• Skip to main content
  • Skip to secondary menu
  • Skip to primary sidebar
  • Skip to secondary sidebar
  • Skip to footer

Technologies.org

Technology Trends: Follow the Money

  • Technology Events 2023-2024
  • Sponsored Post
    • Make a Contribution
  • Technology Markets
    • Venture Capital
  • About
  • Contact

PFIZER AND BIONTECH ANNOUNCE VACCINE CANDIDATE AGAINST COVID-19 ACHIEVED SUCCESS IN FIRST INTERIM ANALYSIS FROM PHASE 3 STUDY

November 9, 2020 By admin Leave a Comment

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study.

After discussion with the FDA, the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases. Upon the conclusion of those discussions, the evaluable case count reached 94 and the DMC performed its first analysis on all cases. The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at 7 days after the second dose. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule. As the study continues, the final vaccine efficacy percentage may vary. The DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities worldwide.

“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”After discussion with the FDA, the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases. Upon the conclusion of those discussions, the evaluable case count reached 94 and the DMC performed its first analysis on all cases. The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at 7 days after the second dose. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule. As the study continues, the final vaccine efficacy percentage may vary. The DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities worldwide.

“I want to thank the thousands of people who volunteered to participate in the clinical trial, our academic collaborators and investigators at the study sites, and our colleagues and collaborators around the world who are dedicating their time to this crucial endeavor,” added Bourla. “We could not have come this far without the tremendous commitment of everyone involved.”

“The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science and a global collaborative effort,” said Prof. Ugur Sahin, BioNTech co-founder and CEO. “When we embarked on this journey 10 months ago this is what we aspired to achieve. Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality. We will continue to collect further data as the trial continues to enroll for a final analysis planned when a total of 164 confirmed COVID-19 cases have accrued. I would like to thank everyone who has contributed to make this important achievement possible.”

The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of November 8, 2020. Approximately 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds. The trial is continuing to enroll and is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued. The study also will evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease. In addition to the primary efficacy endpoints evaluating confirmed COVID-19 cases accruing from 7 days after the second dose, the final analysis now will include, with the approval of the FDA, new secondary endpoints evaluating efficacy based on cases accruing 14 days after the second dose as well. The companies believe that the addition of these secondary endpoints will help align data across all COVID-19 vaccine studies and allow for cross-trial learnings and comparisons between these novel vaccine platforms. The companies have posted an updated version of the study protocol at https://www.pfizer.com/science/coronavirus.

Pfizer and BioNTech are continuing to accumulate safety data and currently estimate that a median of two months of safety data following the second (and final) dose of the vaccine candidate – the amount of safety data specified by the FDA in its guidance for potential Emergency Use Authorization – will be available by the third week of November. Additionally, participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.

Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced.

Based on current projections we expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.

Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-review publication.

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.

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, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de.

Source: Pfizer Inc.

Filed Under: Tech

Reader Interactions

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

Primary Sidebar

Market Analysis

Unfulfilled Dreams: The Aftermath of China’s Stalled Real Estate Developments
Huawei on the Brink: Biden Administration Considers Cutting Off the Tech Giant”
Key Fire Industry Trends for 2023
The Future of Food: Top Trends to Watch in 2023 and Beyond
How to discover the treasure trove of hidden marketing insights by watching customer behavior
Navigating Uncertainty: Prioritizing Hydrogen R&D Efforts for a Sustainable Future
Unleashing the Hidden Talent Pool: The Rise of STARs – Skilled Through Alternative Routes

Market Research Media

Turn Your Story into a Game: The Art of Gamifying Your Plot
The end of cheap money is redrawing the map of corporate earnings
The Future of Virtual Reality: How VR is Changing Industries
Market Research Media Survey: The State of Streaming Services
Media measurement services provide a holistic view of cross-media consumption
Gen Z ranks top in luxury sales
How to market recycled products

Secondary Sidebar

Tech Events

The crypto world is facing a crisis of confidence
ScyllaDB Summit 2023 taking place online on February 15-16, 2023
DLD 2023, an innovation festival, February 1-3, 2023, Tel Aviv, Israel
Cybersecurity Innovations Take Center Stage at Cybertech 2023 in Tel Aviv
Chiplet Summit, January 24-26 2023, the Doubletree by Hilton San Jose Hotel

Venture Capital

The Importance of Diversity and Inclusion in the Workplace
Sequoia Capital announces its $195 Mln dedicated seed fund
Sublime Systems Secures $40 Million Series A to Electrify and Scale Decarbonized Cement Production
actyv.ai Raises Pre-Series A Funding to Fuel Global Expansion, Product Enhancement
Ottopia announces $14.5M Series A Funding Round

Footer

Recent Posts

  • Netlify has acquired Gatsby
  • Potential for disruption: Conference is the most inefficient way to get information
  • Artificial Intelligence: The Future of Healthcare
  • The Rise of Virtual Power Plants: Innovating Energy Management
  • DLD 2023 is coming
  • Barcelona Cybersecurity Congress Has Been a Success
  • The Unstoppable Rise of RISC V Architecture
  • Revolutionizing Education: The Power of Automated Tutoring Lessons
  • Revolutionizing the Fashion Industry: Algae-based Yarns and Dyes Take on Fast Fashion
  • Cybertech 2023 kicks off in Tel Aviv

App Coding

Ondat 2.8 Arrives in GA with Increased Support for Stateful Workloads in Kubernetes
Code Intelligence raises $12M Series A
monday.com Adds Built-In Monetization Solution to the apps marketplace
A developer’s job isn't just to churn out code every day
Platform.sh Secures $140 million in Series D Funding to Support Enterprises in Scaling Fleets of Websites and Applications

API Coding

Apiiro Extends Right from Code to Runtime To Help Developers Fix Risks Faster
WSO2 Completes $93 Million Series E Growth Funding Round with the Investment from Info Edge
RapidAPI opens European headquarters at the new location in Berlin
DarkOwl Announces Release of Ransomware API
Apple Provides Developers with Even More Powerful Technologies to Push the App Experience Forward

Blockchaining

Asia’s Premier Web3 Conference TOKEN2049 Returns to Singapore in September 2023
State of Technology Overview: Blockchaining 2023
What is a blockchain domain?
Join Our Team as a Blockchain Developer - Revolutionize the Future
BSV Blockchain Association sponsors WeAreDevelopers World Congress in Berlin

Event Calendar

NAHB International Builders’ Show (IBS 2023) in Las Vegas from January 31 to February 2, 2023
India’s largest biennial automobile exhibition Auto Expo 2023 held on January 12-15, 2023 at Pragati Maidan, New Delhi
NRF 2023, Retail’s Big Show and Expo, January 15 to 17, 2023, Jacob K. Javits Center, New York
DOMOTEX Hannover 2023′ in Germany from 12-15 January
Electrify Expo Austin Set to Be Largest EV Demo Event of the 2022 Season, November 12-13, 2022, Austin, Texas

Copyright © 2022 Technologies.org

Media Partners: Market Analysis & Market Research and Exclusive Domains

We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept”, you consent to the use of ALL the cookies.
Do not sell my personal information.
Cookie SettingsAccept
Manage consent

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
CookieDurationDescription
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-necessary11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-others11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
cookielawinfo-checkbox-performance11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy11 monthsThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
viewed_cookie_policy11 monthsThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytics
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
Others
Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet.
SAVE & ACCEPT