Scientists Have Uncovered the Likely Cause of a Serious COVID-19 Symptom: Blood Clotting

One of the more surprising symptoms of COVID-19 has been the blood clots that many patients, including younger ones, have experienced with the infection. The clots have in some cases led to dangerous blockages in the lungs, caused strokes and even death, even in people without a history of circulatory conditions.

In a paper published in Science earlier this week, researchers provide a glimpse into what may be driving the clots triggered by COVID-19 infection. The group found that a specific set of antibodies known as autoantibodies—which are rogue versions of cells meant to defend the body from pathogens, but instead attack its own cells (in this case the body’s own blood vessel cells)—may be partly responsible for the clotting risk associated with the disease. Among 172 patients hospitalized with COVID-19, they found that half produced these autoantibodies. In addition, when the scientists injected the autoantibodies into lab mice, the animals developed blood clots.

In April, the same group of scientists reported that the inflammation associated with COVID-19 can lead to clots in small vessels in the lungs, and that these clots are mostly packed with an immune cell known as a neutrophil. In COVID-19 patients, these neutrophils can explode inside small blood vessels, creating sticky molecular traps that attract other clotting factors circulating in the blood. “Evolutionarily, we think these are meant to trap things like bacteria or viruses,” says Yogen Kanthi, an assistant professor at the University of Michigan, investigator at the National Heart, Lung and Blood Institute and one of the study’s authors. “But if [neutrophils] are over stimulated, they can also grow and cause blockages in blood vessels and drive blood clotting.” In that earlier study, Kanthi and his colleagues found that COVID-19 patients who had more of these “traps” in their blood system were more likely to have severe disease or respiratory failure.

“Inflammation begets clotting, and the clotting leads to more inflammation,” he says. “It becomes a relentless self-amplifying loop of inflammation and clotting that results in patients getting sicker.”

In their latest Science paper, the researchers found that the autoantibodies drive this cycle of inflammation and clotting. The autoantibodies found in the COVID-19 patients are the same ones doctors find in patients with an autoimmune disease called antiphospholipid syndrome, in which antibodies seed clots by attracting clotting factors that eventually block blood flow. Understanding how these antibodies contribute to clotting risk among patients with that syndrome led experts like Jason Knight, who study antiphospholipid disease, to anticipate similar clotting among COVID-19 patients. “By May, clotting was all anyone was talking about with COVID-19 patients,” says Knight, an associate professor of rheumatology at the University of Michigan and one of the study authors. “When we started doing autopsies, we saw microvascular clotting in the lungs.”

Such clotting in small vessels—sometimes too small to even pick up by CT scans—is one of the hallmarks of the blood flow blockages linked to COVID-19. Not only do patients develop so-called macrovascular clots in the bigger vessels including veins and arteries, which can lead to deep vein thrombosis and strokes, but infections also seem to sometimes trigger clots in the tiny vessels in the lungs—which can cause respiratory issues—and the autoantibodies may be the reason for that, since they can bind to blood vessel cells everywhere.

In fact, says Kanthi, COVID-19 can be seen as “an extreme version of a number of diseases, one of them being antiphospholipid syndrome.” That means that studying these patients could lead to better understanding of COVID-19 and how the coronavirus is contributing to clotting. To start, Knight is already studying one drug, dipyridamole, which is approved to treat strokes and prevent blood clots in people who receive mechanical heart valves, to see if it can reduce the risk of clotting in COVID-19 patients. The drug is relatively inexpensive and directly tamps down neutrophil activation, which may in turn reduce the formation of the hyperactive neutrophil traps in the vessels. The test for the autoantibodies is already available for doctors to order, so ultimately, says Knight, COVID-19 patients might be tested for their antibody levels and then triaged to receive more aggressive blood thinners or other medications such as dipyridamole, if it proves effective, to protect them from clotting.

The team is currently enrolling COVID-19 patients for the anti-clotting drug study, and could have answers by the end of the year, says Knight. Those findings could open new understanding into how viruses affect the body’s clotting processes; the fact that the body’s autoantibodies can trigger such widespread clotting is new, says Kanthi. “We knew antibodies like this can exist [from our knowledge of antiphospholipid syndrome] but no one ever looked to see if they can cause clotting.”

It’s not clear yet at what point during the infection these autoantibodies start to form, and what makes people more likely to generate them. Genetics, a person’s history of previous viral and bacterial infections, as well as the revved-up immune response launched by COVID-19 likely all contribute to that risk. But the fact that half of patients may generate these potentially clot-promoting antibodies means that better understanding what these risk factors are, and possibly identifying people who harbor them, may help them from experiencing a more severe and potentially deadly COVID-19 infection.

U.S. Sets New Daily COVID-19 Record Amid Election Turmoil

New confirmed cases of the coronavirus in the U.S. have climbed to an all-time high of more than 86,000 per day on average, in a glimpse of the worsening crisis that lies ahead for the winner of the presidential election.

Cases and hospitalizations are setting records all around the country just as the holidays and winter approach, demonstrating the challenge that either President Donald Trump or former Vice President Joe Biden will face in the coming months.

Daily new confirmed coronavirus cases in the U.S. have surged 45% over the past two weeks, to a record 7-day average of 86,352, according to data compiled by Johns Hopkins University. Deaths are also on the rise, up 15 percent to an average of 846 deaths every day.

The total U.S. death toll is already more than 232,000, and total confirmed U.S. cases have surpassed 9 million. Those are the highest totals in the world, and new infections are increasing in nearly every state.

Several states on Wednesday reported grim numbers that are fueling the national trends. Texas reported 9,048 new cases and 126 deaths, and the number of coronavirus patients in Missouri, Nebraska and Oklahoma hospitals set records. About a third of the new cases in Texas happened in hard-hit El Paso, where a top health officials said hospitals are at a “breaking point.”

Public health experts fear potentially dire consequences, at least in the short term.

Trump’s current term doesn’t end until Jan. 20. In the 86 days until then, 100,000 more Americans will likely die from the virus if the nation doesn’t shift course, said Dr. Robert Murphy, executive director of the Institute for Global Health at Northwestern University’s Feinberg School of Medicine, echoing estimates from other public health experts.

“Where we are is in an extremely dire place as a country. Every metric that we have is trending in the wrong direction. This is a virus that will continue to escalate at an accelerated speed and that is not going to stop on its own,” said Dr. Leana Wen, a public health expert at George Washington University.

Dr. Susan Bailey, president of the American Medical Association, said there are things Americans can do now to help change the trajectory.

“Regardless of the outcome of the election, everyone in America needs to buckle down,″ Bailey said.

“A lot of us have gotten kind of relaxed about physically distancing, not washing our hands quite as often as we used to, maybe not wearing our masks quite as faithfully. We all need to realize that things are escalating and we’ve got to be more careful than ever,” she said.

Polls showed the public health crisis and the economy were top concerns for many Americans.

They are competing issues that Trump and Biden view through drastically different lenses.

Trump has ignored the advice of his top health advisors, who have issued increasingly urgent warnings in recent days about the need for preventive measures, instead holding rallies where face coverings were rare and falsely suggesting that the pandemic is waning.

By contrast, Biden has rarely been seen in public without a mask and made public health a key issue. Whether his voice will carry much influence if Trump is declared the winner is uncertain.

“President Trump has already made clear what his strategy is for COVID-19, which is to pretend that there is not a contagious virus all around us,” Wen said. Trump has been touting treatments and vaccines, which won’t be widely available to all Americans until at least mid-2021, she noted.

“There’s a lot of suffering that is going to happen before then, which could have been prevented,” Wen said.

Federal health officials have said they believe a vaccine could get emergency use authorization before the end of the year. The first limited supplies of doses would then be immediately distributed to the most vulnerable populations, which is likely to include frontline health care workers. Doses would then gradually become more widely available.

The timeline hinges on having a vaccine that’s shown to be safe and effective, which experts note is not yet a certainty. “The vaccine has to move at the speed of science,” said Dr. Joshua Sharfstein, vice dean for public health practice at Johns Hopkins University and former Maryland state health department chief.

On the treatment front, the makers of two experimental antibody drugs have asked the Food and Drug Administration to allow emergency use of them for people with mild to moderate COVID-19, and Trump, who received one when he was sickened last month, has said he wanted them available right away.

So far, the FDA has granted full approval to only one drug — the antiviral remdesivir — for hospitalized patients. Dexamethasone or similar steroids are recommended for certain severely ill patients under federal treatment guidelines.

The government continues to sponsor many studies testing other treatments alone and in combination with remdesivir.

But the development of treatments could be affected if Trump makes good on threats to fire Dr. Anthony Fauci, the government’s top infectious disease doctor, or other top health officials Trump has clashed with.

Most Americans support mandating mask-wearing in public and think preventing the virus from spreading is a higher priority than protecting the economy, according to AP VoteCast, a nationwide survey of over 133,000 voters and nonvoters conducted for The Associated Press by NORC at the University of Chicago.

While several European countries have imposed or proposed new lockdowns and other restrictions to control surging cases, Trump has resisted those approaches and has focused on rebuilding the economy.

Absent a national pandemic strategy, curbing virus spread in the U.S. will depend on more Americans taking necessary precautions and the upcoming holiday season will make that a challenge, said Dr. Cedric Dark, an emergency physician in Houston.

“It’s going to be Thanksgiving, winter break for college students, Christmas time and Hannukah,” but families may have to resist close get-togethers this year, he said. Outbreaks on college campuses mean many students may be bringing the virus home and spreading it to parents and grandparents, he said.

Dark, who hasn’t seen his parents in over a year, has had to adjust his own holiday plans. This year, Thanksgiving will be in his parents’ garage, with the door up, chairs at least 6 feet apart, and a space heater if needed.

“We can at least see each other, from a distance,’’ Dark said.

___

AP Medical Writer Marilynn Marchione and AP reporter Candice Choi contributed.

This Election—And a Coming Supreme Court Decision—Will Decide the Future of American Health Care

It’s safe to say that COVID-19, the country’s worst public health crisis in a generation, was the single most important issue in the 2020 Presidential race. It warped the campaign, sickened a candidate, and shaped not only voters’ opinions, but how they cast their ballots.

But amidst this unprecedented crisis, the topic of American health care—the single most important issue in the 2018 midterm race—got relatively little attention once the primary was over. The candidates rarely gave speeches about insurance premiums or co-pays, and most Americans remain unclear about what, exactly, BidenCare is, or whether Donald Trump’s long-promised “brand new, beautiful health care” even exists.

In the closing days of the election, former Vice President Joe Biden tried to change that. In stump speeches across the country, he repeatedly hammered on the point that he and President Donald Trump have two divergent visions of American health care. “Donald Trump thinks healthcare is a privilege,” he told a crowd in Michigan on Oct. 31. “Barack [Obama] and I think it’s a right.”

Implicit in Biden’s stump speech was a broader truth: the future of American health care really does hang in the balance.

The results of the presidential election, combined with a hugely consequential U.S. Supreme Court case challenging the Affordable Care Act (ACA) could not only shape the American health care landscape for decades, but also determine whether millions of Americans immediately lose their health care coverage. In exactly one week, the Supreme Court, which now includes Justice Amy Coney Barrett, will hear oral arguments in California v. Texas, in which a group of conservative state attorneys general, backed by the Trump Administration’s Justice Department, is seeking to invalidate the entirety of the ACA.

If the Supreme Court strikes down the ACA, chaos would likely ensue: the federal funding for Medicaid expansion would evaporate, leaving more than 12 million people who rely on the program to likely lose coverage; the subsidies for those who buy insurance through the ACA’s private insurance marketplaces would also disappear, leaving the majority of those 11.4 million people without insurance; and all insurance providers would suddenly be allowed to discriminate against people who had pre-existing health conditions, including COVID-19, by charging them higher premiums or denying them coverage outright.

“If no part of the political process responds to the Supreme Court holding, the results would be immediate and calamitous,” says Nicholas Bagley, a University of Michigan law professor.

But that outcome is hardly guaranteed. It depends on what happens next—both what the Supreme Court decides and who wins the Presidential election.

Here are three possibilities. The first is that the Supreme Court upholds the ACA, leaving the fate of the law to a newly elected Congress. Another option is that Trump wins the election, a scenario that creates the most uncertainty around the future of American health care, as neither Republicans nor the Trump Administration have produced anything resembling a coherent replacement for the ACA. The third option is that Biden—and enough down-ticket Democrats—win the election and secure majorities in both the House and Senate, setting themselves up to either improve the ACA or pass a new health care law in 2021.

The Supreme Court Might Not Strike Down the ACA

Legal scholars from both sides of the aisle have said they don’t expect the Supreme Court justices to buy the Republicans’ argument that the ACA, stripped of its tax penalty, is unconstitutional.

“The legal arguments themselves are astoundingly weak,” says Katie Keith, a health law professor at Georgetown University. “But the law is in front of the court again 10 years after it was passed. And you can’t really take anything for granted especially with the Affordable Care Act and the political nature of the litigation that we’ve seen against the law.”

Chief Justice John Roberts has ruled in favor of the ACA in its past two Supreme Court cases, and he is expected to side with the liberal bloc again this time. But that means the decision may come down to how Barrett, Trump’s newest appointee, and his two previous judges Neil Gorsuch and Brett Kavanaugh vote. The court is likely to make a decision sometime this spring, and if it does strike down all or most of Obamacare, changes would start right away.

Trump, Who Has So Far Failed To Deliver a Health Care Plan, Wins the Election

While the President has talked and tweeted about a “beautiful” or “far better” health care plan than what Democrats are offering, his policies thus far have included a series of effectively meaningless and legally unenforceable executive orders.

Trump has said repeatedly, for example, that he wants to protect people with pre-existing health conditions, which is one of the most popular provisions of the ACA, but his only move on this so far has been to ask voters to trust him. In September, he announced an executive order declaring that it is “the policy of the United States” to “ensure that Americans with pre-existing conditions can obtain the insurance of their choice at affordable rates.” Such an order is legally unenforceable.

Meanwhile, his Administration has spent the better part of the last four years specifically unwinding precisely those protections. The current case before the Supreme Court, which is backed by the Trump Administration, would eliminate all shields for those with pre-existing conditions. Trump has also promoted short-term health insurance plans that do not have to comply with ACA rules such as covering people with pre-existing conditions, encouraged states to limit access to Medicaid, and cut the budget for outreach and enrollment efforts to help people sign up for insurance.

“This is the rhetorical problem that Republicans have gotten themselves into. Republicans wasted a decade arguing repeal and replace,” says Joel White, a Republican strategist who specializes in health policy. Republicans need to present voters with more choice and lower costs, but so far the GOP health care platform is mostly blank.

Joe Biden, Who Promised a ‘Public Option,’ Wins the Election

Biden’s detailed health care plan centers on building on and improving the Affordable Care Act and creating a government-run public health insurance plan that anyone could choose.

The idea in part is that a so-called public option would allow the federal government to negotiate and pay less to medical providers the way that private insurers do for their enrollees. And while it’s not clear how well this would work, experts say, the public option would be significant in who it covers. Biden would automatically enroll the 4.7 million adults who are eligible for Medicaid but remain uninsured because their states haven’t expanded the program, and he would allow any American who has employer-based insurance to leave their plan and join—a major step toward the long term progressive goal of eliminating private insurance. About 12 million of these people who currently get insurance through their job could find the public option to be cheaper, according to the Kaiser Family Foundation.

Biden would also lower the Medicare eligibility age to 60, allow the federal government to negotiate with pharmaceutical companies over prescription drug prices, and spend $775 billion on caregiving, which will continue to be a significant issue as COVID-19 adds to the ranks of Americans who need long-term medical care and support. “This is the biggest disability boom since AIDS and HIV in the 80s. And beyond that Polio,” says Rebecca Cokley, director of the Disability Justice Initiative at the Center for American Progress. “The social safety net is not prepared for this.”

Of course, Biden’s plans hinge on what the next Congress looks like. If Republicans retain a Senate majority, hopes for sweeping new health legislation dwindle. But even if Democrats seize both houses, Biden will need to negotiate with progressive lawmakers from his own party, who have long pushed for more comprehensive universal health care, like Medicare for All.

Any new legislation would also have to survive what most experts expect would be multiple challenges from states and the insurance industry—case that would land before an even more conservative judiciary. “There are lots of states where you’re going to see intense resistance,” says Jacob Hacker, a political scientist at Yale University who has studied shifts in policy attitudes after economic crises. “That will matter because I think that it will push political leaders towards approaches that do not rely as heavily as the Affordable Care Act does on the states.”

Biden’s campaign estimates that about 97% of Americans would have coverage under his new plan, which would cost about $750 billion over 10 years. “What we’re going to do is going to cost some money,” he admitted during the final presidential debate in October.

But his appeal to voters was clear: with the ACA hanging in the balance, Americans are not only selecting the next President this election, they are, conceivably, choosing the future of American health care.

Frozen Food Packages in China Keep Testing Positive For Coronavirus. Here’s Why Health Experts Aren’t Worried

They’ve reportedly found it on packages of Ecuadorian shrimp, squid from Russia and Norwegian seafood.

Since June, Chinese health authorities have been detecting genetic traces of SARS-CoV-2, the virus that causes COVID-19, on refrigerated and frozen foods from around the world. Then, on Oct. 17, the Chinese Centers for Disease Control (CDC) announced it had isolated active SARS-CoV-2 on packs of imported fish. The agency says this world-first discovery, made while tracing a recent outbreak in Qingdao to two dock workers, shows contaminated food packaging can cause infections.

While it remains unclear if the dock workers actually contracted COVID-19 from the seafood they were handling, the government is stepping up precautions. Qingdao will now scrutinize all incoming frozen food (after testing all 9 million residents), while the Beijing city government has urged companies to avoid importing frozen foods from countries badly hit by the pandemic — though it did not specify which ones.

Concern over possible transmission through imported food is running high in China, which has nearly stamped out domestic transmission of the pathogen. It is one of the only countries to impose wide-scale coronavirus inspections on incoming shipments.

Elsewhere, health authorities have been more skeptical. The U.S. Centers for Disease Control says there is “no evidence” to suggest food is associated with spreading the virus, while the World Health Organization (WHO) says it’s not necessary to disinfect food packaging. New Zealand meanwhile ruled out a theory that an August outbreak was connected to a cold-chain storage facility.

Read more: Wuhan Strives to Return to Normal, But Scars From the Pandemic Run

China’s CDC says 670,000 samples from frozen foods and packaging had been tested for COVID-19 as of Sept. 15. Reportedly, only 22 of them were positive (and prior to the Qingdao case it was not clear if any of the detected coronavirus was still active when thawed).

In recent months, the world’s second-largest economy has nevertheless temporarily suspended a slew of fish and meat imports, disrupting trade with several countries and reportedly causing shipping bottlenecks.

Several health experts have disputed the necessity of such precautions. While cold temperatures can preserve coronaviruses, they remain doubtful food and its packaging pose a major threat.

“It’s theoretically plausible, but the risk is much lower than the other more established routes of transmission for this virus,” says Siddharth Sridhar, a microbiologist at the University of Hong Kong (HKU).

What has China found?

China stepped up monitoring of imported foods after a second wave in June that infected 335 people was linked to Beijing’s sprawling Xinfadi market. The outbreak, which broke the capital’s run of 56 consecutive days without any new local infections, prompted a partial shutdown of the city and a probe into the origins.

Authorities suggested supplies of salmon from Europe may have been the source after the virus was reportedly discovered on a filleting board. This led to a temporary freeze on salmon imports, with repercussions for exporters in Chile, Norway, the Faroe Islands, Australia and Canada. Although others have disputed that the fish were to blame, investigators in China have since doubled down on the potential culprit.

Also in June, China suspended poultry imports from a Tyson Foods plant in the U.S. amid concerns about an outbreak at the facility. And in Tianjin, a major port, authorities reportedly began requiring coronavirus tests for all meat and seafood containers.

At the time, Li Fengqin, the head of the lab at China’s National Center for Food Safety Risk Assessment told reporters that the possibility of contracting the virus from frozen food and packages could not be ruled out.

Other cities jumped into action. In August, Shenzhen—the booming technology hub that borders Hong Kong—set up a central warehouse where all imported food is screened before being sold.

As of early Sept., China had temporarily banned imports from 56 companies in 19 countries, including from the U.S., Indonesia and Europe.

Cui He, president of the China Aquatic Products Processing and Marketing Alliance, acknowledged that it was impractical to institute a total ban on imported frozen food. “More than 100 countries worldwide export frozen seafood to China,” he told state-run media.

Exporters of meat, dairy and other food items have instead been asked to sign documents declaring their products have not been contaminated by coronavirus.

Such scrutiny has drawn flak from industry bodies. In September, the International Commission on Microbiological Specifications for Foods called restrictions around food imports “not scientifically justified.”

Getting COVID-19 from food or packaging isn’t easy

Getting COVID-19 from food packaging is no easy matter and, while possible, depends on a complex series of events, health experts told TIME.

First, an infected person would have to cough or sneeze on packaging. Then, while the virus was still active, someone else would need to touch that packaging before touching their own eyes, nose or mouth.

“Everything we have come to know about this virus indicates airborne person-to-person is the mode of transmission,” says Emanuel Goldman, a professor of microbiology at Rutgers University.

Researchers are still studying how long the virus can remain active on food surfaces in varying temperatures. According to the WHO, coronaviruses in general are very stable in a frozen state, and studies have even shown survival for up to two years at -4°F.

But even if food or packaging does test positive, that doesn’t mean it’s infectious.

“The most commonly used tests can tell us that there has been some viral components on the package, [but] we do not know the state of the virus,” says Sarah Cahill, a senior food standards officer at Codex Alimentarius Commission, the body responsible for developing food standards under the WHO. “Was it still intact? Was it still viable? Was it still capable of causing infection?”

Read More: COVID-19 Is Transmitted Through Aerosols. We Have Enough Evidence, Now It Is Time to Act

How to stay safe

The U.S. Food and Drug Administration says it is aware of China screening incoming produce, seafood and meat for COVID-19. But in a statement emailed to TIME, a spokesperson says, “Currently there is no evidence of food, food containers, or food packaging being associated with transmission of COVID-19.”

Sridhar of HKU does not recommend widespread screening of imported food items, which he likens to “looking for a needle in a haystack.”

Dale Fisher, a professor of medicine at the Yong Loo Lin School of Medicine, National University of Singapore, says China’s concern stems from a different approach to the virus than much of the rest of the world is taking.

He says China has “chosen to monitor this because they have zero tolerance for cases. If you’re not aiming for zero, then there’s a different risk tolerance.”

In any case, regular consumers should not be worried, he says.

“By the time food gets to a consumer it has been stacked and moved around enough to see the virus very diluted and unlikely at an adequate dose to cause infection.”

To avoid getting coronavirus, health experts continue to advise people to wash their hands with soap and water and avoid touching their eyes, nose and mouth.

Keep up to date with our daily coronavirus newsletter by clicking here.

There May Be a Link Between COVID-19 and Preterm Birth, CDC Says

Contracting COVID-19 during pregnancy may put expectant mothers at a higher risk of delivering early, according to new data from the U.S. Centers for Disease Control and Prevention (CDC).

The CDC’s new report is based on data from almost 4,500 people who were diagnosed with COVID-19 during pregnancy and provided public health departments with information about their pregnancy outcomes. Roughly 3,900 mothers gave information about their baby’s gestational age. Within that group, nearly 13% of babies (about 500) were born preterm—slightly but significantly higher than the 2019 national rate of about 10%.

Preterm birth—a birth that occurs before the 37th week of pregnancy—has been on the rise around the world in recent years, though researchers aren’t entirely sure why. Preterm birth is the leading cause of death for children under five years old, according to the World Health Organization. Babies born early can experience both short- and long-term health problems, which tend to be more serious the earlier a baby is born.

Understanding a possible connection between COVID-19 and preterm birth could help inform obstetric care for the rest of the pandemic. Many of the characteristics that put people at increased risk for severe COVID-19 infection, including preexisting health conditions, also increase the risk of preterm birth. Black women also experience higher-than-average rates of both preterm birth and COVID-19 infection. The CDC’s dataset disproportionately included women of color, many of whom had prior health problems, so it’s possible the data reflects some of those preexisting disparities.

The CDC’s report didn’t specify why pregnant women may be at risk of delivering early, but prior studies suggest expectant mothers who get sick with coronavirus are more likely than the general population to have severe symptoms and require intensive care. There may be a link between the two findings.

The report also found that babies were fairly unlikely to contract COVID-19 in the womb. Test results were not available for most babies included in the study, but among the 610 with results available, only 2.6% tested positive within a week of birth. Women diagnosed with COVID-19 a week or less before giving birth appeared to be the most likely to pass the virus to their child, according to the agency.

Half of the babies that tested positive for COVID-19 were born early, but this high positivity rate may reflect better testing practices within intensive care units, the report says.

The CDC’s recommendations for pregnant women and their families are the same as for the general population: wear masks in public spaces, practice social distancing and wash hands frequently. Pregnant women should also stay up-to-date with vaccinations and prenatal appointments to ensure general health, the CDC says.

Kids Are Participating in COVID-19 Vaccine Trials. Here’s What Their Parents Think

Katelyn Evans, 16, has never met Randy Kerr—and there’s no reason she should have. It was 66 years ago that Kerr, then 6, became briefly famous, receiving the first injection of Jonas Salk’s experimental polio vaccine during the massive field trial of hundreds of thousands of children in the spring of 1954. History notes that the vaccine worked, and the children who stepped forward to receive either the actual shot or a placebo were heroically dubbed the Polio Pioneers.

Evans is a pioneer of the modern age, one of an eventual group of 600 children in the 16-to-17 year-old age group (along with 2,000 more between 12 and 15) to volunteer to be part of a Phase 3 trial to test an experimental COVID-19 vaccine made by the multinational pharmaceutical giant Pfizer. The company had already enrolled 42,113 adult volunteers in its Phase 2 and 3 trials, but only recently did the U.S. Food and Drug Administration (FDA) give approval to include children. And Evans, a high school junior in Cincinnati, was among the earliest, receiving her first of two injections on Oct. 14, at Cincinnati Children’s Hospital.

“She was the youngest one to receive the vaccine at that point in time,” says her mother, Laurie Evans, an elementary school teacher. In the spring, the family saw a news report that Pfizer was looking for volunteers and Evans and both of her children signed up. “Katelyn was the only one who got the call,” Laurie says. “I know from the response we’ve gotten that there are some people out there who don’t think this is the smartest thing for us to have done. But I’m more afraid of COVID than the vaccine.”

With good reason. The 8.8 million Americans who have contracted the disease include about 800,000 children, with the American Academy of Pediatrics (AAP) reporting a 13% increase in total pediatric cases in just the first two weeks of October. Children with COVID-19 may typically fare better than adults who catch the virus, but they can still become severely ill: some 3.6% of total U.S. COVID-19 patients who have had to be hospitalized have been children, according to the AAP. That reality makes volunteering for the Pfizer field trial more than an act of public-service heroism; it is also a potential act of preventive medicine.

Certainly, that’s the way Sharat Chandra saw things. Sharat was already part of the Pfizer adult trial and when word first went around that children would soon be included too, he and his wife discussed the possibility of enrolling their 12-year-old son Abhinav, and then posed the question to him.

“I raised it to my son and we felt that it might be a good thing for him because if he got the vaccine, it could protect him from getting the virus himself,” Sharat says. “Because he was attending school in person, we felt that it would be good to minimize his risk for infection, if we can.”

Courtesy of Cincinnati Children’s HospitalAbhinav Chandra participating in Pfizer’s COVID-19 vaccine trial.

Even younger kids could eventually receive the same experimental prevention as part of expanded trials before long. The FDA requires all drugs submitted for approval have a pediatric plan, but that rule is lenient to the point of being no rule at all. “The plan can be simply ‘We don’t have a plan,’” says Dr. Robert Frenck, director of the Cincinnati Children’s Hospitals Center for Vaccine Research. That means a COVID-19 vaccine tested only in adults and then approved could potentially be prescribed off-label to kids—but doctors don’t especially like that idea.

“It’s a hard sell for pediatricians to say to parents, ‘I have a licensed vaccine that hasn’t been tested in the pediatric age group, but I want to give it to your children,’” says Frenck.

For that reason, he and other doctors are advocating for robust testing in the 12-17 age group, pausing to see how that goes, and, if the results are good, continuing to test in younger cohorts. “We are looking to test in older kids and then age de-escalate, even down to as young as six months,” he says.

For now, they’re a long way from that. Pfizer is currently the only company testing its COVID-19 vaccine in children of any age and the eventual sample group of 2,600 total children is not yet fully assembled. Still, while testing in children is not a requirement for the vaccine to be released and be used in kids, Frenck believes that other vaccine developers will take their cue from Pfizer and develop pediatric testing plans of their own. “My assumption is most of the companies—or many of the companies—will follow suit,” he says.

There are, of course, risks associated with choosing to participate in these studies. No experimental vaccine is 100% safe; determining the degree of risk is part of the reason for field trials in the first place. The Pfizer vaccine does not use a killed or weakened virus to trigger the immune response. Rather, it uses messenger RNA (mRNA) from SARS-CoV-2—the virus that causes COVID-19—which prompts the body’s cells to produce coronavirus proteins. That, in turn, causes the immune system to produce antibodies. A vaccine with no whole virus—killed or weakened—makes some parents more comfortable, but the field trial protocols nonetheless call for warning them of all possible adverse outcomes.

“They sent us a whole 11-page document of all the ifs and whys and hows and whats,” says Evans. “They told us [the side effects] that people got in the Phase 1 trials. And it was like a little bit of achy body. A low-grade fever. Little things like that. Nothing drastic or dire.”

Still, the overall process involves both commitment and a certain tolerance for pain and inconvenience. Subjects are enrolled in the trial for two years and in the early phases must report for periodic blood draws and nasal swabs, followed by half a dozen quicker check-ups over the remainder of the two-year period. None of that thrilled Abhinav.

“When we first spoke to him, he wasn’t too excited to be honest,” says Sharat. “And it was not so much the vaccine itself. He wasn’t too excited about the blood draw part of it. That was the main thing he wasn’t happy about.”

The families haven’t been happy about some other things either—not least the inevitable Internet trolling that seems to follow even the most virtuous act.

“I’ve gotten a few comments on Facebook—’What kind of mother would let her kids do that?'” says Evans. “But Katelyn has also had teachers and other students in the hallway say, ‘Hey, my gosh, that’s so cool’ and, ‘You’re so brave!'”

Neither the Chandras nor the Evanses feel especially brave, insisting that they trust the science and the assurances of the doctors who explained the risks and the benefits of participating. One thing they do worry about is whether or not their kids are receiving placebo or the actual injection. Laurie Evans frets that the two-year commitment to which Katelyn agreed means that, if she received a placebo she might be discouraged from getting the actual vaccine when it is approved since that would contaminate the ongoing research. Katelyn herself is concerned about that scenario—especially if her school requires kids to be vaccinated in order to attend. Laurie reports that Pfizer has so far been surprisingly vague on that point so far—not yet spelling out what it will expect from its placebo recipients. But the families have a fail-safe option: “We’re allowed to back out of the trial at any point,” Laurie says.

For now, they have no such plans. The long-ago polio pioneers were lauded as heroes—as they certainly were in an era in which science knew far less about immunology. The COVID-19 pioneers may not receive the same applause, but even if the risks they face are smaller, the nobility of their actions is not.

“We feel like normal, every-day people that are just doing a little teeny-tiny thing that we believe will help lots of people,” says Evans. “Someone has to.”

Young Adults Are Less Likely to Wear Masks, Take Other Measures Against COVID-19, CDC Survey Finds

Survey data released Oct. 27 from the U.S. Centers for Disease Control and Prevention shows that age is a strong predictor of public-health behaviors. According to the agency’s analysis of the survey results, older respondents are more likely to take certain actions or refrain from certain activities in order to mitigate the chances of spreading and contracting COVID-19. Younger adults, on the other hand, were the slowest to embrace the behaviors and continued to lag behind their older counterparts over the seven-week period that the survey was conducted.

The survey asked respondents whether they engage in any of 19 mitigation behaviors, six of which were analyzed in the agency’s published results:

• wearing a face mask
• washing or sanitizing hands
• social distancing when out of the house
• avoiding crowded places
• cancelling or postponing social or recreational activities
• avoiding some or all restaurants

The questions were posed at three intervals: in late April, early May and early June. As shown in the below chart, which captures the situation in June, 38% of 18-to-29 year olds engaged in all six behaviors, while 53% of people age 60 and older did the same.

The CDC suggests that older adults are more likely to take multiple prevention methods because “they might be more concerned about COVID-19, based on their higher risk for severe illness compared with that of younger adults.”

To be sure, the majority of respondents, including those in the youngest group, engaged in at least four behaviors over the survey time period, and only 6% from the entire sample reported one or fewer behaviors.

Not all behaviors stuck over the seven week period, however. Only face mask use increased, going from 78% in April to 89% in June. The other prevention measures declined marginally, except avoiding restaurants, which stayed flat. Yet despite these fluctuations, the age trend stayed the same: the older the group, the more likely they were to engage with a given behavior. The below chart shows in detail how the prevalence of each behavior changed for the oldest and youngest groups.

The lower prevalence of mitigation behaviors in younger adults “might contribute to the high incidence of confirmed COVID-19 cases” among that group, the CDC notes. Indeed, young adults now have the greatest share of COVID-19 cases in the U.S. While this group is less likely to suffer severe illness from COVID-19, it isn’t out of the question.

Additionally, young people’s risk tolerance for COVID-19, and their decisions to forego social health measures, affects not just their peers but also their older and more vulnerable neighbors. The CDC concludes that if younger groups implement public health behaviors more widely, they could “protect persons of all ages by preventing the spread of SARS-CoV-2.” That should be reason enough to step up.

Little Recognition and Less Pay: These Female Healthcare Workers Are Rural India’s First Defense Against COVID-19

Archana Ghugare’s ringtone, a Hindu devotional song, has been the background score of her life since March. By 7 a.m. on a mid-October day, the 41-year-old has already received two calls about suspected COVID-19 cases in Pavnar, her village in the Indian state of Maharashtra. As she gets ready and rushes out the door an hour later, she receives at least four more.

“My family jokes that not even Prime Minister Modi gets as many calls as I do,” she says.

Ghugare, and nearly a million other Accredited Social Health Activists (ASHAs) assigned to rural villages and small towns across India, are on the front lines of the country’s fight against the coronavirus. Every day, Ghugare goes door to door in search of potential COVID-19 cases, working to get patients tested or to help them find treatment.

With 8 million confirmed COVID-19 cases, India has the second-highest tally in the world after the United States and its health infrastructure struggled to cope with the surge in COVID-19 patients this summer. India spends only 1.3% of its GDP on public health care, among the lowest in the world. The situation is stark in rural areas where 66% of India’s 1.3 billion people live and where health facilities are scant and medical professionals can be hard to find.

India’s ASHA program is likely the world’s largest army of all-female community health workers. They are the foot soldiers of the country’s health system. Established in 2005, a key focus of the program was reducing maternal and infant deaths, so all recruits are women. They have also played an essential role in India’s efforts to eradicate polio and increase immunization, according to numerous studies.

Read More: How the Pandemic Is Reshaping India

But even as health authorities have leaned on ASHAs to quell the spread of COVID-19 in rural areas, where a substantial number of new cases have been reported, many of these health care workers say the government is failing them. Pay was meager to begin with, but some workers have reported not being paid for months. Their hours have increased dramatically, but pay rises, when they have come, have not reflected the increased demands. Many ASHAs have also complained about not being provided adequate protective equipment for their high-risk work.

“They are the unsung heroes who are fighting to contain the unfettered spread of the virus in rural areas,” says Dr. Smisha Agarwal, Research Director at the John Hopkins Global Health Initiative. She argues it is vital to improve pay to boost morale and sustain this frontline workforce.

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Ghugare was chosen from her village of 7,000 people in 2011. Since then, she has overseen countless births, meticulously monitored the health of thousands of newborn babies and strictly ensured immunization through door-to-door awareness campaigns. The personal relationships she built over the years have helped in the fight against COVID-19, giving her a good grasp of the medical histories of most of the 1,500 people assigned to her. “It’s all in here,” she says pointing to her head.

Before the pandemic, she was expected to work two to three hours per day, for which she was paid about 2,000 rupees ($27) a month, with incentives for completing tasks in the community. Now, she’s spending 9 to 10 hours a day working to combat COVID-19. She had to cut back her other job working at a farm, and most of the bonuses have dried up as well. The Indian government has given her a 1,000-rupee ($13.50) COVID-19 stipend, but that doesn’t make up for the lost income.

Conditions like these are pushing many of these women to breaking point. Some 600,000 ASHAs went on strike in August to demand better pay and recognition as permanent government employees. (They are currently classified as volunteers, which renders them ineligible for minimum wages and other benefits.)

“The extra work we used to do earlier to ensure our stomachs weren’t empty has stopped now,” Ghugare says.

New Delhi, Aug. 9, 2020. ASHAs protest in New Delhi, demanding better pay and recognition. Photo by T. Narayan/Bloomberg via Getty Images

 

Read More: India’s Biggest Slum Successfully Contained COVID-19. But Can Its Residents Survive the Economic Collapse?

Heading out the door, she puts on a face mask and headscarf to protect herself while mentally running through the symptoms of one of the possible COVID-19 patients she had been phoned about earlier. Knowing that the individual suffers from diabetes, which makes people more vulnerable to coronavirus, Ghugare begins working out how to prioritize the case and arrange transportation to a center, about 40 minutes away, for urgent testing.

Some cases are particularly challenging. There are days when villagers refuse to talk to her. Worried about being forced to go to the hospital and missing work—a major hardship when people depend on daily wages for a hand-to-mouth existence—people often hide symptoms. Then there is also the menace of fake news, often spread on WhatsApp.

Ghugare arrives at a house in the sweltering heat, where it takes her almost 20 minutes to persuade a man to get his wife tested for COVID-19. Because of a false rumor spread via messaging apps, he is convinced his wife’s kidneys will be removed if she goes to hospital. In the end, he relents. “Dealing with fake WhatsApp forwards is one of the most exhausting parts of the job,” Ghugare says.

By around 1:30 p.m., she has already worked six hours. Before the pandemic, she would have wrapped up and headed to her second job. But now she still has a long list to get through to meet her daily target of visiting 50 houses.

Photo by Raj K Raj/Hindustan Times via Getty ImagesNew Delhi, June 25: ASHAs talk amongst themselves while conducting door to door survey to identify COVID-19 cases. Photo by Raj K Raj/Hindustan Times via Getty Images

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Demands like these have driven many ASHAs to protest. “We are warriors who were sent to war without any weapons,” says Sunita Rani, an ASHA from the northern state of Haryana. She has been protesting against the state government since July and says she won’t give up until their demands are met. “If we can fight a virus, we definitely know how to fight our governments.” The Indian government hasn’t yet responded to their demands for permanent government employment.

Most health experts seem to agree that ASHAs are underpaid. But some say that making their roles full-time is more complicated. “The beauty of this role is the mix of incentives that tend to energize ASHAs to perform better,” says Dr. Jyoti Joshi, the director of South Asia at the Center for Disease Dynamics, Economics and Policies, a public health research organization. She says retaining the incentives for completing tasks, while adding benefits like free family health checkups, might be one solution.

Pay varies by state, and salaries can range from 2,000 rupees ($27) to 10,000 rupees ($135) per month, according to a national union for ASHAs. Many workers also depend on receiving bonuses. For instance, Ghugare receives 100 rupees ($1.25) if she vaccinates a child against measles, mumps and rubella and 600 rupees ($8) for delivering a baby for a family living below the poverty line.

Some economists argue that making nearly a million female health care workers full-time employees, and paying them more, will not only benefit India’s health system but might also help revive the country’s battered economy, one of the worst hit by the pandemic. “Employing and putting wages into the hands of so many people will definitely be beneficial to the rural economy, ” says Dipa Sinha, an economist at the Ambedkar University in New Delhi.

It might also help recover India’s plummeting rate of female workplace participation, for which the country is among the bottom 10 in the world. Experts have attributed this to cultural attitudes and the slowdown in the agricultural sector, where most rural women work. Sinha says that this gender disparity plays into the issue of ASHAs not being recognized for their work. “Who volunteers for six to eight hours a day?” she says. “It’s because they are women that their work is undermined. You can’t do this to a cadre of men.”

Ghugare shares that sentiment although she didn’t take part in the protests. With her two children growing older, expenses are increasing. An increased salary with benefits would help her give her family a better life.

As she walks back home at dusk, she knows her day isn’t done yet. There is household work to get to before getting started with a report on the day’s survey. It will be midnight before she calls it a day. That is, if the phone doesn’t ring again.

“It feels like there is a sword over our heads,” she says. “A hanging sword.”

Is There Any Safe Way to Socialize Inside This Winter?

For months, there’s been a relatively easy way to socialize safely during the pandemic: take it outside. But now, with cold weather creeping into many parts of the world, park picnics, socially distant walks and outdoor dining are about to get less appealing for lots of people. Experts have warned for months that indoor gatherings are prime places for the virus to spread—but does that mean there’s no way to see anyone aside from your housemates this winter?

Here’s what five experts said about indoor socializing.

Why is outside safer than in?

SARS-CoV-2, the virus that causes COVID-19, can spread when someone comes into contact with large respiratory droplets, like those that escape with a sick person’s cough or sneeze. These large droplets are unlikely to travel further than six feet, hence the ubiquitous guidance around social distancing—which is usually easier to achieve outside than in.

But someone infected with SARS-CoV-2 is also constantly exhaling tiny respiratory particles, known as aerosols, that linger in the air. (Wearing a mask reduces the number of droplets and aerosols that get into the atmosphere.) In outdoor air, aerosols dissipate fairly quickly. But in an enclosed space, particularly one that is poorly ventilated, they can build up over time and potentially endanger anyone in the room, even people sitting more than six feet away from the sick person.

An Oct. 27 study published in Physics of Fluids found that aerosol transmission is not as much of a risk as droplet transmission, but confirmed that COVID-19 can spread via aerosols, especially in poorly ventilated spaces. Some “super shedders” also produce an above-average number of particles, unknowingly placing those around them at greater risk of infection, the paper found.

“If you walk into a bar and somebody starts smoking, initially you won’t really notice it,” says Shelly Miller, an indoor air expert from the University of Colorado, Boulder. “But eventually the smoke fills the whole bar, and it will stay in there because there’s no ventilation.” The same thing happens with the virus—and the more people who are exhaling aerosols into the air, the faster they build up.

Is there any good way to socialize inside?

Any time you invite someone into your home, you’re increasing your risk of catching or passing on the virus, since people can be infectious without showing symptoms. It’s still best to see people outdoors or virtually.

But if you do decide to have an indoor gathering, try to replicate the things that make outdoor hangs safer, suggests Dr. Beth Thielen, an assistant professor of pediatrics and infectious disease at the University of Minnesota Medical School. Pick as large a space as you can and open windows for ventilation. You should also keep the group small and try to wear masks the whole time, Thielen says.

If it’s too cold to open all the windows, switch up which ones are open, says Lidia Morawska, a World Health Organization consultant and aerosol expert from Australia’s Queensland University of Technology. Studies have shown that people sitting downwind of an infected person are the most likely to get infected, so mixing up airflow may help neutralize risk. “Don’t stay in one place. Mix. Move. Change how you open the windows,” Morawska suggests.

The length of your exposure matters too, Miller says. “If you have really high levels [of particles in the air] but you’re breathing them for a shorter time, your risk is going to be lower,” she says. Miller says she’s invited friends over for 30-minute catch-up sessions, ideally wearing masks, to get in some socializing without spending too long together.

Are public places okay?

In most indoor establishments, you likely have little control over whether windows are open and how many people are inside; you also have no idea whether your fellow patrons have been exposed to the virus. But some public places are likely safer than others.

Dining or drinking inside means you’ll inevitably be around maskless people, which removes a layer of protection. (Speaking loudly over the din of others also leads people to expel more droplets and viral particles, studies have shown.) Sit-down restaurants where people mostly stay at their own tables are likely safer than bars, where people tend to mingle and may ignore public-health guidelines after they’ve had a few drinks, says Dr. Tom Hennessy, an infectious disease epidemiologist at the University of Alaska. In either case, try to pick places that have limited capacity, and avoid establishments that feel hot and stuffy or don’t have many windows—they probably don’t have good ventilation, Miller says.

Public places not meant for eating and drinking, like malls and museums, have some advantages over bars and restaurants, since everybody can remain masked the whole time they’re inside. They also tend to be much larger, allowing viral particles to disperse—especially if they’re operating at reduced capacity. “If you’re in a large room and the room is well-ventilated and there’s not too many people…then the risk [of aerosol transmission] is actually fairly small,” says Daniel Bonn, co-author of the new Physics of Fluids study and an engineering professor at the University of Amsterdam.

Bonn’s study found that aerosol transmission was most likely to occur in enclosed, poorly ventilated places. Very small spaces, like public elevators and bathrooms, were the riskiest, while larger, better-ventilated places, like office buildings, were fairly safe. Bars, restaurants and private homes are likely somewhere in between.

What about quarantine pods?

Some people have formed quarantine “pods” by picking a few close friends or family members to see indoors, while cutting out nearly all other in-person contact. This can be a good system, Thielen says, as long as you’re very clear about ground rules. “You have to know that the people within your pod are not having 10 other pods that they’re getting together with,” Thielen says.

There’s no exact threshold at which a pod gets too big, Hennessy says, but smaller is always better. Each person you add to the group increases the chances of someone having a risky encounter and exposing others. Before you start or expand your pod, it’s also a good idea for everyone to quarantine for a couple weeks and get tested to ensure nobody is unknowingly infected.

Can my kids see their friends?

Early in the pandemic, some studies suggested children are unlikely to catch and spread COVID-19, leading some parents to carry on with indoor playdates. While it’s true that kids are much less likely than adults to develop severe cases of coronavirus, they can and do catch and transmit the virus, as recent studies and case reports have shown. “There are certainly enough well-documented cases of kids transmitting that we should generally be exercising the same precautions as for older family members,” Thielen says.

“Even more than adults, kids are comfortable being outside,” Thielen adds. Take advantage of their resilience by setting up (short) outdoor playdates, even when the weather gets snowy.

Can I see family for the holidays?

Any indoor gathering is risky this year, no matter who you’re seeing or for what purpose. Even for holidays, small, masked gatherings are safest.

If you decide to have prolonged visits with relatives—particularly if they’re elderly or otherwise vulnerable—Hennessy recommends first getting tested, isolating for at least a week and then getting tested again to confirm the negative result. “One test isn’t enough, really,” he says.

The equation gets even more complicated if you have to travel to see family. Though airplanes do have good air filtration systems, Hennessy says it’s still risky to sit shoulder-to-shoulder with lots of other people, potentially for hours. For that reason, people traveling for the holidays should aim to get tested pre- and post-trip, ideally with about a week of isolation after getting off the plane or train. If the logistical headache of isolating for a week post-flight is too much, this may be a year to skip holiday travel, Hennessy says.