RSV vaccines: Questions patients may have and how to answer

In many parts of the country, the fall season means crisp, cool breezes and leaves changing colors followed by a cold, snowy winter. But these seasons also bring with them respiratory syncytial virus (RSV), which can be serious for infants and older adults. And while there are RSV vaccines available for the first time this year, many require further guidance on what to do. 

RSV is a common respiratory virus that usually causes mild, cold-like symptoms with most people recovering in a week or two. According to surveillance from the Centers for Disease Control and Prevention (CDC), there has been an increase in RSV-associated emergency department visits and hospitalizations across the country.

RSV leads to about 2.1 million outpatient visits annually in the U.S., between 58,000 and 80,000 hospitalizations, and 100–300 deaths among children under than 5. For patients 65 or older, each year brings about 60,000–120,000 hospitalizations and 6,000–10,000 deaths, according to the CDC.

Here are some questions patients might have about RSV vaccines, along with the answers that physicians should be ready to share.

The first ever vaccines for RSV were approved by the Food and Drug Administration (FDA) in May for older adults and are now recommended by the CDC’s Advisory Committee on Immunization Practices for those 60 or older under shared clinical decision making. This means patients and their physician decide together after a discussion about the risks and benefits, based on their individual situation.

One vaccine is from GSK and will be marketed under the brand name Arexvy. It contains the same adjuvant—a substance that increases the immune response to a vaccine—used in the recombinant shingles vaccine, Shingrix.

The other vaccine is from Pfizer and is called ABRYSVO. It does not contain an adjuvant, but it is bivalent. These are the first-ever RSV vaccines approved for use in the U.S. Both vaccines are extremely effective at preventing serious illness from RSV infection in older adults.

RSV generally causes mild upper respiratory disease in healthy adults. But for adults 60 or older with certain underlying conditions or other risk factors, RSV can cause serious illness. For example, those with chronic medical conditions such as lung diseases, cardiovascular diseases, neurologic or neuromuscular conditions, kidney disorders, liver disorders, diabetes or moderate or severe immune compromise are good candidates for RSV vaccination, according to the CDC.

Additionally, those who are of advanced age, reside in nursing homes or other long-term care facilities and have underlying medical conditions can also benefit from RSV vaccination.

For now, only one dose of the RSV vaccine is recommended. So far, RSV vaccines appear to provide some protection for at least two RSV seasons. Additional evaluation is planned to assess how long the protection lasts and whether additional doses will be needed.

Vaccination should occur before the onset of the fall and winter RSV season. The tricky part is that the typical RSV seasonality was disrupted by the COVID-19 pandemic. It has not returned to pre-pandemic patterns yet. For physicians recommending RSV vaccination based on shared clinical decision making, a vaccine should be administered as early as the supply becomes available, says the CDC. 

In accordance with the CDC’s general best practices guidelines, it is OK to give RSV vaccines with other vaccines such as the flu and COVID-19. Coadministration can result in an increase in common vaccine side effects. Some studies also suggests that coadministration of flu and RSV vaccines may not produce as strong of an immune response. Additional research is ongoing to further inform guidance on same-day administration of the RSV vaccine and other adult vaccines.

As with other vaccines, patients can expect some side effects from RSV vaccination. Some of the common side effects include fatigue, fever, headache, muscle or joint pain, nausea and diarrhea. The side effects are typically mild, says the CDC.

But there is an important safety concern that requires a close look—a risk of Guillain-Barre syndrome and other inflammatory neurologic events. Guillain-Barre syndrome is a rare autoimmune neurological disorder characterized by ascending weakness and paralysis. The CDC will conduct post-marketing safety surveillance to further inform RSV vaccine recommendations. 

There is also a new shot for babies called nirsevimab. It is a type of immunization that can reduce the risk of both hospitalizations and health care visits for RSV in infants. But it is not a vaccine. It is a long-acting monoclonal antibody.

Nirsevimab was licensed by the FDA on July 17 under an accelerated approval pathway because it was considered a breakthrough therapy. This product was developed jointly by pharmaceutical companies Sanofi and AstraZeneca. It will be sold under the brand name Beyfortus.

It is a single shot that is long lasting and can be given with other age-appropriate childhood vaccines. Studies have shown that protection from nirsevimab lasts for about five months. This is good because the typical RSV season lasts for four to five months.

The CDC recommends one dose of nirsevimab for all infants younger than 8 months, born during—or entering—their first RSV season, which is typically fall through spring.

For a small group of children between 8 and 19 months old who are at increased risk of severe RSV disease—such as children who are severely immunocompromised—a dose is recommended in their second season.

There is also a preventive medication available called palivizumab—marketed as Synagis. It is a monoclonal antibody that is given monthly to babies.  Until access to nirsevimab is widespread, some infants will still need access to palivizumab, which is recommended only for infants with certain high-risk conditions, and only about 2–3% of infants typically receive one or more doses annually. If a child receives nirsevimab, they will not need additional doses of palivizumab during the current respiratory virus season.

For children who are not eligible for the monoclonal antibody shot, following proper infection prevention measures will be key. These are the same infection prevention measures that have been used to help stop the spread of other respiratory illnesses like COVID-19 and the flu.

This means kids should frequently wash their hands and avoid others who may be sick. The CDC also recommends that parents should wipe down any shared objects and toys with a disinfectant.

The FDA recently granted approval to a vaccine that will be administered to pregnant people to protect their babies from RSV through the first six months of life. It’s a single dose shot from Pfizer called ABRYSVO—one of the same vaccines approved for adults 60 or older.

It is FDA approved and CDC recommended for use in 32 to 36 weeks gestational age of pregnancy, using seasonal administration—September through January in most of the continental United States. This vaccine helps a person who is pregnant produce protective antibodies that are then passed on to the fetus through the placenta. 

Most infants will likely only need protection from either the maternal RSV vaccine or the RSV immunization—nirsevimab—for babies, and not both. 

For infants born during or entering their very first RSV season, nirsevimab was 79% effective against RSV medically attended lower respiratory tract illness and 80% effective at preventing hospitalization.

Both vaccines for older adults are also extremely effective at preventing serious illness from RSV infection.

Nirsevimab will be covered by Medicaid and the Children’s Health Insurance Program (CHIP) for kids. Most children enrolled in Medicaid are generally receiving nirsevimab doses through the Vaccines for Children (VFC) program. The maternal RSV vaccine will be included in the VFC program for pregnant people younger than 19.

Additionally, state Medicaid agencies will be required to cover Arexvy and Abrysvo without cost-sharing for nearly all full-benefit beneficiaries 19 or older who are covered under traditional Medicaid as of Oct. 1, if the CDC and ACIP recommendations apply. State separate CHIP programs will also be required to cover these vaccines without cost-sharing for enrollees 19 or older as of Oct. 1, if the CDC and ACIP recommendations apply.

Most private health insurers must cover these immunization products without cost sharing starting with plan years beginning on or after the date that is one year after the ACIP recommendation is adopted by the director of the CDC.