F.D.A. Delays Decision on Juul’s E-Cigarettes but Orders Others Off the Market
The agency had faced a Sept. 9 deadline to decide whether the products could stay on the market but said it needed more time to review evidence.
The Food and Drug Administration on Thursday put off a long-anticipated ruling on whether Juul Labs and other major e-cigarette companies could continue to sell their products in the United States.
The companies are at the center of a review of the vaping industry that the agency has been conducting for the past year. The F.D.A. said on Thursday that it had so far denied the applications of 946,000 flavored e-cigarette products to remain on the market, mostly made by small companies.
No e-cigarettes have been approved through the application process, an agency official said.
“The F.D.A. is committed to completing the review of the remaining products as quickly as possible,” the agency said in a statement Thursday afternoon.
The F.D.A. had earlier signaled that it would rule on the larger companies by Thursday, one year after applications to stay on the market were due. Many public health experts had hoped a ruling on the market leaders would clarify the conditions under which companies could operate.
“They still haven’t made any of the tough decisions,” said Eric Lindblom, a tobacco policy expert at the Georgetown University Law Center. “I expected a little bit more, and I’m not an optimist.”
In a response to the agency’s move, Juul said in a statement that it “respects the central role of the F.D.A.” in concluding a “thorough” review of its applications.
Advocates of e-cigarettes see the products as a way to wean smokers from traditional cigarettes, which are more toxic, while critics say they are just another nicotine delivery system and one that is luring young people to the drug.
Juul, the market leader, whose sleek devices led to a surge in vaping among teenagers who had never smoked, has been at the center of the debate. By pushing back its decision on the company, the F.D.A. appears to be delaying a larger decision about whether the agency sees these devices as creating more harm than good.
The F.D.A. is considering applications for e-cigarette products from around 500 companies, many of them small. Companies have to show that their vaping products are less harmful than traditional cigarettes, and that their usefulness in helping smokers quit outweighs the risk that some people will start using nicotine through the products.
Matthew Myers, president of the Campaign for Tobacco-Free Kids, said that the F.D.A.’s denial of thousands of products was “significant” progress but that much more was needed, such as action on Juul and a ban on all flavored e-cigarettes, including menthol.
“The decisions the F.D.A. still has to make are more important than the ones they’ve made already,” Mr. Myers said. “If they don’t commit to making them promptly, then we have no choice but to ask a court to intervene.”
While overall smoking rates have fallen sharply since the mid-1960s, smoking remains the leading cause of preventable death in the United States, contributing to the deaths of nearly half a million Americans each year. E-cigarettes, which deliver vaporized nicotine without many of the carcinogens inhaled with combustible cigarettes, have been marketed as a safer alternative despite unsettled science about their broader public health impact.
Since e-cigarettes came on the market in the United States in the mid-2000s, youth vaping has increased steadily. By 2019, more than 27 percent of high school students reported in surveys that they vaped. That figure dropped to less than 20 percent during the coronavirus pandemic, which experts said could partly reflect the fact that teenagers were isolated and less likely to use social drugs.
The fate of Juul and other market leaders also is part of a larger conversation about the best way to further discourage cigarette use. Some experts believe the most effective step would be to limit the amount of nicotine levels in traditional cigarettes, making them less appealing.
Juul initially pitched itself as a foe of Big Tobacco. But in December 2018, the company sold a 35 percent stake to Altria, one of the world’s largest cigarette companies, for $12.8 billion.
Critics have argued that Juul’s initial marketing campaigns and flavors like cool cucumber and crème brûlée lured a new generation of young people to nicotine, many of whom became addicted.
The company recently agreed to pay $40 million to settle a lawsuit with the State of North Carolina over its marketing practices, allowing Juul to avoid public testimony from aggrieved teenagers and families. The company still faces thousands of other lawsuits.
Juul officials have long said that the company never sought a youth market. They have argued that Juul has taken aggressive steps to discourage youth use, including suspending its advertising in the United States.
Under pressure from the F.D.A., the company pulled almost all its flavors from the market in 2019. It has since submitted applications for only menthol- and tobacco-flavored products. It is seeking approval for its nicotine pods in two strengths: 5 percent, which is equivalent to the nicotine in an average pack of cigarettes, and 3 percent.
As part of its request to gain approval for its nicotine pods, Juul filed a 125,000-page application to the F.D.A., making the case that its products have public health benefits. Research that the company funded has suggested that the devices can be effective at helping smokers quit. A study that began with 55,000 adult Juul users found that 58 percent of the 17,000 smokers who stayed in the study had stopped smoking at 12 months. Another 22 percent continued to smoke both e-cigarettes and traditional ones but cut their cigarette smoking by at least half.
Several major health organizations — the American Heart Association, the American Lung Association, the American Academy of Pediatrics and the American Cancer Society Cancer Action Network — have asked the F.D.A. to reject Juul’s application.
On Thursday, the American Heart Association said that it was disappointed by the F.D.A.’s inaction on big companies like Juul, which the heart association said “has targeted our nation’s teens for years and contributed to the epidemic of tobacco use among youth.”
Biden Mandates Vaccines for Workers, Saying, ‘Our Patience Is Wearing Thin’
Initially reluctant to enact mandates, the president is now moving aggressively to require vaccination as the Delta variant races across the country.
Katie Rogers and
WASHINGTON — President Biden on Thursday used the full force of his presidency to push two-thirds of American workers to be vaccinated against the coronavirus, reaching into the private sector to mandate that all companies with more than 100 workers require vaccination or weekly testing.
Mr. Biden also moved to mandate shots for health care workers, federal contractors and the vast majority of federal workers, who could face disciplinary measures if they refuse.
The sweeping actions, which the president announced in a White House speech, are the most expansive he has taken to control the pandemic and will affect almost every aspect of society. They also reflect Mr. Biden’s deep frustration with the roughly 80 million Americans who are eligible for shots but have not gotten them.
“We’ve been patient,” Mr. Biden said in a sharp message to those who refuse to be vaccinated. “But our patience is wearing thin. And your refusal has cost all of us.”
Initially reluctant to enact mandates, Mr. Biden is now moving more aggressively than any other president in modern history to require vaccination, experts say. In his remarks, he promised to “protect vaccinated workers from the unvaccinated.”
“We can and we will turn the tide on Covid-19,” he said.
Even so, Mr. Biden conceded that the mandates would take time to “have full impact.” They are also all but certain to be the subject of legal challenges; already, the largest union representing federal workers has raised questions. It is also unclear how many workers subject to the new mandates have already been vaccinated.
Mr. Biden is acting through a combination of executive orders and new federal rules. Under his plan, private-sector businesses that have 100 or more employees will have to require vaccination, or mandatory weekly testing, after the Occupational Safety and Health Administration drafts a rule. Roughly 17 million health care workers employed by hospitals and other institutions that accept Medicare and Medicaid reimbursement will also face strict new vaccination requirements, as will federal contractors and most federal workers.
Experts say Mr. Biden has the legal authority to impose vaccine requirements on the private sector, through laws that require businesses to comply with evidence-based federal health safety standards. OSHA, which enforces workplace safety, has already imposed other pandemic precautions, such as a rule in June requiring health care employers to provide protective equipment and adequate ventilation and ensure social distancing, among other measures. Robert I. Field, a law professor at Drexel University, said that OSHA had the authority to protect workers’ safety, keeping them from being exposed to a potentially deadly virus, by requiring vaccinations.
Lawrence O. Gostin, a Georgetown University law professor who specializes in public health, added: “The president’s plan is bold, audacious and unprecedented. But I do think it’s entirely lawful. He’s on extremely strong legal ground.”
The moves, which Mr. Biden said would cover 100 million people, are part of a broader White House effort to curb the pandemic, which began to spin out of control in July even as Mr. Biden and his top aides were forecasting a “summer of joy” and declaring independence from the virus. Since then, the highly infectious Delta variant has spread rapidly, fueling a spike in cases and deaths.
Also on Thursday, Mr. Biden ordered mandatory vaccination for nearly 300,000 educators in the federal Head Start Program and at more than 200 federally run schools. He announced that he would use the Defense Production Act to increase the production of rapid testing kits and would work with retailers, including Amazon and Walmart, to expand their availability. And he said the Transportation Security Administration would now double fines on passengers who refuse to wear masks.
“If you break the rules, be prepared to pay — and by the way, show some respect,” Mr. Biden said, in a salty reference to angry airline passengers who refuse to mask up. “The anger you see on television toward flight attendants and others doing their jobs is wrong. It’s ugly.”
Experts say vaccine mandates are highly effective at preventing the spread of infectious disease; that is why schools require vaccination against measles, mumps and other childhood ailments. Since the announcement on Aug. 25 that the Pentagon would require active duty military personnel to be vaccinated against Covid-19, the percentage of military members with at least one shot rose from 76.22 percent to 82.96 percent, according to Pentagon data.
But Mr. Biden is unveiling his plan in a deeply polarized environment around Covid-19 vaccination, and experts seemed split on how effective it will be.
Dr. Georges C. Benjamin, executive director of the American Public Health Association, said the actions might be “too little, too late,” and warned that Americans opposed to vaccination might dig in and bristle at being told what to do. The American Hospital Association was cautious, warning that the moves “may result in exacerbating the severe work force shortage problems that currently exist.”
But Dr. William Schaffner, an infectious disease expert at Vanderbilt University, said the policy was necessary, and likened it to military service in a time of war.
“To date we have relied on a volunteer army,” Dr. Schaffner said. “But particularly with the Delta variant, the enemy has been reinforced, and now a volunteer army is not sufficient. We need to institute a draft.”
Slightly more than half of Americans, 53 percent, are fully vaccinated. The number of people seeking shots ticked up considerably in August, as Delta pushed the country’s daily average caseload over 150,000 for the first time since late January, overwhelming hospitals in hard-hit areas and killing roughly 1,500 people a day.
But the vaccination rate has yet to help the nation cross the threshold of “herd immunity” — the tipping point that occurs when widespread vaccination, coupled with natural immunity, slows the spread of a virus. If it continues to spread, officials fear that it will mutate into another, even more dangerous variant that could evade vaccines.
“When you have 75 to 80 million people who are eligible to be vaccinated, who don’t get vaccinated, you’re going to have a dynamic of continual smoldering spread of the infection,” Mr. Biden’s top medical adviser for the coronavirus pandemic, Dr. Anthony S. Fauci, warned in an interview, adding, “It’s very frustrating, because we have the wherewithal within our power to be able to actually suppress it.”
The mandate for federal workers is an especially assertive move by the president. Jen Psaki, the White House press secretary, told reporters on Thursday that aside from some religious and disability exemptions, most would be subject to a 75-day grace period for receiving a vaccine.
If workers decline to receive shots in that time frame, Ms. Psaki said, they will “go through the standard H.R. process,” which she said would include progressive disciplinary action. At least one major labor union challenged the mandate even before Mr. Biden delivered his speech.
Cathie McQuiston, a deputy general counsel for the American Federation of Government Employees, a union representing some 700,000 federal workers, said in an interview that her organization would be working with agencies to “not skip over procedures and make sure employees have due process” if they are disciplined.
The federal employee mandate will apply to employees of the executive branch, including the White House and all federal agencies and members of the armed services — a work force that numbers more than four million — but not to those who work for Congress or the federal court system, according to White House officials.
The mandate for health care workers will apply to those employed by most institutions that accept Medicare and Medicaid reimbursement, including hospitals, dialysis centers and nursing homes, according to the officials. It will be enforced by the Centers for Medicare and Medicaid Services, which regulates the health care industry.
“We would like to be a model for what we think other business and organizations should do around the country,” Ms. Psaki added.
The mandates are a marked shift for a president who, mindful of the contentious political climate around vaccination, initially steered away from any talk of requiring vaccines. In late July, he took one step closer to mandates by announcing that federal workers who refused to be vaccinated would have to undergo regular coronavirus testing. But last month’s decision by the Food and Drug Administration to grant full approval to the Pfizer-BioNTech vaccine to those 16 and older — which also prompted the Pentagon to require its employees to be vaccinated — has strengthened Mr. Biden’s hand.
My job as president is to protect all Americans. So tonight I’m announcing that the Department of Labor is developing an emergency rule to require all employers with 100 or more employees — that together employ over 80 million workers — to ensure their workforces are fully vaccinated or show a negative test at least once a week. Some of the biggest companies are already requiring this: United Airlines, Disney, Tyson Foods and even Fox News. The bottom line — we’re going to protect vaccinated workers from unvaccinated coworkers. Already, I’ve announced we’ll be requiring vaccinations at all nursing home workers who treat patients on Medicare and Medicaid because I have that federal authority. Tonight, I’m using that same authority to expand that to cover those who work in hospitals, home health care facilities or other medical facilities. A total of 17 million health care workers. If you’re seeking care at a health facility, you should be able to know that the people treating you are vaccinated. Simple, straightforward, period. Next, I will sign an executive order that will now require all executive branch federal employees to be vaccinated, all. And I’ve signed another executive order that will require federal contractors to do the same. If you want to work with the federal government and do business with us, get vaccinated.
Companies had put off the question of whether to mandate for months, worried about potential litigation and employee pushback. But stalling vaccination rates and the rise of the Delta variant put new pressure on executives. They were provided cover to go forward with requirements after earlier mandate moves by the Biden administration.
Soon after, Walmart, Walt Disney Company, Google and others said they would adopt mandates. When the Pfizer vaccine received full federal approval late last month, Goldman Sachs, Chevron and others followed suit as Mr. Biden encouraged corporate mandates.
Still, Mr. Gostin said there was much more the president could do. He has already exercised his executive authority to require masks on airplanes and interstate trains and buses, and could similarly mandate vaccination for international or interstate travel — a step that Mr. Gostin described as “low-hanging fruit.”
One thing Mr. Biden cannot do is require all Americans to be vaccinated; in the United States, vaccinations are the province of the states. But Mr. Gostin said the president could also dangle the prospect of federal funding to prod states to require their own workers to be vaccinated, and his administration could offer technical guidance to states that want to develop so-called vaccine passports for people to provide digital proof of vaccination.
But the president made it clear on Thursday that he would do what he could to “require more Americans to be vaccinated to combat those blocking public health,” a reference to Republican governors who have blocked attempts to mandate masks or require vaccines.
“If they will not help,” Mr. Biden said, “if those governors won’t help us beat the pandemic, I’ll use my power as president to get them out of the way.”
Reporting was contributed by Lauren Hirsch, Reed Abelson and Roni Caryn Rabin from New York, and Jennifer Steinhauer and Adam Liptak from Washington.
Biden’s Speech on Vaccine Mandates and the Delta Variant: Full Transcript
“My message to unvaccinated Americans is this: What more is there to wait for?” President Biden said on Thursday. “We’ve been patient, but our patience is wearing thin.”
The following is a transcript of President Biden’s remarks on Thursday about his administration’s push to mandate coronavirus vaccines for two-thirds of American workers as the Delta variant surges across the United States.
Good evening, my fellow Americans. I want to talk to you about where we are in the battle against Covid-19 — the progress we’ve made and the work we have left to do, and it starts in understanding this: Even as the Delta variant 19 has — Covid-19 has been hitting this country hard, we have the tools to combat the virus, if we can come together as a country and use those tools. If we raise our vaccination rate, protect ourselves and others with masking, expanding testing and identify people who are infected, we can and we will turn the tide on Covid-19.
It will take a lot of hard work, and it’s going to take some time. Many of us are frustrated with the nearly 80 million Americans who are still not vaccinated, even though the vaccine is safe, effective and free. You might be confused about what is true and what is false about Covid-19. So, before I outline the new steps to fight Covid-19 that I’m going to be announcing tonight, let me give you some clear information about where we stand.
First, we’ve made considerable progress in battling Covid-19. When I became president, about two million Americans were fully vaccinated. Today, over 175 million Americans have that protection. Before I took office, we hadn’t ordered enough vaccine for every American. Just weeks in office, we did. The week before I took office on Jan. 20 of this year, over 25,000 Americans died that week from Covid-19.
Last week, that grim weekly toll was down 70 percent. And then three months before I took office, our economy was faltering, creating just 50,000 jobs a month. We’re now averaging 700,000 new jobs a month in the past three months. This progress is real. But while America is in much better shape than it was seven months ago, when I took office, I need to tell you a second fact. We’re in the tough stretch, and it could last for a while.
Highly contagious Delta variant that I began to warn America back in July, spread late summer, like it did in other countries before us. While the vaccines provide strong protection for the vaccinated, we read about and hear about and we see the stories of hospitalized people, people on their death beds among the unvaccinated over the past few weeks. This is a pandemic of the unvaccinated.
And it’s caused by the fact that despite America having unprecedented and successful vaccination program — despite the fact that for almost five months, free vaccines have been available in 80,000 different locations — we still have nearly 80 million Americans who have failed to get the shot. And to make matters worse, there are elected officials actively working to undermine the fight against Covid-19. Instead of encouraging people to get vaccinated and mask up, they are ordering mobile morgues for the unvaccinated dying from Covid in our communities. This is totally unacceptable.
Third, if you wonder how all this adds up, here’s the math. The vast majority of Americans are doing the right thing. Nearly three-quarters of the eligible have gotten at least one shot. But one-quarter has not gotten any. That’s nearly 80 million Americans not vaccinated. In a country as large as ours, that’s 25 percent minority. That 25 percent can cause a lot of damage, and they are. The unvaccinated overcrowd our hospitals or overrun the emergency rooms and intensive care units, leaving no room for someone with a heart attack or pancreatitis or cancer.
And fourth, I want to emphasize that the vaccines provide very strong protection from Covid-19. I know there’s a lot of confusion and misinformation, but the world’s leading scientists confirm that if you’re fully vaccinated, your risk of severe illness from Covid-19 is very low. In fact, based on available data from the summer, only one out of every 160,000 fully vaccinated Americans was hospitalized for Covid per day. These are the facts.
So here’s where we stand. The path ahead, even with the Delta variant, is not nearly as bad as last winter. What makes it incredibly more frustrating is that we have the tools to combat Covid-19, and a distinct minority of Americans, supported by a distinct minority of elected officials, are keeping us from turning the corner. These pandemic politics, as I refer to, are making people sick, causing unvaccinated people to die.
We cannot allow these actions to stand in the way of the large majority of Americans who have done their part and want to get back to life as normal. As your president, I’m announcing tonight a new plan to require more Americans to be vaccinated to combat those blocking public health. My plan also increases testing, protects our economy and will make our kids safer in schools.
It consists of six broad areas of action and many specific measures of each of those actions that you can read more about at Whitehouse.gov. Whitehouse.gov. The measures, these are going to take time to have full impact. But if we implement them, I believe and the scientists indicate that the months ahead, we can reduce the number of unvaccinated Americans, decrease hospitalizations and deaths, and allow our children to go to school safely, and keep our economy strong by keeping businesses open.
First, we must increase vaccinations among the unvaccinated with new vaccination requirements. With nearly 80 million eligible Americans who have not gotten vaccinated, many said they were waiting for approval from the Food and Drug Administration, the F.D.A. Well, last month the F.D.A. granted that approval. So, the time for waiting is over.
This summer, we made progress through a combination of vaccine requirements and incentives as well as the F.D.A. approval. Four million more people got their first shot in August than they did in July. But we need to do more. This is not about freedom or personal choice. It’s about protecting yourself and those around you — the people you work with, the people you care about, the people you love.
My job as president is to protect all Americans. So tonight, I’m announcing that the Department of Labor is developing an emergency rule to require all employers with 100 or more employees that together employ over 80 million workers to ensure their work forces are fully vaccinated or show a negative test at least once a week.
Some of the biggest companies are already requiring this: United Airlines, Disney, Tyson Foods and even Fox News. The bottom line: We’re going to protect vaccinated workers from unvaccinated co-workers. We’re going to reduce the spread of Covid-19 by increasing the share of the work force that is vaccinated in businesses all across America.
My plan will extend the vaccination requirements that I previously issued in the health care field. Already, I’ve announced we’ll be requiring vaccinations that all nursing home workers who treat patients on Medicare and Medicaid, because I have that federal authority.
Tonight I’m using that same authority to expand that to cover those who work in hospitals, home health care facilities or other medical facilities. A total of 17 million health care workers. If you’re seeking care at a health facility, you should be able to know that the people treating you are vaccinated — simple, straightforward, period.
Next, I will sign an executive order that will now require all executive branch federal employees to be vaccinated — all. I’ve signed another executive order that will require federal contractors to do the same. If you want to work with the federal government and do business with us, get vaccinated. If you want to do business with the federal government, vaccinate your work force.
And tonight I’m removing one of the last remaining obstacles that make it difficult for you to get vaccinated. The Department of Labor will require employers with 100 or more workers to give those workers paid time off to get vaccinated. No one should lose pay in order to get vaccinated or take a loved one to get vaccinated.
Today, in total, the vaccine requirements in my plan will affect about 100 million Americans — two-thirds of all workers. And for other sectors, I issue this appeal: To those of you running large entertainment venues from sports arenas to concert venues to movie theaters, please require folks to get vaccinated or show a negative test as a condition of entry.
And to the nation’s family physicians, pediatricians, G.P.s — general practitioners — you’re the most trusted medical voice to your patients. You may be the one person who can get someone to change their mind about being vaccinated. Tonight, I’m asking each of you to reach out to your unvaccinated patients over the next two weeks and make a personal appeal to them to get the shot. America needs your personal involvement in this critical effort.
My message to unvaccinated Americans is this: What more is there to wait for? What more do you need to see? We’ve made vaccinations free, safe and convenient. The vaccine is F.D.A. approved. Over 200 million Americans have gotten at least one shot. We’ve been patient, but our patience is wearing thin. And your refusal has cost all of us.
So, please, do the right thing. But don’t just take it from me. Listen to the voices of unvaccinated Americans who are lying in hospital beds, taking their final breath, saying, “If only I had gotten vaccinated.” If only. It’s a tragedy. Please don’t let it become yours.
The second piece of my plan is continuing to protect the vaccinated. The vast majority of you who have gotten vaccinated, I understand your anger at those who haven’t gotten vaccinated. I understand the anxiety about getting a breakthrough case. But as the science makes clear, if you’re fully vaccinated, you’re highly protected from severe illness even if you get Covid-19.
In fact, recent data indicates there’s only one confirmed positive case per 5,000 fully vaccinated Americans per day. You’re as safe as possible, and we’re doing everything we can to keep it that way — keep it that way and keep you safe. That’s where boosters come in — the shots that give you even more protection than after your second shot.
Now, I know there’s been some confusion about boosters, so let me be clear. Last month, our top government doctors announced an initial plan for booster shots for vaccinated Americans. They believe that a booster is likely to provide the highest level of protection yet. Of course, the decision of which booster shots to give or when to start them and who will give them will be left completely to the scientists at the F.D.A. and the Centers for Disease Control.
But while we wait, we’ve done our part. We bought enough boosters, enough booster shots, and the distribution shot is ready to administer them. As soon as they are authorized, those eligible will be able to get a booster right away at tens of thousands of sites across the country — for most Americans, at your nearby drugstore and for free.
The third piece of my plan is keeping — and maybe the most important — is keeping our children safe and our schools open. For any parent, it doesn’t matter how low the risk of any illness or accident is when it comes to your child or grandchild. Trust me. I know. So, let me speak to you directly. Let me speak to you directly to help ease some of your worries.
It comes down to two separate categories: children ages 12 and older, who are eligible for a vaccine now, and children ages 11 and under, who are not yet eligible. The safest thing for your child 12 and older is to get them vaccinated. They get vaccinated for a lot of things. That’s it. Get them vaccinated.
As with the adults, almost all of the serious Covid-19 cases we’re seeing among adolescents are in unvaccinated 12- to 17-year-olds, an age group that lags behind in vaccination rates. So parents, please get your teenager vaccinated.
What about children under the age of 12 who can’t get vaccinated yet? Well, the best way for a parent to protect their child under the age of 12 starts at home. Every parent, every teen sibling, every caregiver around them should be vaccinated. Children have a four times higher chance of getting hospitalized if they live in a state with low vaccination rates rather than states with high vaccination rates.
Now if you’re a parent of a young child and you’re wondering when will it be, when will it be — the vaccine — available for them? I strongly support independent scientific review for vaccine uses for children under 12. We can’t take shortcuts of that scientific work.
But I’ve made it clear, I will do everything within my power to support the F.D.A. with any resource it needs to continue to do this as safely and as quickly as possible. And our nation’s top doctors are committed to keeping the public at large updated on the process so parents can plan.
Now to the schools. We know that if schools follow the science and implement the safety measures like testing, masking, adequate ventilation systems that we provided the money for, social distancing and vaccinations, then children can be safe from Covid-19 in schools. Today, about 90 percent of school staff and teachers are vaccinated. We should get that to 100 percent.
My administration has already required teachers at the schools run by the Defense Department — because I have the authority, as president, in the federal system, the Defense Department and the Interior Department — to get vaccinated. That’s the authority I possess. Tonight I’m announcing that we’ll require all of nearly 300,000 educators in the federal paid program, Head Start program, must be vaccinated as well to protect your youngest, our youngest, most precious Americans, and give parents the comfort.
And tonight I’m calling on all governors to require vaccinations for all teachers and staff. Some already have done so. We need more to step up. Vaccination requirements in schools are nothing new. They work. They are overwhelmingly supported by educators and their unions and all school officials trying do the right thing by our children. I’ll always be on your side.
Let me be blunt. My plan also takes on elected officials in states that are undermining you and these lifesaving actions. Right now, local school officials are trying to keep children safe in a pandemic while their governor picks a fight with them and even threatens their salaries or their jobs. Talk about bullying in schools.
If they will not help, if those governors won’t help us beat the pandemic, I’ll use my power as president to get them out of the way. The Department of Education has already begun to take legal action against states undermining protection that local school officials have ordered. Any teacher or school official whose pay is withheld for doing the right thing, we will have that pay restored by the federal government, 100 percent. I promise you, I will have your back.
The fourth piece of my plan is increasing testing and masking. From the start, America has failed to do enough Covid-19 testing. In order to better detect and control the Delta variant, I’m taking steps tonight to make testing more available, more affordable and more convenient. I’ll use the Defense Production Act to increase production of rapid tests, including those that you can use at home.
While that production is ramping up, my administration has worked with top retailers like Walmart, Amazon and Kroger, and tonight we’re announcing that no later than next week each of these outlets will start to sell at-home rapid test kits at cost for the next three months.
This is immediate price reduction for at-home test kits for up to 35 percent reduction. We’ll also expand free testing at 10,000 pharmacies around the country. And we’ll commit, we’re committing $2 billion to purchase nearly 300 million rapid tests for distribution to community health centers, food banks, schools, so that every American, no matter their income, can access free and convenient tests.
This is important to everyone, particularly for a parent or a child — with a child not old enough to be vaccinated. You’ll be able to test them at home and test those around them. In addition to testing, we know masking helps stop the spread of Covid-19. That’s why when I came into office, I required masks for all federal buildings and on federal lands, on airlines and other modes of transportation.
Today, tonight, I’m announcing that the Transportation Safety Administration, the T.S.A., will double the fines on travelers that refuse to mask. If you break the rules, be prepared to pay. And by the way, show some respect. The anger you see on television toward flight attendants and others doing their jobs is wrong. It’s ugly.
The fifth piece of my plan is protecting our economic recovery. Because of our vaccination program, and the American Rescue Plan, which we passed early in my administration, we’ve had record job creation for a new administration. Economic growth unmatched in 40 years. We cannot let unvaccinated do this progress — undo it. Turn it back. So tonight I’m announcing additional steps to strengthen our economic recovery.
We’ll be expanding Covid-19 economic injury disaster loan programs. That’s a program that’s going to allow small businesses to borrow up to $2 million, from the current $500,000, to keep going if Covid-19 impacts on their sales. These low-interest, long-term loans require no repayment for two years and can be used to hire and retain workers, purchase inventory or even pay down higher-cost debt racked up since the pandemic began. I’ll also be taking additional steps to help small businesses stay afloat during the pandemic.
Sixth, we’re going to continue to improve the care of those who do get Covid-19. In early July, I announced the deployment of surge response teams. These are teams comprised of experts from the Department of Health and Human Services, the C.D.C., the Defense Department and the Federal Emergency Management Agency, FEMA, to areas in the country that need help to stem the spread of Covid-19. Since then, the federal government has deployed nearly 1,000 staff including doctors, nurses, paramedics, into 18 states. Today, I’m announcing that the Defense Department will double the number of military health teams that they will deploy to help their fellow Americans and hospitals around the country.
Additionally, we’re increasing the availability of new medicines recommended by real doctors, not conspiracy theorists. The monoclonal antibody treatments have been shown to reduce the risk of hospitalization by up to 70 percent for unvaccinated people at risk of developing severe disease. We’ve already distributed 1.4 million courses of these treatments to save lives and reduce the strain on hospitals. Tonight, I’m announcing we’ll increase the average pace of shipment across the country of free monoclonal antibody treatments by another 50 percent.
Before I close, let me say this: Communities of color are disproportionately impacted by this virus. As we continue to battle Covid-19, we will ensure that equity continues to be at the center of our response. We’ll ensure that everyone is reached. My first responsibility as president is to protect the American people and make sure we have enough vaccine for every American, including enough boosters for every American who’s approved to get one.
We also know this virus transcends borders. That’s why even as we execute this plan at home we need to continue fighting the virus overseas, continue to be the arsenal of vaccines. We’re proud to have donated nearly 140 million vaccines to over 90 countries, more than all other countries combined — including Europe, China and Russia combined. That’s American leadership on a global stage, and that’s just the beginning. We’ve also now started to ship another 500 million Covid vaccines, Pfizer vaccines, purchased to donate to 100 lower-income countries in need of vaccines, and I’ll be announcing additional steps to help the rest of the world later this month.
As I recently released the key parts of my pandemic preparedness plan so that America isn’t caught flat-footed with a new pandemic comes again, as it will. Next month I’m also going to release a plan in greater detail.
So let me close with this: We’ve made so much progress during the past seven months of this pandemic. The recent increases in vaccinations in August already are having an impact in some states, where case counts are dropping in recent days. Even so, we remain at a critical moment, a critical time. We have the tools. Now we just have to finish the job with truth, with science, with confidence, and together as one nation.
Look, we’re the United States of America. There’s nothing, not a single thing we’re unable to do if we do it together. So let’s stay together.
God bless you all, and all those who continue to serve of on the front lines of this pandemic, and may God protect our troops.
Vaccination Mandates Are an American Tradition. So Is the Backlash.
The roots of U.S. vaccine mandates predate both the U.S. and vaccines.
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As disease and death reigned around them, some Americans declared that they would never get vaccinated and raged at government efforts to compel them. Anti-vaccination groups spread propaganda about terrible side effects and corrupt doctors. State officials tried to ban mandates, and people made fake vaccination certificates to evade inoculation rules already in place.
The years were 1898 to 1903, and the disease was smallpox. News articles and health board reports describe crowds of parents marching to schoolhouses to demand that their unvaccinated children be allowed in, said Michael Willrich, a professor of history at Brandeis University, with some even burning their own arms with nitric acid to mimic the characteristic scar left by the smallpox vaccine.
“People went to some pretty extraordinary lengths not to comply,” said Professor Willrich, who wrote “Pox: An American History,” a book about the civil liberties battles prompted by the epidemic.
If it all sounds familiar, well, there is nothing new under the sun: not years that feel like centuries, not the wailing and gnashing of teeth over masks, and not vaccine mandates either.
As the coronavirus overwhelms hospitals across the South and more than 650,000 Americans — an increasing number of them children — lie dead, the same pattern is emerging. On Thursday, President Biden announced that he would move to require most federal workers and contractors to be vaccinated and, more sweepingly, that all employers with 100 or more employees would have to mandate vaccines or weekly testing. Colleges, businesses and local governments have enacted mandates at a steady pace, and conservative anger has built accordingly.
On Monday, Representative Jim Jordan, Republican of Ohio, tweeted that vaccine mandates were “un-American.” In reality, they are a time-honored American tradition.
But to be fair, so is public fury over them.
“We’re really seeing a lot of echoes of the smallpox era,” said Elena Conis, an associate professor and historian of medicine at the University of California, Berkeley. “Mandates elicit resistance. They always have.”
The roots of U.S. vaccine mandates predate both the U.S. and vaccines. The colonies sought to prevent disease outbreaks by quarantining ships from Europe and sometimes, in the case of smallpox, requiring inoculations: a crude and much riskier predecessor to vaccinations in which doctors rubbed live smallpox virus into broken skin to induce a relatively mild infection that would guard against severe infection later. They were a source of enormous fear and anger.
In January 1777, George Washington mandated inoculations for the soldiers under his command in the Continental Army, writing that if smallpox were to break out, “we should have more to dread from it, than from the Sword of the Enemy.” Notably, it was in large part the soldiers’ desires that overcame his resistance to a mandate.
“They were the ones calling for it,” said Andrew Wehrman, an associate professor of history at Central Michigan University who studies the politics of medicine in the colonial and revolutionary eras. “There’s no record that I have seen — and I’ve looked — of any soldier turning it down, protesting it.”
Buoyed by the success of the mandate, Washington wrote to his brother in June 1777 that he was upset by a Virginia law restricting inoculations. “I would rather move for a Law to compell the Masters of Families to inoculate every Child born within a certain limitted time under severe Penalties,” he wrote.
Over the next century, many local governments did exactly that. Professor Wehrman this week tweeted an example of what, in an interview, he said was a “ubiquitous” phenomenon: The health board in Urbana, Ohio, Jordan’s hometown, enacted a requirement in 1867 that in any future epidemic, “the heads of families must see that all the members of their families have been vaccinated.”
But by the end of the 1800s, opposition was louder and more widespread. Some states, particularly in the West, introduced laws prohibiting vaccine mandates. Others narrowly passed mandates after intense debate.
The reasons for resistance were myriad: Some Americans opposed mandates on the grounds of personal liberty; some because they believed lawmakers were in cahoots with vaccine makers; and some because of safety concerns that were, to be fair, more grounded in reality than the modern equivalent. Vaccines then were not regulated the way they are now, and there were documented cases of doses contaminated with tetanus.
The government’s response resembled what, today, are wild conspiracy theories. Contrary to the assertions of some on the far right, the Biden administration has never suggested going door to door to force people to take coronavirus vaccines. But in the 1890s and 1900s, that actually happened: Squads of men would enter people’s homes in the middle of the night, breaking down doors if necessary, to inject people with smallpox vaccines.
Legally speaking, the Supreme Court resolved the issue of mandatory vaccinations in 1905, ruling 7-2 in Jacobson v. Massachusetts that they were constitutional.
The Constitution “does not import an absolute right in each person to be, at all times and in all circumstances, wholly freed from restraint,” Justice John Marshall Harlan, known for defending civil liberties, wrote. “Real liberty for all could not exist under the operation of a principle which recognizes the right of each individual person to use his own, whether in respect of his person or his property, regardless of the injury that may be done to others.”
In the court of public opinion, there was no such resolution.
The polio vaccine was less controversial, mainly because it wasn’t initially mandated and because it had been funded by a widely respected nonprofit: the National Foundation for Infantile Paralysis, now called the March of Dimes. This reduced opposition based on mistrust of pharmaceutical companies, and most parents willingly got their children vaccinated. The measles vaccine, too, was not particularly controversial because mandates were not initially enforced.
“Nobody was enforcing vaccination, and so it simply didn’t elicit that mistrust,” Professor Conis said. In the smallpox era, by contrast, “skeptical people said, ‘Well, why are we doing this? It just benefits the companies making the vaccine and the doctors administering the vaccine, and why should we trust any of them?’”
But the fear and anger came roaring back with the introduction of childhood vaccination mandates in the 1970s. By 1980, all 50 states required schoolchildren to be vaccinated against an array of diseases.
None of it is new, but one thing distinguishes today’s anti-vaccination protesters from those of the past. The opposition was always political. It wasn’t always partisan.
“There are plenty of echoes today: There are liberty claims, there are strong sentiments about parental rights, there are concerns about the science, there are concerns about the profit involved,” Professor Willrich said. “But this party divide in terms of who is most likely to be hesitant or refuse a vaccine mandate is really, I think, something of our own 21st-century moment.”
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Biden’s Vaccine Push: What You Need to Know
President Biden announced a plan that mandates vaccines for federal employees and workers and calls on schools to adopt vaccine requirements, among other things.
Moving aggressively to combat the spread of the Delta variant, President Biden announced a six-part plan on Thursday that would touch on nearly every aspect of society, in what amounted to the most expansive use of his presidential authority since he took office in January.
Here is what is in the plan.
To increase the number of Americans who are vaccinated, the Labor Department will develop an emergency rule requiring all private-sector businesses with more than 100 employees to require that their workforces be fully vaccinated or test negative at least once a week. The rule would affect an estimated 80 million workers. Employers will also be required to give paid time off for employees to get vaccinated.
In an expansion of his earlier push to vaccinate the federal work force, Mr. Biden signed an executive order requiring all executive branch employees and federal contractors to be vaccinated, with no exception to test out of the requirement.
Mr. Biden said he intended to extend a vaccination requirement that applies to health care workers who treat patients on Medicare and Medicaid in nursing homes to all other medical facilities, including hospitals and at-home care.
“The time for waiting is over,” the president said, estimating that the strategy would affect about 100 million Americans, or two-thirds of the work force.
Mr. Biden pointed to booster shots as a crucial way to continue to protect vaccinated Americans from the coronavirus. Government doctors “believe that a booster is likely to provide the highest level of protection yet,” he said.
The administration has bought the booster shots necessary to give Americans a third shot, and he said the federal government was “ready to administer them as soon as they are authorized.”
It is still unclear when booster shots will be available to the public, and Mr. Biden on Thursday reiterated the administration’s pledge that it would not offer the additional shots until federal regulators backed the proposal.
Last week, top federal health officials told the White House to scale back a plan to offer coronavirus booster shots this month to the general public, saying that their agencies needed more time to collect and review all the necessary data.
Mr. Biden announced a string of measures intended to keep the coronavirus from spreading in schools and infecting children under the age of 12, who are not yet eligible for a vaccine.
For parents, he urged that they ensure children ages 12 and older are vaccinated; for states, he urged mandating school staff and teachers to be inoculated.
Mr. Biden also said that nearly 300,000 educators who work in federally run school programs would be required to be vaccinated.
“About 90 percent of school staff and teachers are vaccinated,” he said. “We should get that to 100 percent.”
While no vaccine has been approved for children under the age of 12, the president said he continued to support the Food and Drug Administration as it worked to approve one “as safely and as quickly as possible.”
The president also slammed efforts by elected officials like Gov. Ron DeSantis of Florida who are dismantling local mask mandates, many of which apply to schools. Mr. Biden said the Education Department was moving to take legal action against those efforts and promised that the federal government would compensate any educator whose pay is withheld “for doing the right thing.”
“Right now, local school officials are trying to keep children safe in a pandemic while their governor picks a fight with them,” he said. “Talk about bullying in schools.”
As part of a broader effort to bolster the affordability and availability of testing, the president said that his administration had teamed up with retailers, including Amazon and Walmart, to lower the cost of at-home Covid-19 rapid tests.
That proposal includes dedicating nearly $2 billion to buy about 300 million rapid tests for community health centers, food banks and schools, “so that every American, no matter their income, can access free and convenient tests.”
He also said that the Transportation Security Administration would double fines on travelers who refused to wear masks.
“If you break the rules, be prepared to pay,” Mr. Biden said.
The president said that he would expand the loan programs run by the Small Business Administration that allow small-business owners to borrow money at low interest rates in order to hire and retain workers, buy inventory or even pay down debt as the coronavirus continues to cripple business.
Even as Mr. Biden heralded that the economy was now averaging 700,000 new jobs a month, he noted that the recovery was still continuing.
“While America is in much better shape than it was seven months ago when I took office,” he said, “we’re in the tough stretch, and it could last for a while.”
The president also outlined measures to address the increasing number of infections and hospitalizations, like bolstering support for overburdened hospitals and speeding new methods of treatment.
Mr. Biden said he would deploy “response teams” that would include experts from a number of government agencies “to stem the spread of Covid-19,” adding to health care teams that have already been deployed by the federal government.
The president also vowed to increase the availability of therapeutics that have been tested and recommended by doctors, including by increasing shipments of monoclonal antibodies.
Weekly Health Quiz: Coffee, Dorm Rooms and Exercise
Ann Patchett on Taking a Bad Fall to Find Good Luck
Ann Patchett finds that misfortune in small doses can cast a glittering light on the rest of life.
On a Sunday morning in the middle of July, I woke up tired. Who knows why? Maybe, like the dog, I had spent the night chasing rabbits in my sleep. I gave serious consideration to skipping my morning exercises (hadn’t the rabbits been enough?), but then decided to push ahead on the belief that an adherence to routine helps more often than it hurts. Surely gold medalist Sunisa Lee had been tired in Tokyo that morning, but she went flying through the air all the same.
When I got to the step-up portion of the 7-Minute Workout, I too was briefly flying. But my liftoff was misaligned, so that coming down I glanced off the edge of my step stool and hit the floor with my full weight on the side of my left foot.
After lying on my back for a few minutes, panting through self-recrimination and the bright crush of pain, I crawled to the phone and called my husband. Karl found me on the floor, foot aloft. He’s a doctor, and he took my tennis shoe off with professional care. “Did you hurt yourself anywhere else?”
I said no, thinking my quickly inflating foot was injury enough.
“Did you hit your head?” He was gently palpating my foot to see what points made me yelp, while introducing the topic of gratitude into the conversation. I had not hit my head.
“That’s how it happens,” he said, helping me to the bed. “You hit your head on the bookcase on the way down. Then it all falls apart.”
Karl said we could go to the emergency room right away or wait until tomorrow to see a doctor in the clinic. I opted for the ice pack, the Motrin and the pile of pillows. I opted to wait. Tennessee, the state where we live, is rife with people who decided to pass on the Covid vaccine, which meant that even though we were vaccinated, emergency rooms were no place to sit and wait.
The next day the orthopedist showed me the X-rays of my left foot. He told me I had badly sprained it, along with tearing some ligaments. He would get me a walking boot and, in time, all would be well. The doctor was almost to the door when he turned and looked at me again. “Let’s get one more X-ray,” he said.
He was smiling when he came back, the bearer of good news. He told me my ankle was fractured. “I’m not going to do surgery,” he said cheerfully. “I could put a screw in there, but I’m not going to do it.” Once immobilized, the bit of bone that had cracked off would mend itself.
“Oh,” Karl said, shaking his head after the doctor left us, “are you ever lucky.” He had seen his share of poor outcomes for ankle surgery. In his long career, he had seen pretty much everything.
When I was a child in Catholic school, the nuns never tired of telling us how lucky we were. Of course we were lucky in the obvious ways that should never be taken for granted — lucky for our health, our food, our families, lucky to be able to go to school — but in the face of real disaster, our luck escalated dramatically.
At 9, when I came back to school after a car accident, they tallied up my good fortune: a broken nose, a broken wrist, my lip stitched back together, shards of glass still pushing out of my skull — it could have been so much worse! My sister was worse, she was still in the hospital. She would be there for awhile, resting between the white sheets of her astonishing luck. She should have been dead, and she wasn’t.
At the time, I thought the nuns were idiots. They simply refused to see how we suffered. But now — 48 years later — I think, man, were we lucky.
“If you won’t even complain about being injured and bedridden, I worry that you’re a constitutionally cheerful person who can see the bright side in any situation and this whole thing isn’t going to work out,” a new young friend teased me in an email. I told her not to worry, I am fully capable of misery and complaint, I’m just saving mine.
Had I leapt up on a step stool and missed my landing two years ago, I doubt I would have managed the situation with quite so much sagacity. I would have found the boot burdensome (it is). I would have said the timing was impossible (no matter what the timing was). But the pandemic has taught me that my plans are of no importance, that everything can be canceled, that I’m lucky to have a house to live in and a person I love to live with.
As is true with most writers, I have a talent for stillness which has only been fortified by the last year and a half. Eight more weeks in the house doesn’t actually constitute a problem. My sprain-ligament-fracture trifecta doesn’t actually constitute a problem. It turns out I know a lot of people who’ve had metal plates screwed into their ankles, and we all know a lot of people who’ve had to deal with things much worse than that.
My friend Sister Nena, who taught me to read when I was 6, called to check on me. She’s broken both of her feet before, once the left and once the right. She wanted to know if I had a walking boot. I told her I did. “Oh,” she said, “you’re so lucky.”
Bad luck in small doses can cast a glittering light on the rest of life. It shows us just how close we came to smashing our heads on the bookcase, and so makes us look at the bookcase (the room, the house, the street, the town, the life) with a new sense of wonder. Sooner or later, in one form or another, the terrible thing will happen. I didn’t understand that when I was young, no matter how many nuns tried to tell me. Now, I think I do. And I’m grateful that this time I got off easy.
Ann Patchett is the co-owner of Parnassus Books in Nashville. Her essay collection “These Precious Days” will be published by HarperCollins in November 2021.
Fauci Says U.S. Virus Cases Are More Than Ten Times Too High
Emily Anthes and
Coronavirus infections are more than ten times higher than they need to be in order to end the pandemic, Dr. Anthony S. Fauci, the nation’s top infectious disease doctor, told the political news site Axios.
There are currently roughly 150,000 new infections a day in the United States. “That’s not even modestly good control,” Dr. Fauci told Axios.
He added, “In a country of our size, you can’t be hanging around and having 100,000 infections a day. You’ve got to get well below 10,000 before you start feeling comfortable.”
Case rates did fall to almost that level in June, when there were roughly 12,000 new infections per day, on average.
But that was before the highly infectious Delta variant spread widely throughout the country, causing a major surge in cases and hospitalizations, especially in areas of the country with low vaccination rates.
That surge has also impacted children, who are currently being hospitalized at the highest levels reported to date, with nearly 30,000 entering hospitals in August. No vaccine has been cleared for children younger than 12, who make up a sizable unvaccinated population in the United States.
In an interview with Apoorva Mandavilli, a New York Times reporter who covers science and global health, Dr. Fauci said that “we are still in the middle of a serious pandemic, and it is definitely involving children.”
“We’re seeing more children in the hospital now, because the Delta variant is more readily transmissible among everybody, adults and children,” Dr. Fauci said in the interview, which appeared on The Times’s website on Thursday.
Children still remain markedly less likely to be hospitalized or die from Covid-19 than adults, especially older adults. But experts say that the growing number of hospitalized children, however small compared with adults, should not be an afterthought, and should instead encourage communities to work harder to protect their youngest residents.
Although concerns have been growing about breakthrough infections, which officials acknowledge are not as rare as they once indicated, the vaccines continue to provide robust protection against the worst outcomes, including hospitalization and death.
Vaccination remains the best path out of the pandemic, experts and health officials have repeatedly said. “The endgame is to suppress the virus,” Dr. Fauci told Axios. “Right now, we’re still in pandemic mode.”
Otro riesgo de la covid: problemas persistentes en los riñones
En un gran estudio reciente, los pacientes recuperados de COVID-19 tuvieron 35 por ciento más probabilidades de sufrir daños a largo plazo en los riñones o un deterioro de la función renal.
Desde el principio de la pandemia, los médicos han descubierto que la gente que experimenta casos graves de COVID-19 a menudo tiene problemas renales y no solo el daño pulmonar característico de esta enfermedad.
Ahora, un estudio muy grande señala que, después de que los pacientes se recuperan de la infección inicial, los problemas renales pueden durar meses y que en algunos pacientes las secuelas pueden originar una reducción considerable de la función renal.
En este estudio, publicado el 1 de septiembre en la revista Journal of the American Society of Nephrology, se descubrió que cuanto más enfermos estuvieran los pacientes al principio, más probable era que sufrieran un daño renal prolongado.
Pero incluso las personas que contraen el virus y presentan una infección menos grave podrían ser vulnerables.
“De manera generalizada, en realidad vemos un mayor riesgo de que se presente una serie de eventos importantes vinculados con el riñón”, señaló F. Perry Wilson, nefrólogo y profesor adjunto de Medicina en la Universidad de Yale, quien no participó en el estudio. “Y lo que más me sorprendió es que estos perduraron”.
Los riñones tienen una participación fundamental en el organismo para eliminar las toxinas y el exceso de líquido de la sangre, ayudar a mantener una presión arterial saludable y regular el equilibrio de electrolitos y de otras sustancias importantes. Cuando los riñones no funcionan bien o de manera eficiente, los líquidos se acumulan y provocan inflamación, presión sanguínea alta, debilidad en los huesos y otros problemas.
El corazón, los pulmones, el sistema nervioso central y el sistema inmunitario pueden sufrir un deterioro. En la etapa terminal de la insuficiencia renal, quizás se necesite la diálisis o un trasplante de riñón. Esta enfermedad podría provocar la muerte.
Este nuevo estudio, el cual se basó en los registros de los pacientes del sistema de salud del Departamento de Asuntos de los Veteranos, analizó la información de 89.216 personas que dieron positivo al coronavirus entre el 1 de marzo de 2020 y el 15 de marzo de 2021, así como la información de 1.637.467 personas que no tuvieron covid.
Entre uno y seis meses después de haberse infectado, los sobrevivientes de covid tuvieron aproximadamente un 35 por ciento más de probabilidades de tener un daño renal o un deterioro considerable en la función renal que quienes no tuvieron covid, señaló Ziyad Al-Aly, director del servicio de investigación y desarrollo en el Sistema de Atención a la Salud de San Luis del Departamento de Asuntos de los Veteranos (VA, por su sigla en inglés) y autor sénior del estudio.
“Las personas que han sobrevivido a los primeros 30 días de la covid están en riesgo de desarrollar insuficiencia renal”, mencionó Al-Aly, nefrólogo y profesor adjunto de Medicina en la Escuela de Medicina de la Universidad de Washington.
Debido a que muchas personas que tienen una función renal disminuida no experimentan dolor ni otros síntomas, “lo que importa en realidad es que la gente sepa que existe un riesgo y que los médicos de los pacientes que tuvieron covid estén muy atentos a la función y a la insuficiencia renal”, explicó.
Los dos grupos de pacientes del estudio diferían en que todos los miembros de un grupo se habían infectado con covid y los miembros del otro grupo podían haber tenido una variedad de otros padecimientos. Los especialistas advirtieron que las comparaciones tenían limitaciones.
Los investigadores intentaron reducir al mínimo las diferencias a través de análisis detallados que ajustaron a partir de una larga lista de características demográficas, enfermedades preexistentes, uso de medicamentos y si las personas estaban en asilos.
Otra limitación es que los pacientes en el estudio del VA eran en su mayoría varones blancos de una edad promedio de 68 años, así que no queda muy claro cuán generalizables son los resultados.
Según los expertos, un aspecto sólido de la investigación es que contempla a más de 1,7 millones de pacientes con expedientes médicos electrónicos detallados, lo que la convierte en el estudio más grande hasta ahora sobre problemas renales vinculados a la covid.
Aunque lo más probable es que los resultados no sean aplicables para todos los pacientes con covid, muestran que entre los participantes del estudio “existe una afectación muy notable a largo plazo para la salud renal de los sobrevivientes de COVID-19, sobre todo para quienes estuvieron muy enfermos durante la enfermedad aguda”, señaló C. John Sperati, nefrólogo y profesor adjunto de Medicina en la Universidad Johns Hopkins, quien no participó en el estudio.
Otros investigadores han descubierto patrones parecidos, “así que este no es el único estudio que indica que estos eventos están ocurriendo después de una infección de COVID-19”, añadió.
Sperati y otros especialistas han señalado que incluso si solo un pequeño porcentaje de los millones de sobrevivientes de COVID-19 en Estados Unidos desarrollasen problemas renales prolongados, el impacto para la atención sanitaria sería muy importante.
Con el fin de evaluar la función renal, el equipo de investigación evaluó los niveles de creatinina, un producto de desecho que los riñones deben eliminar del cuerpo y también un indicador de la adecuada filtración de la sangre, el cual se denomina índice de filtración glomerular.
Wilson explicó que, a lo largo de la vida, los adultos sanos poco a poco pierden la función renal a partir de los treinta y tantos o cuarenta y tantos años a razón de aproximadamente el uno por ciento o menos al año. Las enfermedades y las infecciones importantes pueden provocar una pérdida más significativa o permanente de esta función, la cual puede originar una insuficiencia renal crónica o una insuficiencia renal en etapa terminal.
Según Al-Aly, en el nuevo estudio se descubrió que 4757 sobrevivientes de covid habían perdido al menos un 30 por ciento de la función renal en el año posterior a haber tenido la infección.
Eso equivale a cerca de “30 años de deterioro en la función renal”, afirmó Wilson.
En el estudio se descubrió que existía un 25 por ciento más de probabilidades de que los pacientes que tuvieron covid alcanzaran ese nivel de deterioro que las personas que no contrajeron la enfermedad.
Un grupo más pequeño de sobrevivientes de covid presentó deterioro más acentuado. Pero había un 44 por ciento más de probabilidades de que los pacientes con covid perdieran al menos el 40 por ciento de la función renal y era un 62 por ciento más probable que perdieran al menos el 50 por ciento que los pacientes sin covid.
Al-Aly informó que en 220 pacientes con covid se detectó insuficiencia renal en etapa terminal, la cual se presenta cuando se pierde al menos el 85 por ciento de la función renal. En el estudio se encontró que los sobrevivientes de covid tenían tres veces más probabilidades de recibir este diagnóstico que los pacientes sin covid.
Al-Aly y sus colegas también investigaron un tipo de falla renal repentina llamada insuficiencia renal aguda, la cual otros estudios han encontrado en hasta la mitad de los pacientes hospitalizados con covid. Esta falla puede sanar sin provocar pérdida de la función renal a largo plazo.
No obstante, en el estudio del veteranos, se descubrió que meses después de haber tenido la infección, 2812 sobrevivientes de covid sufrieron insuficiencia renal aguda, casi el doble que los pacientes sin covid, aseveró Al-Aly.
Wilson señaló que los nuevos datos respaldaban los resultados de un estudio con 1612 pacientes que realizaron él y sus colegas en el cual descubrieron que los pacientes con covid que tenían insuficiencia renal aguda presentaron una función renal significativamente peor en los meses posteriores a su salida del hospital comparados con quienes presentaban daños renales agudos resultantes de otras enfermedades.
En el nuevo estudio, los investigadores no compararon de manera directa a los sobrevivientes de covid con las personas infectadas por otros virus, como el de la influenza, lo cual dificultaba saber si “en realidad estás más enfermo que si hubieras tenido otra infección grave”, comentó Sperati.
Sin embargo, en un estudio anterior realizado por el equipo de Al-Aly, en el que se analizaron muchos problemas de salud posteriores a la covid, incluidos los problemas renales, las personas hospitalizadas por COVID-19 tenían un riesgo significativamente mayor de desarrollar problemas de salud a largo plazo en prácticamente todas las categorías médicas, incluidas las afecciones cardiovasculares, metabólicas y gastrointestinales, que las personas hospitalizadas por la gripe.
Todos los tipos de trastornos renales monitoreados en el nuevo estudio fueron mucho más frecuentes en los pacientes de covid que estuvieron más enfermos al principio, es decir, los que pasaron algún tiempo en cuidados intensivos o los que experimentaron una lesión renal aguda en el hospital.
Las personas que estuvieron menos graves durante su hospitalización por covid tenían menos probabilidades de sufrir problemas renales persistentes, pero seguían siendo considerablemente más propensas que los pacientes que no habían tenido covid.
“Las personas que corren mayor riesgo son las que realmente lo pasaron mal ya desde el inicio”, dijo Al-Aly. “Pero realmente, nadie se libra del riesgo”.
El estudio también descubrió que incluso los pacientes de covid que nunca necesitaron hospitalización tenían un riesgo ligeramente mayor de sufrir problemas renales que la población general de pacientes del VA. Pero el riesgo parecía tan pequeño, dijo Sperati, que “no sé si confiaría” en esos resultados.
Wilson observó que algunos pacientes de covid que no necesitaron hospitalización estaban, sin embargo, bastante enfermos y requirieron permanecer en cama durante días. Dijo que es posible que esos fueran los que desarrollaron una disfunción renal a largo plazo, en lugar de las personas en el extremo más leve del espectro de covid.
Los médicos no saben por qué la covid puede provocar daño renal. Los expertos explicaron que es posible que los riñones sean especialmente sensibles al aumento de la inflamación o la activación del sistema inmunitario, o que los problemas de formación de coágulos sanguíneos que casi siempre se observan en los pacientes con covid alteren la función renal.
Sperati dijo que los pacientes de covid en el hospital parecían tener mayor necesidad de diálisis, y más proteínas y sangre en la orina que los pacientes hospitalizados con otras enfermedades graves.
“El coronavirus es probablemente un virus un poco más tóxico para los riñones”, dijo Wilson. “Creo que el síndrome por covid tiene algunos efectos adversos a largo plazo en el riñón”.
Pam Belluck es una reportera de ciencia y salud cuyos galardones incluyen un Premio Pulitzer compartido en 2015 y el premio Nellie Bly a la mejor historia de primera plana. Es autora de Island Practice, un libro sobre un doctor peculiar. @PamBelluck