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Starting Friday at 8 a.m., new capacity restrictions will be imposed on Anchorage bars, restaurants, gyms and other establishments.

The new emergency order, Anchorage Mayor Ethan Berkowitzs 14th during the COVID-19 pandemic, was announced Wednesday afternoon.

The changes once again make for a more fettered city as residents wont be able to enjoy activities like dining out or gathering in large groups as freely as before. For many Anchorage businesses, the new order means fewer customers coming through the doors. It also means many businesses must now keep a log of customers who visit for longer periods, to aid with the citys strained capacity for contact tracing.

The restrictions come as cases in Anchorage and Alaska have surged, and follow capacity restrictions being imposed in several other U.S. cities and states.

Weve seen a rapid acceleration in the number of cases, Berkowitz said in a community briefing Wednesday. Berkowitz said the medical infrastructure is currently unable to keep pace with the rise in COVID-19 transmission.

We are experiencing exponential growth at this time, Anchorage Health Department Director Natasha Pineda said during the briefing.

Since Friday, there have been 260 more cases in Anchorage, Pineda said. The city is averaging 37.9 cases per day. Last week, the city reported 24.9 cases per day. State data updated Wednesday showed 1,068 total Municipality of Anchorage residents have tested positive for COVID-19, including 391 recovered cases, 668 active cases and nine deaths.

Anchorage Mayor Ethan Berkowitz announced new capacity restrictions for bar, restaurants, gyms and other gatherings beginning 8 a.m. on Friday. (Bill Roth / ADN)

On Sunday, the city saw a daily record with 65 new cases, Pineda said.

Currently, our reproduction rate is one of the highest in the country, for the state. I am sure that the Municipality of Anchorage is contributing to that increasing reproduction rate, she said. Which means our virus is growing fast.

Fifty-nine percent of the citys ICU beds are occupied. While those arent all COVID-19 patients, the city is starting to see a creep-up in need for beds for patients with the virus, Pineda said.

The cases are rising and the pressure on our system is imminent, she said.

Under the mayors new order, indoor gatherings will be limited to 25 people, and outdoor gatherings where people are consuming food or beverages will be limited to 50 people.

Bars will be limited to 25% of their maximum building capacity, including staff.

Restaurants and breweries can reach 50% of their maximum capacity indoors, including staff. Outdoor space will be limited to table service only, and tables must be spaced at least 10 feet apart.

When bars and restaurants were operating under limited capacity in May under the second phase of Berkowitzs reopening plan, several cited concerns about being able to turn a profit or break even with limited customers.

Under the new order, other indoor entertainment facilities, such as gyms, bingo halls and theaters, are limited to 50% of their building occupancy. General retail businesses and personal care businesses such as salons do not fall under the capacity restrictions.

The new regulations will not apply to farmers markets, outdoor food truck events or drive-in events where people are in their cars.

A notice requiring patrons to wear masks is posted at the entrance of Spenard Roadhouse on July 22, 2020. (Emily Mesner / ADN)

Also, all businesses that have sit-down service lasting at least 15 minutes must keep a log of all adult customers, recording their first and last names, phone numbers and email addresses to be used by contact tracers in the event of people being exposed to COVID-19 at their establishment. This record must be kept for 30 days.

Places like banks would also have to keep a log of visitors involved in extended, sit-down situations such as applying for a loan.

If a business does have COVID-19 exposure, employees as well as the state and local health departments must be notified. They also must assist public health authorities in alerting customers to the exposure.

Finally, hotels and other lodging are required to inform employees of any guests who are in quarantine or isolation due to travel or COVID-19 exposure. The hotels and lodges must also provide adequate personal protective equipment and cleaning supplies to employees.

Alaska has seen a significant and consistent increase in cases since reopening its economy, regularly hitting record single-day case counts. Recently, there have been several days with more than 100 cases.

Standing still in the face of adversity is not the kind of option that we have, Berkowitz said.

While hospitalizations and deaths are believed to be an especially lagging indicator of how present the virus is, all data is on somewhat of a delay. Pineda said daily case numbers are actually indicative of what was happening 10 to 14 days before.

That is why when we see this significant increase in numbers, were concerned, she said. That means the community spread has been happening over the past two weeks, and its still incubating and moving around our community.

On June 26, Berkowitz imposed a face covering mandate within the municipality to try to limit the spread of the virus when people are in public.

Anchorage Economic and Community Development Director Chris Schutte said there has been enforcement of the citys mask mandate. When someone files a complaint to the city about a business not complying, city workers will call the business and inform them of the mandate, Schutte said.

Schutte said there have been instances where businesses or employees were not complying.

Pineda said compliance is something the community is still working on, and said people should be wearing masks outside if they are coming within 6 feet of non-household members.

Berkowitz and Pineda said the decision to limit capacity is partially driven by the virus surging statewide, and in other parts of the country. Anchorage is the health care hub for Alaska, so outbreaks in other parts of the state can put a strain on the local health care infrastructure.

Part of Alaskas surge has involved the seafood industry.

When we are looking at hundreds of cases coming in from seafood workers, that will put a burden on our ability to provide capacity for people in Anchorage, Berkowitz said.

Clarification: An earlier version of this story cited Mayor Ethan Berkowitz saying general retail businesses would be limited to 50% capacity. The mayor misspoke when he announced that, his spokesperson later said. Those businesses will not be under a capacity restriction.

Also, an earlier version of this story cited Anchorage Health Department Director Natasha Pineda saying the city has had 430 new cases since Friday. The city later said that is incorrect; there were 260 new cases in that time.

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Citing spike in COVID-19 cases, Anchorage mayor announces new restrictions for bars, restaurants and gatherings - Anchorage Daily News

GOVERNOR DISCUSSES REOPENING PLANS WITH ALL WEST VIRGINIA COLLEGE AND UNIVERSITY PRESIDENTS Also, Gov. Justice offered a reminder that he held a virtual meeting on Tuesday with all 27 of West Virginias public and private college and university presidents to discuss reopening plans for the fall semester and how to ensure the safety of West Virginias students, teachers, faculty members, and communities amid the ongoing COVID-19 pandemic.

At the end of day, all of our schools want our kids back and our kids want to be back in school and back on campus, Gov. Justice said. So how do we do that while also protecting our kids, their staff and faculty, and all of the communities where our kids will be? How do we move forward in the best way possible, without disrupting the education process for our students? Not to mention the economics, because we dont want to start losing any of our colleges and universities within the state.

I commend, beyond belief, the incredible plans that these institutions have put forward, Gov. Justice continued. Weve listened to all of them and their plans are spectacular, to ensure, without a doubt, the safety of our kids, the staff, their communities, and everyone.

During Tuesdays meeting, Gov. Justice renewed his calls for all students coming into West Virginia from out-of-state to be tested upon their return. The Governor also advocated for individuals on campuses to wear face coverings to the greatest extent possible and pledged to provide colleges and universities with any additional support they may need to facilitate a safe return.

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COVID-19 UPDATE: Gov. Justice provides more than $4.1 million to help volunteer firefighters; reports modest improvement in case numbers - West...

Megan Kent, 37, a medical speech pathologist who lives just outside Boston, first tested positive for the virus on March 30, after her boyfriend became ill. She couldnt smell or taste anything, she recalled, but otherwise felt fine. After a 14-day quarantine, she went back to work at Melrose Wakefield Hospital and also helped out at a nursing home.

On May 8, Ms. Kent suddenly felt ill. I felt like a Mack truck hit me, she said. She slept the whole weekend and went to the hospital on Monday, convinced she had mononucleosis. The next day she tested positive for the coronavirus again. She was unwell for nearly a month, and has since learned she has antibodies.

This time around was a hundred times worse, she said. Was I reinfected?

There are other, more plausible explanations for what Ms. Kent experienced, experts said. Im not saying it cant happen. But from what Ive seen so far, that would be an uncommon phenomenon, said Dr. Peter Hotez, the dean of the National School of Tropical Medicine at Baylor College of Medicine.

Ms. Kent may not have fully recovered, even though she felt better, for example. The virus may have secreted itself into certain parts of the body as the Ebola virus is known to do and then resurfaced. She did not get tested between the two positives, but even if she had, faulty tests and low viral levels can produce a false negative.

Given these more likely scenarios, Dr. Mina had choice words for the physicians who caused the panic over reports of reinfections. This is so bad, people have lost their minds, he said. Its just sensationalist click bait.

In the early weeks of the pandemic, some people in China, Japan and South Korea tested positive twice, sparking similar fears.

South Koreas Centers for Disease Control and Prevention investigated 285 of those cases, and found that several of the second positives came two months after the first, and in one case 82 days later. Nearly half of the people had symptoms at the second test. But the researchers were unable to grow live virus from any of the samples, and the infected people hadnt spread the virus to others.

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Can You Become Reinfected With Covid-19? It's Very Unlikely, Experts Say - The New York Times

By: Jeff Shuren, M.D., J.D., Director, Center for Devices and Radiological Health

The U. S. Food and Drug Administration has been proactive and supportive of test development by all comers including laboratories, and large and small commercial manufacturers to speed development and to quickly authorize tests that the science supports. The agency engaged with the lab and commercial manufacturer communities even before any cases of COVID-19 were diagnosed in the U.S., working with over 500 developers since January, and has been working around the clock to authorize over 180 Emergency Use Authorizations (EUAs) for tests, including molecular, serology, antigen, and tests with at-home specimen collection indications.

This pandemic has created a demand for new tests that is unprecedented in both volume and urgency. The FDAs important roles in testing include determining whether the tests developed for use in the U.S. provide sufficiently accurate and reliable results and helping to provide timely access to such tests.

In a public health emergency, getting an accurate test is important not only for the individual patient, but for the public at large. False positive or false negative results can contribute to the spread of COVID-19, so all tests used for COVID-19 should be validated before use. Similarly, timely access to diagnostic tests is also critically important. To best address these dual, and sometimes competing, needs, the FDA has used its EUA authorities. EUAs permit the emergency use of a product, in this case a test, when the FDA determines that certain criteria are met based on the totality of the scientific evidence available. The EUA process made it possible for molecular diagnostic tests to be developed, validated, and offered for clinical use within weeks rather than months or longer.

The FDAs EUA authorities allow the FDA to authorize the emergency use of tests more quickly than full FDA approval or clearance because the evidentiary standard is different. For full approval or clearance, we typically require validation testing using patient samples; however, due to the immediate need and the small number of patient samples available, we utilized our emergency authorities to authorize tests based on data from contrived clinical samples or smaller sets of patient samples. For example, early-on in the emergency, instead of using specimens from individuals infected with SARS-CoV-2, developers could add different amounts of inactivated SARS-CoV-2 RNA to human specimens, such as sputum, to assess how well their test could detect the virus. As a result, validation could be completed rapidly, in some cases in only a few days once inactivated RNA became available. This approach was less likely to accurately characterize test performance so the FDA has taken several actions now that clinical specimens have become more readily available.

Once multiple sources of positive patient samples were available, we asked developers of new tests to validate with these clinical samples. In addition, as part of each EUA for a COVID-19 test, the FDA requires that each test developer and its authorized distributors collect test performance information, including any suspected occurrence of false results, and report to the FDA as a condition of authorization. An additional condition of authorization requires test developers to track adverse events and report them to the agency. These actions have helped generate more robust evidence of test performance to help providers, patients, laboratories, and the government make better informed decisions.

Additionally, these conditions enable the FDA to detect trends and take swift action to prevent harm to patients, especially when device malfunctions may affect many tests across the nation (e.g., in sample collection swabs, or shared test reagents). For example, we were able to quickly alert the public about potential inaccuracies with the Abbott ID Now point-of-care test to diagnose COVID-19 when we began to see a trend in the adverse event reports we received. In some cases, such as tests that used contrived clinical samples for validation, we required developers to conduct post-authorization studies as a condition of their authorization to further evaluate the clinical performance of the test using clinical specimens. This approach gives patients timely access to potentially beneficial and high-volume tests while assuring a more robust understanding of test performance in a real-world setting. The agency monitors all of this information so that we are able to take action when a tests benefits no longer outweigh its risks. Finally, the FDA requires that manufacturers of certain tests provide evidence that their manufacturing processes will deliver consistent results, helping to ensure that accurate tests are produced in every manufacturing lot.

Another step the FDA took to support independent validation for SARS-CoV-2 diagnostic tests was providing developers with a reference panel. Starting with live SARS-CoV-2 virus we obtained, FDA personnel in the Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research worked collaboratively to create a reference panel from a validated inactivated viral stock, and made it available to developers of molecular diagnostic tests. The FDA-supplied reference panels include well-characterized samples of the SARS-CoV-2 virus genetic material (RNA). The FDA panel is available as an independent performance validation step for commercial and laboratory developers of SARS-CoV-2 nucleic acid diagnostic tests who previously validated their authorized tests with contrived samples, or who are currently having difficulty validating their new test. Data from use of the reference panel will provide the FDA with more accurate information on the comparative performance of different tests so that we will have a better understanding of which tests are more sensitive than others. The FDA will make this information available on our website.

We recently announced our participation in the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project to advance the development of diagnostics through the generation of real-world evidence. It is organized by the Reagan-Udall Foundation for the FDA in collaboration with Friends of Cancer Research to allow the community to analyze both diagnostic and clinical data in real time, which has the potential to contribute to the scientific evaluation of diagnostic tools and medical interventions for COVID-19. The Accelerator project will leverage FDA's SHIELD initiative, a multi-stakeholder collaboration to improve the quality, interoperability and portability of laboratory data within and between institutions so that diagnostic information can be drawn from different sources or shared between institutions. SHIELD harmonizes COVID-19 test data referenced in the HHS COVID-19 laboratory data reporting requirements, which can be used to evaluate the real-world performance of SARS-CoV-2 diagnostic tests and antibody tests.

Evidence generated by the Accelerator project is intended to be complementary to other studies that have been conducted or are underway as well as to provide actionable information about the prevalence of SARS-CoV-2 in specific populations and highlight individual risk factors for patients. This helps improve our understanding of the disease, tailor public health interventions and strategies to mitigate risks for individuals and communities and help stop the spread of SARS-CoV-2.

Taken together, these actions will, and already are, providing the clinical, patient and consumer communities with more accurate information about diagnostic test performance and allowing for the rapid availability of new, accurate and reliable tests.

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FDA's Ongoing Work to Support and Advance COVID-19 Diagnostic Test Accuracy and Availability - FDA.gov

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The city of Seward became the center of Alaskas two largest coronavirus outbreaks on Wednesday, with a factory trawler and a local seafood-processing plant where a combined 181 people had tested positive.

The American Seafoods ship carrying 85 infected crew members arrived in Seward from Unalaska on Wednesday afternoon.

After the 286-foot American Triumph moored at Sewards cruise ship dock, the crew disembarked and were ushered into the waiting buses by the drivers, who were wearing ventilated PPE suits. A handful of onlookers drove by as the crew disembarked, some with binoculars. They were taken to Anchorage.

Also on Wednesday, 96 seafood workers at the OBI Seafoods processing plant in Seward which employs 262 people tested positive for the novel coronavirus, causing the plant to temporarily shut down, city officials said.

An employee at the plant first tested positive for COVID-19 on Sunday, after seeking medical care for an unrelated health issue, the company said. The plant immediately closed so that the company could test all its employees and disinfect the campus.

The cases included 85 nonresident and 11 resident employees, according to a presentation from Alaskas state medical officer, Dr. Anne Zink, at a community briefing on Wednesday.

The OBI outbreak is the latest to hit the seafood industry in Alaska, occurring just days after the 85 crew members aboard the American Triumph tested positive for the virus, and more than 40 became infected at a plant operated by a Juneau fish processor.

Alaska is currently experiencing three large, separate outbreaks of COVID-19 in the seafood industry, said Dr. Joe McLaughlin, Alaskas State Epidemiologist, in a written statement Wednesday evening. These outbreaks are reminiscent of the meat packing plant outbreaks in the Lower 48 and stress the importance of vigilant symptom screening and prompt facility-wide testing in congregate work settings when index cases are identified.

Until now, the seafood industry has remained relatively unscathed despite concerns earlier in the year about the influx of out-of-state workers and potential for outbreaks in close quarters, on vessels and in processing plants that could overwhelm the states fragile health care system.

In response, 11 seafood companies released a letter addressed to communities to confirm our commitment that we are prioritizing health and safety of local residents in which they detailed their COVID-19 mitigation plans.

With the exception of some smaller outbreaks in Dillingham and Whittier, the companies safety plans appeared to been mostly effective.

From Seward, infected crew from the ship and the plant were headed to Anchorage for isolation or quarantine, officials said. It isnt clear where the workers will be housed while in the city.

The sudden influx of infected people prompted municipal concerns about Anchorage hospital capacity. OBI Seafoods said in a statement that the vast majority of their employees who tested positive are not currently experiencing symptoms of the virus, and none have been hospitalized.

But the possibility that some could get sick enough to need medical care was a factor in Anchorage Mayor Ethan Berkowitzs decision to issue new restrictions on bars and restaurants Wednesday.

Berkowitz at a briefing said the new restrictions stemmed in part from Anchorages role providing medical care for most of the state including infected seafood workers, as well as residents of rural communities that rely on Anchorage hospitals.

When were looking at the hundreds of cases coming in from seafood workers, that will put a burden on our ability to provide capacity for people in Anchorage, he said. And so were watching the numbers not only inside Anchorage, were watching what is happening outside the community.

Crew disembark from the American Triumph and board busses in Seward on Wednesday, July 22, 2020. American Seafoods, which operates the factory trawler, reported over the weekend that 85 crew members tested positive for COVID-19. The crew disembarked in Seward and will be transported to Anchorage where they will be isolated for further care. (Loren Holmes / ADN)

Crew members from the American Triumph are transported by bus from Seward to Anchorage on Wednesday, July 22, 2020. American Seafoods, which operates the factory trawler, reported over the weekend that 85 crew members tested positive for COVID-19. The crew disembarked in Seward and will be transported to Anchorage where they will be isolated for further care. (Loren Holmes / ADN)

The American Triumph docks in Seward on Wednesday, July 22, 2020. American Seafoods, which operates the factory trawler, reported over the weekend that 85 crew members tested positive for COVID-19. The crew disembarked in Seward and will be transported by private bus to Anchorage where they will be isolated for further care. (Loren Holmes / ADN)

The OBI seafood processing plant in Seward, photographed on Wednesday, July 22, 2020. (Loren Holmes / ADN)

OBI Seafoods LLC was formed in June, the result of a merger between major processors Ocean Beauty Seafoods and Icicle Seafoods, and includes five shoreside locations in Alaska.

Earlier this summer, outbreaks were confirmed at two other OBI Seafoods plant locations in Dillingham, where 12 workers tested positive, and at the companys Excursion Inlet salmon processing plant in Southeast Alaska, where three employees also tested positive in late June.

The company has said it has extensive safety protocols in place to prevent an outbreak like this: All employees upon arrival in Alaska are required to quarantine for 14 days, and are then tested a second time, the company said in a statement. Every OBI employee also goes through a symptom and temperature check each day, according to the company.

But the close quarters and long working hours at fish processing plants can make social distancing difficult.

The American Triumph docks in Seward on Wednesday, July 22, 2020. American Seafoods, which operates the factory trawler, reported over the weekend that 85 crew members tested positive for COVID-19. The crew disembarked in Seward and will be transported by private bus to Anchorage where they will be isolated for further care. (Loren Holmes / ADN)

Crew disembark from the American Triumph and board busses in Seward on Wednesday, July 22, 2020. American Seafoods, which operates the factory trawler, reported over the weekend that 85 crew members tested positive for COVID-19. The crew disembarked in Seward and will be transported to Anchorage where they will be isolated for further care. (Loren Holmes / ADN)

Annie Berman reported from Anchorage and Loren Holmes from Seward.

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Seward announced 96 new COVID-19 cases at a seafood plant as a trawler with 85 infected crew arrived. They're all headed for Anchorage. - Anchorage...

The daily COVID-19 death toll in the United States topped 1,000 Tuesday, a grim threshold that's been met four times already within the past month, suggesting that the decline in deaths seen in May and June is reversing.

"That's basically two to three airplanes' worth of people crashing" in a single day, said Dr. Josh Denson, a pulmonary medicine and critical care physician at the Tulane Medical Center in New Orleans. "It's insane."

Full coverage of the coronavirus outbreak

The increase in deaths follows a pattern seen earlier in the pandemic: First, case counts rose. Then, hospitalizations went up. Deaths followed.

That's what's taking place in Houston, where COVID-19 cases have been rising steadily since mid-June.

"In April and May, we had between 200 and 300 cases diagnosed in the greater Houston area on any given day. Now we're around 2,400," said Dr. James McDeavitt, senior vice president and dean of clinical affairs at the Baylor College of Medicine in Houston.

In June, many of those new cases were among younger adults in their 20s, 30s and 40s a population that is generally less vulnerable to severe complications from the illness, and death. That increase appears to have transformed into an increase in hospitalizations and deaths, but within an older population.

"What we saw after about two weeks was the older population starting to catch up again," McDeavitt said, though he pointed out that there is no scientific data yet to link younger partiers with older patients.

"Presumably, younger people were going out and getting infected, and then bringing that back to parents and grandparents," he said.

"Young people are generally fine," said Dr. Michael Wasserman, a geriatrician and president of the California Association of Long Term Care Medicine. "They're not always, but if they give it to grandma, that's a problem."

Indeed, McDeavitt said, more severe outcomes still tend to be among older people and people with underlying conditions such as obesity, type 2 diabetes and high blood pressure.

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The recent spike in cases has those who care for older adults concerned.

"It's frightened the daylights out of me," Wasserman said. "I don't want to see more older adults die again."

It's been well documented that the risk for COVID-19 complications and death increases with age, and it's no surprise that frail people with compromised immune systems are vulnerable.

"The greatest risk for severe illness from COVID-19 is among those aged 85 or older," the Centers for Disease Control and Prevention's website says.

But other factors beyond age and health condition also increase the risk among the elderly.

People in nursing homes or assisted living facilities, for example, can't self-isolate. They "need people to move them or do their bathing," Wasserman said. "The more time staff has to spend with residents, it's going to increase the risk for exposure to the virus."

What's more, older adults are more likely to have dementia, which might mean they're unlikely to isolate in their rooms, wear a mask or wash their hands regularly three cornerstones of infectious disease control.

While there have been advances in COVID-19 therapies, such as the antiviral remdesivir and the steroid dexamethasone, critical care physicians point out there is still no cure for the disease.

Among therapeutics, Denson said, "there's definitely no game-changer" yet.

He recalled a day last week when things were going badly in the COVID-19 intensive care unit. A young patient in his 30s died; a language barrier made conversations with the patient's family difficult; another patient had unforeseen complications.

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"It was very tough," Denson said. But that very afternoon, he got a call out of the blue from a former patient who nearly died of the virus several times during her hospital stay.

"She was as critically ill as any patient I've had," Denson said. "But she survived, called me from her house, doing great, and just wanted to say 'hello' and 'thank you.'"

It was an uplifting reminder that despite the worrisome rise in cases and in deaths, many people do, in fact, recover from COVID-19.

"It's a very survivable illness," Denson said.

Still, until a vaccine or more effective treatment is available, the key moving forward, he and other experts said, is prevention: Remain vigilant about face coverings and physical distancing.

Those are "our only weapons right now, the only things controlling the virus," McDeavitt said. "If we get past this surge, and we revert to old behaviors and take those weapons off the table, we're going to have another surge."

"Let's learn this lesson."

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COVID-19 deaths are rising once again. What's driving the increase? - NBC News

As manufacturers around the world race to develop Covid-19 vaccines, a parallel effort has begun to figure out who in the United States should get them first and how those doses should be distributed.

But already the effort is being complicated by tensions over who gets to make those critical decisions, with some groups feeling sidelined and multiple new actors crowding the stage.

On Tuesday, the National Academy of Medicine, tasked by top U.S. health officials, named an expert panel to develop a framework to determine who should be vaccinated first, when available doses are expected to be scarce. But that panel is ostensibly encroaching on the role of the Advisory Committee on Immunization Practices, a panel that has made recommendations on vaccination policy to the Centers for Disease Control and Prevention for decades, including drawing up the vaccination priority list during the 2009 H1N1 flu pandemic.

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There is also the matter of Operation Warp Speed, the governments vaccine fast-tracking program that has claimed authority over, among other things, distribution decisions when it comes to Covid-19 vaccines.

Amid so many players, public health experts are expressing concern and confusion.

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It seems to me like weve just assigned four different air traffic control towers to land the same plane, said Michael Osterholm, director of the University of Minnesotas Center for Infectious Diseases Research and Policy. Between ACIP, and this new committee, the group working within Operation Warp Speed and just in terms of input from the general community, its not clear to me who will make the final decision and how that process will unfold.

The health of untold numbers could hang in the balance, given that initial batches of vaccine are likely to be available only for a sliver of the population. Additionally, most vaccines will probably be given in two-dose regimens, meaning any figure of available doses would have to be divided in half to see how many people could be vaccinated.

There is no doubt that health care workers will be offered vaccines first. But after that, tough decisions will have to be made about the order in which other frontline workers which? how many? are offered priority access to vaccine and who will follow, in what order.

Normally, such decisions would fall to ACIP, which months ago set up a working group to monitor the evolving science on Covid-19 and the vaccines being developed to protect against it. But its not clear what task ACIP will be handed here.

We havent been given a firm answer as to what our role will be. We are continuing with our routine planning and discussion, and we will come up with what we think are appropriate guidelines for prioritization. But that weve not been given assurances that we will actually be contributing to that, said Jos Romero, the panels chairman.

Romero told STAT he even had applied to be on the National Academys panel after the academy urged people who were interested to nominate themselves. Romero said he never heard back. The agenda for the first public meeting of the panel, scheduled for Friday, states Romero has been invited to speak to the kickoff session. He said late Monday he hadnt received an invitation.

ACIP member Beth Bell, who chairs its Covid-19 vaccines work group, is also concerned about the National Academy panel working on vaccination priorities before ACIP.

Hopefully it wont be a parallel process and itll be something which can complement the work of the ACIP, said Bell, a professor of global health at the University of Washington and a former director of the CDCs national center for emerging and zoonotic infectious diseases.

She seemed to take some solace from the fact that former CDC director Bill Foege one of the architects of the smallpox eradication program and a revered figure in public health circles has been named co-chair of the new panel.

Foege will share chairing duties with Helene Gayle, president and CEO of Chicago Community Trust. Gayle previously worked at the CDC for 20 years on HIV/AIDS and at the Bill and Melinda Gates Foundation. In addition to the co-chairs, the panel is made up of 15 members include vaccine experts, ethicists, experts in vaccine hesitancy, global health, health policy, risk communications, and the delivery of health care to low-income populations.

Francis Collins, director of the National Institutes of Health, first asked National Academy of Medicine President Victor Dzau to create the new panel, even though setting vaccination priorities is a public health role traditionally on the CDCs turf, not the NIHs. Later a letter formally requesting that the panel be struck came from Collins and Robert Redfield, the CDC director.

In an interview, Collins seemed puzzled as to why ACIP members might be concerned about the creation of the expert panel. He said the decision-making framework the panel designs will make their job, I think, a lot more straightforward and less likely to be attacked as being capricious.

This is a discussion which is potentially going to be contentious and we want to try to minimize that, Collins told STAT.

There are certainly parts of society that are suspicious of what the government is doing, no matter what it is, he added. And this takes it out of that framework and provides an opportunity for whose sort of wisest big thinkers to gather and make this kind of a judgment about what those priorities ought to look like, he said.

Whats not to love about this? he said.

Some vaccine developers have embraced the idea of the National Academys involvement, which the body suggests will set a priorities framework that can be used in the United States and beyond.

It is the CDCs responsibility, the ACIP that makes decisions about allocation, but in this very special case, I have personally and I think many of us have called for the National Academy of Medicine to create a mechanism to look at health equity and make sure that the allocation is fair, Julie Gerberding, the chief patient officer at Merck, told a House subcommittee on Tuesday.

Others acknowledge there is confusion about who is doing what and most importantly, who will make the final decisions.

Osterholm, the University of Minnesota expert, called the composition of the National Academy panel outstanding. They couldnt find two better chairs than Bill and Helene.

But the excellence of the panel doesnt negate the fact there isnt much clarity about roles, he said.

At the end of the day, the administration in power when vaccine is approved for use will likely dictate who stands where in the vaccine priority line. The current administrations past decisions about distribution of desperately needed protective equipment for health workers and scarce supplies of the antiviral drug remdesivir dont instill confidence that the painstakingly crafted recommendations of the National Academy group, or of the ACIP, will be followed to the letter.

In the end it will be decided by the U.S. government, Osterholm said. Look at how the remdesivir situation unfolded nationally. That was a terrible situation.

The task of setting priority groups wont be an easy one.

Older adults are most at risk of dying if they become infected. But essential workers in food production and distribution may be at higher risk of contracting the virus. Who should move to the front of the line? Should the vaccination program prioritize people of color, who have contracted and died from Covid-19 in disproportion numbers? At the June meeting of the ACIP, at least one member suggested that should be considered. One of the charges to the National Academy panel is to advise on how communities of color can be assured equitable access to the vaccines.

Other questions asked of the National Academy panel include what criteria should be used to set priorities for equitable allocation of vaccines, and how individual risk, either due to age, underlying health conditions, or occupation or group risks such as people in prisons, the homeless or residents of long term care should be weighed. The panel is also being asked to provide input on how to communicate vaccine priority decisions to the wider public, and how to address vaccine hesitancy, especially in high-risk populations.

Collins said the panel has been asked to come up with interim recommendations by Labor Day, which would then be subject to a short period of public comment. Dzau, the academy president, said last week that the final recommendations would probably take about three months to deliver, which would mean early October.

Dzau strenuously refuted the idea that the new panel might be driving in someone elses lane. The group will create scenarios, he said, of how to deal with the variety of circumstances the country might face, for instance starting to vaccinate with 10 million doses, or 60 million, or 100 million.

I think our job will be to look at the evidence and the strategy of who should get what and how. Some kind of priority list and the rationale for that, Dzau said.

The time frame he and Collins envisage may leave the ACIP with little time to fine-tune the framework the National Academy panel devises. Some of the most aggressive manufacturers have stated they may have enough evidence to support the issuance of an emergency use authorization from the Food and Drug Administration by October.

Beyond questions of priority-setting, there are also concerns about how vaccines will be distributed.

Those concerns were first triggered by the press release announcing the formation of Operation Warp Speed, which claimed distribution as one of the projects responsibilities.

Four organizations representing professionals who make up the last mile of a vaccines journey into arms in the United States wrote to the leaders of Operation Warp Speed on June 23, asking if the project intended to use existing vaccine delivery infrastructure to get Covid-19 vaccines into Americans. They still havent received a reply.

If your job is logistics and you dont know that theres a system out there already, it might be easy for you to start planning things down a different path, said Claire Hannan, executive director of the Association of Immunization Managers, one of the groups. And we dont want that to happen.

Another group that signed the letter, the Association of State and Territorial Health Officials, has since had a discussion with Lt. Gen. Paul Ostrowski, from Operation Warp Speed, said Jim Blumenstock, the organizations chief program officer for health security. Blumenstock said that after the conversation, he felt more confident that traditional vaccine distribution networks would play a part in the roll out of Covid-19 vaccines.

The proof is always in the pudding, he said, recounting that Ostrowski told him that micro-planning for vaccine distribution would start in the next two to three weeks.

STAT asked Operation Warp Speed for interviews about these issues. The requests were neither turned down nor granted they were merely acknowledged.

Hannan, who hadnt heard anything from Operation Warp Speed as of Monday, remains unsettled.

I am still very concerned about how distribution will be carried out and about the lack of planning with state and local public health agencies, she told STAT. We have received no assurance that existing vaccine allocation, distribution, and tracking systems will be used.

Damian Garde contributed reporting

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Confusion spreads over selection of priority groups for Covid-19 vaccines - STAT