Lunes, 18 de Noviembre del 2024
Esta mañana, Pfizer y BioNTech anunciaron los resultados principales de un análisis actualizado de 927 casos sintomáticos confirmados de COVID-19 observados en su estudio fundamental de fase 3 hasta el 13 de marzo de 2021, que muestran que la vacuna COVID-19, BNT162b2, fue 91,3% efectiva contra COVID -19, medido de siete días a seis meses después de la segunda dosis. La vacuna fue 100% eficaz contra enfermedades graves según la definición de los Centros para el Control y la Prevención de Enfermedades (CDC) de EE. UU., Y 95,3% de eficacia contra COVID-19 grave según la definición de la Administración de Drogas y Alimentos de los EE. UU. (FDA). También, se han recopilado datos de seguridad del estudio de fase 3 de más de 12.000 participantes vacunados que tienen un tiempo de seguimiento de al menos seis meses después de la segunda dosis, lo que demuestra un perfil de seguridad y tolerabilidad favorable.
Pfizer and BioNTech Confirm HighEfficacy and No Serious Safety Concerns Through Up to Six Months Following Second Dose in Updated Topline Analysis of Landmark COVID-19 Vaccine Study
• Analysis of 927 confirmed symptomatic cases of COVID-19 demonstrates BNT162b2 is highly effective with 91.3% vaccine efficacy observed against COVID-19, measured seven days through up to six months after the second dose• Vaccine was 100% effective in preventing severe disease as defined by the U.S. Centers for Disease Control and Prevention and 95.3% effective in preventing severe disease as defined by the U.S. Food and Drug Administration
• Vaccine was 100% effective in preventing COVID-19 cases in South Africa, where the B.1.351 lineage is prevalent
• Vaccine safety now evaluated in more than 44,000 participants 16 years of age and older, with more than 12,000 vaccinated participants having at least six months follow-up after their second dose
• The companies plan to share these results with worldwide regulatory agencies soon
New York and Mainz, Germany, April 1, 2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE
(Nasdaq: BNTX) today announced updated topline results from analysis of 927 confirmed
symptomatic cases of COVID-19 observed in their pivotal Phase 3 study through March 13, 2021,
showing the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, was 91.3% effective against COVID-19,
measured seven days through up to six months after the second dose. The vaccine was 100%
effective against severe disease as defined by the U.S. Centers for Disease Control and Prevention
(CDC), and 95.3% effective against severe COVID-19 as defined by the U.S. Food and Drug
Administration (FDA). Safety data from the Phase 3 study has also been collected from more than
12,000 vaccinated participants who have a follow-up time of at least six months after the second dose,
demonstrating a favorable safety and tolerability profile.
“These data confirm the favorable efficacy and safety profile of our vaccine and position us to submit a
Biologics License Application to the U.S. FDA,” said Albert Bourla, Chairman and Chief Executive
Officer, Pfizer. “The high vaccine efficacy observed through up to six months following a second dose
and against the variant prevalent in South Africa provides further confidence in our vaccine’s overall
effectiveness.”
“It is an important step to further confirm the strong efficacy and good safety data we have seen so far,
especially in a longer-term follow-up,” said Ugur Sahin, CEO and Co-founder of BioNTech. “These
data also provide the first clinical results that a vaccine can effectively protect against currently
circulating variants, a critical factor to reach herd immunity and end this pandemic for the global
population.”
About the Analysis
The updated analysis of the Phase 3 clinical trial was conducted in accordance with guidance from the
FDA for all companies investigating COVID-19 vaccines to review safety and efficacy at key
milestones.
Results from this analysis of 46,307 trial participants build upon and confirm previously released data
and demonstrate strong protection against COVID-19 through six months post-second dose. From the
927 confirmed symptomatic cases of COVID-19 in the trial, 850 cases of COVID-19 were in the
placebo group and 77 cases were in the BNT162b2 group, corresponding to vaccine efficacy of 91.3%
(95% confidence interval [CI, 89.0, 93.2]).
Thirty-two cases of severe disease, as defined by the CDC, were observed in the placebo group
versus none in the BNT162b2 vaccinated group, indicating that the vaccine was 100% efficacious in
this analysis against severe disease by the CDC definition (95% CI, [88.0,100.0]). Twenty-one severe
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cases, as defined by the FDA, were observed in the placebo group versus one case in the BNT162b2
vaccinated group, indicating 95.3% efficacy by the FDA definition (95% CI, [71.0, 99.9]).
Efficacy was generally consistent across age, gender, race and ethnicity demographics, and across
participants with a variety of underlying conditions.
A total of 697 cases of COVID-19 were observed in the United States; 647 cases of COVID-19 were
observed in the placebo group versus 50 in the vaccine group, indicating vaccine efficacy of 92.6%
(95% CI, [90.1, 94.5]).
In South Africa, where the B.1.351 lineage is prevalent and 800 participants were enrolled, nine cases
of COVID-19 were observed, all in the placebo group, indicating vaccine efficacy of 100% (95% CI,
[53.5, 100.0]). In an exploratory analysis, the nine strains were sequenced and six of the nine were
confirmed to be of the B.1.351 lineage. These data support previous results from immunogenicity
studies demonstrating that BNT162b2 induced a robust neutralizing antibody response to the B1.351
variant, and although lower than to the wild-type strain, it does not appear to affect the high observed
efficacy against this variant.i
No serious safety concerns were observed in trial participants up to six months after the second dose.
Side effects were generally consistent with previously reported results. Vaccine safety has now been
evaluated in more than 44,000 participants aged 16 years and older with more than 12,000 vaccinated
participants having at least six months of follow-up after their second dose.
Pfizer and BioNTech plan to submit detailed data for scientific peer review and potential publication in
the near future.
The Pfizer-BioNTech COVID-19 Vaccine, BNT162b2, has not been approved or licensed by the U.S.
Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an
Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in
individuals 16 years of age and older. The emergency use of this product is only authorized for the
duration of the declaration that circumstances exist justifying the authorization of emergency use of the
medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or
authorization revoked sooner. Please see Emergency Use Authorization (EUA) Fact Sheet for
Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing
Information available at www.cvdvaccine.com.
The vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both
BioNTech and Pfizer. BioNTech is the Marketing Authorizations Holder in the European Union, and
the holder of emergency use authorizations or equivalent in the United States, United Kingdom,
Canada and other countries in advance of a planned application for full marketing authorizations in
these countries.
AUTHORIZED USE IN THE U.S.:
The Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization
(EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe
acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.
IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE AUTHORIZATION
PRESCRIBING INFORMATION:
• Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a
severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19
Vaccine
• Appropriate medical treatment used to manage immediate allergic reactions must be immediately
available in the event an acute anaphylactic reaction occurs following administration of PfizerBioNTech COVID-19 Vaccine
• Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse
reactions according to the Centers for Disease Control and Prevention guidelines
(https://www.cdc.gov/vaccines/covid-19/)
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• Immunocompromised persons, including individuals receiving immunosuppressant therapy, may
have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine
• The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients
• In clinical studies, adverse reactions in participants 16 years of age and older included pain at the
injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%),
joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%),
nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%)
• Severe allergic reactions, including anaphylaxis, have been reported following the PfizerBioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials. Additional adverse
reactions, some of which may be serious, may become apparent with more widespread use of the
Pfizer-BioNTech COVID-19 Vaccine
• Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are
insufficient to inform vaccine-associated risks in pregnancy
• Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the
breastfed infant or on milk production/excretion
• There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine
with other COVID-19 vaccines to complete the vaccination series. Individuals who have received
one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of PfizerBioNTech COVID-19 Vaccine to complete the vaccination series
• Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS at
https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967. The reports should include
the words “Pfizer-BioNTech COVID-19 Vaccine EUA” in the description section of the report
• Vaccination providers should review the Fact Sheet for Information to Provide to Vaccine
Recipients/Caregivers and Mandatory Requirements for Pfizer-BioNTech COVID-19 Vaccine
Administration Under Emergency Use Authorization
• Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers
Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information
available at www.cvdvaccine-us.com
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.
Pfizer Disclosure Notice
The information contained in this release is as of April 1, 2021. 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 efforts to combat COVID-19, the
collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162 mRNA
vaccine program and the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (including qualitative
assessments of available data, potential benefits, expectations for clinical trials, anticipated timing of
regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing,
distribution and supply) involving 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 clinical trials,
regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks
associated with preclinical and clinical data (including the topline data outlined in this release),
including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of
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existing preclinical, clinical or safety data (including the topline data outlined in this release); the ability
to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety
and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional
studies or in larger, more diverse populations following commercialization; the ability of BNT162b2 to
prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the
vaccine will lead to new information about efficacy, safety, or other developments, including the risk of
additional adverse reactions, some of which may be serious; the risk that preclinical and clinical trial
data (including the topline data outlined in this release) are subject to differing interpretations and
assessments, including during the peer review/publication process, in the scientific community
generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA
vaccine program (including the topline data outlined in this release) will be published in scientific
journal publications and, if so, when and with what modifications and interpretations; whether
regulatory authorities will be satisfied with the design of and results from these and any future
preclinical and clinical studies; whether and when a Biologics License Application for BNT162b2 may
be filed in the U.S. and whether and when other biologics license and/or emergency use authorization
applications or amendments to any such applications may be filed in particular jurisdictions for
BNT162b2 or any other potential vaccines that may arise from the BNT162 program, and if obtained,
whether or when such emergency use authorization or licenses will expire or terminate; whether and
when any applications that may be pending or filed for BNT162b2 (including a potential Biologics
License Application in the U.S. or any requested amendments to the emergency use authorization) or
other vaccines that may result from the BNT162 program may be approved by particular regulatory
authorities, which will depend on myriad factors, including making a determination as to whether the
vaccine’s benefits outweigh its known risks and determination of the vaccine’s efficacy and, if
approved, whether it will be commercially successful; decisions by regulatory authorities impacting
labeling or marketing, manufacturing processes, safety and/or other matters that could affect the
availability or commercial potential of a vaccine, including development of products or therapies by
other companies; disruptions in the relationships between us and our collaboration partners or thirdparty suppliers; risks related to the availability of raw materials to manufacture a vaccine; challenges
related to our vaccine’s ultra-low temperature formulation, two-dose schedule and attendant storage,
distribution and administration requirements, including risks related to storage and handling after
delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations;
the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or
maintain access to logistics or supply channels commensurate with global demand for our vaccine,
which would negatively impact our ability to supply the estimated numbers of doses of our vaccine
within the projected time periods as previously indicated; whether and when additional supply
agreements will be reached; uncertainties regarding the ability to obtain recommendations from
vaccine technical committees and other public health authorities and uncertainties regarding the
commercial impact of any such recommendations; uncertainties regarding the impact of COVID-19 on
Pfizer’s 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, 2020 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.
About BioNTech
Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel
therapies for cancer and other serious diseases. The Company exploits a wide array of computational
discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its
broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based
therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators,
targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine
development and in-house manufacturing capabilities, BioNTech and its collaborators are developing
multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology
pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical
collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche
Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit
www.BioNTech.de.
BioNTech Forward-looking Statements
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This press release contains “forward-looking statements” of BioNTech within the meaning of the
Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but
may not be limited to, statements concerning: BioNTech’s efforts to combat COVID-19; the
collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine (including a potential
second booster dose of BNT162b2 and/or a potential booster dose of a variation of BNT162b2 having
a modified mRNA sequence); our expectations regarding the potential characteristics of BNT162b2 in
our clinical trials and/or in commercial use based on data observations to date; the ability of
BNT162b2 to prevent COVID-19 caused by emerging virus variants; the expected time point for
additional readouts on efficacy data of BNT162b2 in our clinical trials; the nature of the clinical data,
which is subject to ongoing peer review, regulatory review and market interpretation; the timing for
submission of data for, or receipt of, any marketing approval or Emergency Use Authorization; our
contemplated shipping and storage plan, including our estimated product shelf life at various
temperatures; and the ability of BioNTech to supply the quantities of BNT162 to support clinical
development and market demand, including our production estimates for 2021. Any forward-looking
statements in this press release are based on BioNTech current expectations and beliefs of future
events, and are subject to a number of risks and uncertainties that could cause actual results to differ
materially and adversely from those set forth in or implied by such forward-looking statements. These
risks and uncertainties include, but are not limited to: the ability to meet the pre-defined endpoints in
clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical
or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile
observed to date, in the remainder of the trial or in larger, more diverse populations upon
commercialization; the ability to effectively scale our productions capabilities; and other potential
difficulties.
For a discussion of these and other risks and uncertainties, see BioNTech’s Annual Report as Form 20-
F for the Year Ended December 31, 2020, filed with the SEC on March 30, 2021, which is available on
the SEC’s website at www.sec.gov. All information in this press release is as of the date of the release,
and BioNTech undertakes no duty to update this information unless required by law.
Pfizer Contacts:
Media Relations
Jerica Pitts
+1 (347) 224-9084
Jerica.Pitts@pfizer.com
Investor Relations
Chuck Triano
+1 (212) 733-3901
Charles.E.Triano@Pfizer.com
BioNTech Contacts:
Media Relations
Jasmina Alatovic
+49 (0)6131 9084 1513
Media@biontech.de
Investor Relations
Sylke Maas, Ph.D.
+49 (0)6131 9084 1074
Investors@biontech.de
i New England Journal of Medicine. Neutralizing Activity of BNT162b2-Elicited Serum; March 8, 2021. Available at
https://www.nejm.org/doi/full/10.1056/NEJMc210201
