With Covid-19 cases again climbing, health tech companies and researchers are renewing their pitch for wearables and apps as a cutting-edge way to catch new cases and detect when patients are growing sicker.
The flood of tech tools and the marketing machinery playing up their potential promises to give users more timely information and fill key gaps in testing and tracing cases. But it is not altogether certain that these devices will benefit patients. Its not just a basic question of whether a device or algorithm is accurate, health technology experts say, but whether the information provided is actually helpful in delivering better care or stemming the spread of the virus.
It is easy to take an off-the-shelf monitoring device, slap a Covid-19 label on it, and tell the world the device can be used to help lift us out of a public health crisis. It is far more difficult to ensure the product can home in on the unique signature of this virus and improve outcomes for patients, especially when it affects people so differently.
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I can tell you for a given system, it may be 80% accurate. But for me to show you it made someones care better is actually much harder to accomplish, said Karandeep Singh, a physician and professor at the University of Michigan who studies the use of technology in health care.
But in certain clinical settings and populations, apps and wearables might be able to provide significant assistance during the pandemic, experts said. Here are a few questions to ask when trying to differentiate between empty promises and valuable tools.
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Plenty of apps designed to monitor vital signs can accurately detect a fever and changes in respiration, but thats not the same thing as correctly diagnosing Covid-19.
That kind of app is not going to be nearly specific enough, said Singh. Were heading into flu season. You cant tell apart flu from cold from anything else.
John A. Rogers, a biomedical engineer at Northwestern University, has spent months trying to tackle this problem with a wearable he developed for the universitys health system in Chicago. It is a Band-Aid-sized patch that attaches to the users throat to help monitor coughing and respiratory symptoms, such as shortness of breath.
One of the planned uses was to monitor signs of possible infection of frontline health care workers. So far, however, none of the health workers who have tested the device with Northwesterns health system has become sick. Its not clear whether none has contracted the virus, or whether some did but were asymptomatic, which points to a challenge facing any tech tool designed to track Covid-19 symptoms.
You have to have some type of symptoms in order for us to pick anything up, Rogers said. If youre completely asymptomatic were not going to be able to see it. This is not a molecular scale test.
Thats not to say it cant be helpful for other purposes. The wearable, which is experimental and has not been approved by regulators, is also being used to monitor symptoms in hospitalized patients. In one case, Rogers said, it flagged periods where a patient was experiencing a dangerous heart arrhythmia. It also picked up respiratory interruptions at night, helping providers spot signs of sleep apnea.
It turned out to be pretty severe and we could see it pretty clearly, Rogers said.
He said the impact of the wearable is still being evaluated and that his partners at the Shirley Ryan Ability Lab are seeking to develop an AI model that would use the data to help predict infections from symptom data.
A major shortcoming of most wearables is that they are deployed in populations with very low risk of developing the problem they are designed to detect. The Apple Watch, for example, is often used by young, healthy people unlikely to benefit from its ability to detect the heart arrhythmia known as atrial fibrillation.
In Covid-19, that means many symptom tracking apps meant to flag the onset of illness in broad populations are likely to flag perceived problems that dont amount to much. This results in a low positive predictive value, or the probability that a subject who tests positive truly has the illness.
Its going to be crying wolf a lot, Singh said. He said thats a significant drawback in a health care system trying to contend with a pandemic.
With any of these apps, if you identify a problem, usually that problem results in a connection to the health care system, which has a time and a cost value to it. We dont have unlimited resources, he added.
However, the problem of false positives is mitigated in higher-risk populations, such as people who live in nursing homes or whose immune systems are compromised. In those defined user groups, it is helpful to provide caregivers with alerts about sudden changes in vital signs or a fever, because those are more likely to be associated with medical emergencies.
Apps and wearables can collect massive amounts of biological data from patients. But that doesnt mean the information is going to be helpful to doctors who are trying to treat them.
A Covid-19 symptom tracker developed earlier this year by researchers at Kings College London, Harvard University and Stanford compiled symptoms reported by more than 2.6 million people, such as fever, cough, shortness of breath, and loss of taste and smell.
While the researchers are hopeful that the smartphone app can help inform individuals of their risks, and potentially flag infection hot spots, they are not arguing that it would significantly improve the care of infected patients.
Thats because its not clear that providing that information, through this app or another, will help doctors triage patients or change the way they are treating them.
Thats something that remains to be seen, said Andrew Chan, a Harvard professor who helped develop the app. Theres a lot of hope this approach could be used in the setting of Covid because it is so highly infectious and there is a need to keep distance between patients and providers.
But so far, there is no evidence that apps or wearables used to collect biological information on Covid-19 patients is improving their care. Singh said proving a positive effect on care is likely to take years, even in the case of products that have demonstrated an ability to accurately measure changes in symptoms and predict a patients deterioration.
This is all experimental, he said. Studying the impact of a technology like this takes a ton more time than studying the validity of a technology.
HONOLULU (KHON2) -- On Tuesday, The Hawaii Tourism Authority (HTA) reported that 3,029 people arrived in Hawaii. The states mandatory 14-day self-quarantine started on March 26 for all passengers arriving in Hawaii from out of state.
Most of those coming into the state on Tuesday included a total of 979 returning residents. There were 922 visitors. The remaining 1,228 were crew members, military, transit, those who are relocating to the state, and those exempt from the quarantine order.
A U.S. Border Patrol vehicle is stationed in front of the U.S.-Mexico border barrier as construction continues in hard-hit Imperial County on July 22, in Calexico, Calif. Mario Tama/Getty Images hide caption
A U.S. Border Patrol vehicle is stationed in front of the U.S.-Mexico border barrier as construction continues in hard-hit Imperial County on July 22, in Calexico, Calif.
Most Americans support Trump administration efforts to stop immigrants from coming to the United States as long as it's done in the name of slowing the spread of the coronavirus, according to a new NPR/Ipsos poll.
But Trump's anti-immigration rhetoric during the pandemic has done little to budge public opinion on other immigration policies, the poll found. Most of Trump's policies, including his border wall, remain unpopular except among Republicans.
"Americans do want to take steps to limit immigration right now," said pollster Mallory Newall. "But that's not because their views on immigration have changed. It's because they want to do everything in their power to contain the spread of COVID-19."
Meanwhile, immigration is no longer a top concern ahead of the November election. The poll shows it has been eclipsed by the coronavirus, racial justice, unemployment, political extremism and a range of other pressing issues.
The poll was conducted July 30-31 and surveyed 1,115 adults from the continental U.S., Alaska and Hawaii.
The poll found broad support for a single, national strategy to address the pandemic and for more aggressive measures to contain it. Two-thirds of respondents said they believe the U.S. is handling the pandemic worse than other countries, and most favor more aggressive action, including a nationwide order making it mandatory to shelter at home for two weeks.
Since March, Trump has taken broad actions to curtail legal immigration during the pandemic, imposing new limits on green cards and visas for guest workers, and turning away asylum seekers at the southern border. The administration also closed the southern and northern borders to all but "essential" travel.
There is sizable bipartisan support 85% of Republicans and 75% of Democrats for temporarily shutting down the borders. And more than half overall support limits on legal immigrants, though that is largely driven by Republicans.
"I feel like we need to take care of America first," Tammy Bunce, a Republican respondent from Queen Creek, Ariz. "We should be staying at home, and I think other countries should not be coming in until we have the coronavirus especially under control."
Another respondent, Robert Torres of San Leandro, Calif., is a third-generation immigrant from Mexico who identifies as politically independent. He said: "Right now is not a very good time to be immigrating."
That's partly because of the pandemic, Torres says, but also because "there's a lot of undocumented here that should be documented before we start adding to the immigration."
President Trump has made his immigration crackdown a signature policy and key to his argument for reelection.
From the outset of the pandemic, Trump has blamed foreigners for bringing coronavirus to the United States, calling it the "China virus" and "kung flu." He's also returned to a familiar refrain about protecting American jobs as justification for the latest immigration restrictions, pointing to the battered economy.
But Americans remain divided on immigration policy when it's not tied to stopping the spread of the virus.
"I get right now that we got this pandemic going on, that's fine," said Jo Lee of Houston, Texas, in a follow-up interview. "But once this calms down, if somebody really wants to come over here and raise their family and be a citizen, let them do that. I don't have a problem with that," said Lee, who says she often votes for Democrats.
That divide was clear when poll respondents were asked about whether the federal government should provide stimulus relief checks to undocumented immigrants who pay U.S. taxes: 49% of respondents said yes, including 71% of Democrats; 43% said no, including 66% of Republicans.
The NPR/Ipsos poll found that underlying attitudes about immigration are deeply entrenched, remaining remarkably stable since a previous poll in 2018. For example, about 70% of respondents then and now say immigrants are an "important part of our American identity."
And efforts to build a border wall and limit immigration still fail to garner majority support, except among Republicans, according to the poll:
What has changed, according to the new poll, is how much weight Americans place on immigration as an issue.
Two years ago, one in four respondents cited immigration as one of their top concerns, and it ranked fourth behind health care, crime and terrorism. Now 46% of respondents say COVID-19 is a top concern, while immigration has fallen out of the top 10, with only 11% of respondents saying it's one of the topics they find "most worrying."
Immigration is no longer "a major factor when it comes to deciding who to vote for," Ipsos pollster Mallory Newall said.
"That's where we're sort of almost seeing bipartisan agreement," she said. "People may not have the same stance when it comes to how to deal with the virus, how to deal with immigration. But what they do know is that taking care of COVID, and addressing that and taking care of the economy, is priority number one, full stop."
NPR's Senior Producer Marisa Pealoza contributed to this report.
The West Virginia Department of Health andHuman Resources (DHHR) reports as of 10:00 a.m., on August 4,2020, there have been 298,290 total confirmatorylaboratory results received for COVID-19, with 7,051 totalcases and 124 deaths.
DHHR has confirmed the deaths of a70-year old male from Preston County, a 55-year old female from Taylor County,a 68-year old female from Kanawha County, a 73-year old male from Marshall County,a 92-year old male from Grant County, a 43-year old male from Mingo County, anda 91-year old male from Wood County. Eachdeath reported is a solemn reminder of the seriousness of this disease. We sendour deepest sympathy to these families, saidBill J. Crouch, DHHR Cabinet Secretary.
In alignment with updated definitions fromthe Centers for Disease Control and Prevention, the dashboard includes probablecases which are individuals that have symptoms and either serologic (antibody)or epidemiologic (e.g., a link to a confirmed case) evidence of disease, but noconfirmatory test.
CASESPER COUNTY (Case confirmed by lab test/Probable case):Barbour (29/0), Berkeley (637/24), Boone (88/0), Braxton (8/0), Brooke(60/1), Cabell (341/9), Calhoun (6/0), Clay (17/1), Doddridge (4/0), Fayette(131/0), Gilmer (16/0), Grant (80/1), Greenbrier (87/0), Hampshire (74/0),Hancock (100/4), Hardy (53/1), Harrison (198/1), Jackson (158/0), Jefferson(287/5), Kanawha (835/13), Lewis (26/1), Lincoln (68/1), Logan (157/0), Marion(174/4), Marshall (126/3), Mason (50/0), McDowell (45/1), Mercer (167/0),Mineral (112/2), Mingo (142/2), Monongalia (913/16), Monroe (18/1), Morgan(25/1), Nicholas (32/1), Ohio (259/1), Pendleton (40/1), Pleasants (7/1),Pocahontas (40/1), Preston (102/23), Putnam (173/1), Raleigh (191/7), Randolph(203/3), Ritchie (3/0), Roane (14/0), Summers (6/0), Taylor (52/1), Tucker(11/0), Tyler (12/0), Upshur (36/3), Wayne (189/2), Webster (3/0), Wetzel(40/0), Wirt (6/0), Wood (228/12), Wyoming (23/0).
As case surveillance continues at thelocal health department level, it may reveal that those tested in a certaincounty may not be a resident of that county, or even the state as an individualin question may have crossed the state border to be tested.Such is the case of Kanawha and Marion counties in this report.
Pleasenote that delays may be experienced with the reporting of information from thelocal health department to DHHR. Visitthe dashboard at www.coronavirus.wv.gov for more detailed information.
On July 24,2020, Gov. Jim Justice announced that DHHR, the agency in charge of reportingthe number of COVID-19 cases, will transition from providing twice-dailyupdates to one report every 24 hours. This became effective August 1, 2020.
Suriname is preparing to come out stronger from COVID-19. As the pandemic highlights the gaps in the countrys health system, the Government is acting quickly to drive its response, engaging partners, reaching remote communities through primary health care and building a strong foundation for universal health coverage.
About 90% of Surinames landmass is characterized as tropical rainforest. In the most remote villages reside indigenous communities who need access to effective primary health care. This is just one of the many challenges that Surinames health system faces. COVID-19 has further highlighted its small health workforce: just eight physicians and 23 nurses per 10,000 people, health infrastructure that is still being developed and limited emergency response capacity, among others.
Since the start of 2020, WHO, through theUHC Partnership, has expanded its support in strengthening Surinames health system with the goal of helping the country achieve universal health coverage. With funding from the European Union, the Grand Duchy of Luxembourg, Irish Aid, the Government of Japan, the French Ministry for Europe and Foreign Affairs, the UK Department for International Development and Belgium, the Partnership has been supporting work in four main areas: saving lives, protecting health care workers, slowing the spread of the virus and strengthening epidemic intelligence.
PAHO/WHO supported Suriname in advancing preparedness and response capacities. The Central Laboratory of the Bureau of Public Health/Bureau voor Openbare Gezondheidszorg (BOG) was provided reagents for molecular testing. Laboratory technologists were trained in conducting screening and confirmatory tests for COVID-19. This photo was taken in February 2020, before COVID-19 hit the country. (Credit: WHO/PAHO)
Surinames experience in preparing for COVID-19 and its urgent actions to keep its population safe has also brought a unique opportunity to chart a new path for public health in the country.
Looking forward, WHO will continue to support Suriname in building a resilient health system and to develop and maintain capacities to prevent, detect and respond to future outbreaks, epidemics and pandemics.
As a public service, Shaw Media will provide open access to information related to the COVID-19 (Coronavirus) emergency. Sign up for the newsletter here
An outbreak of COVID-19 has been identified at the Texas Roadhouse steakhouse in Crystal Lake, the McHenry County Department of Health said Wednesday in a news release.
Anyone who has worked or eaten at this Texas Roadhouse location between July 19 and August 4 and is experiencing symptoms consistent with COVID-19 is encouraged to get tested for the virus, according to the news release.
The restaurant, located near the intersection of Route 31 and Route 14, closed its doors voluntarily after multiple confirmed cases of COVID-19 were identified among patrons and staff, health department spokeswoman Lindsey Salvatelli said.
Restaurant staff are working alongside McHenry County Health Department officials to reopen once it is safe to do so, according to the release.
Texas Roadhouse, a Western-themed steakhouse, is part of a national chain with locations across the U.S.
Anyone who has come into close contact with an employee or recent patron of the Texas Roadhouse should also consider being tested, the news release stated. A list of local testing centers can be found on the McHenry County Health Department's website under "Access to Healthcare."
Close contact is defined as being within six feet of another person with the virus for at least 15 minutes starting from two days before the person begins experiencing symptoms, according to the health department.
The health department also encouraged anyone who thinks they may have been exposed to the virus and is experiencing COVID-19 symptoms to consult with their primary care physician.
Common symptoms of the novel coronavirus include: fever or chills, cough, shortness of breath, muscle or body aches, headaches, new loss of taste or smell, runny nose, nausea or vomiting, and diarrhea.
More severe symptoms include: trouble breathing, pain or pressure in the chest, confusion, inability to stay awake or bluish lips or face. Anyone displaying these types of symptoms should seek emergency care as soon as possible.
The West Virginia Department of Health andHuman Resources (DHHR) reports as of 10:00 a.m., on August 5,2020, there have been 302,443 total confirmatorylaboratory results received for COVID-19, with 7,159 totalcases and 124 deaths.
In alignment with updated definitions fromthe Centers for Disease Control and Prevention, the dashboard includes probablecases which are individuals that have symptoms and either serologic (antibody)or epidemiologic (e.g., a link to a confirmed case) evidence of disease, but noconfirmatory test.
CASESPER COUNTY (Case confirmed by lab test/Probable case):Barbour (30/0), Berkeley (643/27), Boone (92/0), Braxton (8/0), Brooke(60/1), Cabell (353/9), Calhoun (6/0), Clay (17/1), Doddridge (4/0), Fayette(134/0), Gilmer (16/0), Grant (88/1), Greenbrier (88/0), Hampshire (75/0),Hancock (102/4), Hardy (53/1), Harrison (203/1), Jackson (158/0), Jefferson(287/5), Kanawha (843/13), Lewis (27/1), Lincoln (75/0), Logan (162/0), Marion(175/4), Marshall (126/3), Mason (51/0), McDowell (47/1), Mercer (173/0),Mineral (114/2), Mingo (151/2), Monongalia (913/16), Monroe (18/1), Morgan(25/1), Nicholas (32/1), Ohio (262/1), Pendleton (41/1), Pleasants (8/1),Pocahontas (40/1), Preston (102/23), Putnam (173/1), Raleigh (200/7), Randolph(203/3), Ritchie (3/0), Roane (14/0), Summers (7/0), Taylor (54/1), Tucker(11/0), Tyler (12/0), Upshur (36/3), Wayne (192/2), Webster (3/0), Wetzel(40/0), Wirt (6/0), Wood (228/12), Wyoming (24/0).
As case surveillance continues at thelocal health department level, it may reveal that those tested in a certaincounty may not be a resident of that county, or even the state as an individualin question may have crossed the state border to be tested.
Pleasenote that delays may be experienced with the reporting of information from thelocal health department to DHHR. Visitthe dashboard at www.coronavirus.wv.gov for more detailed information.
On July 24,2020, Gov. Jim Justice announced that DHHR, the agency in charge of reportingthe number of COVID-19 cases, will transition from providing twice-dailyupdates to one report every 24 hours. This became effective August 1, 2020.
Findings based on samples taken from patient care areas
A new study has documented contamination of the environment and air near patients with COVID-19.
August 5, 2020
A study by University of Nebraska Medical Center researchers provides new evidence of infectious SARS-CoV-2 throughout the environment and in air samples collected in COVID-19 patient care areas. SARS-CoV-2 is the virus that causes COVID-19.
The scientists, funded by a U.S. National Science Foundation rapid response grant, published their results in Nature Scientific Reports.
During the initial isolation of 13 people confirmed positive with COVID-19, air and surface samples were collected in 11 isolation rooms to examine environmental contamination.
The researchers found viral contamination on all commonly used surfaces in the rooms, and very high levels of the virus in the air grates. Air samples from hallways outside patient rooms, where staff members were moving in and out, were also positive.
Evidence of the virus in the air and on many commonly used items, including bathroom facilities, indicates that SARS-CoV-2 is widely disseminated in the environment.
The results of the research suggest that COVID-19 patients, even those who are only mildly ill, may spread the virus and contaminate surfaces that pose a risk of transmission. The results also suggest that airborne isolation precautions are appropriate.
"Studies like this are needed to understand proper precautions for healthcare workers, first responders and others who care for the ill and are needed to combat this pandemic," said Joshua Santarpia, a pathologist and microbiologist at the medical center. "This ongoing work will continue to improve our understanding of SARS-CoV-2 transmission and help identify ways to improve safety in the care of patients with COVID-19."
The researchers stress that careful environmental cleaning and disinfection of surfaces, including those in bathrooms, is important. They recommend that appropriate personal protective equipment, including respiratory protection, be used in the treatment of people known or suspected to be infected with SARS-CoV-2.
"This study increases our knowledge of the stability and spread of SARS-CoV-2 in indoor environments," says Joanna Shisler, a program director in NSF's Division of Integrative Organismal Systems. "The information can help us understand how to clean and maintain rooms and buildings to decrease possible virus transmission."
I do, he said at a town hall meeting with Millcreek business people. They tell me Im low risk. They wont tell me Im no risk. So, its important for all of us, I think, to do our part.
He described how the virus affected him, saying he wants to drive home that people should take COVID-19 seriously and follow the relatively simple steps needed to protect against it.
McAdams said he came down with COVID-19 early, just after some Utah Jazz players tested positive and the NBA season was canceled. He and a doctor first thought he just had a cold, so he wasnt tested at a time when they were hard to obtain. When his symptoms worsened and he had trouble breathing, he was tested and found to be positive.
He quarantined at home until one morning when he found he couldnt make it halfway across the bedroom before I was lightheaded and out of breath. I felt like I had just finished running a race.
He ended up in an intensive care unit and was in the hospital for eight days on oxygen.
I lost 13 pounds in the hospital, he said. The COVID diet is not a diet Id recommend.
Even though he was probably soon virus free, he said some symptoms from damage it did lingered for weeks and months. I still have a little bit of a cough, but my doctor says I will be 100% eventually. He said tests show my antibodies are great, and he donates plasma with them to help others.
McAdams said he is 45 years old and healthy, but this still hit me hard. He considers himself lucky as he talks about some acquaintances whose COVID infections ended differently.
Former Utah House Speaker Bob Garff was in the hospital at the same time as I was and died, McAdams noted. He said a former LDS mission companion who lived in Brazil and sent McAdams encouragement when he was in the hospital later died himself at age 44. He said that made the illness really hit home for me.
He urged people to take precautions that he said are easy, even if sometime inconvenient.
I hate wearing a mask, but I do it and things like washing your hands and sanitizing as much as possible. Those precautions are pretty effective. And he said face covering requirements in Salt Lake County, where he used to be mayor, have helped reduce cases there.
I would encourage people to take it seriously and take the precautions, he said.
The pharmaceutical company Moderna started the last, longest step in the process of testing its COVID-19 vaccine candidate at the end of July a Phase 3 clinical trial. Its an enormous undertaking: their goal is to recruit 30,000 people, inject some of them with an experimental vaccine and then follow each and every one of them to see how many contract the coronavirus and how many do not. This will take months, even with the federal governments Operation Warp Speed compressing the timeline whenever possible. Those months may seem endless when over a thousand people are dying from COVID-19 each day in the United States.
The process is long and intensive for a reason, though. Just because a vaccine exists doesnt mean its reasonable or ethical to just give it to people before theres proof it works, and sticking to the process is why the vaccines on the market today are so safe.
Its just fundamentally wrong to think that because theres an emergency, that we should somehow throw out aspects of scientific research, says Alex John London, director of the Center for Ethics and Policy at Carnegie Mellon University.
Researchers already know a lot about a few of the vaccine candidates. Modernas vaccine, for example, has gone through both Phase 1 and Phase 2 clinical trials, and it has been tested in monkeys. The trials didnt raise any major red flags, and they showed that people injected with the vaccine produced antibodies against the coronavirus. But none of them were trying to answer the question people want to know the answer to: can this vaccine stop people from getting COVID-19 in the real world?
To answer that question, researchers turn to a Phase 3 trial. Theyll dose thousands of people with the vaccine candidate, and thousands more with a placebo vaccine. Then, theyll see if fewer people in the vaccine group get COVID-19 than in the placebo group. Theyre also watching for any side effects.
The amount of data we have on COVID-19 vaccines right now is only a fraction of what scientists need before theyd recommend something get widely distributed. The evidence that would convince me to get a COVID-19 vaccine, or to recommend that my loved ones get vaccinated, does not yet exist, Natalie Dean, an assistant professor of biostatistics at the University of Florida, wrote in a New York Times op-ed.
If a vaccine is a car, the Phase 1 and Phase 2 trials happen while its still in the factory. In those trials, scientists are still trying to assemble a vaccine that might work theyre figuring out the pieces that they might need and how they should be used. If that assembly process goes well, the vaccine candidate can move into Phase 3, where its taken for a heavily monitored ride in test tracks and the real world. Phase 1 and 2 lets you say, we have a lot of things we need to clarify and decide on, London says. Phase 3 says, great, now lets test that.
Those real-world tests are often unsuccessful. Only a small percentage of pharmaceutical products even those that look promising in early-stage trials make it through Phase 3 and end up getting approved for use. The success rate is higher in vaccines than treatments, but many of the vaccine successes are for viruses that scientists already know a lot about. New viruses, like the new coronavirus, are much harder to develop vaccines for and have a lower likelihood of success.
Sticking with the car metaphor, once a vaccine hits the test track, theres a chance itll stop running (not actually protect people from COVID-19) or, in the worst-case scenario, crash (have some serious side effects). Its first test drives have to be carefully watched, so that the people designing it can monitor exactly whats happening.
If, as the Phase 3 trials roll on, scientists start to see clear signs that it is working, theyd stop the trial early and start working to get it approved by the Food and Drug Administration. If whatever it is were testing is really showing that its working, scientists would be remiss to continue to test it in people, says Karen Maschke, who studies human research ethics at the Hastings Center in New York. But thats a rare exception to the rule. In almost all cases, you should carry a trial through to the end, she says.
Its particularly important to take vaccines all the way through the process because theyre intended for people who are already healthy. If someone is already sick, the benefits of trying a treatment out (even if its unclear how well it actually works) might be worth the potential risks. Its much harder ethically to justify something thats still experimental for a healthy person. A vaccine is the sort of thing that were going to administer to hundreds of millions of healthy people, or perhaps even this vaccine could even be given to a billion people, London says. We need to know that its safe.
Even if it doesnt come with side effects, giving people an experimental vaccine outside of a clinical trial and before researchers know if it actually works is risky. People who get an unproven vaccine may feel safer and stop taking as many precautions (like wearing masks or avoiding indoor gatherings) against COVID-19, London says. That could increase the spread of the disease if the vaccine doesnt work. We need to know if it works because people are going to change their behavior after they get it, London says.
Releasing a vaccine to the public before its proven to be safe and effective could also erode public trust in vaccines. With concerns about science, and anti-science sentiment, you have to be really, really careful that you get enough data, Maschke says. Researchers need to be able to point to the number of people they tested the vaccine in and their statistical analysis as justification for a recommendation. Trust in the process of developing new drugs and new medicines is fragile, London says. We cant put it in jeopardy.
There isnt usually such focused attention on the clinical trial process, London says. The public has a window into a discussion that theyre not usually a part of, he says. That process can be confusing, even at the best of times. Press releases, sound bites, and jargon can create the illusion that scientists know more about vaccine candidates than they do, or that they look more promising than they actually are. For example, when experts say that a vaccine performed well in a Phase 1 trial, they mean that they didnt see anything that would keep it from moving on to the next stage of the process.
It doesnt mean the things the public is interested in is it safe; if I take this, does it mean I wont have any adverse events a year later; and is it going to protect me if Im exposed to the coronavirus, he says.
Answering those questions is possible, but it will take time. Going at warp speed can save some time, but solid, conclusive answers are worth the wait.
