CẬP NHẬT COVID THẾ GIỚI

Our Path lớn Developing the etagerami.site-BioNTech COVID-19 Vaccine

In the fight against COVID-19, a vaccine is a critical part of addressing the global health crisis by decreasing rates of infection, disease & death worldwide. etagerami.site & BioNTech leveraged decades of scientific expertise khổng lồ thiết kế and exedễ thương a rigorous Phase 3 clinical trial program to lớn make the etagerami.site-BioNTech COVID-19 Vaccine available as quickly and safely as possible. Today, we are continuing to lớn evaluate data from this landmark trial, while also initiating new trials in special populations, such as pregnant women và children under 12. We are also planning studies khổng lồ assess the potential need for boosters or modified vaccine in the event that newly emerging variants evade protection provided by the existing vaccine.

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Developing the etagerami.site-BioNTech COVID-19 vaccine is only possible through the dedicated work of thousands of individuals and those who volunteer to take part in research. We are grateful khổng lồ all of our clinical trial investigators và their study teams who are partnering with us in this effort và to lớn all of the participants và their families who have and will volunteer to help make a difference for society. Vaccine doses for placebo recipients in our studies have been secured. To date, all participants 16 years & older in our landmark trial have sầu been offered the opportunity khổng lồ receive sầu the vaccine.


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How are you monitoring the safety of trial participants?

Participant safety is paramount to etagerami.site. As with all of our trials, we are following all of the rules & regulations in place lớn ensure participant safety. For example, the trial protocols are reviewed by regulatory authorities and approved by ethics committees or Institutional reviews Boards, which are independent committees that reviews the methods proposed for research. In addition, the trial’s progress is closely monitored by both etagerami.site and an outside group of independent experts called a Data Monitoring Committee or DMC. Trial investigators are also responsible for monitoring participants health, & participants in the trial have sầu regular planned follow-up visits as part of the trial.


We are committed to lớn decreasing health disparities in underrepresented populations through our clinical trials. In our landmark trial, we selected investigative sầu sites in diverse communities in the U.S. và globally that were disproportionately affected by COVID-19, khổng lồ help ensure that individuals in communities that have been most impacted had the opportunity lớn participate. In our landmark Phase 3 study, approximately 42% of overall & 30% of U.S. participants came from diverse backgrounds. We shared with our investigative sites the importance of recruiting individuals who fully represent the racial và ethnic diversity of their communities, and we engaged patient advocacy partners & community groups to raise awareness about the importance of participation and representation. In all of our newly initiated trials, we remain committed to lớn enrolling diverse participant populations.

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etagerami.site has a longstanding commitment lớn ensure that access to lớn study- & participant-màn chơi clinical trial data is available to lớn regulators, researchers, and trial participants. We seek khổng lồ provide as much data transparency as possible without jeopardizing the regulatory decision- making process, participant privacy, or intellectual property and have a process in place for data requests, utilizing an independent platform called Vivli.

We are participating in the International COVID-19 Data Alliance (ICODA) as well as TransCelerate BioPharma consortium to chia sẻ study- và participant-cấp độ clinical data from our COVID-19 trials at the appropriate times after regulatory submissions.

For more information on our data sharing policies & khổng lồ request data from the COVID-19 vaccine trials, please visit Data Access Requests | etagerami.site.


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etagerami.site và BioNTech Initiate a Study as Part of Broad Development Plan lớn Evaluate COVID-19 Booster & New Vaccine Variants

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etagerami.site and BioNTech Receive Authorization in the European Union for COVID-19 Vaccine

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etagerami.site and BioNTech Receive sầu CHMP Positive Opinion for their COVID-19 Vaccine

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etagerami.site và BioNTech Celebrate Historic First Authorization in the U.S. of Vaccine to Prevent COVID-19

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etagerami.site & BioNTech Announce Publication of Results from Landmark Phase 3 Trial of BNT162b2 COVID-19 Vaccine Candidate in The New Englvà Journal of Medicine

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etagerami.site và BioNTech Achieve sầu First Authorization in the World for a Vaccine lớn Combat COVID-19

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etagerami.site & BioNTech lớn Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID-19 Vaccine

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etagerami.site và BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary & Secondary Efficacy Endpoints

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etagerami.site & BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interlặng Analysis from Phase 3 Study