RSV Vaccine
| Question | Evidence-Based, Logic-Driven Response (RSV) |
|---|---|
| What is my child’s actual risk of dying from RSV, statistically? | - RSV is extremely common, infecting nearly 100% of children by age 2. - The vast majority experience it as a cold or mild bronchiolitis. - According to CDC and NIH data, RSV hospitalizes ~1–2% of infants, primarily those born premature, with cardiac or lung conditions. - Mortality is exceedingly rare in healthy, full-term infants. U.S. pediatric RSV deaths: ~100–300/year, nearly all with underlying illness. |
| Have you lost an unvaccinated child to RSV? Any patient harmed or lost after the RSV shot or antibody? | Most pediatricians have never lost a healthy infant to RSV. They’ve seen hospitalizations for oxygen support or fluids, but almost no healthy children die. However, RSV vaccine/antibody products are so new (approved in 2023) that serious injuries are just beginning to emerge. |
| Odds of any side effect? Severe side effect? Compared to death from virus? | - Common (from clinical trials): fever, irritability, fatigue. - Severe reactions reported: anaphylaxis, breathing trouble, skin reactions, potential immune dysregulation. - Pfizer's Abrysvo maternal RSV vaccine showed an increase in preterm birth and neonatal deaths in trial groups. - Risk of death from RSV in full-term infants: virtually zero. Risk from unknown immune outcomes post-mAb or maternal injection: not studied long-term. |
| Most severe adverse event you’ve seen? Most common? | Data is still emerging. So far: - For nirsevimab (Beyfortus): cases of hypersensitivity, apnea, rash, and possible sudden infant collapse are under review. - For Abrysvo maternal vaccine: trial data showed higher neonatal mortality, and higher rate of preterm birth. This was serious enough to delay EU approvals. |
| Worst-case outcome from insert or trial data? Any deaths? | - Abrysvo (Pfizer) insert: admits to imbalances in neonatal deaths between vaccine and placebo groups. - GSK’s Arexvy was halted in pregnant women due to preterm birth concerns. - Beyfortus (nirsevimab) has no long-term follow-up. Side effects include: skin reactions, vomiting, hypersensitivity, respiratory issues. |
| Recent VAERS reports? Severity? | These products are too new to have accumulated significant VAERS data, but early signals are emerging: - Reports of infant death, apnea, rash, seizures following Beyfortus are appearing. - Watchdog groups are calling for post-marketing surveillance transparency, especially for preterm birth and neurodevelopment. |
| How many VAERS reports have you filed? Do you follow up post-administration? | Pediatricians do not routinely follow up after monoclonal injection (Beyfortus) or post-maternal vaccination. No structured follow-up exists for immune effects, developmental changes, or regression. |
| Will you test my infant’s antibody levels before deciding on additional doses or exposures? | No antibody testing is offered. The product is given based on birth date, not individual immune status. There is no customization or immune evaluation prior to use. |
| Can you guarantee this won’t cause autoimmune, developmental, or allergic harm? | No. The RSV products have no long-term data. - Beyfortus is a genetically engineered monoclonal antibody that stays in the infant’s body for 4–6 months, yet its long-term impact on the developing immune system is unstudied. - Maternal shots cross the placenta in the third trimester, altering fetal immune programming. |
| Was this tested against a true saline placebo? What were the outcomes? | - Nirsevimab trials used a control group, but not always true saline. - Abrysvo trials were unblinded, and adverse events like preterm labor were dismissed as unrelated, despite statistical imbalance. - True placebo-controlled, long-term trials are lacking or incomplete. |
| Do you have unvaccinated or non-injected patients? Ever advised against RSV intervention? | Most pediatricians are following the new RSV rollout closely but have little real-world experience. Few advise against the shots, despite the novelty and unknowns. |
| If a child or mother experiences a serious adverse event, what’s your next step? | Most providers have no formal guidance on what to do. FDA guidance is vague, and post-market reaction protocols have not been established. Likely outcome: the event is dismissed or blamed on preexisting issues. |
| Can we walk through the package insert and ingredients? | - Beyfortus (nirsevimab): recombinant monoclonal antibody, produced in genetically modified hamster ovary cells, polysorbate 80, L-histidine, sucrose. - Risks: hypersensitivity, apnea, rash, collapse. - Abrysvo (maternal vaccine): RSV F protein + lipid nanoparticles and buffers. Insert warns of fetal risks, preterm labor. |
| How do you distinguish coincidence from causation in adverse reactions? | Most doctors have no system for determining causality — especially with novel products. Temporal events are brushed off as normal unless catastrophic. Yet, patterns (collapse, apnea, seizures) are emerging in post-injection cases. |
| Are there long-term health outcome studies? | No. These products were approved via fast-track, based on short-term immunogenicity endpoints — not long-term child development, immune maturation, allergy risk, or chronic illness tracking. |
| Do you have concern about how fast this was added to the infant schedule? | RSV interventions were rushed into the schedule within a year of approval — despite minimal long-term data and growing global concern. Most doctors are unaware that the FDA’s advisory board had major dissenting voices, especially for maternal RSV shots. |
| Have you observed post-2023 increases in apnea, immune instability, allergic reactions, or SIDS-like events? | It is too early to say definitively, but early anecdotal reports, including rash, lethargy, and developmental delays, are emerging. SIDS-like events have occurred within days of nirsevimab injection, prompting some watchdog groups to call for audits. |
| Would you report and publicly acknowledge injury from RSV shots or antibodies? | Unlikely. There is tremendous professional risk in acknowledging harm from a product just added to the infant and maternal schedules. Most doctors will defer to official guidance and avoid linking any adverse event to the shot. |
| Are you under pressure to administer RSV shots to all newborns? | Yes. Pediatricians are being pushed to co-administer Beyfortus with routine vaccines. Hospitals and insurers are incentivizing RSV injection at birth, even though the benefit is unclear in healthy infants. |
| Do you know how parents can file for injury? | No. As of 2024, RSV shots fall under PREP Act liability protection and may not be covered by VICP. Families have no legal recourse unless fraud or misconduct is proven. The system is opaque, and injury claims will likely go unpaid. |