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RENOIR: Pfizer Trial Finds Adult RSV is Rare--Vaccine No Hospitalization or Death Benefit
Ambulatory RSV Occurred in <1% of all Subjects--Vaccine Not Worth the Effort in Adults
By Peter A. McCullough, MD, MPH
It is common for pharmaceutical companies to report companion trials in the same issue of the New England Journal of Medicine. The MATISSE and RENOIR trials were published together recently and our topic for this issue of Courageous Discourse is the RENOIR adult randomized placebo-controlled trial testing the Pfizer preFusion RSV antigen vaccine in adults. RSV is uncommon in adults and easily treated with nebulizers and advanced medications on occasion. As shown in this very large trial, RSV vaccination did not lead to reductions in hospitalization or adults in either the vaccine or placebo group—because no one become seriously ill.
RENOIR was stopped early at 34,284 participants had received RSVpreF vaccine (unadjuvanted RSVpreF vaccine at a dose of 120 μg (containing 60 μg each of RSV A and RSV B antigens) (17,215 participants) or placebo (17,069 participants). RSV-associated lower respiratory tract illness with at least two signs or symptoms occurred in 11 participants in the vaccine group and 33 participants in the placebo group, (vaccine efficacy, 66.7%; 96.66% confidence interval [CI], 28.8 to 85.8); 2 cases and 14 cases with least three signs or symptoms (vaccine efficacy, 85.7%; 96.66% CI, 32.0 to 98.7). RSV-associated acute respiratory illness occurred in 22 participants in the vaccine group and 58 participants in the placebo group, vaccine efficacy, 62.1%; 95% CI, 37.1 to 77.9). There were no hospitalizations or deaths mentioned in either group. Because data are sparse, we must rely on the lower limit of the confidence interval which is far below 50% for all outcomes, which is unacceptable.
Safety of the vaccine was acceptable with the caveat there were more deaths in the vaccine group; none attributed to the vaccine by Pfizer (Supplemental Table 7).
As an adult medicine doctor, I can tell you this massive trial is unimpressive because RSV is so mild and rare in adults. In other words, 34,284 patients had to be randomized to spare 12 cases of RSV with three symptoms. So why bother with a short term vaccine when it can be easily treated with inhalers or nebulizers at home?
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Walsh EE, Pérez Marc G, Zareba AM, Falsey AR, Jiang Q, Patton M, Polack FP, Llapur C, Doreski PA, Ilangovan K, Rämet M, Fukushima Y, Hussen N, Bont LJ, Cardona J, DeHaan E, Castillo Villa G, Ingilizova M, Eiras D, Mikati T, Shah RN, Schneider K, Cooper D, Koury K, Lino MM, Anderson AS, Jansen KU, Swanson KA, Gurtman A, Gruber WC, Schmoele-Thoma B; RENOIR Clinical Trial Group. Efficacy and Safety of a Bivalent RSV Prefusion F Vaccine in Older Adults. N Engl J Med. 2023 Apr 20;388(16):1465-1477. doi: 10.1056/NEJMoa2213836. Epub 2023 Apr 5. PMID: 37018468.