The highly anticipated rollout of a COVID-19 vaccine poses ethical considerations: When will trial volunteers who got a placebo be vaccinated? And how will this affect the data in those trials?
It's an issue that vaccine manufacturers and study investigators are wrestling with as the Food and Drug Administration is expected to grant emergency authorization this weekend to a vaccine developed by Pfizer and the German company BioNTech. Another vaccine, produced by Moderna, is nearing approval in the United States.
The most vulnerable—health care workers and nursing home residents—are deemed eligible to receive the initial limited supply in accordance with priority recommendations from the Centers for Disease Control and Prevention (CDC).
Cleaning has taken on a whole new meaning in Frank Mosco's household during the COVID-19 pandemic. There's a protocol for everything he and his two teenage daughters do.
Experts agree that over-disinfecting is better than inadequate disinfecting, especially during a pandemic.
"We wipe down every package that comes into the house and the items inside," says Mosco, a technologist and social justice activist in Hastings-on-Hudson, N.Y. "If it's a fruit or vegetable, I use vinegar and water, or water and soap. Then we throw out the boxes, clean up the table, and wash our hands." Only then do they put items away.
As the novel coronavirus continues to pose an invisible threat, parents of infants to adolescents are pondering how vigorously and frequently to clean and disinfect surfaces at home and apply hand sanitizer in public. They also fret over whether there can be too much of a good thing: Will making everything as seemingly germ-free as possible reduce immunity down the road?
Experts agree that over-disinfecting is better than inadequate disinfecting, especially during a pandemic. Every family should assess their particular risks. Factors to consider include pre-existing medical conditions, the number of people living in the same home, and whether anyone works in a hospital or other virus-prone environment, says Kari Debbink, assistant professor of biology at Bowie State University in Bowie, Maryland.
Constantly cleaning everything in sight isn't necessary, she explains, because coronavirus tends to spread mainly via immediate contact with respiratory droplets—catching it from surfaces is a less-likely scenario. The longer the virus stays on a surface, the less contagious it becomes.
Some parents worry that their children's growing bodies may become accustomed to an environment that is "too clean." Debbink, a virologist, offers a salient reminder: "The immune system comes into contact with many, many different antigens every day, and it is 'trained' from birth onwards to respond to pathogens. Doing a little more cleansing and disinfecting during the pandemic will not weaken the immune system."
Other experts agree. "There should be no negative outcome to properly washing your hands more frequently," says Stacey Schultz-Cherry, an infectious diseases specialist at St. Jude Children's Research Hospital in Memphis, Tennessee. "Even with enhanced disinfection, kids are still getting exposed to immune-boosting microbes from playing outside, having pets, etc."
"There's no reason why hand sanitizer would weaken anyone's immune system of any age."
Applying hand sanitizer consisting of at least 60 percent alcohol helps clean hands while outdoors, says Angela Rasmussen, associate research scientist and a virologist at Columbia University's Mailman School of Public Health in New York. "There's no reason why hand sanitizer would weaken anyone's immune system of any age," she adds, and recommends moisturizer so hands don't dry out from frequent use. Meanwhile, "cleaning and disinfecting at home also don't have an impact on antiviral immunity, in kids or adults."
With the coronavirus foremost in parents' minds, Patricia Garcia, a pediatric hospitalist, has fielded many questions about how thoroughly they should wipe, rub, scrub, or mop. As medical director of Connecticut Children's Healthy Homes Program in Hartford, which takes aim at toxins and other housing hazards, she reassures them with this mantra: "You're never going to get it perfectly sterilized, and that's okay."
To quell some of these concerns, in March the U.S. Environmental Protection Agency (EPA) released a list of products for household use. None of these products have been specifically tested against SARS-CoV-2, the novel coronavirus that causes COVID-19. But the agency expects these products to be effective because they have demonstrated efficacy against a different human coronavirus similar to SARS-CoV-2 or an even harder-to-kill virus.
Many products on the list contain isopropyl alcohol or hydrogen peroxide. "When using an EPA-registered disinfectant," the agency's website instructs, "follow the label directions for safe, effective use. Make sure to follow the contact time, which is the amount of time the surface should be visibly wet."
Bear in mind that not all cleaners actually disinfect, cautions Alan Woolf, a pediatrician at Boston Children's Hospital who directs its environmental health center and is a professor at Harvard Medical School. Some cleaners remove visible dirt, grease, and grime, but they don't kill viruses. Disinfectants by their nature inactivate both bacteria and viruses. "That's an important distinction," Woolf says.
Frequently touched surfaces—for instance, doorknobs, light switches, toilet-flushing levers, and countertops—should not only be cleaned, but also disinfected at least daily during a pandemic if someone in the household is sick. The objects one touches upon coming home are the ones most likely to become contaminated with viruses, experts say.
Before bringing items inside, "it might be good to clear off a counter space where they will be placed," says Debbink, the biology professor and virologist. "This way, they come into contact with as few items and surfaces as possible."
If space permits, another option would be to set aside nonperishable items. "I've heard of some families putting things in a 'mud room' and closing the door for 48 hours, some leaving things in their garage or car trunk," says Stephanie Holm, co-director of the Western States Pediatric Environmental Health Specialty Unit at the University of California, San Francisco. "Letting new purchases sit for 48 hours undisturbed would greatly reduce the number of viable viruses present."
Cleaning surfaces is recommended before disinfecting them. Holm suggests using unscented soap and microfiber cloths instead of paper towels, which can transmit bacteria and viruses from one area to another.
Soap has the power to eradicate viruses with at least 20 seconds of contact time. It attacks the coronavirus's protective coat, explains infectious diseases specialist Schultz-Cherry. "If you destroy the coat, the virus is no longer infectious. Influenza virus is also very sensitive to soap."
"The most important thing that parents should do for children's immune systems is make sure they are up to date on all their vaccines."
For cribs, toys, and other mouth-contact surfaces, sanitizing with soap and water, not disinfectants, is advisable, says pediatrician Woolf. Fresh fruits and vegetables also can be cleaned with soap, removing dirt and pesticide residue, he adds.
"Some parents are nervous about using disinfectant on toys, which is understandable, considering many toys end up in children's mouths, so soap and water can be an alternative," says pediatrician Garcia, who recommends using hot water.
While some toys can go in the washing machine and dryer or dishwasher, others need to be cleaned by hand, with dish soap or a delicate detergent, as indicated on their labels. But toys with electrical components cannot be submerged in water, in which case consulting the EPA's list of disinfectants may be a parent's best option, she says.
Labels on the back of cleaning and disinfecting products also contain specific instructions. Not allowing a liquid to sit on a surface for the recommended time results in exposure to chemicals without even accomplishing the intended purpose of disinfection. For most household bleach-containing agents, the advisable "dwell time" is 10 minutes. "Many people don't realize this," says Holm, the environmental health specialist who also trained as a physician.
Beware of combining any type of cleaners or disinfectants that aren't already premixed. Doing so can release harmful gases into the air, she cautions.
During the pandemic, Mosco and his daughters have been very conscientious about decontaminating whatever comes through their doors. Mosco says he doesn't believe the family is overusing cleaning and disinfecting products. Although he's fastidious, he says, "a completely sterile environment is not the goal."
His mother, who was a nurse, instilled in him that exposure to some bacteria is a good thing. In turn, he "always encouraged his kids to play with animals, and to have fun in sand and dirt, with plenty of sunlight to keep their immune systems strong."
Even though a vaccine for coronavirus currently doesn't exist, parents can take some comfort in the best weapon available today to protect kids from deadly pathogens: "The most important thing that parents should do for children's immune systems," says virologist Rasmussen, "is make sure they are up to date on all their vaccines."
When historians of the future look back at the 2020 pandemic, the heroic work of Helen Y. Chu, a flu researcher at the University of Washington, will be worthy of recognition.
Chu's team bravely defied the order and conducted the testing anyway.
In late January, Chu was testing nasal swabs for the Seattle Flu Study to monitor influenza spread when she learned of the first case of COVID-19 in Washington state. She deemed it a pressing public health matter to document if and how the illness was spreading locally, so that early containment efforts could succeed. So she sought regulatory approval to adapt the Flu Study to test for the coronavirus, but the federal government denied the request because the original project was funded to study only influenza.
Aware of the urgency, Chu's team bravely defied the order and conducted the testing anyway. Soon they identified a local case in a teenager without any travel history, followed by others. Still, the government tried to shutter their efforts until the outbreak grew dangerous enough to command attention.
Needless testing delays, prompted by excessive regulatory interference, eliminated any chances of curbing the pandemic at its initial stages. Even after Chu went out on a limb to sound alarms, a heavy-handed bureaucracy crushed the nation's ability to roll out early and widespread testing across the country. The Centers for Disease Control and Prevention infamously blundered its own test, while also impeding state and private labs from coming on board, fueling a massive shortage.
The long holdup created "a backlog of testing that needed to be done," says Amesh Adalja, an infectious disease specialist who is a senior scholar at the Johns Hopkins University Center for Health Security.
In a public health crisis, "the ideal situation" would allow the government's test to be "supplanted by private laboratories" without such "a lag in that transition," Adalja says. Only after the eventual release of CDC's test could private industry "begin in earnest" to develop its own versions under the Food and Drug Administration's emergency use authorization.
In a statement, CDC acknowledged that "this process has not gone as smoothly as we would have liked, but there is currently no backlog for testing at CDC."
Now, universities and corporations are in a race against time, playing catch up as the virus continues its relentless spread, also afflicting many health care workers on the front lines.
"Home-testing accessibility is key to preventing further spread of the COVID-19 pandemic."
Hospitals are attempting to add the novel coronavirus to the testing panel of their existent diagnostic machines, which would reduce the results processing time from 48 hours to as little as four hours. Meanwhile, at least four companies announced plans to deliver at-home collection tests to help meet the demand – before a startling injunction by the FDA halted their plans.
Everlywell, an Austin, Texas-based digital health company, had been set to launch online sales of at-home collection kits directly to consumers last week. Scaling up in a matter of days to an initial supply of 30,000 tests, Everlywell collaborated with multiple laboratories where consumers could ship their nasal swab samples overnight, projecting capacity to screen a quarter-million individuals on a weekly basis, says Frank Ong, chief medical and scientific officer.
Secure digital results would have been available online within 48 hours of a sample's arrival at the lab, as well as a telehealth consultation with an independent, board-certified doctor if someone tested positive, for an inclusive $135 cost. The test has a less than 3 percent false-negative rate, Ong says, and in the event of an inadequate self-swab, the lab would not report a conclusive finding. "Home-testing accessibility," he says, "is key to preventing further spread of the COVID-19 pandemic."
But on March 20, the FDA announced restrictions on home collection tests due to concerns about accuracy. The agency did note "the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection," while adding that "we are actively working with test developers in this space."
After the restrictions were announced, Everlywell decided to allocate its initial supply of COVID-19 collection kits to hospitals, clinics, nursing homes, and other qualifying health care companies that can commit to no-cost screening of frontline workers and high-risk symptomatic patients. For now, no consumers can order a home-collection test.
"Losing two months is close to disastrous, and that's what we did."
Currently, the U.S. has ramped up to testing an estimated 100,000 people a day, according to Stat News. But 150,000 or more Americans should be tested every day, says Ashish Jha, professor and director of the Harvard Global Health Institute. Due to the dearth of tests, many sick people who suspect they are infected still cannot get confirmation unless they need to be hospitalized.
To give a concrete sense of how far behind we are in testing, consider Palm Beach County, Fla. The state's only drive-thru test center just opened there, requiring an appointment. The center aims to test 750 people per day, but more than 330,000 people have already called to try to book a slot.
"This is such a rapidly moving infection that losing a few days is bad, and losing a couple of weeks is terrible," says Jha, a practicing general internist. "Losing two months is close to disastrous, and that's what we did."
At this point, it will take a long time to fully ramp up. "We are blindfolded," he adds, "and I'd like to take the blindfolds off so we can fight this battle with our eyes wide open."
Better late than never: Yesterday, FDA Commissioner Stephen Hahn said in a statement that the agency has worked with more than 230 test developers and has approved 20 tests since January. An especially notable one was authorized last Friday – 67 days since the country's first known case in Washington state. It's a rapid point-of-care test from medical-device firm Abbott that provides positive results in five minutes and negative results in 13 minutes. Abbott will send 50,000 tests a day to urgent care settings. The first tests are expected to ship tomorrow.