Pfizer/ BioNTech’s vaccine candidate BNT162b2 shows 90% efficacy in preventing COVID-19

Pfizer/ BioNTech’s vaccine candidate BNT162b2 shows 90% efficacy in preventing COVID-19

The US drugmaker Pfizer with its German biotech partner BioNTech SE has released first promising interim analysis data from a large-scale phase 3 clinical trial of their coronavirus vaccine candidate BNT162b2 claiming more than 90 per cent efficacy in preventing COVID-19.

The phase 3 clinical trial of BNT162b2 began on July 27. The early data is based on the first interim efficacy analysis conducted on November 8, 2020, by an external, independent Data Monitoring Committee (DMC). The study had enrolled 43,538 people in the US and five other countries. Of these, 38,955 patients have received a second dose of the vaccine candidate as of November 8, 2020. The DMC data is based on the analysis of 94 confirmed cases of COVID-19 in the trial participants.

The interim analysis is based on data from 7 days after the second dose of vaccination. Protection is achieved 28 days after initiation of the vaccination, said Pfizer. Another interim analysis is now planned for 120 cases, according to the updated study protocol.


BNT162b2 is a nucleoside-modified RNA, formulated in lipid nanoparticles. It encodes an optimized SARS-CoV-2 full-length spike protein antigen.
“The vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis,” Pfizer said in a statement.

 

“The first set of results from our phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Dr. Albert Bourla, Pfizer Chairman and CEO.

Pfizer and BioNTech plan to submit data from the full phase 3 trial for scientific peer-review publication. The companies said they have found no serious safety concerns so far. Along with the efficacy data generated from the clinical trial, Pfizer said both the companies are working to prepare the necessary safety and manufacturing data to submit to the US drug regulator to demonstrate the safety and quality of the vaccine product produced.

Based on current projections the company revealed that it expects to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.
 

The shots made by Pfizer and its German partner BioNTech are among 10 possible vaccine candidates in late-stage testing around the world—four of them so far in huge studies in the US. Another US company, Moderna Inc., also has said it hopes to be able to file an application with the FDA later this month.