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The FDA Kicks its COVID Vaccine Effort into High Gear as Crisis Worsens

Friday evening offered a flicker of hope as the Food and Drug Administration authorized Pfizer/BioNTech’s COVID-19 vaccine, the first of its kind available in the United States, for emergency use, setting off a historic mass-vaccination effort to fight the virus that has killed more than 290,000 Americans. The FDA’s green light initiates a highly coordinated and complicated distribution campaign to ship an initial supply of the vaccine, about 2.9 million doses, to vulnerable people throughout the country over the next week, the New York Times reports. The roll out of the vaccine will be left up to the states, which means health officials in each state or jurisdiction will have final say over whom to vaccinate first and how to administer the two-dose vaccine. Most states are prioritizing health-care workers and nursing home residents, and inoculations are expected to begin on Monday. The shots will be free to the public.

The COVID-19 vaccine, a joint effort between Pfizer and its German partner BioNTech, has been hailed as nothing short of miraculous. Vaccines typically take years to develop, but Pfizer’s was found to be 95% effective in less than one, making it the fastest vaccine development in Western history. On Thursday, an advisory panel of outside experts recommended that the FDA issue emergency use authorization for the vaccine in people 16 and older, and the agency had apparently planned to do so on Saturday. But the FDA’s formal announcement instead came late Friday, half a day early, allegedly after the White House threatened to fire the head of the FDA if he didn’t speed things up. Chief of Staff Mark Meadows reportedly told FDA commissioner Stephen Hahn on Friday to either approve the vaccine by the end of the day or submit his resignation, an ultimatum that came as President Donald Trump attacked Hahn on Twitter for supposedly slow-walking the process. (In a statement, Hahn denied the threat to his job, first reported by the Washington Post, claiming it was “an untrue representation of the phone call” and instead saying his agency was “encouraged to continue working expeditiously.”)

The accelerated authorization is not expected to shift the delivery timeline of the first doses, but Trump politicizing the decision—as he has with all things pandemic-related over the past nine months—potentially jeopardizes public confidence in the vaccine. The White House’s latest attack, according to the Post, threatens to undermine “a process that had been designed to show no shortcuts were taken in reviewing the safety and effectiveness of a vaccine as surveys show many people remain unsure whether they will get the shots.” And it comes in the midst of a national spike, as the country continues to surpass devastating pandemic milestones. The U.S. again set single-day records for infections and hospitalizations on Friday, reporting 237,092 new cases and 108,507 hospitalizations. Thursday was the second day in a row that the nation set a record for deaths, surpassing 3,300 COVID-19 fatalities—more than the death toll reached during the 9/11 terrorist attacks. Friday’s death tally, 2,950, was only a slight improvement.

As state health officials prepare to embark on the historic vaccination campaign, they are also sounding the alarm on the worsening crisis. Los Angeles County, where the average number of daily deaths has increased by more than 250 percent over the past month, could see “catastrophic suffering and death” in the coming weeks, health officials warned. “We’re seeing daily numbers of cases and hospitalizations that we’ve not experienced and, frankly, did not anticipate,” said Dr. Barbara Ferrer, the county’s public health director. The number of people killed by COVID-19 in Iowa has risen nearly six-fold since May, according to the Des Moines Register, and as of Friday morning, more than 1 of every 1,000 Iowans has died from the virus. Georgia’s confirmed and suspected COVID-19 death toll “could fill nearly every chair” in the University of Georgia’s Stegeman Coliseum, which seats 10,523, the Atlanta Journal-Constitution reported Friday, as the state surpassed 10,000 coronavirus deaths for the first time.

And health systems across the country are being pushed to their breaking point—if they haven’t already reached it. “Hospitals serving more than 100 million Americans reported having fewer than 15 percent of intensive care beds still available as of last week,” the Times reports, and one in 10 Americans across a large part of the Midwest, South, and Southwest “lives in an area where intensive care beds are either completely full, or fewer than 5 percent of beds are available.”

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