In the midst of exceptionally positive results from COVID-19 vaccine manufacturers, President Trump has voiced his dissatisfaction with the timing of the news, implying that positive data from clinical trials were deliberately withheld until after Election Day.
Now, The Washington Post reports that the U.S. Department of Health and Human Services (HHS) may release a blueprint to lower drug prices within Medicare through an executive order called the most favored nation.
The most favored nation price refers to the lowest price for a pharmaceutical drug or product sold in a member country of the Organization for Economic Cooperation and Development with a similar gross domestic product.
This policy aims to reduce costs for prescription drugs or biological products, especially for elderly Americans.
The Post notes that the policy is unpopular in the pharmaceutical industry because it would force drug manufacturers to accept the lowest price from the government for medicines that were paid in similarly wealthy countries.
Trump has long wanted to cut drug prices, but has hit roadblocks along the way.
Speaking to The Post, one GOP health care lobbyist said that this move is pointed at pharmaceutical companies like Pfizer and Moderna, whose COVID-19 vaccine candidates each recently revealed about 95 percent efficacy rates.
This is basically Trump being pissed off because he thought the industry campaigned against him and delayed in announcing the [vaccine] results, so he is going to get back at them with favored nations, they said.
PROJECTED US CORONAVIRUS DEATHS MORE THAN 400,000 BY MARCH
PFIZER LAUNCHES TRIAL FOR DELIVERIES OF COVID-19 VACCINE IN FOUR STATES
MODERNAS VACCINE DOESNT NEED TO BE STORED IN DEEP-FREEZE CONDITIONS
MORE THAN 1 MILLION US CHILDREN DIAGNOSED WITH COVID-19: REPORT
If the book of nature is written in the language of mathematics, as Galileo once declared, the Covid-19 pandemic has brought that truth home for the worlds mathematicians, who have been galvanized by the rapid spread of the coronavirus.
So far this year, they have been involved in everything from revealing how contagious the novel coronavirus is, how far we should stand from each other, how long an infected person might shed the virus, how a single strain spread from Europe to New York and then burst across America, and how to flatten the curve to save hundreds of thousands of lives. Modeling also helped persuade the Centers for Disease Control and Prevention that the virus can be airborne and transmitted by aerosols that stay aloft for hours.
And at the moment many are grappling with a particularly urgent and thorny area of research: modeling the optimal rollout of a vaccine. Because vaccine supply will be limited at first, the decisions about who gets those first doses could save tens of thousands of lives. This is critical now that promising early results are coming in about two vaccine candidates one from Pfizer and BioNTech and one from Moderna that may be highly effective and for which the companies may apply for emergency authorization from the Food and Drug Administration.
But figuring out how to allocate vaccines there are close to 50 in clinical trials on humans to the right groups at the right time is a very complex problem, says Eva Lee, director of the Center for Operations Research in Medicine and Health Care at theGeorgia Institute of Technology. Lee has modeled dispensing strategies for vaccines and medical supplies for Zika, Ebola, and influenza, and is now working on Covid-19. The coronavirus is so infectious and so much more deadly than influenza, she says. We have never been challenged like that by a virus.
Howard Forman, a public health professor at Yale University, says the last time we did mass vaccination with completely new vaccines, was with smallpox and polio. We are treading into an area we are not used to. All the other vaccines of the last decades have either been tested for years or were introduced very slowly, he says.
Because Covid-19 is especially lethal for those over 65 and those with other health problems such as obesity, diabetes, or asthma, and yet is spread rapidly and widely by healthy young adults who are more likely to recover, mathematicians are faced with two conflicting priorities when modeling for vaccines: Should they prevent deaths or slow transmission?
The consensus among most modelers is that if the main goal is to slash mortality rates, officials must prioritize vaccinating those who are older, and if they want to slow transmission, they must target younger adults.
Almost no matter what, you get the same answer, says Harvard epidemiologist Marc Lipsitch. Vaccinate the elderly first to prevent deaths, he says, and then move on to other, healthier groups or the general population. One recent study modeled how Covid-19 is likely to spread in six countries the U.S., India, Spain, Zimbabwe, Brazil, and Belgium and concluded that if the primary goal is to reduce mortality rates, adults over 60 should be prioritized for direct vaccination. The study, by Daniel Larremore and Kate Bubar of the University of Colorado Boulder, Lipsitch, and their colleagues, has been published as a preprint, meaning it has not yet been peer reviewed. Of course, when considering Covid-19s outsized impact on minorities especially Black and Latino communities additional considerations for prioritization come into play.
Most modelers agree that everything is changing with coronavirus at the speed of light, as applied mathematician Laura Matrajt, a research associate at the Fred Hutchinson Cancer Research Center in Seattle, put it in an email. That includes our understanding of how the virus spreads, how it attacks the body, how having another disease at the same time might raise the risk, and what leads to super-spreader events.
Because vaccine supply will be limited at first, the decisions about who gets those first doses could save tens of thousands of lives.
So far, the research has yielded some surprising results. While children are usually prioritized for flu vaccine, for example, experts say the very young should be a lower priority for Covid-19 vaccines in the United States, because thus far young adults have been primary drivers of transmission. (This is not necessarily true across the globe; in India, for instance, where multiple generations often live together in smaller spaces, new research shows both children and young adults are spreading much of the virus in the two states studied.)
In addition, several models suggest that significant headway can be made against the pandemic even with lower deployment of a vaccine that is only partly effective. And several others emphasize the importance of local infection and transmission rates. According to Lee, whose early assessments of the pandemics origin, virulence, and probable global trajectory proved to be strikingly accurate, New York could potentially contain the virus if about 40 percent of the population were vaccinated, because local transmission of the virus is fairly low (a positivity rate of a little below 3 percent as of Nov. 16), and around 20 percent have already been infected.
The higher the fraction of people in the population who already have antibodies, the more bang for your buck, says Larremore, because you can prioritize giving vaccines to those who dont have antibodies.
All these findings are important because, at the end of the day, you will never have enough vaccines for the entire population, says Lee and not all Americans will take it. In fact, the World Health Organization recently predicted that healthy young adults may not even be able to get a vaccine until 2022, after the elderly, health care workers, and other high-risk groups are vaccinated.
To model the rollout of vaccines, mathematicians must build formulas that reflect the starburst of human life and our complex interactions, using data like housing and socioeconomic status, daily habits, age, and health risks. But first they establish how contagious the virus is its reproductive rate, or R-naught. This represents the number of people that one infected person can be expected to transmit the infection to.
When some fraction (depending on R-naught) of people are immune (either by recovering from natural infection, if that grants immunity, or through vaccination), herd immunity has been achieved. That means that while small outbreaks may still occur, the pandemic will not take off globally again. Given the R-naught of SARS-CoV-2, the virus that causes Covid-19, the World Health Organization has estimated that 65 percent to 70 percent of the population needs to be immune before this can be achieved.
Modeling vaccine rollout requires a complex acrobatics, and while the models to flatten the curve that mesmerized the public last spring took weeks to craft, vaccine distribution models take many months. There are innumerable practical challenges facing modelers. For one thing, many of the vaccines currently in the pipeline including the two candidates from Pfizer and BioNTech and Moderna require two shots, several weeks apart, which involve registries and follow-up to ensure that people get the second, critical booster shot. And as The New York Times noted in late September, Companies may have to transport tiny glass vials thousands of miles while keeping them as cold as the South Pole in the depths of winter.
There is also the question of vaccine efficacy. Will a given vaccine provide robust immunity, and in all groups? Or will it primarily shorten duration of infection and lessen symptoms, which would still be of great value in reducing mortality as well as transmission? And what if a vaccine is less effective among the elderly, as is often the case? At the moment, vaccines using messenger RNA (including those produced by Moderna and Pfizer and BioNTech) are looking pretty good in older adults, according to Kathleen Neuzil, director of the Center for Vaccine Development and Global Health at the University of Maryland School of Medicine. Preliminary analyses of both vaccine candidates show that they may be more than 90 percent effective.
Finally, there is also the vexing question of how long immunity might last after infection. For some viruses, such as the varicella-zoster virus that causes chickenpox, immunity can last for decades. For others, such as the family of coronaviruses that includes SARS-CoV-2 and the common cold, the virus has a relatively high mutation rate that may protect novel strains from our antibodies. That uncertainty is difficult to model precisely, so many modelers assume that, for the time being at least, those who have been infected are immune.
Matrajt, of the Fred Hutchinson Cancer Center in Seattle, remembers vividly how hard it was to begin to construct a model out of thin air when she began working with colleagues on a vaccination model this past April. There were so many uncertainties, she recalls. Together, the researchers developed algorithms based on an astonishing 440 or so combinations of parameters, from transmission to immunity to age groups and mortality. Their computers spent nearly 9,000 hours running equations, and their model, published in August as a preprint, shows that if there is only a low supply of vaccine at first, older adults should be prioritized if the goal is to reduce deaths.
But for vaccines that are at least 60 percent effective, once there is enough to cover at least half the population, switching to target healthy individuals ages 20 to 50 as well as children would minimize deaths. The model also predicts how many deaths can be averted with different amounts of vaccine coverage. For instance, if 20 percent of the population has already been infected and is immune, deaths could be halved by vaccinating just 35 percent of the remainder, if the vaccine is at least 50 percent effective.
In the model by Matrajt and her colleagues, herd immunity is achieved once 60 percent of the population is immune. It is completely normal that different models will give different numbers, she says, explaining why her estimate varies slightly from the WHO figure of 65 percent.
The model does a really nice job looking at a large number of plausible cases, says Michael Springborn, an environmental and resource economist at the University of California, Davis, who just finished his own model with Jack Buckner, a colleague at UC Davis, and Gerardo Chowell, a mathematical epidemiologist at Georgia State University. Their study, released in preprint, also suggests the power of careful initial targeting in reducing deaths.
The models suggest that even a partially-effective vaccine given to just part of the population, says Springborn, can go a really long way to reducing infections and reducing deaths.
Lees modeling, created with software she first developed in 2003, in conjunction with the CDC, for dispensing of supplies in natural disasters and pandemics, analyzes how the disease might be contained in areas with different infection rates and initially scarce vaccine supplies. In New York City, which was hit so hard in the spring, her model predicts that roughly 60 percent of the population may need immunity to contain the pandemic. Assuming 20 percent are already infected, about 40 percent would need to be vaccinated. In San Diego, however, where infection rates have been lower, Lees model suggests that 65 percent will need to achieve immunity through infection or vaccination. In Houston, the figure may be as high as 73 percent because the infection has persisted at a slow burn and because of the citys large, vulnerable Latino and African American populations, who have borne disproportionate risk.
Lee cautions that these results do not mean you can suddenly go to a football game in Houston or Broadway show in New York, but it does mean that with ongoing precautions, the virus might well be contained with the percentages given in her models, until more vaccine arrives.
Though their results vary, most models agree that certain factors are critical, notably age group, which changes the risk of contracting, spreading, and dying from a virus. Its not always predictable: The swine flu, for instance, spared older adults to some degree, while SARS-CoV-2 has severely affected those over 65. Adults 65 and older compose 16 percent of the U.S. population but account for about 80 percent of Covid-19 deaths.
In addition, age indirectly influences transmission patterns. In 2009, Yale epidemiologists Alison Galvani and Jan Medlock published a mathematical model in Science, showing that targeting flu vaccines to children and young adults (in addition to the elderly) could have slashed swine flu infections from 59 million to 44 million; and for seasonal influenza, 83 million infections could plunge to 44 million. Children, it turns out, drive a disproportionate amount of flu transmission, and protecting them protects society at large.
The study, and others like it, inspired a change in CDC policy to prioritize vaccinating children. It was a revolution in how we think about vaccines, says Larremore. Vaccination models now routinely consider the power of indirect protection of the most vulnerable by vaccinating those most responsible for spread.
Age also intersects, in complex ways, with social connectivity in different regions. For instance, African American and Latino communities in the United States have been disproportionately hit by Covid-19, in part because of the prevalence of multiple generations living together: Older individuals are much more exposed to the young adults who might be the likeliest carriers of infection.
Modeling connectivity requires drawing grids that represent how we live and move among each other. In 2008, a landmark paper built a grid that epidemiologists everywhere still use today. It stratified people into groups based on age, from birth to 70 years old and up. In the study, more than 7,000 individuals kept a diary of their contacts nearly 98,000 of them over the course of one day. Contacts were sorted by place (home, school, work, leisure) and by nature (physical or nonphysical, brief or longer lasting). The model found that 5- to 19-year-olds tend to experience the highest incidence of infection when a new pathogen begins to spread in a completely susceptible population, possibly because of their more frequent and physical contact with others. It also showed how profoundly a societys grids of connection influence transmission.
The model was expanded globally in 2017, with contact rates for 152 countries. Its what we all use, says Matrajt, because its the best thing we have to identify how people contact each other. She incorporated the contact grid into her model.
For example, if kids are really the hubs around which society is built, Larremore says, so that if you vaccinate the kids, you fragment that transmission network, then thats going to give us a totally different way of rolling out this vaccine.
The original grid relied on diaries. Today, our ability to gather data through real time cellphone and online activity may be even greater.
When social distancing became widespread this past spring, it dramatically altered the input into the typical transmission model, says Springborn. Data from the Institute for Health Metrics and Evaluation at the University of Washington shows the power of social distancing in reducing transmission. The contact grids in previous studies are from pre-pandemic times, Springborn wrote in an email. We know that contact rates are very different under social distancing and we want to account for that. And we expect social distancing to soften as the number of infections falls. Human nature: As risk falls, so does risk-mitigating behavior.
That needs to be modeled as well. And it will influence the expectations for a vaccines rollout and success. In fact, Lee maintains, if we had 90 percent compliance with face masks and social distancing right now, we could contain the virus without a vaccine.
If kids are really the hubs around which society is built, Larremore says, so that if you vaccinate the kids, you fragment that transmission network, then thats going to give us a totally different way of rolling out this vaccine.
In the study by Springborn, Buckner, and Chowell, social distancing is modeled by creating age-stratified categories for both essential and nonessential workers. Essential workers health care workers, grocery workers, and many schoolteachers, among others are at high risk for infection because they cannot socially distance. This model finds that deaths, as well as total years of life lost, are dramatically decreased when essential workers are prioritized to receive the vaccine. Older essential workers between 40 and 59 should be prioritized first if the goal is to minimize deaths, the authors maintain.
With no vaccine, about 179,000 people may die in the first six months of 2021, Springborn says. His teams model suggests that deaths could decline to about 88,000 simply by introducing a vaccine gradually, giving it to 10 percent of the population each month, and distributing it uniformly without prioritizing any groups. But distributing vaccines in a targeted way, based on peoples ages and whether they are essential workers, could save another 7,000 to 37,000 lives, depending on the situation.
There are other methods of teasing out social connectivity beyond diaries and cellphone data. Census and other data reflect age, profession, and socioeconomic status, and Lee includes them in her models. The zip code gives you a huge amount of information, she says. Public health data on disease prevalence and hospitalizations can tease out the other unrelated diseases that Covid-19 patients have, as well as vulnerabilities in a given area. Even information on a citys housing, whether skyscrapers or single-family homes, can give a clue to how closely people are packed together and how likely they are to interact. Inputting this kind of data allows for a vaccine rollout that is sensitive to local conditions. Lee would need to model about 500 representative cities around the U.S., she says, to cover the country accurately.
As powerful as the models can be, they are an imperfect guide. Inevitably they intersect with deep and broad social concerns. The pandemic has disproportionately harmed and killed minorities and those with lower incomes. For that reason, various groups are looking into the ethical principles that should frame vaccine allocation, according to Hanna Nohynek, deputy head of the Infectious Diseases Control and Vaccinations Unit at the Finnish Institute for Health and Welfare, and a member of the WHOs SAGE Working Group on Covid-19 vaccines.
In the U.S., the National Academies of Sciences, Engineering, and Medicine has begun to model an equitable allocation of a vaccine. In addition, two other important models have emerged, one associated with University of Pennsylvania School of Medicine, and the other with Johns Hopkins University. Both are guided by concerns about ethics, fairness, maximizing benefits, building trust and the greater public good.
But building trust can be challenging in practice. For instance, its widely acknowledged that Black people have experienced hospitalization and death at disproportionately high rates compared to White people. Yet when ethicists begin to talk about prioritizing Black people for vaccines, it can be perceived as an intent to experiment on them by pushing them to the head of the line. If there is concern among African Americans, its a logical reaction to a vast history of centuries of abuse of African Americans in the medical sphere, says medical ethicist Harriet Washington, author of Medical Apartheid.
Ultimately, both ethical and mathematical models have to face real-world practicalities. Its hard because math essentially boils down to a utilitarian calculus, says Lipsitch, the Harvard epidemiologist.
Nonetheless, says Larremore, the models will help guide us in the uncertain early days. Vaccines take a while to roll out, he says. We cant let our foot off the gas the moment a vaccine is announced.
Jill Neimark is a writer based in Atlanta, Georgia, whose work has been featured in Discover, Scientific American, Science, Nautilus, Aeon, NPR, Quartz, Psychology Today, and The New York Times. Her latest book is The Hugging Tree (Magination Press).
The Pfizer/BioNTech vaccine against Covid-19 performs even better than previously thought, with 95% efficacy, equalling the early results from Moderna on Monday, according to an analysis of the final data from their trials, which paves the way for regulators to grant an emergency licence and vaccination campaigns to begin.
The news will excite scientists, public health experts and politicians. Pfizer/BioNTech say they also have the necessary safety data that regulatory bodies require, and will submit the vaccine for emergency approval within days to the US Food and Drug Administration and other regulators around the world.
The Pfizer vaccine, which uses innovative mRNA technology, was the first to publish an early analysis from its phase 3 trials involving 43,000 people worldwide. That analysis of 94 cases of Covid illness showed more than 90% efficacy and caused celebration around the world as it appeared clear that a vaccine was at least possible against the coronavirus that has wreaked havoc in peoples lives and countries economies.
The final results have been published just a week later, based on 170 people in the trial who fell ill with the disease. The new data is even better, with 95% efficacy which means that the vast majority of those who developed symptoms and were confirmed as Covid cases had not been given the Pfizer experimental vaccine. Only eight had been given the vaccine, while the other 162 were in the placebo group.
In further excellent news, a good immune response was consistent across age, gender, race and ethnicity demographics and the jab had over 94% efficacy in those aged over 65, Pfizer said. That is remarkable, because many vaccines do not work so well in older people, whose immune systems weaken with age.
Of those taking part in the trial, 42% were from diverse ethnic backgrounds and 41% were aged between 56 and 85, which is also important as people from BAME groups have been disproportionately affected by the virus.
Ten of the cases resulted in severe illness, as opposed to mild symptoms, and only one of those had been given the experimental vaccine. No serious side-effect issues have been reported, although 2% of people said they suffered a headache and fatigue.
This week, the US company Moderna announced that its vaccine, which also uses mRNA, had 95% efficacy based on interim data. They will now be looking to publish final results and a safety analysis that will allow them to submit for regulatory approval.
Pfizer/BioNTech confirmed they would go within days to regulators around the world for emergency authorisation based on their final data and also manufacturing quality data. They have undertaken to deliver 50m doses of the vaccine this year, with up to 1.3bn next year. The UK has pre-ordered 40m doses and is likely to get a small amount this year. Europe has ordered 200m while the US has ordered 100mn.
We are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against Covid-19 can be achieved very fast after the first 30 g [microgam] dose, underscoring the potential of BNT162 to provide early protection, said Uur ahin, the CEO and co-founder of BioNTech.
These achievements highlight the potential of mRNA as a new drug class. Our objective from the very beginning was to design and develop a vaccine that would generate rapid and potent protection against Covid-19 with a benign tolerability profile across all ages. We believe we have achieved this with our vaccine candidate BNT162b2 in all age groups studied so far and look forward to sharing further details with the regulatory authorities.
I want to thank all the devoted women and men who contributed to this historically unprecedented achievement. We will continue to work with our partners and governments around the world to prepare for global distribution in 2020 and beyond.
Prof Trudie Lang from the Nuffield Department of Medicine at Oxford University, said the data that has been released looked very positive.
This is a remarkable and very reassuring situation that we find ourselves in. To go from identifying a new virus to having several vaccines at the point of applying for regulatory approval is an incredible milestone for science.
Having worked on vaccine development in several diseases such as Malaria, TB and Ebola, I am really encouraged. The progress here, the faster ways of working and the new technologies developed can be taken forward into other vaccine programmes and benefit other diseases.
CHICAGO The city could get its first doses of a coronavirus vaccine by the end of the year, with health care workers first in line.
Still, the vaccine likely wont be widely available to the general public until months into 2021, Dr. Allison Arwady, head of the Chicago Department of Public Health, said during a Tuesday news conference.
I think it is likely we may see the first emergency-use FDA authorization in the next few weeks, Arwady said. If that happens, I think its likely we could have our first COVID-19 vaccine here in Chicago before the end of the year.
Demand for a vaccine is high internationally, and supply and distribution will be highly limited. Officials will prioritize giving the few doses they get in the beginning to health care workers, particularly those working with COVID-19 patients, Arwady said. She said Chicago has about 150,000 health care workers.
After that, first responders and people living in long-term care facilities which have seen numerous deadly outbreaks will get the vaccine.
Only then will the vaccine likely start going out more widely. Its possible the general public could have access to it in the first quarter of 2021, Arwady said.
We dont know [the timeline] for a fact, she said. We will only know that when the vaccine trials are appropriately completed, when the FDA has completed its review and then the CDC also looks at the data and theres an external group of scientists that make recommendations about who should receive this vaccine.
Children likely wont get vaccinated for months since more research needs to be done and since they havent faced the same risks as older people from COVID-19, Arwady said.
The Department of Public Health has already begun building up how many doses of vaccine it can store at once and working with hospitals so they can distribute the vaccine once its more widely available.
The vaccines being trialed will go through all of the appropriate scientific review before theyre distributed widely, Arwady said, and she will not OK their use in Chicago without ensuring theyre safe.
But Arwady said even once the general public starts getting vaccinated, people will still need to wear masks and social distance.
A vaccine is not going to be here for most people within the next few months, Arwady said.
Its going to be months before we have the amount of vaccine [where] we start talking about vaccinating hundreds of thousands or 2.7 million Chicagoans, Arwady said. Throughout most of 2021, even as the vaccine is being rolled out, we are going to need people to keep wearing their masks, to keep social distancing. Even the people who have received the vaccine.
Thats because researchers still need to study the virus and ensure vaccinated people arent still shedding the virus, potentially spreading it to others, Arwady said.
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If daring volunteers get their way, they will soon become infected with Covid-19 on purpose.
Theyre young. Theyre healthy. And they want scientists to give them a candidate vaccine and then deliberately expose them to the coronavirus, so we can all find out faster whether the vaccine is effective.
This is called a human challenge trial, and its controversial for obvious reasons: The volunteers might get sick or even die. But proponents argue that it would speed up vaccine development, and even if it gets us to a successful vaccine just a bit faster, that could still mean many thousands of lives saved.
You may have heard the recent good news on the vaccine front: Pfizer says its vaccine is 90 percent effective and Moderna says its vaccine is nearly 95 percent effective. Those vaccines were developed via conventional clinical trials, not human challenge trials.
Heres the difference: A conventional trial vaccinates people and then waits months to see if they get infected anyway while they go about their normal lives. A challenge trial eliminates the whole wait-and-see period by vaccinating people, exposing them to the virus on the spot, and seeing how well the vaccine protects them. Results come in extremely fast, and theyre reliably instructive because scientists can control all the conditions. They know exactly who was exposed, how big a dose of virus they were exposed to, and how their immune system responded day by day.
A human challenge trial is set to begin in London in January, assuming it gets final ethics and regulatory approval. Scientists have run such trials in the past for influenza, malaria, typhoid, dengue, and cholera, but this will be the first for Covid-19. A company called Open Orphan and its subsidiary hVIVO will run the study. Only healthy volunteers aged 18 to 30 will be allowed to participate. The challenge trial is not meant to replace conventional clinical trials the different types of trials will proceed along parallel tracks.
Many young people are clamoring to participate in a challenge trial. The advocacy group 1DaySooner has gathered the names of nearly 39,000 people in 166 countries who say theyd be interested in volunteering.
In July, the group sent an open letter to Francis Collins, the head of the National Institutes of Health (NIH), calling for human challenge trials in the US. The letter was signed by more than 30 Nobel laureates and many prominent philosophers and psychologists, including Peter Singer, Steven Pinker, and Rebecca Goldstein. They wrote: If challenge trials can safely and effectively speed the vaccine development process, there is a formidable presumption in favor of their use, which would require a very compelling ethical justification to overcome.
So far, the US has not given the green light to such a trial, although the National Institute of Allergy and Infectious Diseases is paying for the preparation of the viral strains that would be needed if a trial gets the go-ahead. In Belgium, the government has dedicated $23.6 million to facilities to host such trials, which may include Covid-19.
The UK trial will begin with an initial phase that isnt about testing vaccines at all; its about answering a preliminary question that lays the groundwork for testing vaccines later. The question is: How much of the virus does someone need to be exposed to in order to launch an infection?
Starting in January, scientists will expose a small group of unvaccinated volunteers (somewhere between 50 and 90 people) to a very low dose of the virus, gradually increasing it until they find the Goldilocks dose enough to infect most participants, but not enough to make them very ill. All participants will be dosed with the virus, as there is no control group, and all will be paid for their time. Theyll be sequestered in a quarantine facility for over two weeks so as to avoid infecting anyone else, and so that doctors can monitor them 24/7 and give them immediate medical care including the antiviral drug remdesivir as soon as they show signs of sickness.
Only after this initial phase concludes in the spring would the company (if it gets approval) actually inject volunteers with candidate vaccines to study their effectiveness. At that point, there would be a control group. Half the volunteers will get a vaccine, half will get a placebo vaccine, and all of them will be exposed to the virus, explained Andrew Catchpole, the chief scientific officer at Open Orphan, whos conducting the study.
But there is no reliable cure for Covid-19. So under these conditions, some say its unethical to infect healthy people with a virus that can cause death or long-term disability. Lets break down the issues at stake to understand if and how a human challenge trial for a Covid-19 vaccine can be done ethically.
One of philosophys most famous thought experiments is known as the Trolley Problem. It poses this dilemma: Should you make the active choice to divert a runaway trolley so that it kills one person if, by doing so, you can save five people along a different track from getting killed?
Consequentialists or utilitarians typically say yes, because youre maximizing overall good and consequences are what matter. Deontologists (also known as Kantians) typically say no, because you have a duty to not kill anyone as a means to an end and your duties are what matter.
A challenge trial is a little bit like a Trolley Problem. Were talking about potentially sacrificing a few healthy volunteers in order to save many thousands of other peoples lives. Again, the utilitarian would say we should go ahead with the trial because of its vast potential for good. But the deontologist may argue that we have a duty not to infect a healthy person with a life-threatening disease for which we have no cure.
Theres a crucial difference, however: The people getting run over in the Trolley Problem arent consenting to their fate. The volunteers in a challenge trial are.
Or are they?
Im not convinced that we can actually obtain informed consent from people given that were still seeing the emerging effects of long Covid, said Angela Rasmussen, a virologist at Columbia University. She was referring to the fact that, for at least 10 percent of people who contract Covid-19, some of the diseases poorly understood effects ranging from brain fog to lung scarring to heart conditions can last for months. Scientists dont yet have a clear understanding of the risk factors for long-term Covid-19, nor can they predict its duration.
Some argue this isnt a problem: The researchers running a human challenge trial can just inform the volunteers that a lot of uncertainty remains about Covid-19, and that they might be signing up for long-term disability. The volunteers can consent to the uncertainty.
Rasmussen is not convinced. People are going to dismiss that, she told me. I dont think its possible to convey the seriousness by just saying its uncertain. Her conviction stems from personal experience: In 2014, she was on an NIH panel on chronic fatigue syndrome. Shed read the facts about the condition, but said she didnt fully internalize on a gut level the quality of the suffering it brought to peoples lives until she actually met people who had the condition.
Being physically unable to get out of bed and having doctors not believe you and having to completely change your life its not the kind of thing you necessarily can understand by reading an informed consent document, Rasmussen said.
Similarly, volunteers in a human challenge trial, who will be young people without experience of persistent illness, might not understand on an emotional level what it means to put themselves at risk of long-term effects from Covid-19. Data from previous studies suggest there is a gap between understanding health risk on an intellectual level and appreciating it emotionally.
Nevertheless, the philosopher and MacArthur genius grant winner Rebecca Goldstein said signing onto 1DaySooners letter in support of challenge trials was almost a no-brainer for her.
I have more faith both in peoples ability to understand the consequences of things, and in some peoples incredible sense of responsibility to others, she told me. Maybe its hard to imagine that there really are altruistic people, and we think, Oh, they just dont understand that harm could come to them. But I do believe there are such people.
Her conviction also stems from personal experience namely, her Jewish familys experience during World War II. I only exist because some of my Hungarian forebears were hidden by people who risked! They knew exactly what was going to happen to them if they got caught. And they did it anyway. To me, this is the same kind of thing.
Goldstein also argued that Rasmussens type of reasoning would have consequences we just couldnt live with as a society. We allow people to volunteer for the army, to become policemen, to become firefighters, she said. How is that any different? Theyre young and they feel invulnerable. Nevertheless, we need them.
Theres another complicating factor here: money. If volunteers are offered payment for participating, there might be a problematic incentive for low-income people to take part in a trial that could harm their health, which is arguably exploitative.
Volunteers in the UK trial will be paid, though exactly how much remains unclear; an ethical review board will decide how they should be compensated. Typically, though, Open Orphan pays people around $5,000 to participate in a challenge trial, which entails over two weeks in quarantine, plus coming in for follow-up visits for up to a year.
At a time when theres skyrocketing unemployment, its going to be attractive to some people to make a few thousand dollars by agreeing to be in a study like that, Rasmussen said.
Goldstein shares this concern. Im a little nervous about that, to tell you the truth, she said. It seems to me that muddies the incentive.
But Seema Shah, a bioethicist at Lurie Childrens Hospital of Chicago and Northwestern University, said we should think about the flip side. If people arent compensated for their time, then they are being exploited. Theyre being asked to subsidize the research. That doesnt seem fair.
She suggested the solution would be to reimburse participants for travel to and from the trial site and compensate them for their time. Specifically, they should be paid wages equivalent to what theyd earn for doing any other sort of unskilled labor. In addition, they should receive free medical care, including for any long-term effects that may result from participating in the study.
This is in line with the wage-payment model outlined years ago by nurse-bioethicist Christine Grady. More recently, bioethicists have authored a report explaining how reimbursement and compensation could be ethically paid out in the case of Covid-19 challenge studies in particular.
That report notes that undue inducement does not seem to be a significant problem based on available evidence. Broadly speaking, that is the impression that emerges from interviews with would-be volunteers. Many of them seem to be motivated not by financial need, but by altruism.
The words of Danica Marcos, a 22-year-old prospective volunteer, are emblematic of their rationale. So many people are struggling right now, and I want this pandemic to be over, she told the Associated Press. Every day that goes on, more cases are going on, more people are dying. And if this vaccine trial could mean that this period of trauma for the whole world will be over sooner, I want to help. I want to be a part of that.
For his part, Catchpole said hes been quite staggered by the numbers of young people wanting to volunteer. We had over 40,000 applications within a week. They pretty much crashed our website and our phones. And were seeing a high percentage very openly stating those altruistic reasons to do their bit.
Initially, proponents advocated for challenge trials on the grounds that theyd help us discover a Covid-19 vaccine faster. But it now looks like a challenge trial wont start its initial phase until January, and wont begin actually testing vaccines until the spring. That doesnt really save us time.
By January, we may already have an Emergency Use Authorization for a vaccine thats gone through clinical trials, like the Pfizer or Moderna vaccine. The reason these trials have been able to get results quickly is that many countries have totally failed to get Covid-19 under control. As the virus has ripped through populations, its infected enough people in Pfizer and Modernas samples that the scientists were able to get the data they needed.
So the case for a challenge trial has changed. Even though it might not get us to the first vaccine faster, advocates say, it could accelerate the development of better second-generation vaccines. After all, the first vaccine is rarely the best, and its likely a few different vaccines will come on the market in the next few years.
To me the question is, is the risk of doing a trial like this sufficiently low and justified by the value? said Shah, the bioethicist. And I think were sort of at a point where were pushing the bounds of whats been accepted in other kinds of research.
On the one hand, the value of getting us to a second-generation vaccine faster is significant. Generally, in order to bring down the cost of any drug or intervention, you need at least four other versions of it available on the market. If you think about trying to get the vaccine to countries that will have great need but wont be able to pay huge amounts of money, you can imagine theres really a need to develop cheaper vaccines for them, she said.
Whats more, a challenge trial could offer scientists valuable information about the pathogenesis of the disease, say, or about the immune responses that vaccinated people mount when exposed to the virus.
Rasmussen, the virologist, acknowledges that could be useful intel, but says its not urgently needed; a challenge trial can wait until we have a vaccine that we know is effective from a regular clinical trial, and better rescue therapies.
In the meantime, Rasmussen argued, the lack of diversity in a challenge trial will limit its scientific utility. A challenge trial is going to have to be done in young healthy people, and thats fine, but that isnt really going to tell us how the vaccine works in people who need it the most elderly people, immunocompromised people, and people with underlying medical conditions.
That said, its not like such a trial would tell us nothing thats of use to these vulnerable populations. If we have a vaccine that works in young healthy people, it may not work as well in the elderly, because their immune systems dont work as well but chances are itll still be effective to some degree.
Whats more, Catchpole said, Its as important to kill a vaccine thats not got any chance as it is to promote one that does. If we can use the challenge model in the younger population to see which vaccine doesnt have efficacy, we can get a very quick read and prioritize the next candidate vaccine.
So where does that leave us? Shah said that at this point, its not clear to her that the value of Covid-19 challenge trials quite justifies the risks. Im glad Im not the one who has to make the call, honestly, because I think its still a very close question whether theyre justified. Theres room for reasonable people to disagree.
Running through this whole debate is a fundamental question about human nature: Is true altruism possible?
Some people are highly skeptical that it is, and the open letter released by 1DaySooner this summer contains a fascinating paragraph betraying an awareness of that: Decades of psychological research on highly altruistic behaviors has demonstrated that a large, and likely growing, fraction of the general population is willing to undergo meaningful risks to benefit others due to genuinely altruistic motivation rather than insensitivity to risk, psychopathology, or other ethically concerning motives.
We can infer the implicit concern that people may be suspicious of someone who volunteers to get Covid-19 that they may assume any such volunteer must be irrational or incapable of understanding the risks.
This concern about altruism isnt new. A long line of philosophers and economists have expressed or observed suspicion toward altruists who are willing to incur a major cost to themselves in order to help perfect strangers.
We can see this, for example, in the 1982 paper Moral Saints by Susan Wolf. The philosopher observes that we dont tend to like extreme altruists (she uses the phrases a moral fanatic and a disgusting goody good) and says, there seems to be a limit to how much morality we can stand.
In more recent years, the Stanford psychologist Benoit Monin has demonstrated an effect called do-gooder derogation. Hes shown that we feel less warm toward people who are extremely altruistic. That may be because they make us feel moral conflict about our own behaviors.
And neuroscientist Molly Crockett at Yale has conducted studies to determine whether people prefer consequentialists or deontologists. To get at that, she showed subjects the classic Trolley Problem and the different ways of responding to it. She found that when people are looking for a friend or spouse, they strongly prefer deontologists, viewing them as more moral and trustworthy. People are suspicious of consequentialists. Its possible that that same suspicion is now being extended to extreme altruists signing up to be exposed to the coronavirus.
But scientific research has shown that some people truly are extreme altruists, who perform impressively noble acts out of a genuine desire to help others. Neuroscientists like Abigail Marsh have shown that extreme altruists may actually have neurological differences that make them predisposed to such extraordinary behavior; theyve got larger amygdalae, for one thing.
Steven Pinker and Peter Singer have argued that this is a more widespread phenomenon than we might think, one not limited to people who are biologically predisposed to extreme altruism. They contend that people everywhere seem to be becoming more altruistic overall. As societies become wealthier and the world globalizes, were expanding our circle of moral concern to include distant strangers. Hence the line in the open letter asserting that a large, and likely growing, fraction of the general population is willing to undergo meaningful risks to benefit others.
Sign up for the Future Perfect newsletter. Twice a week, youll get a roundup of ideas and solutions for tackling our biggest challenges: improving public health, decreasing human and animal suffering, easing catastrophic risks, and to put it simply getting better at doing good.
Will you help keep Vox free for all?
Millions of people rely on Vox to understand how the policy decisions made in Washington, from health care to unemployment to housing, could impact their lives. Our work is well-sourced, research-driven, and in-depth. And that kind of work takes resources. Even after the economy recovers, advertising alone will never be enough to support it. If you have already made a contribution to Vox, thank you. If you havent, help us keep our journalism free for everyone by making a financial contribution today, from as little as $3.
If daring volunteers get their way, they will soon become infected with Covid-19 on purpose.
Theyre young. Theyre healthy. And they want scientists to give them a candidate vaccine and then deliberately expose them to the coronavirus, so we can all find out faster whether the vaccine is effective.
This is called a human challenge trial, and its controversial for obvious reasons: The volunteers might get sick or even die. But proponents argue that it would speed up vaccine development, and even if it gets us to a successful vaccine just a bit faster, that could still mean many thousands of lives saved.
You may have heard the recent good news on the vaccine front: Pfizer says its vaccine is 90 percent effective and Moderna says its vaccine is nearly 95 percent effective. Those vaccines were developed via conventional clinical trials, not human challenge trials.
Heres the difference: A conventional trial vaccinates people and then waits months to see if they get infected anyway while they go about their normal lives. A challenge trial eliminates the whole wait-and-see period by vaccinating people, exposing them to the virus on the spot, and seeing how well the vaccine protects them. Results come in extremely fast, and theyre reliably instructive because scientists can control all the conditions. They know exactly who was exposed, how big a dose of virus they were exposed to, and how their immune system responded day by day.
A human challenge trial is set to begin in London in January, assuming it gets final ethics and regulatory approval. Scientists have run such trials in the past for influenza, malaria, typhoid, dengue, and cholera, but this will be the first for Covid-19. A company called Open Orphan and its subsidiary hVIVO will run the study. Only healthy volunteers aged 18 to 30 will be allowed to participate. The challenge trial is not meant to replace conventional clinical trials the different types of trials will proceed along parallel tracks.
Many young people are clamoring to participate in a challenge trial. The advocacy group 1DaySooner has gathered the names of nearly 39,000 people in 166 countries who say theyd be interested in volunteering.
In July, the group sent an open letter to Francis Collins, the head of the National Institutes of Health (NIH), calling for human challenge trials in the US. The letter was signed by more than 30 Nobel laureates and many prominent philosophers and psychologists, including Peter Singer, Steven Pinker, and Rebecca Goldstein. They wrote: If challenge trials can safely and effectively speed the vaccine development process, there is a formidable presumption in favor of their use, which would require a very compelling ethical justification to overcome.
So far, the US has not given the green light to such a trial, although the National Institute of Allergy and Infectious Diseases is paying for the preparation of the viral strains that would be needed if a trial gets the go-ahead. In Belgium, the government has dedicated $23.6 million to facilities to host such trials, which may include Covid-19.
The UK trial will begin with an initial phase that isnt about testing vaccines at all; its about answering a preliminary question that lays the groundwork for testing vaccines later. The question is: How much of the virus does someone need to be exposed to in order to launch an infection?
Starting in January, scientists will expose a small group of unvaccinated volunteers (somewhere between 50 and 90 people) to a very low dose of the virus, gradually increasing it until they find the Goldilocks dose enough to infect most participants, but not enough to make them very ill. All participants will be dosed with the virus, as there is no control group, and all will be paid for their time. Theyll be sequestered in a quarantine facility for over two weeks so as to avoid infecting anyone else, and so that doctors can monitor them 24/7 and give them immediate medical care including the antiviral drug remdesivir as soon as they show signs of sickness.
Only after this initial phase concludes in the spring would the company (if it gets approval) actually inject volunteers with candidate vaccines to study their effectiveness. At that point, there would be a control group. Half the volunteers will get a vaccine, half will get a placebo vaccine, and all of them will be exposed to the virus, explained Andrew Catchpole, the chief scientific officer at Open Orphan, whos conducting the study.
But there is no reliable cure for Covid-19. So under these conditions, some say its unethical to infect healthy people with a virus that can cause death or long-term disability. Lets break down the issues at stake to understand if and how a human challenge trial for a Covid-19 vaccine can be done ethically.
One of philosophys most famous thought experiments is known as the Trolley Problem. It poses this dilemma: Should you make the active choice to divert a runaway trolley so that it kills one person if, by doing so, you can save five people along a different track from getting killed?
Consequentialists or utilitarians typically say yes, because youre maximizing overall good and consequences are what matter. Deontologists (also known as Kantians) typically say no, because you have a duty to not kill anyone as a means to an end and your duties are what matter.
A challenge trial is a little bit like a Trolley Problem. Were talking about potentially sacrificing a few healthy volunteers in order to save many thousands of other peoples lives. Again, the utilitarian would say we should go ahead with the trial because of its vast potential for good. But the deontologist may argue that we have a duty not to infect a healthy person with a life-threatening disease for which we have no cure.
Theres a crucial difference, however: The people getting run over in the Trolley Problem arent consenting to their fate. The volunteers in a challenge trial are.
Or are they?
Im not convinced that we can actually obtain informed consent from people given that were still seeing the emerging effects of long Covid, said Angela Rasmussen, a virologist at Columbia University. She was referring to the fact that, for at least 10 percent of people who contract Covid-19, some of the diseases poorly understood effects ranging from brain fog to lung scarring to heart conditions can last for months. Scientists dont yet have a clear understanding of the risk factors for long-term Covid-19, nor can they predict its duration.
Some argue this isnt a problem: The researchers running a human challenge trial can just inform the volunteers that a lot of uncertainty remains about Covid-19, and that they might be signing up for long-term disability. The volunteers can consent to the uncertainty.
Rasmussen is not convinced. People are going to dismiss that, she told me. I dont think its possible to convey the seriousness by just saying its uncertain. Her conviction stems from personal experience: In 2014, she was on an NIH panel on chronic fatigue syndrome. Shed read the facts about the condition, but said she didnt fully internalize on a gut level the quality of the suffering it brought to peoples lives until she actually met people who had the condition.
Being physically unable to get out of bed and having doctors not believe you and having to completely change your life its not the kind of thing you necessarily can understand by reading an informed consent document, Rasmussen said.
Similarly, volunteers in a human challenge trial, who will be young people without experience of persistent illness, might not understand on an emotional level what it means to put themselves at risk of long-term effects from Covid-19. Data from previous studies suggest there is a gap between understanding health risk on an intellectual level and appreciating it emotionally.
Nevertheless, the philosopher and MacArthur genius grant winner Rebecca Goldstein said signing onto 1DaySooners letter in support of challenge trials was almost a no-brainer for her.
I have more faith both in peoples ability to understand the consequences of things, and in some peoples incredible sense of responsibility to others, she told me. Maybe its hard to imagine that there really are altruistic people, and we think, Oh, they just dont understand that harm could come to them. But I do believe there are such people.
Her conviction also stems from personal experience namely, her Jewish familys experience during World War II. I only exist because some of my Hungarian forebears were hidden by people who risked! They knew exactly what was going to happen to them if they got caught. And they did it anyway. To me, this is the same kind of thing.
Goldstein also argued that Rasmussens type of reasoning would have consequences we just couldnt live with as a society. We allow people to volunteer for the army, to become policemen, to become firefighters, she said. How is that any different? Theyre young and they feel invulnerable. Nevertheless, we need them.
Theres another complicating factor here: money. If volunteers are offered payment for participating, there might be a problematic incentive for low-income people to take part in a trial that could harm their health, which is arguably exploitative.
Volunteers in the UK trial will be paid, though exactly how much remains unclear; an ethical review board will decide how they should be compensated. Typically, though, Open Orphan pays people around $5,000 to participate in a challenge trial, which entails over two weeks in quarantine, plus coming in for follow-up visits for up to a year.
At a time when theres skyrocketing unemployment, its going to be attractive to some people to make a few thousand dollars by agreeing to be in a study like that, Rasmussen said.
Goldstein shares this concern. Im a little nervous about that, to tell you the truth, she said. It seems to me that muddies the incentive.
But Seema Shah, a bioethicist at Lurie Childrens Hospital of Chicago and Northwestern University, said we should think about the flip side. If people arent compensated for their time, then they are being exploited. Theyre being asked to subsidize the research. That doesnt seem fair.
She suggested the solution would be to reimburse participants for travel to and from the trial site and compensate them for their time. Specifically, they should be paid wages equivalent to what theyd earn for doing any other sort of unskilled labor. In addition, they should receive free medical care, including for any long-term effects that may result from participating in the study.
This is in line with the wage-payment model outlined years ago by nurse-bioethicist Christine Grady. More recently, bioethicists have authored a report explaining how reimbursement and compensation could be ethically paid out in the case of Covid-19 challenge studies in particular.
That report notes that undue inducement does not seem to be a significant problem based on available evidence. Broadly speaking, that is the impression that emerges from interviews with would-be volunteers. Many of them seem to be motivated not by financial need, but by altruism.
The words of Danica Marcos, a 22-year-old prospective volunteer, are emblematic of their rationale. So many people are struggling right now, and I want this pandemic to be over, she told the Associated Press. Every day that goes on, more cases are going on, more people are dying. And if this vaccine trial could mean that this period of trauma for the whole world will be over sooner, I want to help. I want to be a part of that.
For his part, Catchpole said hes been quite staggered by the numbers of young people wanting to volunteer. We had over 40,000 applications within a week. They pretty much crashed our website and our phones. And were seeing a high percentage very openly stating those altruistic reasons to do their bit.
Initially, proponents advocated for challenge trials on the grounds that theyd help us discover a Covid-19 vaccine faster. But it now looks like a challenge trial wont start its initial phase until January, and wont begin actually testing vaccines until the spring. That doesnt really save us time.
By January, we may already have an Emergency Use Authorization for a vaccine thats gone through clinical trials, like the Pfizer or Moderna vaccine. The reason these trials have been able to get results quickly is that many countries have totally failed to get Covid-19 under control. As the virus has ripped through populations, its infected enough people in Pfizer and Modernas samples that the scientists were able to get the data they needed.
So the case for a challenge trial has changed. Even though it might not get us to the first vaccine faster, advocates say, it could accelerate the development of better second-generation vaccines. After all, the first vaccine is rarely the best, and its likely a few different vaccines will come on the market in the next few years.
To me the question is, is the risk of doing a trial like this sufficiently low and justified by the value? said Shah, the bioethicist. And I think were sort of at a point where were pushing the bounds of whats been accepted in other kinds of research.
On the one hand, the value of getting us to a second-generation vaccine faster is significant. Generally, in order to bring down the cost of any drug or intervention, you need at least four other versions of it available on the market. If you think about trying to get the vaccine to countries that will have great need but wont be able to pay huge amounts of money, you can imagine theres really a need to develop cheaper vaccines for them, she said.
Whats more, a challenge trial could offer scientists valuable information about the pathogenesis of the disease, say, or about the immune responses that vaccinated people mount when exposed to the virus.
Rasmussen, the virologist, acknowledges that could be useful intel, but says its not urgently needed; a challenge trial can wait until we have a vaccine that we know is effective from a regular clinical trial, and better rescue therapies.
In the meantime, Rasmussen argued, the lack of diversity in a challenge trial will limit its scientific utility. A challenge trial is going to have to be done in young healthy people, and thats fine, but that isnt really going to tell us how the vaccine works in people who need it the most elderly people, immunocompromised people, and people with underlying medical conditions.
That said, its not like such a trial would tell us nothing thats of use to these vulnerable populations. If we have a vaccine that works in young healthy people, it may not work as well in the elderly, because their immune systems dont work as well but chances are itll still be effective to some degree.
Whats more, Catchpole said, Its as important to kill a vaccine thats not got any chance as it is to promote one that does. If we can use the challenge model in the younger population to see which vaccine doesnt have efficacy, we can get a very quick read and prioritize the next candidate vaccine.
So where does that leave us? Shah said that at this point, its not clear to her that the value of Covid-19 challenge trials quite justifies the risks. Im glad Im not the one who has to make the call, honestly, because I think its still a very close question whether theyre justified. Theres room for reasonable people to disagree.
Running through this whole debate is a fundamental question about human nature: Is true altruism possible?
Some people are highly skeptical that it is, and the open letter released by 1DaySooner this summer contains a fascinating paragraph betraying an awareness of that: Decades of psychological research on highly altruistic behaviors has demonstrated that a large, and likely growing, fraction of the general population is willing to undergo meaningful risks to benefit others due to genuinely altruistic motivation rather than insensitivity to risk, psychopathology, or other ethically concerning motives.
We can infer the implicit concern that people may be suspicious of someone who volunteers to get Covid-19 that they may assume any such volunteer must be irrational or incapable of understanding the risks.
This concern about altruism isnt new. A long line of philosophers and economists have expressed or observed suspicion toward altruists who are willing to incur a major cost to themselves in order to help perfect strangers.
We can see this, for example, in the 1982 paper Moral Saints by Susan Wolf. The philosopher observes that we dont tend to like extreme altruists (she uses the phrases a moral fanatic and a disgusting goody good) and says, there seems to be a limit to how much morality we can stand.
In more recent years, the Stanford psychologist Benoit Monin has demonstrated an effect called do-gooder derogation. Hes shown that we feel less warm toward people who are extremely altruistic. That may be because they make us feel moral conflict about our own behaviors.
And neuroscientist Molly Crockett at Yale has conducted studies to determine whether people prefer consequentialists or deontologists. To get at that, she showed subjects the classic Trolley Problem and the different ways of responding to it. She found that when people are looking for a friend or spouse, they strongly prefer deontologists, viewing them as more moral and trustworthy. People are suspicious of consequentialists. Its possible that that same suspicion is now being extended to extreme altruists signing up to be exposed to the coronavirus.
But scientific research has shown that some people truly are extreme altruists, who perform impressively noble acts out of a genuine desire to help others. Neuroscientists like Abigail Marsh have shown that extreme altruists may actually have neurological differences that make them predisposed to such extraordinary behavior; theyve got larger amygdalae, for one thing.
Steven Pinker and Peter Singer have argued that this is a more widespread phenomenon than we might think, one not limited to people who are biologically predisposed to extreme altruism. They contend that people everywhere seem to be becoming more altruistic overall. As societies become wealthier and the world globalizes, were expanding our circle of moral concern to include distant strangers. Hence the line in the open letter asserting that a large, and likely growing, fraction of the general population is willing to undergo meaningful risks to benefit others.
Sign up for the Future Perfect newsletter. Twice a week, youll get a roundup of ideas and solutions for tackling our biggest challenges: improving public health, decreasing human and animal suffering, easing catastrophic risks, and to put it simply getting better at doing good.
Will you help keep Vox free for all?
Millions of people rely on Vox to understand how the policy decisions made in Washington, from health care to unemployment to housing, could impact their lives. Our work is well-sourced, research-driven, and in-depth. And that kind of work takes resources. Even after the economy recovers, advertising alone will never be enough to support it. If you have already made a contribution to Vox, thank you. If you havent, help us keep our journalism free for everyone by making a financial contribution today, from as little as $3.
With the pandemic cutting an ever-broadening swath through the country, Modernas announcement that preliminary data indicate its COVID-19 vaccine was 95% effective offered Americans a much-needed shot of hope.
It was the second time in as many weeks that independent safety monitors had examined clinical trial data and determined that an experimental vaccine was performing above expectations. Last week Pfizer, in collaboration with its German partner BioNTech, said its vaccine was 90% effective in preventing symptoms of the disease.
The light at the end of the tunnel is getting a little brighter, said Dr. William Schaffner, an infectious disease and preventive medicine expert at Vanderbilt University.
The news comes as multiple states issued new lockdown orders in an effort to stop a third wave of coronavirus infections. More than a million new cases were recorded last week alone, and more than 1,100 Americans are dying each day.
Pfizer and Moderna have yet to release detailed data from this final stage of clinical trials, and the results may change by the time theyre complete. But many experts are optimistic that initial distribution of these vaccines could begin by years end.
The results from Pfizer, and now Moderna, gives me a great deal of encouragement, said Dr. Buddy Creech, director of the vaccine research program at Vanderbilt University Medical Center. The effectiveness levels are beyond our expectations, giving us firm hope that we will see an end to the pandemic once widespread vaccination is possible.
Heres a closer look at where things stand with these front-running vaccines.
The clinical trials are measuring how good experimental vaccines are at reducing a persons risk of becoming infected with the coronavirus that causes COVID-19.
To do this, researchers recruited volunteers who were given two doses of either the vaccine or a placebo without knowing which was which. Then they were encouraged to continue everyday activities.
The trials were designed for an assessment to be made after a pre-specified number of volunteers came down with COVID-19. The Moderna trial, for instance, enrolled 30,000 participants and planned to stop after 151 cases were recorded. So far, 95 individuals have become sick, which was enough for the data monitoring board to provide an early assessment of the vaccines efficacy. Participants will continue to be evaluated to see how the vaccine performs over time.
The conclusion was that after three months of exposure in typical communities around the country, about 29,900 individuals in the Moderna trial remained symptom free. Of the 95 who became ill with COVID-19, 90 were in the placebo group, and five had received the vaccine.
This information allowed the review board to conclude that the vaccine had 94.5% effectiveness. The data are still being evaluated to determine why 5% of those inoculated with the vaccine got ill.
The numbers are similar to the Pfizer trial, which enrolled 44,000 people. However, unlike Moderna, Pfizer did not provide information about disease severity among participants.
The stunning and hopeful news is that the vaccine had an important and positive effect in reducing getting sick, said Dr. Larry Steinman, professor of pediatrics and neurological sciences at Stanford University who was chair of the immunology department program for 10 years.
Researchers need something to compare their vaccine against so they can assess whether its better or worse than doing nothing. In this case, the placebo is merely a saline solution.
But its not only the participants who are kept in the dark about whether they got the experimental treatment or the placebo. The researchers who examine the participants are blinded as well. That way, when they assess a volunteers health, they arent influenced by the knowledge that he or she got or didnt get the experimental vaccine.
Placebo-controlled trials are the best way to take bias out of the equation, said Vanderbilts Creech. They allow us to see how well a vaccine works. By randomizing and by staying blinded as to what a volunteer received, we are able to more fairly judge whether the vaccine works.
The study design also helps researchers identify side effects caused by the vaccine. For instance, if those who received the placebo complained of sore arms as much as those who got the vaccine, it would be reasonable to conclude that the soreness is the result of the needle and not necessarily due to the vaccines active ingredients.
More time is needed for more study participants to become sick. The more cases there are, the more certain researchers can be about saying the outcomes for the two groups of volunteers are different and that the vaccine performed better than the placebo.
Some side effects may take awhile to develop as well, and the trial has to last long enough to give them a chance to crop up.
In general, clinical trials may be stopped ahead of schedule if the early data make it obvious that an experimental medication is completely ineffective, or when the results are so favorable that it is no longer ethically responsible to deny it to those who got the placebo.
Theyve all been minimal. Some participants have reported a sore arm for a day or two. Some complained of headaches and fatigue, as well as general muscle aches and pain. None of these is considered a severe adverse reaction.
Even trials of this size might not be able to detect very rare adverse events, which is why even after a vaccine is approved, monitoring systems continue to look for these rare events in the broader population.
These clinical trials were designed as two-year studies, so its not clear when the final results will be available.
But final results are not necessary for the Food and Drug Administration, which is tasked with vetting new medications for public use, to decide whether to grant any COVID-19 vaccine an Emergency Use Authorization and allow it to be made available to the public. If such an authorization is given, then vaccines could start to be distributed by December.
Vaccines being developed by AstraZeneca and Johnson & Johnson are also considered viable contenders.
Both are in the late-stage clinical trials, with enrollment continuing around the world. These vaccines are made slightly differently from the ones from Pfizer and Moderna, but because they target the same protein on the surface of the virus, we have a lot of confidence that they may enjoy similar efficacy, Creech said.
If the FDA issues an Emergency Use Authorization, the Centers for Disease Control and Prevention will be in charge of overseeing the vaccines distribution to the public. States will develop their own plans as well. While theres still a lot of uncertainty, its already clear that there wont be enough vaccines to go around at first.
Early prioritization schemes put healthcare workers at the front of the line. Theyll be joined by older individuals and those with underlying medical conditions, because people in these groups are more likely to become severely ill if they are infected.
Both Pfizer and Moderna have publicly reported that they will have about 20 million doses by the end of the year, but experts believe it will take until late spring or early summer to produce enough vaccine to immunize a majority of U.S. residents.
But experts say that public health protocols such as wearing masks and maintaining social distance must remain in place for months or even years after vaccines first become available.
What remains to be answered is whether these vaccines will keep people from getting infected. As promising as these trials are, it is not known if the vaccine will stop the spread of the virus.
With the pandemic cutting an ever-broadening swath through the country, Modernas announcement that preliminary data indicate its COVID-19 vaccine was 95% effective offered Americans a much-needed shot of hope.
It was the second time in as many weeks that independent safety monitors had examined clinical trial data and determined that an experimental vaccine was performing above expectations. Last week Pfizer, in collaboration with its German partner BioNTech, said its vaccine was 90% effective in preventing symptoms of the disease.
The light at the end of the tunnel is getting a little brighter, said Dr. William Schaffner, an infectious disease and preventive medicine expert at Vanderbilt University.
The news comes as multiple states issued new lockdown orders in an effort to stop a third wave of coronavirus infections. More than a million new cases were recorded last week alone, and more than 1,100 Americans are dying each day.
Pfizer and Moderna have yet to release detailed data from this final stage of clinical trials, and the results may change by the time theyre complete. But many experts are optimistic that initial distribution of these vaccines could begin by years end.
The results from Pfizer, and now Moderna, gives me a great deal of encouragement, said Dr. Buddy Creech, director of the vaccine research program at Vanderbilt University Medical Center. The effectiveness levels are beyond our expectations, giving us firm hope that we will see an end to the pandemic once widespread vaccination is possible.
Heres a closer look at where things stand with these front-running vaccines.
The clinical trials are measuring how good experimental vaccines are at reducing a persons risk of becoming infected with the coronavirus that causes COVID-19.
To do this, researchers recruited volunteers who were given two doses of either the vaccine or a placebo without knowing which was which. Then they were encouraged to continue everyday activities.
The trials were designed for an assessment to be made after a pre-specified number of volunteers came down with COVID-19. The Moderna trial, for instance, enrolled 30,000 participants and planned to stop after 151 cases were recorded. So far, 95 individuals have become sick, which was enough for the data monitoring board to provide an early assessment of the vaccines efficacy. Participants will continue to be evaluated to see how the vaccine performs over time.
The conclusion was that after three months of exposure in typical communities around the country, about 29,900 individuals in the Moderna trial remained symptom free. Of the 95 who became ill with COVID-19, 90 were in the placebo group, and five had received the vaccine.
This information allowed the review board to conclude that the vaccine had 94.5% effectiveness. The data are still being evaluated to determine why 5% of those inoculated with the vaccine got ill.
The numbers are similar to the Pfizer trial, which enrolled 44,000 people. However, unlike Moderna, Pfizer did not provide information about disease severity among participants.
The stunning and hopeful news is that the vaccine had an important and positive effect in reducing getting sick, said Dr. Larry Steinman, professor of pediatrics and neurological sciences at Stanford University who was chair of the immunology department program for 10 years.
Researchers need something to compare their vaccine against so they can assess whether its better or worse than doing nothing. In this case, the placebo is merely a saline solution.
But its not only the participants who are kept in the dark about whether they got the experimental treatment or the placebo. The researchers who examine the participants are blinded as well. That way, when they assess a volunteers health, they arent influenced by the knowledge that he or she got or didnt get the experimental vaccine.
Placebo-controlled trials are the best way to take bias out of the equation, said Vanderbilts Creech. They allow us to see how well a vaccine works. By randomizing and by staying blinded as to what a volunteer received, we are able to more fairly judge whether the vaccine works.
The study design also helps researchers identify side effects caused by the vaccine. For instance, if those who received the placebo complained of sore arms as much as those who got the vaccine, it would be reasonable to conclude that the soreness is the result of the needle and not necessarily due to the vaccines active ingredients.
More time is needed for more study participants to become sick. The more cases there are, the more certain researchers can be about saying the outcomes for the two groups of volunteers are different and that the vaccine performed better than the placebo.
Some side effects may take awhile to develop as well, and the trial has to last long enough to give them a chance to crop up.
In general, clinical trials may be stopped ahead of schedule if the early data make it obvious that an experimental medication is completely ineffective, or when the results are so favorable that it is no longer ethically responsible to deny it to those who got the placebo.
Theyve all been minimal. Some participants have reported a sore arm for a day or two. Some complained of headaches and fatigue, as well as general muscle aches and pain. None of these is considered a severe adverse reaction.
Even trials of this size might not be able to detect very rare adverse events, which is why even after a vaccine is approved, monitoring systems continue to look for these rare events in the broader population.
These clinical trials were designed as two-year studies, so its not clear when the final results will be available.
But final results are not necessary for the Food and Drug Administration, which is tasked with vetting new medications for public use, to decide whether to grant any COVID-19 vaccine an Emergency Use Authorization and allow it to be made available to the public. If such an authorization is given, then vaccines could start to be distributed by December.
Vaccines being developed by AstraZeneca and Johnson & Johnson are also considered viable contenders.
Both are in the late-stage clinical trials, with enrollment continuing around the world. These vaccines are made slightly differently from the ones from Pfizer and Moderna, but because they target the same protein on the surface of the virus, we have a lot of confidence that they may enjoy similar efficacy, Creech said.
If the FDA issues an Emergency Use Authorization, the Centers for Disease Control and Prevention will be in charge of overseeing the vaccines distribution to the public. States will develop their own plans as well. While theres still a lot of uncertainty, its already clear that there wont be enough vaccines to go around at first.
Early prioritization schemes put healthcare workers at the front of the line. Theyll be joined by older individuals and those with underlying medical conditions, because people in these groups are more likely to become severely ill if they are infected.
Both Pfizer and Moderna have publicly reported that they will have about 20 million doses by the end of the year, but experts believe it will take until late spring or early summer to produce enough vaccine to immunize a majority of U.S. residents.
But experts say that public health protocols such as wearing masks and maintaining social distance must remain in place for months or even years after vaccines first become available.
What remains to be answered is whether these vaccines will keep people from getting infected. As promising as these trials are, it is not known if the vaccine will stop the spread of the virus.
Many are worried about side-effects, and that clinical trials have been conducted too quickly
Nov 17th 2020
AFTER MONTHS of dark headlines about the coronavirus pandemic, at last there is hope on the horizon. Last week Pfizer and BioNTech, two pharmaceutical firms, unveiled early data showing that their experimental vaccine is 90% effective in preventing covid-19. On November 16th Moderna, another pharma company, reported that its jab is nearly 95% effective. Financial markets cheered: on both days the S&P 500, Americas main stockmarket index, set record highs. More vaccines are probably on the way.
But there are still hurdles to overcome. Both vaccines must undergo further testing. Vaccines have to be manufactured in huge quantities and distributed effectively. And people must be willing to have the jabs. This may prove surprisingly problematic. According to a recent poll by Ipsos-MORI, less than three-quarters of adults say they are keen to get vaccinated for covid-19. The poll, which was conducted between October 8th and October 13th, asked 18,000 adults in 15 countries whether they would get a vaccine. Just 73% said they would, down from 77% in August. Only in three countriesMexico, Germany, and South Africawere people more eager to get vaccinated in October than they had been two months earlier. France remained the most reluctant country overall (see chart).
Why the hesitation? The most commonly cited reason was worry about side effects (34%), followed by concerns that clinical trials had moved too quickly (33%). Around one in ten respondents said they are against vaccines altogether. But such anti-vax sentiment is not common. Respondents were more likely to say they would get the vaccine, but not right away. Indeed just 52% said they would accept one within the first three months of its availability; 12% said they would wait at least a year to get inoculated. Some demographic groups are especially suspicious: those with less education in Australia; those on lower incomes in France; and the unemployed and African-Americans in the United States.
Such scepticism could prolong the pandemic, and it is worrying that it appeared to be mounting in the autumnperhaps because of suspicions that vaccines were being rushed through. Public-health authorities will hope that this weeks news might reverse that trend. Most models suggest that, even if the vaccines under development prove highly effective at preventing covid-19, at least two-thirds of the population will have to be vaccinated to quash future outbreaks. Failure to address the publics fears soon could disrupt even the best-laid plans.
Cambridge-based Moderna said its coronavirus vaccine is more than 94% effective in preventing COVID-19, according to preliminary phase three trial data, something CEO Stephane Bancel called a game changer. But once a vaccine is approved, how will it be distributed in Massachusetts, and will people get it?
As pharmaceutical companies across the world race against the clock to find ways to prevent the virus, which in the Bay State alone has spread to more than 184,500 people, killing more than 10,100, according to the state's Department of Public Health, finding an effective vaccine for COVID-19 may end up being the easy part. Getting the vaccinations distributed could prove to be more of a challenge.
Im going to get it as soon as I can cause I want to get out and live my life, one woman in Newton Center said of a coronavirus vaccine.
While COVID-19 vaccines look to be highly effective, not everyone is convinced.
Im not sure yet. But if my doctor approves it, than Id be willing to take it, one woman in Nubian Square said.
With help from the Centers for Disease Control and Prevention, Massachusetts has been working on distribution plans since August. Vaccines will be administered in three phases, using existing healthcare providers and pharmacies at about 4,000 locations across the commonwealth.
Moderna said preliminary phase three trial data shows its coronavirus vaccine is more than 94% effective in preventing COVID-19.
Its going to be tough at the beginning but by the end of the spring if not well before then, in the end of the first quarter, this should be running smoothly, said Barry Bloom, former dean of Harvards T.H. Chan School of Public Health.
The first phase will make shots available to the most vulnerable populations as well as health care and other essential workers.
The state already vaccinates about 3 million people every year, so there are systems in place to help with the distribution of COVID-19 vaccines.
Not everyone believes in vaccines, and experts say so-called vaccination hesitancy could make getting the virus under control more difficult.
I dont trust it, said another woman. I dont even like the flu shot. But I just dont trust it. Its as simple as that.
I have a lot more confidence that we know how to fix a logistical supply chain problem than we do to change peoples attitudes for the safety and efficacy of vaccines, Bloom said.
Another logistical hurdle the state still needs to overcome: how to store one of the vaccines at extremely cold temperatures before its used.
