In first federal ruling on vaccine mandates, judge sides with Houston hospital, dismissing claims from staff resisters

https://www.yahoo.com/news/federal-judge-sides-houston-hospitals-020713664.html

178 staffers at Houston Methodist hospital suspended for not complying with  COVID-19 vaccine mandate - ABC News

In the first federal ruling on vaccine mandates, a Houston judge Saturday dismissed a lawsuit by hospital employees who declined the COVID-19 shot – a decision that could have a ripple effect across the nation.

The case involved Houston Methodist, which was the first hospital system in the country to require that all its employees get vaccinated. U.S. District Judge Lynn N. Hughes said federal law does not prevent employers from issuing that mandate.

After months of warnings, Houston Methodist had put more than 170 of its 26,000 employees on unpaid suspension Monday. They were told they would be fired it they weren’t vaccinated by June 21.

The hospital already had made it clear it means what it says: It fired the director of corporate risk – Bob Nevens – and another manager in April when they did not meet the earlier deadline for bosses.

In recent weeks, a few other major hospitals have followed Houston Methodist’s lead, including the University of Pennsylvania, University of Louisville, New York Presbyterian and several major hospitals in the Washington, D.C. area.

Houston Methodist’s CEO Marc Boom predicts more hospitals soon will join the effort. Many hospitals and employers were waiting for legal clarification before acting.

“We can now put this behind us and continue our focus on unparalleled safety, quality, service and innovation,” Boom said after the ruling. “Our employees and physicians made their decisions for our patients, who are always at the center of everything we do.”

The lawsuit was filed by 117 workers led by Jennifer Bridges, a nurse at Houston Methodist’s Baytown hospital who declined the vaccine because she considers it experimental and dangerous. The judge disagreed, writing: “This claim is false, and it is also irrelevant.”

Learning of the dismissal from USA TODAY, Bridges vowed not to give up. She has initiated a change.org petition that as of Saturday had drawn more than 9,000 signatures and a GoFundMe to pay for the lawsuit that has raised $130,000.

“This doesn’t surprise me,” she said. “Methodist is a very large company and they are pretty well protected in a lot of areas. We knew this was going to be a huge fight and we are prepared to fight it.”

The lawsuit claimed that federal law prohibits employees from being required to get vaccinated without full U.S. Food and Drug Administration approval of the vaccines. Currently, the FDA has authorized the Moderna, Pfizer and Johnson & Johnson vaccines under a special provision for emergencies.

The judge dismissed this argument as well, saying that law does not apply to private employers. He also dismissed an argument that anyone who gets the vaccine is effectively a human subject in an experimental trial.

“The hospital’s employees are not participants in a human trial,” he wrote. “They are licensed doctors, nurses, medical technician, and staff members. The hospital has not applied to test the COVID-19 vaccines on its employees.”

The lawsuit originally was filed in Texas state court but was moved to federal court at Houston Methodist’s request. The federal judge ruled Saturday that Texas state law only protects workers from being fired if they are forced to commit a crime.

The Beginning of the End of the American Pandemic

A tree branch emerging out from the shadows to the light with blooms and bird perched on top.

The country is reopening. What does the future hold?

The story of the American pandemic has unfolded in three chapters. The first began last January, when the coronavirus emerged and the world was plunged into uncertainty about how covid-19 could be treated, how the virus spread, and when it might be defeated. The second started on the morning of November 9, 2020, when Pfizer-BioNTech announced the extraordinary efficacy of its vaccine. Those results made clear that this pandemic would end not through infection but vaccination. Our goals shifted from merely slowing the spread to beginning immunization as quickly as possible. In America, much of the past half year has been devoted to administering vaccines and gathering evidence on how well they work in the real world.

Earlier this month, the Centers for Disease Control and Prevention ushered in the American pandemic’s third chapter. The agency announced that vaccinated people could go without masks or social distancing indoors and outside, in crowds large and small. It carved out a few exceptions—for hospitals, public transportation, and the like—and noted that people still needed to obey federal and local laws. But the broad message was that vaccinated Americans could resume their pre-pandemic lives. The C.D.C. is an agency known for caution, and its new guidance shocked many public-health experts; just two weeks earlier, it had issued far more restrictive recommendations. During the same period, a survey of nearly six hundred epidemiologists found that more than three-quarters of them believed that indoor mask-wearing might remain necessary for another year or more. Still, immediately after the announcement, a number of states lifted their mask mandates. Others will surely follow, as the pressure to return to normal grows. America is now moving swiftly toward reopening.

Despite the C.D.C.’s early stumbles on communication, masks, and tests, it remains perhaps the world’s preëminent public-health agency. Its recommendations carry unparalleled scientific force in the U.S. and beyond. Ultimately, the C.D.C.’s decision reflects real shifts in the weight of the evidence on several fundamental epidemiological questions: Are the vaccines as effective as they were in the trials? Can they protect us against the coronavirus variants? And do they prevent not just illness but transmission? The answers to these questions give us good reason to think that the pandemic’s newest chapter will be its last. Read The New Yorker’s complete news coverage and analysis of the coronavirus pandemic.

On the first question, the nationwide rollout of covid-19 vaccines has proved, beyond any doubt, that they are astonishingly effective at preventing serious illness, even for the most vulnerable people. So-called breakthrough infections, in which the virus weaves its way around some of an individual’s immune system, do occur. But such infections are extremely rare, and—because a person almost always has some effective antibodies and other immune-system defenses—they usually cause mild or no symptoms. In one study, the C.D.C. examined post-vaccination infections among nearly fifteen thousand nursing-home residents and staff members, and discovered only two covid-19 hospitalizations and one death. Another study, involving half a million health-care workers from around the country, found that getting two shots reduced the risk of a symptomatic infection by ninety-four per cent. Moving forward, we should expect to continue seeing breakthrough infections from time to time—but, for the most part, we shouldn’t worry about them. (At the same time, the covid vaccines have proved exceptionally safe. Few dangerous side effects have been linked to the vaccines from Pfizer-BioNTech or Moderna, and the over-all risk of concerning blood clots after receiving Johnson & Johnson’s vaccine is rare—as of last week, when more than nine million doses had been administered, there were thirty confirmed cases.)

The most striking vaccine-efficacy statistic draws on data shared by state governments. Around a hundred and thirty million Americans are fully vaccinated, and the C.D.C. has said that it has received reports of fewer than fourteen hundred covid-19 hospitalizations and three hundred deaths among them. This means that, after vaccination, one’s chances of dying of covid-19 are currently about two in a million, with the likelihood of being hospitalized only slightly higher. Statistics reported by hospitals tend to be accurate; still, even if state governments have missed a few cases here and there, the results are staggeringly good. “The evidence on vaccines just keeps getting better and better,” Robert Wachter, a physician and the chair of medicine at the University of California, San Francisco, told me. “When the trial results first came out, I thought, They can’t actually be this good. The real world is always messier than the trials. What we’ve learned since then is that the vaccines are probably even more spectacular than we initially believed.”

The answer to the second questionwhether the vaccines work against the major coronavirus variants—is also now clear. Earlier this month, a study conducted in Qatar, where the B.1.1.7 and B.1.351 variants predominate, found that the Pfizer-BioNTech vaccine was ninety-seven per cent effective at preventing severe disease. Vaccines from Moderna and Johnson & Johnson also appear to be highly effective against the variants; in fact, these vaccines are already successfully fighting them here in the United States. The B.1.1.7 variant, which is vastly more contagious than the original virus and caused a devastating surge in the U.K. this past winter, now accounts for three-quarters of new U.S. cases—and yet, largely thanks to vaccination, daily infections in this country have fallen by nearly ninety per cent since their peak in January, and are now lower than at any point in the past eight months. The existence of more contagious variants isn’t a reason to doubt the vaccines but to vaccinate people as quickly as possible.

As for the final questionwhether vaccinated people can spread the virus to others, especially unvaccinated people, including children—the evidence is similarly encouraging. Because vaccinated people are unlikely to contract the virus, the vast majority won’t be passing it on. And even the small number of vaccinated people who experience breakthrough infections have much less of the virus circulating in their bodies, and may be less infectious. Real-world data from Israel, which has mounted one of the world’s fastest and most effective vaccination campaigns, is instructive. The country’s progress in immunizing its adults has been linked to significant declines in infections among unvaccinated people; according to one preliminary estimate, each twenty-percentage-point increase in adult vaccination rates reduces infections for unvaccinated children by half. When vaccinated people remove their masks, they pose little threat to others, and they face little peril themselves.

The shift toward reopening is not without risk. The first issue is timing. Less than half of Americans have received even one shot of a covid-19 vaccine, and only around four in ten have been fully vaccinated. This means that the majority of the country remains susceptible to infection and disease. Meanwhile, the pace of vaccinations has slowed: in April, the U.S. was routinely vaccinating about three million people per day, but the daily average is now nearly two million. It’s unclear whether the new guidance will encourage or deter unvaccinated Americans from getting immunized. In a recent survey, unvaccinated Republicans said that they would be nearly twenty per cent more likely to get the shots if it meant that they wouldn’t have to wear a mask anymore. We’ll now find out how they really feel.

Vaccine hesitancy is only part of the picture. Some thirty million Americans—a group larger than anti-vaxxers or the vaccine-hesitant—say that they want to get immunized but haven’t yet done so. Some face language barriers, or fear immigration problems; others have difficulty navigating the health system, or can’t take time off from work. Many of the willing-but-unvaccinated are working-class Americans; four in five don’t have a college degree. The Biden Administration has sent billions of dollars to health centers serving low-income populations, offered tax credits to businesses that provide paid time off for employees to get immunized, and helped assemble thousands of volunteers—known as the covid-19 Community Corps—to assist with vaccine outreach to underserved populations. States, too, are trying to reduce barriers to vaccination, and offering incentives—including payments in Maryland, a lottery in Ohio, and a “Shot and a Beer” program in New Jersey—for residents who remain on the fence. There are, in short, real efforts under way to sway the vaccine-hesitant and make vaccines more accessible.

Still, the new C.D.C. guidance makes these efforts even more urgent. Until now, unvaccinated people have been shielded from high levels of viral exposure by government mandates and social norms that have kept their friends, neighbors, and colleagues masked and distanced, to varying degrees. But, in the coming weeks, those protections will likely erode. For unvaccinated Americans, this could be the most dangerous moment in the pandemic. In most contexts, there is no reliable mechanism for verifying who has and hasn’t been vaccinated. Inevitably, against the C.D.C.’s advice, many unvaccinated people will resume normal life, too, threatening their own health and that of others. When asked how businesses are to know which customers can enter unmasked, Anthony Fauci, the nation’s top infectious-disease expert, told CNN, “They will not be able to know. You’re going to be depending on people being honest enough to say whether they were vaccinated or not.”

“Unvaccinated people are now going to have much higher levels of exposure,” Wachter told me. “That’s especially true in places with lots of community spread and in places where more contagious variants are circulating.” Wachter suggested that the C.D.C. could be making an epidemiological bet. The move “will cause some additional covid cases that otherwise would not have occurred,” he said—but, “if it leads to even a small uptick in vaccination, it will save lives in aggregate.”

Since the start of the pandemic’s second chapter, public-health officials have been working to prevent a catastrophic collision between the ship of reopening and the iceberg of the unvaccinated. By slowing the speed of the ship or shrinking the size of the iceberg, we have sought to reduce the force of the collision. But barring a hundred-per-cent vaccination rate, or something close to it—an outcome that the U.S. was never likely to achieve—a crash of some sort has been inevitable. India’s collision has been titanic—it reopened with a population of more than a billion, even though hardly anyone was vaccinated. In the U.S., the situation is different. Our iceberg has been melting, and we’ve been approaching it slowly. Now we’re taking off the brakes.

The C.D.C. issues guidance, not laws; there are several quantitative measures that states, counties, cities, companies, and individuals can consult in pacing their reopening and squaring the agency’s broad recommendations with local realities. A community’s immunization rate is perhaps the most obvious statistic to track. Experts have argued for meeting a seventy-per-cent immunity threshold before relaxing masking and distancing requirements. No states have got there yet, although some, such as Vermont and Maine, are well on their way. The Biden Administration has said that it hopes to hit the seventy-per-cent target for first shots by the Fourth of July.

Because the vaccines prevent almost all cases of severe covid-19, the number of covid-19 hospitalizations is another good metric to watch. “With vaccines, cases become uncoupled from severe disease,” Monica Gandhi, an infectious-disease doctor at the University of California, San Francisco, who has studied asymptomatic coronavirus transmission, told me. Gandhi was among the first researchers to show that masks protect not just others but wearers, too; when we spoke, before the C.D.C.’s announcement, she said that, in her view, most precautions could end when half of Americans had received their first shot and covid-19 hospitalizations had fallen below sixteen thousand nationally, or about five per hundred thousand people. (At the peak of most flu seasons, the U.S. records five to ten influenza hospitalizations per hundred thousand.) Hospitalizations appear to be falling, unevenly, across the country. However, there are currently thirty thousand Americans hospitalized with covid-19—roughly a quarter of the January peak, but still about twice Gandhi’s threshold.

Herd immunity offers a third benchmark for reopening. The idea is that, once about eighty per cent of the population has been vaccinated or infected, the virus will struggle to spread. Recently, some experts have argued that we might never get to herd immunity because of variants, vaccine hesitancy, and the fact that children under twelve, who make up some fifteen per cent of the U.S. population, are unlikely to be immunized for some time. But the C.D.C.’s recommendation could change the equation. As states lift restrictions and unvaccinated people face higher levels of exposure, more of them are likely to get infected, pushing us closer to the herd immunity threshold. In all likelihood, the U.S. will be able to reach sixty-per-cent vaccination in the coming weeks; meanwhile, perhaps a third of Americans have already been infected. Even assuming significant overlap between the two groups, the combination of vaccination and infection is likely to make it harder for the virus to find new hosts. Marc Lipsitch, the director of Harvard’s Center for Communicable Disease Dynamics, emphasized that, because some parts of the country may reach herd immunity, or something close to it, before others—Connecticut’s current covid-19 immunization rate, for instance, is nearly twice Mississippi’s—unvaccinated adults will face different levels of risk depending on where they live. “There won’t be one national end,” Lipsitch told me. “We’re going to see a fundamental change in terms of what it means to live in this country, but there’s also going to be a lot of local variation.”

Covid-19 deaths give us another way of tracking the pandemic. Experts have argued that the U.S., with a population of three hundred and thirty-two million, should aim for fewer than a hundred coronavirus deaths daily—roughly the toll of a typical flu season. Right now, America is seeing about six hundred covid-19 deaths each day; according to the Institute for Health Metrics and Evaluation, which generates one of the country’s most widely cited pandemic models, that number will likely fall to about a hundred in August. “Things will look very good this summer,” Christopher Murray, the director of the I.H.M.E., told me. “A lot of people will think that we’re done, that it’s all over. But what happens in the fall is the tricky part.” Murray believes that a confluence of factors—the spread of variants, in-person schooling, meaningful numbers of still-unvaccinated people, and the seasonality of the virus—will produce a small winter spike, concentrated in communities with low vaccination rates. It won’t be the apocalyptic surge of New York City in the spring of 2020—or, more recently, those of India or Brazil—but, each week, several thousand unvaccinated Americans could die.

It’s possible, given all this, to imagine a plausible scenario for the conclusion of the American pandemic. The coronavirus disease toll continues to fall throughout the summer. States do away with mask mandates and capacity restrictions; people increasingly return to bars, spin classes, and airports, then to stadiums, movie theatres, and concerts. By midsummer, in communities with high vaccination rates, covid-19 starts to fade from view. In those places, even people who remain unvaccinated are protected, because so little of the virus circulates. But, in other parts of the country, low immunization rates combined with reopening allow the disease to register again. Hospitals aren’t overwhelmed—there’s no need to build new I.C.U.s or call in extra staff—but the collision between ship and iceberg is forceful, and each week thousands of people fall ill and hundreds die. Some victims are vaccine-hesitant; others were unable, for whatever reason, to get vaccinated. Still, perhaps unfairly, these outbreaks come with an aura of culpability: to people in safe parts of the country, the ill seem like smokers who get lung cancer.

In the fall, many unvaccinated children return to school. Scattered infections among them capture headlines, but serious illnesses are exceedingly rare; the overwhelming majority of children remain safe, and, with time, they, too, are immunized. The U.S. approaches something like herd immunity. Some people may still fall ill and die of covid-19—perhaps they are immunocompromised, elderly, or just unlucky—but, by and large, America has gained the upper hand. Meanwhile, in poor nations with few vaccines, the pandemic continues. As crisis wanes in one country, catastrophe ignites in another. Every so often, we learn of a new variant that’s thought to be more contagious, lethal, or vaccine-resistant than the rest; we rush to institute travel bans, only to learn that the variant, or a close cousin, is already circulating in the U.S. and has been largely subdued by the vaccines, as all previous variants have been. In the fall, Americans line up for covid booster shots alongside flu vaccines. The pandemic’s final chapter comes to a close not through official decree but with the gradual realization that covid-19 no longer dominates our lives.

Reopening a country after a pandemic isn’t like flipping a giant switch. It’s more like lighting a series of candles, illuminating one part, then another, until the whole place shines. Many states, counties, cities, and businesses will further loosen their restrictions; others will wait. Communities and individuals will approach the end of the crisis differently, as they’ve approached the rest of it. Some unvaccinated people have already been forgoing precautions; on the other hand, I’ve been vaccinated for months and, since the C.D.C. announcement, have yet to leave my mask behind—whether because of a lingering, irrational fear or simply to avoid dirty looks, I can’t say. Social norms take time to change, even when one of the world’s most respected public-health agencies is telling you to change them.

The pandemic has created not just chaos and suffering but uncertainty. It’s easy, therefore, to be doubtful about the fortunate position in which we seem to find ourselves now. As a physician, I spent the early months of the pandemic caring for covid-19 patients in New York City; they streamed into the hospital day after day, deathly ill. We raced to build covid wards, I.C.U.s, and hospice units. At the time, we had little to offer. There were no proven therapies, and certainly no vaccines. There were weeks when thousands of New Yorkers died, many of them alone in their final moments, while more people were dying across the world. I felt fear, anxiety, and sometimes despair. The scale of the damage—the lives lost, businesses shuttered, dreams shattered, children orphaned, seniors isolated—was crushing, and the path forward was both frightening and unknown.

As good news began to arrive, I greeted it with a blend of guarded skepticism and cautious optimism. First came evidence that outdoor transmission was unlikely. Then we learned that contaminated surfaces rarely spread disease; that some patients can breathe better simply by lying on their bellies; that P.P.E. works; that dexamethasone saves lives. We discovered that immunity lasts many months, perhaps years; that repeat infections are unlikely; and that variants present a surmountable challenge.

Now, study after study, in country after country, has shown that the vaccines are capable of transforming a lethal pathogen into a manageable threat. Examining and reëxamining the vaccine results, I’ve gone through stages, too—caution, hope, and, finally, clarity. We really are that close. The beginning of the end is here.

Some Face Dire Consequences for Delaying Care During Pandemic

Mammogram

Throughout the COVID-19 pandemic, experts have been warning of the dangers of postponed health care services. In January, the American Cancer Society, the National Comprehensive Cancer Network, and 73 other organizations, including many major health care systems, issued a statement stressing the urgency of preventive care. “We urge people across the country to talk with their health care provider to resume regular primary care checkups, recommended cancer screening, and evidence-based cancer treatment (PDF) to lessen the negative impact the pandemic is having on identifying and treating people with cancer,” the groups said.

Essential Coverage

That was sound advice not everyone could follow, as ProPublica’s Duaa Eldeib reported last week in a tragic story about Teresa Ruvalcaba. The 48-year-old single mother of three worked for 22 years at a candy factory on Chicago’s West Side. During the pandemic, disaster struck. “For more than six months, the 48-year-old factory worker had tried to ignore the pain and inflammation in her chest. She was afraid of visiting a doctor during the pandemic, afraid of missing work, afraid of losing her job, her home, her ability to take care of her three children,” Eldeib reported.

“Even though her chest felt as if it was on fire, she kept working. She didn’t want to get COVID-19 at a doctor’s office or the emergency room, and she was so busy she didn’t have much time to think about her symptoms,” Eldeib wrote.

Ruvalcaba’s pandemic fears were typical of patients across the nation, surveys revealed. A 2020 CHCF poll of 2,249 California adults revealed that even when people wanted to see a doctor for an urgent health problem, one-third did not receive care. Nearly half of those surveyed didn’t receive care for their nonurgent health problems.

Nationally, more than one in three people delayed or skipped care because they were worried about exposure to Covid-19, or because their doctor limited services, according to an Urban Institute analysis of a September 2020 survey.

The toll of this disruption in care — the forgone cancer screening, the chest pain that isn’t reported — will devastate some patients and families. Ruvalcaba had to face a diagnosis with a terrible prognosis, inflammatory breast cancer. “If she would have come six months earlier, it could have been just surgery, chemo and done,” Ruvalcaba’s doctor told Eldeib. “Now she’s incurable.”

Doctors expect the delayed care “could cause worsening health conditions, delayed diagnoses and earlier deaths,” Ana Ibarra reported in CalMatters.

“Unfortunately, we know we’re going to see some tragedies related to the delays,” Wiley Fowler, an oncologist at Dignity Health in Sacramento, told Ibarra.

Consequences of Delayed Care

Public health messages early in the pandemic urged people to avoid public places, including doctor’s offices. In April, as Hayley Smith noted in a Los Angeles Times story, the US Centers for Disease Control and Prevention (CDC) and the Centers for Medicare & Medicaid Services “both published guidelines recommending the postponement of elective and nonurgent procedures, including ‘low-risk cancer’ screenings, amid the first wave of the pandemic.”

Patients and doctors listened. Appointments were canceled. “Nonurgent” procedures encompassing a wide array of treatments and operations, including cancer surgeries, were delayed.

Preventive cancer screenings dropped 94% over the first four months of 2020, Eldeib reported. The National Cancer Institute expects to see 10,000 preventable deaths over the next decade because of pandemic-related delays in diagnosis and treatment of breast and colorectal cancer. Screenings for these cancers, which account for about one in six cancer deaths, are routine features of preventive care.

I know I should get another check soon, but the anxiety of COVID feels like more of a priority than the anxiety of cervical cancer.

—Molly Codner, a Southern Californian who received an abnormal Pap smear last summer

In California, cancer deaths have remained roughly the same as prepandemic rates, but that stability is not expected to last. Based on the National Cancer Institute data, Ibarra calculates that an additional 1,200 Californians will die from breast and colon cancer. The National Cancer Institute estimate is conservative “because it only accounts for a six-month delay in care, and people are postponing care longer than that,” Ibarra reported.

Nationally, death rates from cancer are expected to increase in a year or two. Slow-growing cancers will remain treatable despite a delayed diagnosis, Norman Sharpless, MD, director of the National Cancer Institute, told Eldeib. Yet for conditions like Ruvalcaba’s inflammatory breast cancer, delayed care can be disastrous.

Women, People of Color Disproportionately Affected

For women across Southern California, appointments have been delayed, exams canceled, and screenings postponed during the pandemic, Smith reported in the Los Angeles Times. “Some are voluntarily opting out for fear of encountering the virus,” Smith wrote, “while others have had their appointments canceled by health care providers rerouting resources to COVID-19 patients.”

Before Pap smears became part of routine American health care, cervical cancer was one of the deadliest cancers for women. Today, as many as 93% of cervical cancer cases are preventable, according to the CDC, and screenings are a crucial component of preventive care. Yet during the first phase of California’s stay-at-home orders, cervical cancer screenings dropped 80% among the 1.5 million women in Kaiser Permanente’s regional network, Smith wrote.

The effects of the pandemic shutdown extended beyond delayed Pap smears. Women who spoke to Smith said that “mammograms, fertility treatments and even pain prevention procedures have been waylaid by the pandemic.”

Sometimes, obstacles other than the pandemic are continuing to interfere with access to care. One woman had an appointment delayed and then lost her job and her health insurance, Smith reported.

“Molly Codner, 30, has needed a checkup ever since she received an abnormal Pap smear last summer,” Smith wrote, “but like many Southern Californians, the trauma of the last year still weighs heavily on her mind: Nearly a dozen people she knows have had COVID-19.” Codner told Smith that “I know I should get another check soon, but the anxiety of COVID feels like more of a priority than the anxiety of cervical cancer.”

People who face disparities in treatment and care are most likely to be hard hit by pandemic delays. That includes Black people, who were already more likely to die from cancer than any other racial group. Cancer also is the leading cause of death among Latinx people. Breast cancer is the most common cancer diagnosis for Latinx women. Overall, more Americans die of heart disease.

Black adults are more likely than White or Latinx adults to delay or forgo care, according to researchers from the Urban Institute.

Telehealth Solved Access Issues for Some, Not All

Telehealth was a boon for patients during the pandemic year. Yet, as Ibarra notes, “there’s only so much that doctors and nurses can do through a screen.” Dental visits, mammograms, and annual wellness checks were also put on hold by the pandemic.

Unequal access is another challenge for telehealth. The benefits of the telehealth boom were not shared equally, according to a statewide survey conducted last month by the University of Southern California and the California Emerging Technology Fund.

Latinx, Asian, and Black respondents did not use telehealth as often as White respondents. USC researchers attribute these differences to “disparities in income, education and access to any kind of health care.”

Researchers at the Urban Institute report similar findings: “Black and Latinx adults were more likely than White adults to report having wanted a telehealth visit but not receiving one since the pandemic began, and that difficulties getting a telehealth visit were also more common among adults who were in poorer health or had chronic health conditions.”

After controlling for socioeconomic factors and health status, patients with limited English were half as likely to use telehealth compared to fluent English-speaking patients, the Urban Institute said. “Much work remains to ensure all patients have equitable access to remote care during and after the pandemic,” the researchers wrote.

Whether telehealth is conducted by video or phone may be crucial to ensuring access to care. A study of telehealth use at Federally Qualified Health Centers in California in 2020 found that “more primary care visits among health centers in the study occurred via audio-only visits (49%) than in-person (48%) or via video (3%). Audio-only visits comprised more than 90% of all telemedicine visits.”

“For many Californians with low incomes, the ability to connect with a doctor or their care team by phone or video is much more than a convenience,” Chris Perrone, director of CHCF’s Improving Access team, explained on The CHCF Blog. “It’s really the difference between canceling a visit because the barriers are too great or getting the timely care that they or their child needs.”

Pandemic Health Effects Will Outlast COVID-19

Public health efforts might need to focus on two goals at the same time as the US recovers from the pandemic: increasing vaccine uptake to keep COVID-19 in check and proactively managing the fallout from delayed care.

“As we focus on recovery, we have to ensure that we get vaccinated,” Efrain Talamantes, a primary care physician in East Los Angeles, told Ibarra. “But also that we have a concerted effort to manage the chronic diseases that haven’t received the attention required to avoid complications.”

FDA authorizes Pfizer coronavirus vaccine for adolescents 12 to 15 years old

https://www.washingtonpost.com/health/2021/05/10/coronavirus-vaccine-for-kids/?fbclid=IwAR0RKJNrlP3TiTDrvPuczKSHIPmTRds8kdAepwOCSqlrzdDHgGcm9vlBYk8

FDA authorizes Pfizer COVID-19 vaccine in adolescents 12 and up

The Food and Drug Administration cleared the first coronavirus vaccine for emergency use in children as young as 12 on Monday, expanding access to the Pfizer-BioNTech shot to adolescents ahead of the next school year and marking another milestone in the nation’s battle with the virus.

The decision that the two-shot regimen is safe and effective for younger adolescents had been highly anticipated by many parents and pediatricians, particularly with the growing gap between what vaccinated and unvaccinated people may do safely. Evidence suggests that schools can function at low risk with prevention measures, such as masks and social distancing. But vaccines are poised to increase confidence in resuming in-person activities and are regarded as pivotal to returning to normalcy.

“Adolescents, especially, have suffered tremendously from the covid pandemic. Even though they’re less likely than adults to be hospitalized or have severe illness, their lives really have been curtailed in many parts of the country,” said Kawsar R. Talaat, an assistant professor of international health at the Johns Hopkins Bloomberg School of Public Health. “A vaccine gives them an extra layer of protection and allows them to go back to being kids.”

Expert advisers to the Centers for Disease Control and Prevention are scheduled to meet Wednesday to recommend how the vaccine should be used in that age group, and the vaccine can be administered as soon as the CDC director signs off on the recommendation.

In a news briefing Monday evening after the announcement, FDA officials said the Pfizer authorization for 12- to 15-year-olds was a straightforward decision because the data showed that the vaccine was safe and that the response to the vaccine was even better than among the 18- to 25-year-olds who got the shots.

Children rarely suffer serious bouts of covid-19, the illness caused by the coronavirus. But there is no way to predict the few who will become dangerously sick or develop a rare, dangerous inflammatory syndrome. Out of more than 581,000 covid-19 deaths in the United States, about 300 have been people under 18 — a tiny fraction of the total. But that exceeds the number of children who die in a bad flu season.

Children appear to be less efficient at spreading the virus, although their role in transmission is still not fully understood — another reason for pediatric vaccinations.

Clinicians also worry that with a new virus with many unknowns, the possibility exists for long-term impacts of infection, even from the mild or asymptomatic courses of illness common among children.

The Pfizer-BioNTech vaccine, already authorized for adolescents 16 and older, was the first to be tested in younger adolescents. The FDA’s decision will provide a potential path for other vaccine-makers to follow, most of which have launched or plan to initiate trials of their vaccines in teenagers and younger children.

The agency based its authorization on a trial of nearly 2,300 adolescents between 12 and 15 years old, half of whom received the same two-shot regimen shown effective and safe in adults. Researchers took blood samples and measured antibody levels triggered by the shots and foundstronger immune responses in the teens than those found in young adults. There were 16 cases of covid-19 in the trial, all of them among adolescents who received a placebo, suggesting the regimen offered similar protection to younger recipients as it does to adults.

Robert W. Frenck Jr., the researcher who led the adolescent trial at Cincinnati Children’s Hospital Medical Center, said the study was designed to test whether it triggered immune responses, not whether it prevented disease. But because of the number of children who became ill in the placebo arm of the trial, it also became evident the vaccine offered robust protection.

“That really points out how much covid there is in the adolescent community,” Frenck said.

The data has not been published or peer-reviewed, but Kathryn M. Edwards, a pediatric infectious-disease specialist at Vanderbilt University Medical Center, said the results announced by Pfizer were “pretty exciting — it looked very effective and the immune responses were really good.”

Edwards said she is comfortable the benefits of vaccinations are clear among teens, noting that while children, in general, are at lower risk of severe covid-19 than adults, older adolescents seem to be more like adults in their risk for covid-19 than the very youngest children.

Audrey Baker, 15, and Sam Baker, 12, rolled up their sleeves for shots in the Pfizer-BioNTech trial at Cincinnati Children’s Hospital Medical Center. Audrey said she had no hesitation about signing up, and misses little things about how life used to be — eating out in restaurants and seeing family.

“I just trusted the science,” Audrey said. “I knew it was tested in adults. I was really just joining, hoping that maybe I could get vaccinated and help out science.”

Sam said he was more hesitant, in part because participating meant many follow-up lab tests. But he decided to do it and thinks he may have gotten the vaccine in the trial because he developed a headache and fever after his second dose.

Their mother, Rachel Baker, said she felt relief because of Sam’s symptoms.

The biggest benefit has been that I feel a weight off my shoulders,” Rachel said. “We haven’t changed how we do anything. … We’re still masking, we’re still social distancing, but we’re a bit calmer about it all.”

H. Cody Meissner, a pediatrician at Tufts Medical Center and a member of an external advisory committee to the FDA, said he thinks a pediatric vaccine is needed. But he said he would like to see more safety data because the messenger RNA technology at the core of vaccines from Pfizer-BioNTech and the biotechnology company Moderna does not have a long, established safety record, and its first large-scale use began in December.

Meissner abstained from the December vote that overwhelmingly recommended authorization of the Pfizer-BioNTech vaccine for people 16 and older, because he thought the vaccine should be authorized in people 18 and older.

“For those who are eager to get it, it’s important for them to understand that this is very rarely a severe disease in young adolescents, number one, and this is an entirely new vaccine,” Meissner said. “I just don’t want people to get too swept up in fear of hospitalization and death from covid-19 for the first few decades of life.”

But many other physicians take comfort knowing that 250 million shots of messenger RNA vaccine have been given in the United States alone. Serious side effects, such as a risk of anaphylaxis, are extremely rare. Because the trial in teens was an “immune bridging” trial designed to test whether the vaccine triggered immune responses similar to those in adults, researchers did not need to recruit tens of thousands of people to see if those who received a vaccine were protected against illness. The immune bridging technique is commonly used to expand access to vaccines that have been proved effective and safe to adolescents or other populations.

The expansion of eligibility to children will probably ignite debates in families about when to get vaccinated, and among policymakers about whether it should be required.

Dorit Reiss, a law professor focused on vaccine policy at the University of California Hastings College of Law, said she thinks it is unlikely children will be mandated to receive a coronavirus shot until the vaccines win full approval and not just emergency use authorization.

She predicted that acceptance of the vaccine will evolve as more children are vaccinated and depend on the state of the pandemic. She noted that when vaccines are introduced, the rollout often starts slowly before accelerating.

“Nervousness about a new vaccine is normal, especially when it’s for kids,” Reiss said. “Parents that are nervous now might feel different in a few months, once their friends’ kids have gotten vaccinated. And the views of the kids are also going to matter — if teens are going to think this is going to make their lives easier.”

Opening up vaccinations to children may sharpen a debate unfolding globally about the equity of vaccine access. Talaat said that while she can’t wait for her kids to have access to a vaccine, she is troubled by the global inequities as high-risk front-line workers or older people still don’t have access to vaccines in countries where the coronavirus is out of control.

Moderna announced Thursday that an initial analysis of its teen trial found its vaccine was 96 percent effective among participants who received at least one dose. Moderna is in discussions with regulators about the data. Pfizer-BioNTech and Moderna are testing their vaccines in children as young as infants. Johnson & Johnson is planning pediatric trials of its single-shot vaccine.

Trials in younger children are expected to take longer, because researchers must step down gradually in age and determine a safe and effective dose. William Gruber, senior vice president of vaccine clinical research and development at Pfizer, said data from tests in children as young as 2 years old may be available by September or October, with data on children as young as 6 months possible by the end of the year.

Within each age category, a separate risk-benefit assessment may take place. In the youngest children, given the low risk from the coronavirus, side effects may figure more prominently into the analysis, for example. Researchers may end up choosing a lower dose of vaccine. The understanding of children’s role in transmission may also evolve and help guide vaccine use and public policy.

“We are proceeding carefully, cautiously,” Edwards said. “We’re using the same rigid guidelines we use in all vaccines, and we take this very seriously. I think as time goes on and more information becomes available, some of the questions may be easier to address.”

WHO classifies triple-mutant COVID-19 variant from India as global health risk

WHO classifies triple mutant COVID-19 variant in India as global health risk  - The Filipino Times

The World Health Organization said Monday that the coronavirus variant first identified in India last year will be reclassified as a “variant of concern,” indicating that it has become a global health threat.

The B.1.617 variant has been found to spread more easily than the original virus, with some evidence indicating that it may evade some of the protections provided by the vaccines, according to a preliminary study. But the shots are still considered effective. The agency will provide more details on Tuesday.

The highly contagious, triple-mutant variant is also the fourth variant to be designated as a global concern, prompting enhanced tracking and analysis. The other variants are those first detected in Britain, South Africa and Brazil.

“We are classifying this as a variant of concern at a global level,” said Maria Van Kerkhove, WHO technical lead on COVID-19, per Reuters. “There is some available information to suggest increased transmissibility.”

A variant is labeled as “of concern” if it is shown to be more contagious, more deadly or more resistant to current vaccines and treatments, according to the WHO.

The global agency said the predominant lineage of B.1.617 was first identified in India in December, although an earlier version was spotted in October 2020.

The variant has already spread to other countries, and many nations – including the U.S. – have moved to end or restrict travel from India.

“Even though there is increased transmissibility demonstrated by some preliminary studies, we need much more information about this virus variant and this lineage and all of the sub-lineages,” said Maria Van Kerkhove, the WHO’s technical lead for COVID-19.

India reported a record-high of daily coronavirus cases, averaging about 391,000 new daily cases and about 3,879 deaths per day, according to Johns Hopkins University data.

Your questions, answered

No mask, no service, but enforcing the rule at restaurants will be a  challenge | Business Local | buffalonews.com

“A vaccinated friend attended an indoor gathering of 35 people, half of which were unvaccinated. Nobody wore masks or socially distanced. I am vaccinated, but should I avoid contact with this person for some period of time? I am concerned that my friend may have inadvertently been exposed to variants, although no problems as of three days post-event.”

The scenario you describe is likely to be low risk to you and your friend because you’re both vaccinated. It’s not ideal — mostly from the perspective of the people at the meet-up who weren’t vaccinated yet. When non-immunized and immunized people gather in a space, precautions should account for those who haven’t had their shots yet, the Centers for Disease Control and Prevention advises. Those precautions include everyone wearing masks inside in public or indoors if there’s a multi-household mix of people who aren’t vaccinated.

Mingling indoors without masks or distancing is “likely low risk for the vaccinated people,” the CDC writes (the emphasis is the agency’s). That’s because the vaccines are so protective. 

Real-world results continue to support clinical trial conclusions that coronavirus vaccines are highly effective at preventing symptomatic covid-19. In a CDC study of almost 2,500 fully vaccinated health-care workers, only three had confirmed infections. “Front-line workers were 90 percent less likely to be infected with the virus that causes covid-19,” an epidemiologist and author of that study told The Post last month.

Emerging reports also suggest vaccines hinder asymptomatic infection. Two doses of an mRNA vaccine reduced that by 92 percent in Israel, according to a study published this week in The Lancet. And there’s encouraging news that vaccines protect against variants of concern. As we mentioned above, and reported Wednesday, research in the New England Journal of Medicine showed the Pfizer-BioNTech vaccine was “90 percent effective at blocking infections caused by the B.1.1.7 variant,” which is the more transmissible variant first detected in the U.K. The vaccine was slightly less effective, at 75 percent, against the B.1.351 variant identified in South Africa.

It’s good to hear that there haven’t been any problems in the days after this gathering. From what you’ve described, it doesn’t sound as though your friend needs to take any actions like quarantining. In fact, the CDC advises quarantine is generally unnecessary for fully vaccinated people, even after known exposure, unless an immunized person begins to show symptoms.

That said, you’ve asked journalists, not doctors — here’s our usual disclaimer to consult your primary-care physician if you have specific concerns about your susceptibility to the virus. If you’re wary about jumping back into social life, that’s okay, too, and not unusual after living through an ongoing pandemic. Some psychologists suggest easing into social situations post-vaccination, borrowing from principles of exposure therapy; for instance, if you’re anxious and would like to take extra precautions for your next visit with your friend, you might suggest meeting up while outside or you can wear a mask.