Vaccine distribution has begun; FDA officials assure public that Pfizer vaccine is safe

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 Fridaygranted 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.
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📈 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.

CDC advisers meet Saturday to make final recommendation on who should get vaccine first
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.

Friday set another record for COVID-19 cases, deaths
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.

Pfizer's COVID-19 vaccine gets FDA authorization
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

In America's hardest-hit county, COVID deaths claimed parents, friends
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.