Health Headlines

simon2579/iStockBY: CATERINA ANDREANO, ABC NEWS

(WASHINGTON) — Food and Drug Administration Commissioner Dr. Stephen Hahn told Dr. Jennifer Ashton, ABC News' chief health and medical correspondent, that the agency has "all hands on deck" and is "working day and night, and on the weekends" to evaluate and clear multiple coronavirus vaccines for emergency use authorization before they are allowed to be distributed to the general public.

The interview, which took place Tuesday on ABC News' Instagram Live, comes after the FDA commissioner was summoned to the White House to provide an update to President Donald Trump's chief of staff, Mark Meadows, on the status of the emergency use authorization for the vaccines.

Asked by Ashton to explain "what takes so long" to get the COVID-19 vaccines through the emergency use authorization process, Hahn explained the rigorous process the FDA goes through for approval.

He said a typical approval timeline for a set of vaccine clinical trials of this size -- Pfizer and BioNTech had 44,000 people in the trials and Moderna had 30,000 -- "would typically take between three and four months, maybe even longer to review all the data."

The FDA is now trying to get the process completed in about three weeks. Hahn said the FDA is looking at the manufacturing data, specifically the quality around manufacturing, the clinical data that shows whether the vaccine is safe and effective and the data surrounding adverse effects.

Hahn said the FDA and its scientists will ensure "vigorous standards are being enforced when we look at safety and efficacy" of these vaccines. "We need to be able to make this assurance to the American people," he said when asked about vaccine safety.

Asked about the timeline of the emergency use authorization, Hahn said "in terms of setting the appropriate expectations, we are balancing the public health emergency we're facing and the fact that people are getting sick with COVID with the need to get this right."

The vaccines that are being vetted by the FDA for emergency use authorization will require safety follow-ups even after they are approved. Hahn said should either of the vaccines get approved for emergency authorization, the FDA will mandate safety and efficacy follow-ups for a minimum of two years.

"As with any medical product ... there could be long-term side effects that we need to account for, which is why we put in place a very, very vigorous surveillance program," Hahn said.

The FDA is looking at the raw data from Pfizer and Moderna's clinical trials to ensure the safety and efficacy of the vaccines. "We just don't trust a press release. We're going to look at that data and we're going to do our own analysis. And then we're going to look by specific patient groups, we're going to look by ethnic groups, we're going to look at both safety and efficacy from a number of different ways."

Hahn said if the COVID-19 vaccines are as effective as the companies have reported -- with Pfizer and BioNTech reporting a 95% efficacy and Moderna reporting a 94.1% efficacy -- then "thousands if not hundreds of thousands of lives across the globe could be saved." The FDA will work to confirm those efficacy numbers in its review.

The FDA has been reviewing Pfizer's clinical trial data since receiving their emergency authorization approval application on Nov. 20. Moderna announced Monday it will ask the FDA for emergency use authorization for its COVID-19 vaccine. The FDA will hold public hearings about each of the vaccines on Dec. 10 and Dec. 17, respectively. Before the public hearings, the FDA will release documents summarizing their assessment of the vaccine applications. The FDA will make its official authorization decision after these hearings are held.

Pfizer and BioNTech expect to produce up to 50 million vaccine doses worldwide by the end of the year and up to 1.3 billion doses by the end of 2021. Moderna is on track to produce 20 million distributable doses by the end of the year, which is enough doses to vaccinate 10 million people in the U.S. The company is also on track to manufacture 500 million to 1 billion doses worldwide in 2021.

Ashton asked Hahn if people like pregnant women, children, people with kidney failure and other subsets of people who were not represented in the phase three clinical vaccine trials will be advised to take the vaccine.

"It's one of the things we'll have to look at," Hahn said. He said it's unlikely they will initially advise pregnant women to take the vaccine at first, "but we need to look at the data to do that.”

"If we don't have data to support the use of a vaccine, we're going to come out and say that, and then we're going to have to make some decisions about that emergency use authorization process," Hahn told Ashton. "But that's the point of our looking at the data."

Asked if it's possible the FDA will come to one conclusion on the vaccines and the Centers for Disease Control and Prevention will come to another, Hahn said he and CDC Director Robert Redfield are "aligned." Once approved by the FDA, the CDC's Advisory Committee on Immunization Practices will meet to vote on whether to recommend the vaccine's use. The ACIP voted on Tuesday that health care workers and nursing home residents should be first to receive the vaccine.

"We're hand in glove with respect to sharing information. I expect that, in fact, we'll be very aligned moving forward, because the data has to drive the decision that we make with respect to allocation and prioritization," he said.

Hahn said the FDA is "cooperating fully" with President-elect Joe Biden's transition team and that recently they've undergone a pandemic preparedness and response effort to reflect on the lessons learned from their response to COVID-19. He said one of the main lessons the FDA learned was the need for more transparency.

"We need a lot more transparency about the information that goes into our emergency use authorizations. ... This is all about our being a learning organization, and improving moving forward," he said.

"We made a promise to the American people that we're not going to do shortcuts here," Hahn reiterated.

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da-kuk/iStockBy ERIN SCHUMAKER, ABC News

(NEW YORK) -- The coronavirus may have been present in the United States weeks earlier than scientists realized, according to new government research.

While COVID-19 cases were first identified in China in December, the United States did not report its first case until late January.

A study published in the journal Clinical Infectious Diseases Monday suggests that the virus was present in the United States as early as last December.

To come to that conclusion, Centers for Disease Control and Prevention scientists analyzed American Red Cross blood donations collected between Dec. 13, 2019, and Jan. 17, 2020, and found evidence of coronavirus antibodies in 106 out of 7,389 blood donations.

"SARS-CoV-2 infections may have been present in the U.S. in December 2019, earlier than previously recognized," the study authors write. "These findings also highlight the value of blood donations as a source for conducting SARS-CoV-2 surveillance."

Of those donations. 39 samples collected from California, Washington and Oregon between Dec. 13 to Dec. 16 contained antibodies. Sixty-seven samples collected in Connecticut, Iowa, Massachusetts, Michigan, Rhode Island and Wisconsin in early January contained COVID-19 antibodies.

The virus' presence in the United States in December does not mean that COVID-19, the disease the virus causes, was spreading widely in the U.S. at that time.

"Widespread community transmission was not likely until late February," the authors note.

Limitations of the research include the possibility of false-positive antibody tests.

Additionally, blood donations aren't representative of the general population, so the data can't be extrapolated to indicate the magnitude of infections during the study period, nor whether those infections were community- or travel-based.

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bluecinema/iStockBy ANGELINE JANE BERNABE, ABC News

(NEW YORK) -- Molly Everette Gibson may only be less than one month old, but she has already made history.

Weighing 6 pounds, 13 ounces, Molly, who was born on Oct. 26 to parents Tina and Ben Gibson, spent more than 27 years frozen as an embryo before being transferred to her mother's uterus on Feb. 10.

The time the embryo spent in frozen preservation set the new known record for the longest-frozen embryo to ever come to birth, according to research staff at the University of Tennessee Preston Medical Library.

The previous record was set by her sister, Emma Wren Gibson, who was born in 2017.

Emma had been frozen for more than 24 years and both she and her sister were frozen together as embryos, making them full genetic siblings.

“When Tina and Ben returned for their sibling transfer, I was thrilled that the remaining two embryos from the donor that resulted in Emma Wren’s birth survived the thaw and developed into two very good quality embryos for their transfer,” said National Embryo Donation Center lab director and embryologist Carol Sommerfelt, who thawed Molly’s embryo. “This definitely reflects on the technology used all those years ago and its ability to preserve the embryos for future use under an indefinite time frame.”

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alvarez/iStockBY: CHEYENNE HASLETT, ABC NEWS

(NEW YORK) — Rapid tests and reagents -- the medical devices used to process COVID-19 tests -- are in short supply as the U.S. heads deeper into the winter months, according to a survey of 47 states and territories conducted by the nonpartisan Government Accountability Office in their latest report on the CARES Act. The report also looks ahead to vaccine distribution and administration concerns.

One-third to one-half of states said they'd already experienced shortages in either reagents, testing instruments or rapid tests in the last 30 days.

"Most states reported no shortages of swabs or transport media, but one-third to one-half of the 47 states reported shortages in the other three types of testing supplies: reagents (21 states), testing instruments (16 states), and rapid point-of-care tests (24 states)," according to the report.

Half the states and territories that responded said they expected further shortages in rapid tests over the next two months and nearly half said they expected to see a shortage in reagents over the same period. The survey was conducted in October.

"When asked about testing supply availability at testing sites and laboratories for the 60 days following the survey, half the states (22) expected there would be shortages in rapid point-of-care tests, and 20 states expected there would be shortages in reagents," according to the GAO report.

The survey also found that more than half of the states said they didn't expect shortages of swabs or transport media -- two other key components for testing.

However, the GAO report is headlined with a call to action -- "COVID-19: Urgent Actions Needed to Better Ensure an Effective Federal Response" -- and makes 11 recommendations, plus suggestions for congressional review and executive actions.

The report also looks ahead to vaccine preparation across the country, finding that dozens of states feel unprepared to dole out mass quantities in multiple rounds.

In the October survey, one-third of states were "greatly or completely concerned" about having sufficient supplies to administer vaccines and another one-third said they were "moderately concerned."

In open-ended responses, senior officials from six states said they were specifically concerned about needles, citing reports of shortages.

Three of those states also reported challenges maintaining supplies of needles for the flu vaccine, the report said.

This aligns with reporting that at least a dozen states will likely need additional funding or are awaiting additional funding, while other states suggested they are still deciding whether they will need additional funding.

In response to these findings, the GAO said the Department of Health and Human Services repeated its disagreement from the last report, saying that they have made efforts to meet the needs of states and that there aren't many shortages, despite what's in the survey.

"Our report acknowledges those efforts, but we continue to maintain that our recommendations are warranted," the GAO said.

HHS also asked for the names of states with shortages, but the GAO maintained that the point of the report is not for individual follow-up and instead is to "help inform the department's supply efforts moving forward by providing a snapshot of states' needs and concerns."

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MarsBars/iStockBY: STEPHANIE EBBS AND ANTHONY RIVAS, ABC NEWS

(WASHINGTON) — With the Food and Drug Administration set to evaluate the two COVID-19 vaccine candidates in the coming weeks -- good news for a country fatigued by what seems to be a never-ending pandemic -- who will get the first doses?

On Tuesday, independent advisers to the Centers for Disease Control and Prevention will weigh in on that very question.

Once the FDA grants emergency use authorization, there will be a very limited supply of vaccine doses in the early stages of distribution. Given that, public health officials need to decide how to administer them equitably to the people who will be helped by vaccination the most.

Pfizer has said there will be about 6.4 million doses -- enough for about 3 million people -- available in the first shipments with more going out by the end of the year. Moderna, which submitted its application to the FDA this week, is expected to have 20 million doses immediately available if its vaccine is authorized. If both vaccines are authorized quickly there should be enough for 20 million people by the end of the year.

And as vaccine doses gradually become available to more Americans, state and federal governments face the challenge of communicating to the country it will still be necessary to wear masks, stay at home or social distance, and be vigilant about taking steps to limit the spread of the virus until the vast majority of the country is vaccinated.

Here are three things to know ahead of the CDC advisory committee meeting.

CDC advisers are discussing the ethics involved in deciding who gets the first doses

A CDC advisory committee on vaccines, called the Advisory Committee on Immunization Practices or ACIP, is scheduled to vote on who should receive the first round of COVID-19 vaccines.

The committee is made up of experts from around the country who make recommendations about how vaccines should be used, including who should receive certain vaccines and when, and the recommended schedule for vaccinating children. The members don't work for the government but provide independent expertise in how vaccines work, how the immune system responds, family medicine, and infectious diseases.

The committee, which has been meeting and discussing the best way to prioritize COVID-19 vaccines for months, is led by Jose Romero, chair of the Advisory Committee on Immunization Processes and Secretary of Health in Arkansas.

"What the ACIP wants to do is make sure that there is a fair, equitable and transparent distribution of these vaccines within the community, and that that the tiers we identify and we vote on represents the tiers that will get the best, the most benefit from a limited supply of vaccine initially," Romero told ABC News.

After the committee votes on its recommendations, they are then reviewed by CDC Director Robert Redfield and the Department of Health and Human Services and published by the CDC as guidance for states to determine their own plans.

In the case of vaccines not yet approved or authorized, the CDC committee typically makes its recommendations final after FDA weighs in, in part because FDA could put limitations on who can receive the vaccine under an emergency use authorization. For example, the FDA could say the vaccines are not appropriate for use in children under 12 because they don't have data on that age group yet.

HHS Secretary Alex Azar has said he will work with CDC so the FDA committee considering whether vaccines should be authorized and the CDC advisory group can meet at the same time so there are recommendations for how to distribute the initial doses of vaccine available as quickly as possible as shipments start to go out to states.

Health care workers likely to be the first to get vaccine in 'Phase 1a'

The planning for who can get vaccinated has been broken down into phases based on the amount of vaccine available at that time.

The very first round, referred to as "Phase 1a," has been mostly focused on health care workers treating COVID-19 patients and older adults living in nursing homes and long-term care facilities where the virus spread has been hard to contain and especially deadly.

The CDC committee and experts from the National Academies of Sciences, Engineering, and Medicine have also recommended that within each phase of vaccine distribution the government should prioritize reaching the parts of the country most severely affected by the virus first, which includes Black, Hispanic, and low-income communities.

"When we talk about, for example, in health care providers, we're not talking about just the doctors, nurses or respiratory therapists that are taking care of the patients in the hospital. We've expanded that to include the essential individuals that helped make the institution run," Romero told ABC News.

"So that would include, for example, the house cleaning staff that have to turn over the room very quickly to get the next patient in the emergency room, or clean the room for the individual that’s in the intensive care unit, the food delivery staff, the administration staff that are at the front desk of the emergency room."

He added "We look at those groups. We understand that underprivileged minority populations, lower-paid individuals are in that group. And so because of that, that expands the equitability of the recommendation."

States are ultimately in control of how they define the specific groups for each phase of the distribution and if they include other populations at high risk, such as first responders and people with conditions that put them at higher danger of serious illness from the virus.

Some states have already described their plans for who to include in Phase 1a distribution more specifically and submitted them to CDC, though they continue to be updated. In Arkansas, for example, the state's plan prioritizes health care personnel likely to be exposed to patients with COVID-19 as well as personnel providing COVID-19 testing or vaccinations, first responders, and essential government leaders.

As production and distribution of authorized vaccines ramps up states and public health agencies will expand who qualifies to get the vaccine, likely starting with essential workers and people more vulnerable to exposure to serious illness from the virus. Vaccines are expected to become available to the general public and lower risk individuals when there is enough supply to vaccinate the higher risk groups.

State governors and public health departments, not President Trump, will decide where the vaccines go

The FDA's determination that any vaccine is safe and effective is the first major step that has to happen at the federal level before any American can receive that vaccine outside of a clinical trial. Because the COVID-19 pandemic has created such an urgent situation, vaccine companies are applying for emergency use authorization, in which the FDA will authorize the vaccine for specific populations while companies and the agency continue to monitor people who receive it to get more data on potential side effects or how well it prevents people from becoming sick.

The federal government has worked for months with Operation Warp Speed, a combined effort through the Department of Health and Human Services and Department of Defense to distribute a vaccine quickly after the FDA makes a decision. But ultimately Operation Warp Speed will be taking its direction from states on how many doses need to go where and who will be vaccinated first in that state.

Azar and Army Gen. Gustave Perna, who is coordinating the shipments of vaccine doses and supplies, have said they will defer completely to states when deciding where vaccine shipments go.

"Our governors are like air traffic controllers. They'll tell us which hospital, which pharmacies, where they would like it to go. And they will be determining which groups to be prioritized," Azar said in an interview on "CBS This Morning" on Monday.

"I would hope that the science and the evidence will be clear enough that our governors will follow the recommendations that we will make to them, and we'll certainly call out any inequities or injustices that we see in approach. And we'll assess all of our options as we go. … I’ve got a lot of confidence in our governors to do the right thing here.”

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nevodka/iStockBy SASHA PEZENIK, ABC News

(NEW YORK) -- With the steady march toward a safe, effective and authorized coronavirus vaccine, another race now runs alongside: how to dispatch tens of millions of doses across every corner of the nation and globe, and do it safely, securely and swiftly. The solution will involve complicated logistical calculus, experts say, no matter which vaccine gets across the finish line first.

Pfizer's vaccine is likely to be the first to be granted authorization by the Food and Drug Administration, followed by one created by Moderna, and then possibly vaccines from AstraZeneca/Oxford and Johnson & Johnson, if the efficacy and safety data prove solid.

The U.S. government has promised a goal of "shots in arms" within 24 hours of FDA authorization of the first COVID-19 vaccine.

All about the money


Those responsible for the cross-country relay -- state and local public health officials and supply chain experts -- have hustled to marshal their resources, even as shortage concerns linger and officials warn the federal dollars they have received so far will not be enough.

"There's a light at the end, but that tunnel is still very long," Dr. Nirav Shah, director of the Maine Center for Disease Control and Prevention, told ABC News. "We at the state level will soon be handed the baton and we need additional funding support from the federal government. What's at stake is nothing short of the velocity and equity with which we can get this vaccine to everyone in need."

More than a dozen states have told ABC News they will likely need additional funding, or are awaiting additional funding. In response to concerns raised by the National Governors Association, Operation Warp Speed has said it is in the process of planning to make additional funding and resources available to support vaccine operations, information systems and communications campaigns, though some officials still say more will be needed.

"Without those additional resources, it will be like putting up tent poles without having a tent," Shah said. "We've got to think through literally everything, from when the vaccine enters our borders to the time it goes into somebody's arm for injection."

That "last mile" of distribution may pose the rockiest stretch of the journey, experts say. Getting the vaccine from a central transportation hub to its final destination at local hospitals and pharmacies across the country will require unprecedented coordination and delicately calibrated conditions.

The U.S. government estimates having 40 million doses -- enough for 20 million Americans -- by the end of this year if the FDA provides authorization in early December. About half of those vaccine doses will be provided by Pfizer, with the other half by Moderna.

Cold storage, shortage fears


Pfizer's vaccine must be stored at temperatures colder than Antarctica in winter: roughly minus 94 degrees Fahrenheit. Doses would ship in dry ice thermal containers, stored either with replenished dry ice for up to roughly two weeks or stored in ultra-low temperature freezers. Moderna's vaccine also requires cold storage, though not as extreme: It can be stored around minus 4 degrees, the same as a commercial freezer.

Manufacturers, logistics providers, federal and state governments and health care systems have been shoring up their cold chain infrastructure for months, lining up equipment and transportation capacity.

"The clock starts ticking once those dry ice containers start shipping around," Dr. Mark Jarrett, chief quality officer of Northwell Health, New York's largest health system, told ABC News.

The Centers for Disease Control and Prevention told states and localities not to buy ultra-cold freezers for now, since the Pfizer vaccine will be shipped with dry ice "pizza boxes" that can keep it viable for up to 15 days, as long as there's fresh dry ice available. It can then last five additional days in a conventional freezer.

Dry ice faced "significant shortages" during the pandemic's spring surge, President and CEO of the Compressed Gas Association Rich Gottwald told ABC, warning in an April letter to Vice President Mike Pence.

In mid-October, the nation's governors penned a letter to the Trump administration with several concerns, including ultra-cold freezer and dry ice supply, and seeking clarity so that "no one is caught flat-footed when the time comes to vaccinate people."

The Compressed Gas Association now says they expect "sufficient" dry ice supply for COVID-19 vaccines.

"There may be issues with [the] COVID vaccine; the supply of dry ice will not be one of those issues," Gottwald said.

Still, some dry ice manufacturers and distributors are echoing those earlier warnings.

"Our system is already taxed beyond what the supply is right now," Tim Koerner, co-owner of the American Carbonation Corporation, told ABC News. "It could be close to sufficient, but it's gonna be tight."

UPS announced Wednesday it's ramping up dry ice production capabilities and launching a mobile freezer storage unit supply, noting "a major spike in demand" and the need to "plan for what some analysts fear may be a dry ice shortage" amid vaccine preparation.

Public health authorities and hospitals who can afford the investment are acquiring ultra-cold freezers, despite CDC guidance, to maintain supply chain agility.

Unsure how much vaccine they'll be receiving, David Reich, president of The Mount Sinai Hospital and Mount Sinai Queens, said they had bought a number of the freezers to be ready for whatever comes.

Henry Ford Health System in Michigan announced Wednesday it had received and begun installing six specialized freezers for the Pfizer vaccine, and six other freezers for the Moderna vaccine.

Distributing the vaccine


UPS Healthcare is collaborating with Stirling Ultracold, an Ohio company making laboratory-grade ultra-cold freezers, to supply portable models for storage of vaccines.

Demand has "dramatically increased," Stirling Ultracold CEO Dusty Tenney told ABC News. Sales are up 250% since the first quarter, with backorder times up to six weeks.

"There is a lot riding on everyone right now to make sure this is successful," Tenney said.

An onboard computer tracks temperature through the cold chain's many handoffs "to ensure that when they do arrive, there's no waste or loss associated with the vaccine's efficacy," Tenney said.

"Our job is to make sure nowhere in that process does it break down," Tenney added.

Stirling Ultracold hopes to have 2,000 portable freezer units in use by January. Each portable unit can hold 6,000 doses, allowing for 12 million of them throughout the country at a time.

"We were concerned about the freezers, and so we quickly purchased and pre-positioned them at certain sites along the health system," Jarrett, from Northwell Health, said. "That's one thing we've learned in COVID -- was try and be ahead of the curve."

Those freezers don't come cheap: each unit, depending on the model, ranges from $6,000 to more than $10,000.

"You can't strap [vaccine] on the back of 'Bob's truck,'" Shah said. Maine has received $800,000 in federal funding so far, and "significantly more will be needed," as they ramp up logistics and manpower.

Dry ice also has flight restrictions, which could further hamper distribution.

Who gets the vaccine and when?


Not all the vaccine candidates share the need for shipping in extreme temperatures. In addition to Moderna's, which can be held in most standard freezers, the vaccines from AstraZeneca/Oxford and Johnson & Johnson don't need to be frozen at all and can be safely stored for months in a standard refrigerator.

But all vaccine shipments will face logistical problems for one reason or another.

"We need to address the fact that all last miles in this country are not equal. If logistics work against our most-vulnerable populations, we will further exacerbate the impact of this pandemic," said Dr. John Brownstein, an epidemiologist at Boston Children's Hospital and ABC News Contributor.

"We've already seen the incredible divide when it came to testing -- increased travel times for counties with lower population density and higher percent of minority and uninsured. Will the challenges of cold storage and the requirement for two doses further exacerbate health inequities when it comes to immunizations?" Brownstein continued. "We'll need further analysis to understand how these logistical challenges intersect with fair and equitable access."

"We have to be ready for all of it," said Dr. Abinash Virk, infectious disease specialist at the Mayo Clinic. "It's a complicated process now happening at supersonic speed."

Figuring out which front-line staff has priority for the injection's first wave, organizing electronic medical systems and data communication must be done before the first shot and before knowing which vaccine will be the one they're giving, Virk said.

"Pfizer has the most restrictive storage and transport requirements," Virk said. "If we're able to handle that, then, the subsequent ones, hopefully, will be able to handle much easier."

Vaccines requiring two doses offer their own unique coordination: Pfizer's needs a booster after 21 days while Moderna's requires one after 28 days. That means ensuring the right shipment arrives in time for the patient who needs their second dose.

That could get harder in remote areas.

"All this will be unfolding as the vaccine is literally rolling in trucks to get there," Dr. Robert O. Williams III, of the University of Texas at Austin's Division of Molecular Pharmaceutics and Drug Delivery, said. "For rural areas that don't have the same infrastructure and cold infrastructure, that's an added challenge."

"We're the last mile. And that's sometimes the toughest mile," Jarrett said. "And there may be hurdles, but that's never going to stop us from doing the right thing."

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Go Nakamura/Getty ImagesBy THE GMA TEAM, ABC News

(HOUSTON) -- Dr. Joseph Varon, chief of staff at United Memorial Medical Center in Houston, was on his 252nd consecutive day working during the coronavirus pandemic when he took time to comfort a patient on Thanksgiving Day.

Varon, who leads the hospital's coronavirus unit, was dressed in full personal protective equipment (PPE) when he stopped to wrap his arms around a man being treated in the hospital's intensive care unit (ICU).

The photograph, taken by a Getty photographer, quickly went viral as the United States continues to see more than 100,000 newly diagnosed cases of COVID-19 daily.

"He was very sad because he's in a room where he knows nobody," Varon told "Good Morning America" of the patient, who was not identified. "We come in dressed like astronauts, and even though I usually have my picture with me so they can know who I am when I go to see them, it's very frustrating for the patients, and he was very emotional."

"And just when I heard [his emotion], I hugged him," Varon added.

Varon said the journey of fighting COVID-19 has been taxing not just for patients, but for medical staff like himself. He described working around-the-clock, day after day to care for patients.

"My days can be 16 hours ... and then when I get home, I get a million phone calls in the middle of the night," he said. "When I leave my home, I tell my wife, '[I'll] see you,' but I don't know when or what time. Sometimes I don't come back home the same day."

Hospitalizations of COVID-19 patients in the United States reached an all-time high of 93,238 on Sunday, according to the COVID Tracking Project. Current COVID-19 hospitalizations have gone up nearly every day since Oct. 25.

Our daily update is published. Our testing, case, and death statistics continue to be affected by the Thanksgiving holiday. Hospitalizations are less affected by the data slowdown and are at the record-high level of 93,238. pic.twitter.com/LVZnxVme4p

— The COVID Tracking Project (@COVID19Tracking) November 30, 2020

As the number of cases and hospitalizations continues to rise, Varon said he is particularly frustrated by people not practicing COVID-19 safety guidelines, including wearing a face mask and social distancing.

"We're frustrated because we see people, they come in very, very sick and when you ask them, 'How did you get [COVID-19]?,' they basically tell you that they didn't follow any of the things that we've been asking them to please follow -- no social distancing, no wearing masks, going to large gatherings," he said. "And then just coming to us near death."

"We are exhausted. We are tired," he said of his fellow doctors and nurses. "I have nurses [who] are in the middle of the day crying because they keep on getting patients and there are just not enough nurses that can help us."

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Matt Winkelmeyer/Getty Images for NetflixBy MEGAN STONE, ABC News

(NEW YORK) -- Chrissy Teigen is hoping she can help break down the stigma regarding breast milk versus formula by opening up about her own breastfeeding struggles.

In a lengthy Twitter thread on Sunday, the Cravings author called to "normalize formula."

"Normalize breastfeeding is such a huge, wonderful thing. But I absolutely felt way more shame having to use formula because of lack of milk from depression and whatnot," Teigen said, pointing out that pushing breastfeeding can have unintended consequences on a new mom's confidence.

"People have surrogates, people have trouble breastfeeding and all you hear as a new, anxious mom is how breast is best," the 35-year-old went on. "Your baby is gonna be BEAUTIFUL, PERFECT, AND OKAY."

Teigen then explained that when her children were infants, she used to spend a great deal of time pumping on the "highest mode," and "it drove me mad to the point I could only get an ounce. An ounce!"

"The stress of it, combined with the guilt that you cannot do nature's most natural thing for your own baby is too much," the model said. "I dunno why this is my crusade now. I just remember the sadness I felt and want you to know you are doing it right if your baby is fed, mama."

This isn't the first time Teigen has advocated for mothers. Most recently, she defended Meghan Markle from critics after the duchess opened up about her pregnancy loss, weeks after Teigen suffered a pregnancy loss of her own.

Teigen is the mom of Luna, 4, and Miles, 2, both of whom she shares with husband John Legend.

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STR/NurPhoto via Getty ImagesBy SONY SALZMAN, ABC News

(NEW YORK) -- Moderna announced Monday it will ask the Food and Drug Administration for emergency use authorization (EUA) for its COVID-19 vaccine, making it the second company, after Pfizer, to seek EUA for a COVID-19 vaccine in the United States.

Pfizer's public FDA hearing -- a crucial step in the authorization process -- is scheduled for Dec. 10, and the FDA could make its official authorization decision shortly thereafter.

In an early morning press release, Moderna announced that its FDA hearing will be held a week later, on Dec. 17. Moderna also announced its coronavirus vaccine is more than 94% effective, according to the final analysis of its massive Phase 3 trial.

Among the more than 30,000 volunteers in Moderna's Phase 3 trial, 196 ultimately developed COVID-19, but the vast majority of those COVID-19 cases happened among volunteers who had been given a placebo injection -- an imbalance hefty enough for biostatisticians to feel confident the vaccine is highly effective.

"The newly published results from Moderna confirm our enthusiasm for the prospects of their vaccine," said Dr. John Brownstein, an epidemiologist, chief innovation officer at Boston Children's Hospital and contributor to ABC News.

Pfizer said its vaccine was 95% effective in the final analysis, but it had a different number of COVID-19 cases in its trial, so the percentages shouldn't be compared head-to-head without context, experts say.

"The results of both trials are just amazing," said David Benkeser, an assistant professor of biostatistics and bioinformatics at Emory University Rollins School of Public Health.

He added that "94.1% and 95% are statistically indistinguishable at this point, probably coming down to a difference of just one or two cases of COVID-19."

"We do have to be careful not to over-interpret these data, especially when in comparison to the Pfizer analysis," Brownstein cautioned.

Moderna has promised to publish full details from the trial through a formal scientific review process. Additional details about the trial will become available through the FDA's review process, which the agency has pledged will be transparent to the public.

"While 94.1% efficacy is phenomenal, we are still dealing with small sample sizes and likely we will see differences in vaccine effectiveness when deployed in the population," Brownstein said.

But Monday's press release included some new details about Moderna's vaccine, including the fact that it appears to be equally effective among people of different races, ethnicities, ages and genders.

Among the 196 people who developed COVID-19 in the trial, 33 were older adults (ages 65 and up), 29 were Hispanic or Latino, six were Black or African American, four were Asian American and three were multiracial.

Moderna is also claiming that the Phase 3 data shows the vaccine was highly effective at preventing more severe cases of COVID-19. According to the press release, 30 out of the 196 volunteers developed severe illness, but all 30 were among the group of volunteers who got the placebo shot. This shows the vaccine demonstrated 100% efficacy at preventing severe COVID-19, according to the company.

According to Benkeser, this isn't enough data to prove Moderna's vaccine will prevent severe illness in every single person who receives it, "however, it is common for vaccines to be more effective against severe disease than mild disease," he said.

"The idea is that though a vaccine might not fully protect you against infection, it can make the subsequent illness less severe," he added. "Therefore, it really is quite plausible that the short-term efficacy against severe disease is indeed close to 100%."

Meanwhile, no serious safety concerns about the vaccine have been reported to date. People who get the vaccine may experience a sore arm, redness at the injection site, headache, fever, fatigue or other short-term adverse reactions.

Monday's announcement means Moderna is on track to see a possible FDA-authorized vaccine by the end of the year. The company is also on track to produce 20 million doses available for distribution around the U.S. by the end of December: enough doses to vaccinate 10 million people.

Moderna said it will also ask European regulators for a conditional approval, and the company is on track to manufacture 500 million to one billion doses globally in 2021.

Experts said that even the "final" analyses of both vaccine trials -- Pfizer's and Moderna's -- will not provide the final answer about just how well the vaccines will work, especially in the long term, but their results, both boasting greater than 90% efficacy, bode well for the future.

Benkeser said there is still a long way to go until vaccines are widely available, but when they are, Americans should trust the science.

"There's a light at the end of the -- as of yet -- very dark tunnel," he said, "but for the first time since March, I feel hopeful about turning a corner."

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Anatoliy Sizov/iStockBy LESLEY HAULER, ABC News

(NEW YORK) -- As the coronavirus pandemic rages on and quarantine orders are being extended, people have turned to new places to get workout inspiration at home.

Fitness videos on TikTok have grown exponentially since the pandemic began, as many looked for new ways to stay in shape. Fitness challenges like #DragonFlag, #OneMinuteFitness and #PlankChallenge have gone viral in recent months, and celebrities like Carrie Underwood have even joined in.

Experts urge those just starting out to take it slow before jumping into some of the advanced moves seen in popular TikTok videos, and the intense program called 75 Hard that’s trending on the platform is no exception.

The 75 Hard program, created by entrepreneur and podcaster Andy Frisella and described as a "mental toughness" program, outlines rules users must follow for 75 days. They are:

  • Do two 45-minute workouts a day, one of which must be outside
  • Follow a healthy diet with zero alcohol or cheat days
  • Take a progress picture every day
  • Drink one gallon of water daily
  • Read 10 pages a day of a nonfiction book
  • If you fail, you must start over again at Day One

75 Hard found life on TikTok during the pandemic after 22-year-old Rylee Ollearis documented her journey doing the program from May to July. Her first video about it has racked up more than four million views.

"I decided to post on TikTok for my five followers at the time... 'Hey guys, I'm doing this crazy challenge, this crazy program,' and the video started to blow up," Ollearis told ABC News' Good Morning America.

"I've almost given up myself a few too many times in the past," she explained about what drew her to the intense program. "I wanted to prove to myself for this time that I could be tough enough to complete something that I set my mind to."

Ollearis' audio from her Day One video is now used in more than 500 TikTok videos of other users trying out the program for themselves. The hashtag #75Hard itself has over 126 million views on the platform.

The recent college graduate is now a wellness coach and said many people have reached out to her about the program since finding her videos. While she recognized that the program is a major commitment, she said she chose to do it in the middle of quarantine because she could put the majority of her daily focus on making sure she was being mindful with her workouts and recovery.

"Understanding that two 45-minute workouts every single day is a lot. You're pushing your body, but you also have to ensure that you're getting the right recovery, that you're including active rest into those days to make sure that you're not hurting yourself in any way," she said.

Experts raise 'red flags' about 75 Hard


One of the concerns about 75 Hard, according to many experts, is many may opt to ignore the 75 Hard recommendations and begin the workout plan without seeking advice from a physician first, and this can be dangerous.

Nutritionist and dietician Maya Feller said when she first heard about the 75 Hard program, "some internal red flags went up."

"This just seems so dangerous in the wrong hands — and even in the right hands. It's just propelling this really dangerous culture," she told GMA. "It could absolutely set a person up for feeling like, either 'I am doing well, according to this plan,' or 'I'm failing.'"

"We're in the midst of a time where we've lost so much collectively ... So why do we want to put ourselves in a position every day where we have to become tougher and harder, when we're struggling with so much?" she said.

While Feller says there are major benefits of finding a routine and making healthy choices to improve your well-being, she doesn't think 75 Hard is the way for the majority of people.

"It is for a very specific subset of people. ...The program should really be focused on the individuals finding out how to engage in nutrition and intentional movement that is supportive of their metabolic health and their physical ability," she explained.

75 Hard founder Andy Frisella did not respond to Good Morning America's request for comment.

Dr. Robert Glatter, an emergency physician at Lenox Hill Hospital in New York who has treated patients for injuries from working out at home -- though not from TikTok -- voiced concerns particularly about 75 Hard's two-a-day workout schedule.

“I think the routine puts a lot of strain on your body, primarily your kidneys," Glatter said. "The risks include muscle breakdown.”

Along with the strenuous physical toll of 75 Hard, Feller said it may also have negative psychological effects for an impressionable young audience on TikTok.

Feller said she believes 75 Hard's "diet" rule, which she says she considers vague, using terminology like "cheat meals," as well as the mandatory daily progress photo, exemplify the harmful side of diet culture, "which is very strong and very profitable and mostly focused on encouraging people to restrict their food intake ... just for the sake of whittling themselves down to quite slender."

75 Hard's official website has a disclaimer says that "you should consult your physician or other health care professional before starting" the program. The company also told GMA it does not require high-intensity workouts and could include two walks a day. The company also said 75 Hard is "a mental toughness program. It's not promoted nor advertised as a fitness challenge."

TikTok said in a statement to GMA that the company works "to foster a supportive and body-positive environment for our community."

"We encourage people to use good judgement before trying new fitness routines and will remove content that promotes dangerous behaviors to lose weight or eating habits that are likely to cause health issues. We want our community to feel comfortable and confident to be exactly who they are," TikTok said.

Ollearis believes people should do their own research before trying 75 Hard, echoing the statement that the program is about mental toughness and building confidence more than weight loss.

"It's not about the after pictures," she said. "It's a mental toughness challenge to see if you can push yourself to the limit ...The program was created to build confidence, to build grit, to build mental toughness."

If you or someone you know is battling an eating disorder, contact the National Eating Disorders Association (NEDA) at 1-800-931-2237 or NationalEatingDisorders.org.

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Heidi Gutman/ABC NewsBy IVAN PEREIRA, ABC News

(NEW YORK) -- With the novel coronavirus surging in states across the country, state leaders are scrambling to develop plans to contain the outbreak as many critics say the Trump administration remains largely disengaged.

But former health officials and experts told ABC News that those offices may have a stronger ally in their fight next year -- the incoming Biden administration.

Jeanette Kowalik, the director of policy development for the nonprofit health policy group Trust for America's Health and former health commissioner for Milwaukee, said state public health offices have been largely left to their own devices during the pandemic, and as a result, the country has developed a range of rules and regulations.

The pandemic has also become highly politicized, including the debate over mask mandates, with some states refusing to implement such measures despite evidence they can save lives.

President Donald Trump demurred from wearing a mask for months, jabbed President-elect Joe Biden for wearing one and questioned the efficacy of mask wearing. He has also sparred with and publicly contradicted the government's scientific experts.

Overall, the administration, while giving guidance through the Centers for Disease Control and Prevention (CDC), has largely deferred to the states on public health aspects of the pandemic and focused on economic recovery and vaccine development instead.

'Good start' but steep challenges for Biden

Kowalik and other experts predict that governors, mayors and health officials will be receptive to Biden's health policies, which include increased testing and a bigger push for masks across the nation.

"We're trained to adhere to whatever is at the national level," Kowalik told ABC News. "The fact that the Biden administration is committed to science is a good start."

While there may be some state leaders who, due to political ties, refuse to abide by the new administration's guidance, some of the experts said the rising COVID-19 dangers and the possible harsher winter will force them to reconsider.

The country is experiencing a daily caseload that is higher than ever and a death toll approaching the spring peak, and as a result, some leaders are already showing signs of following Biden's example, according to Dr. Georges Benjamin, the executive director of the nonprofit American Public Health Association.

Many health experts say the new administration's challenges are steep, but any amount of increased coordination will go a long way.

Benjamin said the CDC has released broad COVID-19 related guidance including wearing a mask, social distancing and limiting crowds. When it comes to having states enforce those protocols, the agency's members have been "keeping their heads down," because of the current administration's orders to focus on the economy over containing the spread, he said.

Kowalik, who left her position as Milwaukee's health commissioner in September, recalled how there was increased tension between state leaders and health offices over that debate.

State leaders who wanted to ease stay at home restrictions or not issue mask mandates would argue that the White House backed their proposals and move forward, she said.

An exit poll conducted by ABC News during the election found that a majority of Democratic voters favored containing the virus even if the economy took a hit while a majority of Republican voters favored the opposite.

'Major shift in tone' may help bring along opponents

Even though Biden won't assume office until January, many health experts say his announcements and plans during the campaign and transition show a more unified vision dedicated to keeping people healthy.

The president-elect has called for a national pandemic dashboard that breaks down COVID-19 data by ZIP code, expands the nation's testing capability and contact tracing, and for a national mask mandate.

"The Biden administration was clear that it would use science to guide how they manage the pandemic," Kowalik said. "That is a major shift in tone and a clear directive to health officials and leaders."

Experts who spoke with ABC News acknowledged the mask issue will be tough to enforce, especially since many Americans are still reluctant to wear them. However, Biden's continued promotion of the idea, both with his words and image of him wearing one during appearances, sends a strong message to the world, according to Benjamin.

"When you have a president wearing a mask, and encourage governors to do it in a way that is not threatening…that can change people's behavior," Benjamin said.

Kowalik added that the professionals that Biden has already chosen for his COVID-19 response give local health officials promise there will be a stronger direction from Washington.

Two days after he was projected to be the winner of the election, Biden announced a 13-member COVID-19 task board that included former Surgeon General Vivek Murthy and former Food and Drug Administration (FDA) Commissioner Dr. David Kessler.

"The majority of members are people who are well-known," Kowalik said of Biden's team. "That is definitely needed because the situation warrants hard science."

Prioritizing vaccine distribution

Michael Sparer, the chair of the department of health policy and management at Columbia University's Mailman School of Public Health, told ABC News the most important part of the Biden administration's COVID response will be eventual vaccine distribution.

Trump's Operation Warp Speed initiative laid out the groundwork for developing and delivering the vaccine in unprecedented time. However, the president was critical of the FDA's strict guidelines over the vaccine's approval.

Sparer said he expects Biden will build on this groundwork and provide states with a more detailed rollout, without any conflict with the FDA over approval or with the states over distribution.

"It will be distributed locally, but the effort by the Biden administration will be done under a national plan," Sparer said. "There will be efforts to straddle that middle ground."

Tailored reopening plans

Kowalik said the new administration's health departments would also offer state leaders a compromise by providing states with advisories and reopening plans that fit their specific needs.

She noted the Trump administration attempted this strategy in April with its reopening benchmarks offered to states that were contingent on increased testing and data that showed a continuous downward trend in cases.

However, the administration allowed several states to move forward with their reopenings in the spring despite not meeting the criteria. Biden had conference calls with governors and mayors and said he will continue to reach out during his transition and first weeks in office. He's also pushed for a "dimmer switch" method of reopening that is selective with restrictions.

"The CDC usually had a couple of options that were malleable," Kowalik said. "Having more than one plan for states to choose from and an overall outline of goals is key."

Benjamin acknowledged that partisan politics may prevent full cooperation, but the virus' growing threat has already forced some state leaders to rethink their strategies.

On Nov. 16, Iowa Gov. Kim Reynolds reversed her stance on a statewide mask mandate after her state saw a record 1,500 people hospitalized that day.

Around that same time in Wyoming, 21 health officials wrote a letter to Gov. Mark Gordon to implement a mask mandate as the seven-day average of new cases has jumped from 73.4 on Nov. 1 to 218.1 on Nov. 23, according to state health data.

"A vast majority of the people have not yet seen the disease affect somebody," Benjamin said. "I think as [the COVID-19 numbers] grow, there will be more recognition from those leaders that they need to listen to the science."

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JodiJacobson/iStockBy NICOLE PELLETIERE, ABC News

(NEW YORK) -- Before making a Pilgrim sandwich or a turkey pot pie, be sure to check guidelines for the fridge life of your favorite Thanksgiving eats.

Here's how long your leftovers will last in the fridge, freezer or both, according to the U.S. Department of Health and Human Services:

Turkey

Lasts four days in the fridge. Four months in freezer for best quality -- after four months it can dry out and lose flavor.

How to store turkey: Cut leftover turkey into small pieces and store separately in small containers.

Gravy

Up to four days in fridge. Up to four months in freezer.

Reheat gravy by bringing to a rolling boil. Cover to heat all the way through.

Homemade cranberry sauce

A week to 10 days in fridge. Freezing not recommended.

Canned cranberry sauce

Refrigerate after opening. Lasts one to two weeks. Freezing not recommended.

Potatoes and yams

Four days in fridge. Up to two months in freezer.

Stuffing

Up to four days in fridge. Two to three months months in freezer.

Pies

Fruit pies can be kept at room temperature for two days, according to Bettycrocker.com. They can then be stored in the fridge, loosely covered, for up to two more days. An unbaked crust will keep for two months in the freezer, while a baked crust will keep for four months.

More tips...

  • Refrigerate all leftovers within two hours at 40 degrees Fahrenheit or colder.
  • Leftovers should always be reheated to 165 degrees Fahrenheit.

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Lindsay FilcikBy GENEVIEVE SHAW BROWN, ABC News

(NEW YORK) -- Representation matters.

That's the reason behind one mom's viral post about dolls with disabilities. Her daughter, Ivy, has Down syndrome and now has a doll that looks just like her.

Lindsay Filcik told ABC News' Good Morning America she believes it is important for children with disabilities to see themselves represented in the toys they play with.

Her post has nearly 18,000 likes so far. She wrote in part, "Every single human being deserves to see somebody who looks like them in movies, books, commercials, and toys. Unfortunately for far too long that has not been the case. People of all races, abilities, body types, genders, religions, etc. need to be represented in what we watch, read, and play with. Recently we are seeing steps to remedy this problem in the media and I appreciate that! Representation matters!"

She continued: "Imagine being a child with a disability and all you ever see are typical, able bodied children. What message does that send you about yourself? That you are ‘abnormal’. That you are not worthy of being shown to the world. I know you’re reading this cringing inside, because of course no child should ever be made to feel that way. Lack of representation also hurts those children who are represented. They grow up with the incredibly skewed perception that everybody looks like them. And anybody who doesn’t isn’t ‘normal’ and should be feared. That my friends is how racism and ableism can be perpetuated in our kids without us even realizing it. Representation matters!"

The Grand Rapids, Michigan, mom's post includes two other girls playing with dolls who have disabilities similar to their own.

She wrote, "Look at these beautiful girls. Each one is represented by a doll that looks like them. Ivy has Down syndrome. Her doll looks just like her with almond shaped eyes and a button nose! Our friend Eliza has Spina Bifida. Her doll has forearm crutches (or sticks as Eliza says) & AFOs just like her! Our friend Stella has Spinal Muscular Atrophy. Her doll has a wheelchair just like her! Representation matters! "

Filick told GMA the post has been well received by parents of both disabled and non-disabled kids.

"Several parents of children who don't have disabilities told me they are adding a doll with a disability to their kids' Christmas lists," she said. "They had just never thought of it before."

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nevodka/iStockBy SASHA PEZENIK, ABC News

(NEW YORK) -- With the steady march toward a safe, effective and authorized coronavirus vaccine, another race now runs alongside: how to dispatch tens of millions of doses across every corner of the nation and globe, and do it safely, securely and swiftly. The solution will involve complicated logistical calculus, experts say, no matter which vaccine gets across the finish line first.

Pfizer's vaccine is likely to be the first to be granted authorization by the Food and Drug Administration, followed by one created by Moderna, and then possibly vaccines from AstraZeneca/Oxford and Johnson & Johnson, if the efficacy and safety data prove solid.

The U.S. government has promised a goal of "shots in arms" within 24 hours of FDA authorization of the first COVID-19 vaccine.

All about the money

Those responsible for the cross-country relay -- state and local public health officials and supply chain experts -- have hustled to marshal their resources, even as shortage concerns linger and officials warn the federal dollars they have received so far will not be enough.

"There's a light at the end, but that tunnel is still very long," Dr. Nirav Shah, director of the Maine Center for Disease Control and Prevention, told ABC News. "We at the state level will soon be handed the baton and we need additional funding support from the federal government. What's at stake is nothing short of the velocity and equity with which we can get this vaccine to everyone in need."

More than a dozen states have told ABC News they will likely need additional funding, or are awaiting additional funding. In response to concerns raised by the National Governors Association, Operation Warp Speed has said it is in the process of planning to make additional funding and resources available to support vaccine operations, information systems and communications campaigns, though some officials still say more will be needed.

"Without those additional resources, it will be like putting up tent poles without having a tent," Shah said. "We've got to think through literally everything, from when the vaccine enters our borders to the time it goes into somebody's arm for injection."

That "last mile" of distribution may pose the rockiest stretch of the journey, experts say. Getting the vaccine from a central transportation hub to its final destination at local hospitals and pharmacies across the country will require unprecedented coordination and delicately calibrated conditions.

The U.S. government estimates having 40 million doses -- enough for 20 million Americans -- by the end of this year if the FDA provides authorization in early December. About half of those vaccine doses will be provided by Pfizer, with the other half by Moderna.

Cold storage

Pfizer's vaccine must be stored at temperatures colder than Antarctica in winter: roughly minus 94 degrees Fahrenheit. Doses would ship in dry ice thermal containers, stored either with replenished dry ice for up to roughly two weeks or stored in ultra-low temperature freezers. Moderna's vaccine also requires cold storage, though not as extreme: It can be stored around minus 4 degrees, the same as a commercial freezer.

Manufacturers, logistics providers, federal and state governments and health care systems have been shoring up their cold chain infrastructure for months, lining up equipment and transportation capacity.

"The clock starts ticking once those dry ice containers start shipping around," Dr. Mark Jarrett, chief quality officer of Northwell Health, New York's largest health system, told ABC News.

The Centers for Disease Control and Prevention told states and localities not to buy ultra-cold freezers for now, since the Pfizer vaccine will be shipped with dry ice "pizza boxes" that can keep it viable for up to 15 days, as long as there's fresh dry ice available. It can then last five additional days in a conventional freezer.

Dry ice faced "significant shortages" during the pandemic's spring surge, President and CEO of the Compressed Gas Association Rich Gottwald told ABC, warning in an April letter to Vice President Mike Pence.

In mid-October, the nation's governors penned a letter to the Trump administration with several concerns, including ultra-cold freezer and dry ice supply, and seeking clarity so that "no one is caught flat-footed when the time comes to vaccinate people."

The Compressed Gas Association now says they expect "sufficient" dry ice supply for COVID-19 vaccines.

"There may be issues with [the] COVID vaccine; the supply of dry ice will not be one of those issues," Gottwald said.

Still, some dry ice manufacturers and distributors are echoing those earlier warnings.

"Our system is already taxed beyond what the supply is right now," Tim Koerner, co-owner of the American Carbonation Corporation, told ABC News. "It could be close to sufficient, but it's gonna be tight."

UPS announced Wednesday it's ramping up dry ice production capabilities and launching a mobile freezer storage unit supply, noting "a major spike in demand" and the need to "plan for what some analysts fear may be a dry ice shortage" amid vaccine preparation.

Public health authorities and hospitals who can afford the investment are acquiring ultra-cold freezers, despite CDC guidance, to maintain supply chain agility.

Unsure how much vaccine they'll be receiving, David Reich, president of The Mount Sinai Hospital and Mount Sinai Queens, said they had bought a number of the freezers to be ready for whatever comes.

Henry Ford Health System in Michigan announced Wednesday it had received and begun installing six specialized freezers for the Pfizer vaccine, and six other freezers for the Moderna vaccine.

Distributing the vaccine

UPS Healthcare is collaborating with Stirling Ultracold, an Ohio company making laboratory-grade ultra-cold freezers, to supply portable models for storage of vaccines.

Demand has "dramatically increased," Stirling Ultracold CEO Dusty Tenney told ABC News. Sales are up 250% since the first quarter, with backorder times up to six weeks.

"There is a lot riding on everyone right now to make sure this is successful," Tenney said.

An onboard computer tracks temperature through the cold chain's many handoffs "to ensure that when they do arrive, there's no waste or loss associated with the vaccine's efficacy," Tenney said.

"Our job is to make sure nowhere in that process does it break down," Tenney added.

Stirling Ultracold hopes to have 2,000 portable freezer units in use by January. Each portable unit can hold 6,000 doses, allowing for 12 million of them throughout the country at a time.

"We were concerned about the freezers, and so we quickly purchased and pre-positioned them at certain sites along the health system," Jarrett, from Northwell Health, said. "That's one thing we've learned in COVID -- was try and be ahead of the curve."

Those freezers don't come cheap: each unit, depending on the model, ranges from $6,000 to more than $10,000.

"You can't strap [vaccine] on the back of 'Bob's truck,'" Shah said.

Maine has received $800,000 in federal funding so far, and "significantly more will be needed," as they ramp up logistics and manpower.

Dry ice also has flight restrictions, which could further hamper distribution.

Who gets the vaccine and when?

Not all the vaccine candidates share the need for shipping in extreme temperatures. In addition to Moderna's, which can be held in most standard freezers, the vaccines from AstraZeneca/Oxford and Johnson & Johnson don't need to be frozen at all and can be safely stored for months in a standard refrigerator.

But all vaccine shipments will face logistical problems for one reason or another.

"We need to address the fact that all last miles in this country are not equal. If logistics work against our most-vulnerable populations, we will further exacerbate the impact of this pandemic," said Dr. John Brownstein, an epidemiologist at Boston Children's Hospital and ABC News Contributor.

"We've already seen the incredible divide when it came to testing -- increased travel times for counties with lower population density and higher percent of minority and uninsured. Will the challenges of cold storage and the requirement for two doses further exacerbate health inequities when it comes to immunizations?" Brownstein continued. "We'll need further analysis to understand how these logistical challenges intersect with fair and equitable access."

"We have to be ready for all of it," said Dr. Abinash Virk, infectious disease specialist at the Mayo Clinic. "It's a complicated process now happening at supersonic speed."

Figuring out which front-line staff has priority for the injection's first wave, organizing electronic medical systems and data communication must be done before the first shot and before knowing which vaccine will be the one they're giving, Virk said.

"Pfizer has the most restrictive storage and transport requirements," Virk said. "If we're able to handle that, then, the subsequent ones, hopefully, will be able to handle much easier."

Vaccines requiring two doses offer their own unique coordination: Pfizer's needs a booster after 21 days while Moderna's requires one after 28 days. That means ensuring the right shipment arrives in time for the patient who needs their second dose.

That could get harder in remote areas.

"All this will be unfolding as the vaccine is literally rolling in trucks to get there," Dr. Robert O. Williams III, of the University of Texas at Austin's Division of Molecular Pharmaceutics and Drug Delivery, said. "For rural areas that don't have the same infrastructure and cold infrastructure, that's an added challenge."

"We're the last mile. And that's sometimes the toughest mile," Jarrett said. "And there may be hurdles, but that's never going to stop us from doing the right thing."

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tuachanwatthana/iStockBy IVAN PEREIRA and CAMMERON PARRISH, ABC News

(LOS ANGELES) -- Los Angeles County is on the brink of ordering new restrictions to combat the rising coronavirus cases, but the latest proposal made by the Health Department won't bring the area to a complete lockdown.

Health officials presented their recommendations for a future stay-at-home order during a meeting with county supervisors Tuesday, though the LA County Board of Supervisors has not moved forward with the "Safer at Home" order as of Wednesday afternoon.

The county set a threshold of a five-day case average of 4,500 or higher for a stay-at-home order to go into effect. On Monday, the county surpassed that threshold, but on Tuesday, the average was around 4,200, according to the Health Department.

LA County health officials said a new "Safer at Home" order would not be as restrictive as the one issued in March that closed schools and barred travel outside a household, except for groceries.

Their new recommendations include a ban of all public and private gatherings involving people not in the same household, except for outdoor church services and outdoor protests, and a 50% capacity requirement at outdoor retail stores.

The Health Department also recommended a 35% capacity for essential indoor businesses and a 20% capacity for non-essential indoor businesses. Under the recommended order, shoppers, employees and people who attend permitted gatherings would be required to wear face masks, according to the Health Department.

Outdoor parks, beaches and trails will remain open, and outdoor recreation will be permitted as long as residents practice social distancing and wear a mask, the department said.

"I know for sure we're not going back to all of the restrictions that were in place in the original Safer At Home order,'' LA County Public Health Director Barbara Ferrer told reporters during a conference call Tuesday.

The Health Department recommendations come as both LA and California continue to see spikes in cases and pressure on its health care providers. On Wednesday, Los Angeles reported 4,311 new cases and 49 new deaths.

Los Angeles County surpassed the county that encompasses Brooklyn, New York, as the county with the most COVID-19 fatalities in the country, with 7,543 total deaths, according to the Health Department and John Hopkins University’s Coronavirus Resource Center.

Health officials said Wednesday during a virtual news conference that one out of every 145 Los Angeles County residents is currently infectious, and they are expecting shortages in hospital beds, including ICU beds, in the next two to four weeks.

Dr. Christina Ghaly, the director of the Los Angeles County Department of Health Services, said there will likely be a doubling of cases every two weeks, possibly even tripling.

Despite holding off on a full stay-at-home order, county supervisors have proceeded with a plan to prohibit in-person dining. Eateries and bars will be able to offer take-out options, but they cannot serve customers either indoors or outdoors for the next three weeks, according to the order.

“From Oct. 31 to Nov. 14, outbreaks at food facilities have increased by 200%," Dr. Muntu Davis, the LA County Public Health Officer, said during the news conference.

County business leaders, including the Chambers of Commerce for West Hollywood and Culver City, also held a news conference Wednesday to denounce the move. They warned they may have to make tough decisions.

"On the eve of the Thanksgiving holiday, our businesses may have to lay off hundreds, if not collectively thousands of employees," Genevieve Morrill, president and CEO of the West Hollywood Chamber of Commerce, said.

The business leaders called on the county and state to consider long-term solutions that would not harm their operations and asked for a COVID-19 emergency business interruption fund to offset their losses.

"Just checking the boxes off to show the public that you’re doing something is not enough," Morrill said.

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News Bulletin for Tues., Dec. 1, 2020

(*Bulletin)COVID-19 outbreak reported at Chautauqua Co. Jail... The Chautauqua County Sheriff's Department is dealing with a COVID-19 outbreak in the county jail in Mayville.  Sheriff Jim ...

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