Pfizer/BioNTech evaluates BNT162b2 for large scale clinical trial
Category: #health  By Pankaj Singh  Date: 2020-08-24
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Pfizer/BioNTech evaluates BNT162b2 for large scale clinical trial

The ongoing coronavirus outbreak has brought about major changes to every aspect of life. In times like these, the need to develop a novel treatment for COVID-19 disease is of paramount importance. In a bid to develop an efficient vaccine, Pfizer Inc. and BioNTech SE, leading pharmaceutical companies, have reportedly profiled its COVID-19 vaccine candidate named ‘BNT162b2’ for large scale clinical trials. 

After widespread review of clinical and pre-clinical data from initial studies, both companies have decided to advance their BNT162b2 vaccine candidate into large scale safety and efficacy evaluations. The most vital finding from an initial clinical trials is that BNT162b2 recipients disclosed no severe systemic events.

For the record, Pfizer and BioNTech evaluated the four potential COVID-19 vaccines, each of which embodies a unique combination of messenger RNA format and target antigen. The company’s BNT162b1 candidate encodes the SARS-CoV-2 receptor-binding domain (RBD), and the other, BNT162b2, encodes the full-length SARS-CoV-2 spike protein to improve its antibody capacity.

During initial studies, BNT162b1 and BNT162b2 emerged as strong potential candidates based on the evaluations of immune and safety response. Both companies then selected BNT162b2 as the candidate to progress to clinical Phase study based on the findings of preclinical and clinical studies, including select immune response and tolerability parameters.

The placebo-controlled, randomized, observer-blind dose-escalation study included healthy adults aged 18–55 and 65–85. They were administered two doses at 21-day placebo cycles, or one of the two vaccinations listed above. As seen for many vaccinations, the immunogenicity of both vaccinations declined with age, resulting in lower humoral responses among 65–85-year-olds relative to 18–55-year-olds.

In the next steps, Pfizer/BioNTech will evaluate efficiency and safety of BNT162b2 at 30 µg dose level in up to 30,000 people from diverse backgrounds – including individuals with stable chronic underlying health conditions, ethnic occupational exposure, and from numerous and racial backgrounds.

 

Source credit - https://www.news-medical.net/news/20200823/PfizerBioNTech-COVID-19-vaccine-candidate-BNT162b2-profiled-for-large-scale-clinical-trials.aspx



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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