Pfizer Obtains Breakthrough Therapy Designation from the FDA for its Respiratory Syncytial Virus Vaccine Candidate for the Prevention of RSV in the Elderly

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

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

“Today’s decision is a significant step forward in our efforts to help protect vulnerable populations, especially the elderly, from certain potentially serious respiratory diseases, including RSV,” said Kathrin U. Jansen. , Ph.D., Senior Vice President and Head of Vaccines. Research and Development at Pfizer Inc. “The clinical and economic burden of RSV represents a critical need, and we look forward to our continued dialogue with the FDA to expedite the development of our RSV vaccine candidate.”

In September 2021, Pfizer announced the launch of RENOIR (RSV vaccine Eefficacy study iNOTOolder adults Iimmune to RSV disease), a Phase 3 clinical trial (NCT05035212) evaluating the efficacy, immunogenicity and safety of a single dose of RSVpreF in adults aged 60 years or older. This study is still ongoing.

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

RSV Burden

RSV is a contagious virus and a common cause of respiratory disease.2 The virus can affect an infected person’s lungs and airways and can be life-threatening for young infants, chronically ill children and the elderly.3,4,5,6 In the United States alone, among the elderly, RSV infections account for approximately 177,000 hospitalizations and 14,000 deaths each year.7 For children under five in the United States, 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 the elderly and the medical community is limited to providing only supportive care to adults with the disease.

About RSVpreF

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

Earlier this month, Pfizer announced that RSVpreF had 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 of the birth until the age of six months by active immunization of pregnant women. The FDA designation was informed by the results of RSVpreF’s Phase 2b proof-of-concept study (NCT04032093), which evaluated the safety, tolerability, and immunogenicity of RSVpreF in vaccinated pregnant women aged 18 to 49 years old 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 an international multicenter Phase 3 clinical trial (NCT04424316) evaluating the efficacy and safety of RSVpreF when given to pregnant women to help protect their babies against RSV after the birth. This study is still ongoing.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring people therapies that dramatically extend and improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of healthcare products, including innovative medicines and vaccines. Every day, Pfizer colleagues work in developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. In line with our responsibility as one of the world’s leading innovative biopharmaceutical companies, we work with healthcare providers, governments and local communities to support and expand access to reliable and affordable healthcare in the whole world. For over 170 years, we’ve worked to make a difference for everyone who counts on us. We regularly post information that may be important to investors on our website at Also, to learn more, visit us at and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at


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

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

A more detailed description of the risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and its subsequent reports on Form 10-Q, including in sections herein entitled “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, and in its subsequent reports on Form 8-K, all of which are filed with the United States Securities and Exchange Commission and available at and www.

Category: Vaccines

1 US Food and Drug Administration (FDA). Revolutionary therapy. Updated January 4, 2018. Accessed February 10, 2022.

2 Centers for Control and Prevention of Disasters. Respiratory syncytial virus (RSV) infection. Updated December 18, 2020. Accessed February 22, 2022.

3 Centers for Control and Prevention of Disasters. Disease or condition of the week – Respiratory syncytial virus (RSV) infection. Updated September 14, 2021. Accessed February 22, 2022.

4 Centers for Control and Prevention of Disasters. RSV transmission. Updated December 18, 2020. Accessed February 22, 2022.

5 Centers for Control and Prevention of Disasters. Respiratory Syncytial Virus (RSV) Infection – Older Adults Are at High Risk of Severe RSV Infection Fact Sheet. Accessed February 10, 2022.

6 Centers for Control and Prevention of Disasters. RSV in infants and young children. Updated December 18, 2020. Accessed February 22, 2022.

7 Falsey AR, et al. Respiratory syncytial virus infection in the 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. Hospitalizations Associated with Respiratory Syncytial Virus in Young Children: 2015-2016 Pediatrics. 2020 Jul;146(1):e20193611. doi:10.1542/peds.2019-3611. Published online June 16, 2020.


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Source: Pfizer Inc.

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