Tag Archives: iab-vaccines

Covid-19 is a leading cause of death for children in the US, despite relatively low mortality rate



CNN
 — 

Covid-19 has become the eighth most common cause of death among children in the United States, according to a study published Monday.

Children are significantly less likely to die from Covid-19 than any other age group – less than 1% of all deaths since the start of the pandemic have been among those younger than 18, according to federal data. Covid-19 has been the third leading cause of death in the broader population.

But it’s rare for children to die for any reason, the researchers wrote, so the burden of Covid-19 is best understood in the context of other pediatric deaths.

“Pediatric deaths are rare by any measure. It’s something that that we don’t expect to happen and it’s a tragedy in a unique way. It’s a really profound event,” said Dr. Sean O’Leary, chair of the American Academy of Pediatrics’ Committee on Infectious Diseases.

“Everyone knows that Covid is the most severe in the elderly and immunocompromised and that it’s less severe in children, but that does not mean it’s a benign disease in children. Just because the numbers are so much lower in children doesn’t mean that they’re not impactful.”

In 2019, the last year before the pandemic, the leading causes of death among children and young adults ages 0 to 19 included perinatal conditions, unintentional injuries, congenital malformations or deformations, assault, suicide, malignant neoplasms, diseases of the heart and influenza and pneumonia.

The researchers’ analysis of data from the US Centers for Disease Control and Prevention found that there were 821 Covid-19 deaths in this age group during a 12-month period from August 2021 to July 2022. That death rate – about 1 for every 100,000 children ages 0 to 19 – ranks eighth compared with the 2019 data. It ranks fifth among adolescents ages 15 to 19.

Covid-19 deaths displace influenza and pneumonia, becoming the top cause of death caused by any infectious or respiratory disease. It caused “substantially” more deaths than any vaccine-preventable disease historically, the researchers wrote.

According to CDC data, children are less vaccinated against Covid-19 than any other age group in the US. Less than 10% of eligible children have gotten their updated booster shot, and more than 90% of children under 5 are completely unvaccinated.

“If we looked at all those other leading causes of death – whether you’re talking about motor vehicle accidents or childhood cancer – and we said, ‘Gosh, if we had some simple, safe thing we could do to get rid of one of those, wouldn’t we just jump at it?” And we have that with Covid with vaccines,” said O’Leary, who is also a professor of pediatric infectious disease at the University of Colorado School of Medicine and Children’s Hospital Colorado.

A CDC survey of blood samples suggest that more than 90% of children have already had Covid-19 at least once.

There is uncertainty about exactly how much risk the virus will continue to pose, O’Leary said, but the potential benefits of vaccination clearly outweigh any potential risks.

“Vaccination clearly is our best option right now,” and the benefits clearly outweigh the risks, he said. “Better safe than sorry.”

The findings of the new study, published in JAMA Network Open, may underestimate the mortality burden of Covid-19 because the analysis focuses on deaths where Covid-19 was an underlying cause of death but not those where it may have been a contributing factor, the researchers wrote. Also, other analyses of excess deaths suggest that Covid-19 deaths have been underreported.

As Covid-19 continues to spread in the US, the researchers say that intervention methods such as vaccination and ventilation will “continue to play an important role in limiting transmission of the virus and mitigating severe disease.”

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



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



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



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



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



CNN
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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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Flu turned deadly within 48 hours for this young family. Now they get vaccinated every year



CNN
 — 

Jessica Richman felt fear rush over her – again.

In October, she watched her 3-year-old daughter, Layla, become unusually lethargic, develop a high fever and start to have shortness of breath. It was a painful reminder of her other daughter, Cayden, who died of the flu in December 2014.

Cayden had been the same age as Layla.

“It was very similar symptoms to Cayden. So, of course, I jumped into high gear,” Richman said.

When Layla’s symptoms began on Halloween, Richman took her to an urgent care clinic in their hometown of Newport News, Virginia.

“Her heart rate was elevated. Her fever was very high. They kept her there for most of the afternoon to observe her,” Richman said. “I explained to the doctor that was there that I have lost a 3-year-old daughter to the flu, so this was very scary for me. He really took that to heart.”

Layla’s medical team diagnosed her with influenza and gave her Motrin for her fever and the antiviral Tamiflu to treat the infection.

“She felt better fairly quickly, within 24 hours,” Richman said.

Richman’s experience during this flu season was dramatically different than in 2014, when she lost her beloved Cayden.

One key difference: Cayden was unvaccinated in 2014. Layla got her vaccine in September.

“I really think that the vaccine played a big role,” said Richman, who serves as secretary for the nonprofit Families Fighting Flu.

Even though Layla became sick when she encountered the flu virus weeks after vaccination, “she recovered quickly,” Richman said, adding that no one else in their household – which also includes her husband, Matt, and their 6-year-old son, Parker – caught the flu from Layla.

All of them had been vaccinated before Layla’s illness.

The US Centers for Disease Control and Prevention estimates that at least 16,000 people have died of flu this season, and at least 79 deaths have been in children.

Seasonal flu activity continues to be very prevalent across the United States but has been declining in most areas in recent weeks. Still, public health officials encourage people to get their annual flu vaccine as the best way to protect against that virus.

Many people who don’t get their seasonal flu shot are not necessarily anti-vaccination. They simply might not have had the time. That was the case for Cayden in 2014.

That year, Richman and Cayden’s father got their flu shots, but Cayden’s vaccination had to be rescheduled because she had a cold at the time.

“Because I also at the time was ill-informed about the flu, I didn’t feel that it was super urgent to go and immediately get her flu shot as soon as she was well,” Richman said. “I kind of put it off.”

One Thursday some weeks later, Cayden wasn’t her usual talkative and bubbly self. The 3-year-old, affectionately known as CadyBug, was fatigued and developed a cough. She stayed home from daycare with her father, and he took her to the pediatrician’s office.

The doctor thought Cayden’s symptoms were probably from a cold virus and sent her home without testing for the flu, Richman said.

The next morning, Cayden still had a fever. She was coughing and kept asking for water. Her father took her back to the pediatrician’s office but was sent home again.

“No one tested her for the flu. No one seemed to think that this was flu,” Richman said. “She was sent home that Friday afternoon.”

When they got home, Cayden’s symptoms worsened.

“She deteriorated very, very fast. It was in a matter of hours,” Richman said. “It was very deep, shallow breaths. She was not breathing correctly.”

Richman said that she was driving home from work when she got a chilling phone call from Cayden’s father: Cayden had stopped breathing during her nap. He had called 911. Richman arrived home to find emergency vehicles in front of her house and paramedics working on Cayden.

“She could not be resuscitated at the house,” Richman said. “In the ambulance ride, they had not told me at the time that she could not be resuscitated, but I could tell because I was riding in an ambulance and there was no noise. So I knew that it was over.”

When Cayden died, her parents still had no idea that it was because of the flu.

“It wasn’t until we received an autopsy that I clearly understood that it was the flu that caused her lungs to fill with mucus until she could no longer breathe,” Richman said. “I had no idea what happened until we got the autopsy back.”

Before Cayden’s tragic death, her mother was unaware that the flu could turn fatal.

“I was completely taken aback,” she said. “I had no idea that that could ever happen.”

Nearly a decade later, Richman and her family get their flu shots together each year in remembrance of Cayden. They wear pink and share social media posts about it, using the hashtag #pinkforcadybug, since pink was Cayden’s favorite color.

The most common symptoms of flu are fever, body ache and shaking chills. In some cases, it can cause lower respiratory tract infections known as pneumonia or directly infect heart cells and brain cells, causing inflammation of those organs, Dr. Tara Vijayan, an infectious disease doctor at the David Geffen School of Medicine at the University of California, Los Angeles, said in an email.

She added that inflammation can result in the body’s own cells dying.

“More commonly, however, if the flu is going to cause severe disease it is because it disrupts the lining of the respiratory tract such that the lungs become more susceptible to other bacterial pneumonias,” Vijayan said. “Generally, those who are unvaccinated and have multiple medical problems or have lowered immune systems are at highest risk, but we have seen death in younger otherwise healthy people.”

She added that people older in age or who are pregnant are also at high risk of complications.

Treating patients with severe flu is a frequent but difficult experience for Dr. Ali Khan, who specializes in internal medicine at one of the primary care network Oak Street Health’s Chicago locations.

“It is an incredibly difficult infection to watch as a clinician,” Khan said, adding that flu infections can turn deadly when someone gets a superimposed bacterial infection like pneumonia or develops severe sepsis.

“We get folks who are coming in to hospitals with seizures or with encephalitis caused by the flu. Folks who are coming in with significant muscle injury and breakdown, like the kind that you get when you’re quite dehydrated and overly fatigued,” he said. “Suffice to say, I’ve seen this far too many times than I’d ever like to see as a clinician.”

It’s not too late to get this season’s flu shot if you haven’t done so, Khan said.

“We’re not out of the woods yet,” he said. “Absolutely, you can still get vaccinated.”

Vijayan had similar sentiments.

“Our flu rates were unexpectedly high in the late fall and it does seem to be leveling off, but I would absolutely be concerned about another rise in cases this winter,” she said. “It is absolutely not too late to get the flu shot.”

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



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



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



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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