by John M. Simpson.<\/p>\n
The animal rights organization People for the Ethical Treatment (PETA) is well known for attention-grabbing tactics.\u00a0 Even in \u201cnormal\u201d times, PETA can be counted on to push the envelope (or break through it entirely).\u00a0 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\u2019s long-standing opposition to the use of animals in testing the safety and efficacy of drugs and vaccines to cure and prevent human disease.\u00a0 PETA has made several recent statements suggesting the coming demise of animal testing that are quite misleading.<\/p>\n
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.\u00a0 As explained<\/a> on the NIH website, the \u201cspike\u201d on the SARS-CoV-2 coronavirus (the \u201cS\u201d protein\u201d) is how the virus fuses to and invades human cells.\u00a0 The vaccine, dubbed mRNA-1273, uses \u201cmessenger\u201d RNA to direct the body\u2019s cells to express just the protein \u201cspike\u201d on the SARS-CoV-2 virus in its prefusion form which, in turn, elicits an immune response.\u00a0 The theory is that the body will have the same immune response when the real virus shows up and the spike\u2019s fusion process will be disrupted, thereby preventing or slowing infection by the virus.\u00a0 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.<\/p>\n 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 \u201cpointless.\u201d<\/p>\n \u25baIn a statement<\/a> dated March 16, 2020, and entitled \u201cCoronavirus Vaccine:\u00a0 NIH Isn\u2019t Waiting for Pointless Animal Tests,\u201d PETA proclaimed that NIH was \u201cfinally heeding PETA\u2019s call.\u00a0 According to BBC News, the agency isn\u2019t waiting for the typical, lengthy animal-testing phase and is instead heading straight for human trials. While this won\u2019t stop all tests on animals for the vaccine, it should pave the way for safe straight-to-human vaccine trials from now on.\u201d<\/span><\/strong><\/p>\n \u25baIn a statement<\/a><\/span><\/strong>\u00a0dated April 9, 2020, PETA wrote that \u201cPETA 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.\u201d<\/span><\/strong><\/p>\n \u25baIn a statement<\/a> dated May 5, 2020, PETA stated:\u00a0 \u201cLast 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\u2019t predict whether a drug will work in humans.\u00a0 But in this case, the company started developing a COVID-19 vaccine in January, and by March, the FDA and NIH both agreed: It\u2019s time to see if this vaccine is effective in humans.\u201d<\/span><\/strong><\/p>\n 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<\/em><\/strong> animal testing.\u00a0 So what did happen?<\/p>\n In the first place, in announcing the FIH trials on March 16, NIAID expressly stated<\/a> that \u201c[t]he mRNA-1273 vaccine has shown promise in animal models<\/em><\/strong>, and this is the first trial to examine it in humans.\u201d\u00a0 (Emphasis added).\u00a0 Moreover, as reported<\/a> by Forbes<\/em>, 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:<\/p>\n NIAID investigators have conducted preclinical immunogenicity testing of mRNA-1273 in mouse models.<\/span>\u00a0<\/strong> These studies show that the vaccine produces a potent antibody response against the COVID-19 virus.\u00a0 This data is not yet published.\u00a0 However, while these studies are supportive of the Phase 1 trial, they are not the basis for starting the clinical trial.\u00a0 The safety assessment is based on prior human studies of other vaccines developed using the mRNA platform technology.\u00a0 NIAID is following FDA guidance in performing the Phase 1 clinical trial.\u00a0 The studies in mice and future studies in nonhuman primates, in addition to the information from the Phase 1 clinical trial, will establish the rationale for testing the vaccine in larger trials if warranted.<\/span><\/strong>\u00a0 (Emphasis added).<\/p><\/blockquote>\n None of PETA\u2019s statements acknowledges, or was revised to acknowledge, NIAID\u2019s March 18 statement.<\/p>\n Other reporting during this same time frame (here<\/a> and here<\/a>) indicates that animal testing is being done on the mRNA-1273 vaccine at the same time that the human trials are being conducted.\u00a0 \u201cStandard\u201d 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.\u00a0 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.\u00a0 As recently as May 4, Dr. Anthony Fauci, the head of NIAID, stated in an interview<\/a> with National Geographic<\/em>, that, with respect to mRNA-1273 and a vaccine developed at Oxford University, they \u201care inducing, at least in animal models<\/em><\/strong>, really rather substantial immune responses, particularly the mRNA vaccine.\u201d\u00a0 (Emphasis added).\u00a0 Furthermore, as reported<\/a> in Science<\/em>, apart from mRNA-1273 itself, the mRNA technology platform has a history of being tested in animal models.<\/p>\n 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.\u00a0 A recent report<\/a> of a workshop of the International Coalition of Medicines Regulatory Authorities (ICMRA), which included the U.S. Food and Drug Administration, stated certain agreed\u00a0 positions as to proceeding to FIH clinical trials.\u00a0 Two of those positions were:\u00a0 “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.\u00a0 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.”<\/p>\n So, yes, animal testing played, is playing, and will continue to play, a significant role in the development of mRNA-1273.\u00a0 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.\u00a0 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.\u00a0 \u00a0There 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.<\/p>\n 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.\u00a0 As detailed by a recent article <\/em><\/a>in Science<\/em>, 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.\u00a0 The Syrian hamster appears to be one promising candidate.<\/p>\n","protected":false},"excerpt":{"rendered":" by John M. Simpson. The animal rights organization People for the Ethical Treatment (PETA) is well known for attention-grabbing tactics.\u00a0 Even in \u201cnormal\u201d times, PETA can be counted on to push the envelope (or break through it entirely).\u00a0 As non-animal humans worldwide suffer through the current COVID-19 pandemic, PETA has seized upon the crisis to … <\/p>\n