FDA poised to authorize first coronavirus vaccine in the U.S., a rare moment of hope

The vaccine's clearance was moved up by about 12 hours after the White House pressured the agency Friday to complete its work by day's end. White House Chief of Staff Mark Meadows on Friday told FDA Commissioner Stephen Hahn to be prepared to submit his resignation if the agency did not authorize the vaccine by the end of the day, according to people familiar with the situation who spoke on the condition of anonymity because they were not authorized to discuss what happened.

Meadows's threat followed months of efforts by FDA scientists to keep the review process apolitical and transparent in hopes of boosting public confidence in the shots. The FDA already had planned to clear the vaccine Saturday morning, and accelerating the authorization to Friday night was not expected to change the timeline for the first shots.

The last-minute injection of chaos and pressure into the approval process comes at a crucial inflection point, with record-setting daily death tolls projected to worsen this winter, even as federal, state and local officials prepare an unprecedented mass vaccination effort.

The nation set a record for covid-19 deaths on Thursday, the second day in a row with more than 3,300 reported. The death tally for Friday was 2,950, only slightly lower, while more than 237,000 new infections were reported.

While a potential lifesaver for those who receive it, the vaccine is not likely to have a dramatic impact on the immediate course of the pandemic. The initial supply of vaccines will fall far short of the 300 million doses some officials had hoped for last spring, when Operation Warp Speed was created. On Friday, federal officials announced they would purchase an additional 100 million doses of Moderna's soon-to-be approved vaccine, bringing the expected supply of the two leading vaccines to 300 million, probably by midyear.

Still, many saw the imminent arrival of even a limited supply as a source of hopeamid forecasts of a deadly winter.The two-shot vaccine, which has been shown to be 95 percent effective in randomized trials involving tens of thousands of people, has already been cleared by Britain, Canada, Bahrain and Saudi Arabia.

The vaccine from Pfizer and German firm BioNTech was expeceted to be authorized just 336 days after the genetic blueprint of a novel coronavirus was shared online by Chinese scientists. Its clearance would set in motion a highly choreographed and complex distribution process aimed at speeding vaccines throughout the United States.

Federal officials have said distribution of the first 2.9 million doses would begin within 24 hours of the agency's announcement. An advisory panel for the Centers for Disease Control and Prevention has recommended that health-care workers and nursing home residents be the first recipients, and is expected to give its final blessing to the vaccine this weekend, paving the way for inoculations to begin early next week.

The record-breaking time frame of the vaccine's development creates a new paradigm, proving that fast and flexible technologies paired with a single-minded focus by pharmaceutical companies and government can accomplish in 11 months what typically takes years. It also marks a rare triumph for the Trump administration, which in many other areas - such as ensuring adequate testing supplies and providing consistent guidance on masks - has failed to produce a coherent and sustained response to the crisis.

"It's an all-capital-letters, followed by several exclamation points" accomplishment, said Howard Markel, a medical historian at the University of Michigan who predicted that the scientists who were responsible will be lionized for ending the pandemic.

Pfizer and its Germany-based partner, BioNTech, harnessed a fast, flexible genetic technology that had been in development for decades but never deployed in an approved medical product. It was used to build a vaccine that surpassed all expectations by being 95 percent effective at preventing disease in a large clinical trial.

Harvard political scientist Daniel Carpenter said it was unprecedented to go from the discovery of a disease to the development of a vaccine in 11 months. The shortest timeline previously was for the mumps vaccine, which took four years. Most vaccines are produced for ailments that have been around for a long time, after years of research often marked by failures and disappointments. In the case of AIDS, there still is no vaccine, nearly four decades after HIV was identified.

Meanwhile, the FDA, working closely with the companies, conducted an accelerated review that compressed into three weeks the typical months-long scrutiny of safety, effectiveness and data on manufacturing quality.

Operation Warp Speed, the administration's effort to accelerate the development and distribution of coronavirus vaccines and treatments, has spent billions of dollars on a portfolio of vaccines, with Pfizer-BioNTech's being the first to cross the finish line. Unlike the other companies, Pfizer and BioNTech did not take government money for research and development, but they did receive a $1.95 billion contract for 100 million doses, about 25 million of which will be delivered this year.

"To get there has required a host of innovations. . . . Any one of those would have been cause for considerable amazement," said Francis S. Collins, director of the National Institutes of Health. "But when you put them together, it's a path so revolutionary it would be hard to imagine somebody contemplating it five years ago."

But while the vaccine enterprise has been impressive, its credibility has been repeatedly threatened by the president, who for months pressured the FDA to authorize a vaccine before Election Day and, when that did not happen, bitterly accused the agency and Pfizer of orchestrating delays to harm his reelection prospects. On Friday, he continued his criticism on Twitter, calling the agency "a big, old, slow turtle," adding, "Get the dam vaccines out NOW."

Experts said the president's behavior risks undermining public confidence - not because it would force a vaccine through prematurely, but because it creates the appearance that politics, not science, drove the decisions.

"There was no plausible way the FDA would not authorize this vaccine . . . but this makes it appear [their decision] is politically motivated," said Dorit Reiss, a professor of law at the University of California Hastings College of the Law who writes about vaccine policy. "Making it appear there was political pressure will undermine trust."

The FDA has repeatedly said its scientists would review the vaccine and come to their own independent judgments, and on Friday, Hahn denied the White House brought pressure to speed the authorization.

"This is an untrue representation of the phone call with the Chief of Staff," Hahn said in a statement. "The FDA was encouraged to continue working expeditiously on Pfizer-BioNTech's EUA request. FDA is committed to issuing this authorization quickly, as we noted in our statement this morning."

A White House official declined to comment on the latest pressure, saying, "We don't comment on private conversations, but the Chief regularly requests updates on progress toward a vaccine."

The political machinations are in sharp contrast to the scientific achievement in producing a vaccine in record time. Pfizer-BioNTech's product, and another vaccine right on its heels from biotechnology company Moderna, both use a snippet of genetic material encapsulated in a fat bubble to instruct cells to build the spiky proteins that dot the coronavirus. These shots will be the first time the genetic technology has been used in people outside clinical trials.

The government's big bet on the promising method, which allowed for much faster vaccine development, was controversial but is paying off: Moderna's shot is expected to be authorized shortly after a review by the FDA's outside advisers scheduled for Thursday.

Formidable challenges lay ahead involving the massive scale-up of manufacturing and a complicated distribution plan headed by cash-strapped states. On scientific questions, experts still do not know how long the vaccine's protection lasts.

While the CDC has recommended who should get the shots first, starting with health-care workers and nursing home residents, states ultimately will have the final say on which groups get priority.

Much of the general population - including younger people who do not have underlying health conditions or jobs that put them at risk - is unlikely to be offered the vaccine before late spring or early summer. And if a significant proportion of Americans spurn the shot, efforts to banish the coronavirus or turn it into a low-level threat could be made much more difficult.