Tag: emergency use authorization
The Pandemic Isn’t Over for Immunocompromised People
When the coronavirus pandemic began, Emily Landon thought about her own risk only in rare quiet moments. An infectious-disease doctor at the University of Chicago Medicine, she was cramming months of work into days, preparing her institution for the virus’s arrival in the United States. But Landon had also recently developed rheumatoid arthritis—a disease in which a person’s immune system attacks their own joints—and was taking two drugs that, by suppressing said immune system, made her more vulnerable to pathogens.
How Many Lives Could the FDA Have Saved From COVID?
The first COVID-19 vaccine could arrive before Election Day, Donald Trump avowed in the summer of 2020. But government regulators wanted things to work out differently: “The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics,” he wrote on Twitter. “Obviously, they are hoping to delay the answer until after November 3rd.”
Regulators did, in fact, end up slowing the process: In
FDA Delays Carry a Death Toll
This morning, the FDA granted full approval to the Pfizer vaccine for use in people 16 and older. Although “the vaccine approval was the fastest in the agency’s history,” as The Washington Post noted, serious side effects have proved extremely rare. Nevertheless, anti-vaccine activists—and the politicians and pundits pandering to them—have criticized the accelerated approval process as rushed. Yet the problem with the FDA is precisely the opposite: The agency too often fails to recognize the danger of being
Pfizer Vaccine Full Approval: Why the FDA Took So Long
After months of anticipation, Americans have a fully licensed COVID-19 vaccine. Today, the FDA announced the approval of Pfizer-BioNTech’s shot for people 16 and older—the first complete thumbs-up among the three vaccines available in the U.S.
The pervasive mood has been: Finally. Pfizer’s shot was given its emergency use authorization—the vaccine’s training wheels—back in December, and the company submitted its application for full approval in May. While America’s emergency-use vaccination rollout has saved an untold number of lives, many