COVID-19 Vaccine Trial Put on Hold Over Safety Concerns
After a study participant in the United Kingdom fell ill, AstraZeneca said in a statement that it would review safety and efficacy data. Then the company released a second statement, saying it initiated the pause even though the study participant is expected to make a full recovery, according to STAT News.
Despite the pause, adverse reactions are very common in clinical trials as is pausing for a safety and efficacy review. It also does not mean the vaccine candidate is a failure. However, it does make it increasingly unlikely that the vaccine will be approved and ready for distribution by Election Day, as President Trump has often said a vaccine would be.
In a statement, according to The New York Times, AstraZeneca described the pause as a "routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials."
AstraZeneca was not clear about how long the pause in the vaccine trial will last. The late-stage vaccine trial so far has included 17,000 people in Europe, the U.S., Brazil and South Africa, according to The Guardian. Phase 3 trials include a large number of study participants for exactly this reason; only by testing a large number of people do rare side-effects emerge.
"This is the whole point of doing these Phase 2, Phase 3 trials," said Dr. Phyllis Tien, an infectious disease physician at the University of California, San Francisco, as The New York Times reported. "We need to assess safety, and we won't know the efficacy part until much later. I think halting the trial until the safety board can figure out whether or not this was directly related to the vaccine is a good idea."
While the exact condition that the study participant suffered has not been released, The New York Times is reporting that sources are saying the person received a diagnosis of transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections. It's unclear if the diagnosis is directly related to the vaccine candidate or not.
Robert Booy, a University of Sydney professor of vaccinology, told The Guardian that if the sickness is unrelated to the vaccine candidate then the trial might be paused for just one week, but it may extend to one month. He said that the pause "is more likely the product of being super careful" rather than a problem with the vaccine.
"This could have just been a high fever and it turns out they've got appendicitis," he said. "My bet would be that they find something in this participant that is not causal [from the vaccine]. It'll take them about one to two weeks to ascertain this, and then they will probably restart the trial in a month."
AstraZeneca said in a statement that it was "working to expedite the review of the single event to minimize any potential impact on the trial timeline," and did not waver from its commitment "to the safety of our participants and the highest standards of conduct in our trials," as The New York Times reported.
AstraZeneca was one of nine companies that signed a pledge Tuesday to assure the public that a vaccine would not be rushed due to politics. In a rare move, nine companies working on a vaccine made a joint pledge to "stand with science" and insisted that they would not be rolled out prematurely without proving beyond a doubt that they are safe and effective, according to The New York Times.
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By Dana M Bergstrom, Euan Ritchie, Lesley Hughes and Michael Depledge
In 1992, 1,700 scientists warned that human beings and the natural world were "on a collision course." Seventeen years later, scientists described planetary boundaries within which humans and other life could have a "safe space to operate." These are environmental thresholds, such as the amount of carbon dioxide in the atmosphere and changes in land use.
The Good and Bad News<p><span>Ecosystems consist of living and non-living components, and their interactions. They work like a super-complex engine: when some components are removed or stop working, knock-on consequences can lead to system failure.</span></p><p>Our study is based on measured data and observations, not modeling or predictions for the future. Encouragingly, not all ecosystems we examined have collapsed across their entire range. We still have, for instance, some intact reefs on the Great Barrier Reef, especially in deeper waters. And northern Australia has some of the most intact and least-modified stretches of savanna woodlands on Earth.</p><p><span>Still, collapses are happening, including in regions critical for growing food. This includes the </span><a href="https://www.mdba.gov.au/importance-murray-darling-basin/where-basin" target="_blank" rel="noopener noreferrer">Murray-Darling Basin</a><span>, which covers around 14% of Australia's landmass. Its rivers and other freshwater systems support more than </span><a href="https://www.abs.gov.au/ausstats/[email protected]/latestproducts/94F2007584736094CA2574A50014B1B6?opendocument" target="_blank" rel="noopener noreferrer">30% of Australia's food</a><span> production.</span></p><p><span></span><span>The effects of floods, fires, heatwaves and storms do not stop at farm gates; they're felt equally in agricultural areas and natural ecosystems. We shouldn't forget how towns ran out of </span><a href="https://www.mdba.gov.au/issues-murray-darling-basin/drought#effects" target="_blank" rel="noopener noreferrer">drinking water</a><span> during the recent drought.</span></p><p><span></span><span>Drinking water is also at risk when ecosystems collapse in our water catchments. In Victoria, for example, the degradation of giant </span><a href="https://theconversation.com/logging-must-stop-in-melbournes-biggest-water-supply-catchment-106922" target="_blank" rel="noopener noreferrer">Mountain Ash forests</a><span> greatly reduces the amount of water flowing through the Thompson catchment, threatening nearly five million people's drinking water in Melbourne.</span></p><p>This is a dire <em data-redactor-tag="em">wake-up</em> call — not just a <em data-redactor-tag="em">warning</em>. Put bluntly, current changes across the continent, and their potential outcomes, pose an existential threat to our survival, and other life we share environments with.</p><p><span>In investigating patterns of collapse, we found most ecosystems experience multiple, concurrent pressures from both global climate change and regional human impacts (such as land clearing). Pressures are often </span><a href="https://besjournals.onlinelibrary.wiley.com/doi/abs/10.1111/1365-2664.13427" target="_blank" rel="noopener noreferrer">additive and extreme</a><span>.</span></p><p>Take the last 11 years in Western Australia as an example.</p><p>In the summer of 2010 and 2011, a <a href="https://theconversation.com/marine-heatwaves-are-getting-hotter-lasting-longer-and-doing-more-damage-95637" target="_blank" rel="noopener noreferrer">heatwave</a> spanning more than 300,000 square kilometers ravaged both marine and land ecosystems. The extreme heat devastated forests and woodlands, kelp forests, seagrass meadows and coral reefs. This catastrophe was followed by two cyclones.</p><p>A record-breaking, marine heatwave in late 2019 dealt a further blow. And another marine heatwave is predicted for <a href="https://www.theguardian.com/environment/2020/dec/24/wa-coastline-facing-marine-heatwave-in-early-2021-csiro-predicts" target="_blank" rel="noopener noreferrer">this April</a>.</p>
What to Do About It?<p><span>Our brains trust comprises 38 experts from 21 universities, CSIRO and the federal Department of Agriculture Water and Environment. Beyond quantifying and reporting more doom and gloom, we asked the question: what can be done?</span></p><p>We devised a simple but tractable scheme called the 3As:</p><ul><li>Awareness of what is important</li><li>Anticipation of what is coming down the line</li><li>Action to stop the pressures or deal with impacts.</li></ul><p>In our paper, we identify positive actions to help protect or restore ecosystems. Many are already happening. In some cases, ecosystems might be better left to recover by themselves, such as coral after a cyclone.</p><p>In other cases, active human intervention will be required – for example, placing artificial nesting boxes for Carnaby's black cockatoos in areas where old trees have been <a href="https://www.environment.gov.au/biodiversity/threatened/publications/factsheet-carnabys-black-cockatoo-calyptorhynchus-latirostris" target="_blank" rel="noopener noreferrer">removed</a>.</p><p><span>"Future-ready" actions are also vital. This includes reinstating </span><a href="https://www.abc.net.au/gardening/factsheets/a-burning-question-fire/12395700" target="_blank" rel="noopener noreferrer">cultural burning practices</a><span>, which have </span><a href="https://theconversation.com/australia-you-have-unfinished-business-its-time-to-let-our-fire-people-care-for-this-land-135196" target="_blank" rel="noopener noreferrer">multiple values and benefits for Aboriginal communities</a><span> and can help minimize the risk and strength of bushfires.</span></p><p>It might also include replanting banks along the Murray River with species better suited to <a href="https://www.abc.net.au/gardening/factsheets/my-garden-path---matt-hansen/12322978" target="_blank" rel="noopener noreferrer">warmer conditions</a>.</p><p>Some actions may be small and localized, but have substantial positive benefits.</p><p>For example, billions of migrating Bogong moths, the main summer food for critically endangered mountain pygmy possums, have not arrived in their typical numbers in Australian alpine regions in recent years. This was further exacerbated by the <a href="https://theconversation.com/six-million-hectares-of-threatened-species-habitat-up-in-smoke-129438" target="_blank" rel="noopener noreferrer">2019-20</a> fires. Brilliantly, <a href="https://www.zoo.org.au/" target="_blank" rel="noopener noreferrer">Zoos Victoria</a> anticipated this pressure and developed supplementary food — <a href="https://theconversation.com/looks-like-an-anzac-biscuit-tastes-like-a-protein-bar-bogong-bikkies-help-mountain-pygmy-possums-after-fire-131045" target="_blank" rel="noopener noreferrer">Bogong bikkies</a>.</p><p><span>Other more challenging, global or large-scale actions must address the </span><a href="https://www.youtube.com/watch?v=iICpI9H0GkU&t=34s" target="_blank" rel="noopener noreferrer">root cause of environmental threats</a><span>, such as </span><a href="https://www.nature.com/articles/s41559-018-0504-8" target="_blank" rel="noopener noreferrer">human population growth and per-capita consumption</a><span> of environmental resources.</span><br></p><p>We must rapidly reduce greenhouse gas emissions to net-zero, remove or suppress invasive species such as <a href="https://onlinelibrary.wiley.com/doi/abs/10.1111/mam.12080" target="_blank" rel="noopener noreferrer">feral cats</a> and <a href="https://theconversation.com/the-buffel-kerfuffle-how-one-species-quietly-destroys-native-wildlife-and-cultural-sites-in-arid-australia-149456" target="_blank" rel="noopener noreferrer">buffel grass</a>, and stop widespread <a href="https://theconversation.com/to-reduce-fire-risk-and-meet-climate-targets-over-300-scientists-call-for-stronger-land-clearing-laws-113172" target="_blank" rel="noopener noreferrer">land clearing</a> and other forms of habitat destruction.</p>
Our Lives Depend On It<p>The multiple ecosystem collapses we have documented in Australia are a harbinger for <a href="https://www.iucn.org/news/protected-areas/202102/natures-future-our-future-world-speaks" target="_blank">environments globally</a>.</p><p>The simplicity of the 3As is to show people <em>can</em> do something positive, either at the local level of a landcare group, or at the level of government departments and conservation agencies.</p><p>Our lives and those of our <a href="https://theconversation.com/children-are-our-future-and-the-planets-heres-how-you-can-teach-them-to-take-care-of-it-113759" target="_blank">children</a>, as well as our <a href="https://theconversation.com/taking-care-of-business-the-private-sector-is-waking-up-to-natures-value-153786" target="_blank" rel="noopener noreferrer">economies</a>, societies and <a href="https://theconversation.com/to-address-the-ecological-crisis-aboriginal-peoples-must-be-restored-as-custodians-of-country-108594" target="_blank" rel="noopener noreferrer">cultures</a>, depend on it.</p><p>We simply cannot afford any further delay.</p><p><em><a rel="noopener noreferrer" href="https://theconversation.com/profiles/dana-m-bergstrom-1008495" target="_blank" style="">Dana M Bergstrom</a> is a principal research scientist at the University of Wollongong. <a rel="noopener noreferrer" href="https://theconversation.com/profiles/euan-ritchie-735" target="_blank" style="">Euan Ritchie</a> is a professor in Wildlife Ecology and Conservation, Centre for Integrative Ecology, School of Life & Environmental Sciences at Deakin University. <a rel="noopener noreferrer" href="https://theconversation.com/profiles/lesley-hughes-5823" target="_blank">Lesley Hughes</a> is a professor at the Department of Biological Sciences at Macquarie University. <a rel="noopener noreferrer" href="https://theconversation.com/profiles/michael-depledge-114659" target="_blank">Michael Depledge</a> is a professor and chair, Environment and Human Health, at the University of Exeter. </em></p><p><em>Disclosure statements: Dana Bergstrom works for the Australian Antarctic Division and is a Visiting Fellow at the University of Wollongong. Her research including fieldwork on Macquarie Island and in Antarctica was supported by the Australian Antarctic Division.</em></p><p><em>Euan Ritchie receives funding from the Australian Research Council, The Australia and Pacific Science Foundation, Australian Geographic, Parks Victoria, Department of Environment, Land, Water and Planning, and the Bushfire and Natural Hazards CRC. Euan Ritchie is a Director (Media Working Group) of the Ecological Society of Australia, and a member of the Australian Mammal Society.</em></p><p><em>Lesley Hughes receives funding from the Australian Research Council. She is a Councillor with the Climate Council of Australia, a member of the Wentworth Group of Concerned Scientists and a Director of WWF-Australia.</em></p><p><em>Michael Depledge does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</em></p><p><em>Reposted with permission from <a href="https://theconversation.com/existential-threat-to-our-survival-see-the-19-australian-ecosystems-already-collapsing-154077" target="_blank" style="">The Conversation</a>. </em></p>
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