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US maternal death rate rose sharply in 2021, CDC data shows, and experts worry the problem is getting worse | CNN

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CNN
—

As women continue to die due to pregnancy or childbirth each year in the United States, new federal data shows that the nation’s maternal death rate rose significantly yet again in 2021, with the rates among Black women more than twice as high as those of White women.

Experts said the United States’ ongoing maternal mortality crisis was compounded by Covid-19, which led to a “dramatic” increase in deaths.

The number of women who died of maternal causes in the United States rose to 1,205 in 2021, according to a report from the National Center for Health Statistics, released Thursday by the US Centers for Disease Control and Prevention. That’s a sharp increase from years earlier: 658 in 2018, 754 in 2019 and 861 in 2020.

That means the US maternal death rate for 2021 – the year for which the most recent data is available – was 32.9 deaths per 100,000 live births, compared with rates of 20.1 in 2019 and 23.8 in 2020.

The new report also notes significant racial disparities in the nation’s maternal death rate. In 2021, the rate for Black women was 69.9 deaths per 100,000 live births, which is 2.6 times the rate for White women, at 26.6 per 100,000.

The data showed that rates increased with the mother’s age. In 2021, the maternal death rate was 20.4 deaths per 100,000 live births for women under 25 and 31.3 for those 25 to 39, but it was 138.5 for those 40 and older. That means the rate for women 40 and older was 6.8 times higher than the rate for women under age 25, according to the report.

The maternal death rate in the United States has been steadily climbing over the past three decades, and these increases continued through the Covid-19 pandemic.

Questions remain about how the pandemic may have affected maternal mortality in the United States, according to Dr. Elizabeth Cherot, chief medical and health officer for the infant and maternal health nonprofit March of Dimes, who was not involved in the new report.

“What happened in 2020 and 2021 compared with 2019 is Covid,” Cherot said. “This is sort of my reflection on this time period, Covid-19 and pregnancy. Women were at increased risk for morbidity and mortality from Covid. And that actually has been well-proven in some studies, showing increased risks of death, but also being ventilated in the intensive care unit, preeclampsia and blood clots, all of those things increasing a risk of morbidity and mortality.”

The American College of Obstetricians and Gynecologists previously expressed “great concern” that the pandemic would worsen the US maternal mortality crisis, ACOG President Dr. Iffath Abbasi Hoskins said in a statement Thursday.

“Provisional data released in late 2022 in a U.S. Government Accountability Office report indicated that maternal death rates in 2021 had spiked—in large part due to COVID-19. Still, confirmation of a roughly 40% increase in preventable deaths compared to a year prior is stunning new,” Hoskins said.

“The new data from the NCHS also show a nearly 60% percent increase in maternal mortality rates in 2021 from 2019, just before the start of the pandemic. The COVID-19 pandemic had a dramatic and tragic effect on maternal death rates, but we cannot let that fact obscure that there was—and still is—already a maternal mortality crisis to compound.”

Health officials stress that people who are pregnant should get vaccinated against Covid-19 and that doing so offers protection for both the mother and the baby.

During the early days of the pandemic, in 2020, there was limited information about the vaccine’s risks and benefits during pregnancy, prompting some women to hold off on getting vaccinated. But now, there is mounting evidence of the importance of getting vaccinated for protection against serious illness and the risks of Covid-19 during pregnancy.

The Covid-19 pandemic also may have exacerbated existing racial disparities in the maternal death rate among Black women compared with White women, said Dr. Chasity Jennings-Nuñez, a California-based site director with Ob Hospitalist Group and chair of the perinatal/gynecology department at Adventist Health-Glendale, who was not involved in the new report.

“In terms of maternal mortality, it continues to highlight those structural and systemic problems that we saw so clearly during the Covid-19 pandemic,” Jennings-Nuñez said.

“So in terms of issues of racial health inequities, of structural racism and bias, of access to health care, all of those factors that we know have played a role in terms of maternal mortality in the past continue to play a role in maternal mortality,” she said. “Until we begin to address those issues, even without a pandemic, we’re going to continue to see numbers go in the wrong direction.”

Some policies have been introduced to tackle the United States’ maternal health crisis, including the Black Maternal “Momnibus” Act of 2021, a sweeping bipartisan package of bills that aim to provide pre- and post-natal support for Black mothers, including extending eligibility for certain benefits postpartum.

As part of the Momnibus, President Biden signed the bipartisan Protecting Moms Who Served Act in 2021, and other provisions have passed in the House.

In the United States, about 6.9 million women have little or no access to maternal health care, according to March of Dimes, which has been advocating in support of the Momnibus.

The US has the highest maternal death rate of any developed nation, according to the Commonwealth Fund and the latest data from the World Health Organization. While maternal death rates have been either stable or rising across the United States, they are declining in most countries.

“A high rate of cesarean sections, inadequate prenatal care, and elevated rates of chronic illnesses like obesity, diabetes, and heart disease may be factors contributing to the high U.S. maternal mortality rate. Many maternal deaths result from missed or delayed opportunities for treatment,” researchers from the Commonwealth Fund wrote in a report last year.

The ongoing rise in maternal deaths in the United States is “disappointing,” said Dr. Elizabeth Langen, a high-risk maternal-fetal medicine physician at the University of Michigan Health Von Voigtlander Women’s Hospital. She was not involved in the latest report but cares for people who have had serious complications during pregnancy or childbirth.

“Those of us who work in the maternity care space have known that this is a problem in our country for quite a long time. And each time the new statistics come out, we’re hopeful that some of the efforts that have been going on are going to shift the direction of this trend. It’s really disappointing to see that the trend is not going in the right direction but, at some level, is going in the worst direction and at a little bit of a faster rate,” Langen said.

“In the health care system, we need to accept ultimate responsibility for the women who die in our care,” she added. “But as a nation, we also need to accept some responsibility. We need to think about: How do we provide appropriate maternity care for people? How do we let people have time off of work to see their midwife or physician so that they get the care that they need? How do all of us make it possible to live a healthy life while you’re pregnant so that you have the opportunity to have the best possible outcome?”

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Celebrities may have helped shape anti-vaccine opinions during Covid-19 pandemic, study finds | CNN

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CNN
—

Covid-19 vaccines are known to be safe and effective, and they’re available for free, but many Americans in the US refuse to get them – and a recent study suggests that celebrities may share some of the blame for people’s mistrust.

Celebrities have long tried to positively influence public health, studies show, but during the Covid-19 pandemic, they also seemed to have a large influence on spreading misinformation.

Decades ago, in the 1950s, people could see stars like Elvis Presley, Dick Van Dyke and Ella Fitzgerald in TV ads that encouraged polio vaccination. This celebrity influence boosted the country’s general vaccination efforts, and vaccination nearly eliminated the deadly disease.

In 2021, US officials used celebrities in TV ads to encourage more people to get vaccinated against Covid-19. Big names like lifestyle guru Martha Stewart, singer Charlie Puth and even Senate Minority Leader Mitchell McConnell showed up in spots that had billions of ad impressions.

The world isn’t restricted to only three TV networks any more, so celebrities like actress Hilary Duff, actor Dwayne “The Rock” Johnson, singer Dolly Parton and even Big Bird also used their enormous presence on Instagram and Twitter to promote a pro Covid-19 vaccine message.

But social media also became a vehicle for celebrities to cast doubt about the safety and effectiveness of the vaccine and even to spread disinformation about Covid.

Their negative messages seemed to find an audience.

For their study, published in the journal BMJ Health & Care Informatics, researchers examined nearly 13 million tweets between January 2020 and March 2022 about Covid-19 and vaccines. They designed a natural language model to determine the sentiment of each tweet and compared them with tweets that also mentioned people in the public eye.

The stars they picked to analyze included people who had shared skepticism about the vaccines, who had Covid-related tweets that were identified as misinformation or who retweeted misinformation about Covid.

They included rapper Nicki Minaj, football player Aaron Rodgers, tennis player Novak Djokovic, singer Eric Clapton, Sen. Rand Paul, former President Donald Trump, Sen. Ted Cruz, Florida Gov. Ron DeSantis, TV host Tucker Carlson and commentator Joe Rogan.

The researchers found 45,255 tweets from 34,407 unique authors talking about Covid-19 vaccine-related issues. Those tweets generated a total of 16.32 million likes. The tweets from these influencers, overall, were more negative about the vaccine than positive, the study found. These tweets were specifically more related to antivaccine controversy, rather than news about vaccine development, the study said.

The highest number of negative comments was associated with Rodgers and Minaj. Clapton had “very few” positive tweets, the study said, and that may have had an influence, but he also caught flak for it from the public.

The most-liked tweet that mentioned Clapton and the vaccine said, “Strongly disagree with [EC] … take on Covid and the vaccine and disgusted by his previous white supremacist comments. But if you reference the death of his son to criticize him, you are an ignorant scumbag.”

Trump and Cruz were found to have the most substantial impact within this group, with combined likes totaling more than 122,000.

They too came in for criticism on the topic, with many users wondering whether these politicians were qualified to have opinions about the vaccines. The study said the most-liked tweet mentioning Cruz was, “I called Ted Cruz’s office asking to make an appointment to talk with the Senator about my blood pressure. They told me that the Senator was not qualified to give medical advice and that I should call my doctor. So I asked them to stop advising about vaccines.”

The most-liked tweet associated with Rogan was an antivaxx statement: “I love how the same people who don’t want us to listen to Joe Rogan, Aaron Rodgers about the covid vaccine, want us to listen to Big Bird & Elmo.”

Posts shared by news anchors and politicians seemed to have the most influence in terms of the most tweets and retweets, the study found.

“Our findings suggest that the presence of consistent patterns of emotional content co-occurring with messaging shared by those persons in the public eye that we’ve mentioned, influenced public opinion and largely stimulated online public discourse, for the at least over the course of the first two years of the Covid pandemic,” said study co-author Brianna White, a research coordinator in the Population Health Intelligence lab at the University of Tennessee Health Science Center – Oak Ridge National Laboratory Center for Biomedical Informatics.

“We also argue that obviously as the risk of severe negative health outcomes increase with the failure to comply with health protective behavior recommendations, that our findings suggest that polarized messages from societal elite may downplay those severe negative health outcome risks.”

The study doesn’t get into exactly why celebrity tweets would have such an impact on people’s attitudes about the vaccine. Dr. Ellen Selkie, who has conducted research on influence at the intersection of social media, celebrity and public health outcomes, said celebrities are influential because they attract a lot of attention.

“I think part of the influence that media have on behavior has to do with the amount of exposure. Just in general, the volume of content that is focused on a specific topic or on a specific sort of interpretation of that topic – in this case misinformation – the repeated exposure to any given thing is going to increase the likelihood that it’s going to have an effect,” said Selkie, who was not involved in the new research. She is an adolescent health pediatrician and researcher with UW Health Kids and an assistant professor of pediatrics at the University of Wisconsin School of Medicine and Public Health.

Just as people listen to a friend’s thoughts, they’ll listen to a celebrity whom they tend to like or identify with because they trust their opinion.

“With fandoms, in terms of the relationship between musical artists and actors and their fans, there is this sort of mutual love that fans and artists have for each other, which sort of can approximate that sense that they’re looking out for each other,” Selkie said.

She said she would be interested to see research on the influence of celebrities who tweeted positive messages about the Covid-19 vaccine.

The authors of the study hope public health leaders will use the findings right away.

“We argue this threat to population health should create a sense of urgency and warrants public health response to identify, develop and implement innovative mitigation strategies,” the study says.

Exposure to large amounts of this misinformation can have a lasting impact and work against the public’s best interest when it comes to their health.

“As populations grow to trust the influential nature of celebrity activity on social platforms, followers are disarmed and open to persuasion when faced with false information, creating opportunities for dissemination and rapid spread of misinformation and disinformation,” the study says.

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Cancer screenings could be back to normal after millions missed during Covid-19 pandemic | CNN

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CNN
—

Millions of people across the United States missed routine cancer screenings during the second year of the Covid-19 pandemic, with the prevalence of screening for breast, cervical and prostate cancers in the previous year falling anywhere from 6% to 15% between 2019 and 2021, according to a new study from the American Cancer Society.

“We were thinking there would be a rebound in late 2020,” said Dr. William Dahut, chief scientific officer of the American Cancer Society. “We were surprised to see the continued increase in the number of folks not getting their screenings.”

But more recently, it appears that people are starting to return to routine screenings at rates seen before the pandemic, separate research suggests.

Rates of screening for breast, cervical and colon cancers may have returned to normal, according to more recent data published last week in the journal Epic Research, which is owned by the health care software company Epic.

“As screening rates returned to normal from the drop we previously reported, rates of cancer diagnosis returned to normal as well,” Dr. Chris Alban, a clinical informaticist at Epic Research, wrote in an email.

“We haven’t seen evidence that the screenings missed during the pandemic resulted in worsened patient outcomes, though we plan to monitor this trend to see whether it holds over time,” he said. “The recommended intervals between screenings for a given cancer can be several years, so evidence of advanced cancers can take a long time to appear.”

Due to the declines in cancer screenings as well as barriers to accessing treatment in the early days of the pandemic, not only did physicians nationwide worry that screening and treatment delays led to patients arriving at their offices with advanced cancer, some anecdotally reported seeing upticks in advanced cancers at the time.

The prevalence of screening for breast, cervical and prostate cancers did not return to pre-pandemic levels in 2021, the second year of the Covid-19 pandemic, according to the American Cancer Society’s new study, published Thursday in the Journal of Clinical Oncology.

The study included data on more than 60,000 adults in the United States who were eligible for screening for breast, cervical, prostate and colorectal cancers between 2019 and 2021. The data came from the US Centers for Disease Control and Prevention’s National Health Interview Survey.

The researchers found that between 2019 and 2021, the overall prevalence of eligible adults who completed screening in the previous year fell 6% for breast cancer, 15% for cervical cancer and 10% for prostate cancer. That means there were about 1 million fewer people who got screened for breast cancer, 4.4 million fewer screened for cervical cancer and about 700,000 fewer screened for prostate cancer.

“These declines have significant public health implications as they are expected to lead to more advanced stage cancer diagnosis in the future,” the researchers wrote.

The prevalence of screening for colorectal cancer was unchanged, the researchers found.

The growing popularity of at-home colon cancer screening tests probably offset any decline in colorectal cancer screenings, they wrote.

The researchers also found some racial differences, as the Asian community had the largest declines in breast, cervical and prostate cancer screenings.

“These findings are especially concerning as cancer is the leading cause of death in both Asian American men and women,” wrote the researchers, all from the American Cancer Society.

Dahut said that anyone who missed a routine cancer screening during the early days of the pandemic should catch up now.

“Even in the best of times, the number of folks who are screened is far too low,” he said. “Go ahead and follow the guidelines, get screened when appropriate, and the outcomes will be better.”

The Epic Research study involved data on 373,574 cancer diagnoses entered in patients’ charts in the US between January 2018 and December 2022.

The data came from 190 health care organizations that use software from Epic for their electronic health records. Together, these organizations represent 1,123 hospitals and more than 22,500 clinics, and they agreed to contribute to the de-identified data set, meaning no individual patient can be identified within the data.

The data showed a clear decrease in cancer cases early in the pandemic, which correlates with a decline in screening, but screening rates appeared to return to normal last year, as did cancer detection rates. The data also did not appear to show a significant rise in new diagnoses of advanced cancers through the end of last year.

It’s “good news” that the data demonstrate a return to pre-Covid rates of cancer screening, Dr. Arif Kamal, the American Cancer Society’s chief patient officer – who was not involved in the Epic Research study – wrote in an email. He called the new data intriguing but emphasized that more time is needed to determine whether or when rates of advanced cancers may increase due to missed screenings. It could take years.

“Conclusions regarding whether advanced cancer rates have increased due to missed screenings are a bit premature to reach. This is because cancer takes years to develop, and the resulting effect of missed cancers cannot be known after only a few years,” Kamal said.

“We remain hopeful that as cancer screening rates have returned to baseline, that the two years of missed screenings will not have a long-lasting effect on cancer incident or mortality,” he said. “But more time will tell.”

The data from Epic Research’s study is encouraging, as it suggests that more advanced cancers are not being seen, Dr. David Cohn, chief medical officer for the Ohio State University Comprehensive Cancer Center, wrote in an email.

“Whether this holds up over the next few years is yet to be seen,” he added.

Cohn, a practicing gynecologic oncologist who was not involved in either new study, said that he is “always concerned” about a decrease in screening rates and the resulting impact on later cancer diagnoses.

Yet “these data suggest that folks are getting back to the core business of screening,” he said, “such that these data will hopefully hold up over the next few years without seeing an increase in later diagnoses.”

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First on CNN: HHS secretary sends letter to state governors on what’s to come when Covid-19 public health emergency ends | CNN

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CNN
—

Plans are moving forward at the US Department of Health and Human Services to prepare for the end of the nation’s Covid-19 public health emergency declaration in May.

On Thursday, HHS Secretary Xavier Becerra sent a letter and fact sheet to state governors detailing what exactly the end of the emergency declaration will mean for jurisdictions and their residents.

“Addressing COVID-19 remains a significant public health priority for the Administration, and over the next few months, we will transition our COVID-19 policies, as well as the current flexibilities enabled by the COVID-19 emergency declarations, into improving standards of care for patients. We will work closely with partners including state, local, Tribal, and territorial agencies, industry, and advocates, to ensure an orderly transition,” Becerra wrote in a draft of the letter obtained by CNN.

“In the coming days, the Centers for Medicare & Medicaid Services (CMS) will also provide additional information, including about the waivers many states and health systems have adopted and how they will be impacted by the end of the COVID-19 PHE,” he wrote. “I will share that resource with your team when available.”

Declaring a public health emergency in the United States means that certain actions, access to funds, grants, waivers and data – among other steps – can happen more quickly in response to the crisis for the duration of the emergency. A declaration lasts 90 days – unless HHS ends it – and may be renewed.

On January 30, the White House announced its intention to end the Covid-19 national and public health emergencies on May 11, signaling that the administration considers the nation to have moved out of the emergency response phase.

Becerra had agreed to give governors a 60-day notice to prepare for the end of the emergency. Thursday’s letter was sent 90 days ahead of the emergency’s planned end.

“We are having ongoing conversations about what else we need to do in the next 90 days to ensure a smooth transition. I can tell you that every one of our agencies has been working hard on this plan,” an HHS official told CNN. “We’re going to have a series of additional materials that will go out, as well as a series of conversations over the coming days and weeks.”

The end of the public health emergency will affect some Medicare and state Medicaid flexibilities provided for the duration of the emergency. This includes waivers like the requirement for a three-day hospital stay before Medicare will cover care at a skilled nursing facility.

“We’ve been working closely with the governors on the public health emergency. This is a combination of both federal flexibilities that we allow, and the states are often the ones who are using those flexibilities,” the HHS official said.

“Just about every aspect of the pandemic response, I would say, has been in partnership with our state partners. And so, I think they have been, frankly for months now, the ones that we have been going to and the ones that we publicly committed to notifying in advance of changes to the public health emergency declaration.”

But the emergency’s end will not impact the authorizations of Covid-19 devices, including tests, vaccines and treatments that have been authorized for emergency use by the US Food and Drug Administration.

During the Covid-19 pandemic, the FDA has issued about 15 times as many emergency use authorizations as it did for all other previous public health emergencies, Commissioner Dr. Robert Califf said Wednesday in a joint hearing of the House Oversight and Investigations and Health subcommittees.

“Today, we’ve issued EUAs or provided traditional marketing authorizations to over 2,800 medical devices for Covid-19, which is 15 times more EUAs than all other previous emergencies combined,” Califf said. He added that the effects of the end of the emergency declaration will be “modest” because the “EUAs are independent of the public health emergency, so we can keep them going as long as we need to.”

The emergency is slated to end May 11. “What happens on May 12? On May 12, you can still walk into a pharmacy and get your bivalent vaccine,” Dr. Ashish Jha, the White House’s coronavirus response coordinator, wrote on Twitter last week.

He said that at some point, probably in the summer or early fall, the Biden administration will transition from federal distribution of Covid-19 vaccines and treatments to purchases through the regular health care system – but that’s not happening quite yet.

Overall, there are additional Medicaid waivers and other flexibilities that states and territories have received under the public health emergency. Some of those will be terminated. But state Medicaid programs will have to continue covering Covid-19 testing, treatments, and vaccinations without cost-sharing through September 30, 2024.

The end of the public health emergency declaration means Medicare beneficiaries will face out-of-pocket costs for over-the-counter home Covid-19 tests and treatment. However, people with Medicare will continue to have no cost for medically necessary lab-conducted Covid-19 tests ordered by their health care providers.

Covid-19 vaccinations will continue to be covered at no cost for all Medicare beneficiaries.

Those with private insurance could face charges for lab tests, even if they are ordered by a provider, according to the Kaiser Family Foundation. Vaccinations will continue to be free for those with private insurance who go to in-network providers, but going to an out-of-network providers could incur charges once federal supplies run out.

And the privately insured will not be able to get free at-home tests from pharmacies and retailers anymore unless their insurers choose to cover them.

Americans with private insurance have not been charged for monoclonal antibody treatment since they were prepaid by the federal government, though patients may be charged for the office visit or administration of the treatment, according to Kaiser. But that is not tied to the public health emergency, and the free treatments will be available until the federal supply is exhausted. The government has already run out of some of the treatments so those with private insurance may already be picking up some of the cost.

The uninsured had been able to access no-cost testing, treatments and vaccines through a different pandemic relief program. However, the federal funding ran out in the spring of 2022, making it more difficult for those without coverage to obtain free services.

Also, the “ability of health care providers to safely dispense controlled substances via telemedicine without an in-person interaction is affected; however, there will be rulemaking that will propose to extend these flexibilities,” according to the letter’s fact sheet.

One of the most meaningful pandemic enhancements for states is no longer tied to the public health emergency. Congress severed the connection in December as part of its fiscal year 2023 government funding package, which state Medicaid officials had urged lawmakers to do.

States will now be able to start processing Medicaid redeterminations and disenrolling residents who no longer qualify, starting April 1. They have 14 months to review the eligibility of their beneficiaries.

As part of a Covid-19 relief package passed in March 2020, states were barred from kicking people off Medicaid during the public health emergency in exchange for additional federal matching funds. Medicaid enrollment has skyrocketed to a record 91 million people since then.

A total of roughly 15 million people could be dropped from Medicaid when the continuous enrollment requirement ends, according to an analysis the Department of Health and Human Services released in August. About 8.2 million folks would no longer qualify, but 6.8 million people would be terminated even though they are still eligible, the department estimated.

Many who are disenrolled from Medicaid, however, could qualify for other coverage.

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The virus threat is easing, but US hospitals are still as full as ever | CNN

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CNN
—

At Massachusetts General Hospital in downtown Boston, the hallways of the emergency department are lined with dozens of patients waiting to get a room upstairs.

“Imagine spending days and nights in the hallway under fluorescent lights in the ER next to a trauma bay while [patients] have heart failure, kidney failure or pneumonia,” said Dr. Melissa Mattison, a physician and chief of hospital medicine at Mass General, which is a founding member of Mass General Brigham.

“Everybody’s doing their best, but where do they go to the bathroom? How do they take a shower if they want to clean up? How do they eat? There’s no privacy. It’s just, it’s awful. It’s absolutely awful.”

As of Friday, about 87% of all available hospital beds in the state are in use, and capacity strains have eased little despite a dramatic decrease in the number of people being treated for respiratory illness.

“Every day, our emergency room has a backlog of anywhere between 25 and 100 patients waiting for a bed upstairs. So if today, that number was 25, and two weeks ago, it was 100 – yes, that’s better, but there’s still a long line,” Mattison said. “Maybe the patients aren’t piled like sardines in the ER as much when you only have 35 patients waiting compared to 75. But it’s still not great.”

The winter triple threat of flu, Covid-19 and RSV is easing across the United States, and as in Massachusetts, most states are now reporting low or minimal levels of respiratory illness activity overall.

Nationwide, emergency department visits for the respiratory viruses are a third of what they were a month ago, federal data shows. Flu hospitalizations are nearly as low as they’ve been all season, since October. Hospitalizations for Covid-19 – the last of the three viruses to trend down – have been falling for the past few weeks, and just 4% of hospital beds nationwide are being used by Covid-19 patients.

That’s a dramatic shift from January 2022, when Covid-19 patients were filling most hospital beds amid the early Omicron surge. But hospitals are still about as full as they’ve ever been during the pandemic – at least three-quarters of available beds across the country were in use for all of 2022 – and that doesn’t seem likely to change any time soon.

Hospitals were facing capacity and resource challenges long before the pandemic hit, experts say, in large part because the people who are being admitted are sicker than they were before.

“It’s been a continuing trend over the last decade or so that there’s been this greater acuity of patients inside the hospitals,” said Nancy Foster, vice president for quality and patient safety with the American Hospital Association. “So what you see is this incredibly sick group of people inside of hospitals. If you’re a doctor or nurse or respiratory therapist or pharmacist or any other health professional working inside the hospital, that means it’s always a difficult puzzle you’re trying to solve to help that patient out.”

At Mass General, an emergency department boarder program – which outlines plans for how to cover patients who were waiting for a bed – was well-established years before the pandemic hit, Mattison said.

Hospitals started to report capacity data to the federal government in 2020 under a pandemic requirement, so there’s no federal data to compare to pre-pandemic years.

But Mattison was quick to say her hospital is 99% full now, like it was in 2019 and years before the pandemic. Still, she says, “how long is that waiting list, and who’s on that waiting list? That’s something that’s not reflected in that metric.”

By and large, the mix of patients in hospitals is similar to what it was pre-pandemic, said Aaron Wesolowski, vice president of policy research, analytics and strategy at the American Hospital Association.

As the share of Covid-19 patients drops, it’s perhaps “a breath less stressful” for health care providers who felt frustrated by the lack of tools available to help people as they so desperately wanted to in the early days of the pandemic, Foster said.

In fact, for most categories of care – with infectious disease as a noticeable exception – the number of people seen in inpatient and emergency department settings in 2022 was lower than it was in 2019, Wesolowski said, citing data from Strata, a health care data analytics firm.

A mix of complicating factors were exacerbated during the pandemic, experts say, straining resources more than ever.

“Length of stay is longer because people are needing more acute care. Because of work force pressures, there are not as many people who can be treated in an inpatient setting all at once,” Wesolowski said. “So both things, I think, can be true.”

Samuel Scarpino, director of AI and life sciences at Northeastern University, says it’s a “perfect storm” of issues: Covid-19 and the ongoing infection control measures that hospitals have to keep in place, a backlog of other patients with a delayed need for acute care, and work force burnout three years into a pandemic.

The biggest risk factor in the equation is still Covid-19, he says, not because a new variant will necessarily cause more hospitalizations but because the unpredictability is forcing hospitals to leave more beds open as a buffer just in case.

“The biggest risk is almost certainly the uncertainty associated with what’s coming,” said Scarpino, who was previously vice president at the Rockefeller Foundation’s Pandemic Prevention Institute.

Foster, of the American Hospital Association, says the pandemic emergency declaration has granted a number of flexibilities – such as telehealth – that have helped more patients have options for care that are outside of hospitals.

The federal government has continuously renewed the emergency declaration since January 2020, but it is likely to come to an end in May.

Without it, Foster says, hospitals would probably be even more full than they already are – particularly as alternative options for care outside of the hospital may become more limited again.

“Part of the reason we have the kind of inpatient hospital capacity that we have right now is that we do have a number of flexibilities that were granted to hospitals by [the Centers for Medicare and Medicaid Services] and other federal agencies and the states during Covid that are being used for a wide variety of patients,” she said. “If those were to disappear overnight, we would be struggling to care for the current level of patients.”

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FDA vaccine advisers vote to harmonize Covid-19 vaccines in the United States | CNN

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CNN
—

A panel of independent experts that advises the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to update all Covid-19 vaccines so they contain the same ingredients as the two-strain shots that are now used as booster doses.

The vote means young children and others who haven’t been vaccinated may soon be eligible to receive two-strain vaccines that more closely match the circulating viruses as their primary series.

The FDA must sign off on the committee’s recommendation, which it is likely to do, before it goes into effect.

Currently, the US offers two types of Covid-19 vaccines. The first shots people get – also called the primary series – contain a single set of instructions that teach the immune system to fight off the original version of the virus, which emerged in 2019.

This index strain is no longer circulating. It was overrun months ago by an ever-evolving parade of new variants.

Last year, in consultation with its advisers, the FDA decided that it was time to update the vaccines. These two-strain, or bivalent, shots contain two sets of instructions; one set reminds the immune system about the original version of the coronavirus, and the second set teaches the immune system to recognize and fight off Omicron’s BA.4 and BA.5 subvariants, which emerged in the US last year.

People who have had their primary series – nearly 70% of all Americans – were advised to get the new two-strain booster late last year in an effort to upgrade their protection against the latest variants.

The advisory committee heard testimony and data suggesting that the complexity of having two types of Covid-19 vaccines and schedules for different age groups may be one of the reasons for low vaccine uptake in the US.

Currently, only about two-thirds of Americans have had the full primary series of shots. Only 15% of the population has gotten an updated bivalent booster.

Data presented to the committee shows that Covid-19 hospitalizations have been rising for children under the age of 2 over the past year, as Omicron and its many subvariants have circulated. Only 5% of this age group, which is eligible for Covid-19 vaccination at 6 months of age, has been fully vaccinated. Ninety percent of children under the age of 4 are still unvaccinated.

“The most concerning data point that I saw this whole day was that extremely low vaccination coverage in 6 months to 2 years of age and also 2 years to 4 years of age,” said Dr. Amanda Cohn, director of the US Centers for Disease Control and Prevention’s Division of Birth Defects and Infant Disorders. “We have to do much, much better.”

Cohn says that having a single vaccine against Covid-19 in the US for both primary and booster doses would go a long way toward making the process less complicated and would help get more children vaccinated.

Others feel that convenience is important but also stressed that data supported the switch.

“This isn’t only a convenience thing, to increase the number of people who are vaccinated, which I agree with my colleagues is extremely important for all the evidence that was related, but I also think moving towards the strains that are circulating is very important, so I would also say the science supports this move,” said Dr. Hayley Gans, a pediatric infectious disease specialist at Stanford University.

Many others on the committee were similarly satisfied after seeing new data on the vaccine effectiveness of the bivalent boosters, which are cutting the risk of getting sick, being hospitalized or dying from a Covid-19 infection.

“I’m totally convinced that the bivalent vaccine is beneficial as a primary series and as a booster series. Furthermore, the updated vaccine safety data are really encouraging so far,” said Dr. David Kim, director of the the US Department of Health and Human Services’ National Vaccine Program, in public discussion after the vote.

Thursday’s vote is part of a larger plan by the FDA to simplify and improve the way Covid-19 vaccines are given in the US.

The agency has proposed a plan to convene its vaccine advisers – called the Vaccines and Related Biological Products Advisory Committee, or VRBPAC – each year in May or June to assess whether the instructions in the Covid-19 vaccines should be changed to more closely match circulating strains of the virus.

The time frame was chosen to give manufacturers about three months to redesign their shots and get new doses to pharmacies in time for fall.

“The object, of course – before anyone says anything – is not to chase variants. None of us think that’s realistic,” said Jerry Weir, director of the Division of Viral Products in the FDA’s Office of Vaccines Research and Review.

“But I think our experience so far, with the bivalent vaccines that we have, does indicate that we can continue to make improvements to the vaccine, and that would be the goal of these meetings,” Weir said.

In discussions after the vote, committee members were supportive of this plan but pointed out many of the things we still don’t understand about Covid-19 and vaccination that are likely to complicate the task of updating the vaccines.

For example, we now seem to have Covid-19 surges in the summer as well as the winter, noted Dr. Michael Nelson, an allergist and immunologist at the University of Virginia. Are the surges related? And if so, is fall the best time to being a vaccination campaign?

The CDC’s Dr. Jefferson Jones said that with only three years of experience with the virus, it’s really too early to understand its seasonality.

Other important questions related to the durability of the mRNA vaccines and whether other platforms might offer longer protection.

“We can’t keep doing what we’re doing,” said Dr. Bruce Gellin, chief of global public health strategy at the Rockefeller Foundation. “It’s been articulated in every one of these meetings despite how good these vaccines are. We need better vaccines.”

The committee also encouraged both government and industry scientists to provide a fuller picture of how vaccination and infection affect immunity.

One of the main ways researchers measure the effectiveness of the vaccines is by looking at how much they increase front-line defenders called neutralizing antibodies.

Neutralizing antibodies are like firefighters that rush to the scene of an infection to contain it and put it out. They’re great in a crisis, but they tend to diminish in numbers over time if they’re not needed. Other components of the immune system like B-cells and T-cells hang on to the memory of a virus and stand ready to respond if the body encounters it again.

Scientists don’t understand much about how well Covid-19 vaccination boosts these responses and how long that protection lasts.

Another puzzle will be how to pick the strains that are in the vaccines.

The process of selecting strains for influenza vaccines is a global effort that relies on surveillance data from other countries. This works because influenza strains tend to become dominant and sweep around the world. But Covid-19 strains haven’t worked in quite the same way. Some that have driven large waves in other countries have barely made it into the US variant mix.

“Going forward, it is still challenging. Variants don’t sweep across the world quite as uniform, like they seem to with influenza,” the FDA’s Weir said. “But our primary responsibility is what’s best for the US market, and that’s where our focus will be.”

Eventually, the FDA hopes that Americans would be able to get an updated Covid-19 shot once a year, the same way they do for the flu. People who are unlikely to have an adequate response to a single dose of the vaccine – such as the elderly or those with a weakened immune system – may need more doses, as would people who are getting Covid-19 vaccines for the first time.

At Thursday’s meeting, the advisory committee also heard more about a safety signal flagged by a government surveillance system called the Vaccine Safety Datalink.

The CDC and the FDA reported January 13 that this system, which relies on health records from a network of large hospital systems in the US, had detected a potential safety issue with Pfizer’s bivalent boosters.

In this database, people 65 and older who got a Pfizer bivalent booster were slightly more likely to have a stroke caused by a blood clot within three weeks of their vaccination than people who had gotten a bivalent booster but were 22 to 42 days after their shot.

After a thorough review of other vaccine safety data in the US and in other countries that use Pfizer bivalent boosters, the agencies concluded that the stroke risk was probably a statistical fluke and said no changes to vaccination schedules were recommended.

At Thursday’s meeting, Dr. Nicola Klein, a senior research scientist with Kaiser Permanente of Northern California, explained how they found the signal.

The researchers compared people who’d gotten a vaccine within the past three weeks against people who were 22 to 42 days away from their shots because this helps eliminate bias in the data.

When they looked to see how many people had strokes around the time of their vaccination, they found an imbalance in the data.

Of 550,000 people over 65 who’d received a Pfizer bivalent booster, 130 had a stroke caused by a blood clot within three weeks of vaccination, compared with 92 people in the group farther out from their shots.

The researchers spotted the signal the week of November 27, and it continued for about seven weeks. The signal has diminished over time, falling from an almost two-fold risk in November to a 47% risk in early January, Klein said. In the past few days, it hasn’t been showing up at all.

Klein said they didn’t see the signal in any of the other age groups or with the group that got Moderna boosters. They also didn’t see a difference when they compared Pfizer-boosted seniors with those who were eligible for a bivalent booster but hadn’t gotten one.

Further analyses have suggested that the signal might be happening not because people who are within three weeks of a Pfizer booster are having more strokes, but because people who are within 22 to 42 days of their Pfizer boosters are actually having fewer strokes.

Overall, Klein said, they were seeing fewer strokes than expected in this population over that period of time, suggesting a statistical fluke.

Another interesting thing that popped out of this data, however, was a possible association between strokes and high-dose flu vaccination. Seniors who got both shots on the same day and were within three weeks of those shots had twice the rate of stroke compared with those who were 22 to 42 days away from their shots.

What’s more, Klein said, the researchers didn’t see the same association between stroke and time since vaccination in people who didn’t get their flu vaccine on the same day.

The total number of strokes in the population of people who got flu shots and Covid-19 boosters on the same day is small, however, which makes the association a shaky one.

“I don’t think that the evidence are sufficient to conclude that there’s an association there,” said Dr. Tom Shimabukuro, director of the CDC’s Immunization Safety Office.

Nonetheless, Richard Forshee, deputy director of the FDA’s Office of Biostatistics and Pharmacovigilance, said the FDA is planning to look at these safety questions further using data collected by Medicare.

The FDA confirmed that the agency is taking a closer look.

“The purpose of the study is 1) to evaluate the preliminary ischemic stroke signal reported by CDC using an independent data set and more robust epidemiological methods; and 2) to evaluate whether there is an elevated risk of ischemic stroke with the COVID-19 bivalent vaccine if it is given on the same day as a high-dose or adjuvanted seasonal influenza vaccine,” a spokesperson said in a statement.

The FDA did not give a time frame for when these studies might have results.

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It’s been three years since the first Covid-19 case in the United States. What have we learned and what more do we need to understand? | CNN

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CNN
—

It’s been three years since the first Covid-19 case was diagnosed in the United States, on January 20, 2020. In the time since, nearly 1.1 million Americans have died from the coronavirus; the US has reported 102 million Covid cases, more than any other country, according to Johns Hopkins University. Both figures, many health officials believe, are likely to have been undercounted.

There have also been remarkable scientific achievements in our response to the pandemic, not least of which is the development of Covid-19 vaccines. But there are still many unanswered questions. To help with reflections on what we’ve learned and what more we need to understand, I spoke with CNN Medical Analyst Dr. Leana Wen, an emergency physician, public health expert and professor of health policy and management at the George Washington University Milken Institute School of Public Health. She is also author of “Lifelines: A Doctor’s Journey in the Fight for Public Health.”

CNN: You’re a physician caring for patients, a public health researcher and professor. What are the key lessons you’ve learned from the last three years of Covid-19?

Dr. Leana Wen: There are three main lessons that come to mind. First, we have seen how much the global scientific community has come together and delivered some truly incredible achievements. Less than a year after Covid-19 was declared a pandemic, we had a vaccine developed, authorized and being distributed. The scientific community has rallied on many other aspects of the response to Covid-19, including to identify treatments and improve surveillance testing.

Many of the scientific developments will last beyond this pandemic and help with other aspects of our infectious disease response. For instance, the technology behind mRNA vaccines could be used to make vaccines for other diseases. The wastewater surveillance being used to identify and track Covid-19 may be helpful for detecting other viruses.

Second, Covid-19 has unmasked many existing crises and amplified them for the world to see. The coronavirus didn’t create health disparities — these long-predated the virus — but exacerbated existing ones.

There were also many faults with the public health infrastructure that, while long known to those of us in the field, have been exposed for all to see. Data systems are not integrated between public health agencies, for example, and city and county health departments are woefully underfunded given their many responsibilities. These stem from the fragmented health care system we have in the US, as well as the ongoing lack of investment in local public health agencies.

At the same time, Covid has also demonstrated how crucial public health is. There is a saying that “public health saved your life today, you just don’t know it.” I think there is much more recognition among many that public health is essential to preventing problems that can have a major impact on people’s health and well-being.

With that said, Covid-19 occurred during a time of deep division. Virtually every aspect of the pandemic has become politicized and polarized. So thirdly, there has been rampant misinformation and disinformation that’s made the response much more challenging. We are seeing the lasting effects, such as reduced uptake of routine childhood immunizations. I’m very concerned that public health itself has become politicized in a way that could harm our response to future pandemics.

CNN: You mentioned that we’ve learned a lot scientifically. What more do we need to understand about Covid-19?

Wen: At this point in the pandemic, a lot of people have moved on from Covid-19 and no longer think about it as a major factor in their everyday lives. However, there are millions of Americans vulnerable to severe illness who remain very concerned about the coronavirus. These are people who are immunocompromised, elderly or with multiple underlying illnesses. To me, the most important research questions pertain to these individuals.

There are some antiviral medications that are effective for Covid-19 treatment, such as Paxlovid. Some patients are not eligible for Paxlovid, though, and other options are becoming more limited. The US Food and Drug Administration has revoked their authorization for monoclonal antibodies that could treat Covid-19 infection, as they no longer appear to be effective against new circulating variants. Recently, the FDA has also said that the preventive antibody Evusheld may be ineffective against some variants, including the XBB.1.5 variant that’s currently dominant in the US.

It should be an urgent priority to focus on developing better treatments for those most vulnerable to severe disease from Covid-19. I also hope that there will be much more investment into finding better vaccines. The vaccines that we have are excellent at protecting against severe disease, which is most important. However, they are not very effective at preventing infection.

The ideal vaccine would be more effective at reducing infection, and target the virus broadly so that we are not always trying to anticipate what variant will develop next — and then scrambling to find a vaccine that works against that variant. There is research being undertaken into nasal vaccines and pan-coronavirus vaccines, for example. I hope these efforts will be expedited.

CNN: We are learning more about long Covid, but is this an area that needs more research?

Wen: Absolutely. We know that many people have lingering symptoms after a Covid-19 infection. According to a large study from Israel, most symptoms resolve within the first year after infection for people with mild illness. However, there are some who have lasting symptoms, like fatigue, headache, palpitations and shortness of breath, that are so debilitating they can no longer work.

There is a lot that we don’t yet know about long Covid. The most important is how to treat patients who have it. The physiological mechanisms behind what’s causing their lingering symptoms are also unclear, along with exactly how common they are.

There are long waits to get into specialized clinics that treat this condition at present, so a lot more education needs to be done for primary care physicians and other clinicians who will probably end up being the main health care providers for many people suffering from long Covid.

CNN: What do you anticipate will happen in this coming year around Covid-19?

Wen: Right now, China is undergoing a massive surge of cases. It’s the last major country to have enforced a strict zero-Covid policy, and now that policy has been reversed. Once China’s infection numbers stabilize, Covid-19 will probably become endemic there, as it has become in most other parts of the world.

There will, no doubt, be new variants that arise. We need to keep on top of them and monitor accordingly to see if they are more deadly and/or evade the effectiveness of existing vaccines. The key, as I said earlier, is to develop vaccines that can more broadly cover variants.

And we must again remember that, while many people have resumed pre-pandemic lives, others have not. In the next year of Covid-19, I believe that the focus needs to be much more specific to these individuals who need our help the most. We should target boosters and treatments to those most vulnerable, for example.

Finally, there should be a much greater effort to rebuild our public health infrastructure. This is long overdue. Doing so is critical not just for preparing for the next pandemic, but also for improving health and well-being for all Americans.

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Flu, Covid-19 and RSV are all trending down for the first time in months | CNN

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CNN
—

A rough respiratory virus season in the US appears to be easing, as three major respiratory viruses that have battered the country for the past few months are finally all trending down at the same time.

A new dataset from the US Centers for Disease Control and Prevention shows that the number of emergency department visits for the three viruses combined – flu, Covid-19 and RSV – have dropped to the lowest they’ve been in three months. The decline is apparent across all age groups.

Measuring virus transmission levels can be challenging; health officials agree that Covid-19 cases are vastly undercounted, and surveillance systems used for flu and RSV capture a substantial, but incomplete picture.

But experts say that tracking emergency department visits can be a good indicator of how widespread – and severe – the respiratory virus season is.

“There’s the chief complaint. When you show up to the emergency room, you complain about something,” said Janet Hamilton, executive director at Council of State and Territorial Epidemiologists. “Being able to look at the proportion of individuals that seek care at an emergency department for these respiratory illness concerns is a really good measure of the respiratory disease season.”

In the week following Thanksgiving, emergency department visits for respiratory viruses topped 235,000 – matching rates from last January, according to the CDC data.

While the surge in emergency department visits early in the year was due almost entirely to Omicron, the most recent spike was much more varied. In the week ending December 3, about two-thirds of visits were for flu, about a quarter were for Covid-19 and about 10% were for RSV.

Grouping the impact of all respiratory viruses together in this way offers an important perspective.

“There’s a strong interest in thinking about respiratory diseases in a more holistic way,” Hamilton said. “Transmission is the same. And there are certain types of measures that are good protection against all respiratory diseases. So that could really help people understand that when we are in high circulation for respiratory diseases, there are steps that you can take – just in general.”

Now, Covid-19 again accounts for most emergency department visits but flu and RSV are still the reason behind about a third of visits – and they’re all trending down for the first time since the respiratory virus season started picking up in September.

More new data from the CDC shows that overall respiratory virus activity continues to decline across the country. Only four states, along with New York City and Washington, DC, had “high” levels of influenza-like illness. Nearly all states were in this category less than a month ago.

Whether that pattern will hold is still up in the air, as vaccination rates for flu and Covid-19 are lagging and respiratory viruses can be quite fickle. Also, while the level of respiratory virus activity is lower than it’s been, it’s still above baseline in most places and hospitals nationwide are still about 80% full.

RSV activity started to pick up in September, reaching a peak in mid-November when 5 out of every 100,000 people – and 13 times as many children younger than five – were hospitalized in a single week.

RSV particularly affects children, and sales for over-the-counter children’s pain- and fever-reducing medication were 65% higher in November than they were a year before, according to the Consumer Healthcare Products Association. While “the worst may be over,” demand is still elevated, CHPA spokesperson Logan Ramsey Tucker told CNN in an email – sales were up 30% year-over-year in December.

But this RSV season has been significantly more severe than recent years, according to CDC data. The weekly RSV hospitalization rate has dropped to about a fifth of what it was two months ago, but it is still higher than it’s been in previous seasons.

Flu activity ramped up earlier than typical, but seems to have already reached a peak. Flu hospitalizations – about 6,000 new admissions last week – have dropped to a quarter of what they were at their peak a month and a half ago, and CDC estimates for total illnesses, hospitalizations and deaths from flu so far this season have stayed within the bounds of what can be expected. It appears the US has avoided the post-holiday spike that some experts cautioned against, but the flu is notoriously unpredictable and it’s not uncommon to see a second bump later in season.

The Covid-19 spike has not been as pronounced as flu, but hospitalizations did surpass levels from the summer. However, the rise in hospitalizations that started in November has started to tick down in recent weeks and CDC data shows that the share of the population living in a county with a “high” Covid-19 community level has dropped from 22% to about 6% over the past two weeks.

Still, the XBB.1.5 variant – which has key mutations that experts believe may be helping it to be more infectious – continues to gain ground in the US, causing about half of all infections last week. Vaccination rates continue to lag, with just 15% of the eligible population getting their updated booster and nearly one in five people remain completely unvaccinated.

Ensemble forecasts published by the CDC are hazy, predicting a “stable or uncertain trend” in Covid-19 hospitalizations and deaths over the next month.

And three years after the first Covid-19 case was confirmed in the US, the virus has not settled into a predictable pattern, according to Dr. Maria Van Kerkhove, the World Health Organization’s technical lead for the Covid-19 response.

“We didn’t need to have this level of death and devastation, but we’re dealing with it, and we are doing our best to minimize the impact going forward,” Van Kerkhove told the Conversations on Healthcare podcast this week.

Van Kerkhove says she does believe 2023 could be the year in which Covid-19 would no longer be deemed a public health emergency in the US and across the world, but more work needs to be done in order to make that happen and transitioning to longer-term respiratory disease management of the outbreak will take more time.

“We’re just not utilizing [vaccines] most effectively around the world. I mean 30% of the world still has not received a single vaccine,” she said. “In every country in the world, including in the US, we’re missing key demographics.”

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Study shows convalescent plasma works for immune-compromised Covid-19 patients, but it can be hard to find | CNN

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CNN
—

Convalescent plasma – a once-celebrated treatment for Covid-19 that has largely fallen out of favor – does work well for people who are immune-compromised, according to a study published Thursday.

The report in the journal JAMA Network Open analyzed the results of nine studies and found that immune-compromised Covid-19 patients were 37% less likely to die if they got convalescent plasma, an antibody-rich blood product from people who’d recovered from the virus.

Although it’s legal to use convalescent plasma to treat Covid patients who are immune-compromised, as inpatients or outpatients, government guidelines are neutral about whether the treatment works, so some hospitals offer it but others do not.

“Our concern is that many patients who need [convalescent plasma] are not getting it,” said Dr. Arturo Casadevall, an infectious disease expert at Johns Hopkins University and a co-author of the new study. “This is really important because these people can be treated, and they could have better outcomes with this material if we can just get the word out.”

He said it’s to everyone’s advantage to treat immune-compromised patients quickly.

Immune-compromised people sometimes have “smoldering Covid” for months because they lack the antibodies to fight it off, which gives the virus plenty of opportunities to mutate in the person’s body.

“These immune-compromised patients are essentially variant factories,” said Dr. Michael Joyner, an anesthesiologist at the Mayo Clinic and another study co-author. “And you do not want a bunch of people running around out there making weird variants.”

There are about 7 million immune-compromised people in the US, and treating them if they contract Covid-19 has proved challenging.

Many of them can’t take the antiviral drug Paxlovid because it interferes with other medicines they take.

Monoclonal antibodies, once popular for prevention and treatment for this group, aren’t used anymore because coronavirus variants have changed over time. One of the advantages of convalescent plasma is that as long as it’s been donated recently, there’s a high likelihood it will have antibodies to currently circulating variants, according to advocates for the treatment.

But the National Institutes of Health’s Covid-19 treatment guidelines say there’s not enough evidence to recommend either for or against the use of convalescent plasma in people with compromised immune systems.

Three times last year – in May, August and December – Casadevall, Joyner and dozens of other doctors from Harvard, Stanford, Mayo, Columbia and other academic medical centers wrote emails to scientists at the National Institutes of Health, sending them research materials and urging them to revise the guidelines. They say they have not received a response.

Joyner said he’s “frustrated” with the NIH’s “bureaucratic rope-a-dope,” calling the agency’s guidelines a “wet blanket” that discourages doctors from trying convalescent plasma on these people.

Some patient advocates say they’re angry.

“This lack of response to the researchers is infuriating,” said Janet Handal, co-founder of the Transplant Recipient and Immunocompromised Patient Advocacy Group.

Several large randomized clinical trials on the general population, including one in India and one in the UK, have found that convalescent plasma did not reduce Covid-19 deaths or prevent severe illness, and the treatment is no longer authorized in the US for people who have healthy immune systems.

The nine studies analyzed in the new report are much smaller and looked only at immune-compromised patients.

Dr. Peter Horby, a professor at the University of Oxford and the co-principal investigator of the large UK study, said that a large randomized clinical trial should be done on immune-compromised patients before clinical practice guidelines for this group are changed.

He said that support for convalescent plasma to treat Covid-19 has been based on “an emotional feeling that something had to be done.”

“We’ve seen time and again that people’s beliefs and emotions about what works can be wildly wrong, and so the best thing to do is to evaluate these things properly in trials,” he said.

At the beginning of the pandemic, there was great enthusiasm for convalescent plasma as Covid-19 survivors sought to save lives, donating antibodies against the virus to people who were sometimes at death’s door.

In August 2020, the US Food and Drug Administration granted emergency use authorization for the treatment, but some questioned whether it was politically motivated and whether the data really showed that it worked.

Then, the large clinical trials suggested convalescent plasma didn’t work.

“We didn’t see a benefit,” said Horby, director of Oxford’s Pandemic Sciences Institute.

But there was one exception.

Horby said his study did find “some evidence of some benefit” in Covid-19 patients who had not developed antibodies against the virus. This would most likely include immune-compromised patients because their faulty immune systems don’t always generate antibodies the way they should, even after infection.

When this group of patients received convalescent plasma, Horby said, they had a slightly shortened hospital stay and a slightly lower risk of ending up on a ventilator compared with similar patients who did not receive convalescent plasma.

Joyner and Casadevall, the Mayo and Hopkins doctors, point to that finding – and a similar one in a large trial in Australia, Canada, the UK and the US, as well as results of smaller studies – as an indication that convalescent plasma is worth trying in immune-compromised patients.

Immune-compromised patients who catch Covid-19 can get convalescent plasma relatively easily if they’re patients at Hopkins, Mayo or several other medical centers.

But many other people might have a difficult time accessing it.

It took Bernadette Kay of Manhattan Beach, California, months to get it, and she had to be “relentless” and call in the help of several “angels” in New York, Maryland, Minnesota and California to finally make it work.

Kay, 64, who has a compromised immune system because of a drug she takes for rheumatoid arthritis, got Covid-19 in July. She took two monoclonal antibodies, as well as remdesivir and Paxlovid – twice. But she still tested positive on and off for months and had fatigue, congestion and headaches.

“I felt like half a person,” she said. “I was not an able-bodied person. I was disabled because of lack of energy. It feels dark – a heavy feeling in your forehead and your face.”

Kay said she saw several doctors and none of them suggested convalescent plasma. That’s where her first angel came in: her daughter, who had signed her up for the Transplant Recipient and Immunocompromised Patient Advocacy Group.

That group, as well as the CLL Society, an advocacy organization for cancer patients, have been helping immune-compromised people when they get infected with Covid-19, connecting them with experts and offering guidance on how to arrange to have the plasma ordered.

Kay says Handal, the co-founder of the immune-compromised patients’ group, was her second angel, because she pointed her to angels No. 3 and 4: Joyner, the Mayo doctor, and Dr. Shmuel Shoham, an infectious disease expert at Hopkins.

Joyner and Shoham pointed Kay to her fifth angel: Chaim Lebovits, a businessman, leader in the New York’s Hasidic Jewish community and co-founder of the Covid Plasma Initiative.

Lebovits reached out to a hospital and blood bank near Kay that could procure the plasma once a doctor ordered it. Kay then reached out to six local doctors, most of them infectious disease experts, inquiring about convalescent plasma, but she didn’t make any progress.

“I think they thought it was quack medicine,” she said.

By this time, it was November, four months after she initially tested positive for Covid. She sought out a seventh doctor, sending him information from plasma experts, including a slide presentation by Joyner and Casdevall. She said that doctor, after conferring with someone at the blood bank that Libovits had suggested, agreed to order the plasma.

That’s where her sixth angel came in: Robert Simpson, vice president for hospital services at the San Diego Blood Bank, who arranged to have the blood flown in from Stanford University Medical Center.

“Robert watched the flight on Flight Tracker and had a courier waiting to bring it to the hospital,” Kay said, adding that she calls her angels collectively her “circle of love.”

Two to three weeks after her infusion, she began to feel better. She tested negative on January 4 and has continued to feel well and test negative since then.

“My energy level is back to normal. I don’t feel like half a person,” she said.

She said she’ll never know for sure exactly what spurred her recovery, but “I think it was plasma that made the difference, because in six months, nothing else made a difference.”

Kay, who works in health care, said most other people wouldn’t have known how to navigate the system like she did or might have given up in frustration.

“With the help of Janet [Handal] and her team of scientists, I’ve been able to get where I am today,” she said. “But it was not easy. This was driven by my bullheaded advocacy, because that’s who I am. I think I’m a total anomaly. No one has the persistence that I have.”

Joyner said that while he and his colleagues wait for a response from their emails to the NIH, they’ve formed the National Covid-19 Convalescent Plasma Project, and they have a phone meeting every Thursday night to discuss their progress.

“We’ve encountered many roadblocks,” said Dr. Liise-anne Pirofski, chief of the Division of Infectious Diseases at the Albert Einstein College of Medicine. “It’s just not viewed as part of the Covid-19 treatment armamentarium, and it should be.”

Pirofski, Joyner and Casadevall say they receive no financial benefit from convalescent plasma. They think one reason convalescent plasma isn’t more widely used is that there isn’t a pharmaceutical company spending money to advocate for it.

Handal, who runs the Facebook group for people who are immune-compromised, said that after she sent several emails to the NIH, agency scientists wrote back, inviting her and other leaders of her group to a meeting next week.

She plans to tell them that they need to review their Covid-19 plasma guidelines and fund more research on the coronavirus and the immune-compromised, as they have few treatment options and so often isolate at home with their families to avoid the virus.

“It is unconscionable that the NIH has let stand for months its guideline on Covid convalescent plasma, which says there is not enough information to make a recommendation, while we who are immune-compromised see our treatments dwindle,” she said. “The NIH needs to speak to the clinician researchers who are experts, prioritize the immune-compromised and fund the research needed to keep us safe.”

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Should you attend that New Year’s Eve party? Our medical analyst weighs in | CNN

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At the end of 2020 and 2021, many people greeted the start of the coming year hunkered down due to the risk of Covid-19. But now, New Year’s Eve events and celebrations are back in a big way. A lot of people have plans to attend social functions, whether they are crowded festivities with thousands or house parties with a few relatives and friends.

These gatherings are occurring as the United States is in the midst of a triple threat — a confluence of respiratory syncytial virus or RSV, influenza and Covid-19. All three viral infections are spread from person to person, and gatherings involving many people can increase transmission at a time when hospital capacity nationwide is at near-record levels: More than 70% of inpatient beds are in use across the country, according to the US Department of Health and Human Services.

What should you consider in deciding whether to attend New Year’s Eve parties? How can you gauge the risk of specific events? Are there individuals who may want to take more precautions, and which mitigation measures can reduce risk if they go? If you find out later that an attendee was ill, when should you test afterward to make sure you are in the clear? And what happens if you develop symptoms after an event?

To guide you through these questions, I spoke with CNN Medical Analyst Dr. Leana Wen, an emergency physician, public health expert and professor of health policy and management at the George Washington University Milken Institute School of Public Health. She is also the author of “Lifelines: A Doctor’s Journey in the Fight for Public Health.”

CNN: What should people consider in deciding whether to attend New Year’s Eve parties?

Dr. Leana Wen: People should start by considering three factors. First, what is your risk and the risk of your household from severe outcomes due to respiratory viruses? If everyone is generally healthy and you have already resumed other aspects of pre-pandemic activities, it might be reasonable to do the same for New Year’s get-togethers. But if someone is elderly or severely immunocompromised, you may wish to take additional precautions.

Second, what’s the importance of these events to you, compared with the importance of avoiding infection? Virtually every in-person interaction has some level of risk. That doesn’t mean everyone should avoid in-person activities permanently, but if you do attend a higher-risk event, know that you have a chance of getting a respiratory infection from it. Whether you go depends on how you weigh the importance of that event versus your desire to not get sick.

Third, is there a specific timing issue for which you really don’t want to get sick heading into the new year? For example, someone who has an operation scheduled the week after New Year’s may wish to be extra careful, so they don’t get an infection and then have to postpone their surgery. Someone else may have an important work event or school exam, and the desire to avoid any infection before that occasion could outweigh the desire to participate in New Year’s Eve celebrations. These are all things to consider and will vary depending on individual preference.

CNN: How can people gauge the risk of different New Year’s Eve events?

Wen: The risk depends on the type of event and what kind of mitigation measures are put into place, if any.

The more people, the higher the risk. A small gathering of, say, 10 close friends means that you could potentially contract respiratory viruses from one of these 10. Especially if these friends have been fairly cautious themselves, chances are low that none of these 10 are infected coming into the party. Compare that with a large party of 1,000 people. In this case, chances are much higher that someone at that party is infectious.

An outdoor event will be lower risk than an indoor event. Indoor events where everyone is spaced out, and where there is good ventilation, will be safer than ones where people are crowded close together.

In addition to space and ventilation, another mitigation measure that can make a difference is testing. If the event requires same-day rapid Covid-19 tests, that reduces risk. And it helps if the organizers emphasize that people who are symptomatic should not attend.

CNN: What are some things people can do to reduce their risk if they do go to an event?

Wen: Flu, RSV and a lot of other respiratory infections are spread through droplets. Washing your hands well and often can reduce your risk. Bring hand sanitizer with you in case it’s not readily available and use it frequently, especially after shaking hands and touching commonly used surfaces like shared serving utensils.

You could also stand near windows and try to stay away from crowds, especially if people are gathering in areas that aren’t well-ventilated.

Covid-19 is airborne in addition to being transmitted through droplets. Studies have shown that masks reduce the risk of Covid-19 transmission. Some venues may require masks, but even if they don’t, if you are someone who is very concerned about Covid-19, you could wear a high-quality N95 or equivalent mask during the event.

If you find out a partygoer at an event you attended had Covid-19, take a test five days after the gathering, Wen advised.

CNN: If you find out that someone at an event had Covid-19, when should you test afterward to make sure you are in the clear?

Wen: If you are asymptomatic, you should test at least five days after the event. If you test earlier than that, the test result might be negative, and you could still have contracted Covid-19, even if the virus in your body hasn’t replicated enough for the test to detect it yet. To be certain, I’d test five days after and then again two days after that.

CNN: What if you saw other people on New Year’s — if you were exposed on New Year’s Eve, could you infect people the day after?

Wen: The incubation period for Covid-19 is at least two days. Even if you did contract Covid-19 on New Year’s Eve, you wouldn’t have enough virus in your system to infect other people the day after. By the next day, two days after exposure, it’s possible.

CNN: What happens if you develop symptoms after an event?

Wen: If you develop symptoms, you should test for Covid-19, and then, if you test positive and you are eligible for Paxlovid, speak with your health care provider about taking the antiviral treatment. Inform the event organizer right away so that they can alert others.

Viral symptoms are not just due to Covid-19, of course. If you are someone who is particularly vulnerable, you should call your health care provider, who can test you for influenza and prescribe the antiviral Tamiflu. Children and other vulnerable people should get tested for RSV, too.

Otherwise, the advice is the same as pre-pandemic: Refrain from going to public places while symptomatic. Use standard measures to treat viral syndromes — such as fluids, rest, fever-reducing medicines and other symptom-based treatment.

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