By Karen Kier
Pharmacist on behalf of the ONU HealthWise team
Sir Hugh Beaver, the managing director of Guinness Breweries in Dublin, Ireland, contemplated how one could verify who was first in the world. The Guinness World Records were born. His idea intrigued twin brothers Norris and Ross McWhirter to publish the Guinness Book of World Records. The first book hit the bestseller list by Christmas of 1955. The book is currently published in 100 countries in 23 languages. The publisher maintains over 53,000 records.
On May 5, 2023, the coronation of King Charles III was celebrated. King Charles set the record for the longest term as heir-apparent for the British monarchy. His record started at the age of 3 when his mother became queen on February 6, 1952. King Charles III waited 70 years and 214 days to accept the crown. This surpassed his great-great-grandfather Edward VII’s record of 59 years and 73 days in replacing Queen Victoria.
On May 3, 2023, the Food and Drug Administration (FDA) was the first in the world to approve the respiratory syncytial virus (RSV) vaccine. The FDA approved the GSK (GlaxoSmithKline) RSV vaccine with the brand name of Arexvy. The FDA approved the vaccine prior to other countries evaluating the clinical data including Europe and Japan. After years of research, GSK will produce the first in the world RSV vaccine.
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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 as part of the tridemic 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 for those with underlying diabetes or heart and lung disease.
On February 16, 2023, the New England Journal of Medicine published the phase three study of the GSK respiratory syncytial virus vaccine. The study involved approximately 25,000 individuals 60 years and older divided into two groups. One treatment group received the active RSV vaccine, while the second group received a placebo or no vaccine. The endpoint of the study was evaluating the number of cases of diagnosed RSV in each group.
The study reported seven 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 active vaccine or placebo. The vaccine was determined to be 82.6% effective in preventing an RSV infection in adults over 60 years. The vaccine was slightly more effective in preventing the A strain of RSV at a rate of 84.6% versus 80.9% in preventing an infection with 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 separate calculation for this group.
A phase three trial evaluates not only how well the vaccine works, but the safety as well. The vaccine is injected into the deltoid muscle in the arm, which is the same site used for both the flu vaccine and the COVID-19 vaccine. The most common side effects reported were pain at the injection site, muscle pain, stiff joints, headache, and overall being tired. The FDA is requiring the company to continue to monitor safety after the vaccine is available on the market. One concern was the rare development of atrial fibrillation (abnormal rhythm of the heart) in 10 patients who received the vaccine compared to 4 individuals who developed atrial fibrillation in the placebo group.
The vaccine will be available in the US for the 2023/2024 RSV season, which occurs in the winter months. The Advisory Committee on Immunizations Practices (ACIP) consists of vaccine experts who will make a recommendation to the CDC for the use of the RSV vaccine in the US. The ACIP will meet in June of 2023 to make the final recommendations.
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 on 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.
Although GSK was the first in the world to get an FDA-approved RSV vaccine, Moderna and Pfizer have RSV candidates in clinical studies.
ONU HealthWise is offering bivalent mRNA COVID-19 vaccines Monday through Friday from 10:00 a.m.- 5:00 p.m. Please call the pharmacy for more information.
ONU HealthWise Pharmacy
419-772-3784
