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For a nation ravaged by the pandemic, this week marks a pivotal moment — the final push by federal regulators to clear the first experimental coronavirus vaccine for a besieged populace. If all goes as expected over the next few days, the Food and Drug Administration could give emergency authorization to the vaccine as early as week’s end, triggering the start of an unprecedented effort to inoculate enough Americans to confer individual immunity and eventually stop the virus’s spread. That next chapter, however, is filled with herculean challenges, including ramping up production to tens of millions of doses, shipping them in specially designed boxes packed with dry ice to keep them ultracold and vaccinating people in every corner of the United States. (McGinley, 12/7)

U.S. regulators Tuesday released their first scientific evaluation of Pfizer’s COVID-19 vaccine and confirmed it offers strong protection, setting the stage for the government to green light the biggest vaccination effort in the nation’s history. The analysis by Food and Drug Administration scientists comes ahead of a Thursday meeting where the agency’s independent advisers will debate if the evidence is strong enough to recommend vaccinating millions of Americans. A final FDA decision and the first shots could follow within just days. They are among a whirlwind of developments that are expected to make multiple vaccines available by early next year, in the U.S. and beyond. (Neergaard and Perrone, 12/8)

The Food and Drug Administration has found that there are "no specific safety concerns" that would stop the agency from approving the COVID-19 vaccine made by Pfizer and BioNTech for emergency use. Career scientists at the FDA analyzed the data from the ongoing Pfizer trial to form their own conclusions about its safety and efficacy. Stephen Hahn, who heads the FDA, says the public analysis is a "very, very important part of our promise to the American people that we won't cut corners in how we assess the safety and effectiveness of a vaccine." (Chang, 12/8)

In related news —

It was a simple thing. A swipe with an alcohol pad, a tiny needle prick in the upper arm and the application of a small Band-Aid. But the health care workers receiving a new coronavirus vaccine here on Tuesday, among the first in Britain, know it’s more than that. “I’m excited for the world, really,” said Dr. Chris Hingston. “I just feel very lucky that we’re making this first step back toward normality.” (Specia, 12/8)

The new Covid-19 vaccines from Pfizer and Moderna seem to be remarkably good at preventing serious illness. But it’s unclear how well they will curb the spread of the coronavirus. That’s because the Pfizer and Moderna trials tracked only how many vaccinated people became sick with Covid-19. That leaves open the possibility that some vaccinated people get infected without developing symptoms, and could then silently transmit the virus — especially if they come in close contact with others or stop wearing masks. (Mandavillil, 12/8)

KHN: What Seniors Can Expect When COVID Vaccines Begin To Roll Out 
Vaccines that protect against COVID-19 are on the way. What should older adults expect? The first candidates, from Pfizer and Moderna, could arrive before Christmas, according to Alex Azar, who heads the Department of Health and Human Services. (Graham, 12/9)

KHN: It’s Time To Scare People About COVID 
I still remember exactly where I was sitting decades ago, during the short film shown in class: For a few painful minutes, we watched a woman talking mechanically, raspily through a hole in her throat, pausing occasionally to gasp for air. The public service message: This is what can happen if you smoke. I had nightmares about that ad, which today would most likely be tagged with a trigger warning or deemed unsuitable for children. But it was supremely effective: I never started smoking and doubt that few if any of my horrified classmates did either. (Rosenthal, 12/9)