Merck Provides Update on FDA Review of Supplemental Biologics License Application for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for Use in Infants and Children

Rhea-AI Summary

Merck (NYSE: MRK) announced an extension of the Prescription Drug User Fee Act (PDUFA) date for their Pneumococcal 15-valent Conjugate Vaccine, VAXNEUVANCE, to July 1, 2022. The FDA requested additional analyses of data from pediatric studies, which Merck has provided. The vaccine is aimed at infants and children aged 6 weeks to 17 years for preventing invasive pneumococcal disease. Previously, VAXNEUVANCE received Priority Review from the FDA, and the company remains confident in the strength of its pediatric data.

Positive

• FDA extended PDUFA date to July 1, 2022, indicating progress in vaccine application.
• VAXNEUVANCE has received Priority Review status from the FDA.

Negative

• FDA requested additional data analyses, indicating potential delays in approval.

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date of the supplemental biologics license application (sBLA) for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) in infants and children to July 1, 2022. The FDA requested additional analyses of data from the pediatric studies, which Merck has submitted to the FDA. No new studies have been requested by the FDA.

In December 2021, Merck announced that the FDA accepted the company’s application for VAXNEUVANCE for the prevention of invasive pneumococcal disease in children 6 weeks through 17 years of age and it was granted Priority Review.

“We are confident in the strength of the data from our pediatric studies with VAXNEUVANCE and will continue to work expeditiously with the FDA to bring this important vaccine forward to infants and children in the United States as soon as possible,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories.

About VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine)

VAXNEUVANCE, Merck’s 15-valent pneumococcal conjugate vaccine, consists of purified capsular polysaccharides from S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F individually conjugated to CRM197 carrier protein. VAXNEUVANCE is indicated for active immunization of adults 18 years of age and older for the prevention of invasive disease caused by the S. pneumoniae serotypes contained in the vaccine. It is currently under investigation in the pediatric population. VAXNEUVANCE previously received Breakthrough Therapy designation and Priority Review from the FDA for the prevention of invasive pneumococcal disease in children 6 weeks through 17 years of age.

Select Safety Information for VAXNEUVANCE in Adults 18 Years of Age and Older

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.

The most commonly reported solicited adverse reactions in individuals 18 through 49 years of age were: injection site pain (75.8%), fatigue (34.3%), myalgia (28.8%), headache (26.5%), injection site swelling (21.7%), injection site erythema (15.1%) and arthralgia (12.7%).

The most commonly reported solicited adverse reactions in individuals 50 years of age and older were: injection site pain (66.8%), myalgia (26.9%), fatigue (21.5%), headache (18.9%), injection site swelling (15.4%), injection site erythema (10.9%) and arthralgia (7.7%).

Vaccination with VAXNEUVANCE may not protect all vaccine recipients.

About Merck

For over 130 years, Merck, known as MSD outside the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. 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., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, 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 products that the products 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.pdf.

and Patient Information at https://www.merck.com/product/usa/pi_circulars/v/vaxneuvance/vaxneuvance_ppi.pdf.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220401005105/en/

Media:

Melissa Moody

(215) 407-3536

Kimberly Petrillo

(267) 742-2813

Investors:

Peter Dannenbaum

(908) 740-1037

Alexis Constantine

(908) 740-1051

Source: Merck & Co., Inc.

FAQ

What is the new PDUFA date for VAXNEUVANCE from Merck?

The new PDUFA date for VAXNEUVANCE is July 1, 2022.

Why did the FDA extend the PDUFA date for Merck's VAXNEUVANCE?

The FDA requested additional analyses of data from pediatric studies for VAXNEUVANCE.

What age group is VAXNEUVANCE intended for?

VAXNEUVANCE is intended for infants and children aged 6 weeks to 17 years.

What type of vaccine is VAXNEUVANCE?

VAXNEUVANCE is a Pneumococcal 15-valent Conjugate Vaccine.