Updated: March 28, 2020, 11:20 AM CT
The following is a list of frequently asked questions about the impacts of the COVID-19 pandemic on research facilities and research animals. AMP will continuously update this document as new data, questions and concerns arise.
Questions About the Role of Animals in the Development of a COVID-19 Vaccine
Question: How are vaccines developed?
Vaccines work by triggering our bodies to develop acquired immunity to specific infectious diseases. Immunity is frequently created by introducing the body to a weakened or dead form of the disease-causing microbe. This essentially teaches the immune system how to fight off infection.
The creation of every vaccine features several important steps. These include cellular work, animal studies and human clinical trials, all of which are necessary in order to develop safe and effective vaccines.
historyofvaccines.org – Vaccine Development, Testing, and Regulation
Question: Why are animals necessary for the development of a COVID-19 vaccine?
Animal studies are required for any and all vaccines to ensure that they are both safe and effective prior to approval for public use. These studies help scientists answer important questions including the following:
- Is the vaccine effective?
- Does it provide partial or full protection?
- How long will protection last? Months? Years?
- How big of a dose and how many doses are required in order to protect vaccine recipients?
- Are there side effects? How common are they? How serious are they?
It’s also worth noting that COVID-19 likely began as a bat virus that possibly passed through another animal before infecting humans. Because diseases can be passed from other animals to humans, as they have many times in the past, understanding how diseases and treatments respond in various species is crucial.
Question: Because lives are in jeopardy, should animal trials be skipped in this case?
While everyone wants a COVID-19 vaccine to be developed ASAP, there are serious problems and risks that arise if we intend to skip important steps in the development process. This is why even the vaccine candidate currently being tested in humans is also undergoing animal tests.
Over the past few weeks, various experts have highlighted the many serious risks associated with skipping animal tests. For example, one vaccine previously developed to combat another coronavirus that impacted felines actually increased the risk of infection. A separate troubling issue surfaced as researchers worked to create a vaccine following the 2003 outbreak of Severe Acute Respiratory Syndrome (SARS). They found some vaccinated animals developed more severe disease compared with unvaccinated animals when they were exposed to the virus. Yet another risk in the attempt to quickly develop a vaccine is that long-term concerns could be overlooked. In their efforts to create a treatment, scientists need to use all research methods available to determine whether COVID-19 might mutate and cause future infections. Otherwise, any recently introduced vaccine might potentially become obsolete.
Nature – Don’t rush to deploy COVID-19 vaccines and drugs without sufficient safety guarantees
Question: Isn’t a COVID-19 vaccine currently being tested without the use of animals?
No. There are no vaccines that are being tested without animal studies. Those opposed to necessary research in animals have made this claim – but it is untrue.
A vaccine candidate developed jointly by the National Institutes of Health and a company named Moderna is currently being tested in humans. At the same time, scientists at the NIH are conducting animal studies in parallel. See this story in STAT. In fact, some of the data from those animal studies is already available. As the NIH stated on March 16, the day when the first human study participant received the vaccine:
“The mRNA-1273 vaccine has shown promise in animal models, and this is the first trial to examine it in humans.”
The decision to allow both animal and human studies to take place at the same time is not because animal studies are unnecessary. It is because COVID-19 is a highly lethal virus that has rapidly spread around the world causing a global emergency.
The ability to conduct animal and human studies concurrently is also possible because the mRNA vaccination approach has also been analyzed in past studies of related coronaviruses that cause severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). In addition, several mRNA vaccine studies have taken place in animals in the past. Press releases here, and here from Moderna demonstrate this.
Furthermore, below is a small sampling of past research papers where studies in animals provided important data allowing for the development of mRNA vaccine technology:
- Role of the inflammasome-related cytokines Il-1 and Il-18 during (mouse) infection with murine coronavirus
- Modified mRNA/lipid nanoparticle-based vaccines expressing respiratory syncytial virus F protein variants are immunogenic and protective in rodent
- A Modified mRNA Vaccine Targeting Immunodominant NS Epitopes Protects Against Dengue Virus Infection in HLA Class I Transgenic Mice
- Long-term efficacy and safety of mRNA therapy in two murine (mouse) models of methylmalonic acidemia
- Novel mRNA-Based Therapy Reduces Toxic Galactose Metabolites and Overcomes Galactose Sensitivity in a Mouse Model of Classic Galactosemia
Finally, NIAID Director Dr. Anthony Fauci, M.D., recently spoke about the critical role of animals in developing a safe and effective COVID-19 vaccine. Watch him make these statements here.
Question: What species of animals are required for the development of a COVID-19 vaccine?
Vaccine development involves a variety of animal species in order to gain critical information about the safety and efficacy of a candidate before it is offered to human volunteers. Mice are playing an important role in current efforts to develop a coronavirus vaccine. According to news reports, it’s also likely that ferrets, hamsters and/or monkeys will also be required. One reason why a variety of species are necessary is because some animals are more susceptible to certain diseases than others. In short, the best animal model is often the one that responds to infection similarly to the way that humans do.
Also, in many cases, researchers might study several different specially bred mouse models of a disease. Together this variation provides important information to assist in developing the safest and most effective treatments possible.
It’s also important to recognize that safety approvals by the FDA regularly require studies in at least two different species in order to reduce risk.
New York Times – These Lab Animals Will Help Fight Coronavirus
Question: How long will it likely take to develop a COVID-19 vaccine?
News reports have claimed the development of a COVID-19 vaccine could take anywhere from several months to several years. The fact is, the answer is unknown simply because it depends on the success of current vaccine development efforts. It’s also important to recognize all the things that will likely need to occur before a vaccine is released to the public. These include:
- Preclinical testing of vaccine candidates
- Animal efficacy and safety tests
- Human clinical trials
- Federal approvals
- Creation of a manufacturing pipeline for a vaccine
- Quality control testing and approvals
- Vaccine manufacturing
- Vaccine distribution
- Vaccine delivery
- Vaccination timeline needs (if for instance, vaccination requires more than one dose in order to achieve immunity.)
Question: What’s the status of the development of a vaccine?
Several vaccine candidates that use a variety of approaches are currently being developed. According to the Regulatory Affairs Professionals Society, more than 30 separate attempts are taking place including two candidates currently being tested in human clinical trials. A list of the various approaches along with the companies and research institutions behind them can be found here.
Despite these aggressive efforts, experts say it’s unlikely a vaccine will be approved for use and available to the public this year. See the information above that explains why this is the case.
Question: As we wait for a vaccine to be developed, what else is the research community doing to attempt to save lives?
It’s impossible for the experts to determine how long the pandemic will last. In China, where extensive restrictions were put into place to attempt to contain the disease, recent reports suggest that the situation has improved greatly. However, this is not to say that the outbreak has ended in that country. And predictions about the length of the entire worldwide pandemic have varied from a few months to a year and a half.
While a vaccine is likely many months off, it is possible that attempts to investigate available drugs and treatments may unearth therapies that could significantly reduce the mortality rate of COVID-19. These kinds of studies are already underway and while there are currently no proven therapies for the disease, it is hoped that one or several can be discovered. Recently, STAT News published a list of experimental drugs to treat COVID-19 and their guesses as to when those might be available or when we may have efficacy data.
Questions about animals not involved in COVID-19 research.
Question: What are research organizations doing about the thousands of animals currently not involved in COVID-19 studies
Several health research organizations across the country have publicly disclosed their role in the development of new coronavirus treatments and vaccine candidates. In addition, many have started to communicate about the status of research projects in other areas, including those that involve animals.
At some institutions, leaders have asked research staff to plan for the worst-case scenario where animals might need to be euthanized. Making plans in preparation for a crisis and initiating those plans are two entirely separate things which is why it is important that the public understand the difference between the two.
Question: Why are some institutions talking about euthanizing animals not involved in COVID-19 research?
Many research organizations are requiring employees to work from home unless their job requires them to remain onsite. This is the case because COVID-19 has been shown to be highly contagious and by reducing social interactions we are more likely to reduce transmission from person-to-person. In addition, people can unknowingly become infected several days before symptoms surface, which allows the disease to spread even further. This makes the rapid expansion of cases highly-likely and also a severe risk, one that could push our country’s health delivery capabilities well past their capacity. In addition, responsible research organizations are planning for various scenarios including those where animal care staff might be unable to come to work due to illness.
Because of this, research programs are ensuring that everything is in place to implement disaster plans if needed. Animal care staff are considered essential personnel. They are therefore part of the workforce that continues to go to work each day to ensure the animals in their care have what they need. Leaders at research institutions across the U.S. are planning for various scenarios including those where animal care staff are unable to work due to illness or if resources are not available to provide care for the animals.
Again, planning for the worst-case scenario is not the same as initiating those plans, which is why it is important for the public to understand the difference between the two.
Question: Are animals currently being euthanized?
In response to the previously mentioned concerns about additional disease transmission, many research organizations have made the decision to place non-essential research projects on hold. In several cases this means that projects are being halted and will resume once the outbreak has subsided. In other situations, certain projects cannot easily be placed on hold. In these cases, the involved rodents may need to be humanely euthanized. In situations where this becomes necessary, it is not a step that is being taken lightly.
Question: Some organizations have volunteered to accept research animals from studies that have been halted. Are research institutions transferring their animals to these groups?
There are several reasons why research organizations are unable to transfer animals to groups that have offered to take them. One primary reason is the risk that this would pose to the individuals who receive the animals, likely rodents, as well as the public at large.
Another primary reason this is impossible is the risk it would pose to the animals themselves. Mice and rats involved in research are provided with expert care which includes high quality food and water. They also receive daily health checkups from trained animal care specialists and on-site treatment from veterinarians who are very familiar with rodent health and illness. It would be highly unethical to transfer these animals to individuals who lack the financial resources and expertise required to take care of them. In addition, the vast majority of animal studies in this country take place in rats and mice meaning that a single institution may have tens of thousands of rodents. Even if only a small percentage of these animals were transferred to a private citizen or group, they would not have the space, resources or knowledge required to ensure the safety of these animals, themselves or their neighbors.
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