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First RSV Vaccine For Older Adults Approved In U.S.

An electron micrograph of the respiratory syncytial virus (RSV), which kills an estimated 160,000 people worldwide each year. BSIP / UIG via Getty Images

Last week, the U.S. Food and Drug Administration (FDA) gave the world's first approval of a vaccine to target respiratory syncytial virus (RSV) in older adults. The agency greenlit the shot for people 60 and older, who are at a higher risk from the potentially deadly virus.

"It's a very big deal to have options available to prevent RSV disease," Barney Graham, senior adviser for global-health-equity trials at Morehouse School of Medicine, tells Nature News' Myriam Vidal Valero.

But before the vaccine can go into arms, it must be recommended by the Centers for Disease Control and Prevention (CDC), which could happen after an agency vaccine expert panel meets on June 21 and 22, according to Stat News' Helen Branswell. GSK, the pharmaceutical company behind the vaccine, said it would be available in the U.S. In the fall, per the New York Times' Christina Jewett.

Most of the time, RSV infections cause only mild, cold-like symptoms, according to the CDC. But in some cases, the virus is linked to more serious illness, particularly in infants and older adults. RSV can lead to lower respiratory tract disease, which can cause lung infections like pneumonia and bronchiolitis, per a statement from the FDA.

Anually, an estimated 60,000 to 160,000 older adults in the U.S. Are hospitalized and 6,000 to 10,000 die because of RSV infections, according to the CDC. An estimated 58,000 to 80,000 children under five are hospitalized with RSV each year.

While it is not common for children in the U.S. To die from the virus, it's the second-highest cause of death in children under one worldwide, according to Stat News. The National Institute of Allergy and Infectious Diseases estimates that RSV leads to an estimated 160,000 total deaths each year.

The FDA's approval was informed by a trial of 25,000 adults aged 60 and older. Half the participants were given the vaccine, while the other half received a placebo. Compared to the placebo group, those who got the vaccine were 82.6 percent less likely to develop RSV-related lower respiratory tract disease and 94.1 percent less likely to develop RSV-related severe lower respiratory tract disease, according to the FDA's statement. The results of the trial were published in February in the New England Journal of Medicine.

GSK's RSV vaccine is not the only one that could soon be available to the public. Later this month, the FDA is expected to approve an RSV vaccine for older adults from Pfizer, writes the New York Times. A large study found that shot to be almost 67 percent effective at preventing RSV-related illness.

The FDA will decide by August whether to approve Pfizer's RSV vaccine for pregnant people to prevent illness in infants. And the agency is considering a monoclonal antibody treatment for babies, writes the Washington Post's Carolyn Y. Johnson and David Ovalle.

In a separate study of GSK's vaccine, one participant developed a rare disorder called Guillain-Barré syndrome—when the body's immune system attacks its nerve cells—nine days after they received the vaccine. And in another study, two participants who received the RSV vaccine and an FDA-approved influenza vaccine developed a rare type of inflammation of the brain and spinal cord, and one of them died.

Approximately 2,500 participants received the RSV vaccine in these two other trials. The FDA is requiring GSK to conduct a study tracking the two rare possible side effects after the vaccines are available to the public.

GSK hopes its vaccines will be available before the winter RSV season begins, according to the Washington Post. Last winter's season was particularly strong, with children's hospitals overwhelmed while the country also grappled with Covid-19 and the flu.

While GSK has not said how much the vaccine will cost, insurance companies typically cover a lot of a vaccine's price, per the New York Times.

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Filed Under: Disease and Illnesses, Health, Vaccines, Viruses

FDA Approves First RSV Vaccine For Adults After 60 Years In The Making

After 60 years of trial and error, the Food and Drug Administration (FDA) approved the first vaccine to prevent respiratory syncytial virus (RSV) on May 3. More preventative shots for the respiratory virus are on the way.

[Related: How our pandemic toolkit fought the many viruses of 2022.]

The FDA approved Arexvy from pharmaceutical company GSK. The vaccine is designed to protect those over 60 in a single dose. A vaccine from Pfizer is currently under consideration for older adults and pregnant people as a maternal vaccination to protect newborn babies. Sanofi and AstraZeneca's monoclonal antibody treatment for babies that offers vaccine-like protection during RSV season is also under consideration by the FDA. Additionally, a late-stage trial of an RSV vaccine that uses mRNA technology from Moderna showed promise in late-stage trials. 

The vaccine could be available as soon as this fall, pending a recommendation for its use from the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices, which will meet in June. GSK says it has "millions of doses ready to be shipped," according to a recent earnings presentation.

"Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV," said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, in a statement. "Today's approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA's continued commitment to facilitating the development of safe and effective vaccines for use in the United States."

RSV can affect all age groups, but it is particularly worrisome in babies and older adults. It is a highly contagious virus that causes infections of the lungs and breathing passages. According to the Centers for Disease Control and Prevention (CDC), RSV leads to approximately 60,000 to 120,000 hospitalizations and 6,000 to 10,000 deaths among adults 65 years of age and older every year. It is also a common cause of lower respiratory tract disease in older adults. This disease affects the lungs and can cause life-threatening pneumonia and bronchiolitis.

The virus circulates seasonally, usually beginning in the fall and peaking in the winter. The 2022-2023 RSV season started particularly early and flooded hospitals and pediatric wards across the United States, leading pharmacies to limit the sales of children's medicines.

According to the results of a clinical trial of close to 25,000 older adults, the GSK vaccine was 83 percent effective at preventing lower respiratory tract disease by the virus. It was 94 percent effective at preventing severe disease in seniors. In the trial, severe disease was defined as the need for supplemental oxygen or a mechanical help to breathe. The results were published in the New England Journal of Medicine in February. 

[Related: Fighting RSV in babies starts with a mother's antibodies.]

The vaccine works by using a small piece of the virus called a fusion protein, or F-protein. The F-protein sticks out on the virus' surface and helps it latch onto cells in the upper airway and infect them. The F-proteins were made in a lab with specially programmed cells. 

In 2013, researchers at the National Institutes of Health discovered how to freeze the normally wiggly and shape-shifting F-protein in the shape that it takes before it fuses onto a cell. When it's in this shape, the body can produce antibodies against it. The GSK vaccine uses this pre-fusion form of the F-protein and an ingredient called an adjuvant that can boost immune activity.

The search for a vaccine to RSV began in the 1960s, but has been mired by tragedy. Two toddlers died after receiving an experimental shot in the 60's after it unexpectedly caused them to contract a very serious version of the virus. Many of the safety measures currently in place during vaccine trials were put in place after the failures of the RSV vaccine.

Barney Graham, a vaccine scientist at Morehouse School of Medicine worked alongside Jason McLellan, a structural biologist at the University of Texas at Austin, and Peter Kwong, a vaccine scientist at the National Institutes of Health, to jump-start the RSV vaccine field after decades of failure.

"This is my life's work, so it's kind of amazing to see it come to this point," Graham told The Washington Post.  "It's exciting for me to see this happening because of all the other people who've come before me working on RSV, some of whom are no longer with us. I wish they could see this is happening. It's been a long struggle."

How Often Should You Get A Pneumonia Shot?

Pneumonia vaccines help prevent invasive pneumococcal diseases. People should get a pneumonia shot at least once in their life. The type of shot will depend on a person's age and health status.

Pneumonia is an infection that causes inflammation in the lung's air sacs. The inflammation can cause the sacs to fill with pus or fluid. Typical symptoms include cough, fever, chills, and difficulty breathing.

There are two types of pneumonia: bacterial and viral. According to the American Lung Association, bacterial pneumonia is more common and results in a more serious illness.

Pneumonia is common among children and older adults, but according to the Centers for Disease Control and Prevention (CDC), people over the age of 65 years are most at risk for serious illness or death.

In this article, we look at more information about the pneumonia vaccine and when a person should receive it.

How often a person should get the pneumonia vaccine depends on their age and overall health.

The CDC recommend the following schedules:

Infants should receive the PCV13 vaccine at 2, 4, 6, and 12–15 months.

Adults only need one dose of PCV13.

A single dose of PPSV23 is sufficient for anyone who needs it, such as those over 65 years of age and people with underlying health conditions.

A person under the age of 65 years should receive the PPSV23 vaccine if they smoke, are receiving chemotherapy treatment, or have any of the following conditions:

A person can get both vaccines if they have any of the above conditions or any of the following:

cerebrospinal fluid leak

cochlear implants

anatomic or functional asplenia, which is when the tissue of the spleen does not work

However, the CDC recommend that if people need to have both vaccines, they should get them in separate visits.

Who should not get the vaccine?

People should not get the vaccine if they have had a life threatening allergic reaction to a previous dose.

Additionally, a person should not undergo vaccination if they have had an allergic reaction to medication containing diphtheria toxoid or an earlier form of the pneumonia vaccination (PCV7).

Lastly, people who are sick or have allergic reactions to any of the ingredients of the vaccine should talk to a doctor before getting the shot.

A pneumonia shot will not reduce pneumonia. However, it helps prevent invasive pneumococcal diseases, such as meningitis, endocarditis, empyema, and bacteremia, which is when bacteria enter the bloodstream.

Noninvasive pneumococcal disease includes sinusitis.

There are two types of pneumonia shots available. Which type a person gets depends on their age, whether or not they smoke, and the presence of any underlying medical conditions.

The two types are:

Pneumococcal conjugate vaccine (PCV13): Healthcare providers recommend this vaccine for young children, people with certain underlying conditions, and some people over the age of 65 years.

Pneumococcal polysaccharide vaccine (PPSV23): Healthcare providers recommend this vaccine for anyone over 65 years of age, people with certain underlying conditions, and people who smoke.

According to the CDC, PCV13 protects children and others against 13 different strains of bacterial pneumonia. PCSV23 protects older adults and others who need it against 23 different strains of bacterial pneumonia.

Although the pneumonia shots will not prevent a person from ever getting pneumonia, they may help in reducing cases of invasive pneumococcal diseases.

At least one dose of PCV13 protects:

roughly 8 in 10 babies from invasive pneumococcal disease

45 in 100 adults 65 years or older against pneumococcal pneumonia

75 in 100 adults 65 years or older against invasive pneumococcal disease

One dose of PCSV23 helps protect about 50–85 out of 100 healthy adults against invasive pneumococcal disease.

If a person receives a second pneumonia shot too soon, they may experience worse side effects than someone receiving the vaccine for the first time. In particular, severe localized, arthritis-like reactions are more frequent.

The general CDC guidelines for people who are 65 years of age or older vary, depending on the type of vaccine.

If a person received one dose of PPSV23 prior to the age of 65 years, they should get one final shot after this age. However, they should wait until it has been at least 5 years since the first shot. For example, if they received their first shot at 62 years of age, they should wait until they are 67 years old for the second and final dose.

If a person wants both PCV13 and PPSV23 after the age of 65 years, they should get the PCV13 first and wait 1 year to get the PPSV23 shot. If they have already received the PPSV23, they should wait at least 1 year before getting the PCV13 shot.

Most people who get the pneumonia vaccine will not experience any side effects. However, as with any medication or vaccine, there is a risk that a person will develop side effects. These side effects typically disappear after a few days.

Some potential mild side effects from PCV13 include:

fever

a reaction at the injection site, such as swelling, redness, or pain and tenderness

irritability

loss of appetite

a headache

chills

feeling tired

Some potential mild side effects from PPSV23 include:

muscle aches

fever

a reaction at the injection site, such as tenderness, redness, or swelling

With PCV13, there is some risk of seizure in young children if they receive the shot at the same time as a flu vaccine. A parent or caregiver should talk to a doctor about the best times to get each shot.

A person who is over 65 years of age should talk to their doctor about which pneumonia vaccine may be best for them. The doctor can help determine whether they should get the vaccination, which vaccination to get, and when to get it.

Parents and caregivers of young children should talk to a pediatrician about the schedule for the pneumonia vaccination. The pediatrician can also address any questions or concerns about the safety and effectiveness of the vaccination.

A person does not need to see a doctor for mild reactions to the vaccine, such as tenderness at the injection site, fever, or fatigue.

However, if a person experiences any life threatening side effects, they should seek emergency help immediately.

Signs and symptoms of allergic reactions in children may include:

Allergic reactions in adults can lead to:

respiratory symptoms, such as wheezing

labored breathing

persistent coughing

vomiting

abdominal pain

low blood pressure

chest pain

The pneumonia vaccination is a safe and effective way to help prevent some of the most severe cases of pneumonia.

Healthcare providers recommend the shot for infants, people with weakened immune systems, and those who are over 65 years of age. People who have certain medical conditions or are allergic to the vaccine should not get the shot.

Pneumonia vaccination may cause mild side effects in some people, but these should go away on their own within a few days.

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