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PRESS RELEASE
Pfizer and BioNTech - USA/Germany
Pfizer Submitted an EUA Request for Its COVID-19 Vaccine - What’s Next?
Pfizer and BioNTech announced that they have submitted a request to the U.S. Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) of their COVID-19 vaccine candidate. If authorized by the FDA, then the investigational vaccine could be used in high-risk populations in the U.S. by the end of December 2020. On our path toward making a potential vaccine publicly available, we want to make sure that the public is updated on our progress and next steps in our development process.
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Our Progress in Developing a Potential COVID-19 Vaccaine
In the fight against COVID-19, a vaccine is a critical part of addressing the global health crisis by decreasing rates of infection, disease and death worldwide. Pfizer and BioNTech are leveraging our decades of scientific expertise and working together to make our COVID-19 vaccine candidate available as quickly and safely as possible. The Phase 3 clinical trial began in late July, and participants 12 and over are now eligible to participate.
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Pfizer and BioNTech to Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID-19 Vaccine (Friday, November 20, 2020 - 06:45am)
In addition to today’s submission to the FDA, the companies have already initiated rolling submissions across the globe including in Australia, Canada, Europe, Japan and the U.K., and plan to submit applications immediately to other regulatory agencies around the world.
Based on current projections, the companies expect to produce globally up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021; the companies will be ready to distribute the vaccine within hours after authorization.
BNT162b2 demonstrated a vaccine efficacy rate of 95%, with no serious safety concerns observed to date.
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Coronavirus Scientific Resources
Resources to educate and collaborate on COVID-19 responses. In confronting this crisis, we believe that science will win. Be sure to keep up with all of our important updates surrounding COVID-19, including press releases, supply updates and more.
A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals
>>>> READ MORE (PDF, 146 pages) <<<<
More COVID-19 reports
 Viewpoint by Jayasri Priyalal*
SINGAPORE (IDN) – They are fighting an invisible enemy taking a warpath. Many countries grappling with the COVID-19 pandemic interpret the situation like a war. Frontline, heroes, are found in the battlefield scenarios.
These heroes come from different professions, medical and health care workers being the binding force, the rest including, security, transport, postal logistic, financial service providers, and employees attached to retail industries etc. Aside from them, many unsung heroes are working in hospitals, morgues in burial grounds and the health and sanitary service providers who provide an invaluable essential service to keep the communities together.
Read More
 But the Next Decade Might Trigger the Change Needed
Viewpoint by Jenny Larsen*
VIENNA (IDN) – Industrial development in Africa has been sluggish for some decades. Now, as the effects of the COVID-19 pandemic kick in, hopes for better progress, at least in the short term, appear to be fading. But if countries grasp the right opportunities, the next decade can deliver the industrial change needed to meet the challenges ahead.
Industrialization and development go hand in hand. There is hardly a country in the world that has developed without building a strong manufacturing base. But for Africa – sometimes referred to as the continent of the future – the fruits of industrialization have often seemed just out of reach.
Read More
News for a Sustainable World, Peace and Security
Jörg-Werner Busse
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