Pfizer Inc. and BioNTech SE announced Monday that their COVID-19 vaccine candidate demonstrated efficacy against the virus above 90 percent in participants without prior evidence of infection.

These results were based on the first interim efficacy analysis conducted on November 8, 2020, by an external, independent Data Monitoring Committee (DMC) from the two companies' Phase 3 clinical study.

A statement from Pfizer said that the case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90 percent, at 7 days after the second dose. This meant that participants became immune after 28 days from when they were first vaccinated. The vaccine is taking over two doses, and the DMC did not report any serious safety concerns.

The Phase 3 clinical trial of the vaccine began on July 27 and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of November 8, 2020.

"Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccines ability to prevent COVID-19," Pfizer Chairman and CEO Dr. Albert Bourla said.

Further testing of efficacy and safety will need to be conducted before the Food and Drug Administration (FDA) can approve the vaccine.

Pfizer and BioNTech are continuing to accumulate safety data and currently estimate that a median of two months of safety data following the second (and final) dose of the vaccine candidate – the amount of safety data specified by the FDA in its guidance for potential Emergency Use Authorization – will be available by the third week of November. Additionally, participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.

Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced.

"Based on current projections we expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021," Pfizer said.

Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-review publication.

In October, Pfizer Inc. and BioNTech SE announced an agreement with the Ministry of Public Health in Qatar to supply their BNT162 mRNA-based vaccine candidate against SARS-CoV-2, subject to clinical success and regulatory approval, by the end of 2020 to 2021.

Source: Qatar News Agency, Pfizer; Cover image: Pfizer

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