A day after authorizing the first COVID-19 vaccine in the U.S., federal officials said Saturday that distribution has begun.
“As I speak today, right now, vaccines are being packaged,” Gen. Gustave Perna, co-leader of Operation Warp Speed in charge of logistics, said Saturday. “Tomorrow morning, vaccines will start rolling from manufacturing to distribution hubs. By Monday, vaccines will be received.”
The vaccine will be sent to to 636 locations nationwide this week, with 145 sites receiving doses Monday, 425 on Tuesday and the final 66 on Wednesday, Perna said.
No vaccine was prepositioned in advance, Perna said. “We did not want to presume” emergency use authorization, he said. “We did all of our rehearsals … Under no circumstances did we want to get ahead of the great FDA and their decision making.”
Earlier Saturday, Food and Drug Administration officials reassured the American public that the agency did not cut corners in its review.
“Science and data guided the FDA’s decision. We worked quickly because of the urgency of this pandemic, not because of any other external pressure,” FDA Commissioner Stephen Hahn said. “I will absolutely take this COVID-19 vaccine.”
Hahn said reports Friday that the White House had threatened to fire him if the agency did not authorize the vaccine were “inaccurate.”
The United States is on the cusp of having lost 300,000 people to COVID-19 since the start of the pandemic, and federal regulators are under intense pressure to quickly roll out the vaccine to health care and other frontline workers nationwide.
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Here are today’s top headlines:
- An advisory committee to the Centers for Disease Control and Prevention was meeting Saturday to vote on a final recommendation on who should get the vaccine first.
- The Food and Drug Administration late Friday granted emergency authorization to Pfizer/BioNTech’s vaccine that data shows is highly effective at preventing a disease.
- In a video announcing the emergency authorization, President Donald Trump called the vaccine a “medical miracle” that will “save millions of lives and end the pandemic once and for all.” He said the first doses would be administered in the U.S. “in less than 24 hours.”
- The promising news will not immediately end the pandemic, which is still raging out of control. Dr. Ugur Sahin, CEO of BioNTech estimated it would be until March or April before the vaccine could impact the virus’ spread — underscoring the need for measures like mask-wearing and social distancing in the meantime.
- About 1 in 8 U.S. hospitals had little or no intensive care unit beds available last week, according to new federal data. Experts say the number of hospitals struggling to accommodate the nation’s sickest patients likely will increase following another week of record COVID-19 cases.
📈 Another day of record deaths in the US: On Friday, 3,309 people in the U.S. died from the coronavirus, according to Johns Hopkins University data. The previous record was set Wednesday at 3,124, the first time the daily death toll surpassed 3,000. As of Saturday, more than 295,500 people in the U.S. have died, with more than 15.9 confirmed cases. The global totals: 71.2 million cases and nearly 1.6 million deaths.
📰 What we’re reading: We’re answering your questions about the vaccine, like: What are the side effects? Can you still get sick? Is it safe during pregnancy? Read more here.
FDA: No corners cut in reviewing Pfizer/BioNTech vaccine
Amid concerns about how quickly the FDA issued an emergency authorization for the Pfizer/BioNTech vaccine, agency leaders Saturday stressed that they conducted a thorough, transparent review before concluding it’s safe.
Hahn said the agency was “very concerned about vaccine hesitancy” and made the process as transparent as possible by posting trial data and documents online.
“Let me be clear. Efficiency does not mean any cutting of corners,” Hahn said. The FDA “found ways to cut the red tape,” but “important safety checks remained in place,” he said.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the FDA requires vaccine developers to monitor for “any significant adverse events” as they go through the standard approval process. The FDA and the Centers for Disease Control and Prevention are monitoring as well, he said.
Officials provided more information about whether certain groups of people should get the vaccine. People who are pregnant or immunocompromised, who were not included in safety trials, should discuss the vaccine with their providers “on an individual basis,” Marks said.
An advisory committee to the Centers for Disease Control and Prevention meets Saturday to vote on a final recommendation on who should get the vaccine first.
The Advisory Committee on Immunization Practices provides guidance for the CDC to set adult and childhood immunization schedules, including the ages the vaccine should be given, the number of doses needed, the amount of time between doses and precautions and contraindications.
The committee consists of 15 experts who are voting members and primarily responsible for the vaccine recommendations. The secretary of the U.S. Department of Health and Human Services selects the committee members.
Who is likely to be first in line? Health care workers and nursing home residents. Here’s what we know about how the vaccine will be delivered.
On the same day that the FDA approved the first vaccine for emergency use in the United States, the nation reached another milestone in COVID-19 cases and deaths.
The country recorded 3,309 coronavirus deaths Friday, according to Johns Hopkins University data, surpassing Wednesday’s record when 3,124 people died. Friday also saw the highest number of daily cases to date in the U.S., 231,775.
In what is hoped to be the beginning of the end of America’s COVID-19 pandemic, the U.S. Food and Drug Administration on Friday evening authorized the first vaccine to prevent people from getting sick.
What this means: The Pfizer/BioNTech vaccine received emergency use authorization, which is not full approval. Although it has received all the standard short-term safety and effectiveness reviews, the vaccine has not been tested for the two years typical of an approved vaccine – so it is not yet clear how long protection will last.
When will you get it? Frontline health care workers and nursing home residents are expected to get the vaccine first. More doses will be rolled out in the weeks and months to come, with Pfizer and Moderna each expected to deliver 100 million doses of their vaccines by the middle of next year.
What about other vaccines? Next week, a similar COVID-19 vaccine developed by the Massachusetts-based Moderna will go through the same review process, and could swiftly be cleared for use.
– Karen Weintraub
Just over a month ago, the coronavirus pandemic tore through Quinter, Kansas, a rural town of 1,000, killing 20 residents. Here, where most everyone knows most everyone else, the pandemic has killed farmers and their wives. The town’s unofficial historian. The beloved grandmother whose sour cream chocolate cake with chocolate fudge frosting was always the talk of the party. The mom whose piano-playing still echoes in the heads of her friends.
And it has drained the hearts of the survivors. Those who feel guilty about recovering. The ambulance workers battling to treat their own relatives. The exhausted doctor who watched nearly half his patients die.
As of Thursday, the coronavirus has killed a higher percentage of Gove County residents than any other county in the United States: one out of every 132 people. Even today, mask-wearing remains controversial. Friendships are strained as authorities struggle to persuade their neighbors to follow basic public health guidelines, such as avoiding large gatherings.
“We are living through history right now, and I worry what the history books will say about us,” said Ericka Nicholson, 47, who helps run the town’s volunteer ambulance service and survived the infection. Read more from Gove County, Kansas.
– Trevor Hughes
We asked you to tell us your biggest questions about the COVID-19 vaccines. Here are some answers.
About 1 in 8 U.S. hospitals had little or no intensive care unit space available last week. Experts say the number of hospitals struggling to accommodate the nation’s sickest patients likely will increase after another week of record COVID-19 cases.
The federal government this week released a sweeping database showing a one-week average of COVID-19 patients in hospitals nationwide. It’s the first time the Department of Health and Human Services has provided such detailed information on nearly 5,000 U.S. hospitals since the pandemic began.
The absence of hospital-level information has been a blind spot in the pandemic, as administrators must call neighboring hospitals to transfer patients when they run out of beds and staff.
“We know what’s happening in our system, but I don’t know what’s happening in the other systems,” said Dr. Lewis Kaplan, professor of surgery at University of Pennsylvania Hospital in Philadelphia. “To have a coordinated effort you need to have that kind of data so everyone knows where everyone else happens to be.” Read more.
– Ken Alltucker and Aleszu Bajak
The Trump administration announced Friday that it has purchased an additional 100 million doses of a coronavirus vaccine made by Moderna, bringing the federal government’s total order from the company to 200 million doses. The additional doses would “provide for continuous delivery through the end of June 2021,” the Department of Health and Human Services said in a press release.
“Securing another 100 million doses from Moderna by June 2021 further expands our supply of doses across the Operation Warp Speed portfolio of vaccines,” HHS Secretary Alex Azar said in a statement. “This new federal purchase can give Americans even greater confidence we will have enough supply to vaccinate all Americans who want it by the second quarter of 2021.”
Moderna became the second vaccine maker in the U.S. to request authorization from the FDA at the end of last month. The company’s latest findings showed that of 196 people in the clinical trial who caught COVID-19, 185 of them had received the placebo, while only 11 had received the vaccine. That works out to an effectiveness rate above 94%.
After spending over 80 days battling COVID-19 in a Wisconsin hospital, Nancy Van Dyn Hoven on Friday was reunited with her family and friends — just in time for the holidays.
“Other than 2020 being awful, this is just the best,” Van Dyn Hoven, 60, said Friday at home, chuckling with her husband, Dennis, and daughter, Stacy Arnoldussen. “It’s all I could ask for.”
Dr. Anthony Zeimet, an infectious diseases specialist at the hospital and Nancy’s doctor, said the severity of her illness was particularly surprising because she was just 59 years old — she turned 60 in the hospital — and had no underlying health conditions that would put her at higher risk of severe illness.
“The virus kind of ravaged her body,” Zeimet said. “It just goes to show that, with COVID, we don’t know who’s going to do well or do poorly. Nancy was someone who, when she was first admitted, we thought she’d do pretty well. … Unfortunately, she ended up being here for 80-plus days.”
Although Nancy’s recovery is far from over and she has a long road of rehabilitation services ahead, Friday marked the end of a months-long struggle with the virus. Read more.
— Samantha West, Appleton Post-Crescent
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