically, many vaccine-preventable diseases occur outside of the U.S. where American troops are often deployed. “[I]t’s totally normal for DoD to be the contracting agency; as funders, they have an interest in demanding that their funding recipients perform R&D that is compliant with FDA regs and likely to obtain authorization/approval if the resulting product is good.”

As for the claim the Department of Defense used “shady” contracting methods, Rutschman explained that the contracting mechanism, known as “other transaction authority,” or OTA, simply allows the department to purchase items or services quickly — and is hardly unprecedented.

“DoD had used the OTA pathway many times before COVID-19,” she said. “This form of contracting enables the government to move faster; it is perfectly legal and well-regulated.”