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

November 12, 2024 3:00 am ET RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that new clinical and real-world data for the company’s 9-valent Human Papillomavirus (HPV) vaccine, GARDASIL ® 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), evaluating the burden and incidence of certain HPV-related cancers and diseases, will be presented at the International Papillomavirus Conference (IPVC) 2024 in Edinburgh, UK, from November 12-15. Data to be presented include results from the BROADEN and PROGRESS studies evaluating the prevalence of oral HPV infection and burden of HPV-related oropharyngeal and other head and neck cancers, as well as studies evaluating the age of disease-causal HPV infection among females and highlighting the importance of protecting both females and males from HPV-related cancers and diseases through vaccination. “These data support the value of adult vaccination and strengthen our understanding that disease-causal HPV infection can happen later in life, reinforcing the importance of HPV vaccination for both females and males beginning at age 9,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “While historically the HPV vaccination conversation has focused on preventing certain HPV-related cervical cancers in women, we also continue to see the growing incidence of HPV-related oropharyngeal and other head and neck cancers, particularly in men. In both men and women globally, there are approximately 666,000 new diagnoses of certain HPV-related cancers annually. The breadth of data we are presenting at the conference continues to demonstrate the link between HPV and certain HPV-related cancers in males and females and the role HPV vaccination can play in prevention.” Details on key abstracts for Merck: New Data Analyses of HPV-Related Cancers and Diseases in Women and Men Abstract Title Details Immunogenicity Of 9-Valent HPV (9VHPV) Vaccine In Male Clinical Trial Participants: A Post-Hoc Analysis By Baseline Demographic Characteristics. A. Luxembourg. ID #2172. TOPIC AS02: CLINICAL RESEARCH. CLINICAL SCIENCE ORAL ABSTRACT SESSION 05: HPV VACCINES Sequential Human Papillomavirus Infection Between Anogenital Anatomical Sites In Men. G. Nahhas. Poster #230. Session: 1 Estimating The Age of Acquisition of Disease-Causal HPV Infection Onset In Women Who Develop CIN2+ In England. K. Engelbrecht. Poster #209. Session: 1 Estimating The Age Of Disease-Causal HPV Infection Based On The Natural History Of CIN2+ Among Females In Canada. A. Cherif. Poster #219. Session: 2 Data Assessing Burden of Oral HPV Infection and HPV-Related Head and Neck Cancers in Men and Women Abstract Title Details Oral Human Papillomavirus Prevalence And Genotyping Among Adults In The United Kingdom – PROGRESS Study. O. Ovcinnikova. Poster #229. Session: 1 Oral Human Papillomavirus Incidence Among A General Adult Population In The US: Results From The PROGRESS (Prevalence Of Oral HPV Infection, A Global Assessment) Study. M. Felsher. Poster #228. Session: 1 Preliminary Results Of The BROADEN Study: Burden Of Human Papillomavirus-Related Head And Neck Cancers. T. Waterboer. ID#1292. TOPIC AS03: PUBLIC HEALTH, EPIDEMIOLOGY AND IMPLEMENTATION SCIENCE. ORAL ABSTRACTS SESSION 01: HPV AND HPV-DRIVEN CANCER IN THE HEAD AND NECK The BROADEN-China Study: Increasing Burden of Human Papillomavirus-Related Head and Neck Cancers in China. S. Zhang. ID#2397. TOPIC AS03: PUBLIC HEALTH, EPIDEMIOLOGY AND IMPLEMENTATION SCIENCE. ORAL ABSTRACTS SESSION: PUBLIC HEALTH LATE BREAKING ORAL ABSTRACTS Indication for GARDASIL 9 GARDASIL 9 is a vaccine indicated in females 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58; cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11 . GARDASIL 9 is indicated in males 9 through 45 years of age for the prevention of anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11. The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. GARDASIL 9 does not eliminate the necessity for vaccine recipients to undergo screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers as recommended by a health care provider. GARDASIL 9 has not been demonstrated to provide protection against diseases caused by: - HPV types not covered by the vaccine - HPV types to which a person has previously been exposed through sexual activity Not all vulvar, vaginal, anal, oropharyngeal and other head and neck cancers are caused by HPV, and GARDASIL 9 protects only against those vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58. GARDASIL 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers; or cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal intraepithelial neoplasia (AIN). Vaccination with GARDASIL 9 may not result in protection in all vaccine recipients Select Safety Information for GARDASIL 9 GARDASIL 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]. Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following HPV vaccination. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion. Safety and effectiveness of GARDASIL 9 have not been established in pregnant women. The most common (≥10%) local and systemic adverse reactions in females were injection-site pain, swelling, erythema, and headache. The most common (≥10%) local and systemic reactions in males were injection-site pain, swelling, and erythema. The duration of immunity of a 2-dose schedule of GARDASIL 9 has not been established. Dosage and Administration GARDASIL 9 should be administered intramuscularly in the deltoid or anterolateral area of the thigh. For individuals 9 through 14 years of age, GARDASIL 9 can be administered using a 2-dose or 3-dose schedule. For the 2-dose schedule, the second dose should be administered 6–12 months after the first dose. If the second dose is administered less than 5 months after the first dose, a third dose should be given at least 4 months after the second dose. For the 3-dose schedule, GARDASIL 9 should be administered at 0, 2 months, and 6 months. For individuals 15 through 45 years of age, GARDASIL 9 is administered using a 3-dose schedule at 0, 2 months, and 6 months. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . About Merck’s global commitment to supply and access to HPV vaccines Merck is committed to ensuring adequate global supply and supporting broader, equitable access to our HPV vaccines to help protect against certain HPV-related cancers and diseases. This commitment is enabled through significant capital investments, including more than $2 billion to help increase capacity through additional manufacturing facilities that allowed for a nearly doubling of supply of our HPV vaccines from 2017-2020 and then, supply was doubled again between 2020-2024 to address increasing global demand. As a result, we expect to supply sufficient quantities of our HPV vaccines to meet anticipated demand and will continue to expand supply capacity in the future. Global equitable access to our HPV vaccines is a key part of our efforts and key partnerships help us achieve these goals. In 2024, Merck reaffirmed its commitment to Gavi, the Vaccine Alliance, through an agreement with UNICEF, to supply low- and middle-income countries with over 115 million doses of HPV vaccine by 2025, to appropriately support local immunization programs. Merck has consistently increased our supply commitment to Gavi from 1.7 million doses in 2017 to more than 30 million doses in 2024. Additionally, we are working to ensure continued supply in countries with existing HPV vaccination programs and currently supply approximately 150 National Immunization Programs globally. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( www.sec.gov ). Please see Prescribing Information for GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) at https://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_pi.pdf a nd Patient Information/Medication Guide for GARDASIL 9 at https://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_ppi.pdf Media Contacts: Julie Cunningham +1 (617) 519-6264 Muchena Zigomo +1 (267) 309-5591 Investor Contacts: Peter Dannenbaum +1 (732) 594-1579 Damini Chokshi +1 (732) 594-1577 Source: Merck & Co., Inc.

Coming out of Covid, the vaccine market appeared to experience a renaissance as the innovations of the pandemic unleashed new products and a new impetus to prevent infections. But just a few years later, the sector is facing headwinds in China, a weakening market for RSV vaccines in the West, and an incoming White House that’s allied itself with a leading vaccine skeptic, Robert F. Kennedy Jr. Kennedy, a longtime anti-vaccine advocate, is expected to have a significant hand in the Trump administration’s drug and food policy, and the campaign has talked about having him lead a review of vaccine safety. That political development has spooked investors. On Wednesday morning, the day after the election, shares of major vaccine developers fell, including a 2.9% dip for GSK and 5% for Moderna. In the hours after the election, Kennedy said he doesn’t plan to try and take vaccines off the market — an idea that would be difficult in any case, given how the FDA functions. “If vaccines are working for somebody, I’m not going to take them away,” he told NBC News. “People ought to have choice and that choice ought to be informed by the best information.” But Kennedy’s possible elevation is almost certain to grow a trend of vaccine hesitancy in the US, which has seen some rates of childhood vaccination decline even before the Covid-19 pandemic disrupted some routine preventive healthcare. On Wednesday, in an interview at the Financial Times’ Global Pharma and Biotech Summit in London, GSK CEO Emma Walmsley said transparency is key to rebuilding faith in vaccines. “You don’t just shout, ‘Trust us,'” she said. “You bring the facts forward, and I hope science and truth will prevail.” The uncertainty over the Trump administration’s health policies comes amid trouble in China. Merck has wrestled with a broader corruption crackdown that’s put a damper on sales of Gardasil , and GSK said the economic slowdown there has impacted vaccine volumes. After a rapid launch of the RSV vaccines approved last year, this year has shown far weaker sales. Pfizer’s third-quarter sales dropped 5%, while GSK had a massive 73% decline compared to the third quarter of 2023. Moderna, which had its adult vaccine approved over the summer, reported just $10 million in revenue , well below the other two pharmas. The figures validate pessimism heading into the vaccination campaign after the CDC slightly narrowed its RSV recommendations over the summer , and executives at all three vaccine manufacturers pointed to the revised recommendations as impacting the market in the second season. Vaccine prescription data through the last week of October showed continued decline for both GSK and Pfizer's RSV shots, with roughly 1.5 million total inoculations, compared with four million through the same period in 2023, according to Jefferies. Moderna is capturing just 1% of the market share, leaving analysts to conclude that this year will be “negligible” for the company. And GSK adjusted its guidance for vaccine sales, expecting low single-digit decline in 2024 after originally forecasting low-to-mid single-digit growth. Moderna CEO Stéphane Bancel said Thursday that pharmacies and patients are prioritizing Covid and flu vaccines this fall, suggesting more RSV shots could come at the beginning of the new year. "I think it will be quite interesting to see what happens in Q1 potentially, and does the shape of a curve of RSV look different than what we saw in the previous season," he said. That the once-beaming RSV opportunity — which public health experts have hailed as a great breakthrough — could slide so quickly is alarming to vaccine makers and investors. Advisors to the CDC don’t seem to be itching to swiftly expand the recommended age groups either, holding firm on its new guidance when the Advisory Committee on Immunization Practices convened in October. There have been a few bright spots. Moderna on Thursday surprised investors by exceeding Covid-19 vaccine sales estimates for the third quarter and posting a profit. Bancel said that earlier FDA approval of the updated vaccines allowed the company to better meet demand. And Pfizer is seeing stabilizing demand for their Covid-19 shots. CEO Albert Bourla told investors recently that he expects the company will stop segmenting out its Covid business, equipped with a more sure sense of demand moving forward. "We will stop separating our business to Covid/non-Covid because it's Pfizer business," he said.