Animals In Batch Testing: Need For 3rs
In the absence of Dr Suresh Jadhav, Executive Director of the Serum Institute of India Pvt. Ltd., his speech was conveyed by Dr. Sunil Goel, Additional Director also of the Serum Institute.
The greatest hurdle identified is the lack of international harmonization, which forces vaccine manufacturers to meet the differing requirements of the different authorities of the countries they export to. While the obvious solution would be the harmonization of test requirements or mutual acceptance of test data, Goel advocated for the Pharmacopoeial Discussion Group to prioritize harmonization of monographs that describe challenge assays that are used as routine batch potency tests. Such result, he stated, would prevent unnecessary animal use and suffering, and would also permit the use of serological and in vitro methods of potency determination in all regulatory regions.
The Important Role Of Animal Research In Mrna Covid
| August 18, 2021
As the global COVID-19 pandemic continues, safe and effective vaccines are playing a pivotal role in preventing severe disease and death and limiting the spread of SARS-CoV-2, the virus that causes COVID-19. The urgency of the COVID-19 pandemic necessitated rapid vaccine development and testing. Fortunately, NIAIDs decades-long support and conduct of coronavirus and vaccine research laid the groundwork for helping to develop a safe and effective COVID-19 vaccine in record speed.
COVID-19 Animal Models
Syrian hamsters are another important animal model for COVID-19 because disease in those animals closely resembles the disease in humans. Additionally, older male hamsters develop more severe disease than young female hamsters, which reflects some of the differences seen in humans infected by SARS-CoV-2. Hamster models have contributed to the evaluation of investigational COVID-19 vaccine candidates, immunotherapies, and antiviral drugs.
A New Type of Vaccine
Looking to the Future
We Dont Need Animal Testing To Develop Effective Vaccines
With most places currently under some form of quarantine restrictions, it can feel as though our lives are on hold until an effective COVID-19 vaccine is rolled out throughout the general population. Unlike with other diseases, scientists are under pressure from governments and policymakers to resolve the problem as quickly as possible.
Animal testing is costly both in terms of time and money, especially when it requires genetically modified animals to be bred for use. The use of animals therefore doesnt lend itself to the challenging task of creating and distributing a vaccine within a short timespan. Some countries have carried out clinical trials on humans with minimal safety testing on animals first.
A new paper published in the Archives of Toxicology explores the possibilities of using alternative, animal-free methods to vaccine development. Compared with other medicines, vaccines face particular pricing pressures, due to the processes involved in producing cell mediums, conducting lengthy trials, and carrying out batch release controls. For these reasons, vaccine development isnt a very attractive area for private businesses to engage in, with only a few major pharma companies involved in the work. Governments and nonprofits often need to step in to support research and production in this area. The majority of vaccine producers are European, while the U.S. makes up more than 40% of vaccine consumption.
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Ferret Chosen As Animal Model To Test Coronavirus Vaccines
A team led by India-born virologist Seshadri Vasan has established an animal model the ferret as a preclinical model to test COVID-19 vaccines and therapies.
Vasan, who holds an honorary chair in Health Sciences at the University of York, UK, leads the Dangerous Pathogens team at the Australian Animal Health Laboratory and is senior principal research consultant for Health and Biosecurity at the Commonwealth Scientific and Industrial Research Organization , Australia’s national science agency.
His team has shown that ferrets the domesticated form of the European polecat could be used as a preclinical model for COVID-19 vaccine and therapies. Ferrets are a popular model for influenza and other respiratory infections because their lung physiology is similar to that of humans, and researchers hope they will mimic aspects of COVID-19 in people, such as its spread. Vasan, who is currently based at the high-containment laboratory in Geelong, Australia, has found that the animals are susceptible to SARS-CoV-2.
There are many vaccines1 for COVID-19 under development of which eight are funded by The Coalition for Epidemic Preparedness Innovations , a foundation that takes donations from philanthropic, and civil society organisations to finance independent projects to develop vaccines against emerging infectious disease.
References
1. Hidgson, J. The pandemic pipeline. Nat. Biotechnol. doi: 10.1038/d41587-020-00005-z
doi: https://doi.org/10.1038/nindia.2020.60
The Ugly Truth About Coronavirus Vaccine Testing
Everyone loves a monkey, right? They are cute, clever and cheeky. Most of us feel warm and at peace with life when we see pictures and nature documentaries of them playing and swinging through trees.
They are our closest cousins. Loveable creatures. Some parents even call their children cheeky monkeys.
But what about the monkeys that spend their whole lives restrained in laboratories, with scientists hurting them to see what happens?
The hunt for a coronavirus vaccine has been horrendous for some animals. As part of the drive to save human lives, thousands of cheeky monkeys, ferrets, cats, mice and hamsters have been deliberately infected and experimented on in labs.
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Fitting Vaccine Research Into One Year Were Animals Used
in silicoin vitro
- For all SARS-CoV-2 vaccine candidates it is necessary to obtain data in animals and to characterise 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 .
Fitting vaccine research into one year How was this possible3Rs in vaccine development and productionin vitro in silicoAccelerating Global Deletion of the Abnormal Toxicity Test – Planning common next steps
References
Rabies Potency Testing: Glycoprotein Assay
Koraphong Pinyosukhee of the Institute of Biological Products, Department of Medical Sciences of Thailand’s Ministry of Public Health . He presented Thailand’s Institute of Biological Products efforts for the validation of a method for potency testing and consistency of production of rabies vaccine based on the assay of Glycoprotein by ELISA as an alternative to the National Institute of Health test.
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The Nature Of Coronaviruses
Scientists now understand that a virus is not a cell, but a piece of genetic informationDNA or RNAencased in a protein package, sometimes with an additional fatty layer surrounding it. Because they are not cells, they need to enter a host cell in order to take over its reproductive mechanism and reproduce. Both influenza viruses and the various coronaviruses that includes SARS and COVID-19 are RNA viruses. Viruses are highly adaptable, varying to suit their host and in response to antibodies the host develops to fight them. These processes of recombination and reassortment are why we need a newly formulated flu shot each year. Given the multiple variants of COVID-19 that have appeared, which make the virus more infective, or more deadly, or both, we may see many versions of COVID-19 vaccines, and like flu, we may need them on an annual basis.
SARS-CoV focused attention on human coronaviruses. In 2012, another one known as MERS made the leap from camels to humans in Saudi Arabia. There have been only about 2500 cases, but a whopping 35 percent of its victims have died. Toward the end of 2019, another coronavirus emerged, as we all know. What had already become known as COVID-19 was isolated in January 2020, and a few weeks later gained the official name SARS-CoV2 .
Thousands Of Monkeys Imprisoned In Laboratories Are Susceptible To Contracting The Novel Coronavirus And They Have No Line Of Defense Against It
Many novel coronavirus infections have been asymptomatic, thereby increasing the likelihood that lab staff may have already exposed these sensitive animals to the virus. Laboratories could very well become dangerous hotbeds for COVID-19, with a negative impact on experimental results.
Any experiments conducted on monkeys compromised with the novel coronavirus would be worthless. Thats why PETA is demanding that one facility, the Washington National Primate Research Center, immediately stop all experiments on primates and transfer the animals to sanctuaries, where they can live in peace for the remainder of their lives. Please help us.
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Alternatives To Animal Testing
Vaccine development is a lengthy process that can take upwards of 20 years to finish. Scientists first test vaccines on animals to satisfy FDA requirements. The goal is to ensure that the vaccines are safe and effective before testing them on humans.
Animal testing causes immense suffering to thousands of mice, rats, rabbits, dogs, and primates that are experimented on in labs.
According to the National Anti-Vivisection Society , animal testing is used as a stepping stone toward clinical trials.
However, the organization notes that this is dangerous for two reasons: the species difference and the possibility of contamination from unknown animal diseases.
Vaccines, it adds, need to be developed with sophisticated, human-based methods.
Nowadays, many viral vaccines such as polio, rubella, rabies, measles, and smallpox can be produced in cultures from human cells, says the website.
Technological advancements may afford researchers the ability to conduct vaccine testing without the use of animals.
Computerized human-patient simulators, human volunteerslike those trying the coronavirus vaccineand computer models are alternatives to animal testing.
Studies show that computer models are especially promising because they can accurately predict how new drugs will react in the human body.
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Towards Deletion Of General Batch Safety Tests: Recent Progress And Next Steps
of the European Commission, Joint Research Centre, Italy.
Halder reported on the progress achieved for veterinary vaccines . Thus, European Pharmacopoeia deleted the LABST already in 1997 and the TABST in 2013. Furthermore, she mentioned the possibility of waiving the TABST if consistency of production was demonstrated as outlined in VICH GL50 and GL55 . This is applicable for VICH regions however, the OIE refers to these VICH guidelines in its Terrestrial Manual. A comparable guideline on waiving possibilities for the LABST is close to publication .
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What Our Experts Say
The Johnson & Johnson COVID-19 vaccine was first tested in rhesus macaques, and later in Syrian golden hamsters. The details of both studies have been published in the science journal Nature.
In the first trial, 32 primates received a single dose of the viral vector-based vaccine and 20 received a placebo. Viral vector vaccines use a modified version of a harmless virus to activate the immune system and trigger our immune systems to fight against a harmful virus, such as COVID-19. After four weeks, all vaccinated macaques demonstrated immune responses. After 6 weeks, when exposed to the original strain of COVID-19 or the B.1351 variant, 5 out of every 6 vaccinated monkeys were completely protected against both forms of the virus.
The researchers concluded that a single dose of the vaccine was effective at providing complete or near-complete immunity in rhesus macaques.
In the second trial, 50 hamsters received a single dose of the vaccine and 10 received a placebo. After 4 weeks, the hamsters were exposed to a high dose of COVID-19. The researchers found that vaccinated hamsters lost less weight and had less virus in their lungs and other organs compared to hamsters that received a placebo. There was no mortality among vaccinated hamsters, while some of the unvaccinated hamsters died. This study demonstrated that a single dose of the Johnson & Johnson vaccine protected the hamsters against severe clinical disease and death after being exposed to a high dose of coronavirus.
Pasteur And The Model Vaccine
The classic model of vaccine development goes back to Louis Pasteur in the 1880s. He made his rabies vaccine by passing the infectious agent, now known to be a virus, through the bodies of rabbits, dogs, and monkeys to weaken it. Pasteur then reversed this process to build immunity, beginning by injecting a very weak version of the virus and progressively increasing its virulence until the bodyhuman or animalcould resist the disease. Because of the long incubation period of rabies, for which symptoms could emerge weeks after infection, this method prevented both the dreaded symptoms and almost certain death.
Pasteur, at the dawn of the germ theory of disease, did not fully understand how infection or immunity worked. He assumed, correctly, that rabies was caused by a microscopic entity, but unlike the bacteria with which he had previously worked, he could not see the rabies virus under the conventional optical microscopes then in use. In Pasteurs time, virus simply meant any infectious agent, and its action was not thought to be any different than that of bacteria it was just smaller. By the turn of the twentieth century, filterable virus identified a microbe that was invisible under optical microscopes and could seep through the pores of a porcelain laboratory filter.
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Collaboration And Communication Of Regulatory Bodies And Industry: Panel Discussion
A panel discussion was dedicated to the collaboration and communication between regulatory bodies and industry, and it was kickstarted by two questions: what the regulatory expectations are when a company wishes to change a testing method? and what is the effective interaction between industry and regulators?
Robin Levis cited the human rabies vaccine as an important showcase of the complexity of implementing change from the perspective of regulatory authorities. While a new method or assay must be able to secure the quality/safety/potency of a product, other guarantees must also be in place, including for example the proved availability of needed reagents for both manufacturers and regulatory, and an effective experience of manufacturers in the implementation of the consistency approach.
Sunil Goel voiced the effect of the absence of harmonized requirements for the testing strategies has on manufacturers, that is forcing them to continue to use very variable required tests instead of in vitro assays already established in the product’s development to monitor the product before the release.
William McCauley , U.S.A.) expanded on Goel’s critical report, stating that the lack of harmonized difficulties also affects the U.S. veterinary vaccine manufacturers, and informed on an initiative of AHI to petition the US Department of Agriculture, expressing support for the Department’s activities, but also to openly ask for more concrete actions.
Regulatory Acceptance For The Substitution Of In Vitro For In Vivo Vaccine Potency And Safety Assays: Science Versus The Fear Factor
Dean Smith, Health Canada’s Center for Biologics Evaluation, discussed the barriers to the development and authorization of in vitro assays for legacy vaccines, citing the European Pharmacopoeia General Chapter 5.2.14, as an important tool to address these barriers and drive the approval and implementation of alternative methods. Smith began the presentation illustrating a complex “catch-22” that regulators and manufacturers are locked in. As long as regulators are convinced of the superiority of in vivo methods, and are unwilling changing long held assumptions regarding the performance and value of animal assays, manufacturers will have no incentive to invest and develop innovative in vitro assay alternatives. However, Smith noted that Quality Control without in vivo testing for vaccines is already well established for several products. He gave the examples of two of highly effective types of human products: 1) Human Papilloma Virus vaccines , and 2) Meningococcal and Pneumococcal Bacterial Conjugate vaccines . With both groups of vaccines, the key quality attributes necessary to ensure the safety and efficacy profile of the products are accurately and robustly controlled using a combination physical/chemical and in vitro methods .
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Can I Get A Covid
The goal of being vegan and advocating for animal rights should always be to bring about positive change for animals. As long as tests on animals are a legal requirement, refusing to take a medicine on ethical grounds will not help animals who have already been used in tests or spare any the same fate in the future.
What needs to happen is a change in the law so that animals are no longer required to suffer in tests, and you can most effectively bring this about by using your voice to speak out for animals in laboratories and supporting our work. To keep yourself and others as fit and healthy as possible and allow you to continue advocating for animals please follow the advice of your health-care provider on taking a medicine.
Urge the Government to End to All Experiments on Animals
Implementation Of 3rs In Quality Control Testing Of Vaccines
Sunil Goel, Additional Director of the Serum Institute of India Pvt. Ltd, described its organization’s commitment to the development, introduction, validation, and implementation of 3Rs and consistency-based approaches, and how such activities are helped by the fact that Indian Pharmacopoeia always proved supportive and receptive to such endeavors.
The first progress described was related to the DTP group of vaccines, for which the Institute secured successes in both replacement and reduction. Replaced was the conventional lethal challenge on guinea pigs/mice for potency testing by two assays, a Vero cell assay for the potency testing of the diphtheria component, and a T-ELISA for the potency testing of the tetanus component. Both assays required about 3 years from development to final acceptance by National Control Laboratory , with a first approval requiring 1 in 10 batches potency testing, and since 2017 an approval requiring 1 in 25 batches to be tested . The replacement reduced the number of guinea pigs used per batch from 232 to 30 . On the reduction front, the SIIPL secured authorization, by sharing data on a large number of batches, to switch from a multi-dilution assay to a single-dilution assay, receiving approval first from the National Control Laboratory /National Regulatory Authority and the WHO.
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