The USA on Saturday reported its 16 millionth COVID-19 case — one more signal the virus is spreading quickly, at the same time as newly licensed vaccines are already being distributed and vaccinations are anticipated to start Monday, based on federal officers.

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“As I communicate as we speak, proper now, vaccines are being packaged,” Gen. Gustave Perna, co-leader of Operation Warp Pace in control of logistics, stated Saturday. “Tomorrow morning, vaccines will begin rolling from manufacturing to distribution hubs. By Monday, vaccines shall be obtained.”






© Graeme Jennings, AP
FILE – On this Sept. 23, 2020 file photograph, Dr. Stephen Hahn, commissioner of the U.S. Meals and Drug Administration, testifies throughout a Senate Senate Well being, Schooling, Labor, and Pensions Committee Listening to on the federal authorities response to COVID-19 on Capitol Hill in Washington. Hahn stated Thursday’s assembly on Dec. 10 of the vaccine advisory panel is “an necessary day for all of America.” He hopes it can result in the start of the top of the coronavirus pandemic. (Graeme Jennings/Pool by way of AP, File)

The vaccine shall be despatched to to 636 hospitals, clinics and public well being methods nationwide, with 145 websites receiving doses Monday, 425 on Tuesday and the ultimate 66 on Wednesday, Perna stated. No vaccine doses had been positioned upfront, he stated.

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Vaccinations will start Monday, Dr. Nancy Messonnier, director of the Nationwide Heart for Immunization and Respiratory Illnesses on the Facilities for Illness Management and Prevention, stated throughout a gathering Saturday.

Well being care employees and nursing dwelling residents are first in line. Sufferers and caregivers will obtain reality sheets describing the dangers and advantages, she stated.

Earlier Saturday, Meals and Drug Administration officers reassured the American public that the company didn’t lower corners in its overview and urged folks to get vaccinated. The USA is on the cusp of shedding 300,000 folks to COVID-19.

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Listed here are as we speak’s prime headlines:

  • An advisory committee to the Facilities for Illness Management and Prevention voted Saturday to advocate the Pfizer/BioNTech vaccine for folks 16 and older. Now it goes to the director of the CDC for his signature.
  • The Meals and Drug Administration late Friday granted emergency authorization to Pfizer/BioNTech’s vaccine that analysis reveals is very efficient at stopping a illness.
  • The promising information is not going to instantly finish the pandemic, which is raging uncontrolled. Dr. Ugur Sahin, CEO of BioNTech, estimated it might be March or April earlier than the vaccine may impression the virus’ unfold — underscoring the necessity for measures like mask-wearing and social distancing within the meantime. 
  • About 1 in Eight U.S. hospitals had few or no intensive care unit beds accessible final week, based on new federal knowledge. Consultants say the variety of hospitals struggling to accommodate the nation’s sickest sufferers possible will improve following one other week of document COVID-19 instances.
  • Two Florida males are dealing with federal expenses that allege they stole almost 200 ventilators the US shipped to El Salvador to assist the Central American nation deal with coronavirus sufferers.

📈 One other day of document deaths within the US: On Friday, 3,309 folks within the U.S. died from the coronavirus, based on Johns Hopkins College knowledge. The earlier document was set Wednesday at 3,124, the primary time the every day dying toll surpassed 3,000. As of Saturday, about 297,000 folks within the U.S. have died, with greater than 16 million confirmed instances. The worldwide totals: 71.5 million instances and 1.6 million deaths.

📰 What we’re studying: We’re answering your questions in regards to the vaccine, like: What are the unwanted side effects? Can you continue to get sick? Is it protected throughout being pregnant? Learn extra right here.

12-county California area has 0.0% accessible ICU capability

In San Joaquin County, a part of California’s huge Central Valley that produces a lot of the nation’s vegetables and fruit, the coronavirus is spreading like a weed and the hospitals are working out of beds for the sickest sufferers.

San Joaquin is a part of a 12-county area that on Saturday, based on the California Division of Public Well being, had 100% of its intensive care unit beds stuffed, the very best charge wherever in California. And with instances persevering with at an unprecedented charge, the dying toll inevitably will develop, too.

A brand new stay-at-home order was imposed this week however it’s unknown whether or not it can have the supposed consequence of lastly altering sufficient folks’s habits to gradual infections as a vaccine is broadly rolled out.

— The Related Press

UPS Worldport hub in Louisville to quickly ship vaccine

The primary shipments of Pfizer/BioNTech’s COVID-19 vaccine will transfer via UPS’ Worldport international air hub on the Louisville, Kentucky, airport Sunday, an organization spokesman instructed The Courier Journal, a part of the USA TODAY Community.

UPS stated the vaccine will originate from storage websites in Michigan and Wisconsin.

“The vaccines shall be transported to UPS Worldport amenities in Louisville, the place they are going to be expedited Subsequent Day Air to pick out locations, together with hospitals, clinics and different medical amenities, to inoculate healthcare employees,” the corporate stated in a information launch.

The shipments will arrive on the hub to be sorted and shall be shipped out — all on Sunday, UPS spokesman Jim Mayer stated. He stated he didn’t know what number of doses shall be shifting via. Mayer beforehand stated that UPS will ship to states within the japanese half of the US. FedEx will ship to the western half of the U.S.

– Ben Tobin, Louisville Courier Journal

‘We’re not taking a victory lap,’ Operation Warp Pace official says

The chief working officer of Operation Warp Pace, the White Home effort to fund, produce and distribute a vaccine, cheered the emergency authorization of the Pfizer/BioNTech vaccine however warned of a tricky street forward.

“Whereas this second is extraordinary … we’ve loads of work to do. We’re not taking a victory lap,” Perna stated Saturday.

He stated it would not have made a distinction to Operation Warp Pace if the FDA had licensed the vaccine Saturday as a substitute of Friday. “Our final objective was to get it there no later than Monday morning,” he stated.

Perna reiterated that Operation Warp Pace would not distribute the second vaccine dose or a portion held in reserve till it has “final confidence” that there are sufficient doses and the fragile distribution system works. That would change in January or February.

“We would like no vaccines on a shelf,” Perna stated. “Doesn’t matter how efficient a vaccine is that if it is on a shelf.”

Perna stated vaccine doses had been not positioned upfront as a result of the operation “didn’t wish to presume” emergency use authorization. “On no account did we wish to get forward of the nice FDA and their resolution making,” he stated.

FDA: No corners lower in reviewing Pfizer/BioNTech vaccine

Amid considerations about how rapidly the FDA issued an emergency authorization for the Pfizer/BioNTech vaccine, company leaders  careworn Saturday that they carried out a radical, clear overview.

“Science and knowledge guided the FDA’s resolution. We labored rapidly due to the urgency of this pandemic, not due to some other exterior strain,” FDA Commissioner Stephen Hahn stated. “I’ll completely take this COVID-19 vaccine.”

Hahn stated stories Friday that the White Home had threatened to fireplace him if the company didn’t authorize the vaccine had been “inaccurate.”

Hahn stated the company was “very involved about vaccine hesitancy” and made the method as clear as doable by posting trial knowledge and paperwork on-line.

“Effectivity doesn’t imply any slicing of corners,” Hahn stated. The FDA “discovered methods to chop the pink tape,” however “necessary security checks remained in place,” he stated.

Dr. Peter Marks, director of the FDA’s Heart for Biologics Analysis and Analysis, stated the FDA requires vaccine builders to monitor for “any important opposed occasions” as they search normal approval. The FDA and the CDC are monitoring as effectively, he stated.

Officers supplied extra details about whether or not sure teams of individuals ought to get the vaccine. People who find themselves pregnant or immunocompromised, who weren’t included in security trials, ought to focus on the vaccine with their suppliers “on a person foundation,” Marks stated.

Vaccination websites shall be geared up to deal with allergic reactions, official says

Websites the place the Pfizer/BioNTech vaccine are administered shall be ready to deal with allergic reactions, Marks stated. About 1.6% of the inhabitants has had a extreme allergic response to meals or one thing within the atmosphere however are eligible to obtain the vaccine, Marks stated. Solely individuals who have had a extreme allergic response to a earlier dose of the vaccine or one in every of its elements mustn’t obtain the vaccine.

Consultants say the components within the Pfizer/BioNTech vaccine look typical: an energetic ingredient (on this case, messenger RNA), fat, salt and sugars.

Dr. Matthew Heinz, a hospitalist based mostly in Tucson, Arizona, stated if any a part of the vaccine had been to set off an allergic response, it may very well be one of many elements of the fats molecule. However that is uncommon. “We’re speaking about plenty of comparatively delicate reactions that you could depend on one hand,” out of tens of hundreds of individuals within the research, he stated.

Two British folks with extreme allergic reactions apparently had reactions to Pfizer/BioNTech’s vaccine this week. Allergic reactions weren’t a major drawback within the U.S. trial, by which greater than 20,000 folks obtained two doses of the vaccine. The U.S. trials saved out topics who’ve had extreme allergic reactions.

— Adrianna Rodriguez

Friday set one other document for COVID-19 instances, deaths

On the identical day that the FDA authorised the primary vaccine for emergency use in the US, the nation reached one other milestone in COVID-19 instances and deaths.

The nation recorded 3,309 coronavirus deaths Friday, based on Johns Hopkins College knowledge, surpassing Wednesday’s document when 3,124 folks died. Friday additionally noticed the very best variety of every day instances up to now within the U.S.: 231,775.

Pfizer’s COVID-19 vaccine will get FDA authorization

In what’s hoped to be the start of the top of America’s COVID-19 pandemic, the FDA on Friday night licensed the primary vaccine to stop folks from getting sick. 

What this implies: The Pfizer/BioNTech vaccine obtained emergency use authorization, which isn’t full approval. Though it has obtained all the usual short-term security and effectiveness evaluations, the vaccine has not been examined for the 2 years typical of an authorised vaccine. So it isn’t but clear how lengthy safety will final.  

When will you get it? Frontline well being care employees and nursing dwelling residents are anticipated to get the vaccine first. Extra doses shall be rolled out within the weeks and months to come back, with Pfizer and Moderna every anticipated to ship 100 million doses of their vaccines by the center of subsequent 12 months. 

What about different vaccines? Subsequent week, an identical COVID-19 vaccine developed by the Massachusetts-based Moderna will undergo the identical overview course of, and will swiftly be cleared to be used.

– Karen Weintraub

In America’s hardest-hit county, COVID deaths claimed mother and father, buddies

Simply over a month in the past, the coronavirus pandemic tore via Quinter, Kansas, a rural city of 1,000, killing 20 residents. Right here, the place most everybody is aware of most everybody else, the pandemic has killed farmers and their wives. The city’s unofficial historian. The beloved grandmother whose bitter cream chocolate cake with chocolate fudge frosting was all the time the speak of the celebration. The mother whose piano-playing nonetheless echoes within the heads of her buddies.

And it has drained the hearts of the survivors. Those that really feel responsible about recovering. The ambulance employees battling to deal with their personal relations. The exhausted physician who watched almost half his sufferers die. 

As of Thursday, the coronavirus has killed the next share of Gove County residents than some other county in the US: one out of each 132 folks. Even as we speak, mask-wearing stays controversial. Friendships are strained as authorities wrestle to influence their neighbors to observe fundamental public well being pointers, corresponding to avoiding giant gatherings.

“We live via historical past proper now, and I fear what the historical past books will say about us,” stated Ericka Nicholson, 47, who helps run the city’s volunteer ambulance service and survived the an infection. Learn extra from Gove County, Kansas.

– Trevor Hughes

You Requested, We Answered: What to know in regards to the COVID-19 vaccines

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Relentless coronavirus surge fills 1 in Eight hospital ICU items

About 1 in Eight U.S. hospitals had little or no intensive care unit area accessible final week. Consultants say the variety of hospitals struggling to accommodate the nation’s sickest sufferers possible will improve after one other week of document COVID-19 instances.

The federal authorities this week launched a sweeping database exhibiting a one-week common of COVID-19 sufferers in hospitals nationwide. It’s the primary time the Division of Well being and Human Companies has supplied such detailed data on almost 5,000 U.S. hospitals for the reason that pandemic started. 

The absence of hospital-level data has been a blind spot within the pandemic, as directors should name neighboring hospitals to switch sufferers once they run out of beds and employees.

“We all know what’s taking place in our system, however I don’t know what’s taking place within the different methods,” stated Dr. Lewis Kaplan, professor of surgical procedure at College of Pennsylvania Hospital in Philadelphia. “To have a coordinated effort you must have that form of knowledge so everybody is aware of the place everybody else occurs to be.” Learn extra. 

– Ken Alltucker and Aleszu Bajak

US buys one other 100M doses of Moderna’s vaccine

The Trump administration introduced Friday that it has bought an extra 100 million doses of a coronavirus vaccine made by Moderna, bringing the federal authorities’s complete order from the corporate to 200 million doses. The extra doses would “present for steady supply via the top of June 2021,” the Division of Well being and Human Companies stated in a press launch.

“Securing one other 100 million doses from Moderna by June 2021 additional expands our provide of doses throughout the Operation Warp Pace portfolio of vaccines,” HHS Secretary Alex Azar stated in an announcement. “This new federal buy can provide Individuals even larger confidence we can have sufficient provide to vaccinate all Individuals who need it by the second quarter of 2021.”

Moderna turned the second vaccine maker within the U.S. to request authorization from the FDA on the finish of final month. The corporate’s newest findings confirmed that of 196 folks within the scientific trial who caught COVID-19, 185 of them had obtained the placebo, whereas solely 11 had obtained the vaccine. That works out to an effectiveness charge above 94%.

Wisconsin lady reunites with household after battling virus for almost Three months

After spending over 80 days battling COVID-19 in a Wisconsin hospital, Nancy Van Dyn Hoven on Friday was reunited along with her household and buddies — simply in time for the vacations.

“Aside from 2020 being terrible, that is simply the perfect,” Van Dyn Hoven, 60, stated Friday at dwelling, chuckling along with her husband, Dennis, and daughter, Stacy Arnoldussen. “It is all I may ask for.” 

Dr. Anthony Zeimet, an infectious illnesses specialist on the hospital and Nancy’s physician, stated the severity of her sickness was notably shocking as a result of she was simply 59 years outdated — she turned 60 within the hospital — and had no underlying well being circumstances that might put her at larger threat of extreme sickness.

“The virus form of ravaged her physique,” Zeimet stated. “It simply goes to point out that, with COVID, we do not know who’s going to do effectively or do poorly. Nancy was somebody who, when she was first admitted, we thought she’d do fairly effectively. … Sadly, she ended up being right here for 80-plus days.”

Though Nancy’s restoration is way from over and he or she has an extended street of rehabilitation companies forward, Friday marked the top of a months-long wrestle with the virus. Learn extra.

— Samantha West, Appleton Put up-Crescent

This text initially appeared on USA TODAY: Coronavirus updates: California area has 0.0% accessible ICU capability; US stories 16 millionth case; vaccinations to start Monday

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