By Karen Kier
Pharmacist on behalf of the ONU HealthWise team
In 1983, the Police released their number one hit Every Breath You Take. The bestselling single was from their last studio album Synchronicity. The group was inducted into the Rock and Roll Hall of Fame in 2003 and in 2015, the band was awarded for the most played song in radio history.
Gordon Sumner aka Sting left the band in 1985 to pursue a solo career. Sting was awarded a star on the Hollywood Walk of Fame in 2000 and was a Kennedy Center Honoree in 2014. In March of 2021, he released Duets with 17 tracks collaborating with superstars such as Eric Clapton, Mary J. Blige, and Annie Lennox. In 2021, he had a role in Hulu’s Only Murders in the Building starring Steve Martin, Martin Short, and Selena Gomez.
Respiratory syncytial virus (RSV) can make every breath we take difficult. The virus in especially dangerous for children under 2 years and adults over 60 years. RSV is responsible for 6 to 13 thousand deaths each year. There are limited treatments for managing RSV other than supportive care and no vaccine is currently approved in the United States.
Two investigational vaccines were evaluated by an expert panel. The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) reviewed clinical studies for one vaccine from Pfizer and one from GlaxoSmithKline (GSK). The committee made recommendations on both vaccines on March 2, 2023 after meeting for four days.
The VRBPAC agenda and meeting materials are public and on the FDA website. You can watch recordings on YouTube. The major discussions about the 2 RSV vaccine candidates including how well they work (efficacy) and safety components. This committee provides expert opinion to the FDA, but it is up to the FDA to make the final ruling.
The GSK vaccine known by RSVpreF3 and the requested brand name of Arexvy was presented with data from 5 clinical studies in humans. The phase 3 efficacy and safety trials compared the RSVpreF3 vaccine to placebo in 25,000 adults over 60 years. This was a single-dose study and the primary outcome was PCR confirmed RSV infection.
The overall vaccine efficacy was reported at 82.6% in adults over 60 years. Seven cases were reported in vaccinated subjects with 40 cases observed in the placebo group. The vaccine was well tolerated with the most common side effects being injection site pain, muscle aches, tiredness, and headache. The GSK vaccine contains an adjuvant ingredient to boost the immune response, which is the same adjuvant used in GSK’s shingles vaccine (SHINGRIX).
The GSK vaccine was reported to have a 94.1% effectiveness in reducing severe disease over the 6.7 months of the study. The vaccine maintained its efficacy in subgroups analyzed including those over the age of 70 years and individuals with multiple disease states or who were described as fit. The subgroup over the age of 80 years did not have quite the same positive results as those under 80 years. In addition, those who were defined as frail did not see the same benefit as their physically fit counterparts.
The VRBPAC experts voted 12 to 0 to recommend approval to the FDA of the GSK’s RSVpreF3 vaccine based on its effectiveness and 10 to 2 to approve the safety profile of the vaccine. The FDA will make a final ruling on approval by May 3, 2023.
The expert panel also evaluated evidence presented by Pfizer for its RSV vaccine known as RSVpreF or bivalent RSV prefusion vaccine with the proposed brand name of Abrysvo. The Pfizer vaccine is a single injection of 2 different strains of RSV known as A and B. The researchers presented data from the phase 3 efficacy and safety study known as Renoir. The study started August of 2021 and involved 240 study locations in 7 countries with 45,000 participants. One half of the study subjects received the active RSV vaccine while the other half received a placebo.
The Renoir study evaluated 2 primary endpoints for the Pfizer vaccine. The first endpoint was the ability of the vaccine to prevent negative outcomes when patients 60 years and older had 2 or more RSV symptoms and the second endpoint was in patients with 3 or more symptoms. The vaccine displayed a 66.7% efficacy for 2 symptoms and an 85.7% effectiveness for 3 or more symptoms. The side effects were reported as mild to moderate and were similar to the GSK vaccine.
The VRBPAC experts voted 7 to 4 to recommend approval to the FDA for Pfizer’s RSV vaccine. The FDA has until May 3 to make the final decision on approval. The Renoir study is still ongoing with a completion date of June 2023. Some of the experts wanted to see more of the final data prior to voting and were part of the dissenting group.
We may have to hold our breath until the FDA makes a final decision on the impact of the RSV vaccine on every breath that we take!
ONU HealthWise is offering COVID-19 vaccines as well as flu shots Monday-Friday from 10:00 a.m.-5:00 p.m. The bivalent COVID-19 vaccines are available. Clinics are Monday-Friday from 4:00-6:00 p.m. Please call the pharmacy for information.
ONU HealthWise Pharmacy
419-772-3784
