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Pfizer said Friday it is asking U.S. regulators to allow emergency use of its COVID-19 vaccine, starting the clock on a process that could bring limited first shots as early as next month and eventually an end to the pandemic -- but not until after a long, hard winter. The action comes days after Pfizer Inc. and its German partner BioNTech announced that its vaccine appears 95% effective at preventing mild to severe COVID-19 disease in a large, ongoing study. (Neergaard, 11/20)

Pfizer and BioNTech said they will submit to the US Food and Drug Administration today for an emergency use authorization for their coronavirus vaccine candidate. This is the first coronavirus vaccine to seek a regulatory OK in the United States. The companies said in a statement that their vaccine candidate, known as BNT162b2, will potentially be available for use in high-risk populations in the United States by the middle to end of December. (Gumbrecht, 11/20)

Pfizer and its German partner BioNTech will be the first companies to seek emergency authorization for a coronavirus vaccine in the United States, prompting Health and Human Services Secretary Alex Azar to say that there was “light at the end of the tunnel.” The move means a vaccine could be available on a limited basis within weeks. But conditions around the country remain dire: The United States reported more than 185,000 new coronavirus cases on Thursday, yet another record. Coronavirus-related hospitalizations are also at an all-time high. (Noori Farzan and Mellen, 11/20)

The application also includes safety data on about 100 children 12-15 years of age. The company said 45% of U.S. trial participants are 56-85 years old. If the data is solid, “we literally could be weeks away from the authorization of a 95% effective vaccine,” U.S. Health Secretary Alex Azar said on CBS’ “This Morning”. (11/20)

As part of that review, FDA scientists are expected to look at data from individual patients, such as for indications of any troubling side effects. After the FDA staff review, an independent panel of doctors from major U.S. academic centers will meet to advise the FDA on the vaccines’ efficacy—likely in early December. ... After the review, the FDA then will decide whether to grant an “emergency use authorization,” a quicker version of the normal FDA approval. (Burton and Walker, 11/19)

A key step along the way is a meeting of outside FDA advisers, all experts in infectious diseases and vaccines. They’re set to confer Dec. 8-10, according to a person with knowledge of the situation. The FDA will spend the few short weeks between the emergency authorization request and the meeting sorting through the trial data. (Edney, 11/20)

After Pfizer’s leading COVID-19 vaccine turned in strong data in a late-stage trial, the company planned to submit its program to U.S. authorities for an emergency use authorization “within days.” And as soon as it gets go-aheads from regulators, it'll be ready to distribute, CEO Albert Bourla says.Once granted an authorization, Pfizer plans to begin shipping doses “within hours” of the notice, Bourla told Sky News after the company’s positive phase 3 announcement. And it'll start shipping those doses wherever the vaccine is authorized first, he added, raising the prospect of a “race to regulate” as authorities seek to quickly review data and secure early doses for their countries. (Sagonowsky, 11/19)

Dr. Margaret Hamburg, former Food and Drug Administration commissioner in the Obama administration, told CNBC on Wednesday that she trusts the regulatory agency will adhere to strict scientific principles as it evaluates coronavirus vaccines. “It’s an agency that is so committed to strong science, the integrity of the people who work there,” Hamburg said on “Closing Bell.” “And I really feel confident that everyone there has been working 24/7 to help accelerate the process of vaccine development and review as much as possible but that no corners will be cut in terms of assuring the soundness of the scientific data on which decisions will be made.” (Stankiewicz, 11/18)