Measles, Mumps and Rubella Vaccine (GSK)

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

The CDC officially adopted Covid-19, MMR and chickenpox vaccine recommendations from new advisors that HHS Secretary Robert F. Kennedy Jr. used to replace a longstanding group of public health experts. Under the new recommendations, the agency will now advise that anyone six months and older consult a healthcare provider before receiving the Covid-19 shot. It will also now recommend that children under age 4 receive the chickenpox vaccine separately from a combined vaccine against measles, mumps and rubella. The recommendations, finalized Monday, were put forward by the Advisory Committee on Immunization Practices (ACIP) last month. In a statement, acting CDC director Jim O’Neil claimed that prior recommendations, which broadly recommended that everyone six months and older receive a Covid-19 vaccine annually, “deterred health care providers from talking about the risks and benefits of vaccination for the individual patient or parent.” Providers were already required to offer statements on vaccines’ risks and benefits. And earlier this year, ACIP seemed poised to change its Covid-19 recommendation to focus on more at-risk populations before Kennedy in June removed all of the group’s voting members . Many of the new members added by Kennedy since then have shared his skepticism about vaccines. They have particularly taken issue with the mRNA technology underpinning the Covid-19 vaccines made by Moderna and Pfizer. Other vaccines and recommendations are getting additional scrutiny as well. The vote not to recommend that children under age 4 receive a combined MMRV vaccine followed a re-evaluation of the risk of febrile seizures after the administration of that vaccine. Some members were confused last month when they first voted on the recommendation , learning in real time that the decision could leave some parents paying for the vaccine out of pocket. Currently, the combined MMRV shot accounts for about 15% of first doses of the vaccines against the diseases, with most people getting the split shot that the CDC now recommends, according to the CDC . The agency may go a step further and separate the combined MMR vaccine, according to O’Neil, who said in a post on X Monday that he wanted vaccine manufacturers “to develop safe monovalent vaccines to replace the combined MMR.” The ACIP group also debated, and ultimately postponed, a vote on delaying the hepatitis B birth dose, an idea that received significant pushback from clinicians and key Republican Senator Bill Cassidy (R-LA). President Donald Trump subsequently said in a press conference that he thinks the hepatitis B vaccine should be delayed until age 12, advice that runs counter to medical experts who have said the birth dose protects newborns in case their mother wasn’t screened for the virus during pregnancy. Despite replacing specific recommendations with guidance that people talk with a healthcare provider, the new Covid-19 recommendations should still allow for broad insurance access. The new guidance, formally referred to as shared clinical-decision making, “allows for immunization coverage through all payment mechanisms,” according to the CDC. The group of vaccine advisors is currently scheduled to meet again later this month, but that’s likely to change. An administration official familiar with the planning told Endpoints News last week that the CDC is considering pushing the meeting to December.