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The journey of a lifetime - development of Pfizer's COVID-19 vaccine.
Thorn, Chelsea R; Sharma, Divya; Combs, Rodney; Bhujbal, Sonal; Romine, Jennifer; Zheng, Xiaolu; Sunasara, Khurram; Badkar, Advait.
  • Thorn CR; Pharmaceutical Research and Development, Biotherapeutics Pharm Sci, Pfizer Inc., USA.
  • Sharma D; Pharmaceutical Research and Development, Biotherapeutics Pharm Sci, Pfizer Inc., USA.
  • Combs R; Bioprocess Research and Development, Biotherapeutics Pharm Sci, Pfizer Inc., USA.
  • Bhujbal S; Pharmaceutical Research and Development, Biotherapeutics Pharm Sci, Pfizer Inc., USA.
  • Romine J; Bioprocess Research and Development, Biotherapeutics Pharm Sci, Pfizer Inc., USA.
  • Zheng X; Bioprocess Research and Development, Biotherapeutics Pharm Sci, Pfizer Inc., USA.
  • Sunasara K; Bioprocess Research and Development, Biotherapeutics Pharm Sci, Pfizer Inc., USA.
  • Badkar A; Pharmaceutical Research and Development, Biotherapeutics Pharm Sci, Pfizer Inc., USA. Electronic address: advait.v.badkar@pfizer.com.
Curr Opin Biotechnol ; 78: 102803, 2022 Sep 01.
Article in English | MEDLINE | ID: covidwho-20243793
ABSTRACT
It would be apt to say that one of the greatest accomplishments in modern medicine has been the development of vaccines against COVID-19, which had paralyzed the entire world for more than a year. Pfizer and BioNTech codeveloped the first COVID-19 vaccine that was granted emergency-use authorization or conditional approval in several regions globally. This article is an attempt to go 'behind-the-scenes' of this development process and highlight key factors that allowed us to move with this unprecedented speed, while adhering to normal vaccine-development requirements to generate the information the regulatory authorities needed to assess the safety and effectiveness of a vaccine to prevent an infectious disease, including quality and manufacturing standards. This is also a story of how Pfizer and BioNTech leveraged our combined skill sets and experience to respond to the global health crisis to progress this program swiftly while ensuring the compliance with our high-quality standards and keeping patient safety at the forefront. We will also highlight multiple other factors that were instrumental in our success.

Full text: Available Collection: International databases Database: MEDLINE Topics: Vaccines Language: English Journal: Curr Opin Biotechnol Journal subject: Biotechnology Year: 2022 Document Type: Article Affiliation country: J.copbio.2022.102803

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Full text: Available Collection: International databases Database: MEDLINE Topics: Vaccines Language: English Journal: Curr Opin Biotechnol Journal subject: Biotechnology Year: 2022 Document Type: Article Affiliation country: J.copbio.2022.102803