Tag Archives: Viruses

Business

FDA wants to simplify the use and updating of Covid-19 vaccines

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CNN
 — 

The US Food and Drug Administration wants to simplify the Covid-19 vaccine process to look more like what happens with the flu vaccine, according to documents posted online on Monday. That could include streamlining the vaccine composition, immunization schedules and periodic updates of Covid-19 vaccines.

The FDA said it expects to assess circulating strains of the virus that causes Covid-19 at least annually and decide in June which strains to select for the fall season, much like the process to update annual flu vaccines.

Moving forward, the agency said, most people may need only one dose of the latest Covid-19 shot to restore protection, regardless of how many shots they have already received. Two doses may be needed for people who are very young and haven’t been exposed, or for the elderly or immune-compromised, according to the FDA’s briefing document for its vaccine advisers.

The agency is urging a shift toward only one vaccine composition, rather than a combination of monovalent vaccines, which are currently used for primary shots and target only one strain, and bivalent vaccines, which are currently used for booster doses and target more than one strain.

“This simplification of vaccine composition should reduce complexity, decrease vaccine administration errors due to the complexity of the number of different vial presentations, and potentially increase vaccine compliance by allowing clearer communication,” the FDA said.

The FDA’s plan was first reported by National Public Radio.

The agency’s independent vaccine advisers, the Vaccines and Related Biological Products Advisory Committee, are scheduled to meet on Thursday to discuss the future of Covid-19 vaccine regimens, and will be asked to vote on whether they recommend parts of FDA’s plan.

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US

Jeff Zients to replace Ron Klain as White House chief of staff

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CNN
 — 

Jeff Zients, who ran President Joe Biden’s Covid-19 response effort and served in high-ranking roles in the Obama administration, is expected to replace Ron Klain as the next White House chief of staff, according to three people briefed on the matter.

Klain is expected to step down in the coming weeks.

The move to replace Klain is particularly important for Biden, who has entered a critical moment in his presidency and his political future. As he continues to weigh whether to seek reelection in 2024, the early stages of a special counsel investigation into his handling of classified documents has rattled Democrats and emboldened congressional Republicans, who now hold the House majority and have pledged their own probes.

Biden decided on Zients after an internal search when it became clear that Klain favored Zients as his successor, a factor that played a big role in the president’s decision. Klain had tapped Zients to lead a talent search for expected staff turnover following the midterm elections, but that didn’t ultimately materialize after Democrats performed better than expected. Klain is now the most significant departure and is being replaced by the person he picked to help bring in new team members.

A source said Klain will continue to be involved and remain close to the West Wing. Biden’s core political and legislative team – which includes Steve Ricchetti, Anita Dunn, Mike Donilon, Jen O’Malley Dillon, Bruce Reed and Louisa Terrell – will continue to advise him. Zients’ new role is being compared to when Jack Lew was Obama’s chief of staff and others, like David Plouffe, focused more on his political portfolio.

Additional political talent is expected to join for the likely re-election campaign, CNN is told.

In replacing Klain with Zients, Biden is turning to a consultant with more business experience than political background as he enters the third year of his presidency.

The decision to pick Zients surprised some internally given that there were differences in Biden’s and Zients’ management styles early on in the administration. But Biden was impressed with his job as the coronavirus response coordinator when Zients inherited what officials described as a “largely dysfunctional” effort by the Trump administration.

Another factor in the search was how this stretch of Biden’s presidency will focus on implementing the legislation enacted in his first two years, and Zients is seen internally as a “master implementor,” one source said. His operational skills were on display as his handled the coronavirus response and helped with the bungled 2013 launch of HealthCare.gov during the Obama administration.

Zients now has a closer relationship with Biden and with his senior advisers and multiple Cabinet members.

While Zients is not viewed as a political operator, his deep experience inside two administrations and his reputation for technocratic skill would likely serve as assets at a time when both are viewed as critical for what Biden faces in the year ahead. Still, he will be tasked with replacing an official who was a central force inside the administration – and someone with a rapport developed over decades with Biden himself.

Klain, who had long planned to depart the White House after Biden’s first two years, has targeted the weeks after the February 7 State of the Union address for the end of his tenure.

A number of top officials had been viewed as top candidates to succeed Klain, including Cabinet members and close Biden advisers such as Ricchetti, counselor to the president, and Dunn, the senior adviser with a wide-ranging strategy and communications portfolio.

But while Zients isn’t among the tight-knit circle of long-tenured Biden advisers, he’s been deeply intertwined with the team since the 2020 campaign, when he served as co-chairman of Biden’s transition outfit.

After the election Biden tapped Zients to lead the administration’s Covid-19 response effort as he entered office with the country facing dueling public health and economic crises. While Zients left that role last spring, he was once again brought into White House operations a few months later when Klain asked him to lead the planning for the expected turnover inside the administration that historically follows a president’s first midterm elections.

Zients was tasked with conducting a wide and diverse search for prospective candidates outside the administration to fill Cabinet, deputy Cabinet and senior administration roles, officials said, in an effort that would be closely coordinated with White House counterparts.

But even as wide-scale turnover has remained minimal for an administration that has taken pride in its stability in the first two years, now, the official leading the planning effort may soon shift into one of, if not the, most critical role set to open.

The White House chief of staff is a grueling and all-consuming post in any administration, and Klain’s deep involvement across nearly every key element of process, policy and politics touching the West Wing only served to elevate that reality.

A long-time Washington hand with ties Democratic administrations – and Biden – that cross several decades, Klain is departing at a moment that officials inside the West Wing have spent the last several months viewing as a high point.

Biden entered 2023 on the heel of midterm elections that resulted in an expanded Senate majority for his Democratic Party and the defiance of widespread expectations of massive GOP victories in the House.

The sweeping and far-reaching cornerstones of Biden’s legislative agenda have largely been signed into law, the result of a series of major bipartisan wins paired with the successful navigation of intraparty disputes to secure critical Democratic priorities.

Biden has made clear to advisers that the successful implementation of those laws – which is now starting to kick into high gear across the administration – is one of their most critical priorities for the year ahead.

But Zients will also inherit a West Wing now faced with a new House Republican majority that is girding for partisan warfare – and wide-scale investigations into the administration and Biden’s family.

This story has been updated with additional information.

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Health

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

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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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Health

Grizzly bears test positive for bird flu in Montana, officials say

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CNN
 — 

Three grizzly bears were euthanized in Montana after they became ill and tested positive for the highly pathogenic avian influenza (HPAI) virus, according to the state’s Department of Fish, Wildlife & Parks.

These were the first documented cases of bird flu in a grizzly in Montana and the first nationwide for this outbreak of HPAI, according to Dr. Jennifer Ramsey, the department’s wildlife veterinarian.

The juvenile bears were in three separate locations in the western part of the state during the fall, the Department of Fish, Wildlife & Parks said in a statement.

The bears “were observed to be in poor condition and exhibited disorientation and partial blindness, among other neurological issues,” the statement said. “They were euthanized due to their sickness and poor condition.”

Avian influenza – commonly called bird flu – is a naturally occurring virus that spreads quickly in birds. There were documented cases of HPAI in a skunk and a fox in Montana last year, and the virus has been seen in raccoons, black bears and a coyote in other states and countries, according to the Montana agency.

“The virus is spread from one bird to another,” Dr. Ramsey told CNN via email. “These mammals likely got infected from consuming carcasses of HPAI infected birds.”

“Fortunately, unlike avian cases, generally small numbers of mammal cases have been reported in North America,” Ramsey said. “For now, we are continuing to test any bears that demonstrate neurologic symptoms or for which a cause of death is unknown.”

While finding three grizzlies with bird flu in a short period of time may raise concerns, Ramsey said it may well be that there have been more cases that haven’t been detected.

“When wildlife mortalities occur in such small numbers or individuals, and in species like skunks, foxes and bears that don’t spend a lot of time in situations where they are highly visible to the public, they can be hard to detect,” the wildlife veterinarian said.

“When you get that first detection you tend to start looking harder, and you’re more likely to find new cases,” she said. “When a large number of birds are found dead on a body of water, it gets noticed and reported… when someone sees a dead skunk, they may think nothing of it and not report it.”

While it’s unknown just how prevalent the virus is in wild birds, “we know that the virus is active basically across the entire state due to the wide distribution of cases of HPAI mortality in some species of wild birds,” Ramsey said.

The US Centers for Disease Control and Prevention said in November the country was approaching “a record number of birds affected compared to previous bird flu outbreaks,” with more than 49 million birds in 46 states dying or being killed due to exposure to infected birds.

Human infections with bird flu are rare but are possible, “usually after close contact with infected birds. The current risk to the general public from bird flu viruses is low,” the CDC says on its website.

The Montana Department of Fish, Wildlife & Parks is asking people to report any birds or animals acting “unusual or unexplained cases of sickness and/or death.”

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Health

Decreasing rates of childhood immunization are a major concern. Our medical analyst explains why

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CNN
 — 

Vaccine rates for measles, polio, diphtheria and other diseases are decreasing among US children, according to a new study from the US Centers for Disease Control and Prevention.

The rate of immunizations for required vaccines among kindergarten students declined from 95% to approximately 94% during the 2020-21 school year. It dropped further — to 93% — in the 2021-22 school year.

That’s still a high number, so why is this drop in immunization significant? What accounts for the decline? What might be the consequences if these numbers drop further? If parents are unsure about vaccinating their kids, what should they do? And what can be done on a policy level to increase immunization numbers?

To help us with 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 author of “Lifelines: A Doctor’s Journey in the Fight for Public Health.”

CNN: Why is it a problem that childhood immunization rates are declining?

Dr. Leana Wen: The reduction of vaccine-preventable diseases is one of the greatest public health success stories in the last 100 years.

The polio vaccine was introduced in the United States in 1955, for example. In the four years prior, there were an average of over 16,000 cases of paralytic polio and nearly 2,000 deaths from polio each year across the US. Widespread use of the polio vaccine had led to the eradication of polio in the country by 1979, according to the CDC, sparing thousands of deaths and lifelong disability among children each year.

The measles vaccine was licensed in the US in 1963. In the four years before that, there were an average of over 500,000 cases and over 430 measles-associated deaths each year. By 1998, there were just 89 cases recorded — and no measles-associated deaths.

These vaccines are very safe and extremely effective. The polio vaccine, for example, is over 99% effective at preventing paralytic polio. The measles vaccine is 97% effective at preventing infection.

We can do this same analysis for other diseases for which there are routine childhood immunizations.

It’s very concerning that rates of immunization are declining for vaccines that have long been used to prevent disease and reduce death. That means more children are at risk for severe illness — illness that could be averted if they were immunized. Moreover, if the proportion of unvaccinated individuals increases in a community, this also puts others at risk. That includes babies too young to be vaccinated or people for whom the vaccines don’t protect as well — for example, patients on chemotherapy for cancer.

CNN: What accounts for the decline in vaccination numbers?

Wen: There are probably many factors. First, there has been substantial disruption to the US health care system during the Covid-19 pandemic. Many children missed routine visits to the pediatrician during which they would have received vaccines due to pandemic restrictions. In addition, some community health services offered also became disrupted as local health departments focused on Covid-19 services.

Second, disruption to schooling has also played a role. Vaccination requirements are often checked prior to the start of the school year. When schools stopped in-person instruction, that led to some families falling behind on their immunizations.

Third, misinformation and disinformation around Covid-19 vaccines may have seeded doubt in other vaccines. Vaccine hesitancy and misinformation were already major public health concerns before the coronavirus emerged, but the pandemic has exacerbated the issues.

According to a December survey published by the Kaiser Family Foundation, more than one in three American parents said vaccinating children against measles, mumps, and rubella shouldn’t be a requirement for them to attend public schools, even if that may create health risks for others. This was a substantial increase from 2019, when a similar poll from the Pew Research Center found only 23% of parents opposed school vaccine requirements.

CNN: What are some consequences if immunization rates drop further?

Wen: If immunization rates drop further, we could see more widespread outbreaks. Diseases that were virtually eliminated in the US could reemerge, and more people can become severely ill and suffer lasting consequences or even die.

We are already seeing some consequences: Last summer, there was a confirmed case of paralytic polio in an unvaccinated adult in New York. It’s devastating that a disease like polio has been identified again in the US, since we have an extremely effective vaccine to prevent it.

There is an active measles outbreak in Ohio. As of January 17, 85 cases have been reported. Most of the cases involved unvaccinated children, and at least 34 have been hospitalized.

CNN: If parents are unsure of vaccinating their kids, what should they do?

Wen: As parents, we generally trust pediatricians with our children’s health. We consult pediatricians if our kids are diagnosed with asthma and diabetes, or if they have new worrisome symptoms of another illness. We should also consult our pediatricians about childhood immunizations; parents and caregivers with specific questions or concerns should address them.

The national association of pediatricians, the American Academy of Pediatrics, “strongly recommends on-time routine immunization of all children and adolescents according to the Recommended Immunization Schedules for Children and Adolescents.”

CNN: What can be done to increase immunization numbers?

Wen: There needs to be a concerted educational campaign to address why vaccination against measles, mumps, rubella, chickenpox, polio and so forth is so crucial. One of the reasons for vaccine hesitancy, in my experience, is that these diseases have been rarely seen in recent years. Many people who are parents now didn’t experience the devastation of these diseases growing up, so may not realize how terrible it would be for them to return.

Specific interventions should be targeted at the community level. In some places, low immunization levels may be due to access. Vaccination drives at schools, parks, shopping centers, and other places where families gather can help increase numbers. In other places, the low uptake may be because of vaccine hesitancy and misinformation. There will need to be different strategies implemented in that situation.

Overall, increasing immunization rates for vaccine-preventable childhood diseases needs to be a national imperative. I can’t underscore how tragic it would be for kids to suffer the harms of diseases that could be entirely prevented with safe, effective and readily available vaccines that have been routinely given for decades.

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Health

When young children test positive for Covid-19 and another respiratory virus, their illness is much more severe, a new study suggests

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CNN
 — 

When Covid-19 patients younger than 5 also test positive for another respiratory virus, they tend to become sicker and develop more severe disease, a new study suggests.

Among hospitalized children younger than 5, testing positive for both Covid-19 and another respiratory virus at the same time is associated with about twice the odds of severe respiratory illness than those who tested negative for other viruses, according to the study published Wednesday in the journal Pediatrics.

The study comes amid a harsh season of respiratory viruses, including RSV, flu, Covid-19 and other viruses that overwhelmed children’s hospitals. The findings demonstrate the impact respiratory viruses have on pediatric hospitals and how “continued surveillance” of circulating Covid-19 and other illnesses can help predict future surges in hospitalizations, wrote the researchers, from the US Centers for Disease Control and Prevention and various universities and health departments across the United States.

Caring for young children with overlapping respiratory illnesses was something Jenevieve Silva has experienced firsthand throughout the Covid-19 pandemic.

“The height of the illnesses was from September through mid-November, when our household just could not catch a break,” she said.

The mother of eight, based in San Jose, California, said that her toddler-age twin boys “have been battered by viruses” since they started preschool in May 2021.

Last October, Silva’s twins tested positive for Covid-19 and then developed what their pediatrician suspected was another respiratory viral infection, possibly respiratory syncytial virus or RSV, around the same time.

“Based on what the pediatrician told us, she said ‘I highly believe that they had these overlapping viruses,’” Silva said, adding that the boys’ symptoms included shortness of breath, cough, fatigue, and fever, with one twin having a 105-degree fever for four days straight.

Warm baths and massaging Vicks VapoRub onto their backs and chest helped ease their pain, but watching her boys battle these respiratory illnesses was “brutal,” Silva said.

“They had just looked so frail – they looked sick, like something deeper than just back-to-back viruses,” she said. “It was hell. I mean, it was really bad.”

The boys have recovered and are currently “doing great” and have gained healthy weight, Silva said, but she worries that they developed asthma following their illnesses.

Ever since October, when they had the overlapping viruses, “the doctor has now said it seems like that might have triggered asthma in them. And so now, ever since then, when they get a cold, they have asthma symptoms – violent episodes of coughing, sometimes throwing up,” Silva said.

“I can’t be the only mom dealing with virus after virus,” she said, adding that for other parents out there, she has a message of hope: “Be patient. Listen to your doctor.”

The new study included data on 4,372 children who were hospitalized with Covid-19. Among those who were tested for other respiratory viruses, 21% had a codetection, meaning another respiratory virus was also detected in their test results. The data came from the US Centers for Disease Control and Prevention’s Covid-19 hospitalization surveillance network called COVID-NET, with data from across 14 states.

The researchers noted that they focused on codetection, not coinfection, since testing wouldn’t necessarily show that a child was actively infected with both viruses just because they test positive.

Overall, “this study found that respiratory virus codetections were rare in the first year of the pandemic, RSV and rhinovirus or enterovirus codetections increased during the Delta-predominant period and influenza codetections were infrequent throughout the first 2 years of the pandemic,” the researchers wrote in their study.

The data also showed that children with codetections were more likely to be younger than 5, receive increased oxygen support, and be admitted to the intensive care unit. No significant associations were seen among children 5 and older.

Specifically for children younger than 2, testing positive for respiratory syncytial virus or RSV while having Covid-19 was significantly associated with severe illness.

More research is needed on the precise impact that two respiratory viruses can simultaneously have on the body, said Dr. William Schaffner, a professor in the Division of Infectious Diseases at Vanderbilt University Medical Center and medical director of the National Foundation for Infectious Diseases, who was not involved in the new study.

“But we do think that being attacked by two viruses, particularly if you are less than five years of age, it’s been clearly demonstrated by this study, it does tend to make your illness more severe, more likely to be prolonged in the hospital, more likely to be in the pediatric intensive care unit,” Schaffner said. “And so clearly, having your lungs and your throat and your body – generally your immune system – attacked by two viruses simultaneously, understandably might make some young children more severely ill.”

Dr. Asuncion Mejias, associate professor of pediatric infectious diseases at Nationwide Children’s Hospital, said hospitalized children she has treated for Covid-19 and codetections of other respiratory viruses often require increased oxygen support and treatment in the intensive care unit.

“Covid is a very proinflammatory virus, so it really weakens your immune response,” said Mejias. “And when you haven’t recovered yet, and you get a second hit, in this case, RSV or rhinovirus, you develop a more severe disease.”

Overall, Schaffner said that these new study findings are more reason why it remains important to make sure children are up to date on their Covid-19 vaccinations as well as vaccinated against the flu.

Mejias agreed, emphasizing the importance of safe practices to prevent the spread of viruses to children too young to be vaccinated.

“The pandemic taught us how contagious these viruses are,” Mejias said about respiratory pathogens.

“If somebody is sick, try to avoid contact,” she said. “These viruses are not only transmitted by saliva and secretions but by hands. It can survive in your hands for more than 30 minutes. So if you touch your mouth and then touch a little baby, the baby can self inoculate the virus and become infected. So washing hands and all these measures are very important.”

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Health

Large new review underscores the risks of Covid-19 during pregnancy

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CNN
 — 

Pregnant women and their developing babies are at higher risk for severe outcomes if they get Covid-19, and now a large, international review is helping to underscore how devastating those risks can be.

The study draws on data from 12 studies from as many countries—including the United States. Altogether, the studies included more than 13,000 pregnant women—about 2,000 who had a confirmed or probable case of Covid-19. The health outcomes for these women and their babies were compared to about 11,000 pregnancies where the mother tested negative for Covid-19 or antibodies to it at the time of their deliveries.

Across the studies about 3% of pregnant women with Covid-19 needed intensive care, and about 4% needed any kind of critical care, but this was far higher than the numbers of pregnant women who needed that kind of care outside of a Covid-19 infection.

Compared to pregnant individuals who weren’t infected, those who got Covid-19 were nearly 4 times more likely to be admitted to an intensive care unit. They were 15 times more likely to be ventilated and were 7 times more likely to die. They also had higher risks for pre-eclampisa, blood clots, and problems caused by high blood pressure. Babies born to moms who had Covid-19 were at higher risk for preterm birth and low birth weights.

Previous studies have suggested that Covid-19 may increase the risk of stillbirth, but this study didn’t find that same link.

Still, the findings paint a clear picture that shows the risks of pregnancy are amplified by Covid-19 infections.

“It’s very clear and even it’s consistent, you know, whether we’re talking about Sweden where we have really generally great pregnancy outcomes to other countries that you know, have bigger problems with maternal morbidity and mortality, that having COVID and pregnancy increases risk for both mom and baby,” said lead study author Emily Smith, who is an assistant professor of global health at George Washington University.

The study has some caveats that may limit how applicable the findings are to pregnant individuals in the Omicron era.

First, the studies were conducted relatively early in the pandemic, at a time when most people were still unvaccinated and uninfected. That means people in the study were likely at higher risk not just because they were pregnant, but also because they were immunologically naïve to the virus—they didn’t have any pre-existing immunity to help them fight off their infections.

Since then, many pregnant individuals have gotten vaccinated, or had Covid-19 or both. As of the first week of January, about 72% of pregnant people in the U.S. have had their primary series of Covid-19 vaccines, and about 95% of Americans are estimated to have had Covid-19 at least once, or been vaccinated against it, according to data from the Centers for Disease Control and Prevention. That means it’s likely they have some immune memory against the virus that may help protect against severe outcomes.

That immune memory appears to fade over time, however. CDC data show just 19% of pregnant women have had an updated booster, meaning many people may not have as much protection against the virus as they think they do.

Lead study author Emily Smith, who is an assistant professor of global health at George Washington University, says the study results reflect the risk of Covid-19 and pregnancy in unvaccinated people.

Unfortunately, Smith says, many countries still don’t have clear guidelines advising vaccination during pregnancy. And there are some parts of the world, such as China, that still have substantial proportions of their population who’ve never been been infected.

For people who are trying to weigh the risks and benefits of Covid-19 vaccination during pregnancy, Smith says this study helps tip the scales firmly on the side of vaccination.

“It’s worth it to protect yourself in pregnancy,” Smith said.

She says this study didn’t look at the benefits of vaccination in pregnancy, but other studies have, showing big decreases in the risk of stillbirth, preterm birth and severe disease or death for mom.

“And so that’s kind of the complementary story,” said Smith.

Dr. Justin Lappen, division director of Maternal Fetal Medicine at the Cleveland Clinic, praised the study and said its findings reinforce and advance previous research, which has found that Covid-19 markedly increases the risk of severe outcomes for mom and baby. He wasn’t involved in the study.

He says the findings highlight the importance of preventing and treating Covid-19 in pregnant women.

Therapies that are indicated or otherwise recommended should not be withheld specifically due to pregnancy or breastfeeding, Lappen wrote in an email to CNN.

The study is published in the journal BMJ Global Health.

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Business

CDC identifies possible safety issue with Pfizer’s updated Covid-19 vaccine but says people should still get boosted

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CNN
 — 

The US Centers for Disease Control and Prevention said Friday that there is a possible safety issue with the bivalent Covid-19 vaccine made by Pfizer and BioNTech but that it is unlikely to represent a true risk. The agency said it continues to recommend that people stay up-to-date with Covid-19 vaccines.

The CDC said one of its vaccine safety monitoring systems – a “near real-time surveillance system” called the Vaccine Safety Datalink – detected a possible increase in a certain kind of stroke in people 65 and older who recently got one of Pfizer’s updated booster shots.

A rapid response analysis of that signal revealed that seniors who got an bivalent booster might be more likely to have ischemic strokes within the first three weeks after their shots, compared with weeks four through six.

Ischemic strokes, the most common form, are blockages of blood to the brain. They’re usually caused by clots.

The Vaccine Safety Datalink, or VSD, is a network of large health systems across the nation that provides data about the safety and efficacy of vaccines through patients’ electronic health records. The CDC said it had identified possible confounding factors in the data coming from the VSD that may be biasing the data and need further investigation.

Of about 550,000 seniors who got Pfizer bivalent boosters and were tracked by the VSD, 130 had strokes in the three weeks after the shot, according to a CDC official who spoke to CNN on condition of anonymity because they weren’t authorized to share the data. None of the 130 people died.

The number of strokes detected is relatively small, said Dr. William Schaffner, an infectious disease expert at Vanderbilt University and a member of the CDC Advisory Committee on Immunization Practices’ Covid-19 Vaccine Work Group.

“These strokes are not a confirmed adverse event at the moment,” he said. “It’s like a radar system. You’re getting a blip on the radar, and you have to do further investigation to discover whether that airplane is friend or foe.”

The same safety signal has not been detected with the bivalent Moderna booster, the CDC said in its notice.

The agency noted that it has looked for and failed to find the same increase in strokes in other large collections of medical records, including those maintained by Medicare, the US Department of Veterans Affairs, as well as its Vaccine Adverse Event Reporting System, known as VAERS.

Neither Pfizer nor other countries that are using the vaccine have seen any increase in this kind of stroke, the agency said, and the signal was not detected in any other databases.

The CDC says that it does not recommend any change to vaccination practices at this time and that the risks of Covid-19 for older adults continue to outweigh any possible safety issues with the vaccine.

“Although the totality of the data currently suggests that it is very unlikely that the signal in VSD represents a true clinical risk, we believe it is important to share this information with the public, as we have in the past, when one of our safety monitoring systems detects a signal,” the notice says.

“CDC and FDA will continue to evaluate additional data from these and other vaccine safety systems. These data and additional analyses will be discussed at the upcoming January 26 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.”

Pfizer said in a statement Friday, “Neither Pfizer and BioNTech nor the CDC or the U.S. Food and Drug Administration (FDA) have observed similar findings across numerous other monitoring systems in the U.S. and globally and there is no evidence to conclude that ischemic stroke is associated with the use of the companies’ COVID-19 vaccines.

“Compared to published incidence rates of ischemic stroke in this older population, the companies to date have observed a lower number of reported ischemic strokes following the vaccination with the Omicron BA.4/BA.5-adapted bivalent vaccine.”

The bivalent boosters from Pfizer/BioNTech and Moderna protect against the original strain of the coronavirus as well as the Omicron BA.4 and BA.5 subvariants. Only about 50 million Americans ages 5 and up have gotten them since they were authorized last fall, according to CDC data.

Schaffner said he was part of a briefing Thursday with members of the Covid-19 Vaccine Work Group. He couldn’t share specific details about the briefing but said the safety signal was discussed.

His biggest takeaway was that the safety surveillance system is working.

It’s very likely that this is a false signal, he said, but it’s being investigated, which is important.

“You want a surveillance system that occasionally sends up false signals. If you don’t get any signals, you’re worried that you’re missing stuff.”

Schaffner said he would absolutely tell people to get their Covid-19 booster if they haven’t done so yet – even those 65 and older.

“Undoubtedly, the risk of a whole series of adverse events, including hospitalization, is much, much greater with Covid-19 than it is from the vaccine,” he said.

He also said the signal – if real – may be more a factor of numbers than an indication that one manufacturer’s vaccine is riskier than the other.

Nearly two-thirds of the people in the US who’ve gotten an updated booster – 32 million – have gotten Pfizer, compared with about 18 million Moderna shots.

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Health

Flu activity peaked without post-holiday spike in cases, but respiratory virus season is still in full swing

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CNN
 — 

Flu continues to be very prevalent in the US, but the first wave of the season – which swept through the country weeks earlier than usual – appears to have peaked.

The weeks after the year-end holidays brought sustained high levels of transmission and hospitalization, but flu activity doesn’t seem to have spiked as many public health experts cautioned.

Still, even after weeks of improvement, data published Friday by the US Centers for Disease Control and Prevention shows that more than 12,400 people were admitted to the hospital for flu in the first week of the new year, and nearly 9% of lab tests were positive for flu.

About 4% of everyone who visited a health care provider last week had respiratory virus symptoms, including fever plus a cough or sore throat, which is nearly twice as high as the national baseline.

Flu is notoriously unpredictable, and a season can bring multiple peaks of activity.

“It’s pretty clear that there was a peak of activity, but that doesn’t mean we won’t have another one,” Lynnette Brammer, lead of the CDC’s domestic influenza surveillance team, said last week. “Things could turn around and go back up.”

Flu vaccination rates remain far below ideal levels, and hospitals remain very full, leaving the US vulnerable as respiratory virus season drags on.

“It’s certainly something we’re gonna watch really carefully. We’re just going to have to keep an eye on all the data, see what viruses are circulating and who’s getting sick, and what sort of impact that’s having,” Brammer said.

“And I want to remind people that if they haven’t yet gotten vaccinated, please do so. It’s not too late.”

As of December 31, about 171 million doses of flu vaccine have been distributed in the US – enough to cover only about half of the population. Just 40% of adults had gotten their shot by the end of November, and just 48% of children had gotten their shot by the end of December, according to CDC data.

Through January 7, the CDC estimates that there have been 24 million illnesses, 260,000 hospitalizations and 16,000 deaths from flu this season.

Although this season did hit earlier than usual, outcomes are within an expected range – at least so far.

“It’s not an unusually high influenza season. It’s sort of falling in with the mid- to higher range, but it’s within the limits of what we normally expect to see during a regular flu season, unfortunately,” Brammer said. “So basically, this is looking like a typical flu season, except in terms of the timing. It was just a little bit earlier than normal.”

Overall, flu and other respiratory virus activity remains “high” or “very high” in about half of states, according to the new CDC data, and the US continues to contend with multiple respiratory viruses that are circulating at high levels.

RSV activity has also peaked in the US, reaching a season high in mid-November. But even after a sharp decrease in trends over the past month and a half, weekly hospitalization rates for RSV remain higher than the peaks for most recent seasons.

RSV is particularly dangerous for children, and at least 13 out of every 100,000 children younger than 5 were hospitalized for RSV in the last week of the year, bringing the cumulative hospitalization rate this season up to 5 out of every 1,000 children in this age group.

Meanwhile, Covid-19 activity has been trending up for the past few months.

Hospitalizations have been on the rise since November and have surpassed the most recent peak from this summer, before the updated booster shot was available, federal data shows.

Case reporting has become more irregular over the course of the pandemic, but wastewater monitoring data from Biobot Analytics suggests that Covid-19 activity is higher than it was during the Delta surge, too.

The rapidly growing Omicron subvariant XBB.1.5 now accounts for an estimated 43% of new Covid-19 cases in the US, according to the CDC, making it the strain that is causing the most new infections in the US.

Notably, it is the only variant that is gaining ground in the U.S.

XBB.1.5 was first detected in New York in October. It grew quickly throughout the Northeast, and the CDC estimates that it accounts for more than 80% of new cases in that region.

From there, XBB.1.5 seems to be picking up steam along the Eastern Seaboard. It now accounts for about half of Covid-19 cases in the mid-Atlantic states and nearly one-third of cases in the Southeast. It is less prevalent in other US regions.

The rise of XBB.1.5 has coincided with an increase in Covid-19 hospitalizations, especially among seniors.

XBB.1.5 has a key mutation that helps it bind more tightly to cells. Experts believe that may be helping it be more infectious.

Still, just 16% of the US population has received their updated Covid-19 booster shot. Data from October shows that people ages 5 and up who had received an updated booster had 19 times lower risk of dying from Covid-19 compared with those who were unvaccinated. Chances of testing positive were three times lower for those who had their updated booster.

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Health

Long-term symptoms from mild Covid resolve within year, study says

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CNN
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The majority of long Covid symptoms resolve within the first year after infection for people with mild cases of Covid-19, according to a large study conducted in Israel.

“Mild disease does not lead to serious or chronic long term morbidity in the vast majority of patients,” said study coauthor Barak Mizrahi, a senior researcher at KI Research Institute in Kfar Malal, via email.

The study, published Wednesday in the journal The BMJ, compared thousands of vaccinated and unvaccinated people with mild Covid symptoms who were not hospitalized with people who tested negative for the virus. Long Covid was defined as symptoms that continue or appear more than four weeks after an initial Covid-19 infection.

“I think this study is reassuring in that most ongoing symptoms following COVID do improve over the first several months following the acute infection,” said Dr. Benjamin Abramoff, director of the Penn Medicine Post-COVID Assessment and Recovery Clinic, via email. He was not involved in the study.

But not for everyone. Abramoff said his clinic continues to see many patients with severe long Covid symptoms lasting longer than one year following their infection.

“This is particularly true in those individuals who had severe persistent symptoms early after their acute infection,” said Abramoff, who leads the American Academy of Physical Medicine and Rehabilitation’s long Covid collaborative.

Dr. Jonathan Whiteson, an associate professor of rehabilitation medicine at the NYU Grossman School of Medicine, sees the same in his clinic.

“I continue to see many patients from the ‘first wave’ of COVID who had mild to moderate acute COVID (and were) never hospitalized who have significant persistent and functionally limiting symptoms nearly 3 years later,” said Whiteson via email. He was not involved with the study.

Israeli researchers analyzed the medical records of nearly 300,000 people diagnosed with mild cases of Covid-19 and compared their health over the next year with approximately 300,000 people who didn’t have Covid. The average age of those who tested positive for Covid was 25 years, and 51% were female.

Researchers looked for 65 conditions that have been associated with long Covid and divided those into two time frames: early, or the first 30 to 180 days after catching Covid; and late, or 180 to 360 days post infection.

After controlling for age, sex, alcohol and tobacco use, preexisting conditions, and the different variants of Covid-19, researchers found a significant risk of brain fog, loss of smell and taste, breathing problems, dizziness and weakness, heart palpitations, and strep throat in both the early and late time periods.

Chest pain, cough, hair loss, muscle and joint pain, and respiratory disorders were significantly increased only during the early phase, according to the researchers.

Difficulty with breathing was the most common complaint, the study found. Being vaccinated reduced the risk of respiratory issues, but researchers found vaccinated individuals had a “similar risk for other outcomes compared with unvaccinated infected patients,” according to the study.

“Because of the study’s size, it was possible to look at the change in symptom prevalence over time and the effects of other factors on persistent symptoms,” said Dr. Peter Openshaw, a professor of experimental medicine at Imperial College London, in a statement.

“Smell disorder typically resolved at about 9 months, but when they were present concentration and memory changes tended to be more persistent,” said Openshaw, who was not involved in the study.

Only slight differences appeared between men and women in the study, but children had fewer early symptoms than adults, which were mostly gone by year’s end. No real differences were found between the original wild-type of SARS-CoV-2 (March 2020 to November 2020), the Alpha variant (January 2021 to April 2021) and the Delta variant (July 2021 to October 2021).

“Patients with mild Covid-19 had an increased risk for a small number of health outcomes, with only a few symptoms persisting a year from SARS-CoV-2 infection and their risk decreased with time from infection,” Mizrahi said via email.

However, “we are not claiming there are no patients who suffer from long COVID symptoms like dyspnea (difficulty breathing), weakness, cognitive impairment etc.,” he added. “(Our study) does not contradict evidence that a small number of patients do suffer from long lasting symptoms as seen in this analysis.”

Researchers pointed to certain limitations in the study, such as the possibility of diagnostic errors or failure to record some milder symptoms over time. Abramoff agreed.

“This design of this study is not able to detect the severity of these symptoms, and there are potentially other missed patients due to using medical coding to detect persistent Long COVID symptoms,” Abramoff said.

It could also be difficult to apply the findings of the study to other countries, such as the United States, due to differences in how doctors code symptoms. For example, the study did not identify several conditions frequently found in long Covid clinics in the US, said Dr. Monica Verduzco-Gutierrez, professor and chair of the department of rehabilitation medicine at the Long School of Medicine at UT Health, San Antonio.

“The most common symptom of Long COVID is fatigue, and that was not on this list. Also missing was post-exertional malaise, dysautonomia/POTS, or ME/CFS. These are some of the major presentations I am seeing in my clinic population, so it is a major limitation of this study to not have those outcomes,” said Verduzco-Gutierrez, who was not involved in the new study.

Post-exertional malaise is an overwhelming exhaustion after even a minimal amount of effort. Unlike regular exhaustion, it can take days to weeks for a person to recover, and the malaise can be reactivated if activity is resumed too quickly.

Postural orthostatic tachycardia syndrome, or POTS, is a bump in heart rate after sitting up or standing that can lead to dizziness or fainting. It’s a form of dysautonomia, a disorder of the autonomic nervous system. “There is usually no cure for dysautonomia,” according to the National Institute of Neurological Disorders and Stroke.

Myalgic encephalomyelitis/chronic fatigue syndrome, or ME/CFS, is a serious long-term illness, in which people have overwhelming fatigue that is not improved by rest. The condition can impact sleep and thinking processes, cause pain in many parts of the body, and keep people from doing most daily activities.

Responding to this concern, Mizrahi told CNN that “post exertional malaise was not included in this study as it is not a diagnosis that commonly prescribed in Israel.” In addition, he said, dysautonomia/POTS was only assigned an International Classification of Diseases, or ICD medical code, as of October 2022, so it too was not included in the study.

However, symptoms of POTS and other conditions may have been included under more general categories such as cardiac arrhythmias or palpitations, he said.

In addition, Mizrahi said fatigue was coded under “weakness” in the study. In fact, researchers found weakness to be the second most common symptom reported in the study, and it continued to plague people ages 19 to 60, for months.

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