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A Change Is Gonna Come: Vaccines update

By Karen Kier
Pharmacist on behalf of the ONU HealthWise team

In 1964, Sam Cooke wrote the powerful soul ballad A Change Is Gonna Come.  Rolling Stone magazine listed this song at number 3 of their top 500 Greatest Songs of All Time.  

Some significant changes are coming for vaccines including respiratory syncytial virus (RSV), flu and COVID-19. 

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 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 is ABRYSVOTM and is approved for those 60 years and older.  The Pfizer vaccine is also FDA-approved to be administered during pregnancy to help prevent an RSV infection in a newborn baby. It is to be given during weeks 32 to 36 of the pregnancy during the months between September to January when the RSV risk is the highest.  

On May 31, 2024, the FDA approved the first mRNA RSV vaccine (mRESVIA) researched by Moderna.  They were one of the leaders in developing the mRNA COVID-19 vaccine. This mRNA RSV vaccine is approved for adults 60 years and older.  A clinical study involving over 37,000 adults in 22 countries reported an overall effectiveness in preventing lower respiratory tract infections by about 84%.  This number is similar to those seen with both GSK and Pfizer’s vaccines.  

The 2024-2025 influenza (flu) shots for this fall will primarily be trivalent.  The vaccines will cover two type A influenza strains and one type B.  The type A-like viruses will include H1N1 and H3N1.  The B/Victoria lineage will be the third component in the vaccines.  Previous influenza vaccines contained the B/Yamagata lineage but this has been removed from the 2024-2025 shots because it has not been a cause in the United States since 2020. 

The CDC keeps data on hospitalizations when an individual has been infected with more than one virus at a time.  For the 2023-2024 season, they reported 901 cases of both flu and RSV in the same person and 950 cases of both flu and COVID-19 in the same patient. These numbers translated into 5% of flu cases admitted to the hospital were coinfected with COVID-19, while 2% of flu cases were coinfected with RSV.   

An FDA advisory panel met on June 5, 2024 to discuss the next round of mRNA COVID-19 vaccines.  The panel evaluated current data regarding circulating strains in the United States to give its recommendation.  The JN.1 variant had the greatest influence in February of 2024, but this dominance has been overtaken by the KP.2 and KP.3 variants.  The KP variants were responsible for over 50% of the COVID-19 cases by late May.  

The advisory panel is recommending a stronger protection from JN.1 variants and this includes the KP.2 and KP.3.  They follow a similar lineage.  The FDA needs to consider these recommendations and make a final decision regarding the next generation of COVID-19 vaccines.  Both Pfizer and Moderna have reported the ability to produce the new version of the vaccine for the fall when the FDA makes the final decision. Stay tuned for more information about COVID-19 vaccine changes in the next few months. 

Changes in the fall season vaccines are gonna come! Talk to your pharmacist or healthcare provider. 

ONU Healthwise is offering the flu and COVID-19 vaccine clinics Monday through Friday from 4:00- 6:00 p.m. Call 419-772-3784 for more information.