PFIZER AND BIONTECH
CONCLUDE PHASE 3 STUDY OF COVID-19 VACCINE CANDIDATE, MEETING ALL PRIMARY
EFFICACY ENDPOINTS
Wednesday, November 18, 2020 - 06:59am
- Primary efficacy analysis demonstrates BNT162b2 to be 95% effective
against COVID-19 beginning 28 days after the first dose;170 confirmed
cases of COVID-19 were evaluated, with 162 observed in the placebo group
versus 8 in the vaccine group
- Efficacy was consistent across age, gender, race and ethnicity
demographics; observed efficacy in adults over 65 years of age was over
94%
- Safety data milestone required by U.S. Food and Drug Administration
(FDA) for Emergency Use Authorization (EUA) has been achieved
- Data demonstrate vaccine was well tolerated across all populations
with over 43,000 participants enrolled; no serious safety concerns
observed; the only Grade 3 adverse event greater than 2% in frequency was
fatigue at 3.8% and headache at 2.0%
- Companies plan to submit within days to the FDA for EUA and share
data with other regulatory agencies around the globe
- The companies expect to produce globally up to 50 million vaccine
doses in 2020 and up to 1.3 billion doses by the end of 2021
- Pfizer is confident in its vast experience, expertise and existing
cold-chain infrastructure to distribute the vaccine around the world
NEW YORK & MAINZ,
Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that, after conducting the final
efficacy analysis in their ongoing Phase 3 study, their mRNA-based COVID-19
vaccine candidate, BNT162b2, met all of the study’s primary efficacy endpoints.
Analysis of the data indicates a vaccine efficacy rate of 95% (p<0.0001) in
participants without prior SARS-CoV-2 infection (first primary objective) and
also in participants with and without prior SARS-CoV-2 infection (second
primary objective), in each case measured from 7 days after the second dose.
The first primary objective analysis is based on 170 cases of COVID-19, as
specified in the study protocol, of which 162 cases of COVID-19 were observed
in the placebo group versus 8 cases in the BNT162b2 group. Efficacy was
consistent across age, gender, race and ethnicity demographics. The observed
efficacy in adults over 65 years of age was over 94%.
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There were 10 severe cases
of COVID-19 observed in the trial, with nine of the cases occurring in the
placebo group and one in the BNT162b2 vaccinated group.
To date, the Data
Monitoring Committee for the study has not reported any serious safety concerns
related to the vaccine. A review of unblinded reactogenicity data from the
final analysis which consisted of a randomized subset of at least 8,000
participants 18 years and older in the phase 2/3 study demonstrates that the
vaccine was well tolerated, with most solicited adverse events resolving
shortly after vaccination. The only Grade 3 (severe) solicited adverse events
greater than or equal to 2% in frequency after the first or second dose was
fatigue at 3.8% and headache at 2.0% following dose 2. Consistent with earlier
shared results, older adults tended to report fewer and milder solicited
adverse events following vaccination.
In addition, the companies
announced that the safety milestone required by the U.S. Food and Drug
Administration (FDA) for Emergency Use Authorization (EUA) has been achieved.
Pfizer and BioNTech plan to submit a request within days to the FDA for an EUA
based on the totality of safety and efficacy data collected to date, as well as
manufacturing data relating to the quality and consistency of the vaccine. These
data also will be submitted to other regulatory agencies around the world.
“The study results mark an
important step in this historic eight-month journey to bring forward a vaccine
capable of helping to end this devastating pandemic. We continue to move at the
speed of science to compile all the data collected thus far and share with
regulators around the world,” said Dr. Albert Bourla, Pfizer Chairman and CEO.
“With hundreds of thousands of people around the globe infected every day, we
urgently need to get a safe and effective vaccine to the world.”
“We are grateful that the
first global trial to reach the final efficacy analysis mark indicates that a
high rate of protection against COVID-19 can be achieved very fast after the
first 30 µg dose, underscoring the power of BNT162 in providing early
protection,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “These
achievements highlight the potential of mRNA as a new drug class. Our objective
from the very beginning was to design and develop a vaccine that would generate
rapid and potent protection against COVID-19 with a benign tolerability profile
across all ages. We believe we have achieved this with our vaccine candidate
BNT162b2 in all age groups studied so far and look forward to sharing further
details with the regulatory authorities. I want to thank all the devoted women
and men who contributed to this historically unprecedented achievement. We will
continue to work with our partners and governments around the world to prepare
for global distribution in 2020 and beyond.”
The Phase 3 clinical trial
of BNT162b2 began on July 27 and has enrolled 43,661 participants to date,
41,135 of whom have received a second dose of the vaccine candidate as of
November 13, 2020. Approximately 42% of global participants and 30% of U.S.
participants have racially and ethnically diverse backgrounds, and 41% of
global and 45% of U.S. participants are 56-85 years of age. A breakdown of the
diversity of clinical trial participants can be found here from approximately 150 clinical trials
sites in United States, Germany, Turkey, South Africa, Brazil and Argentina.
The trial will continue to collect efficacy and safety data in participants for
an additional two years.
Based on current
projections, the companies expect to produce globally up to 50 million vaccine
doses in 2020 and up to 1.3 billion doses by the end of 2021. Four of Pfizer’s
facilities are part of the manufacturing and supply chain; St. Louis, MO;
Andover, MA; and Kalamazoo, MI in the U.S.; and Puurs in Belgium. BioNTech’s German
sites will also be leveraged for global supply.
Pfizer is confident in its
vast experience, expertise and existing cold-chain infrastructure to distribute
the vaccine around the world. The companies have developed specially designed,
temperature-controlled thermal shippers utilizing dry ice to maintain
temperature conditions of -70°C±10°C. They can be used be as temporary storage
units for 15 days by refilling with dry ice. Each shipper contains a
GPS-enabled thermal sensor to track the location and temperature of each
vaccine shipment across their pre-set routes leveraging Pfizer’s broad
distribution network.
Pfizer and BioNTech plan to
submit the efficacy and safety data from the study for peer-review in a
scientific journal once analysis of the data is completed.
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 150 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.
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