The Booster Industrial Complex Marches On
No RCTs for efficacy. No non-inferiority trials for safety. No problem — the FDA picks a strain, the WHO picks another, and the virus picks neither
By Peter A. McCullough, MD, MPH
Many in the MAHA Coalition were hoping that this past May the US FDA would simply give up on unnecessary COVID-19 boosters. Yes again, the leaders at HHS and FDA that were brought into power by MAHA have disappointed their coalition.
🦠 The Perpetual Booster Carousel: FDA’s Fall 2026 Decision and the Unending Chase
📋 The Late May 2026 Decision
On May 28, 2026, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 8-0-1 to recommend that fall 2026 COVID-19 boosters target the XFG variant — nicknamed “stratus” — a recombinant spawn of two Omicron sublineages now responsible for over half of U.S. infections. The lone abstention came from Dr. Hana El Sahly of Baylor, who noted the data showed an XFG-targeting vaccine wasn’t overwhelmingly superior to existing formulations.
The FDA is expected to rubber-stamp the recommendation, and manufacturers — Pfizer, Moderna, and Sanofi (which now markets the Novavax protein-based shot) — will begin cranking out doses for the fall respiratory season.
🔄 The Unprecedented History of Serial Boosting
What we’re witnessing is historically unprecedented in vaccinology. Consider the timeline:
Fall 2021: “Booster” doses authorized for the original Wuhan-strain mRNA vaccines, roughly 8 months after the primary series rollout
Summer/Fall 2022: Bivalent boosters targeting BA.4/BA.5 authorized without human efficacy data — a first in FDA history, relying on mouse immunogenicity studies
Fall 2023: Monovalent XBB.1.5 boosters rolled out
Fall 2024: JN.1-lineage boosters
Fall 2025: Updated JN.1 subvariant boosters
Fall 2026 (proposed): XFG-targeted shots
That’s six years of annual — sometimes biannual — reformulation. No other vaccine in the history of medicine has been re-engineered and redeployed this frequently without completed phase III efficacy trials for each iteration. The influenza vaccine, for all its well-documented shortcomings, at least has decades of safety surveillance and established manufacturing platforms. The mRNA COVID products represent a fundamentally different risk calculus being treated with the same regulatory casualness as a flu shot swap-out. Unlike the influenza vaccines, mRNA and its product the Spike protein, accumulate in the human body causing disease and disability over time.
