Pfizer Granted FDA Breakthrough Therapy Designation for Respiratory Syncytial Virus Vaccine Candidate for the Prevention of RSV in Older Adults

Pfizer Inc. (NYSE:PFE) today announced that its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age or older.

The FDA decision is primarily informed by the positive results of a proof-of-concept, Phase 2a study evaluating the safety, immunogenicity, and efficacy of a single dose of 120µg RSVpreF in a human viral challenge model in healthy adults 18 to 50 years of age.

"Today's decision is a significant step forward in our efforts to help protect vulnerable populations, particularly older adults, against certain potentially serious respiratory illnesses, including RSV," said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer Inc. "The clinical and economic burden of RSV represents a critical need, and we look forward to our ongoing dialogue with the FDA to accelerate the development of our RSV vaccine candidate."

In September 2021, Pfizer announced the initiation of RENOIR ( R SV vaccine E fficacy study i N   O lder adults I mmunized against R SV disease), a Phase 3 clinical trial (NCT05035212) evaluating the efficacy, immunogenicity, and safety of a single dose of RSVpreF, in adults ages 60 years or older. This study remains ongoing.

The FDA's Breakthrough Therapy Designation is designed to expedite the development and review of drugs and vaccines that are intended to treat or prevent serious conditions and preliminary clinical evidence indicates that the drug or vaccine may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s). 1

Burden of RSV

RSV is a contagious virus and a common cause of respiratory illness. 2 The virus can affect the lungs and breathing passages of an infected individual and can be potentially life-threatening for young infants, children with chronic medical conditions, and older adults. 3,4,5,6 In the United States alone, among older adults, RSV infections account for approximately 177,000 hospitalizations and 14,000 deaths each year. 7 For children younger than five years old in the U.S., approximately 2.1 million outpatient visits and 58,000 hospitalizations occur each year. 8,9

RSV is a disease for which there are currently no prophylactic, therapeutic, or vaccine options for older adults and the medical community is limited to offering only supportive care for adults with the illness.

About RSVpreF

Pfizer's investigational RSV vaccine candidate builds on foundational basic science discoveries including those made at the National Institutes of Health (NIH), which detailed the crystal structure of prefusion F, a key form of the viral fusion protein (F) that RSV uses to attack human cells. The NIH research showed that antibodies specific to the prefusion form were highly effective at blocking virus infection, suggesting a prefusion F-based vaccine may confer optimal protection against RSV. After this important discovery, Pfizer tested numerous versions of the viral protein, and identified those that elicited a strong anti-viral immune response in pre-clinical evaluation. The vaccine candidate is composed of two preF proteins selected to optimize protection against RSV A and B.

Earlier this month, Pfizer announced RSVpreF received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of RSV-associated lower respiratory tract disease in infants from birth up to six months of age by active immunization of pregnant women. The FDA designation was informed by the results of the Phase 2b proof-of-concept study of RSVpreF (NCT04032093), which evaluated the safety, tolerability and immunogenicity of RSVpreF in vaccinated pregnant women ages 18 through 49 and their infants. This followed the FDA's November 2018 decision to grant Fast Track status to RSVpreF.

In June 2020, Pfizer announced the initiation of a multicenter, international Phase 3 clinical trial (NCT04424316) evaluating the efficacy and safety of RSVpreF when administered to pregnant women to help protect their babies from RSV after birth. This study remains ongoing.

About Pfizer: Breakthroughs That Change Patients' Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com . In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

DISCLOSURE NOTICE:

The information contained in this release is as of March 24, 2022. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about Pfizer's respiratory syncytial virus vaccine candidate (RSVpreF), including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when biologic license applications may be filed in any jurisdictions for RSVpreF for any potential indications; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether RSVpreF will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of RSVpreF; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities regarding RSVpreF and uncertainties regarding the commercial impact of any such recommendations; uncertainties regarding the impact of COVID-19 on our business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com .

Category: Vaccines


1 U.S. Food and Drug Administration (FDA). Breakthrough Therapy. https://www.fda.gov/forpatients/approvals/fast/ucm405397.htm . Updated January 4, 2018. Accessed February 10, 2022.

2 Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV). https://www.cdc.gov/rsv/index.html . Updated December 18, 2020. Accessed February 22, 2022.

3 Centers for Disease Control and Prevention. Disease or Condition of the Week - Respiratory Syncytial Virus Infection (RSV). https://www.cdc.gov/dotw/rsv/index.html . Updated September 14, 2021. Accessed February 22, 2022.

4 Centers for Disease Control and Prevention. RSV Transmission. https://www.cdc.gov/rsv/about/transmission.html . Updated December 18, 2020. Accessed February 22, 2022.

5 Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV) – Older Adults are at High Risk for Severe RSV Infection Fact Sheet. https://www.cdc.gov/rsv/factsheet-older-adults.pdf . Accessed February 10, 2022.

6 Centers for Disease Control and Prevention. RSV in Infants and Young Children. https://www.cdc.gov/rsv/high-risk/infants-young-children.html . Updated December 18, 2020. Accessed February 22, 2022.

7 Falsey AR, et al. Respiratory Syncytial Virus Infection in Elderly and High-Risk Adults. N Engl J Med 2005; 352:1749-1759. DOI: 10.1056/NEJMoa043951

8 Hall CB, et al. The Burden of Respiratory Syncytial Virus Infection in Young Children. N Engl J Med. 2009; 360:588-598. DOI: 10.1056/NEJMoa0804877

9 Rha B, et al. Respiratory Syncytial Virus-Associated Hospitalizations Among Young Children: 2015-2016 Pediatrics. 2020 Jul;146(1):e20193611. doi: 10.1542/peds.2019-3611. Epub 2020 Jun 16.

Media:
PfizerMediaRelations@Pfizer.com
+1 (212) 733-1226

Investor:
IR@Pfizer.com
+1 (212) 733-4848

News Provided by Business Wire via QuoteMedia

PFE
The Conversation (0)
Arvinas and Pfizer Announce Upcoming Vepdegestrant  Poster Presentations at the 2023 European Society for Medical Oncology  Breast Cancer Annual Congress

Arvinas and Pfizer Announce Upcoming Vepdegestrant Poster Presentations at the 2023 European Society for Medical Oncology Breast Cancer Annual Congress

Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) today announced they will present updated data related to vepdegestrant (ARV-471) at the 2023 European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress. Vepdegestrant is a novel investigational PROTAC ® estrogen receptor (ER) protein degrader that is being jointly developed by Arvinas and Pfizer for the treatment of patients with early and locally advanced or metastatic ER positivehuman epidermal growth factor receptor 2 (HER2) negative (ER+HER2-) breast cancer. Four posters will be presented during the poster session at the annual congress, which will be held from May 11-13, 2023, in Berlin, Germany.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Pfizer Reports First-Quarter 2023 Results

Pfizer Reports First-Quarter 2023 Results

  • First-Quarter 2023 Revenues of $18.3 Billion
    • Expected Decline in Comirnaty (1) Revenue Drove 26% Operational Decrease in First-Quarter 2023 Revenues
    • First-Quarter 2023 Revenues from Comirnaty (1) and Paxlovid of $7.1 Billion
    • Excluding Contributions from Comirnaty (1) and Paxlovid, Revenues Grew 5% Operationally
  • First-Quarter 2023 Reported Diluted EPS (2) of $0.97, a Year-Over-Year Decline of 29%, and Adjusted Diluted EPS (3) of $1.23, a Year-Over-Year Decline of 24%
  • Pfizer Reaffirms Full-Year 2023 Financial Guidance (4)
  • Pfizer Continued to Make Significant Progress Toward an Unprecedented Number of Anticipated New Product and Indication Launches; Milestones Include FDA Approvals for Zavzpret, Cibinqo for Adolescents and Prevnar 20 in Pediatric Patients

Pfizer Inc. (NYSE: PFE) reported financial results for the first quarter of 2023 and reaffirmed full-year 2023 financial guidance.

The first-quarter 2023 earnings presentation and accompanying prepared remarks from management as well as the quarterly update to Pfizer's R&D pipeline can be found at www.pfizer.com .

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
XTANDI®  plus Leuprolide Reduced the Risk of Metastasis by 58% in Non-Metastatic Hormone-Sensitive Prostate Cancer versus Placebo plus Leuprolide

XTANDI® plus Leuprolide Reduced the Risk of Metastasis by 58% in Non-Metastatic Hormone-Sensitive Prostate Cancer versus Placebo plus Leuprolide

Data from Phase 3 EMBARK trial to be presented as a plenary session during the 2023 American Urological Association Annual Meeting

Results show the potential for XTANDI to add to the standard of care in prostate cancer, if approved

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
U.S. FDA Approves PREVNAR 20®, Pfizer's 20-valent Pneumococcal Conjugate Vaccine for Infants and Children

U.S. FDA Approves PREVNAR 20®, Pfizer's 20-valent Pneumococcal Conjugate Vaccine for Infants and Children

  • PREVNAR 20 offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine, helping to protect against all 20 serotypes contained in the vaccine
  • PREVNAR 20 builds on PREVNAR 13 ® and includes seven additional serotypes shown to be associated with antibiotic resistance, heightened disease severity, invasive potential, and prevalence in pediatric pneumococcal cases. 1
  • The vaccine further advances Pfizer's pediatric pneumococcal vaccine portfolio and builds on more than 20 years of Pfizer leadership, legacy and innovation in developing pneumococcal conjugate vaccines

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved PREVNAR 20 ® (20-valent Pneumococcal Conjugate Vaccine) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcal) serotypes contained in the vaccine in infants and children six weeks through 17 years of age, and for the prevention of otitis media in infants six weeks through five years of age caused by the original seven serotypes contained in PREVNAR ® .

"Today's FDA approval of our vaccine, PREVNAR 20, now offers parents the ability to help protect their children against 20 pneumococcal serotypes in circulation, which represent the majority of pneumococcal disease in U.S. infants and children," 1,2 said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. "This important PREVNAR 20 approval builds on more than 20 years of real-world impact with PREVNAR and PREVNAR 13, safety data, and effectiveness; highlighting Pfizer's leadership in developing groundbreaking pneumococcal conjugate vaccines to help protect infants and their families from life threatening infections. We are grateful to the families and clinical investigators who participated in this research and our colleagues who have worked tirelessly to develop this breakthrough vaccine."

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Pfizer Declares Second-Quarter 2023 Dividend

Pfizer Declares Second-Quarter 2023 Dividend

Board of Directors approves quarterly cash dividend of $0.41 per share

Pfizer Inc. (NYSE: PFE) today announced that its board of directors declared a $0.41 second-quarter 2023 dividend on the company's common stock, payable June 9, 2023, to holders of the Common Stock of record at the close of business on May 12, 2023. The second-quarter 2023 cash dividend will be the 338th consecutive quarterly dividend paid by Pfizer.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

European Commission Approves Pfizer's RSV Vaccine ABRYSVO® to Help Protect Adults Aged 18-59 Against RSV Lower Respiratory Tract Disease

  • ABRYSVO is the first and only RSV vaccine approved in the European Union (EU) for non-pregnant adults aged 18-49

Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has issued a decision amending the marketing authorization for ABRYSVO ® , the company's bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, to extend the indication to include prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 years of age. This expands the previous authorization for individuals aged 60 and older, and ABRYSVO now offers in the EU the broadest RSV vaccine indication, which includes:

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

ViiV Healthcare Announces Reimbursement for APRETUDE for HIV-1 Pre-Exposure Prophylaxis under the Non-Insured Health Benefits Program

ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. and Shionogi as shareholders, is pleased to announce that APRETUDE (cabotegravir tablets and extended release injectable suspension) is now covered under the federal Non-Insured Health Benefits (NIHB) Program for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at risk individuals who are HIV-1 negative. 1

The Non-Insured Health Benefits (NIHB) Program provides eligible First Nations and Inuit people with coverage for a range of health benefits that are not otherwise covered through private, provincial, or territorial health insurance plans or social programs. 2 In Canada approximately 10 per cent of all people living with HIV are Indigenous 3 , despite making up just five per cent of the country's population. 4 Economic, social and systemic barriers, along with the lasting effects of racism and colonialism, all contribute to the disproportionate burden of HIV experienced by Indigenous people. 5

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Dexcom Appoints Jon Coleman as Chief Commercial Officer

DexCom, Inc. (NASDAQ: DXCM), the global leader in glucose biosensing, today announced the appointment of Jon Coleman as chief commercial officer. In this role, Mr. Coleman will assume responsibility for Dexcom's global commercial organization, including global sales, marketing and customer experience.

Mr. Coleman joins Dexcom with more than 30 years of global commercial leadership experience across multiple healthcare segments and channels. Mr. Coleman served as an executive officer of Masimo Corporation (NASDAQ: MASI), where he held roles of increasing responsibility across his fifteen-year tenure. This included serving as president of Masimo's commercial teams where he oversaw the consolidation of its worldwide hospital sales, OEM, alternate care sales, and clinical teams along with the customer service and hospital conversion teams. Mr. Coleman also held significant roles at Pfizer's (NYSE: PFE) Consumer Healthcare business, leading as vice president and general manager of Canada and the Caribbean region after several years of regional leadership in Asia and Latin America. Across his various roles at these organizations, Mr. Coleman established a track record of scaling operations, developing innovative products, entering new markets, and delivering strong growth performance.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Pfizer Invites Public to View and Listen to Webcast of April 29 Conference Call with Analysts

Pfizer Inc. (NYSE: PFE) invites investors and the general public to view and listen to a webcast of a conference call with investment analysts at 10:00 a.m. EDT on Tuesday, April 29, 2025. The purpose of the call is to provide an update on Pfizer's results, as reflected in the company's First Quarter 2025 Performance Report, to be issued that morning.

To view and listen to the webcast and view the Performance Report, visit our web site at www.pfizer.com/investors . Information on accessing and registering for the webcast will be available at www.pfizer.com/investors beginning today. Participants are advised to register in advance of the conference call.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Cardiol Therapeutics (TSX:CRDL)

Cardiol Therapeutics


Keep reading...Show less

BMO Expands Canadian Depositary Receipt Lineup with 10 New Listings from Europe and Japan

BMO's CDRs offer enhanced portfolio diversification opportunities for Canadian investors enabling them to hold shares in international companies that trade on a Canadian exchange in Canadian dollars

Bank of Montreal (BMO) announced 10 new CDRs will begin trading on the Cboe Canada exchange today. The initial offering of these new CDRs has closed.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×