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CDC's ACIP Unanimously Votes to Provisionally Recommend Use of Merck's VAXNEUVANCE(TM) (Pneumococcal 15-valent Conjugate Vaccine) as an Option for Pneumococcal Vaccination in Infants and Children

MRK

VAXNEUVANCE is the first new pneumococcal conjugate vaccine for pediatric populations to be recommended in almost a decade

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) unanimously voted to include VAXNEUVANCETM (Pneumococcal 15-valent Conjugate Vaccine) as a recommended option for vaccination in infants and children, including routine use in children under 2 years of age. Specifically, the ACIP voted to recommend that VAXNEUVANCE may be used as an option to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for children aged under 19 years according to currently recommended PCV13 dosing and schedules. Additionally, the ACIP unanimously voted to include VAXNEUVANCE in the Vaccines for Children program.

These provisional recommendations will be reviewed by the director of the CDC and the Department of Health and Human Services, and final recommendations will become official when published in the CDC’s Morbidity and Mortality Weekly Report (MMWR).

VAXNEUVANCE is indicated for active immunization for the prevention of invasive disease caused by the Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in individuals 6 weeks of age and older. VAXNEUVANCE is contraindicated for individuals with a severe allergic reaction (e.g., anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid. See additional Select Safety Information for VAXNEUVANCE below.

“VAXNEUVANCE includes key serotypes that continue to cause serious disease in children under 5 years of age, specifically the 13 serotypes shared with PCV13, and the two unique serotypes, 22F and 33F. Serotypes 3, 22F and 33F are responsible for more than a quarter of all invasive pneumococcal disease cases in children. Today’s vote reinforces the importance of VAXNEUVANCE as an option to help reduce the burden of invasive disease in the pediatric population,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “We applaud the ACIP and the CDC for their continued efforts to address invasive pneumococcal disease in children, and look forward to its final, published recommendations.”

Select Safety Information for VAXNEUVANCE for infants and children

Do not administer VAXNEUVANCE to individuals with a severe allergic reaction (e.g., anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid.

Some individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to VAXNEUVANCE.

Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination of premature infants should be based on the infant’s medical status and the potential benefits and possible risks.

The most commonly reported solicited adverse reactions in children vaccinated with a four-dose series at 2, 4, 6, and 12 through 15 months of age, provided as a range across the series, were: irritability (57.3% to 63.4%), somnolence (24.2% to 47.5%), injection-site pain (25.9% to 40.3%), fever ≥38.0°C (13.3% to 20.4%), decreased appetite (14.1% to 19.0%), injection-site induration (13.2% to 15.4%), injection-site erythema (13.7% to 21.4%) and injection-site swelling (11.3% to 13.4%).

The most commonly reported solicited adverse reactions in children and adolescents 2 through 17 years of age vaccinated with a single dose were: injection-site pain (54.8%), myalgia (23.7%), injection-site swelling (20.9%), injection-site erythema (19.2%), fatigue (15.8%), headache (11.9%) and injection-site induration (6.8%).

Vaccination with VAXNEUVANCE may not protect all vaccine recipients.

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 Twitter, Facebook, Instagram, YouTube and LinkedIn.

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. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. 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 the global outbreak of novel coronavirus disease (COVID-19); 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, 2021 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 VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine) at https://www.merck.com/product/usa/pi_circulars/v/vaxneuvance/vaxneuvance_pi.pdfand Patient Information/Medication Guide for VAXNEUVANCE at https://www.merck.com/product/usa/pi_circulars/v/vaxneuvance/vaxneuvance_ppi.pdf.