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Last update 09 Dec 2025

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

Last update 09 Dec 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Virus-like particle vaccine, Prophylactic vaccine, Multivalent vaccine

+ [1]

Synonyms

Human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle vaccine, Human papillomavirus (types 6, 11, 16, 18) L1 VLP vaccine, Human papillomavirus quadrivalent (types 6, 11, 16, 18) recombinant vaccine

+ [14]

Target-

Action-

Mechanism-

Therapeutic Areas

NeoplasmsInfectious DiseasesDigestive System Disorders+ [2]

Active Indication

Anal intraepithelial neoplasiaHuman Papillomavirus-Related Anus NeoplasmsAnal Precancerous Condition+ [10]

Inactive Indication

HPV16 InfectionHuman Papillomavirus-Related Cervical Adenocarcinoma In SituHuman Papillomavirus-Related Cervical Intraepithelial Neoplasia+ [5]

Originator Organization

Emmanuel College, University of Queensland

Active Organization

Merck Sharp & Dohme BV

Merck Sharp & Dohme Corp.Merck Sharp & Dohme LLC

+ [1]

Inactive Organization

Merck Sharp & Dohme (Ireland) Ltd.

SK bioscience Co., Ltd.

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (08 Jun 2006),

Human Papillomavirus Infection

Regulation-

114

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

NCT07256912

/ Not yet recruitingPhase 4IIT

A Randomized, Active Controlled, Assessors-blind Trial to Establish Non-inferiority of Immunogenicity of a Single-dose of CERVAVAC® Quadrivalent HPV Vaccine Compared to the Gardasil® Quadrivalent Vaccine Among Girls and Boys Aged 9 to 14 Years and in Girls/Women Aged 15 to 20 Years in Zambia

The goal of this study is to compare the immune response of the single dose of the CERVAVAC vaccine with the single dose of Gardasil vaccine in girls/women aged 9 to 20 and boys aged 9 to 14 at 6 months, 12 months and 24 months post vaccination. The vaccine will be given randomly to the boys and girls/women in these age group and they will be followed up to check the immune status developed in them after vaccination. The status of immune response developed by the two differnet vaccines will be compared in these group of participants of the study.

Start Date15 Jan 2026

Sponsor / Collaborator

International Agency for Research on Cancer

NCT06650956

/ RecruitingNot ApplicableIIT

Integrated Service Delivery to Improve Adolescent Health and HPV Vaccination in Lao PDR: a Quasi-Experimental Mixed-Methods Study

The goal of this study is to find out if adding HPV vaccination to adolescent health services works to increase HPV vaccine uptake in 10-13-year-old girls in Laos. The study will also look at the effects of adding HPV vaccination on the use of other health services in 10-13-year-old boys and girls.
The main questions the study aims to answer are:
1. Does adding HPV vaccination to adolescent health services increase HPV vaccine uptake in girls aged 10-13 years compared to girls who only receive standard HPV vaccination services?
2. Does adding HPV vaccination to adolescent health services increase the use of other health services in 10-13-year-old adolescent boys and girls compared to adolescents who only receive standard HPV vaccination services?
3. What are the barriers and facilitators to using the combined intervention in Laos?
4. What are the opinions of adolescents, caregivers, healthcare providers, and other stakeholders on the combined intervention?
5. How much does it cost and how well it works to combine HPV vaccination with adolescent health services, as opposed to providing HPV vaccination alone?
Researchers will compare a combined intervention to standard HPV vaccination services to see if the combined intervention works to increase HPV vaccination uptake and the use of other health services. The combined intervention includes HPV vaccination given at schools, health facilities, and through community outreach. It also includes education on sexual and reproductive health, counseling, and other health services. Participants in the combined intervention group will:
1. Receive the HPV vaccine at school or at a health facility.
2. Take part in group discussions about sexual and reproductive health.
3. Take part in individual counseling sessions.
4. Use other health services as needed.
Participants in the comparison group will receive standard HPV vaccination services, including:
• HPV vaccination given at schools, health facilities, and through community outreach.

Start Date01 Nov 2024

Sponsor / Collaborator

Health Ltd.

[+1]

CTRI/2024/08/072040

/ Not yet recruitingPhase 2IIT

Antibody Response following One Dose of Cervavac® as compared to One Dose of Gardasil® Vaccine in Healthy Girls Aged 9-14 Years: A Non-inferiority, Multicenter, Double-blind, Randomized Controlled trial - Academic HPV Vaccine Trial

Start Date30 Aug 2024

Sponsor / Collaborator

Indian Council of Medical Research

100 Clinical Results associated with Human papillomavirus quadrivalent (types 6, 11, 16, 18) vaccine, recombinant(Emmanuel College, University of Queensland)

100 Translational Medicine associated with Human papillomavirus quadrivalent (types 6, 11, 16, 18) vaccine, recombinant(Emmanuel College, University of Queensland)

100 Patents (Medical) associated with Human papillomavirus quadrivalent (types 6, 11, 16, 18) vaccine, recombinant(Emmanuel College, University of Queensland)

634

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

31 Dec 2025·Human Vaccines & Immunotherapeutics

Adverse events following 9-valent human papillomavirus vaccine (GARDASIL® 9) reported to the Vaccine Adverse Event Reporting System (VAERS), 2015–2024

Article

Author: Liang, Guojun ; Song, Yang ; Liu, Qiong

GARDASIL 9, a 9-valent HPV vaccine approved in 2014, is widely administered for the prevention of HPV-related malignancies. Although clinical trials demonstrated a favorable safety profile, rare or delayed-onset adverse events may not be captured pre-licensure. Post-marketing surveillance using VAERS offers a complementary approach for signal detection and safety monitoring. We conducted a retrospective pharmacovigilance analysis of VAERS reports following GARDASIL 9 administration from January 1, 2015 to December 31, 2024. Adverse events were encoded using MedDRA v26.0 and categorized by System Organ Class. Disproportionality analyses using four independent algorithms (ROR, PRR, IC, EBGM) were applied to identify positive safety signals. Subgroup assessments included serious reports, death reports, and reports in pregnant individuals. Among reported events, most were non-serious and consistent with known reactogenicity patterns, including syncope, headache, and injection site reactions. However, signals were also detected for certain events not listed in product labeling, including postural orthostatic tachycardia syndrome, eye movement disorder, autoimmune thyroiditis, and posture abnormality. In 57 death reports, neurological terms showed signal elevation but lacked consistent etiologic patterns. No positive signals were detected in the 18 pregnancy-associated reports. This VAERS-based analysis supports the established safety of GARDASIL 9 while highlighting rare signals that warrant further investigation. Given the limitations of passive surveillance, integration with active monitoring systems is essential to refine safety profiles and support ongoing public health vaccination efforts.

31 Dec 2025·Human Vaccines & Immunotherapeutics

Real-world safety of HPV vaccines over 18 y: A comprehensive analysis of U.S. VAERS reports

Article

Author: Wei, Jinbao ; Huang, Yirong ; Fu, Honghong ; Zhou, Yanyan ; Wang, Xinjin ; Su, Yonglong ; Wu, Xiaohong

Human papillomavirus (HPV) vaccination is central to preventing cervical and other HPV-associated cancers. Although clinical trials have established favorable safety profiles, long-term, brand-specific real-world data remain limited. We evaluated adverse events (AEs) reported to the U.S. Vaccine Adverse Event Reporting System (VAERS) for Cervarix® (bivalent), Gardasil® (quadrivalent), and Gardasil-9® (9-valent) between January 2006 and December 2024. Domestic VAERS reports listing ≥1 HPV vaccine were extracted, deduplicated, and classified by brand. Disproportionality analyses were performed using reporting odds ratios (RORs) and 95% confidence intervals (CIs), adjusting for multiplicity with a 5% Benjamini - Hochberg false discovery rate (FDR). Time-to-onset was assessed with Kaplan-Meier analysis. This analysis of 76,575 HPV vaccine adverse event reports shows improving safety profiles across vaccine generations. Serious adverse events decreased significantly from Cervarix® (33.4%) to Gardasil® (16.2%) to Gardasil-9® (7.8%). The most common signals were presyncope for Cervarix® (ROR 11.5) and administration errors for Gardasil® and Gardasil-9®, including inappropriate scheduling (ROR 19.5) and incorrect storage (ROR 12.1). Most adverse events (82.9%) occurred within 7 d post-vaccination, with 62.5% occurring on the same day. Gardasil-9® exhibited the narrowest IQR for time to onset (0-1 d), compared to other HPV vaccines. HPV vaccines demonstrate a consistent, favorable safety profile in U.S. real-world practice. Most reported AEs were acute vasovagal reactions, and strongest signals reflected preventable errors. Strengthening provider education in cold-chain management and schedule adherence may further enhance vaccine safety. Continued active surveillance is recommended.

31 Dec 2025·Expert Review of Vaccines

Post-marketing surveillance for the safety of the quadrivalent human papillomavirus vaccine: a retrospective real-world study in China

Article

Author: Meng, Ruogu ; Wang, Jianmei ; Ma, Rui ; Liu, Peipei ; Liu, Zhike ; Zhan, Siyan ; He, Bingjie ; Liu, Zuoxiang ; Yang, Yu

BACKGROUND:

The potential occurrence of autoimmune- and pregnancy-related adverse events with the quadrivalent human papillomavirus (4vHPV) vaccine has previously not been assessed in the real-world setting in China.

RESEARCH DESIGN AND METHODS:

A retrospective active post-marketing surveillance of the 4vHPV vaccine has been conducted among Chinese women aged 20-45 years between January 2018 and March 2021 in the Ningbo city. Incidences of seven pre-specified autoimmune diseases diagnosed within 6 months after the 4vHPV vaccination were calculated. Cases of stillbirth and 23 congenital anomalies diagnosed within 3 months from birth in infants were collected in women with maternal exposure to the 4vHPV vaccine.

RESULTS:

A total of 195,593 doses of the 4vHPV vaccine were administered to 76,212 women. New-onset cases of autoimmune diseases were diagnosed in 113 women, comprising 71 cases of Hashimoto's disease (130.84/100,000 person-years), 24 cases of Graves' disease (44.21/100,000 person-years), 1 case of optic neuritis (1.84/100,000 person-years), and 17 cases of uveitis (31.31/100,000 person-years). Among the 168 women with maternal exposure to the 4vHPV vaccine, five cases of congenital heart disease were observed in their infants.

CONCLUSIONS:

These findings confirm the favorable benefit/risk profile of the 4vHPV vaccine in Chinese women in the routine healthcare setting.

204

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

24 Nov 2025

·www.fiercepharma.com

In Q3, drugmakers saw a marked decline in US vaccine sales as Eli Lilly kicked into higher gear

Major vaccine makers reported significant declines in U.S. sales and demand in the third quarter. Anti-vaccine sentiment is alive and well, especially in the U.S. And it was evident in recent weeks as drugmakers revealed their third-quarter earnings, replete with declining vaccine sales.Pfizer’s numbers (PDF) were particularly indicative of the erosion in demand for immunizations in the U.S. While sales of its Prevnar franchise of pneumococcal vaccines were up 18% year over year outside of the U.S., they were down 12% in the U.S. The same was true of COVID shot Comirnaty, which saw a 9% sales increase internationally and a 25% decline domestically.Meanwhile, sales of Pfizer’s new respiratory syncytial virus (RSV) vaccine Abrysvo were up 81% outside of the U.S. and down 34% in the U.S., with CEO Albert Bourla, Ph.D., saying the company was “experiencing the headwind of a more difficult-to-activate population as we enter the third season of RSV.”Sanofi, for its part, sustained an 8% year-over-year decline in its vaccine revenues, with Chief Financial Officer François Roger noting a “negative buzz” around the jabs. In the company's earnings announcement, CEO Paul Hudson attributed the shortfall to “increased price competition and lower vaccination rate.”GSK managed to squeak out a 2% overall increase in vaccine revenue despite a 15% decline of sales in the U.S., which the company chalked up largely to plummeting demand for its shingles jab Shingrix.As for Merck, which has been hindered for more than a year by declining demand in China for its HPV shot Gardasil, sales of each of its vaccines were down in the third quarter except for Capvaxive, which CFO Caroline Litchfield said is off to a “very strong launch.” The shot, which is the first designed specifically to prevent pneumococcal disease in adults, has generated sales of $530 million in its first four quarters on the market. The third-quarter results were even more grim for companies that specialize in vaccines and depend largely on U.S. sales. Moderna sustained a 45% year-over-year decrease in revenue during the quarter as its RSV shot mResvia drummed up sales of just $2 million and its COVID vaccine Spikevax pulled in $971 million, which was down from $1.8 billion during the same period last year. With the result, Moderna reduced the top end of its 2025 guidance from $2.2 billion to $2 billion.Another company that has been impacted by declining demand for vaccines has been CSL. Last month, the Australian drugmaker backtracked on its plan to spin out its vaccine division, CSL Seqirus, because of the “heightened volatility in the current U.S. influenza vaccine market,” Chairman Brian McNamee explained. He added that the timing of the transaction would “not fully capture Seqirus’ value potential.”Citing insurance claims data, CSL’s leaders said they expect this season's flu vaccination rates in the U.S. to decline by 12% overall and by 14% for people ages 65 and older compared with last year. Lilly is No. 1 again Among the industry's largest companies, there was no surprise at the top of the growth rankings as Eli Lilly pulled off a whopping 54% increase. It was the fourth straight period in which the Indianapolis company delivered the highest sales bump among large biopharma companies. It also was the largest quarterly sales bump for a top-25 drugmaker since the COVID years.The performance is more evidence that Lilly has widened the gap on its rival in the diabetes and obesity market, Novo Nordisk. The Danish company had just a 5% revenue increase in the third quarter. Novo also saw a 2% quarter-to-quarter sales slide, which was its second straight period with a sequential revenue decline.Lilly’s boost was fueled by sales of its tirzepatide products, which exceeded $10 billion for the quarter. The figure included $6.5 billion sales for diabetes drug Mounjaro and $3.6 billion for obesity treatment Zepbound.The only time in history that a single drug has exceeded sales of $10 billion in a quarter came in the COVID years, when Pfizer and BioNTech’s Comirnaty passed the threshold in three straight periods, maxing out at $13.2 billion in the first quarter of 2022. On its current trajectory, sales of tirzepatide products figure to increase again in the coming periods. The scale-up has been remarkable this year, starting at $6.1 billion in the first quarter. In the second quarter, tirzepatide’s combined sales finally topped those of Novo’s semaglutide products, which was significant because Novo’s Ozempic was first to the market in 2017, compared to Mounjaro, which came along five years later.Tirzepatide also has supplanted Merck’s cancer treatment Keytruda as the current top-selling drug, a crown it has held since 2023. Through the first three quarters of the year, tirzepatide has generated sales of $24.8 billion compared to $23.2 billion for Keytruda. Big gainers in Q3 No company in the industry approached Lilly’s revenue bump in the quarter. The only other top-25 companies by sales that achieved a double-digit increase in the third quarter were the Japanese duo of Astellas (13%) and Daiichi Sankyo (12%), followed by Amgen (12%), AstraZeneca (11%) and Vertex (11%).Another company that thrived in the third quarter was AbbVie, with a 9% sales gain thanks in large part to Skyrizi, which the company is now projecting will achieve sales of $17.3 billion this year, up from $11.7 billion in 2024. The Illinois company also is back in the good graces of investors as it enjoyed a 25% increase in its market cap in the third quarter, according to a report from GlobalData.Johnson & Johnson, meanwhile, turned in a 7% sales increase, which was its largest quarterly boost since 2023. The showing is further evidence that J&J’s shedding of its consumer health unit has helped facilitate growth. Two of the catalysts for the performance were autoimmune star Tremfya, which grew sales 41% to $1.4 billion, and depression drug Spravato, which became a blockbuster last year and accomplished a 61% sales increase in the third quarter.Amgen’s double-digit increase (PDF) came on top of 9% increases in the first two quarters of this year as the company appears to be hitting its stride after its 2023 acquisition of Horizon Therapeutics. There were many plusses with Amgen, including its biosimilars, which were up 52% thanks largely to its Eylea knockoff, Pavblu. Its older medicines, like Prolia and Repatha—both on the market for more than a decade—had big surprise sales boosts in the third quarter. AbbVie, J&J and Amgen were among the group of drugmakers that bumped up their annual revenue projection after reporting third-quarter numbers. The only top-25 companies that reduced their annual revenue estimates were Takeda (PDF) and Merck, which dropped its projection by $300 million as Keytruda’s sales in the third quarter failed to meet expectations.Lilly increased (PDF) its guidance by more than $2 billion, while Bristol Myers Squibb bumped up (PDF) its estimate by $1.2 billion. Despite its U.S. vaccine sales struggles, GSK boosted (PDF) the top end of its 2025 revenue projection from an increase of 5% to 7%. Astellas and Daiichi each increased (PDF) their revenue projection by 100,000 million Japanese yen, which works out to about $650 million. U.S. rebound continued in Q3 Aside from the decline in vaccine sales, it was a strong quarter for biopharma overall as 21 of the world’s top 25 drugmakers achieved year-over-year revenue increases.It was another period of recovery following an unusual first quarter in which seven of the world’s top 25 companies saw falling sales, with each of the seven decliners based in the U.S. In the second quarter, the trend faded as four of the seven U.S. companies accomplished sales increases. Then, in the third quarter, Pfizer was the only U.S. company that sustained a revenue decrease.Of the non-U.S. companies that saw their sales decline in the third quarter, none were a surprise. Takeda had the largest sales falloff (PDF) among the industry’s top 25 companies at 8%, which matched its decline in the previous quarter. Meanwhile, Roche was down by 1% after a flat performance in the second quarter. Bayer was the other decliner (PDF), at 3%, following a trend that has been in place since 2023.

VaccineAcquisitionDrug ApprovalIPOClinical Result

07 Nov 2025

·www.biospace.com

Pesky ‘Macro Factors’—aka RFK Jr.—Come for Vaccine Pharmas’ Wallets

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

VaccinemRNA

31 Oct 2025

·pharma.economictimes.indiatimes.com

Merck posts higher third-quarter sales as Keytruda offsets drop in HPV vaccine

Bengaluru: Merck & Co posted higher third-quarter revenue on Thursday, as growth from its blockbuster cancer drug Keytruda offset falling sales from human papillomavirus vaccine Gardasil in China. However, shares fell nearly 2% after Merck lowered the high end of its revenue forecast for the full year. It now expects revenue of $64.5 billion to $65.0 billion compared with its prior view of $64.3 billion to $65.3 billion. J.P.Morgan analysts called the quarterly beat "modest," adding the annual forecasts were "largely reiterated." Merck shares have fallen about 5% so far in 2025, as investors weigh the company's efforts to grow beyond Keytruda against broader industry headwinds, including potential U.S. drug pricing reforms. "We do expect continued growth in Keytruda, albeit at a slightly slower pace than we've seen as we are getting to peak penetration in some of the indications, and we do expect some headwind from price in our ex-U.S. markets," said CFO Caroline Litchfield. Merck is working to add new drugs to its pipeline before Keytruda faces competition from cheaper biosimilars later this decade. The company is focusing on newer drugs, including lung disease treatments Winrevair, from its 2021 acquisition of Acceleron Pharma, and Ohtuvayre, which was recently acquired in a $10 billion takeover of UK-based Verona Pharma. Sales of Winrevair rose 141% to $360 million in the quarter. However, Bernstein analyst Courtney Breen said the drug's sales were materially below expectations, calling it "not a good sign for a key growth driver for the company." Merck posted revenue of $17.28 billion in the quarter, compared with analyst estimates of $16.96 billion, according to LSEG data. On an adjusted basis, the company earned $2.58 per share, topping Wall Street estimates by 23 cents. Sales of immunotherapy Keytruda rose 10% to $8.1 billion in the quarter. Gardasil sales fell to $1.75 billion, but came in ahead of the Wall Street forecast of $1.66 billion. The company has not been making new shipments of the vaccine for China. It has said distributors there are working through their inventories after a fall in demand due to pressure on consumer spending in the country. Excluding China, Gardasil sales fell 3%, mainly due to lower sales in Japan following the end of reimbursement for the catch-up vaccination program. Merck said it expects full-year earnings of $8.93 to $8.98 a share, compared with its prior forecast of $8.87 to $8.97. (Reporting by Michael Erman and Christy Santhosh in Bengaluru; Editing by Stephen Coates and Bill Berkrot)

AcquisitionVaccineIPODrug ApprovalImmunotherapy

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

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Anal intraepithelial neoplasia	China	Merck Sharp & Dohme Corp.	02 Jan 2025
Human Papillomavirus-Related Anus Neoplasms	China	Merck Sharp & Dohme Corp.	02 Jan 2025
Anal Precancerous Condition	Japan	Merck Sharp & Dohme Corp.	25 Dec 2020
Adenocarcinoma in Situ	Japan	Merck Sharp & Dohme Corp.	01 Jul 2011
Uterine Cervical Cancer	Japan	Merck Sharp & Dohme Corp.	01 Jul 2011
Vulvar Neoplasms	Japan	Merck Sharp & Dohme Corp.	01 Jul 2011
Anus Neoplasms	European Union	Merck Sharp & Dohme (Ireland) Ltd.	19 Sep 2006
Anus Neoplasms	Iceland	Merck Sharp & Dohme (Ireland) Ltd.	19 Sep 2006
Anus Neoplasms	Liechtenstein	Merck Sharp & Dohme (Ireland) Ltd.	19 Sep 2006
Anus Neoplasms	Norway	Merck Sharp & Dohme (Ireland) Ltd.	19 Sep 2006
Condylomata Acuminata	European Union	Merck Sharp & Dohme (Ireland) Ltd.	19 Sep 2006
Condylomata Acuminata	Iceland	Merck Sharp & Dohme (Ireland) Ltd.	19 Sep 2006
Condylomata Acuminata	Liechtenstein	Merck Sharp & Dohme (Ireland) Ltd.	19 Sep 2006
Condylomata Acuminata	Norway	Merck Sharp & Dohme (Ireland) Ltd.	19 Sep 2006
Human Papillomavirus-Related Cervical Carcinoma	European Union	Merck Sharp & Dohme (Ireland) Ltd.	19 Sep 2006
Human Papillomavirus-Related Cervical Carcinoma	Iceland	Merck Sharp & Dohme (Ireland) Ltd.	19 Sep 2006
Human Papillomavirus-Related Cervical Carcinoma	Liechtenstein	Merck Sharp & Dohme (Ireland) Ltd.	19 Sep 2006
Human Papillomavirus-Related Cervical Carcinoma	Norway	Merck Sharp & Dohme (Ireland) Ltd.	19 Sep 2006
Precancerous Conditions	European Union	Merck Sharp & Dohme (Ireland) Ltd.	19 Sep 2006
Precancerous Conditions	Iceland	Merck Sharp & Dohme (Ireland) Ltd.	19 Sep 2006

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Uterine Cervical Dysplasia	NDA/BLA	China	Merck Sharp & Dohme Corp.	11 Jul 2023
Cervical Adenocarcinoma In Situ	Phase 3	China	Merck & Co., Inc.	31 Aug 2018
Human Papillomavirus-Related Cervical Adenocarcinoma In Situ	Phase 3	China	Merck Sharp & Dohme Corp.	31 Aug 2018
Human Papillomavirus-Related Cervical Intraepithelial Neoplasia	Phase 3	China	Merck Sharp & Dohme Corp.	31 Aug 2018
Glandular and Epithelial Neoplasms	Phase 3	-	Merck Sharp & Dohme LLC	01 Apr 2006
Neoplasms	Phase 3	-	Merck Sharp & Dohme Corp.	16 Jun 2004
Cervical Intraepithelial Neoplasia	Phase 3	-	Merck Sharp & Dohme LLC	14 Jun 2002
Vagina Carcinoma	Phase 3	-	Merck Sharp & Dohme Corp.	01 Dec 2001
Vaginal intraepithelial neoplasia	Phase 3	-	Merck Sharp & Dohme Corp.	01 Dec 2001
Vulvar intraepithelial neoplasia	Phase 3	-	Merck Sharp & Dohme Corp.	01 Dec 2001

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00798265 (CTgov)	Phase 1	Human Papillomavirus Infection \| HIV Infections	26	Survey+Gardasil (Cohort 1 - 0.5 mL Dose Injected Intramuscular (IM))	cwhypmqhpn = raikzbuceo kmbuyibzrq (lqouwpoixw, aatednvppj - pvdhsfqumh) View more	-	20 Nov 2024
				Survey+Gardasil (Cohort 3 - 0.5 mL Dose Injected Intramuscular (IM))	gjcooejjyz(ajaplkjisl) = mwpelvckkj pxzvjcjayb (auueugqcey, wsevyhahmp - ziamsiqify) View more
NCT00122681 \| NCT00169494 \| NCT00092534 (NCT00122681, NCT00169494, NCT00092534, Pubmed \| BMJ Open)	Phase 3	HPV-related carcinoma	3,341	Human papillomavirus vaccine (non-HPV-vaccinated cohorts)	cnsdhxtxoo(dskdnzlyfa) = ryrdkpopix dpiaaihbxb (gqplqcllju )	-	30 Dec 2021
NCT00090285 (Pubmed \| Clin Infect Dis)	Phase 3	Human Papillomavirus Infection	1,399	HPV Vaccine (Heterosexual men (HM))	mqnugoycpo(unpsveatev) = nywyiljcgn idgjxvpuwx (fwcsefeouh )	-	15 Jul 2021
				HPV Vaccine (Men who have sex with men (MSM))	mqnugoycpo(unpsveatev) = zemdwzomeq idgjxvpuwx (fwcsefeouh )
NCT03493542 (Pubmed) Manual	Phase 3	Human Papillomavirus Infection	766	The quadrivalent human papillomavirus Vaccine (aged 9-19 years)	jgzttzvqpu(dbkhgihpde) = Anti-HPV6/11/16/18 antibody GMTs at Month 7 in participants aged 9-19 years were non-inferior to those in participants aged 20-26 years. iasdgmqgsl (xmskgjivet ) View more	Positive	22 Jan 2021
				The quadrivalent human papillomavirus Vaccine (aged 20-26 years)
NCT01928225 (CTgov)	Phase 2	Squamous Intraepithelial Lesions of the Cervix \| HIV Infections	180	Human Papillomavirus vaccine (Human Papillomavirus Vaccine)	anpdwyzldp = aktewkdpyu tchxompkxw (azaiicwiyt, ffxlwkjwss - gputbaovdj) View more	-	24 Jun 2020
				Human Papillomavirus vaccine (Saline Placebo)	anpdwyzldp = qlufoiqymm tchxompkxw (azaiicwiyt, nqjsicilzf - xghnoppire) View more
NCT02199691 (CTgov)	Phase 2	Meningitis, Meningococcal	1,715	Meningococcal Polysaccharide (Serogroups A, C, Y, and W13 (Group 1: MenACYW Conjugate Vaccine)	cgdmuctalt = phfwxhyynm cqiglqdbiq (pvxjutndgp, cgqltwpcke - qsaqhuyprj) View more	-	09 Jun 2020
				W135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine+Meningococcal (Groups A, C, Y and W135) Oligosaccharide (Group 2: MENVEO® Vaccine)	cgdmuctalt = tiznwupvod cqiglqdbiq (pvxjutndgp, vhyeswmrfd - mrzrsnlovk) View more
NCT03493542 (V501-213, CTgov)	Phase 3	Human Papillomavirus-Related Cervical Adenocarcinoma In Situ \| Human Papillomavirus-Related Cervical Intraepithelial Neoplasia \| Human Papillomavirus-Related Cervical Carcinoma	766	V501	qpfxpxucwu(ochqoloywo) = tmntzwdmnq bogcppewvp (xnbegidtdi, kvdndvylfx - jrwttuuxvn) View more	-	04 May 2020
NCT02576054 (V501-200, Pubmed \| Jpn J Infect Dis) Manual	Phase 3	Human Papillomavirus Infection	99	Quadrivalent HPV Vaccine	fgdczunhxb(zipcamcumx) = tzmbgiwhxu rjvolfvpbx (qfcybviifh, 94.4 - 100.0) View more	Positive	19 Sep 2019
NCT01424644 (Pubmed \| Infect Dis Ther)	Phase 4	-	801	Quadrivalent Human Papillomavirus Vaccine (HPV4 + Tdap + MenACWY)	fvcvxlnhfr(skizamlipt) = jimvvhfqhe hvwyeqzgpg (tpzkzsnjil )	-	01 Sep 2019
NCT01092195 (CTgov)	Phase 1	-	64	Gardasil (Transplant With Immunosuppression)	iyalobfqlz = lupqjrsxjo obghctcgjl (oaxohlgksq, iipfemtbro - fhgueskfdc) View more	-	01 Jul 2019
				Gardasil (Transplant With no Immunosuppression)	iyalobfqlz = jjstkwlzey obghctcgjl (oaxohlgksq, skfonyxubh - idertrofzd) View more

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