By Karen Kier, Pharmacist on behalf of the ONU HealthWise team
Take My Breath Away was the love ballad written for the 1986 movie Top Gun. The song was performed by the Berlin. The song won the Academy Award and the Golden Globe for the best original song.
Some Top Gun fans wondered why the song did not make the soundtrack for the 2022 Top Gun: Maverick release. The music producer gave a logical explanation as to why it was not repeated. In the movie, Maverick has a new love interest so the song would not fit.
RSV or respiratory syncytial virus can take your breath away.
RSV was first discovered in 1956 and is a viral infection which mimics a cold for most individuals. The virus can be very serious for infants under 2 years and adults over 65 years. As other viruses, RSV has multiple strains with the predominant being subgroup A and subgroup B.
RSV had a significant surge in the winter of 2022/2023 with COVID-19 and influenza. RSV was responsible for over 177,000 hospitalizations and 14,000 deaths for those over 65 years. The risk of serious illness is increased with underlying diabetes or heart and lung disease.
On May 3, 2023, the FDA approved the GSK (GlaxoSmithKline) RSV vaccine with the brand name of Arexvy. The vaccine was approved for those 60 years of age and up to prevent RSV lower lung infection. The GSK vaccine is a recombinant subunit of prefusion RSV F glycoprotein antigen (RSVPreF3) with an adjuvant to enhance vaccine response.
On February 16, 2023, the New England Journal of Medicine (NEJM) published the phase 3 study of the GSK vaccine. The study involved approximately 25,000 individuals 60 years and older divided into 2 groups. One treatment group received the active RSV vaccine, while the second group received a placebo or no vaccine.
The study reported 7 cases of RSV in the vaccine group compared to 40 cases in the placebo participants. Each participant was followed for 6.7 months after receiving either the vaccine or placebo. The vaccine was determined to be 82.6% effective in preventing a RSV infection in adults over 60 years. The vaccine was slightly more effective in preventing the A strain at a rate of 84.6% versus 80.9% in preventing the B strain. The vaccine reduced the risk of severe RSV infection in older adults by 94.1%. The study evaluated the vaccine’s effectiveness in those over the age of 70 years and found a risk reduction of 84.4%. The study did not have enough participants over the age of 80 to make a calculation for this group.
On May 31, 2023, the FDA approved Pfizer’s bivalent RSV prefusion F (RSVperF) vaccine composed of 2preF proteins against RSV A and RSV B. The brand name of the vaccine is ABRYSVOTM and is approved for those 60 years and older. The phase 3 study in 34,284 participants was published in NEJM on April 20, 2023. There were 13 cases of RSV in the vaccine group compared to 47 in the placebo group. The side effects were mild and included injection site pain and tiredness.
The Advisory Committee on Immunizations Practices (ACIP) consists of vaccine experts who will make recommendations to the CDC for the use of the RSV vaccines. The ACIP met and on June 29, 2023, the CDC announced the committee’s decision. The language indicated the RSV vaccines by both GSK and Pfizer may be given in a single dose to adults 60 years and older with shared clinical decision-making.
What does this mean?
The committee changed the language from should receive to may receive with shared clinical decision-making. The change in the verb from should to may is important. The committee is indicating this is not a vaccine required for everyone, but rather a decision made with your healthcare professional. The vaccines evidence to prevent severe RSV infections was strongest in individuals with diabetes, lung and heart disease.
A second study was completed in 976 participants to evaluate the GSK RSV vaccine when given in conjunction with the flu vaccine (Fluarix Quadrivalent). The participants in this study were over the age of 60 years. The study provided one dose of the flu vaccine on day 1 with a single dose of the RSV vaccine 30 days later on day 31. The study demonstrated no interference of either vaccine to the benefit of the other vaccine. Both vaccines maintained their activity. The study evaluated safety as well. There were 3 cases of rare side effects with the combination including 2 patients who had an inflammation of the brain and spinal cord and one patient who developed a neurologic condition known as Guillain-Barre´syndrome.
The vaccines will be available for the 2023/2024 RSV season, which occurs in the winter months.
Talk to your healthcare professional before RSV takes your breath away.
ONU HealthWise is offering bivalent mRNA COVID-19 vaccines Monday through Friday from 10:00 a.m. to 5:00 p.m. The pharmacy will be offering the RSV vaccines when they are available to the market. The anticipated release will be closer to the RSV winter season. Please call the pharmacy for more information.
ONU HealthWise Pharmacy
419-772-3784
