United States: While COVID-19 Spreads, PETA Spreads Misinformation On Animal Testing

The animal rights organization People for the Ethical Treatment (PETA) is well known for attention-grabbing tactics.  Even in "normal" times, PETA can be counted on to push the envelope (or break through it entirely).  As non-animal humans worldwide suffer through the current COVID-19 pandemic, PETA has seized upon the crisis to promote its animal rights agenda, including the organization's long-standing opposition to the use of animals in testing the safety and efficacy of drugs and vaccines to cure and prevent human disease.  PETA has made several recent statements suggesting the coming demise of animal testing that are quite misleading.

On March 16, 2020, the National Institute of Allergies and Infectious Diseases (NIAID) announced that human trials would begin on a vaccine for COVID-19, dubbed mRNA-1273, that had been developed jointly by NIAID and Moderna, Inc.  As explained on the NIH website, the "spike" on the SARS-CoV-2 coronavirus (the "S" protein") is how the virus fuses to and invades human cells.  The vaccine, dubbed mRNA-1273, uses "messenger" RNA to direct the body's cells to express just the protein "spike" on the SARS-CoV-2 virus in its prefusion form which, in turn, elicits an immune response.  The theory is that the body will have the same immune response when the real virus shows up and the spike's fusion process will be disrupted, thereby preventing or slowing infection by the virus.  The vaccine went to first-in-human (FIH) trials relatively quickly in contrast to the greater time it takes to produce vaccines based on a weakened or dead form of the virus.

PETA seized upon the speed with which mRNA-1273 went to FIH trials as evidence that animal testing had essentially been skipped for this vaccine thereby, according to PETA, demonstrating that testing drugs in animal models is "pointless."

In a statement dated March 16, 2020, and entitled "Coronavirus Vaccine:  NIH Isn't Waiting for Pointless Animal Tests," PETA proclaimed that NIH was "finally heeding PETA's call.  According to BBC News, the agency isn't waiting for the typical, lengthy animal-testing phase and is instead heading straight for human trials. While this won't stop all tests on animals for the vaccine, it should pave the way for safe straight-to-human vaccine trials from now on."

In a statement dated April 9, 2020, PETA wrote that "PETA and compassionate people everywhere were heartened to learn that, in order to speed up the development of a potential coronavirus vaccine, the National Institutes of Health (NIH) quickly began testing directly on humans without waiting for the results of the typical, lengthy animal-testing phase, showing that the results yielded by tests on animals are not necessary and are slowing down the development of medicines that will help humans."

In a statement dated May 5, 2020, PETA stated:  "Last month, for the first time in history, both the FDA and the U.S. National Institutes of Health (NIH) greenlighted a landmark human clinical trial of a vaccine without first requiring extensive animal tests. Companies are usually required to spend years putting animals through the agony of new product tests before human clinical trials are allowed to begin, even though those animal tests don't predict whether a drug will work in humans.  But in this case, the company started developing a COVID-19 vaccine in January, and by March, the FDA and NIH both agreed: It's time to see if this vaccine is effective in humans."

A reasonable person could form the impression from these statements that mRNA-1273 went to FIH trials with little or no animal testing, particularly since all three statements were made by PETA in making the argument that drugs and vaccines can be brought to market and safely and effectively used by the American public without animal testing.  So what did happen?

In the first place, in announcing the FIH trials on March 16, NIAID expressly stated that "[t]he mRNA-1273 vaccine has shown promise in animal models, and this is the first trial to examine it in humans."  (Emphasis added).  Moreover, as reported by Forbes, in response to the controversy stirred by the implication that mRNA-1273 had not undergone extensive animal testing before FIH trials, NIAID stated on March 18 that:

None of PETA's statements acknowledges, or was revised to acknowledge, NIAID's March 18 statement.

Other reporting during this same time frame (here and here) indicates that animal testing is being done on the mRNA-1273 vaccine at the same time that the human trials are being conducted.  "Standard" mice were dosed the same day that the FIH trials began, and once transgenic mice who are susceptible to SARS-CoV-2 are bred and delivered, they will be utilized in the animal testing as well.  Thus, the results of the Phase 1 human trials and the results of the parallel animal testing will determine whether the vaccine moves to the next Phase.  As recently as May 4, Dr. Anthony Fauci, the head of NIAID, stated in an interview with National Geographic, that, with respect to mRNA-1273 and a vaccine developed at Oxford University, they "are inducing, at least in animal models, really rather substantial immune responses, particularly the mRNA vaccine."  (Emphasis added).  Furthermore, as reported in Science, apart from mRNA-1273 itself, the mRNA technology platform has a history of being tested in animal models.

The course taken with mRNA-1273 appears to align with the global position on the regulatory considerations related to the preclinical data required to support proceeding to FIH trials for SARS-CoV-2 vaccine candidates.  A recent report of a workshop of the International Coalition of Medicines Regulatory Authorities (ICMRA), which included the U.S. Food and Drug Administration, stated certain agreed  positions as to proceeding to FIH clinical trials.  Two of those positions were:  "For all SARS-CoV-2 vaccine candidates it is necessary to obtain data in animals and to characterize the immune response induced by a SARS-CoV-2 vaccine candidate.  It is not required to demonstrate the efficacy of the SARS-CoV-2 vaccine candidate in animal challenge models prior to proceeding to FIH clinical trials."

So, yes, animal testing played, is playing, and will continue to play, a significant role in the development of mRNA-1273.  What apparently was different with this vaccine was that the animal testing piece that includes challenges to the animal model with the actual virus will occur simultaneously with the Phase 1 human testing.  But animal testing for immune response clearly preceded the FIH human trials, and the mRNA technology platform also had a history of testing of animals and humans.   There is little room to conclude from the regulatory progression of mRNA-1273 that testing new drugs and vaccines on animals is "pointless" or is, or should be, on the way out.

It is also clear that animal models will have a central role in the development of other vaccines and therapeutics against SARS-CoV-2 as well.  As detailed by a recent article in Science, not only is there a race to develop vaccines and drugs to combat COVID-19, there is a parallel race to develop animal models to test them.  The Syrian hamster appears to be one promising candidate.

Originally published May 9, 2020

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.