Instagram Posts Spread Texas Legislator’s False Claims on Vaccine Screening

SciCheck Digest

Animal testing and clinical trials were conducted before the COVID-19 vaccines were granted emergency use authorization in the U.S. But a state senator in Texas falsely claimed at a hearing that animal tests were “stopped” because the “animals were dying” and that “they didn’t do the human testing.” A clip of his erroneous remarks is spreading on social media.

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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How were the vaccines tested?

The authorized vaccines were initially tested in early phase clinical trials, in which scientists evaluated different doses, checked for the expected immune responses and monitored for potential safety issues. To find out whether the shots prevent disease and are safe, the vaccines that passed the first set of tests were then evaluated in phase 3 trials. The Moderna phase 3 trial included about 30,000 volunteers, while the Pfizer/BioNTech and Johnson & Johnson trials included about 44,000 each. In each of these trials, half of the participants received a placebo, while the other half received the vaccine, and the volunteers were followed over time to see if they fell ill with COVID-19 and had any adverse reactions.  

The trials were overseen by independent data and safety monitoring boards, and the results were reviewed not only by the Food and Drug Administration, which made the decision to authorize the vaccines for emergency use, but also by an outside panel of experts advising the agency. Another independent group, the CDC’s Advisory Committee on Immunization Practices, also reviewed the data and recommended use of the vaccines.

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Full Story

The COVID-19 vaccines now authorized for emergency use in the U.S. were subject to the same forms of research routinely expected of all vaccines — even though they were manufactured in record time. In part, the process was sped up thanks to previous, related vaccine research and because some of the early testing stages were consolidated.

But a Texas state lawmaker recently claimed, falsely, that animal trials for the vaccines were “stopped” because “the animals were dying.” And his words are now fueling widely viewed social media posts seeking to discredit the vaccines.

“COVID Jab: They Skipped all Animal Trials Because all Animals Were Dying & Went Directly to People,” reads the text of a video meme repeatedly posted on Instagram. It also cites where the video was taken: “Texas State Senate, May 2021.”

In the video clip, a man can be heard saying, “what I have read, they actually started the animal tests and because the animals were dying, they stopped the tests.” He claims that the “American people are now the guinea pigs” and continues: “They didn’t do the human testing and they stopped the animal tests because the animals were dying, and then they turned it out for the public.”

But none of that is accurate.

We traced the clip back to a May 6 public hearing before the Texas State Senate Committee on State Affairs, which was considering legislation by Republican state Sen. Bob Hall. The bill in question seeks to prohibit any mandates requiring COVID-19 vaccination.

Among the witnesses testifying was Dr. Angelina Farella, a pediatrician who criticized the COVID-19 vaccines and also repeated some erroneous claims about the vaccines.

Farella wrongly claimed, for example, that “we have in excess of 4,000 deaths and this thing has not been pulled yet.” There have not been 4,000 deaths confirmed to be due to the vaccine as Farella suggested. The figure may refer to reports submitted to a federal database used to monitor vaccine safety — but, as we’ve explained, anyone can submit such reports, so they’re not verified or proof that the vaccine caused the reported problem. The system has been frequently misrepresented.

Nearly 44 minutes into the committee hearing, during an exchange with Farella, Hall also suggested that the COVID-19 vaccine should have been “pulled from the market” and made his erroneous claim about testing.

Hall, May 6: And have you seen any other vaccine that was put out for the public that skipped the animal tests?

Farella: Never before — especially for children.

Hall: What I have read, they actually started the animal tests and because the animals were dying, they stopped the tests. Folks, I think that’s important to understand there. That what we’re talking about is, the American people are now the guinea pigs. This is the test program that’s going on. They didn’t do the human testing and they stopped the animal tests because the animals were dying, and then they turned it out for the public.

But as we said, testing on both animals and humans was conducted before the COVID-19 vaccines were granted emergency use authorization by the Food and Drug Administration. And it is not the case that animal tests on the vaccines “stopped” or that the “animals were dying.”

In the development of Moderna’s vaccine, a preclinical study published in July showed vaccinated monkeys that were challenged with the SARS-CoV-2 virus rapidly cleared the pathogen from their bodies, as we’ve explained. And a study published the following month found that in mice, the vaccine successfully prevented infection in the lung and nose.

Similarly, the Pfizer/BioNTech vaccine underwent preclinical testing in both mice and monkeys, as is noted in an FDA memo laying out the information considered in authorizing the vaccine for emergency use.

And the Johnson & Johnson vaccine was also tested in several nonclinical studies involving animals, including hamsters and monkeys.

Hall’s claim that “they didn’t do the human testing” is also verifiably false.

The FDA’s decision to grant the emergency use authorizations for each of the vaccines reviewed data from clinical trials — each involving tens of thousands of participants. All of the trials provided an equal number of participants with a vaccine and a placebo.

We reached out to Hall’s office to ask what he was referencing when he made his remarks, but didn’t hear back. As the Texas Tribune has documented, Hall has spread other misinformation about COVID-19 throughout the pandemic.

The false narrative that animal tests were “skipped” for the mRNA vaccines — those from Pfizer/BioNTech and Moderna — was fact-checked by our colleagues at the Associated Press in November. And we’ve previously reported on other claims about the COVID-19 vaccines that misrepresented old studies involving animals and vaccine candidates for other coronaviruses.

Editor’s note: SciCheck’s COVID-19/Vaccination Project is made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over our editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation. The goal of the project is to increase exposure to accurate information about COVID-19 and vaccines, while decreasing the impact of misinformation.

Sources

Corbett, Kizzmekia S., et al. “Evaluation of the mRNA-1273 Vaccine against SARS-CoV-2 in Nonhuman Primates.” New England Journal of Medicine. 28 Jul 2020.

Dupuy, Beatrice. “Pfizer and Moderna did not skip animal trials.” Associated Press. 25 Nov 2020.

“Emergency Use Authorization for Pfizer-BioNTech COVID-19 Vaccine Review Memo.” Food and Drug Administration. 11 Dec 2020.

“Janssen COVID-19 Vaccine EUA FDA review memorandum.” Food and Drug Administration. 27 Feb 2021. 

McDonald, Jessica. “A Guide to Pfizer/BioNTech’s COVID-19 Vaccine.” FactCheck.org. Updated 9 Apr 2021.

McDonald, Jessica. “A Guide to Moderna’s COVID-19 Vaccine.” FactCheck.org. Updated 9 Apr 2021.

Mercado, Noe B., et al. “Single-shot Ad26 vaccine protects against SARS-CoV-2 in rhesus macaques.” Nature. 30 Jul 2020.

Mulcahy, Shawn. “Texas GOP state senator urged use of unproven hydroxychloroquine treatment for COVID-19. Now he’s spreading doubt about vaccines.” Texas Tribune. 17 May 2021.

“Pfizer and BioNTech Announce Data from Preclinical Studies of mRNA-Based Vaccine Candidate Against Covid-19.” Press release, Pfizer. 9 Sep 2020.

“Single Dose of Johnson & Johnson COVID-19 Vaccine Candidate Demonstrates Robust Protection in Pre-clinical Studies.” Press release, Johnson & Johnson. 30 Jul 2020.

Texas State Senate. “SB 1669, Relating to prohibited discrimination regarding vaccination status and mandates for receiving or participating in the administration of vaccines; authorizing administrative penalties.” (introduced 11 Mar 2021)

Texas State Senate. “Senate Committee on State Affairs (Part I).” 6 May 2021.

Tostanoski, Lisa H., et al. “Ad26 vaccine protects against SARS-CoV-2 severe clinical disease in hamsters.” Nature Medicine. 3 Sep 2020.

Vogel, Annette B., et al. “A prefusion SARS-CoV-2 spike RNA vaccine is highly immunogenic and prevents lung infection in non-human primates.” bioRxiv. 8 Sep 2020.

Vogel, Annette B., et al. “BNT162b vaccines protect rhesus macaques from SARS-CoV-2.” Nature. 1 Feb 2021.  

The post Instagram Posts Spread Texas Lawmaker’s False Claims on Vaccine Testing appeared first on FactCheck.org.

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