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BioNTech Quote on COVID-19 Vaccine Safety and Efficacy – Honesty and Risks Explained

„We may not be able to demonstrate sufficient efficacy or safety of our COVID-19 vaccine and/or variant-specific formulations to obtain permanent regulatory approval in the United States, the United Kingdom, the European Union, or other countries where it has been authorized for emergency use or granted conditional marketing approval. Significant adverse events may occur during our clinical trials or even after receiving regulatory approval, which could delay or terminate clinical trials, delay or prevent regulatory approval or market acceptance of any of our product candidates.“

BioNTechBioNTech warns that permanent approval of its COVID-19 vaccine depends on efficacy and safety, with risks during clinical trials.
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BioNTech is a German biotechnology company specializing in the development of immunotherapies, particularly mRNA-based vaccines.

This statement demonstrates the scientific honesty and transparency of a company that, despite success and recognition, warns of potential risks and obstacles.


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Quote by BioNTech about COVID-19 vaccine safety and efficacy risks and regulatory challenges

BioNTech SE was founded in 2008 in Mainz, Germany, and gained worldwide recognition for developing one of the first approved mRNA-based COVID-19 vaccines in collaboration with Pfizer. The company researches personalized cancer vaccines and other immunotherapeutic approaches.

Quotation by Angela Merkel about conditional approval of vaccines and its effects on millionsCopyright © yoice.net – Quote Artwork
31. January 2026
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"All of these vaccines have conditional approval. During this conditional approval, we are gathering experience for the first time regarding the question: What happens when this vaccine is applied to millions of people?" Angela Merkel
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Quote from BioNTech about BN162 (Comirnaty) vaccine effectiveness against alpha and beta variants and booster recommendationsCopyright © yoice.net – Quote Artwork
1. February 2026
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"The current BN162 (Comirnaty) vaccine can induce antibody formation against the alpha and beta variants under laboratory conditions. No data is available on later variants. There has been no variant adaptation of the vaccine since the start of the vaccination campaign, and no adaptation is planned for the boosters. There is no general recommendation for a booster, and the benefits of vaccination must always be weighed up on an individual basis," BioNTech
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Quote by David Malpass on the World Bank's role in vaccine distribution in developing countriesCopyright © yoice.net – Quote Artwork
1. February 2026
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"The immediate problem is indemnification. Pfizer has been hesitant to go into some of the countries because of the liability problems, they don’t have a liability shield. So we work with the countries to try to do that. But I think also some of the other vaccine manufacturers may be able to go into countries because they’re operating through subsidiaries. This is all something that we’re exploring, and our goal, my goal, is to have vaccines available throughout the developing world based on what their countries decide. We’ve got financing available but the countries need to choose systems and then begin buying or receiving the vaccines." David Malpass
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