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

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CNN
 — 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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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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Covid-19 vaccine boosters for kids age 5 and under

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CNN
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Last week, the US Food and Drug Administration authorized the bivalent Covid-19 booster for children 6 months to 5 years old. The US Centers for Disease Control and Prevention has since recommended the booster, and now everyone 6 months and older is able to receive the updated coronavirus vaccine except kids who got three doses produced by Pfizer/BioNTech.

Which young children are now eligible to receive the booster? What if kids haven’t started or completed the full series — do they now get the updated booster or the original monovalent vaccine? Can parents and guardians choose between the updated booster and the original shot? What are possible side effects? What if kids had Covid-19 already? And which families should consider the updated booster now and who could wait?

To help us answer 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” and the mother of two young children, ages 2 and 5.

CNN: Let’s start with what has just changed in the recommendations: Which young children who received either the Pfizer or Moderna vaccine are now eligible to receive the booster?

Dr. Leana Wen: There are two vaccines authorized for young children: Moderna and Pfizer. For the youngest age group, the Moderna vaccine was designed to be a two-dose primary vaccine, while the Pfizer version was designed to be a three-dose primary vaccine. That means young children are considered to have completed their primary series if they completed two doses of the Moderna vaccine or if they completed three doses of Pfizer.

As a reminder, there is now a bivalent booster available for older children and adults. This combines the original (also called monovalent) vaccine with a vaccine that specifically targets the BA.4 and BA.5 Omicron subvariants. Because Omicron subvariants constitute virtually all new infections, the hope is that the bivalent booster will provide better, more directed protection.

What federal health officials have now said is that children 6 months through 5 years old who received both doses of the original Moderna vaccine are able to get the updated bivalent vaccine — if it has been at least two months since they completed the primary vaccine series.

For children who received the Pfizer vaccine, the guidance is a little different, because the primary series already involves three doses. Federal health officials have said that children 6 months through 4 years old who have not yet completed their three vaccine doses can receive the third dose as the bivalent vaccine. Let’s say a child has started this series and has had one or two doses of the original Pfizer vaccine. The third dose can now be the updated booster.

CNN: What if kids haven’t started or completed the full series — do they now get the updated booster or the original monovalent vaccine?

Wen: The answer is different for Moderna vs. Pfizer. For Moderna, the primary series is two doses, so a child needs to complete the two initial shots with the original formulation. The booster — the third dose — is the bivalent vaccine. For Pfizer, the primary series is three doses. The first two doses still need to be the original formulation, but the third shot is now the bivalent vaccine.

CNN: What about young children who completed three doses of the Pfizer vaccine — are they eligible for a fourth dose?

Wen: No. The FDA explicitly says that children 6 months through 4 years old who have completed their three-dose primary series with the original Pfizer vaccine are not eligible for a fourth shot of the bivalent booster. That’s because the primary series of three vaccine doses is still expected to have strong protection against severe illness to Omicron. This recommendation will be reevaluated as new data comes out.

CNN: Can parents and caregivers who have not completed the primary series of Moderna choose the bivalent vaccine as their second dose?

Wen: No. The FDA authorization for the adult primary series for Moderna — the two doses — is for the original monovalent vaccine. Similarly, there is no choice for which vaccine formulation is administered as the booster for Pfizer in adults. Only the bivalent booster is available as the third shot, not the original monovalent, which is still given as doses one and two. This mirrors the authorization given for adults — the primary series is the monovalent vaccine, with the only booster for Pfizer and Moderna for adults being the updated booster.

CNN: What are possible side effects from the updated booster?

Wen: It’s expected that children who get the updated booster will have similar types of side effects to the original vaccines. These side effects tend to be mild and short-lasting, usually resolving in the first 24 hours after inoculation. Adverse reactions can include pain and swelling in the injection site, fatigue, crankiness, sleepiness, headache, muscle aches and sometimes fever. Many children experience no side effects. The risk of serious side effects, such as myocarditis (an inflammation of the heart muscle), is expected to be exceedingly rare in this younger age group.

CNN: What if kids had Covid-19 already?

Wen: People who had Covid-19 can wait three months until after they have recovered from the coronavirus to receive another vaccine dose, according to the CDC. They probably have very good protection against infection in this period.

Many studies have shown that hybrid immunity — recovery from Covid-19 combined with vaccination — conveys very strong protection, arguably even more so than vaccination and boosters alone. In my opinion, I believe a case can be made that if a young child received the primary series and already had Covid, they could wait to receive another booster dose. This is especially true if they had Covid recently, in the last year. To my knowledge, there is no research that shows additional benefit of boosters to young children who recently had Covid-19 infection and who have received their primary vaccinations.

CNN: Which families should consider the updated booster now and who should wait?

Wen: First, I think it’s important to point out that the uptake of the primary series of the Covid-19 vaccines among young children is very low. According to the CDC, less than 5% of kids 5 and younger are fully vaccinated. That means we are referring to a very small pool of kids newly eligible for the updated boosters.

There’s one group that I would definitely recommend getting the updated booster. That’s the group of kids who received their first one or two doses of the Pfizer vaccine. These kids need to complete their primary series. The third dose of that series is now the updated bivalent booster. There’s no reason for families of these children to wait; they should complete the primary series, and it’s a bonus that the third dose is updated to target Omicron.

For children who received the two doses of the Moderna vaccine, I think the decision-making is different and will depend on families’ individual circumstances. Some families are very concerned about Covid-19 infection. Perhaps their child has underlying medical conditions, or they live with someone who is elderly, immunocompromised or otherwise very vulnerable to severe outcomes from Covid-19. Perhaps the family is welcoming a newborn soon, and that baby will be particularly vulnerable to coronavirus infection. I think it’s reasonable to decide that, since Covid-19 cases are rising, this is the time to get their young child the updated booster.

I also think it’s reasonable to wait. My children (ages 2 and 5) received the Moderna vaccines over the summer. They are eligible to be boosted, but I am holding off because the protection that they have against severe illness remains strong. The booster will convey additional protection against symptomatic infection, but that effect is probably short-lasting, according to a June study.

To be clear, I believe it’s crucial for older adults and vulnerable individuals to receive the updated booster. I also think it’s generally a good thing that people can choose the booster if they wish, as there are compelling individual reasons for different households.

Parents and caregivers who have questions should consult their pediatrician to decide the best course of action for their family’s specific circumstances. Finally, families whose children have yet to receive any Covid-19 vaccines should consider starting, especially if their kids are not known to have had Covid-19.

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Measles outbreak in central Ohio grows to more than 50 children, driven by ‘lack of vaccination’

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CNN
 — 

A measles outbreak in central Ohio is growing, sickening more than 50 children, with many of them needing hospitalization, according to data updated Tuesday by Columbus Public Health.

None of the children had been fully vaccinated against measles.

Since the start of the outbreak in November, at least 58 measles cases have been identified in Columbus and Franklin, Ross and Richland counties, and there have been 22 hospitalizations, according to Columbus Public Health.

Of those cases, 55 were in unvaccinated children. The other three were only partially vaccinated, meaning they received one dose of their MMR or measles, mumps and rubella vaccine when two are needed for a person to be considered fully vaccinated.

Experts recommend that children get the vaccine in two doses: the first between 12 months and 15 months of age, and a second between 4 and 6 years old. One dose is about 93% effective at preventing measles if you come into contact with the virus. Two doses are about 97% effective.

Nationwide, more than 90% of children in the US have been vaccinated against measles, mumps and rubella by age 2, according to the US Centers for Disease Control and Prevention.

“Measles can be very serious, especially for children under age 5,” Columbus Public Health spokesperson Kelli Newman wrote in an email Monday.

All of the Columbus cases have been in children: 12 in infants younger than 1, 28 in toddlers ages 1 to 2, 13 in children ages 3 to 5, and five in ages 6 to 17.

That corresponds to about 71% of cases being reported in 1- to 5-year-olds.

While the specifics of each hospitalized measles case can vary, “many children are hospitalized for dehydration,” Newman wrote. “Other serious complications also can include pneumonia and neurological conditions such as encephalitis. There’s no way of knowing which children will become so sick they have to be hospitalized. The safest way to protect children from measles is to make sure they are vaccinated with MMR.”

Some of the children visited a grocery store, a church and department stores in a mall while they were contagious, according to Columbus Public Health’s list of exposure sites.

Measles is a highly infectious disease that can spread through the air when an infected person coughs or sneezes or if someone comes into direct contact with or shares germs by touching contaminated objects or surfaces.

“Measles can be a severe illness and can commonly lead to complications which require hospitalization, especially in young children,” Dr. Matthew Washam, medical director of epidemiology and infection control at Nationwide Children’s in Columbus, wrote in an email Tuesday.

In the Ohio outbreak, the hospitalized children have been seen at Nationwide Children’s Hospital.

“Most children can usually recover at home with supportive care and can receive antibiotics for less severe complications, such as ear infections. Some children develop more severe complications, such as dehydration requiring intravenous fluids, pneumonia and/or croup which require respiratory support, or rarely more severe complications such as encephalitis,” Washam wrote.

“The mainstay of treatment for all children with measles is supportive care,” he added. “In the hospital, this can include intravenous fluids, antibiotics for secondary bacterial infections, and respiratory support amongst other supportive care measures. Some children with measles may also be treated with vitamin A given the association of lower vitamin A levels with more severe measles illness.”

The measles outbreak is “very concerning,” said Dr. Nora Colburn, an adult infectious diseases physician at The Ohio State University Wexner Medical Center in Columbus, who has been watching the outbreak closely along with her colleagues.

“What’s really driving this is unfortunately a lack of vaccination, which is just heartbreaking,” said Colburn, who also serves as the medical director of clinical epidemiology for the Richard M. Ross Heart Hospital at the OSU Wexner Medical Center.

“For measles, it is the most infectious disease we have,” she said. “And so it is very concerning as an infectious disease physician, as also a mother of a young child and as a community member.”

During the early days of the Covid-19 pandemic, while most people stayed home and some health-care facilities were closed, many children missed their routine immunizations, including the MMR vaccine – and they still may not have gotten all their recommended shots. That’s true around the world as well as in the US.

“The concern now is that we’ve had this global dip in vaccination coverage as a result of the pandemic, probably not actually from vaccine hesitancy or refusal but just there were a lot of kids that missed their checkups during the pandemic, and we really haven’t completely caught those kids up,” said Dr. Sean O’Leary, chair of the American Academy of Pediatrics’ Committee on Infectious Diseases and professor of pediatric infectious disease at the University of Colorado School of Medicine and Children’s Hospital Colorado.

“Measles is such a contagious disease that when you see those dips, we really worry about the potential for large outbreaks,” he said. “You need to really maintain a high vaccination coverage to keep measles from spreading.”

About 90% of unvaccinated people who are exposed to measles will become infected, according to Columbus Public Health, and about 1 in 5 people in the US who get measles will be hospitalized.

While the measles outbreak spreads across central Ohio, the United States has been battling a surge of respiratory illnesses, such as flu and RSV, or respiratory syncytial virus, and the ongoing Covid-19 pandemic.

Pediatric hospitals nationwide have been overwhelmed by this rise in respiratory infections and are bracing for the possibility of even more cases over the holiday season.

“I can’t even imagine if your hospital is already chock full and all of a sudden you’ve got to deal with measles, because measles is a really problematic infection-control situation, too. You need negative-pressure rooms, everyone has to wear N95 masks, and it’s incredibly contagious in a hospital,” O’Leary said.

“There’s a lot of risk particularly to immunocompromised patients that are also in children’s hospitals,” he said. “It’s a real problem.”

Nationwide Children’s Hospital confirmed to CNN in an email Tuesday that it has seen a surge in other respiratory illnesses, such as flu and RSV, but remains able to keep caring for patients.

“The current surge in respiratory illnesses such as the flu and RSV is being seen locally. While we are experiencing some visits and admissions related to measles, volumes are relatively low compared to flu and RSV. Measles poses a greater strain on resources related to public health efforts, including contact tracing, containment, education, and immunizations,” the hospital statement said. “While busy, our hospital remains able to continue to provide care for patients.”

With each of these respiratory illnesses, it sometimes can be difficult to determine which infection a person has as the symptoms – such as fever, cough, and runny nose – can be similar.

“To have RSV, influenza, Covid at the same time as the holidays, and then now we have measles on top of it, which can have overlapping symptoms of fever and cough and fatigue, it can be really challenging to kind of sort out which infection is what,” Colburn said, adding that it is important for anyone with symptoms to stay home and get tested.

Measles symptoms may include fever, cough, runny nose, watery eyes and a rash of red spots. In rare cases, it may lead to pneumonia, encephalitis or death.

“Wearing your mask, especially in crowded areas, is really important, especially for our immunocompromised patients. I really worry about measles in adult patients who cannot get the MMR vaccines,” she said. “We can’t give it to severely immunocompromised patients or pregnant women. So it’s really important that everybody else gets vaccinated to cocoon those very vulnerable people and decrease the circulation of measles in our community.”

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As measles outbreak sickens children in Ohio, local health officials seek help from CDC

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CNN
 — 

A growing measles outbreak in Columbus, Ohio, has sickened dozens of unvaccinated children and hospitalized nine of them, and local public health officials are seeking assistance from the US Centers for Disease Control and Prevention.

“We asked the CDC for assistance and they will be sending two epidemiologists at the end of the month to assist with our local investigation,” Kelli Newman, a spokesperson for Columbus Public Health, told CNN in an email Thursday.

The CDC confirmed Thursday that it is aware of the cases and is “deploying a small team to Ohio to assist on the ground with the investigation.”

“State and local health authorities are in the process of notifying potentially exposed residents, making sure they are vaccinated, and helping any community members who may have been exposed understand the signs and symptoms of measles infection,” CDC spokesperson Kristen Nordlund said in an email to CNN. “Anyone who may have been exposed should follow up with their healthcare provider.”

When the measles outbreak was first reported last week, only four confirmed cases had been identified in one child-care facility, which temporarily closed – but the number of cases and facilities involved has grown.

“As of today, we are investigating 24 cases of measles at nine day cares and two schools,” Newman said. “All cases are in unvaccinated children, and all but one are less than 4 years old. One child is 6 years old.”

Health officials with Columbus Public Health and Franklin County Public Health have been investigating these cases and tracing any contacts who may have been exposed to the measles virus.

Officials at Columbus Public Health are encouraging parents to make sure their children are up to date on their immunizations, including the measles, mumps and rubella vaccine, known as the MMR vaccine.

Experts recommend that children receive the vaccine in two doses: first between 12 months and 15 months of age and a second between 4 and 6 years old. One dose is about 93% effective at preventing measles if you come into contact with the virus. Two doses are about 97% effective.

“We are working diligently with the cases to identify any potential exposures and to notify people who were exposed,” Columbus Public Health Commissioner Dr. Mysheika Roberts said in a news release last week. “The most important thing you can do to protect against measles is to get vaccinated with the measles-mumps-rubella (MMR) vaccine, which is safe and highly effective.”

About 90% of unvaccinated people who are exposed to measles will become infected, according to Columbus Public Health, and about 1 in 5 people in the US who get measles will be hospitalized.

However, the CDC says that more than 90% of children in the US have been vaccinated against measles, mumps and rubella by age 2.

Measles is a highly contagious disease that can spread through the air when an infected person coughs or sneezes or if someone comes into direct contact with or shares germs by touching the same objects or surfaces. Measles symptoms may include fever, cough, runny nose, watery eyes and a rash of red spots. In rare cases, it may lead to pneumonia, encephalitis or death.

The measles outbreak in Columbus is a “fairly typical scenario” of an infectious virus finding its way into one environment and spreading among unvaccinated people, said Dr. David Freedman, professor emeritus of infectious diseases at the University of Alabama at Birmingham and founding director of the Travelers’ Health Clinic.

Freedman said that during the early days of the Covid-19 pandemic, while many people stayed home and some health-care facilities were closed, many children missed their routine immunizations – and they still may not have gotten their MMR shots.

“There are a lot of children nationwide that are behind on their routine vaccinations. So I think the message is still, if your child is 1 year of age or older, they need to be vaccinated,” said Freedman, a spokesperson for the Infectious Diseases Society of America.

“Measles is not particularly a wintertime disease. It is not as likely to be affected by travel because it usually is in young, not immune children. Most adults are vaccinated,” he said. However, he added, “measles is highly contagious. Measles is probably the most contagious disease we know. It’s probably 10 times as contagious as Covid is.”

In 1912, measles became a nationally notifiable disease in the United States, meaning health care providers and laboratories were required to report diagnosed cases. In the decade afterward, an average of about 6,000 measles-related deaths were reported annually.

In the 1950s, researchers isolated the measles virus in a patient’s blood, and in the 1960s, they were able to transform that virus into a vaccine. The vaccine was licensed and then used as part of a vaccination program.

Before the measles vaccination program was introduced in the United States in 1963, an estimated 3 million to 4 million people got the disease each year nationwide, according to the CDC. Afterward, cases and deaths from measles in the United States and other developed countries plummeted. There were 963 cases reported in the United States in 1994 and 508 in 1996.

The last major measles outbreak reported in the US was in 2019. It was the largest since the disease was declared eliminated in 2000 and involved more than a thousand confirmed cases in 31 states – the highest number of cases reported in the US since 1992.

Overall, the number of measles infections reported in the United States each year remains low because of the widespread use of vaccines, said Dr. Martin Hirsch, professor of medicine at Harvard University and Massachusetts General Hospital, who also serves as editor of the Journal of Infectious Diseases.

As of October 28, a total of 33 measles cases have been reported this year in five jurisdictions across the United States, according to the CDC.

“Over 90% of people in the United States have been vaccinated against measles, and even though it’s a highly transmissible virus, I wouldn’t expect to see the rates, for example, that we’re seeing with RSV now because we don’t have an RSV vaccine,” Hirsch said, referring to a surge of respiratory syncytial virus infections across the country, mostly among children.

“Most of the cases of measles that we do see in the United States result from people who are coming to this country from other countries where the immunization rates are much less, followed by transmission to US residents who are not vaccinated,” said Hirsch, a spokesperson for the Infectious Diseases Society of America. “So the possibility that someone carrying measles virus coming into the country could spread into an unvaccinated population is always there.”

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New RSV vaccines may soon put an end to rough seasons

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CNN
 — 

It’s shaping up to be a severe season for respiratory syncytial virus infections – one of the worst some doctors say they can remember. But even as babies struggling to breathe fill hospital beds across the United States, there may be a light ahead: After decades of disappointment, four new RSV vaccines may be nearing review by the US Food and Drug Administration, and more than a dozen others are in testing.

There’s also hope around a promising long-acting injection designed to be given right after birth to protect infants from the virus for as long as six months. In a recent clinical trial, the antibody shot was 75% effective at heading off RSV infections that required medical attention.

Experts say the therapies look so promising, they could end bad RSV seasons as we know them.

And the relief could come soon: Dr. Ashish Jha, who leads the White House Covid-19 Response Task Force, told CNN that he’s “hopeful” there will be an RSV vaccine by next fall.

Charlotte Brown jumped at the chance to enroll her own son, a squawky, active 10-month-old named James, in one of the vaccine trials this summer.

“As soon as he qualified, we were like ‘absolutely, we are in,’ ” Brown said.

Babies have to be at least 6 months old to enter the trial, which is testing a vaccine developed at the National Institutes of Health – the result of decades of scientific research.

Brown is a pediatrician who cares for hospitalized children at Vanderbilt University Medical Center in Nashville, and she sees the ravages of RSV firsthand. A recent patient was in the back of her mind when she was signing up James for the study.

“I took care of a baby who was only a few months older than him and had had nine days of fever and was just absolutely pitiful and puny,” she said. Brown said his family felt helpless. “And I was like, ‘this is why we’re doing it. This single patient is why we’re doing this.’ “

Even before this year’s surge, RSV was the leading cause of infant hospitalizations in the US. The virus infects the lower lungs, where it causes a hacking cough and may lead to severe complications like pneumonia and inflammation of the tiny airways in the lungs called bronchiolitis.

Worldwide, RSV causes about 33 million infections in children under the age of 5 and hospitalizes 3.6 million annually. Nearly a quarter-million young children die each year from complications of their infections.

RSV also preys on seniors, leading to an estimated 159,000 hospitalizations and about 10,000 deaths a year in adults 65 and over, a burden roughly on par with influenza.

Despite this heavy toll, doctors haven’t had any new tools to head off RSV for more than two decades. The last therapy approved was in 1998. The monoclonal antibody, Synagis, is given monthly during RSV season to protect preemies and other high-risk babies.

The hunt for an effective way to protect against RSV stalled for decades after two children died in a disastrous vaccine trial in the 1960s.

That study tested a vaccine made with an RSV virus that had been chemically treated to render it inert and mixed with an ingredient called alum, to wake up the immune system and help it respond.

It was tested at clinical trial sites in the US between 1966 and 1968.

At first, everything looked good. The vaccine was tested in animals, who tolerated it well, and then given to children, who also appeared to respond well.

“Unfortunately, that fall, when RSV season started, many of the children that were vaccinated required hospitalization and got more severe RSV disease than what would have normally occurred,” said Steven Varga, a professor of microbiology and immunology at the University of Iowa, who has been studying RSV for more than 20 years and is developing a nanoparticle vaccine against the virus.

A study published on the trial found that 80% of the vaccinated children who caught RSV later required hospitalization, compared with only 5% of the children who got a placebo. Two of the babies who had participated in the trial died.

The outcomes of the trial were a seismic shock to vaccine science. Efforts to develop new vaccines and treatments against RSV halted as researchers tried to untangle what went so wrong.

“The original vaccine studies were so devastatingly bad. They didn’t understand immunology well in those days, so everybody said ‘oh no, this ain’t gonna work.’ And it really was like it stopped things cold for 30, 40 years,” said Dr. Aaron Glatt, an infectious disease specialist at Mount Sinai South Nassau in New York.

Regulators re-evaluated the guardrails around clinical trials, putting new safety measures into place.

“It is in fact, in many ways, why we have some of the things that we have in place today to monitor vaccine safety,” Varga said.

Researchers at the clinical trial sites didn’t communicate with each other, Varga said, and so the US Food and Drug Administration put the publicly accessible Vaccine Adverse Events Reporting System into place. Now, when an adverse event is reported at one clinical trial site, other sites are notified.

Another problem turned out to be how the vaccine was made.

Proteins are three-dimensional structures. They are made of chains of building blocks called amino acids that fold into complex shapes, and their shapes determine how they work.

In the failed RSV vaccine trial, the chemical the researchers used to deactivate the virus denatured its proteins – essentially flattening them.

“Now you have a long sheet of acids but no more beautiful shapes,” said Ulla Buchholz, chief of the RNA Viruses Section at the National Institutes of Allergy and Infectious Diseases.

“Everything that the immune system needs to form neutralizing antibodies that can block and block attachment and entry of this virus to the cell had been destroyed in that vaccine,” said Buchholz, who designed the RSV vaccine for toddlers that’s being tested at Vanderbilt and other US sites.

In the 1960s trial, the kids still made antibodies to the flattened viral proteins, but they were distorted. When the actual virus came along, these antibodies didn’t work as intended. Not only did they fail to recognize or block the virus, they triggered a powerful misdirected immune response that made the children much sicker, a phenomenon called antibody-dependent enhancement of disease.

The investigators hadn’t spotted the enhancement in animal studies, Varga says, because the vaccinated animals weren’t later challenged with the live virus.

“So of course, we require now extensive animal testing of new vaccines before they’re ever put into humans, again, for that very reason of making sure that there aren’t early signs that a vaccine will be problematic,” Varga said.

About 10 years ago, a team of researchers at the NIH – some of the same investigators who developed the first Covid-19 vaccines – reported what would turn out to be a pivotal advance.

They had isolated the structure of the virus’s F-protein, the site that lets it dock onto human cells. Normally, the F-protein flips back and forth, changing shapes after it attaches to a cell. The NIH researchers figured out to how freeze the F-protein into the shape it takes before it fuses with a cell.

This protein, when locked into place, allows the immune system to recognize the virus in the form it’s in when it first enters the body – and develop strong antibodies against it.

“The companies coming forward now, for the most part, are taking advantage of that discovery,” said Dr. Phil Dormitzer, a senior vice president of vaccine development at GlaxoSmithKline. “And now we have this new generation of vaccine candidates that perform far better than the old generation.”

The first vaccines up for FDA review will be given to adults: seniors and pregnant woman. Vaccination in pregnancy is meant to ultimately protect newborns – a group particularly vulnerable to the virus – via antibodies that cross the placenta.

Vaccines for children are a bit farther behind in development but moving through the pipeline, too.

Four companies have RSV vaccines for adults in the final phases of human trials: Pfizer and GSK are testing vaccines for pregnant women as well as seniors. Janssen and Bavarian Nordic are developing shots for seniors.

Pfizer and GSK use protein subunit vaccines, a more traditional kind of vaccine technology. Two other companies build on innovations made during the pandemic: Janssen – the vaccine division of Johnson & Johnson – relies on an adenoviral vector, the same kind of system that’s used in its Covid-19 vaccine, and Moderna has a vaccine for RSV in Phase 2 trials that uses mRNA technology.

So far, early results shared by some companies are promising. Janssen, Pfizer and GSK each appear effective at preventing infections in adults for the first RSV season after the vaccine.

In an August news release, Annaliesa Anderson, Pfizer’s chief scientific officer of Vaccine Research and Development, said she was “delighted” with the results. The company plans to submit its data to the FDA for approval this fall.

GSK has also wrapped up its Phase 3 trial for seniors. It recently presented the results at a medical conference, but full data hasn’t been peer reviewed or published in a medical journal. Early results show that this vaccine is 83% effective at preventing disease in the lower lungs of adults 60 and older. It appears to be even more protective – 94% – for severe RSV disease in those over 70 and those with underlying medical conditions.

“We are very pleased with these results,” Dormitzer told CNN. He said the company was moving “with all due haste” to get its results to the FDA for review.

“We’re confident enough that we’ve started manufacturing the actual commercial launch materials. So we have the bulk vaccine actually in the refrigerator, ready to supply when we are licensed,” he said.

Even as the company applies for licensure, GSK’s trial will continue for two more RSV seasons. Half the group getting the vaccine will be followed with no additional shots, while the other group will get annual boosters. The aim is to see which approach is most protective to guide future vaccination strategies.

Janssen’s vaccine for older adults appears to be about 70% to 80% effective in clinical trials so far, the company announced in December.

In a study on Pfizer’s vaccine for pregnant women published in the New England Journal of Medicine this year, the company reported that the mothers enrolled in the study made antibodies to the vaccine and that these antibodies crossed the placenta and were detected in umbilical cord blood just after birth.

The vaccines for pregnant women are meant to get newborns through their first RSV season. But not all newborns will benefit from those. Most maternal antibodies are passed to baby in the third trimester, so preemies may not be protected, even if mom gets the vaccine.

For vulnerable infants and those whose mothers decline to be vaccinated, Dr. Helen Chu, an infectious disease specialist at the University of Washington, says the long-acting antibody shot for newborns, called nirsevimab, should cover them for the first six months of life. She expects it to be a “game-changer.”

That shot, which has been developed by AstraZeneca, was recently recommended for approval in the European Union. It has not yet been approved in the United States.

The field is so close to a new approval that public health officials say they’ve been asked to study up on the data.

Chu, who is also a member of an RSV study group of the Advisory Committee on Immunization Practices, a panel that advises the US Centers for Disease Control and Prevention on its vaccine recommendations, says her group has started to evaluate the new vaccines – a sign that an FDA review is just around the corner.

No companies have yet announced that process is underway. FDA reviews can take several months, and then there are typically discussions and votes by FDA and CDC advisory groups before vaccines are made available.

“We’ve been working on this for several months now to start reviewing the data,” Chu said. “So I think this is imminent.”

Watching this year’s RSV season unfold, Brown, the pediatrician who enrolled her son in the vaccine trial for toddlers, says progress can’t come fast enough.

“The hospital is surging. We’re not drowning the way some states are. I mean, Connecticut, South Carolina, North Carolina, they’re really drowning. But our numbers are huge, and our services are so busy,” she says.

Brown says her son is mostly healthy. He doesn’t have any of the risks for severe RSV she sees with some of her patients, so she was happy to have a way to help others.

And while it’s far too early to say whether the vaccine James is helping to test will prove to be effective, the trial was unblinded last week, and Brown learned that her son was in the group that got the active vaccine, not the placebo

He has done well through this heavy season of illness, she says. The NIH-sponsored study they participated in is scheduled to be completed next year.

The vaccine, which is made with a live but very weak version of virus, is given through a couple of squirts up the nose, so there are no needles. The hardest part for squirmy James, she said, was being held still.

“If we can do anything to move science forward and help another child, like, sorry, James. You had to have your blood drawn, but it absolutely was worth it.”

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Should your child receive the updated Covid-19 booster?

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CNN
 — 

Last week, the US Centers for Disease Control and Prevention issued guidance recommending the updated Covid-19 booster for children ages 5 to 11. Previously, the bivalent booster was recommended for children 12 and older, as well as for all adults. Now, the Pfizer/BioNTech booster is available for children 5 and older, and the Moderna booster can be given to children 6 and older.

What should parents consider when deciding whether to get the updated booster for their children? Are there circumstances that might prompt families to wait? Are there any downsides? What about children who just turned 5 — should they get the new booster? If a child has not been vaccinated yet, are they eligible for the updated booster?

To guide us through these questions, I spoke with CNN Medical Analyst Dr. Leana Wen, an emergency physician 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,” and the mother of two young children.

CNN: Who is now eligible to receive the updated Covid-19 booster? Does it matter how many vaccines they’ve previously received?

Dr. Leana Wen: Essentially, everyone 5 and above can receive the new bivalent Covid-19 booster, as long as they have completed their primary vaccine series. It doesn’t matter how many boosters they may have had. That means a child who received just the initial two doses of Pfizer or Moderna can get the booster, as can a child who already got one booster dose, as long as it’s been at least two months since their last vaccine dose.

CNN: What should parents and caregivers consider before choosing the updated booster for their children?

Wen: There are two key questions to ask. First, is your child at high risk for severe illness due to Covid-19? The most important reason to get vaccinated is to reduce the chance of hospitalization and other severe outcomes. The initial two doses of the vaccine are very good at achieving this for most children. Some may still be at higher risk for worse outcomes, however — if a child has serious underlying medical conditions, for example, is on chemotherapy or is a transplant recipient. A booster dose would be advisable in these circumstances.

Second, is it very important for you to avoid Covid-19 infection in your children? Many families have decided that once their kids are vaccinated, if the risk of severe illness is very low, they do not prioritize eliminating Covid-19 infection.

On the other hand, others remain very vigilant and cautious. Perhaps they are concerned about the unknowns around long Covid. Perhaps they want to avoid their kids being sick, leading to missed school days and work days for caregivers. Or perhaps there is another household member to protect, such as an elderly grandparent or someone else with chronic underlying conditions. All of these are reasonable considerations for getting kids the booster sooner than later.

One thing I’ll caution is that we don’t know how long the booster will be effective in reducing symptomatic infection. Some studies have shown that the effectiveness of the primary vaccine against symptomatic infection may wane within a few months. That said, a lot can happen with Covid-19. We could see rising cases this fall and winter. There could be a new variant that becomes dominant. Many parents may want to get their kids optimal protection in case of another surge, and then decide again next year if another booster is needed.

CNN: Are there circumstances that might prompt families to wait to boost their kids?

Wen: If a child has just had Covid-19, I think it’s advisable to wait at least three months, as the CDC recommends before boosting. Reinfection is unlikely in this time period, and it might be beneficial to allow the body time to develop its own immune response.

The same goes with a previous vaccine. The CDC says that children and adults can get the updated booster as long as it’s been at least two months since their last vaccine shot.

I think these are both minimum intervals. Many experts, including me, believe that there is benefit to waiting longer — perhaps four to six months — after infection or last vaccination. That longer time period can allow the body to develop improved immunity before another boost, as some studies have suggested. However, I also understand and appreciate the CDC’s need to have streamlined guidance, and it’s reasonable to follow their guidelines as stated.

CNN: Is there any downside to giving kids the booster?

Wen: This is an important question to ask. The way that I’d answer is to clarify that every intervention — including vaccines — has upsides and potential downsides. Parents and families will weigh the upsides and downsides differently. The evidence is very clear that for the initial vaccines, the upsides far outweigh any potential risk. The evidence is less clear for boosters.

In the case of a child with serious underlying medical conditions, for example, there is a significant upside to getting the booster to prevent severe outcomes due to Covid-19. For other children, especially for younger children under 12, the initial vaccines are probably still very protective, and it’s not yet clear what the added benefit of the booster is in reducing the risk of hospitalization.

There are some common side effects to Covid-19 vaccines. The vast majority are benign and self-resolving; symptoms like body aches, fatigue, fever, and soreness around the site of the booster jab usually go away in a couple of days. (There are very rare cases of myocarditis, an inflammation of the heart muscle most often seen in the adolescent male. These, too, tend to resolve on their own and do not cause long-term effects.) Broadly speaking, these should not be a major consideration for parents.

The CDC has recommended the booster, and I think it’s reasonable for parents who wish to follow the guidance to do so. For those on the fence, having a frank conversation with your pediatrician about your family’s specific circumstances can also guide you in your decision.

CNN: What about children who just turned 5 — should they get the new booster?

Wen: I have a son who recently turned 5, and received his primary series when he was 4. His last shot was in July. I am not planning to give him the booster yet. I’m waiting at least six months for the reasons mentioned above.

CNN: Can parents and caregivers choose to give their kids a dose of the original booster?

Wen: No. The US Food and Drug Administration has withdrawn its authorization for the original monovalent vaccine and replaced it with the updated bivalent booster. That means you can only receive the updated booster. That applies to children as well as adults.

CNN: If a child has not been vaccinated yet, are they eligible for the updated booster?

Wen: No. Children who have not yet been vaccinated can only receive the original vaccine for their primary series. Parents who wish for their kids to get the updated bivalent vaccine have to complete the primary series — two doses of Pfizer or Moderna — and then get the updated booster.

I want to emphasize the importance of the primary series. Numerous studies have found that the first two doses are highly protective against severe illness, including in kids. In one New England Journal of Medicine study, the first two doses of the Pfizer or Moderna vaccines reduced hospitalization among children by more than 80%. This should be a call to action for families who have not yet gotten their kids any Covid-19 vaccines to get them the initial vaccination.

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Epstein-Barr: Researchers speed efforts for vaccine against virus linked with mono, MS

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Maybe you’ve never heard of the Epstein-Barr virus. But it knows all about you.

Chances are, it’s living inside you right now. About 95% of American adults are infected sometime in their lives. And once infected, the virus stays with you.

Most viruses, such as influenza, just come and go. A healthy immune system attacks them, kills them, and prevents them from sickening you again. Epstein-Barr and its cousins, including the viruses that cause chickenpox and herpes, can hibernate inside your cells for decades.

This viral family has “evolved with us for millions of years,” said Blossom Damania, a virologist at the University of North Carolina-Chapel Hill. “They know all your body’s secrets.”

Although childhood Epstein-Barr infections are typically mild, exposure in teens and young adults can lead to infectious mononucleosis, a weeks-long illness that sickens 125,000 Americans a year, causing sore throats, swollen glands, and extreme fatigue. And while Epstein-Barr spends most of its time sleeping, it can reawaken during times of stress or when the immune system is off its game. Those reactivations are linked to a long list of serious health conditions, including several types of cancer and autoimmune diseases.

Scientists have spent years trying to develop vaccines against Epstein-Barr, or EBV. But recently several leaps in medical research have provided more urgency to the quest — and more hope for success. In just the past year, two experimental vaccine efforts have made it to human clinical trials.

What’s changed?

First, the Epstein-Barr virus has been shown to present an even greater threat. New research firmly links it to multiple sclerosis, or MS, a potentially disabling chronic disease that afflicts more than 900,000 Americans and 2.8 million people worldwide.

The journal Science in January published results from a landmark 20-year study of 10 million military personnel that offers the strongest evidence yet that Epstein-Barr can trigger MS. The new study found that people infected with Epstein-Barr are 32 times as likely as people not infected to develop MS.

And shedding new light on the mechanisms that could explain that correlation, a separate group of scientists published a study in Nature describing how the virus can cause an autoimmune reaction that leads to MS. The disease, which usually strikes between ages 20 and 40, disrupts communication between the brain and other parts of the body and is often marked by recurring episodes of extreme fatigue, blurred vision, muscle weakness, and difficulty with balance and coordination. At its worst, MS can lead to impaired speech and paralysis.

Amplifying that newfound urgency, several new studies suggest that reactivation of the Epstein-Barr virus also is involved with some cases of long covid, a little-understood condition in which patients experience lingering symptoms that often resemble mononucleosis.

And just as crucial to the momentum: Advances in vaccine science spurred by the pandemic, including the mRNA technology used in some covid vaccines, could accelerate development of other vaccines, including ones against Epstein-Barr, said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine. Hotez co-created a low-cost, patent-free covid vaccine called Corbevax.

Some researchers question the need for a vaccine that targets a disease like MS that, while debilitating, remains relatively rare.

Eliminating Epstein-Barr would require vaccinating all healthy children even though their risk of developing cancer or multiple sclerosis is small, said Dr. Ralph Horwitz, a professor at the Lewis Katz School of Medicine at Temple University.

Before exposing children to the potential risks of a new vaccine, he said, scientists need to answer basic questions about MS. For example, why does a virus that affects nearly everyone cause disease in a small fraction? And what roles do stress and other environmental conditions play in that equation?

The answer appears to be that Epstein-Barr is “necessary but not sufficient” to cause disease, said immunologist Bruce Bebo, executive vice president for research at the National MS Society, adding that the virus “may be the first in a string of dominoes.”

Hotez said researchers could continue to probe the mysteries surrounding Epstein-Barr and MS even as the vaccine efforts proceed. Further study is required to understand which populations might benefit most from a vaccine, and once more is known, Hotez said, such a vaccine possibly could be used in patients found to be at highest risk, such as organ transplant recipients, rather than administered universally to all young people.

“Now that we know that Epstein-Barr is very tightly linked to MS, we could save a lot of lives if we develop the vaccine now,” Damania said, “rather than wait 10 years” until every question is answered.

Moderna and the National Institute of Allergy and Infectious Diseases launched separate clinical trials of Epstein-Barr vaccines over the past year. Epstein-Barr vaccines also are in early stages of testing at Opko Health, a Miami-based biotech company; Seattle’s Fred Hutchinson Cancer Center; and California’s City of Hope National Medical Center.

Scientists have sought to develop vaccines against Epstein-Barr for decades only to be thwarted by the complexities of the virus. Epstein-Barr “is a master of evading the immune system,” said Dr. Jessica Durkee-Shock, a clinical immunologist and principal investigator for NIAID’s trial.

Both MS and the cancers linked to Epstein-Barr develop many years after people are infected. So a trial designed to learn whether a vaccine can prevent these diseases would take decades and a lot of money.

Moderna researchers initially are focusing on a goal more easily measured: the prevention of mononucleosis, which doubles the risk of multiple sclerosis. Mono develops only a month or so after people are infected with Epstein-Barr, so scientists won’t have to wait as long for results.

Mono can be incredibly disruptive on its own, keeping students out of class and military recruits out of training for weeks. In about 10% of cases, the crippling fatigue lasts six months or more. In 1% of cases, patients develop complications, including hepatitis and neurological problems.

For now, the clinical trials for Epstein-Barr immunizations are enrolling only adults. “In the future, the perfect vaccine would be given to a small child,” Durkee-Shock said. “And it would protect them their whole life, and prevent them from getting mono or any other complication from the Epstein-Barr virus.”

The NIAID vaccine, being tested for safety in 40 volunteers, is built around ferritin, an iron-storage protein that can be manipulated to display a key viral protein to the immune system. Like a cartoon Transformer, the ferritin nanoparticle self-assembles into what looks like a “little iron soccer ball,” Durkee-Shock said. “This approach, in which many copies of the EBV protein are displayed on a single particle, has proved successful for other vaccines, including the HPV and hepatitis B vaccine.”

Moderna’s experimental vaccine, being tested in about 270 people, works more like the company’s covid shot. Both deliver snippets of a virus’s genetic information in molecules called mRNA inside a lipid nanoparticle, or tiny bubble of fat. Moderna, which has dozens of mRNA vaccines in development, hopes to learn from each and apply those lessons to Epstein-Barr, said Sumana Chandramouli, senior director and research program leader for infectious diseases at Moderna.

“What the covid vaccine has shown us is that the mRNA technology is well tolerated, very safe, and highly efficacious,” Chandramouli said.

But mRNA vaccines have limitations.

Although they have saved millions of lives during the covid pandemic, the antibody levels generated in response to the mRNA vaccines wane after a few months. It’s possible this rapid loss of antibodies is related specifically to the coronavirus and its rapidly evolving new strains, Hotez said. But if waning immunity is inherent in the mRNA technology, that could seriously limit future vaccines.

Designing vaccines against Epstein-Barr is also more complicated than for covid. The Epstein-Barr virus and other herpesviruses are comparatively huge, four to five times as large as SARS-CoV-2, the coronavirus that causes covid. And while the coronavirus uses just one protein to infect human cells, the Epstein-Barr virus uses many, four of which are included in the Moderna vaccine.

Earlier experimental Epstein-Barr vaccines targeting one viral protein lowered the rate of infectious mononucleosis but failed to prevent viral infection. Targeting multiple viral proteins may be more effective at preventing infection, said Damania, the UNC virologist.

“If you close one door, the other door is still open,” Damania said. “You have to block infection in all cell types to have a successful vaccine that prevents future infections.”

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Polio is back — how concerned should Americans be?

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CNN
 — 

New York’s governor has declared a state of emergency after health officials detected poliovirus in the wastewater of five counties – evidence the disease is circulating. The declaration also follows a report from the US Centers for Disease Control and Prevention of an unvaccinated person in Rockland County, New York, who was diagnosed with paralytic polio this summer – the first case identified in the United States in nearly a decade.

Understandably, these events have sparked a lot of questions: Why does one case of polio worry officials? What does it mean to find poliovirus in wastewater? Who should be worried about contracting the disease? If someone had the vaccine years ago, are they still protected now?

To understand more about this disease, which most people alive today have never experienced, I spoke with CNN Medical Analyst Dr. Leana Wen, an emergency physician 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: So far, there has been only one documented case of paralysis due to poliovirus in New York. Why does one case worry health officials?

Dr. Leana Wen: An August report from the CDC said that “even a single case of paralytic polio represents a public health emergency in the United States.” This is for two main reasons.

First, polio is a disease with the potential for very severe consequences. During its peak in the 1940s and 1950s, polio resulted in tens of thousands of children becoming paralyzed every year. Thousands died from the virus.

This changed with the introduction of vaccines that are highly effective – more than 99% effective at protecting against paralytic polio. Thanks to massive vaccination campaigns, the last incidence of wild-type polio occurred in 1979 – and it had been considered to be eliminated in the United States. The reemergence of such a disease, which can have such serious impacts, is a major threat.

Second, the one case of paralytic polio may be the tip of a large iceberg. Most cases of polio infection are asymptomatic and do not cause paralysis. Symptoms – which can include fatigue, fever and diarrhea – tend to be mild and can resemble those of other viruses. Public health officials are worried there are many other people who may be infected with polio and could be transmitting it unknowingly.

This is particularly concerning because Rockland County, where the recent paralytic case of the virus was diagnosed, has a polio vaccination rate of just 60%. In some parts of the county, the vaccination rate is as low as 37%. These numbers are far below the threshold needed for herd immunity, and that means there are a lot of individuals in the area who are vulnerable to polio infection and potential severe outcomes.

CNN: What does it mean that poliovirus has been detected in the wastewater of five counties, including New York City?

Wen: Finding poliovirus in sewage means one of two things: That there are people actively infected with polio who are shedding the virus, or that the virus signal could be from people who recently received the oral polio vaccine (OPV). OPV is no longer given in the United States – since 2000, the version used in the US is the inactivated polio vaccine (IPV), which is injected – but other countries are still using OPV, and it’s possible that travelers from those places are shedding virus from the vaccine.

In rare circumstances, the weakened virus from people who just received OPV could cause paralytic polio in unvaccinated individuals – which is a major reason why OPV is no longer used in the US.

One additional point of concern is that a wastewater sample from Nassau County on Long Island has been genetically linked to the paralytic polio case identified in Rockland County. (The two counties are not adjacent, rather approximately 40 miles apart.) This is further evidence of community spread that’s going largely undetected.

CNN: How can people contract polio?

Wen: Polio is an infectious disease that can be transmitted in a number of ways. A primary route is fecal-oral, meaning someone could get polio if they come into contact with feces from an infected person. This could occur, especially in children, through putting objects like toys that have been contaminated with feces into the mouth.

Poliovirus could also be transmitted through the respiratory route – for example, if someone who is infected coughs or sneezes and those droplets land around your mouth. It’s worth nothing that people who are vaccinated could also contract polio and pass it on to others, though they are extremely well-protected from severe illness themselves.

CNN: Should New Yorkers be worried about contracting polio?

Wen: Again, people who are vaccinated against polio are extremely well-protected from paralytic polio, and should not be concerned at this point. It should be pointed out, however, that while IPV is very good at preventing the most severe potential effects of the disease, people who received the vaccine could still be carriers of polio and could transmit it to others. Those at risk for serious outcomes are people who are unvaccinated and those who are incompletely vaccinated, including young children under 6 who have not yet completed their polio vaccine series.

CNN: How many polio vaccines should someone receive?

Wen: The CDC recommends children receive four doses of IPV. The first is given at 2 months of age, the second at 4 months, the third between 6 and 18 months old and the fourth between 4 and 6 years old.

Adults who have never been vaccinated against polio should receive three doses of IPV. The first should be given as soon as possible, the second one to two months after that and the third six to 12 months after the second.

CNN: If someone had the vaccine years ago, are they still protected? Who should get a polio booster now?

Wen: The protection against severe disease remains strong for many years after immunization; it’s believed it probably lasts for a lifetime. There is no need for most vaccinated people to get more doses.

However, if someone has not completed their original vaccine series, they should get their remaining doses. Some fully vaccinated people can also receive an additional lifetime booster of IPV under specific circumstances – for example, if they have direct contact with someone suspected of having polio or if they are health care workers with higher risk of exposure to people with the disease.

CNN: What if you’re not sure whether you were vaccinated? Say you don’t recall getting the vaccine, and it’s been many years. Is there a blood test you can take to verify either way?

Wen: You could check with your primary care physician’s office or state health department to see whether they have records of your immunizations. If they don’t, and there is no other way for you to verify – for example, by asking parents or other relatives or caregivers – you should speak with your health care provider about getting the full vaccine series for polio now. There is no blood test that can reliably detect whether you’re fully vaccinated against polio.

CNN: What if you or your family members haven’t yet gotten vaccinated against poliovirus?

Wen: People who have yet to receive any doses or are incompletely vaccinated should make sure to get their entire polio vaccine series right away. This is particularly important if they live in or around Rockland County in New York – but really everyone should get caught up with their routine immunizations.

It was a tragedy decades ago that so many children became permanently paralyzed and even died from polio. This should not happen again, since we have such effective vaccines that can prevent severe consequences of the disease.

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