The Food and Drug Administration on Friday gave emergency use authorization to the nation’s first coronavirus vaccine, launching what scientists hope will be a critical counteroffensive against a pathogen that has killed more than 290,000 Americans, shredded the nation’s social and political fabric and devastated the economy, The Washington Post reports.
The historic authorization of the vaccine from Pfizer and BioNTech for people age 16 and older, just 336 days after the genetic blueprint of a novel coronavirus was shared online by Chinese scientists, sets in motion a highly choreographed and complex distribution process aimed at speeding vaccines throughout the United States to curb the pandemic.
The FDA action came after 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 clear the vaccine by day’s end, 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 try to ward off President Trump’s importuning on the vaccine and 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 delivery timeline of the first shots.
The nation set a record for covid-19 deaths Thursday for the second day in a row, surpassing 3,300. The death tally for Friday was 2,950, only slightly lower, bringing the U.S. death toll to nearly 295,000.
Federal officials have said distribution of the first 2.9 million doses of the highly effective vaccine would begin within 24 hours of an authorization. Meanwhile, an advisory committee for the Centers for Disease Control and Prevention, which has recommended that health-care workers and nursing home residents be the first recipients, was expected to bless the vaccine on Saturday, paving the way for inoculations to begin early next week.
The vaccine achievement creates a paradigm for vaccine development, 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. And it marks a rare triumph for the Trump administration, which in many other areas — such as ensuring adequate testing supplies and providing consistent guidance on whether to wear masks — has failed to produce a coherent and sustained response to the crisis.
Daniel Carpenter, a political scientist at Harvard University, 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.
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 clinical trial with tens of thousands of participants. The vaccine has already been approved in Britain, Canada, Saudia Arabia and Bahrain.
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.
But while the vaccine enterprise has been impressive, its credibility has been repeatedly threatened by Trump, 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 deliberately 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.”
The White House maneuvers seemed designed to ensure Trump gets credit just as the vaccine crosses the finish line. But experts said his behavior risked undermining public confidence — not because it would force a vaccine through prematurely but because it could create the appearance that politics, not science, drove the decision.
“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 who writes about vaccine policy at the University of California Hastings College of the Law. “Making it appear there was political pressure will undermine trust.”
Hahn, in a statement Friday, dismissed reports that his job was threatened. “This is an untrue representation of the phone call with the Chief of Staff,” he said. “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.”
The White House said in an email that “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 impressive scientific achievement of producing a vaccine in record time. The Pfizer-BioNTech product, and the one right on its heels, from biotechnology company Moderna, 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.
FDA emergency authorizations are temporary approvals used to accelerate the availability of medical products during a public health emergency. They require less data than regular approvals and can be issued based on a lower standard. In the case of a vaccine, however, the FDA has said it would use rigorous criteria because millions of healthy people are expected to receive it.
Government officials project that Moderna and Pfizer will be able to deliver 40 million doses of vaccine this year, enough for 20 million people to receive the full regimen. The pace of vaccination is projected to increase in the first months of next year as manufacturing capacity increases and as other vaccines potentially come online. Data on the effectiveness of a one-shot vaccine from Johnson & Johnson is expected in early January.
To ensure that companies understood the FDA’s expectations, the agency took the unusual step of issuing guidelines in June that specified any vaccine should be at least 50 percent effective compared with a placebo, or saltwater shot. A few months later, after it became clear the agency would employ an emergency use authorization to clear the vaccine, the FDA spelled out detailed standards and called for the manufacturers to produce two months of safety data on half of the trial participants.
That safety requirement meant any vaccine would be delayed until after Election Day, infuriating Trump, who tweeted angrily about the FDA and Pfizer. White House ire intensified when Britain authorized the vaccine first, on Dec. 2.
On the AMA webinar, Marks acknowledged that the agency had paid a price for its careful scrutiny. “Unfortunately, there is a cost to being this careful. Another regulatory agency made the vaccine available before we did,” he said. “That’s because we are really taking care to make sure when people get this vaccine, we will have really vetted it for safety.”
Harvard’s Carpenter said being careful will pay off in the long run with greater acceptance of the vaccine, boosting public health. “You need to think about the confidence effects,” he said.
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