The Food and Drug Administration approved Pfizer-BioNTech’s Covid-19 vaccine for emergency use on Friday, setting off a flurry of logistical steps that have led to the first vaccine doses being administered today.
Based on distribution priorities outlined by the Centers for Disease Control and Prevention last week, states have created guidelines that put frontline healthcare workers and residents of long-term care facilities first in the queue for vaccines, Ed Cara reports for Gizmodo. Today, critical care nurse Sandra Lindsay of the Long Island Jewish Medical Center in Queens, New York, received the first dose of Pfizer’s vaccine in the United States, reports ABC News.
About 2.9 million doses of the vaccine will be distributed around the country this week, according to the New York Times.
“The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide,” says FDA commissioner Stephen M. Hahn in a statement.
Pfizer announced in November that its vaccine is 95 percent effective after two doses, given three weeks apart, which means that the 100 million doses that Pfizer has sold to the U.S. will vaccinate 50 million people. Only 20 million of those doses are expected to be available in the U.S. by the end of this year, reports Gizmodo. To put that in perspective, California has about 2.4 million healthcare workers in total, and the state will receive 327,000 doses of the vaccine in the first shipment from Pfizer this week, which is enough to vaccinate about 163,500 people, per the Los Angeles Times.
The general public will most likely need to wait until at least next spring or summer to receive a Covid-19 vaccine. But for frontline healthcare workers who have faced Covid-19 transmission risks for months on end, the vaccine can’t come soon enough, Usha Lee McFarling reports for STAT News.
“I’m concerned about my health because I have asthma. I see the reality of this virus in the hospital every day,” says Juan Anchondo, a medical-surgical nurse at Las Palmas Medical Center in El Paso, Texas, to STAT.
He adds, “it’s not a silver bullet,” but rather a solution that should be one part of a larger national program to fight the pandemic. Hospitals still need personal protective equipment, more testing and more staffing, he says.
“I feel hopeful today. Relieved. I feel like healing is coming,” says Lindsay, the nurse who received the first dose of the vaccine in New York and the whole US, per ABC News. “…I want to instill public confidence that the vaccine is safe. We're in a pandemic. And so we all need to do our part to put an end to the pandemic.”
The FDA’s emergency use authorization allows Pfizer’s vaccine to be distributed to people over 16 years old without full FDA approval. The decision is based on safety data available from the Phase 1 and Phase 2 vaccine trials and a safety database of thousands of Phase 3 trial participants. Pfizer plans to apply for full FDA approval in April 2021 when it has collected six months of safety data, per the New York Times. At that point, the company will be able to sell the vaccine directly to hospitals instead of selling to the U.S. government.
The vaccine comes with unique logistical challenges. Beyond the unprecedented scale of the distribution, Pfizer’s vaccine also needs to be stored at super-cold temperatures to protect the fragile molecules from degrading. Other vaccines that are still under development or FDA review can be stored at less extreme temperatures.
“We know that in the early weeks and months of vaccine distribution, supplies will be limited. This have been a historic effort to create this vaccine in a record period of time,” says Colorado’s coronavirus incident commander Scott Bookman to the Colorado Sun’s Jesse Paul and John Ingold. “And while we’re going to get there, it’s going to take many months to get this out to the general public.”