Scores of coronavirus vaccines are in competition how will scientists choose the best? Nature.com
As the world waits for a coronavirus vaccine, tens of thousands of people could die. But some scientists believe a vaccine might already exist.
Surprising new research in a niche area of immunology suggests that certain live vaccines that have been around for decades could, possibly, protect against the coronavirus. The theory is that these vaccines could make people less likely to experience serious symptoms or even any symptoms if they catch it.
At more than 25 universities and clinical centers around the world, researchers have begun clinical trials, primarily in health care workers, to test whether a live tuberculosis vaccine that has been in use for 99 years called the bacillus Calmette-Gurin, or B.C.G., vaccine, could reduce the risks associated with the coronavirus.
Another small but esteemed group of scientists is raising money to test the potential protective effects of a 60-year-old live polio vaccine called O.P.V.
Its counterintuitive to think that old vaccines created to fight very different pathogens could defend against the coronavirus. The idea is controversial in part because it challenges the dogma about how vaccines work.
But scientists understanding of an arm of immunology known as innate immunity has shifted in recent years. A growing body of research suggests that live vaccines, which are made from living but attenuated pathogens (as opposed to inactivated vaccines, which use dead pathogens) provide broad protection against infections in ways that no one anticipated.
We cant be certain as to what the outcome will be, but I suspect itll have an effect on the coronavirus, said Jeffrey Cirillo, a microbiologist and immunologist at Texas A&M University who is leading one of the B.C.G. trials. Question is, how big will it be?
Scientists stress that these vaccines will not be a panacea. They might make symptoms milder, but they probably wont eliminate them. And the protection, if it occurs, would most likely last only a few years.
Still, these could be a first step, said Dr. Mihai Netea, an immunologist at Radboud University in the Netherlands who is leading another one of the trials. They can be the bridge until you have the time to develop a specific vaccine.
The first evidence to suggest that live vaccines could be broadly protective trickled in nearly a century ago, but no one knew what to make of it. In 1927, soon after B.C.G. was rolled out, Carl Naslund of the Swedish Tuberculosis Society observed that children vaccinated with the live tuberculosis vaccine were three times less likely to die of any cause compared with kids who werent.
One is tempted to explain this very low mortality among vaccinated children by the idea that B.C.G. vaccine provokes a nonspecific immunity, he wrote in 1932.
Then, in clinical trials conducted in the 1940s and 50s in the United States and Britain, researchers found that B.C.G. reduced nonaccidental deaths from causes other than tuberculosis by an average of 25 percent.
Also in the 1950s, Russian researchers, including Marina Voroshilova of the Academy of Medical Science in Moscow, noticed that people who had been given the live polio vaccine, compared with people who hadnt, were far less likely to fall ill with the seasonal flu and other respiratory infections. She and other scientists undertook a clinical trial involving 320,000 Russians to more carefully test these mysterious effects.
They found that among individuals who had received the live polio vaccine, the incidence of seasonal influenza was reduced by 75 percent, said Konstantin Chumakov, Voroshilovas son, who is now an associate director for research in the U.S. Food and Drug Administrations Office of Vaccines Research and Review.
Recent studies have produced similar findings. In a 2016 review of 68 papers commissioned by the World Health Organization, a team of researchers concluded that B.C.G., along with other live vaccines, reduce overall mortality by more than would be expected through their effects on the diseases they prevent.
The W.H.O. has long been skeptical about these nonspecific effects, in part because much of the research on them has involved observational studies that dont establish cause and effect. But in a recent report incorporating newer results from some clinical trials, the organization described nonspecific vaccine effects as plausible and common.
Dr. Stanley Plotkin, a vaccinologist and emeritus professor at the University of Pennsylvania who developed the rubella vaccine but has no involvement in the current research, agreed. Vaccines can affect the immune system beyond the response to the specific pathogen, he said.
Peter Aaby, a Danish anthropologist who has spent 40 years studying the nonspecific effects of vaccines in Guinea-Bissau, in West Africa, and whose findings have been criticized as implausible, is hopeful that these trials will be a tipping point for research in the field. Its kind of a golden moment in terms of actually having this taken seriously, he said.
The possibility that vaccines could have nonspecific effects is brow-furrowing in part because scientists have long believed that vaccines work by stimulating the bodys highly specific adaptive immune system.
After receiving a vaccine against, say, polio, a persons body creates an army of polio-specific antibodies that recognize and attack the virus before it has a chance to take hold. Antibodies against polio cant fight off infections caused by other pathogens, though so, based on this framework, polio vaccines should not be able to reduce the risk associated with other viruses, such as the coronavirus.
But over the past decade, immunologists have discovered that live vaccines also stimulate the innate immune system, which is less specific but much faster. They have found that the innate immune system can be trained by live vaccines to better fight off various kinds of pathogens.
For instance, in a 2018 study, Dr. Netea and his colleagues vaccinated volunteers with either B.C.G. or a placebo and then infected them all with a harmless version of the yellow fever virus. Those who had been given B.C.G. were better able to fight off yellow fever.
Research by Dr. Netea and others shows that live vaccines train the bodys immune system by initiating changes in some stem cells. Among other things, the vaccines initiate the creation of tiny marks that help cells turn on genes involved in immune protection against multiple pathogens.
This area of innate immunity is one of the hottest areas in fundamental immunology today, said Dr. Robert Gallo, the director of the Institute of Human Virology at the University of Maryland School of Medicine and co-founder of the Global Virus Network, a coalition of virologists from more than 30 countries. In the 1980s, Dr. Gallo helped to identify H.I.V. as the cause of AIDS.
Dr. Gallo is leading the charge to test the O.P.V. live polio vaccine as a treatment for coronavirus. He and his colleagues hope to start a clinical trial on health care workers in New York City and Maryland within six weeks.
O.P.V. is routinely used in 143 countries, but no longer in the United States. An inactivated polio vaccine was reintroduced here in 1997, in part because one out of every 2.7 million people who receive the live vaccine can actually develop polio from it.
But O.P.V. does not pose this risk to Americans who have received a polio vaccine in the past. We believe this is very, very, very safe, Dr. Gallo said. Its also inexpensive at 12 cents a dose, and is administered orally, so it doesnt require needles.
Some scientists have raised concerns over whether these vaccines could increase the risk for cytokine storms deadly inflammatory reactions that have been observed in some people weeks after they have been infected with the coronavirus. Dr. Netea and others said that they were taking these concerns seriously but did not anticipate problems. For one thing, the vaccines will be given only to healthy people not to people who are already infected.
Also, B.C.G. may actually be able to ramp up the bodys initial immune response in ways that reduce the amount of virus in the body, such that an inflammatory response never occurs. It may lead to less infection to start with, said Dr. Moshe Arditi, the director of the Infectious and Immunological Diseases Research Center at Cedars-Sinai Medical Center in Los Angeles, who is leading one of the trial arms.
The science on this is still early days. Several pre-prints scientific papers that have not yet been peer-reviewed published over the past few months support the idea that B.C.G. could protect against the coronavirus. They have reported, for instance, that death rates are lower in countries that routinely vaccinate children with B.C.G. But these studies can be fraught with bias and difficult to interpret; its impossible to know whether the vaccinations, or something else, provided the protection.
Such studies are at the very bottom of the evidence hierarchy, said Dr. Christine Stabell Benn, who is raising funds for a Danish B.C.G trial. She added that the protective effects of a dose of B.C.G given to adults decades ago, when they were infants, may well differ from the protective effects the vaccine could provide when given to adults during an outbreak.
In the end, said Dr. Netea, only the clinical trials will give the answer.
Thankfully, that answer will come very soon. Initial results from the trials that are underway may be available within a few months. If these researchers are right, these old vaccines could buy us time and save thousands of lives while we work to develop a new one.
Melinda Wenner Moyer is a science and health writer and the author of a forthcoming book on raising children.
There is currently no vaccine for SARS-CoV-2, the virus that causes the novel coronavirus disease COVID-19 that has infected millions of people around the world.
But some posts on Facebook point out that a canine coronavirus vaccine has been around for years, and question why it hasnt been made for humans.
One post shares a photo displaying a vial of the vaccine, with text along the top that says, "Now this was 2001 tell me why 19 years later they say there is no vaccine share before they take it down again."
The posts caption reads: "Canine vaccine for dogs and not humans? And since 2001.....STAY WOKE PEOPLE!!" Other versions that have been debunked went even further and questioned why the dog vaccine isnt being used in humans.
A couple of key problems here:
The vaccine is for dogs, not humans.
Its not for COVID-19.
The post was flagged as part of Facebooks efforts to combat false news and misinformation on its News Feed. (Read more about our partnership with Facebook.)
RELATED: Bovine coronavirus vaccine wont help humans
The term "coronavirus" refers to a large family of viruses that are known to cause various illnesses ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS), according to the World Health Organization.
The novel coronavirus SARS-CoV-2 at the center of the current pandemic was discovered in 2019. It had not been previously identified in humans. No vaccine for it could have been developed before that.
The vaccine in the photo is real, but its for canine coronavirus disease, known also as CCoV.
Merck Animal Health makes the vaccine and now includes a note on its webpage explaining that canine coronaviruses "are not the same virus as SARS-CoV-2 that is responsible for causing the COVID-19 infection."
According to VCA Animal Hospitals, which operates nearly 800 animal hospitals in the U.S., the canine coronavirus comes from the Coronaviridae family and is a "highly infectious intestinal infection in dogs, especially puppies."
"There are many types of coronavirus, each affecting different animal species, including humans. Canine coronavirus (CCoV) is not the same virus as SARS-CoV-2," which causes COVID-19, the company says. "CCoV does not affect people. CCoV causes gastrointestinal problems in dogs, as opposed to respiratory disease."
A vaccine is available for dogs with canine coronavirus, which causes gastrointestinal issues. It is not for prevention of COVID-19 in humans; there is no vaccine for that.
We rate this False.
A vaccine would be the ultimate weapon against the coronavirus and the best route back to normal life. Officials like Dr. Anthony S. Fauci, the top infectious disease expert on the Trump administrations coronavirus task force, estimate a vaccine could arrive in at least 12 to 18 months.
The grim truth behind this rosy forecast is that a vaccine probably wont arrive any time soon. Clinical trials almost never succeed. Weve never released a coronavirus vaccine for humans before. Our record for developing an entirely new vaccine is at least four years more time than the public or the economy can tolerate social-distancing orders.
But if there was any time to fast-track a vaccine, it is now. So Times Opinion asked vaccine experts how we could condense the timeline and get a vaccine in the next few months instead of years.
Heres how we might achieve the impossible.
Start trials early
Rely on work from studying SARS and MERS to shorten preparations before clinical trials
Dont wait for academic research
Skip to clinical phases using what we know about the coronavirus so far
Normally, researchers need years to secure funding, get approvals and study results piece by piece. But these are not normal times.
There are already at least 254 therapies and 95 vaccines related to Covid-19 being explored.
If you want to make that 18-month timeframe, one way to do that is put as many horses in the race as you can, said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine.
Select vaccines by clinical trial start date
Wuhan Institute and Sinopharm
Uses 1 microgram of
mRNA, meaning it
could be more easily
mass produced
Exploring a new form of
oral vaccine, which has
never been licensed
Select vaccines by clinical trial start date
Wuhan Institute and
Sinopharm
Uses
1 microgram
of mRNA, so
it may be
more easily
mass
produced
Exploring a new form of
oral vaccine, which has
never been licensed
Note: Clinical trial start dates are approximate. Compiled by Robert van Exan.
Despite the unprecedented push for a vaccine, researchers caution that less than 10 percent of drugs that enter clinical trials are ever approved by the Food and Drug Administration.
The rest fail in one way or another: They are not effective, dont perform better than existing drugs or have too many side effects.
Note: Between 2006 and 2015. Source: Biotechnology Innovation Organization, Biomedtracker, Amplion.
Fortunately, we already have a head start on the first phase of vaccine development: research. The outbreaks of SARS and MERS, which are also caused by coronaviruses, spurred lots of research. SARS and SARS-CoV-2, the virus that causes Covid-19, are roughly 80 percent identical, and both use so-called spike proteins to grab onto a specific receptor found on cells in human lungs. This helps explain how scientists developed a test for Covid-19 so quickly.
Theres a cost to moving so quickly, however. The potential Covid-19 vaccines now in the pipeline might be more likely to fail because of the swift march through the research phase, said Robert van Exan, a cell biologist who has worked in the vaccine industry for decades. He predicts we wont see a vaccine approved until at least 2021 or 2022, and even then, this is very optimistic and of relatively low probability.
And yet, he said, this kind of fast-tracking is worth the try maybe we will get lucky.
Note: Rotavirus and HPV vaccines include time from filing of the first investigational new drug to approval. Source: Plotkins Vaccines (7th edition)
The next step in the process is pre-clinical and preparation work, where a pilot factory is readied to produce enough vaccine for trials. Researchers relying on groundwork from the SARS and MERS outbreaks could theoretically move through planning steps swiftly.
Sanofi, a French biopharmaceutical company, expects to begin clinical trials late this year for a Covid-19 vaccine that it repurposed from work on a SARS vaccine. If successful, the vaccine could be ready by late 2021.
Use pandemic speed timeline
Start subsequent steps before previous phases are completed
Push to large-scale tests sooner
Move more swiftly to Phase 3 trials by combining phases
Use emergency provision
Vaccinate front-line and essential workers early
As a rule, researchers dont begin jabbing people with experimental vaccines until after rigorous safety checks.
They test the vaccine first on small batches of people a few dozen during Phase 1, then a few hundred in Phase 2, then thousands in Phase 3. Months normally pass between phases so that researchers can review the findings and get approvals for subsequent phases.
But if we do it the conventional way, theres no way were going to be reaching that timeline of 18 months, said Akiko Iwasaki, a professor of immunobiology at Yale University School of Medicine and an investigator at the Howard Hughes Medical Institute.
There are ways to slash time off this process by combining several phases and testing vaccines on more people without as much waiting.
Last week the National Academy of Sciences showed an overlapping timeline, describing it as moving at pandemic speed.
Its here that talk of fast-tracking the timeline meets the messiness of real life: What if a promising vaccine actually makes it easier to catch the virus, or makes the disease worse after someones infected?
Thats been the case for a few H.I.V. drugs and vaccines for dengue fever, because of a process called vaccine-induced enhancement, in which the body reacts unexpectedly and makes the disease more dangerous.
Researchers cant easily infect vaccinated participants with the coronavirus to see how the body behaves. They normally wait until some volunteers contract the virus naturally. That means dosing people in regions hit hardest by the virus, like New York, or vaccinating family members of an infected person to see if they get the virus next. If the pandemic subsides, this step could be slowed.
Thats why vaccines take such a long time, said Dr. Iwasaki. But were making everything very short. Hopefully we can evaluate these risks as they occur, as soon as possible.
This is where the vaccine timelines start to diverge depending on who you are, and where some people might get left behind.
If a vaccine proves successful in early trials, regulators could issue an emergency-use provision so that doctors, nurses and other essential workers could get vaccinated right away even before the end of the year. Researchers at Oxford announced this week that their coronavirus vaccine could be ready for emergency use by September if trials prove successful.
So researchers might produce a viable vaccine in just 12 to 18 months, but that doesnt mean youre going to get it. Millions of people could be in line before you. And thats only if the United States finds a vaccine first. If another country, like China, beats us to it, we could wait even longer while it doses its citizens first.
You might be glad of that, though, if it turned out that the fast-tracked vaccine caused unexpected problems. Only after hundreds or thousands are vaccinated would researchers be able to see if a fast-tracked vaccine led to problems like vaccine-induced enhancement.
Its true that any new technology comes with a learning curve, said Dr. Paul Offit, the director of the Vaccine Education Center at the Childrens Hospital of Philadelphia. And sometimes that learning curve has a human price.
Make vaccines early
Build and manufacture early, anticipating that factories will be useful for a future vaccine and that the product will clear regulatory hurdles
Take a bet on a successful mRNA vaccine
This experimental technology may be faster to produce than traditional vaccines
Once we have a working vaccine in hand, companies will need to start producing millions perhaps billions of doses, in addition to the millions of vaccine doses that are already made each year for mumps, measles and other illnesses. Its an undertaking almost unimaginable in scope.
Companies normally build new facilities perfectly tailored to any given vaccine because each vaccine requires different equipment. Some flu vaccines are produced using chicken eggs, using large facilities where a version of the virus is incubated and harvested. Other vaccines require vats in which a virus is cultured in a broth of animal cells and later inactivated and purified.
Those factories follow strict guidelines governing biological facilities and usually take around five years to build, costing at least three times more than conventional pharmaceutical factories. Manufacturers may be able to speed this up by creating or repurposing existing facilities in the middle of clinical trials, long before the vaccine in question receives F.D.A. approval.
They just cant wait, said Dr. Iwasaki. If it turns out to be a terrible vaccine, they wont distribute it. But at least theyll have the capability to do so if the vaccine is successful.
The Bill and Melinda Gates Foundation says it will build factories for seven different vaccines. Even though well end up picking at most two of them, were going to fund factories for all seven, just so that we dont waste time, Bill Gates said during an appearance on The Daily Show.
In the end, the United States will have the capacity to mass-produce only two or three vaccines, said Vijay Samant, the former head of vaccine manufacturing at Merck.
The manufacturing task is insurmountable, Mr. Samant said. I get sleepless nights thinking about it.
Consider just one seemingly simple step: putting the vaccine into vials. Manufacturers need to procure billions of vials, and billions of stoppers to seal them. Sophisticated machines are needed to fill them precisely, and each vial is inspected on a high-speed line. Then vials are stored, shipped and released to the public using a chain of temperature-controlled facilities and trucks. At each of these stages, producers are already stretched to meet existing demands, Mr. Samant said.
Its a bottleneck similar to the one that caused a dearth of ventilators, masks and other personal protective equipment just as Covid-19 surged across America.
If you talk about vaccines long enough, a new type of vaccine, called Messenger RNA (or mRNA for short), inevitably comes up. There are hopes it could be manufactured at a record clip. Mr. Gates even included it on his Time magazine list of six innovations that could change the world. Is it the miracle were waiting for?
Rather than injecting subjects with disease-specific antigens to stimulate antibody production, mRNA vaccines give the body instructions to create those antigens itself. Because mRNA vaccines dont need to be cultured in large quantities and then purified, they are much faster to produce. They could change the course of the fight against Covid-19.
On the other hand, said Dr. van Exan, no one has ever made an RNA vaccine for humans.
Researchers conducting dozens of trials hope to change that, including one by the pharmaceutical company Moderna. Backed by investor capital and spurred by federal funding of up to $483 million to tackle Covid-19, Moderna has already fast-tracked an mRNA vaccine. Its entering Phase 1 trials this year and the company says it could have a vaccine ready for front-line workers later this year.
Could it work? Yeah, it could work, said Dr. Fred Ledley, a professor of natural biology and applied sciences at Bentley University. But in terms of the probability of success, what our data says is that theres a lower chance of approval and the trials take longer.
The technology is decades old, yet mRNA is not very stable and can break down inside the body.
At this point, Im hoping for anything to work, said Dr. Iwasaki. If it does work, wonderful, thats great. We just dont know.
The fixation on mRNA shows the allure of new and untested treatments during a medical crisis. Faced with the unsatisfying reality that our standard arsenal takes years to progress, the mRNA vaccine offers an enticing story mixed with hope and a hint of mystery. But its riskier than other established approaches.
Fast-track federal approvals
Shorten approval window from a year to six months
Imagine that the fateful day arrives. Scientists have created a successful vaccine. Theyve manufactured huge quantities of it. People are dying. The economy is crumbling. Its time to start injecting people.
But first, the federal government wants to take a peek.
That might seem like a bureaucratic nightmare, a rubber stamp that could cost lives. Theres even a common gripe among researchers: For every scientist employed by the F.D.A., there are three lawyers. And all they care about is liability.
Yet F.D.A. approvals are no mere formality. Approvals typically take a full year, during which time scientists and advisory committees review the studies to make sure that the vaccine is as safe and effective as drug makers say it is.
While some steps in the vaccine timeline can be fast-tracked or skipped entirely, approvals arent one of them. There are horror stories from the past where vaccines were not properly tested. In the 1950s, for example, a poorly produced batch of a polio vaccine was approved in a few hours. It contained a version of the virus that wasnt quite dead, so patients who got it actually contracted polio. Several children died.
The same scenario playing out today could be devastating for Covid-19, with the anti-vaccination movement and online conspiracy theorists eager to disrupt the public health response. So while the F.D.A. might do this as fast as possible, expect months to pass before any vaccine gets a green light for mass public use.
At this point you might be asking: Why are all these research teams announcing such optimistic forecasts when so many experts are skeptical about even an 18-month timeline? Perhaps because its not just the public listening its investors, too.
These biotechs are putting out all these press announcements, said Dr. Hotez. You just need to recognize theyre writing this for their shareholders, not for the purposes of public health.
Covid-19 lives in the shadow of the most vexing virus weve ever faced: H.I.V. After nearly 40 years of work, here is what we have to show for our vaccine efforts: a few Phase 3 clinical trials, one of which actually made the disease worse, and another with a success rate of just 30 percent.
Deaths from
Covid-19 in
the U.S.
Deaths from
H.I.V./AIDS
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, speaks during a news conference at the White House on April 16. Chris Kleponis/Polaris/Bloomberg via Getty Images hide caption
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, speaks during a news conference at the White House on April 16.
There's a chance that hundreds of millions of doses of a potential COVID-19 vaccine could be available by early next year, Dr. Anthony Fauci, a key member of the White House coronavirus task force, said Thursday, even though the federal government has not approved a vaccine against the virus.
In an appearance on NBC's Today Show, Fauci was asked whether he thought it was "in the realm of possibility" to have a potential vaccine ready for wide distribution by January.
"I do," Fauci replied. "I mean, I'm obviously part of the team that's involved in that."
Fauci, who heads the National Institute of Allergy and Infectious Diseases, noted that the ideal plan for a potential vaccine is to ensure it is safe and effective and can be rapidly scaled up for distribution.
Of course, the Food and Drug Administration has not approved a vaccine for the coronavirus. Noting that vaccine trials are still in the early phase, Fauci added that to accelerate production, the companies making the medicine would need to do so "at risk."
"In other words, you don't wait until you get an answer before you start manufacturing. You at risk proactively start making it, assuming it's going to work," Fauci said. "And if it does, then you can scale up and hopefully get to that timeline."
"I think that is doable if things fall in the right place," Fauci said.
Fauci was responding to a question about media reports that the Trump administration is launching a project dubbed Operation Warp Speed, to speed up delivery of a vaccine against COVID-19. The deadly disease has been diagnosed in more than a million people in the U.S.
The White House plan aims to bring together pharmaceutical companies, government agencies and the military with the goal of substantially shrinking the development time for a vaccine.
Bloomberg News, which first reported the existence of the plan to accelerate vaccine delivery, says the government's goal is to have as many as 300 million vaccine doses by early 2021.
As NPR science correspondent Joe Palca has reported, advances in science have revolutionized the speed at which vaccines can be developed.
"In the past it used to take 5-10 years to make a vaccine, and now people are talking about a year or 18 months. So it's really going faster than expected," Palca reported on NPR's Morning Edition this month.
He added that in addition to a vaccine that is safe for people, there are other factors to consider.
"You want one that generates a strong and lasting immune response. You need to be able to manufacture it. Sometimes you come up with a brilliant idea of how to package the virus and you just can't make it at a scale that would be useful. You want to have a vaccine that doesn't require special handling," Palca reports.
During the NBC interview, Fauci was asked whether he is nervous that stay-at-home orders are beginning to lift in many states, including Alabama, Texas, Arizona and Florida.
White House social distancing guidelines are set to expire at the end of April.
Fauci declined to give detailed assessments on individual states, but he pointed to White House guidelines for reopening state and local economies, which call for a "downward trajectory" of documented COVID-19 cases over a 14-day period.
Fauci said he expects to see an uptick in coronavirus cases when towns and states reopen for business.
"When you pull back, there will be cases," Fauci said. "And what we need to do is make sure they have in place the capability of identifying, isolating and contact-tracing individuals."
While he said he was "cautiously optimistic," Fauci also said governments must have "the core principles of the guidelines" before reopening.
"You can't just leap over things and get into a situation where you're really tempting a rebound. That's the thing I get concerned about," Fauci said. "I hope they don't do that."
NEW YORK (CBSNewYork) In what is thought to be the Holy Grail of this COVID-19 pandemic, dozens of companies are racing to produce a vaccine that will be safe and effective at preventing the novel coronavirus infection.
But coronaviruses have been notoriously difficult to make vaccines against, and we dont know which of the many vaccine approaches will actually work. Thats why federal health officials announced a new kind of vaccine Manhattan Project, called Operation Warp Speed.
The ambitious effort calls for making 300 million doses of a vaccine by the end of the year.
Were in phase one. When you go to next phase, you work quickly to get an answer as to whether it works and is safe. And if it is, you ramp up production, you dont wait to get the answer before you start production, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.
In other words, the government wants all of the potential manufacturers to go ahead and make their vaccines, risking that theirs will be proven safe and effective, and then be prepared to manufacture the millions of doses required.
Theres risk here. That means choosing in advance which vaccine you think will work, putting capital at risk, manufacturing it with the hope that they work, said CBS News medical contributor Dr. David Agus.
But Agus says its also key to think forward.
Watch Jessica Laytons report
Perhaps the vaccine furthest along in testing comes from the University of Oxford in England. That team says it has already vaccinated hundreds of people with their experimental COVID-19 vaccine and expect trial results in mid-June. At that point, thousands of volunteers will have to be vaccinated to see if they are truly protected and get fewer infections than a control group.
The probably earliest time that we could probably scale manufacturing would be the beginning of July, but the intention is to make enough doses so that were it approved in, say, September, we would actually have 30 million doses, said Dr. John Bell, of the University of Oxford.
Its pretty wild. I mean, this is the university that survived the plague in the 1300s. They had developed a vaccine for MERS, a former virus, that was tried in patients, did not spread the virus, so the vaccine was shelved. And they just switched out the portion from MERS to COVID-19 and put it into monkeys and challenged monkeys with the virus, After 28 days, no signs or symptoms from the virus at all, said CBS News contributor Dr. David Agus. So, because it had already been in patients, a similar virus, theyre starting out with 6,000 patients over the next six weeks.
That test phase can take many months, unless regulators are willing to conditionally approve the vaccine based on preliminary evidence.
The university is partnering with U.K.-based global biopharmaceutical company AstraZeneca to manufacture this vaccine on a large scale. Both groups have agreed to operate on a not-for-profit basis for the duration of the pandemic.
Fauci is also expressing hope about a drug called Remdesivir, which could be used on patients hospitalized with the with the virus. Its being tested now at the National Institutes of Health, although it is still early in that process.
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Agus spoke about the potential treatment on CBS This Morning.
You know, mid-January was my first meeting on COVID-19, and literally every day since then, weve dreamt of the moment we could say that we have a drug that we know works. And we can say that here, Agus said. We have something in our arsenal to treat the disease. That is exciting.
Agus said the drug has been tried on 1,000 patients and decreased hospitalizations by about four days and a declining death rate. The drug has been tried on people who are moderately to severely ill.
Agus cautioned the National Institutes of Health study hasnt yet been peer reviewed.
He called the two developments big, big steps.
Certainly, an amazing day in the fight against COVID-19. First positive one in a while, Agus said.
Its an optimistic and aggressive timeline, but if it happens, it would be just in time for a potential second wave of the virus.
Twitter has said that tweets posted early Tuesday morning by Tesla and SpaceX CEO Elon Musk that irresponsibly call for restrictions put in place to defend against the spread of COVID-19 dont violate its guidelines around inaccurate or disputed information about the coronavirus that could cause harm. Musk tweeted a series of things on Tuesday, including an endorsement of a controversial Wall Street Journal op-ed with the caption Give people their freedom back!
A Twitter spokesperson told TechCrunch that these tweets, which also include an urging to FREE AMERICA NOW, are not currently in violation of the Twitter rules. According to the company, it has said previously that its not enforcing punitive or corrective action on each instance of tweets about COVID-19 that dont provide a full picture or that appear to contain info thats disputed by other sources.
Twitter says that it has removed over 2,400 Tweets since March 18 when it implemented its new policy, and that its automated filtering systems have addressed in some way or another as many as 3.4 million accounts which seemed to be spamming or providing manipulative info regarding COVID-19 discussions. Thus far, however, some of the most influential sources of have not been subject to punitive or corrective action under the policy.
President Trumps tweets calling to liberate states, for instance, which bear a content and formatting similarity to the new tweets by Musk, have not been removed or disputed by the social network, and Twitter provided a similar statement about those missives not currently violating its rules.
Trump and Musk represent some of the most influential Twitter users, with 78.9 million and 33.3 minion users respectively, so their voices have outweighed impact on the community and public discourse relative to spam or automated misinformation accounts. In both cases, these messages indirectly seek to encourage the curtailing or disruption of social distancing, isolation and quarantine measures, even as the U.S. surged past 1 million diagnosed cases this week, with many more likely undiagnosed and therefore unaccounted for in the total.
States are already beginning to ease restrictions, and seeing resurgences in case numbers. Some more rural states that previously seemed less impacted are seeing spikes, even as they began to partially reopen, including Iowa. Leading experts including Dr. Anthony Fauci of the U.S. federal coronavirus task force have warned against the consequences of relaxing rules too soon, and the WHO and CDC are still warning of the impact of opening up too soon as well.
When major decisions must be made amid high scientific uncertainty, as is the case with Covid-19, we cant afford to silence or demonize professional colleagues with heterodox views. Even worse, we cant allow questions of science, medicine, and public health to become captives of tribalized politics. Today, more than ever, we need vigorous academic debate.
To be clear, Americans have no obligation to take every scientists idea seriously. Misinformation about Covid-19 is abundant. From snake-oil cures to conspiracy theories about the origin of SARS-CoV-2, the virus that causes the disease, the internet is awash with baseless, often harmful ideas. We denounce these: Some ideas and people can and should be dismissed.
At the same time, we are concerned by a chilling attitude among some scholars and academics, who are wrongly ascribing legitimate disagreements about Covid-19 to ignorance or to questionable political or other motivations.
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A case in point involves the response to John Ioannidis, a professor of medicine at Stanford University, who was thrust into the spotlight after writing a provocative article in STAT on Covid-19. He argued in mid-March that we didnt have enough information on the prevalence of Covid-19 and the consequences of the infection on a population basis to justify the most extreme lockdown measures which, he hypothesized, could have dangerous consequences of their own.
We have followed the dialogue about his article from fellow academics on social media, and been concerned with personal attacks and general disparaging comments. While neither of us shares all of Ioannidis views on Covid-19, we both believe his voice and those of other legitimate scientists is important to consider, even when we ultimately disagree with some of his specific analyses or predictions.
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We are two academic physicians with different career interests who sometimes disagree on substantive issues. But we share the view that vigorous debate is fundamental to the existence of universities, where individuals with different ideas who have a commitment to reason compete to persuade others based on evidence, data, and reason. Now is the time to foster not stifle open dialogue among academic physicians and scientists about the current pandemic and the best tactical responses to it, each of which involve enormous trade-offs and unanticipated consequences.
Since Covid-19 first emerged at the end of 2019, thousands of superb scientists have been working to answer fundamental, vital, and unprecedented questions. How fast does the virus spread if left unabated? How lethal is it? How many people have already had it? If so, are they now immune? What drugs can fight it? What can societies do to slow it? What happens when we selectively evolve and relax our public health interventions? Can we develop a vaccine to stop it? Should governments mandate universal cloth masks?
For each of these questions, there are emerging answers and we tend to share the consensus views: Without social distancing, Covid-19 would be a cataclysmic problem and millions would die. The best current estimate of infection fatality rates may be between 0.4% and 1.5%, varying substantially among age groups and populations. Some fraction of the population has already been infected by SARS-CoV-2 and cleared the virus. For reasons that arent yet totally clear, rates of infection have been much higher in Lombardy, Italy, and New York City than in Alaska and San Francisco. To date no drug has shown to be beneficial in randomized trials the gold standard of medicine. And scientists agree that it will likely take 18 months or longer to develop a vaccine, if one ever succeeds. As for cloth masks, we see arguments on both sides.
At the same time, academics must be able to express a broad range of interpretations and opinions. Some argue the fatality rate will be closer to 0.2% or 0.3% when we look back on this at a distance; others believe it will approach or eclipse 1%. Some believe that nations like Sweden, which instituted social distancing but with fewer lockdown restrictions, are pursuing the wisest course at least for that country while others favor the strictest lockdown measures possible. We think it is important to hear, consider, and debate these views without ad hominem attacks or animus.
Covid-19 has toppled a branching chain of dominoes that will affect health and survival in myriad ways. Health care is facing unprecedented disruption. Some consequences, like missed heart attack treatment, have more immediate effects while others, like poorer health through economic damage, are no less certain but their magnitude wont immediately become evident. It will take years, and the work of many scientists, to make sense of the full effects of Covid-19 and our responses to it.
When the dust settles, few if any scientists no matter where they work and whatever their academic titles will have been 100% correct about the effects of Covid-19 and our responses to it. Acknowledging this fact does not require policy paralysis by local and national governments, which must take decisive action despite uncertainty. But admitting this truth requires willingness to listen to and consider ideas, even many that most initially consider totally wrong.
A plausible objection to the argument we are making that opposing ideas need to be heard is that, by giving false equivalence to incorrect ideas, lives may be lost. Scientists who are incorrect or misguided, or who misinterpret data, might wrongly persuade others, causing more to die when salutatory actions are rejected or delayed. While we are sympathetic to this view, there are many uncertainties as to the best course of action. More lives may be lost by suppressing or ignoring alternate perspectives, some of which may at least in part ultimately prove correct.
Thats why we believe that the bar to stifling or ignoring academics who are willing to debate their alternative positions in public and in good faith must be very high. Since different states and nations are already making distinct choices, there exist many natural experiments to identify what helped, what hurt, and what in the end didnt matter.
We believe that the bar to stifling or ignoring academics who are willing to debate their alternative positions in public and in good faith must be very high.
Society faces a risk even more toxic and deadly than Covid-19: that the conduct of science becomes indistinguishable from politics. The tensions between the two policy poles of rapidly and systematically reopening society versus maximizing sheltering in place and social isolation must not be reduced to Republican and Democratic talking points, even as many media outlets promote such simplistic narratives.
These critical decisions should be influenced by scientific insights independent of political philosophies and party affiliations. They must be freely debated in the academic world without insult or malice to those with differing views. As always, it is essential to examine and disclose conflicts of interest and salient biases, but if none are apparent or clearly demonstrated, the temptation to speculate about malignant motivations must be resisted.
At this moment of massive uncertainty, with data and analyses shifting daily, honest disagreements among academic experts with different training, scientific backgrounds, and perspectives are both unavoidable and desirable. Its the job of policymakers, academics, and interested members of the public to consider differing point of views and decide, at each moment, the best courses of action. A minority view, even if it is ultimately mistaken, may beneficially temper excessive enthusiasm or insert needed caveats. This process, which reflects the scientific method and the culture that supports it, must be repeated tomorrow and the next day and the next.
Scientific consensus is important, but it isnt uncommon when some of the most important voices turn out to be those of independent thinkers, like John Ioannidis, whose views were initially doubted. Thats not an argument for prematurely accepting his contestable views, but it is a sound argument for keeping him, and others like him, at the table.
Vinay Prasad is a hematologist-oncologist and associate professor of medicine at the Oregon Health and Science University and author of Malignant: How Bad Policy and Bad Evidence Harm People with Cancer (Johns Hopkins University Press, April 2020). Jeffrey Flier is an endocrinologist, professor of medicine, and former dean of Harvard Medical School.
The progressive advocacy group FWD.US recommends Arizona release at least 10,000 inmates, or one-quarter of the prison population, to make a significant impact in stopping the spread of the virus. Jimmy Jenkins/KJZZ hide caption
The progressive advocacy group FWD.US recommends Arizona release at least 10,000 inmates, or one-quarter of the prison population, to make a significant impact in stopping the spread of the virus.
In Arizona, a woman behind bars at the Perryville women's prison reports hearing coughing echoing through the warehouse-style dorms all night.
In New Jersey, an immigrant detainee being held in the Essex County jail has been put on quarantine cleaning duty even though he's been sick. He fears he's spreading the coronavirus.
And at the Etowah County jail in Alabama, Karim Golding, an immigrant detainee who's fighting deportation to Jamaica, says he's been feeling short of breath and worries he got coronavirus from the guards or new detainees coming in and out.
"At the end of the day I want to be tested because I want to know did you give me the coronavirus?" Golding said. "Did you willfully give me the coronavirus and put my life at risk?"
Across the country, the spread of coronavirus behind bars is likely much more rampant than what's known right now. In prisons, jails and immigration detention centers, there is very little diagnostic testing.
And when widespread testing has been done in a few places, the results show the virus has infected huge numbers of the confined population. One Ohio prison recently found that more than 70% of inmates are positive for COVID-19.
Felicity Rose, director of research and policy for criminal justice reform at the progressive advocacy group FWD.US, says the lack of testing is leading to a false sense of security.
"We know that it's spreading among staff and that staff are bringing it into and out of the facilities," Rose said. "We know there are people who are asymptomatic and are able to pass it along, but we just don't know how many. So it's a ticking time bomb."
Inmates, detainees and their advocates say it's impossible to maintain social distancing behind bars, and they say masks as well as soap and cleaning supplies are limited and sometimes not available at all. In some places, if inmates try to make their own masks out of their T-shirts, they can be disciplined for "destruction of state property."
State, local and federal officials say they are taking steps to protect the detained population and staff, and that people behind bars can get immediate medical treatment when needed. To force social distancing, many facilities have stopped visitation and lock detainees in cells for at least 23 hours a day to limit the amount of time in common areas.
But one epidemiological model suggests coronavirus will spread rapidly in prisons, jails and detention centers unless more steps are taken, according to FWD.US, which advocates for changes to the criminal justice and immigration systems.
In Arizona, for instance, the model predicts that 99% of the Arizona inmate population will be infected within the next few weeks. But so far, less than 1% of 42,000 in Arizona prisons have been tested for COVID-19. The state reported on Monday that 44 inmates have tested positive.
Officials there do not disclose any information about staff testing or results. According to unions representing correctional officers in the state, at least 20 officers have tested positive, though union leaders believe the number is much higher. They say hundreds of employees have shown up to work with COVID-19 symptoms and been sent home.
Compounding the problem, union leaders say, is that the correctional officers were barred for a time from wearing masks for fear that would cause panic among the inmates. Officers can now bring their own masks in, but inmates are not allowed to wear any kind of mask. Some have been tasked with making cloth masks for the officers.
Testing also has been limited among detainees being held by Immigration and Customs Enforcement, which often contracts with county jails for space. Overall, about 2% of 32,000 immigrants detained by ICE have been tested. When they are tested, about 50% are coming back positive.
The agency says more than 300 detainees and 35 employees at ICE detention centers have tested positive. But ICE does not report how many contractors have gotten sick, including medical and corrections staff.
Officials at many prisons, jails and detention centers say they are following guidelines from the Centers for Disease Control and Prevention, and that testing can only be done when there are symptoms. At the Etowah County jail, for instance, an ICE spokesman says there are no suspected cases of COVID-19.
But critics say the lack of testing is masking the problem.
The ACLU warns that as many as 200,000 people could die in the U.S. from COVID-19 double the government estimate unless more steps are taken to reduce prison and jail populations.
A number of states and localities have released older, medically compromised inmates who are not considered safety or flight risks.
ICE also has released hundreds of detainees, and in some cases federal judges have intervened and ordered their release. Most immigrant detainees have no criminal record. They are being held on civil immigration violations, and judges have found their detention during a pandemic to be excessive punishment.
But some states, such as Arizona, have refused to release inmates. Instead, police and sheriff's deputies are choosing to cite people rather than book them, and prosecutors are agreeing to hold fewer people awaiting trial in jail.
As a result, jail populations have declined. In Maricopa County, which operates the fourth largest jail system in the United States, the daily population has shrunk from 8,000 inmates to 5,000 in recent weeks.
Still, advocates say that's not enough. In Arizona, FWD.US recommends the state release at least 10,000 inmates, or one-quarter of the prison population, to make a significant impact in stopping the spread of the virus.
Jimmy Jenkins is a reporter for KJZZ. Matt Katz is a reporter for WNYC.
