The Pharmaceutical Industry trumpeted another breakthrough as the FDA recently approved the world’s first vaccine for Respiratory Syncytial Virus (RSV), a common respiratory illness that usually causes mild, cold-like symptoms.
According to the CDC those at greatest risk from RSV are:
Premature infants; Infants, especially those 6 months and younger; Children younger than 2 years old with chronic lung disease or congenital (present from birth) heart disease; Children with weakened immune systems; Children who have neuromuscular disorders, including those who have difficulty swallowing or clearing mucus secretions.
While noting that, “All but the youngest of children have had RSV multiple times, but few of us would know with any certainty that this bad cold was caused by that bad virus”, Pharma soldiered on with its mission to rid the world of this scarcely problematic condition.
The rollout is planned for Fall of 2024 with the shots marketed for individuals 60 years of age and older. While the injections are being sold as protection for older adults this alleged disease has historically been noted for primarily attacking young children.
For over 50 years the Pharmaceutical Industry produced a series of failures in pursuit of a viable RSV vaccine. Previous attempts resulted in disastrous outcomes for some children. In an earlier trial 80% of the children given the shot were hospitalized with severe respiratory disease and two died.
The industry claims that this decades-old problem has now been solved by pivoting away from older methods of development to the innovative use of protein-structure-based vaccine design – the same approach which enabled the rapid development of the Covid vaccine.
The protein-based RSV vaccines are designed to introduce the desired molecule into cells in order to produce an immune response and theoretically train the immune system to recognize a protein on RSV’s surface.
According to GSK, AREXVY “contains a recombinant subunit prefusion RSV F glycoprotein antigen RSVPreF3 combined with GSK’s proprietary AS01E adjuvant.”
The composition of the protein is duly noted in the package insert:
The RSVPreF3 antigen is expressed by culturing genetically engineered Chinese Hamster Ovary cells in media containing no antibiotics or animal-derived proteins. The RSVPreF3 protein is purified by several chromatographic and filtration steps, formulated with excipients, filled into vials, and lyophilized (freeze dried).
Also described in the insert is the preparation for delivery:
AREXVY is supplied in 2 vials that must be combined prior to administration. Prepare AREXVY by reconstituting the lyophilized antigen component (a sterile white powder) with the accompanying adjuvant suspension component (an opalescent, colorless to pale brownish sterile liquid). Use only the supplied adjuvant suspension component for reconstitution. The reconstituted vaccine should be an opalescent, colorless to pale brownish liquid. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to 2 administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.
While the medical industry has been claiming for years that RSV is a childhood disease, GSK itself notes that based on animal models it is “strongly suggested that AREXVY would be unsafe in individuals younger than 2 years of age because of an increased risk of enhanced respiratory disease. AREXVY is not approved for use in persons <60 years of age.”
Also mentioned in the package insert, “In a clinical study that enrolled pregnant individuals who received an investigational unadjuvanted RSV vaccine that contained the same RSVPreF3 antigen as AREXVY, an increase in preterm births was observed compared to pregnant individuals who received placebo.”
Despite this and other concerns Dr. Phil Dormitzer, chief of vaccine research and development for GSK spoke enthusiastically about this new development, “This is a very exciting time with multiple potential RSV solutions coming out after years of really nothing.”
Moderna has an RSV mRNA vaccine candidate in the pipeline geared towards older adults while Pfizer’s RSV prospect is said to be targeting older people and pregnant women claiming its product will stop RSV in newborn infants.
Data reported to the CDC indicated that 14% of pregnant women in Pfizer’s trial sustained an adverse event, with 4.2% sustaining a “serious” adverse event, 1.7% experiencing a “severe” adverse event and 0.5% suffering a “life-threatening” adverse event. Nevertheless, it is expected that Pfizer’s product will receive FDA approval this Fall.
Similarly, the same data showed that 37.1% of infants whose mothers received the experimental Pfizer vaccine experienced adverse events within one month of birth — with 15.5% classified as “serious,” 4.5% as “severe” and 1% as “life-threatening.”
Analysts estimate that the RSV vaccine market is positioned to reach $10 billion by the year 2030. In a conference call to investors and analysts GSK stated that it already has “millions of doses” of Arexvy “ready to be shipped.”
If the public wasn’t aware that RSV was a problem in need of a solution that too is in the pipeline as evidenced by infectious disease “expert” Dr. William Schaffner’s recent statement, “We’ll have to educate the population that this virus that not everyone has heard about is actually an important threat to their health in the wintertime.”
One can only imagine what that “education” will look like.