RSV Jab Halted by FDA for Infants 5-8 Months Old. How About All Others?

Due to "imbalance" is safety signals.

As University of Minnesota reports on Dec. 11, 2024, “Pediatric RSV vaccine trials on hold, FDA says”:

A briefing document from the Food and Drug Administration (FDA) says that enrollment for all clinical studies of vaccines for respiratory syncytial virus (RSV) in infants is on hold over concerns about potential safety findings from a clinical trial involving two vaccine candidates.

The document, released ahead of a meeting tomorrow of the FDA's Vaccine and Related Biologic Products Advisory Committee (VRBPAC), revealed that a phase 1 trial evaluating the safety, tolerability, and immunogenicity of two Moderna RSV vaccine candidates (mRNA-1365 and mRNA-1345) in infants aged 5 months to 8 months was paused in July after five cases of severe to very severe lower RSV respiratory tract infection (LRTI) were reported in infants who received a 15-microgram (μg) dose of mRNA-1345 (3 cases) or a 15-μg dose of mRNA-1365 (2 cases), compared with 1 case in the placebo group. 5 of the 6 infants required hospitalization, with 1 needing mechanical ventilation.

Visiting the referenced document, “Considerations for Respiratory Syncytial Virus (RSV) Vaccine Safety in Pediatric Populations” (FDA, 2024.12.12), we further learn the following details of these cases:

Basically, getting a jab “protecting” a baby from RSV gives the baby 500% higher odds of unfortunate severe RVS infection accompanied by coinfections within a month of the last jab (a series of 3!).

Nevertheless, the caring FDA approved three RSV jabs for 18+:

Abrysvo for active immunization for the prevention of LRTD caused by RSV in:

• individuals 60 years of age and older; and

• individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV

• Pregnant individuals at 32 through 36 weeks gestational age: Although not licensed for use in children, Abrysvo was approved on August 21, 2023, for active immunization of pregnant individuals at 32 through 36 weeks gestational age (GA) for the prevention of LRTD and sLRTD caused by RSV in infants from birth through 6 months of age. On September 22, 2023, the ACIP recommended Abrysvo for pregnant persons at 32-36 weeks GA using seasonal administration (meaning September-January in most of the U.S.) to prevent RSV-LRTD in infants <6 months of age (CDC, 2024a).

Arexvy for active immunization for the prevention of LRTD caused by RSV in:

• individuals 60 years of age and older; and Considerations for RSV Vaccine Safety in Pediatric Populations VRBPAC Briefing Document 9 of 39

• individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV

mResvia for active immunization for the prevention of LRTD caused by RSV in:

• individuals 60 years of age and older

Those 60+ seem to be able to withstand anything coming their way, FDA gathers. Or else, they must be disposed of on a priority basis?

Don’t we wish we were all deemed to be 5-8 months old!