CDC Panel Divided on Recommending RSV Vaccine for All Older Adults 

The U.S. Centers for Disease Control and Prevention’s (CDC) panel of experts voted on Wednesday against recommending the RSV vaccine for all older adults. Instead, the Advisory Committee on Immunization Practices (ACIP) concluded that anyone aged 60 and older “may” consider receiving a single dose of either Pfizer’s or GSK’s new RSV vaccine and that the decision should be made through shared clinical decision-making, based on a thorough risk assessment, in consultation with their doctors. Earlier in the day, the committee intended to vote on a more definitive recommendation that would have endorsed the vaccination of all people aged 65 and older. That recommendation was subsequently modified to a broader stance following concerns expressed by several committee members. Their apprehension stemmed from the limited availability of data on vaccine efficacy, specifically in individuals over 75 and other high-risk groups. “Those who are at high risk for disease and for high risk for hospitalizations and death were actually not included in the trials,” said Dr. Helen Keipp Talbot, an infectious disease specialist at Vanderbilt University and a committee member. “The patient population that participated in the study were younger and healthier and had fewer comorbid conditions, were not immunocompromised, and were not living in nursing homes.” Dr. Michael Melgar, a CDC medical officer who presented the clinical data for Pfizer and GSK at the ACIP panel meeting, noted that there might be instances where “the benefit might not consistently outweigh the unknown risk” for individuals aged 60 to 64. The committee conducted a vote, resulting in a 9 to 5 recommendation that individuals aged 65 and older may consider receiving an RSV vaccine after discussing it with their physicians. Subsequently, the committee voted 13 to 0, with one abstention, to extend the same recommendation to individuals aged 60 to 64. “There was a substantial minority opinion not to recommend either vaccine, based on currently available evidence,” Melgar said. Concerns within this minority group revolved around the overall balance of benefits and risks at the population level, considering the uncertain risk of inflammatory neurologic events in contrast to the limited evidence of efficacy in key groups most vulnerable to severe RSV illness and hospitalization. (Ethan Miller/Getty Images) Five trial participants developed inflammatory neurologic complications during Pfizer and GSK’s clinical trials (pdf). These complications included three cases of Guillain-Barré syndrome and two cases of suspected acute disseminated encephalomyelitis (ADEM). Whether these occurrences indicated a genuine safety concern or were simply random incidents was uncertain. “They felt that it’s imperative to demonstrate efficacy in these groups prior to making a recommendation further,” Melgar said. RSV, a common respiratory virus, typically manifests as flu-like symptoms in individuals, including a runny nose, reduced appetite, coughing, fever, and wheezing. While most healthy adults recover from RSV within a few weeks, in more severe cases, especially among older adults, infants under 6 months of age, or those with weakened immune systems, RSV can progress to severe infections such as bronchiolitis (inflammation of the small airways in the lungs) and pneumonia, leading to hospitalization. On May 3, the U.S. Food and Drug Administration (FDA) approved GSK’s Arexvy, the world’s first RSV vaccine, specifically for adults aged 60 and over. Up to $295 a Dose While recognizing the potential benefits of RSV vaccination for older adults, the committee highlighted several unclear factors that necessitate careful consideration. The panel identified key uncertainties, including the yet-to-be-determined cost of acquiring the vaccine, which may be subject to fluctuations, as well as the annual incidences of RSV illness and hospitalization and the duration of protection provided by RSV vaccination. Pfizer has indicated an estimated pricing range of $180 to $270 per dose for the vaccine, although this figure remains subject to potential changes due to ongoing price negotiations concerning the shots. GSK, on the other hand, expects to set the price of its vaccine within the range of $200 to $295 per dose. Both companies believe that RSV vaccines will eventually generate substantial revenue, reaching the multibillion-dollar mark in sales. Vials on a production line at the factory of GlaxoSmithKline in Saint-Amand-les-Eaux, northern France, on Dec. 3, 2020. (Francois Lo Presti/AFP via Getty Images) How Effective Are the RSV Vaccines? Pfizer reported that its vaccine demonstrated 66.7 percent effectiveness in preventing moderate lower respiratory tract illness with two or more symptoms and 85.7 percent in preventing disease with three or more symptoms in individuals aged 60 and older. Pfizer’s vaccine is based on mRNA technology, which instructs human cells to produce th

CDC Panel Divided on Recommending RSV Vaccine for All Older Adults 

The U.S. Centers for Disease Control and Prevention’s (CDC) panel of experts voted on Wednesday against recommending the RSV vaccine for all older adults.

Instead, the Advisory Committee on Immunization Practices (ACIP) concluded that anyone aged 60 and older “may” consider receiving a single dose of either Pfizer’s or GSK’s new RSV vaccine and that the decision should be made through shared clinical decision-making, based on a thorough risk assessment, in consultation with their doctors.

Earlier in the day, the committee intended to vote on a more definitive recommendation that would have endorsed the vaccination of all people aged 65 and older.

That recommendation was subsequently modified to a broader stance following concerns expressed by several committee members. Their apprehension stemmed from the limited availability of data on vaccine efficacy, specifically in individuals over 75 and other high-risk groups.

“Those who are at high risk for disease and for high risk for hospitalizations and death were actually not included in the trials,” said Dr. Helen Keipp Talbot, an infectious disease specialist at Vanderbilt University and a committee member. “The patient population that participated in the study were younger and healthier and had fewer comorbid conditions, were not immunocompromised, and were not living in nursing homes.”

Dr. Michael Melgar, a CDC medical officer who presented the clinical data for Pfizer and GSK at the ACIP panel meeting, noted that there might be instances where “the benefit might not consistently outweigh the unknown risk” for individuals aged 60 to 64.

The committee conducted a vote, resulting in a 9 to 5 recommendation that individuals aged 65 and older may consider receiving an RSV vaccine after discussing it with their physicians. Subsequently, the committee voted 13 to 0, with one abstention, to extend the same recommendation to individuals aged 60 to 64.

“There was a substantial minority opinion not to recommend either vaccine, based on currently available evidence,” Melgar said. Concerns within this minority group revolved around the overall balance of benefits and risks at the population level, considering the uncertain risk of inflammatory neurologic events in contrast to the limited evidence of efficacy in key groups most vulnerable to severe RSV illness and hospitalization.

Epoch Times Photo
(Ethan Miller/Getty Images)

Five trial participants developed inflammatory neurologic complications during Pfizer and GSK’s clinical trials (pdf). These complications included three cases of Guillain-Barré syndrome and two cases of suspected acute disseminated encephalomyelitis (ADEM). Whether these occurrences indicated a genuine safety concern or were simply random incidents was uncertain.

“They felt that it’s imperative to demonstrate efficacy in these groups prior to making a recommendation further,” Melgar said.

RSV, a common respiratory virus, typically manifests as flu-like symptoms in individuals, including a runny nose, reduced appetite, coughing, fever, and wheezing.

While most healthy adults recover from RSV within a few weeks, in more severe cases, especially among older adults, infants under 6 months of age, or those with weakened immune systems, RSV can progress to severe infections such as bronchiolitis (inflammation of the small airways in the lungs) and pneumonia, leading to hospitalization.

On May 3, the U.S. Food and Drug Administration (FDA) approved GSK’s Arexvy, the world’s first RSV vaccine, specifically for adults aged 60 and over.

Up to $295 a Dose

While recognizing the potential benefits of RSV vaccination for older adults, the committee highlighted several unclear factors that necessitate careful consideration.

The panel identified key uncertainties, including the yet-to-be-determined cost of acquiring the vaccine, which may be subject to fluctuations, as well as the annual incidences of RSV illness and hospitalization and the duration of protection provided by RSV vaccination.

Pfizer has indicated an estimated pricing range of $180 to $270 per dose for the vaccine, although this figure remains subject to potential changes due to ongoing price negotiations concerning the shots. GSK, on the other hand, expects to set the price of its vaccine within the range of $200 to $295 per dose. Both companies believe that RSV vaccines will eventually generate substantial revenue, reaching the multibillion-dollar mark in sales.

gsk vials
Vials on a production line at the factory of GlaxoSmithKline in Saint-Amand-les-Eaux, northern France, on Dec. 3, 2020. (Francois Lo Presti/AFP via Getty Images)

How Effective Are the RSV Vaccines?

Pfizer reported that its vaccine demonstrated 66.7 percent effectiveness in preventing moderate lower respiratory tract illness with two or more symptoms and 85.7 percent in preventing disease with three or more symptoms in individuals aged 60 and older.

Pfizer’s vaccine is based on mRNA technology, which instructs human cells to produce the virus protein, triggering an immune response, without containing any antigens.

GSK’s Arexvy vaccine showed about 83 percent effectiveness in preventing lower respiratory tract disease in older adults and 94 percent in preventing severe disease.

Arexvy is a non-mRNA vaccine composed of an RSV antigen enveloped in lipids. The chosen antigen, the fusion (F) protein, remains consistent across RSV seasons, potentially providing long-lasting protection against RSV viruses.

Linda Wastila, who has a doctorate in health policy and is a pharmacotherapy and drug policy expert from the University of Maryland, questioned the rush for RSV vaccines.

“GSK’s recent approval for a protein-based product is geared toward older adults, who are at some risk for developing pneumonia and bronchitis as complications from RSV infection,” she told . “In this age group, RSV itself is not that common, and complications even less common, and RSV infection itself is very mild—a moderate, cold-like condition,” she added.