SIOUX FALLS, S.D. (KELO) South Dakota is on pace for even more coronavirus deaths, hospitalizations and cases, according to several models that project the progress of the pandemic in the U.S.
The models are similar in their projections.
While universities and organizations are assembling models to project the pandemic in the U.S. and its states, South Dakota Department of Health officials said Oct. 14 that the state is not working with its own forecasts on the future of the pandemic in South Dakota.
As it has been since the beginning, COVID is somewhat unpredictable, DOH secretary Kim Malsam-Rysdon said.
The numbers that are being shared each week are critical to the response, she said. As cases increase, the state would expect to see increases in hospitalizations and other numbers, Malsam-Rysdon said.
To say because we have this many cases today means we will need this many hospital beds tomorrow just hasnt been proven or borne out, Malsam-Rysdon said.
A joint model from Google and Johns Hopkins predicts that South Dakota will have 4,200 new COVID-19 cases from Oct. 13 through Oct. 26. The state will have 92 more deaths.
Hospitalizations would peak at 355 hospital beds during this two-week period with 215 in intensive care units and 144 on ventilators.
The state had 13 more COVID-19 deaths reported on Oct. 15. There were 797 new cases which includes 700 RT-PCR and 97 antigen cases, according to the South Dakota Department of Health website.
The model broke down the numbers by county. Minnehaha County is projected to have 69 more deaths and 1,035 more new cases. The daily hospitalizations will peak at 164 for the area.
As of Oct. 15, the state had 304 COVID-19 patients in the hospital and a total of 2,000 total hospitalized since the pandemic started in the state.
The Institute of Health Metrics and Evaluation at the University of Washington says South Dakota is on track for 332.36 deaths by Oct. 26. The state would have 579.83 new cases on Oct. 26. The model says if masks were mandated there would be 234.7 new cases that day.
The model projects 830 COVID-19 deaths by February 1, 2021.
On Oct. 26, 332 (331.8) hospital beds would be needed and 85 (84.6) ICU beds would be needed.
The models also reflect an uptick in hospitalizations and deaths which trail behind increases in cases.
In an Oct. 8 story by Courtney Collen published by Sanford Health News, Dr. Allison Suttle talks about the prior weeks COVID-19 numbers.
The story said While human behavior dictates how this virus spreads, Dr. Suttle says what weve seen in the last seven days will predict what we see next.
The Sanford story lists hand washing, social distancing of six feet, wearing a mask in public and staying home when sick as proper health and safety behaviors during the pandemic.
Weve seen an increase in cases which will continue and ultimately lead to hospitalizations. We start seeing those hospitalizations about two to three weeks after we see an increase in the number of cases. The only way we start seeing that trend decrease is if all the people start doing all of those behaviors (listed above) and then well see less cases, and then that downward trend, Suttle said in the Oct. 8 Sanford story.
The Centers for Disease Control lists multiple models in its forecasts for COVID-19 cases, deaths and related data.
The list includes Google and Johns Hopkins, the Iowa State model, the MIT model, the model from UCLA and about a dozen others.
Models from Iowa State and MIT all project steady daily increases in deaths in South Dakota. The COVID-19 forecast model from UCLA shows a nearly steady toll with no significant increase and no decreases after Oct. 1.
The UCLA model projects 229,000 total deaths in the U.S. on Oct. 31. Iowa State has 229,000. Iowa States range is from 228,000 to 230,000 while UCLAs range is from 226,00 to 230,000.
UCLAs model incorporates the reopening of states and lessened social distancing. Iowa States model does not make specific assumptions about interventions in effect.
The Bob Pango, or bobpango model, is also listed on the CDC website. Bob Pango has been analyzing data for 31 years, according to his website.
The bobpango model projects 43.463 deaths in the state as of Oct. 26. The high end of the model shows 372.21 deaths while the low end shows 328.902.
The projected number of active cases would be 3,813.6 on Oct. 26.
The model forecasts for longer than two weeks. By the end of the year, South Dakota would have 563.418 deaths and 5,160 current infections.
Under this model, South Dakota would have a projected 384.741 deaths as of Nov. 7. The high end of the model shows 483.537 on Nov. 7 while the long end range shows 354.954.
Keep reading
Your Guide To Coronavirus
KELOLAND News is covering the COVID-19 pandemic. This is your guide to everything you need to know to prepare. We also have the latest stories from across the globe feeding into this page.
LATEST STORIES
PIERRE, S.D. (KELO) After a slight delay in reporting new COVID-19 case counts, three more deaths were announced by the South Dakota Department of Health Friday afternoon. On Friday, 793 new coronavirus cases were announced, bringing the []
PIERRE, S.D. (KELO) The lasted coronavirus numbers for South Dakota have not yet been posted on the states Department of Health website.
PIERRE, S.D. (KELO) More mass testing has taken place in South Dakota Department of Corrections facilities.
Today, Hamm believes the pharmaceutical industry is corrupt, and that its attempting to spin up a coronavirus vaccine too quickly. (The latter is a worry of the scientific community too, stoked by President Donald Trumps ceaseless chatter about having a vaccine ready before Election Dayand the very name of the governments vaccine project, Operation Warp Speed.) Though Hamm fears contracting COVID-19, when the coronavirus vaccine becomes available, he intends to avoid getting immunized.
People like Hamm might be the missing piece to the puzzle of ending the pandemic for good. Developing a safe, effective coronavirus vaccine will be a monumental achievement, but it might not be enough. Encouraging people to actually get the vaccine might be the real battle, and people are even less predictable than viruses.
If the coronavirus vaccine is 75 percent effectivewhich would be excellent, considering that the flu shot is only about 50 percent effectiveroughly two-thirds of the population would need to be vaccinated, according to Paul Offit, the director of the Vaccine Education Center at the Childrens Hospital of Philadelphia. That number is enough to reach herd immunitythe level at which everyone is protected because there are not enough vulnerable people for the virus to pass between.
Read: A new understanding of herd immunity
Unfortunately, in some polls, far fewer than two-thirds of Americans say they are interested in getting a coronavirus vaccine. Though this number might change as we learn more about the vaccines effectiveness and side effects, at some points only about 50 percent of Americans have said they plan to get the vaccine when it becomes available. Some reports suggest that Facebook groups formerly dedicated to merely asking questions about vaccines have switched to more vociferous anti-vaccine views in recent months.
Convincing people like Hamm that the vaccine is safe and effective will be a thorny and complicated task, for which experts say there is no one best approach. Its something the United States government should start preparing for nowbut isnt.
Its hard to pin down just who, exactly, the vaccine-hesitant are. White adults are more likely to be vaccinated than Black adults are, perhaps because the latter have less access to medical care, and decades of maltreatment have eroded their trust in the medical establishment.
Anti-vaccine groups have also targeted Black people. About a decade ago, anti-vaxxers in Minnesota invited the discredited researcher Andrew Wakefield, who falsely tied vaccines to autism, to give talks to the states Somali immigrant community. Vaccination rates among Somalis plummeted, and a few years later, the community suffered a large measles outbreak.
Otherwise, experts told me, theres a loose correlation between being Republican and questioning vaccines, and also between harboring vaccine skepticism and believing in conspiracy theories or having a lower level of education. But in general, vaccine skepticism spans from Goop-reading Californians to the ultra-Orthodox Jews of New York. In some ways, being anti-vaccine is a deeply American sentiment: Its the stubborn belief that individuals know better than the government.
PIERRE, S.D. (KELO) Thirteen new COVID-19 deaths were announced along with a new active case count record in the latest update from the South Dakota Department of Health.
The death toll in South Dakota rose to 304. The 13 new deaths included eight men and five women. One death was listed in the 40-49 age range, one in the 60-69 age range, three in the 70-79 age range and eight victims listed in the 80+ age range. The new deaths were listed in the following counties: Beadle, Brule, Gregory, Jerauld (2), Lincoln, Meade (2), Minnehaha (3), Oglala Lakota and Pennington County.
On Thursday, 797 new coronavirus cases were announced, bringing the states total case count to 31,012, up from Wednesday (30,215). Total recovered cases is now at 23,576, up from Wednesday (23,320).
Active cases are now at 7,132, up from Wednesday (6,604). Its also the highest active case count in South Dakota since the pandemic started.
Current people in South Dakota hospitals for COVID-19 is at 304, up from Wednesday (303). Total hospitalizations for South Dakota residents from COVID-19 are now at 2,000, up from Wednesday (1,963).
Total persons tested negative is now at 193,227, up from Wednesday (192,106).
There were 1,918 new persons tested reported on Thursday.
The first patient enrolled in Pfizer's COVID-19 vaccine clinical trial at the University of Maryland School of Medicine in Baltimore receives an injection in May. AP hide caption
The first patient enrolled in Pfizer's COVID-19 vaccine clinical trial at the University of Maryland School of Medicine in Baltimore receives an injection in May.
Pfizer, the apparent front-runner in developing a COVID-19 vaccine for the United States, says its results won't be ready until mid-November at the earliest. That dims any lingering expectation that there could be a vaccine by Election Day, as President Trump has asserted.
Trump's hopes had been bolstered by Pfizer executives, who have said they could have clinical trial results sometime in October. Even if that were so, a pre-election vaccine would mean the Food and Drug Administration would have to give an almost immediate thumbs-up.
Pfizer Chairman and CEO Albert Bourla said in a public statement Friday that it is indeed possible the company could have enough data to know this month whether the vaccine it is developing actually protects people from coronavirus infection. But the company won't have data showing the vaccine is safe before the third week of November at the earliest.
The FDA said earlier this month that, before it reviews a coronavirus vaccine application, a company must have safety data that extends for a median of two months. That means Pfizer needs to wait until half of the volunteers in its ongoing trial have been followed for at least two months before the company can submit its material for FDA review.
"We estimate that we will reach this milestone in the third week of November," Bourla wrote.
The company has been waiting for a certain number of people in its study to come down with COVID-19. Once that threshold has been reached, scientists can analyze the data and see whether those who got sick were in the group that got vaccinated or in the comparison group, which received a dummy shot. The vaccine must reduce the risk of infection by at least 50% to be considered for FDA emergency authorization.
Polls show many Americans are hesitant about taking a coronavirus vaccine and concerned that the approval process could be driven by politics. But vaccine companies have said they won't let that happen, and Pfizer said its announcement underscores its commitment to safety.
You can contact NPR science correspondent Richard Harris at rharris@npr.org.
The United States, China, and other countries are ramping up production of experimental COVID-19 vaccinesa Beijing production line for one is shown herebut a limited supply of the first one with proven efficacy will likely still complicate the ethics of testing the other candidates.
By Jon CohenOct. 14, 2020 , 7:30 PM
Sciences COVID-19 reporting is supported by the Pulitzer Center and the Heising-Simons Foundation.
Success in the push to find a COVID-19 vaccine at record-breaking speed could hand the world a new problem. The first vaccine to cross the finish line might be only marginally effective, yet it could become the enemy of the goodor even the greatcandidates in the wings by disrupting ongoing studies.
In all likelihood, the U.S. Food and Drug Administration (FDA) or other regulators will issue the first COVID-19 vaccine approval or emergency use authorization (EUA) for one vaccine while many other candidates have clinical trials still underway or in the planning. At that point, ongoing studies of any vaccineincluding that first onecould become unethical because half the participants would get a placebo, at a time a vaccine with established efficacy will be available. Its a very vexing issue, says Christine Grady, who heads the bioethics department at the National Institutes of Health (NIH) Clinical Center, which organized a grand roundswebinaron the challenges last week.
Whats really important is that the science does continue, says Seth Berkley, who helps run the COVID-19 Vaccine Global Access Facility, an international effort to develop and manufacture a portfolio of COVID-19 vaccines. He explains that the world needs multiple vaccines against the pandemic coronavirus. Not only might some work better than others, but factors such as cost or side effects mean some might offer benefits to specific groups, such as the elderly, pregnant women, or those in low-income countries.Even if multiple ones work, they may have characteristics that are particularly important for one population versus the other, says Berkley, who also heads the advocacy group Gavi, the Vaccine Alliance.
According to the World Health Organizations 2 October update of the COVID-19 vaccine landscape, 42 candidates are in clinical trials. Ten are in phase III trials, in which tens of thousands of participants randomly and blindly receive either the candidate or a placebo while their health is closely monitored. If efficacy signals surface during scheduled, interim analyses of the studies, vaccinemakers could seek EUAs before a trial reaches its planned end date (see graphic, below). The EUA guidance issued by FDA stipulates that a candidate only needs to achieve 50% efficacy at preventing symptomatic COVID-19 and, as an added measure of safety, have had 2 months pass after roughly half the participants have received their final dose. (Russia and China have already granted their versions of EUAs for various vaccines but without any evidence of efficacy.)
Participants in the NIH webinar agreed that the first EUA for a COVID-19 vaccine will change the landscape for that vaccines phase III trial and others. Should the blinded trial continue, to make sure that the early benefits pan out over a longer period of time, or should people in the placebo group immediately receive the vaccine? What if stopping the initial trial early reduces its ability to detect rare side effects, assess how long protection lasts, or compare the vaccines efficacy in the elderly versus young adults?
The efficacy trials planned by Operation Warp Speed, the U.S. COVID-19 vaccine effort, plan to take interim looks at data based on differentnumbers (roughly 50, 100, 150)of participants developing disease symptoms or other eventsthat allow researchers to gauge the impact of the candidate in people who receive the vaccine versus a placebo.
(GRAPHIC) C. BICKEL/SCIENCE; (Data) COVID-19 Prevention Network
And should ongoing phase III trials of other vaccines replace their placebo with the one that just showed efficacy? Will participants of those other trials drop outen masse? Will people refuse to even join new trials of yet other candidate vaccines, reasoning that they can get one that already works to some extent?
For all these questions, Grady tellsScienceInsider, the ethical equation boils down to a fairly simple calculus: the individual versus the societal value. During the webinar, philosopher Joseph Millum framed the issue as fundamental to all clinical research. Clinical research is ethically challenging because it exposes participants to risks for the benefit of others, not for the benefit of participants themselves, said Millum, who works with Grady at the NIH Clinical Center.
Yet scientists and ethicists dont always solve the simple calculus the same way. Grady say if early results for a COVID-19 vaccine candidate lead to an EUA, participants in that trial would have a right to know whether they had received a worthless placebo or a vaccine that potentially could help them. Its a benefit that people in the trial should have access to, she contends.
Millum counters theres a need to balance the risk to the individual in a blinded study versus the benefit to society of continuing the trial. Participants in the placebo arm are only being exposed to risk in the sense that the researchers are not providing something that could protect, he said at the webinar. If the chance that a person in the trial would be exposed to SARS-CoV-2 is relatively low, Millum said, then continuing the blinded study could then be justified in light of the need to gather socially valuable information. This is especially true, he added, given that the world will likely benefit from having more than one COVID-19 vaccine, both because of the needs of different populations and so that supply can meet demand.
Stanford University epidemiologist Steven Goodman agreed, stressing that vaccine studies differ dramatically from treatment trials, which aim to help people who have a disease. If someone asked me whether a therapy for a serious disease should first be given to people participating in the control arms of the clinical trial testing that therapy, Goodman reasoned, I would say, absolutely, yes.But people receiving a placebo in a vaccine trial dont need it the way sick people need a treatment, he argued. A widely used vaccine, he noted, can create herd immunity by reducing spread of a virus in a community. If everyone around you has gotten a highly effective vaccine, you dont need it, Goodman said. That shows that you dont have a problem that needs treating, but the population does. Whats more, people have many nonmedical ways to protect themselves from SARS-CoV-2, including masks and social distancing. In fact, if you can do those things, you might lower your individual risk more than what a partly effective vaccine could achieve, he said.
Grady said the questions become far more complicated when it comes to the impact of an EUA on other COVID-19 vaccine trials. If a trial of a different candidate has yet to start, ethical considerations may demand using the newly permitted product instead of a placebo.Such studies, known as a noninferiority or superiority trial, are slower and more costly more than trials comparing a vaccine with a placebo. If a trial is already underwayespecially if it is close to fully enrolledinvestigators could explain to participants the value to society of continuing the blinded study. They might choose to stick with the study, she says, especially if they were given this promise: Whenever this trial is finished, we will give you the vaccine thats the most effective.
If the approved vaccine only offers a modest benefit, Grady adds, participants may be more willing to continue in a blinded study. A 50% chance of receiving a potentially better vaccine by staying in the trial might, in the end, be a better gamble. Many people in vaccine trials also have strong altruistic motives for participating, she notes. And if the first COVID-19 vaccine given an EUA or approval is scarce, the incentive to leave the trial may be lower. If its not available, its not available, Grady says. Those who take part in a study of an unproven candidate at least have some chance of being protected.
If an EUA or a full approval does disrupt vaccine trials, Berkley says, bridging studies could fill the gap. If researchers can identify the immune factors that correlate with protection by the approved vaccine, then efficacy trials can pivot to quickly assessing whether other candidates trigger a similar response, avoidinga placebo comparison. (Researchers would have to inform potential participants that a proven vaccine existed, but they would not face the more serious ethical dilemma that a placebo presents.) Those correlates of protection could be enough proof of efficacy for an EUA or full approval of a COVID-19 vaccine. Its the same practice used to approve each years influenza vaccine. Bridging studies are also routinely used after a vaccine proves itself in an efficacy trial to show that it works in different populations. Thats whats so beautiful about having the correlate of immunity and an understanding of the vaccine, Berkley says.
The telltale sign of efficacy for a COVID-19 vaccine, researchers suspect, will be antibodies that neutralize the spike, the surface protein of SARS-CoV-2, preventing the virus from infecting cells. If trials find that a certain level of these neutralizing antibodies do correlate with protection against infection or severe disease, they can serve as a benchmark for comparing vaccines in development to proven ones. I think thats the way it will ultimately get done, Berkley says.
Then again, many vaccines on the market do not have a clear correlate of protection, and immune responses beyond antibodies to spike could play key roles in COVID-19 protection. If it turns out that the hypothesis of a spike protein turns out not to be correct, thats the whole front line set of vaccines, Berkley says. Bridging studies, he says, are going to be a challenge if you come up with a completely new approach.
Grady says shes glad to see that these complicated topics are moving beyond backroom discussions between public health officials, ethicists, and scientists. This is something that everybody needs to be talking about.
Vaxart, a California biotech firm that is attempting to develop a Covid-19 vaccine, has come under scrutiny from federal prosecutors and the Securities and Exchange Commission.
The company announced in June that it had been selected to participate in Operation Warp Speed, the U.S. governments flagship effort to develop cures and treatments for Covid-19. That sent Vaxarts stock price soaring, allowing a hedge fund that controlled the company to reap an instant $200 million profit by selling shares.
The New York Times reported the next month that Vaxart appeared to have overstated its involvement in Operation Warp Speed.
Vaxart said it had received a subpoena from the Justice Department concerning its role in Operation Warp Speed and the stock sales in July, the company disclosed in a securities filing this week.
In August, the S.E.C.s enforcement division requested documents from the company about the same matter, Vaxart said in the filing, which was reported earlier by Fierce Pharma, a trade publication.
We are cooperating with the U.S. attorneys office regarding these requests and have provided documents and information in response, Vaxart said in the securities filing. It added that it had voluntarily provided documents requested by the S.E.C. and is cooperating with this informal inquiry.
A number of shareholder lawsuits have also been brought against Vaxart, its executives and its board, accusing the company of misleading investors by overstating its role in Operation Warp Speed.
Vaxart is one of dozens of companies pursuing coronavirus vaccines. But the company, which had just 15 employees this summer, is not among the drug makers that have received substantial funding for their research and production efforts through Operation Warp Speed.
Nonetheless, the company in June issued a news release that stated: Vaxarts Covid-19 Vaccine Selected for the U.S. Governments Operation Warp Speed. That sent shares of the company soaring, and within days, a hedge fund, Armistice Capital, had sold shares worth more than $200 million.
But Vaxarts involvement in Operation Warp Speed was limited. Its vaccine candidate was one among those being tested in an animal trial sponsored by the federal initiative. Officials at the Department of Health and Human Services, which is coordinating Operation Warp Speed, distanced the department from the company, saying it was involved only in preliminary studies but had not yet won government support.
The value of Vaxart stock has fallen more than 50 percent since mid-July, when it hit new highs on the heels of its Operation Warp Speed announcement.
This week, the company said that it had begun its Phase 1 trial and that initial tests on hamsters had yielded promising results.
Dr. Robert Redfield made the announcement in a discussion with SC leaders Thursday, saying state health departments have until Friday to submit a vaccination plan.
COLUMBIA, S.C. The nation's top public health official stopped by the Capital City today.
Dr. Robert Redfield, Director of the Centers for Disease Control and Prevention (CDC), joined state leaders to discuss the short and long-term effects of COVID-19 in our state.
Redfield also unveiled details on a possible vaccine plan.
"The outbreak is on the increase now and we've got to be vigilant," said Redfield during the discussion with state leaders.
Redfield stressed that the threat of coronavirus is still out there, saying what happens over the next three or four months is in the hands of the American public.
According to The COVID Tracking Project, cases are going up in 37 states. In 42 states, including South Carolina, hospitalizations are also on the rise.
"Where I am worried is the home gatherings, and we're looking at a big one coming up," said Redfield.
Thursday, Redfield commended South Carolina's response to the pandemic and applauded USC's strategy to curb the spread of coronavirus.
As of Monday, the university has an overall infection rate of 0.56%. Thursday, USC reported zero positive test results out of 499 students and faculty tested.
"Within the last four months, it turns out that the universities now are the safest place in town," said Redfield.
Also discussed Thursday among state leaders were the indirect health effects of COVID-19, such as the pandemic's effect on chronic conditions, substance abuse and mental health.
Since the pandemic began, South Carolina has seen an increase in alcohol and substance abuse.
DHEC says suspected opioid overdoses are 50% higher from January to August of 2020 compared to the same time last year.
USC President Bob Caslen said the university sends out a mental health survey every week. "20 to 25% say that they are struggling with COVID here on campus," said Caslen. "Both students and faculty."
Earlier this year, the South Carolina Department of Mental Health (DMH) and the South Carolina Department of Alcohol and Other Drug Abuse Services (DAODAS) launched a statewide support line for those in need of mental health or substance use services. 1-844-SC-HOPES connects callers to trained clinicians who can address their needs.
"Health is available and Hope is available. We say social isolation, but the key to this is staying connected in the safest way possible," said Sara Goldsby, DAODAS Director.
One of the biggest questions about the pandemic involves a vaccine. Many wonder when it will be available.
Dr. Redfield believes a vaccine will be ready to be distributed by January 1, 2021, "Which I think is really nearly miraculous," said Redfield. "When you can think within nine months we're going to have potentially one or two approved vaccines, that's something that normally takes four to six years."
States must submit their vaccine distribution plan to the CDC by Friday, October 16.
We checked with SCDHEC, who told us they're on target to have their plan submitted on time.
We requested a copy of DHEC's vaccine distribution plan. We'll let you know when we get it.
Health experts urge South Carolinians to continue to take the pandemic seriously by washing your hands, social distancing, avoiding large crowds - especially indoors - and wearing a mask.
"If we all did that, we would really control this pandemic," said Redfield. "We wouldn't eliminate it, but we would bring it back under control within 6 to 12 weeks."
How long will it take to protect the entire world from the coronavirus?
Only now is it becoming clear that, in the best-case scenario, it will take at least 18 months, beginning early in 2021, for vaccines to reach every part of the world where they are urgently needed.
One measure of the magnitude of the task is that to deliver a single dose of vaccine to the world population of 7.8 billion people would take the equivalent of 8,000 flights by the worlds largest cargo airplane, the Boeing 747.
The whole program depends on whether there will be enough airplanes to deliver the vaccine dosesand whether the will and means exist to build a global network able to meet the exacting standards required to keep vials of vaccine at critical temperatures, from when they leave the manufacturer to when they finally reach the places where they will be administered, no matter how far and remote.
This infrastructure involves special handling via dedicated warehouses, moving through airports where customs and border controls, a frequent choke point, must allow fast tracking, and similarly secure and dedicated ground transportation.
Make no mistake, this is truly a moonshot moment. A new global airlift for life-saving meds has to be built at a speed that has never before been accomplished. And, once more, the planning has exposed significant disparities in the resources of advanced nations and those of the underdeveloped world.
In North America, Europe, Russia, China and Southeast Asia, the means exist to rapidly ramp up supply chains and safely deliver vaccines to large populations during 2021.
In Africa, Central and South America and the Indian subcontinent, critical infrastructure will have to be created from scratch. (India has no air cargo infrastructure equal to the needs of its 1.35 billion population.)
And experts warn that even in the developed world, there are serious challenges to overcome.
At the heart of these challenges is the cold chain. This is an already well-established system that ensures that vaccines and other temperature-critical medications are maintained at precise temperatures for the entire time they spend in transit, no matter if the journey takes many days and passes through great variations in climate and handling through airports and ground delivery.
In many of the countries in Africa, Central America and South America you cannot rely on the same infrastructure for a temperature-controlled environment as you can in the developed world. For them, to create what is needed will probably require a combination of commercial and military resources.
The cold chain was initially created because vaccines to treat smallpox, measles and ebola needed to move through it in order to safely and swiftly get where they were neededindeed, the world eradication of smallpox would not have been possible without it.
This was one of the greatest leaps ever in global infrastructure in the cause of preventing needless deaths, but it is dwarfed by what confronts a world desperate to gain control of the coronavirus pandemic. The cold chain will have to be hugely expanded.
COVAX, an alliance of vaccine producers and international health agencies created to handle the pandemic, aims to produce two billion doses by the end of 2021. This assumes that all nine of the present vaccines being developed and tested in the COVAX program will prove safe and effective. (Six of them are part of the U.S. governments $6 billion Operation Warp Speed, and two of them are being developed in China.)
Expecting instant success of all of the vaccines is already a roll of the dice. As The Daily Beast has reported, the vaccines have been developed at an unprecedented speed, their long-term effects are still unknown, and testing is far from complete.
And the problem for the cold chain is that there are basically two groups of vaccines in the pipeline. One group has to be kept in very deep freeze, at a temperature of minus 112 degrees Fahrenheit, the other at between 35 and 46 degrees Fahrenheit.
This means that vaccines requiring the deep freeze will likely be confined to parts of the world where such demanding standards of the cold chain can be assured, while the others get directed to places where the handling and distribution systems will be less sophisticated and, in many cases, dont even exist yet.
Glyn Hughes, global head of cargo at the International Air Transport Association, IATA, which represents all the worlds airlines, is closely involved in planning the massive airlift. He told The Daily Beast:
There is no time to be lost. In many of the countries in Africa, Central America and South America you cannot rely on the same infrastructure for a temperature-controlled environment as you can in the developed world. For them, to create what is needed will probably require a combination of commercial and military resources.
Another gap in the coverage would be the inability to establish secure cold chain infrastructure in black hole nations like Venezuela, Yemen, Syria and Iraq, where either war or endemic corruption make it near impossible to carry out safe delivery and distribution.
And there is another specter to watch out for. In countries like Nicaragua, where Daniel Ortega has been the strongman since 2007, or the Philippines, where Rodrigo Duterte rules with an equally iron grip, there is little doubt that the ruling juntas would get priority and perhaps even withhold the vaccines from their opponents, which would amount to biological warfare.
There is also disagreement among the planners about how to phase deliveries of the vaccines, particularly if shortages occur because some vaccines fail to make it through testing.
Some argue that achieving world coverage would happen faster if, at first, only enough vaccines to cover 20 percent of the population of each country were delivered.
Others believe that it is more efficient to give full coverage to each country rather than to return later to serve the 80 percent missed in the first wave.
Even at the optimistic rate of administering a million doses a day it would take 83 days (almost three months) to cover the German population, a country with a highly developed medical infrastructure.
All of this highlights the very real risk of confusing priorities with privilege. Who would be included if only one fifth of the people could be vaccinated? Inevitably such a system would favor elites, like politicians, the wealthy, the military and law enforcement. Would frontline medical staff be included? Would those most at risk because of either their health or their age have to wait?
Alexandre de Juniac, CEO of IATA, has called the vaccine airlift the mission of the century.
Experts at international relief agencies like Gavicreated in 2000 to ensure that children get the vaccines they need and credited with having saved the lives of 20 million childrenworry that there will be an unseemly stampede in the rich world to get the vaccines while the poor world, with its weak infrastructure, gets left behind.
In addition to these challenges, there may not be enough space on airplanes to carry the vaccines.
There is a world shortage of air cargo capacity. This is due partly to the grounding of thousands of passenger airplanes that would normally carry cargo (alongside passengers luggage) in their belly holds, and partly to the pandemic causing millions of people to shop onlineand this, in turn, has swollen the competition for air cargo space on the planes that remain in the skies.
And yet the irony is that thousands of widebody jets that could be adapted for this new mission are parked at airports and airfields all over the world for lack of passengers.
Getting them back into the air wont be easy, and someone has to pony up the money to do it because most international airlines are broke. As Hughes points out, Its better to have airplanes flying than grounded, where maintaining them in the required condition is costly.
But airplanes brought back specifically for the airlift would have to fly with empty cabins.
Early in the pandemic, when there was an urgent need to fly PPE and hospital equipment where it was needed, cabins were usedsupplies were strapped to seats and even stuffed into overhead bins.
But passenger cabin climates cant be adapted to the needs of the cold chain. Vaccines will have to go into special temperature-controlled containers in the belly holdsand, even then, it will take time to provide enough of those containers.
Alexandre de Juniac, CEO of IATA, has called the vaccine airlift the mission of the century.
However, when the readers of the industry publication Air Cargo News were polled on their expectations of the airlift, only 11 percent of them felt that the industry was ready to go.
One glaring problem is the absence of a single coordinating international body able to attack all the impedimentstechnical, regulatory, diplomatic and culturalthat lie in the path of such an ambitious program.
It might seem that the International Civil Aviation Organization, the ICAO, a United Nations body, would be such a body because it is the only one that directly links commercial aviation to the governments of 193 nationsthat includes every nation that has an airline.
However, the ICAO has frequently proved unable to use diplomacy effectively with such a variety of political regimes to wrangle and has become notoriously bureaucratic and sclerotic. When asked by The Daily Beast about its role, a spokesman took most of an email to explain what they cant do rather than what they can and wrapped up by saying, The planning and allocating of air cargo capacity will therefore continue to be a management decision in the airlines concerned.
The IATA is much more proactive but they, too, have limited leverage with the airlines. They cant make the airlines spend money they dont have, and the total cost of the airlift is expected to be north of $18 billion.
They are, for example, hoping that new air corridors between continents, nations and cities would get passengers back in the air and, at the same time, generate a lot more space for vaccines in the belly cargo.
The air corridors are designed to make passengers feel safe during the pandemic. That requires all the airports to be compliant with new health and safety standardssomething that, so far, the U.S. government has conspicuously failed to support. Moreover, this plan will become harder to achieve as infection rates spike again, as they are in Europe.
The expanded cold chain will need a wide reach to include all the places where the nine candidate vaccines are being developed: the U.S., U.K.,France, Austria, China, Hong Kong and Australia.
For sure, an enormous load will fall on the worlds handful of freight-only carriers. Fedex, UPS and DHL are all upping their game and will underpin the resources of Project Warp Speed in America.
Isabel Rollison, a spokesperson for Fedex, told The Daily Beast: We have added more than 10 secure cold chain facilities across our global network. At present we have more than 90 cold chain facilities across the Americas, Asia, Australia and Europe.
To complement our existing cold chain capabilities in support of the vaccine distribution we are exploring a combination of solutions, including stationary freezers, temperature-controlled ocean containers and refrigerated trailers.
And China, the origin of the pandemic, is creating a Fedex clone. Its airlines found it hard to handle the surge of demand for PPE, ventilators and drugs in the early stages of the crisis, trying to meet both its own national needs and strenuous demands for help from abroad.
Now the State Council, the Communist Partys powerful central planning force, has demanded the consolidation of the countrys air cargo carriers. The largest of those has a fleet of only 58 freighters. Fedex alone has a fleet of 378 widebodies. The Chinese airlines are being told to follow the Fedex model and integrate their infrastructure with ground services.
Hughes believes that once the immediate urgency has passed the dependency on airlifts will be eased by addingas Fedex is obviously already planningocean shipping with cold-chain-compliant containers for longer-term readiness.
Ultimately, for the airlines, if they bring off this mammoth airlift, we could see another case of never letting a good crisis go to waste (the most spectacular example being Amazon.). The expanded cold chain infrastructure will be permanent. The coronavirus vaccine will likely become part of an annual regimen like flu shots. Other health emergencies will need the same rapid response. Air cargo is becoming a goldmine. Just look at the Fedex stock price. It has more than doubled over the last six months.
Half a million sharks could be killed in order to save the world from the coronavirus. Buzz60
Conservationist groups are concerned demandfor a coronavirus vaccine will strainan already taxedresource: sharks.
Shark liver oil contains the natural occurring substance squalene. Scientists use squalene for adjuvants that are added to vaccines to enhance immune response and increase effectiveness.
We are in no way prioritizing sharks over human health, but we simply have to ask why more sustainable squalene sources are not being considered as an option, said Stefanie Brendl, founder of Shark Allies, a nonprofit group dedicated to the protection of sharks and rays.
In many shark species, 50% to 80% of the weight of their liver is squalene, according to Dr. Corey Casper, president and CEO of the Infectious Disease Research Institute. A single shark could yield up to 300 grams of squalene, enough for about 30,000 doses of vaccine adjuvant.
The oil in a shark's liver helps regulate its buoyancy in the water. Deep-sea sharks, which have higher concentrations of oil in their liver, are sought by fishermen,as are large sharks in more shallow waters.
Shark Allies lists more than 50 species targeted for their livers. Though most are relatively obscure creatures of the deep ocean, others are more well-known, such as whale sharks, great white sharks and basking sharks all of which are considered vulnerable or endangered by the International Union for Conservation of Nature.
Before the pandemic,about 3 million sharks a yearwereharvested for their livers. In a worst-case scenario, Shark Allies estimates 500,000 more sharks will be needed to meet COVID-19 demand.
That number is based on an assumption ofevery person in the world getting two doses of the vaccine made with a shark-based squalene adjuvant.Most candidate vaccines listed by the World Health Organization don't contain that type of immunity-boosting agent,sothe actual number of sharks needed forCOVID-19 vaccines is likely to be far lower.
Is politics rushing a vaccine?Experts say politics will have a hard time getting in the way of a safe, effective COVID-19 vaccine
'Promising, but... surprising': Small study finds Moderna's COVID-19 vaccine may work equally well in older people as it does in younger adults
GSKis one of the few companies manufacturingan adjuvant with shark-based squalene to support multiple COVID-19 vaccine candidates. In a statement to USA TODAY, the company said research into squalene alternatives is ongoing, but they won't be anoption within the time frame of the pandemic.
The amount of squalene that will be needed to manufacture the intended 1 billion doses of its adjuvant system represents a very small proportion of the animal-derived squalene used worldwide the vast majority of squalene produced is used by other industries including the cosmetic industry, GSK said in the statement.
According to a study in 2012 by BLOOM, a nonprofit group that works to preservemarine life, about 90% of the worlds shark liver oil production feeds the needs of the cosmetics industry, which uses squalene or its hydrogenated form, squalane for its anti-inflammatory properties that reduceskin redness and swelling.
Pointing to someone worse doesnt really relieve your burden of doing the right thing, Shark Allies' Brendl said. The numbers are a little bit out of proportion, but we should change the thing we can change especially when its in our control.
Without masks and a vaccine, we could reach Herd Immunity from COVID-19, but deaths would skyrocket. We break down the science of it. USA TODAY
More cosmetic companies are switching from shark-based to plant-based squalene. California-based biotechnology company Amyris created aplant-based squalene by fermenting sugarcanein Brazil.
Amyris CEO John Melo said the company could create the worlds supply for squalene in a matter of months at half the cost of harvesting shark livers.
"We can do that all day long, he said. We can do a billion vaccines this month and the next month. We can do that on demand.
The company developed a method by which it extracts a small amount of squalene from low-yield sources such as sugar cane and uses a chemical method to develop a semi-syntheticsqualene that is amplified,according to Casper, who disclosed that the Infectious Disease Research Institute is working with Amyris for its "promising alternative."
Amyris has a long history of making squalane for cosmetics but has only recently begun producing squalene for pharmaceuticals. Itsresearch suggests plant-based squalene performs at the same levelas that derived from sharks.
Everybody in the world deserves to have access to a clean and sustainable vaccine without killing one shark, Melo said.
Flu vaccine: 1 in 3 parents say they won't vaccinate their kids against flu this year, poll finds
Horseshoe crabs: They have a vital role in the development of a coronavirus vaccine. Here's why
Though this semi-synthetic alternative exists, Casper said there's no other natural resource that meets thedemand for a COVID-19 vaccine becauseextracting squalene from a plant source can be "extremely limiting."
Astudy in 2014 in BioMed Research International foundan entire olive tree would yield 16 grams of squalene, about 5% of the yield of a shark, enough for about 1,600 doses of vaccine. Olives are the most plentiful plant source for squalene.
"We are in crisis because we cannot source enoughsqualenefrom the only viable natural source (sharks), but with innovative methods, we can develop semi- or fully synthetic alternatives," Casper said.
GSK said in its statement its committed to exploring the potential for alternative sources of its raw materials when possible, including non-animal-derived sources of squalene foruse in adjuvants.
Brendl is aware it may be too late to stop using shark-based adjuvants for the immediateCOVID-19 vaccine pushbut hopes pharmaceutical companies can make the change by the second orthird generations of the vaccine.
We are not trying to stop anything its just something that we should all in our conscious calculate and try to do better, she said. We can do both: We can take care of sharks and make this vaccine.
Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
Autoplay
Show Thumbnails
Show Captions
Read or Share this story: https://www.usatoday.com/story/news/health/2020/10/15/covid-19-vaccine-shark-oil-used-adjuvant-worries-conservationists/3588596001/
