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Pfizer, partner moving ahead with COVID-19 vaccine trials

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Pfizer Inc. and BioNTech, a German company, have started late-phase human trials in the race to develop a COVID-19 vaccine.

The announcement late Monday, on the same day that U.S. drugmaker Moderna announced it had begun human trials of its own COVID-19 vaccine candidate, came after an extensive review of preclinical and clinical data from phase 1/2 clinical trials, and in consultation with the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research and other global regulators, Pfizer and BioNTech said.

On Tuesday, Pfizer reported a 32% decline in second-quarter profit, mainly due to the coronavirus pandemic's impact on the company's ability to market and sell new prescriptions. Second-quarter revenues totaled $11.8 billion, down 11% from the previous year. Still, the company's positive outlook for the rest of the year drove the price of its shares up 4%.

Pfizer and BioNTech said they decided to advance one of four vaccine candidates they had been studying. In the phase 2/3 study, the vaccine candidate will be delivered at a 30-microgram dose level in a two-dose regimen.

“Our selection of the BNT162b2 vaccine candidate and its advancement into a Phase 2/3 study are the culmination of an extensive, collaborative and unprecedented R&D program involving Pfizer, BioNTech, clinical investigators, and study participants with a singular focus of developing a safe and effective COVID-19 RNA vaccine,” said Kathrin U. Jansen, senior vice president and head of Pfizer vaccine research and development. “The initiation of the Phase 2/3 trial is a major step forward in our progress toward providing a potential vaccine to help fight the ongoing COVID-19 pandemic, and we look forward to generating additional data as the program progresses.”

The phase 2/3 study will involve up to 30,000 participants between 18 and 85 years of age. The companies plan to enroll a diverse population, including participants in areas where there is significant transmission of SARS-CoV-2, the coronavirus that causes COVID-19. By the end of the trial, the phase 2/3 study is expected to be active at approximately 120 clinical investigational sites around the world, including 39 states across the U.S. and countries including Argentina, Brazil and Germany.

If the phase 2/3 trial is successful, Pfizer and BioNTech expect to be ready to seek emergency use authorization or some form of regulatory approval as early as October 2020. If authorization or approval is obtained, the companies currently aim to supply globally up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021.

The U.S. government reached a $1.95 billion agreement with the two companies last week to produce and deliver 100 million doses of their COVID-19 vaccine by the end of the year. Earlier this month, the companies were granted fast-track designation by the Food and Drug Administration.

On the day the agreement was announced, Gov. Ned Lamont visited Pfizer’s research and development facilities on Eastern Point Road in Groton, where staff has been working on tasks related to the vaccine.

b.hallenbeck@theday.com

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