Human papillomavirus quadrivalent (types 6, 11, 16, 18) vaccine, recombinant(Emmanuel College, University of Queensland)

iStock, Maria Bobrova Following restricted vaccine approvals and changes to CDC immunization schedules, Merck, Pfizer, GSK and Sanofi are all suffering revenue hits to their vaccine programs. A much talked about threat of declining U.S. vaccination rates amid Health Secretary Robert F. Kennedy Jr.’s rhetoric has begun to show up on pharma companies’ balance sheets. The industry’s four major vaccine makers—GSK, Pfizer, Sanofi and Merck—all reported declines in their vaccines businesses for the third quarter, each citing a drop in vaccine rates in the U.S. Sanofi was the first canary , on Oct. 24 reporting a 17% decline in sales of its COVID-19 and flu vaccines. The legacy vaccine business declined 8% to €3.36 billion ($3.9 billion). “As expected, our flu vaccines business declined because of increased price competition and lower vaccination rate,” CEO Paul Hudson said in a statement that accompanied the earnings release. Then came GSK, which blamed “macro factors around vaccines” for a reduction in the vaccines business . While the prize of that portfolio, the shingles vaccine Shingrix, grew 13% worldwide, the U.S. market numbers were bleak: the vaccine’s sales shrank 15%. Merck has already been struggling with HPV vaccine Gardasil, with headwinds in China forcing the company to pause shipments. But this quarter , the U.S. also contributed to the woes, with CFO Caroline Litchfield blaming those pesky “macro factors.” Sales of Merck’s MMRV vaccine Proquad, the MMR vaccine M-M-R II and the chicken pox vaccine Varivax were also down 3% due to lower demand in the U.S. Opinion A Flu Season in Flux Presents Risks, Opportunities for Biopharma The coming flu season is the clearest indication yet that biopharma’s long-standing assumptions about predictability, prevention and portfolio structure are no longer guaranteed. October 28, 2025 · 7 min read · Tom Sebok As for Pfizer, the New York pharma’s COVID-19 business, which includes the therapeutic Paxlovid and the BioNTech-partnered mRNA vaccine Comirnaty, contributed to a 6% year-over-year decrease in revenue. Comirnaty was down 20% for the third quarter, collecting revenues of $1.15 billion worldwide. U.S. sales fell 25%. “[T]he asset has been at the center if political friction and anti-vaccine rhetoric,” BMO Capital Markets analyst Evan Seigerman and his colleagues wrote in a note to investors on Monday. While Paxlovid was impacted by lower infection rates, prospects for Comirnaty were dimmed by the FDA’s recent approval that limits use to older and at-risk populations and the CDC’s subsequent narrowing of the agency’s recommendations for COVID-19 shots. Moderna, the famed biotech struggling in its post-pandemic reality, also reported declines for its COVID-19 shot Spikevax and limited uptake for its new RSV shot on Thursday. A Year of Vaccine Debates Kennedy has stirred the vaccine pot since taking the helm as health secretary earlier this year. In March, highly respected regulator Peter Marks  was forced to resign  as head of the FDA’s Center for Biologics Evaluation and Research after refusing to give Kennedy’s team editing access to the agency’s Vaccines Adverse Event Reporting System (VAERS). Marks said at the time that he feared “they’d write over it or erase the whole database,” according to the  Associated Press . Then in April, Kennedy announced a “massive testing and research effort” to nail down the cause of autism , which he has previously blamed on vaccines. Later in the month, HHS announced that placebo controls would be required in trials of new vaccines,  a policy  experts have speculated is a codification of  anti-vaccine activism .  Editorial Kennedy’s Hunt for a Connection Between Vaccines and Autism Is a Sham The Health and Human Services Secretary said that he will find and eliminate the cause of autism by September, an idea that suggests how little he knows about the condition. April 17, 2025 · 3 min read · Dan Samorodnitsky Read More Perhaps the biggest bombshell landed in late May when the secretary surprised even CDC staffers with a social media announcement that the agency would remove recommendations for healthy children and healthy pregnant women to receive routine COVID-19 vaccination—a decision that was ultimately reinforced by the FDA’s restricted approval. Not two weeks later, Kennedy ousted all 17 members of the CDC’s Advisory Committee on Immunization Practices and replaced them with new advisors, many of whom have histories of anti-vaccine viewpoints, and reportedly fired CDC Director Susan Monarez because she refused to pre-approve the new committee’s recommendations. While Kennedy claims to be on a mission to restore public trust in the country’s health agencies, his tactics thus far seem to be falling short . Industry and analysts initially downplayed the secretary’s anti-vaccine rhetoric but eventually the “[u]ncertainty around public vaccine perception and ACIP recommendations have promoted more bearish sentiments,” Seigerman and his colleagues wrote in a note about BioNTech earnings, which actually achieved a third-quarter beat due to those low expectations. The pharmas themselves understandably don’t want to outright blame the health secretary and the CEOs have danced around the issues on their respective earnings calls in the past couple of weeks. But it’s hard to argue that four pharmas reporting the same thing for a typically stable business isn’t concerning. This is not business as usual. If you look past the numbers here, there are real people going without vaccines for potentially devastating diseases. The consequences have never been more obvious on suppressed immunization rates than for measles—a disease eradicated from the U.S. 25 years ago thanks to vaccine coverage. This year, across 40+ states, there have been more than 1,600 confirmed measles cases, most associated with the 44 recorded outbreaks of the disease, according to CDC data updated Nov. 4. That’s compared to a total of 285 cases and 16 outbreaks last year. The biggest outbreak of 2025, in West Texas, led to the first measles deaths in a decade. All because a regulator, who sits at America’s critical and storied agency that is supposed to help Americans be healthier, has been given free rein to further shake public trust in vaccines. These backslides, compared with worldwide increases in vaccine sales reported by each of the pharmas, are a global embarrassment. This is not making America greater; it’s making America sicker. Editorial Desperate Times, Desperate Measures? RFK’s Vaccine Campaign Only Breeds More Distrust Vaccine skepticism is at an all-time high in the U.S., and HHS Secretary Robert F. Kennedy Jr. is making some drastic moves in the name of reversing that trend. But misinformation and inconsistencies within the country’s healthcare agencies highlight problems with his approach. June 6, 2025 · 8 min read · Jef Akst Read More