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Pfizer Granted FDA Breakthrough Therapy Designation for 20-Valent Pneumococcal Conjugate Vaccine for the Prevention of Invasive Disease and Pneumonia in Adults Aged 18 Years and Older

Breakthrough Therapy Designation Designed by FDA to Expedite the Development and Review of Drugs and Vaccines Which May Demonstrate Substantial Improvement Over Available Therapy 1

Thursday, September 20, 2018 - 8:00am

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) announced today that its 20-Valent Pneumococcal
Conjugate Vaccine (20vPnC) candidate, PF-06482077, received Breakthrough
Therapy designation from the US Food and Drug Administration (FDA) for
the prevention of invasive disease and pneumonia caused by Streptococcus
pneumoniae serotypes in the vaccine in adults aged 18 years and older.2
Pfizer expects to start Phase 3 trials in a few months.

The FDA decision is informed by the results of the 20vPnC Phase 2
randomized, double-blind trial to evaluate the safety and immunogenicity
of a multivalent pneumococcal conjugate vaccine in adults 60 through 64
years of age. Pfizer will seek to present and publish outcomes from this
clinical trial at a future date.

“We look forward to continuing our dialogue with the FDA so that we can
accelerate the development program of the adult indication of Pfizer’s
20-valent next-generation pneumococcal vaccine candidate,” said Kathrin
U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research &
Development, Pfizer. “There continues to be a global health need to
protect against the potentially devastating effects of invasive
pneumococcal disease and pneumonia caused by additional serotypes, and
we are dedicated to continue to build on our expertise in pneumococcal
conjugate vaccines with this vaccine candidate.”

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).3 Drugs and
vaccines that receive Breakthrough Therapy Designation are eligible for
all features of the FDA’s Fast Track designation, which may include more
frequent communication with the FDA about the drug’s development plan
and eligibility for Accelerated Approval and Priority Review, if
relevant criteria are met.4

The FDA previously granted Fast Track designation for 20vPnC in October
2017 for use in adults aged 18 years and older.5 The FDA’s
Fast Track approach is a process designed to facilitate the development
and expedite the review of new drugs and vaccines intended to treat or
prevent serious conditions and address an unmet medical need.4

Pfizer Inc: Working together for a healthier world™

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to people that extend and significantly improve their lives. We strive
to set the standard for quality, safety and value in the discovery,
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DISCLOSURE NOTICE: The information contained in this release is as of
September 20, 2018. 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
20-Valent Pneumococcal Conjugate Vaccine (20vPnC) candidate,
PF-06482077, and a potential indication to prevent invasive disease and
pneumonia caused by Streptococcus pneumoniae in adults aged 18 years and
older, including its potential benefits, and plans to initiate Phase 3
trials in the coming months, 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 trial
completion dates and regulatory submission dates, as well as the
possibility of unfavorable clinical trial results, including unfavorable
new clinical data or additional analyses of existing clinical data; the
risk that clinical trial data are subject to differing interpretations,
and, even when we view data as sufficient to support the safety and/or
effectiveness of a product candidate, regulatory authorities may not
share our views and may require additional data or may deny approval
altogether; whether regulatory authorities will be satisfied with the
design of and results from our clinical studies; whether and when any
biologics license applications may be filed in any jurisdictions for
20vPnC for any indications; whether and when any such applications may
be approved by regulatory authorities, which will depend on the
assessment by such regulatory authorities of the benefit-risk profile
suggested by the totality of the immunogenicity and safety information
submitted and, if approved, whether 20vPnC will be commercially
successful; decisions by regulatory authorities regarding labeling and
other matters that could affect the availability or commercial potential
of 20vPnC; uncertainties regarding the ability to obtain recommendations
from vaccine technical committees and other public health authorities
regarding 20vPnC and uncertainties regarding the commercial impact of
any such recommendations; 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, 2017 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




1 U.S. Food and Drug

Data on file. Pfizer Inc., New York, NY.
3 U.S. Food and
Drug Administration. Breakthrough Therapy

U.S. Food and Drug Administration. Fast Track

Data on file. Pfizer Inc., New York, NY.


Pfizer Inc.
Jessica Smith
(212) 733-6213
[email protected]
Ryan Crowe
(212) 733-8160
[email protected]