Safety and Efficacy of the BioNTech-Pfizer Covid-19 Vaccine

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Publication Date

Spring 2021


The World Health Organization declared COVID-19 a worldwide pandemic in early 2020 and SARS-CoV-2 infection has afflicted people worldwide. The advancements to control the spread in addition to saving millions of lives has resulted in the development of a two-dose regimen of BNT162b2 presents a 95% protection rate against COVID-19 in individuals of 16 years & older. This two-dose regimen has evidence of the safety and efficacy of two 30-μg administered intramuscularly 21-days apart. Through the sponsorship of BioNTech as well as the design and conduction of the experimental trials of Pfizer, a total of 43,448 persons 16 years & older underwent randomized trials of receiving either the BNT162b2 vaccine or a standardized saline placebo. There are two primary end points that were monitored in the efficacy of BNT162b2 against confirmed COVID-19 with an onset of at least 7 days after the second dose in participants who had been without serologic or virologic evidence of the infection up to seven days after the second does. The secondary primary end-point was efficacy in participants with as well as participants without evidence of prior infection. The data collected ended on October 9, 2020, with 37,706 participants. These participants had a median of at least 2 months of safety data available after the second dose and contributed to the main safety data set. The following results do demonstrate that COVID-19 can be prevented by immunization and provide proof that RNA-based vaccines are a reliable approach for protecting humans against infectious.


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