Roundup Record Tribune & Winnett Times -

Drugmaker on pace to seek approval later this month

By Tom Howell Jr. - The Washington Times

A coronavirus vaccine from Pfizer proved more than 90% effective in a preliminary analysis of a trial involving thousands of enrollees, a major milestone in the race for shots that can reel in the pandemic.

The drugmaker said it tallied 94 infections in trial participants and looked at who received the vaccine, versus the placebo, to determine its efficacy. Recipients achieved protection 28 days after the second dose of the vaccine.

“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 vaccine’s ability to prevent COVID-19,” Pfizer Chairman and CEO Dr. Albert Bourla said.

The news will reverberate around the country and the world. The U.S. is recording over 100,000 new infections per day, signaling a potentially rocky road ahead as winter looms.

“We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen,” Dr. Bourla said. “With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis.”

Pfizer will not seek emergency approval of its candidate immediately, however.

The Food and Drug Administration wants two months of safety data from half of the trial participants after their second dose, pushing the timeline to the latter half of November.

President Trump had openly suggested a vaccine might arrive before Election Day, but that didn’t happen. His administration will likely oversee the launch of the immunization campaign, but not its conclusion.

President-elect Joseph R. Biden said the development is “excellent news” but warned it that a sufficient share of the U.S. population will not be vaccinated until deep into 2021, so people shouldn’t start throwing their masks away.

“I congratulate the brilliant women and men who helped produce this breakthrough and to give us such cause for hope,” Mr. Biden said. “At the same time, it is also important to understand that the end of the battle against COVID-19 is still months away.”

Pfizer said it will continue to analyze participants until it counts up 164 cases of the virus, allowing it to form a final analysis.

The New York company, which is working with BioTech of Mainz, Germany, is among several front-runners in the global chase for a vaccine that can bring the coronavirus down to manageable levels.

Johnson & Johnson, Moderna and AstraZeneca are steeped in late-stage trials, giving the U.S. a few promising candidates.

Pfizer says it expects to be able to produce up to 50 million doses by the end of 2020 and up to 1.3 billion doses in 2021.

Copyright © 2020 The Washington Times, LLC.