POST 110. January 13, 2021. CORONAVIRUS. ““The (federal) government is changing the way it allocates Covid vaccine doses, now basing it on how quickly states can administer shots and the size of their elderly population.”… “New York State sent a letter to hospitals saying if they don’t use their vaccine allocations by the end of this week, they won’t receive any further allocations.”

“The government is changing the way it allocates Covid vaccine doses, now basing it on how quickly states can administer shots and the size of their elderly population.”

States will be given two weeks to prepare for the change, Health and Human Services Secretary Alex Azar told reporters during a news briefing.

That should give states enough time to improve their data reporting to the government and ensure all vaccinations are being “promptly” documented, he said.

The federal government is changing the way it allocates coronavirus vaccine doses, now basing it on how quickly states can administer shots and the size of their elderly population, Health and Human Services Secretary Alex Azar said Tuesday.

States will be given two weeks to prepare for the change, Azar told reporters during a news briefing. That should give states enough time to improve their data reporting to the government and ensure all vaccinations are being “promptly” documented, he said.

States aren’t currently reporting vaccinations in a timely matter, Azar said, adding that vaccine doses “are sitting in freezers in hospitals.”…

The Trump administration will also stop holding back millions of doses reserved for the second round of shots of Pfizer’s and Moderna’s two-dose vaccines, the official said, adding they’ve released doses that had been held in reserve on Sunday. President-elect Joe Biden’s transition team announced a similar plan Friday.

Some 53 million Americans who are 65 and older and 110 million people between 16 and 64 with comorbid conditions will now be eligible to receive the vaccine if every state adopts the guidelines, according to the CDC.

Vaccine doses were previously allocated based on the number of adults in each state. But U.S. officials are complaining the pace of vaccinations has been too slow as the supply of vaccine doses exceeds demand.

Arkansas and Georgia are the two worst performers, vaccinating 1,355 and 1,346 people, respectively, per 100,000, according to CDC data. Meanwhile, the Dakotas and West Virginia are giving more than 5,000 shots per 100,000 people, according to the agency.

As of Monday morning, more than 25.4 million doses had been distributed across the U.S., but just over 8.9 million shots have been administered, according to CDC data. The number is a far cry from the federal government’s goal of inoculating 20 million Americans by the end of 2020 and 50 million Americans by the end of this month.

State and local health officials have said they are strapped for cash. They blame insufficient funding and inconsistent communication from the federal government for the slow rollout.” (A)

“The Trump administration on Tuesday issued new guidelines that expand coronavirus vaccine eligibility to everyone age 65 and older as well as to those with comorbid conditions, like diabetes.

The states’ focus on vaccinating health-care workers and nursing homes has created a bottleneck, a senior administration official told CNBC, speaking on condition of anonymity in advance of the formal announcement.

“The states are being told immediately they need to expand to 65-plus as well as those under 65 with comorbid conditions,” the official said.

The administration will also stop holding back millions of doses reserved for the second round of shots of Pfizer and Moderna’s two-dose vaccines, the official said, adding they released doses that had been held in reserve on Sunday.

“States should not be waiting to complete phase 1a prioritization before proceeding to broader categories of eligibility,” Azar said Tuesday, explaining the new guidance. “Think of it like boarding an airplane. You might have a sequential order in which you board people. But you don’t wait ’til literally every person from a group is boarded before moving on to the next.”

Some 53 million Americans who are 65 and older and 110 million people between 16 and 64 with comorbid conditions will now be eligible to receive the vaccine if every state adopts the guidelines, according to the Centers for Disease Control and Prevention” (B)

“Azar also announced the government will release all available vaccine to states instead of holding back doses for scheduled second shots. Federal officials had been keeping vaccine in reserve to guarantee second doses but Azar said increased vaccine supply and the pace of manufacturing will ensure everyone who gets a first dose will get a second dose on schedule.                       

Both vaccines authorized for use were studied in a two-dose regimen, with the Pfizer-BioNTech doses given 21 days apart and Moderna’s 28 days apart.

“Based on the science and evidence we have it is imperative that people receive their second dose on time,” Azar said. “That’s what the science says and ignoring that would be reckless.”

U.S. officials also are asking states to expand the locations where people can be vaccinated by adding community health centers, pharmacies and mass vaccination sites.

“Hospitals made sense as the early distribution sites when the focus was on health care workers, but they are not where most Americans go to get vaccines,” Azar said. “States should move on.”

He said the federal government will deploy teams to support states doing mass vaccinations efforts. The government has partnered with 19 pharmacy chains and is ready to distribute vaccine to their locations, he added. “ (C)

“Across New York State, medical providers in recent weeks had the same story: They had been forced to throw out precious vaccine doses because of difficulties finding patients who matched precisely with the state’s strict vaccination guidelines — and the steep penalties they would face had they made a mistake.

On Saturday, state health officials responded to the outcry over discarded vaccines by again abruptly loosening guidelines as coronavirus cases continued to rise.

Now, medical providers can administer the vaccine to any of their employees who interact with the public if there are extra doses in a vial and no one from “the priority population can come in before the doses expire,” the new guidelines read. A pharmacy’s “store clerks, cashiers, stock workers and delivery staff” could qualify, the guidelines said. California last week took a similar step.

This is the second time in two days that Gov. Andrew M. Cuomo’s administration has loosened the restrictions around who can get vaccinated in New York State. On Friday, the governor announced that medical providers could vaccinate a wider range of essential workers, including teachers, as well as New Yorkers 75 years and older starting as early as Monday. That same day, the governor also expanded the types of medical professionals that can administer vaccines to include licensed practical nurses, pharmacists, dentists and podiatrists.” (D)

“As many as 7 million New Yorkers are potentially eligible to receive the COVID-19 vaccine immediately under the new Centers for Disease Control and Prevention (CDC) guidelines released Tuesday — and Governor Andrew Cuomo said it’ll take a miracle to make it happen.

New York has struggled to administer the vaccine to high-risk health care workers and essential workers as part of phases 1a and 1b, which covers about 5.3 million people statewide. But the new CDC guidance recommends that all people 65 and older, as well as individuals with compromised immune systems, be vaccinated right away; that change, Cuomo said, adds another at least 1.7 million New Yorkers to the list.

That number could be higher, the governor indicated, because the CDC did not make clear who would be defined as immunocompromised and immediately eligible for the vaccine. A number of conditions could make one immunocompromised — such as cancer, heart disease, hypertension, obesity, asthma, COPD and diabetes.

The challenge is that the federal government, at present, only releases to New York about 300,000 doses of the COVID-19 vaccine per week. Vaccine recipients also need to get two doses of the Pfizer and Moderna vaccines, the only ones currently available for use, to be considered fully immunized.

At the current rate, barring a dramatic uptick in dosage supply, it will take at least six months to vaccinate all the eligible New Yorkers under the new CDC guidance, Cuomo said.

The governor intimated that it seemed that the outgoing Trump administration was setting up the incoming Biden administration to fail.

“I believe this has to be the first thing Biden looks at, because I think it’s going to create national frustration and suggest that the government is not capable” of handling the COVID-19 vaccinations, Cuomo said. “And the last thing we need right now is people losing belief in the competence of government.”

Melissa DeRosa, secretary to the governor, told the press that the federal government has not provided the state with “any additional information” on responding to the CDC change, and said it reminded her of the response received during the start of the first COVID-19 wave in March and April 2020.

“They’re expecting people on the ground to make massive policy changes on a dime,” DeRosa said, “but they’re giving us little to no guidance on how to implement it.” (E)

“New York has already started administering Covid-19 vaccines from Pfizer and Moderna, though the rollout has been slower than planned. Cuomo pushed the state’s hospitals to administer the vaccine faster. He said hospitals are facing fines of up to $100,000 if they don’t administer their allocations of coronavirus vaccines by the end of this week.

The state has received more than 774,000 Covid-19 vaccine doses but has given just 237,000 shots as of Saturday, according to the Centers for Disease Control and Prevention.

Hospitals that have received Covid-19 vaccines over the last three weeks have used only about 46% of the doses on average, according to a slide Cuomo presented at the briefing. While some hospitals have administered nearly all of their doses, others have used as little as 15%, according to the governor.

“This is a management issue of the hospitals. They have to move the vaccine, and they have to move the vaccine faster,” Cuomo said.

Cuomo said the New York State Department of Health sent a letter on Sunday to all hospitals saying if they don’t use their vaccine allocations by the end of this week, they’ll be fined up to $100,000 and they won’t receive any further allocations.

Moving forward, the state’s hospitals will be required to use their doses within a week of receiving them. Providers who fall seriously behind could be issued further sanctions, he said.

“You have the allocation, we want it in people’s arms as soon as possible,” Cuomo said. “We’ll use other hospitals who can administer it better.” (F)

“Hospitals are throwing out doses of Pfizer’s coronavirus vaccine because the federal government is giving some of the facilities syringes that can only extract five doses from vials that often contain more.

Pharmacists discovered early in the U.S. vaccination push that the standard five-dose vials of the vaccine from Pfizer and its German partner BioNTech often contained enough material for six or even seven shots.

Regulators in the U.S. and Europe agreed to allow use of those “overfill” doses to maximize the reach of coronavirus vaccines amid the raging pandemic.

But some syringes distributed by Operation Warp Speed, the federal Covid-19 vaccine program, aren’t efficient enough to extract a sixth dose, according to hospital lobbyists. They say the issue appears to stem from supply chain problems that have troubled the nation’s pandemic response from the start…

Federal officials acknowledged to POLITICO they are aware of the syringe problem. “Operation Warp Speed is quickly evaluating options to reconfigure the accompanying ancillary supply kits to accommodate the potential additional doses,” according to a Department of Health and Human Services spokesperson….

Nancy Foster, the AHA’s vice president of quality and patient safety policy, said the mix of different syringes is raising questions about the ability to deliver a second dose to everyone who’s gotten a first shot.

“With the second dose of Pfizer that is now going into people’s arms, we’ve been given different syringes, less efficient, so you need to draw up a little bit of extra vaccine, to get the right amount of dose into the person’s arm,” Foster said. “We don’t have that sixth dose now.”

Pfizer ships its vaccine in trays of 195 vials — each designed to contain five doses. Hospitals that squeezed out the extra doses initially were able to vaccinate an extra 195 people per container of the Pfizer shot, Foster said. Now they need to make sure they can administer the second round of shots.

But Mitchel Rothholz, the immunization policy lead for the American Pharmacists Association, said that ensuring second doses for everyone who’s been vaccinated so far should not be difficult. That’s because the number of second, or booster, shots that are sent to vaccination sites are based on the number of initial inoculations at each site.

“The way they’re tracking is not by the vials, it’s by the doses given,” Rothholz said.” (G)

“Operation Warp Speed chief advisor Dr. Moncef Slaoui has submitted his resignation at the request of the incoming Biden team under a plan that would see him stay in the role for a month to help with the transition, according to two people familiar with the situation.

Slaoui’s role leading vaccine development for the unprecedented government effort is expected to be diminished after next Wednesday’s inauguration, said the people, who spoke on condition of anonymity because the plan wasn’t announced. It would end by Feb. 12.

It’s not clear who will take scientific lead for the Biden team focused on Covid vaccines or if someone will be appointed to that role. Two vaccines are already authorized in the U.S. and three more are in late-stage clinical trials. Jeff Zients is Biden’s coordinator of the Covid-19 response, while Bechara Choucair will be Covid vaccine coordinator, focused on speeding inoculations.

Slaoui’s contract includes 30 days’ notice before termination, and the Biden team has not asked Slaoui to stay on past that, one of the people said.” (H)

“Last week, after finishing inoculations of some front-line hospital staff, Jupiter Medical Center was left with 40 doses of precious covid vaccine. So, officials offered shots to the South Florida hospital’s board of directors and their spouses over age 65.

But that decision sparked outrage among workers left unvaccinated, including those at one of the hospital’s urgent care clinics, or who believe the hospital was currying favor with wealthy insiders before getting all its staffers protected, according to a hospital employee who spoke on the condition of not being named.

The move also prompted dozens of calls from donors looking to get vaccinated.

The hospital received 1,000 doses of the Moderna vaccine two days before Christmas, fewer than half of what it requested from the state to cover its workforce. Officials prioritized delivering the vaccine to front-line medical workers who requested it, performing inoculations on Christmas Eve or the holiday weekends.

Patti Patrick, a hospital vice president, said the hospital acted appropriately in its offerings of the vaccine, which has a short shelf life once vials are opened. Neither she nor other administrators who don’t work directly with patients were included in this first round of shots.

“This was a simple way to move 40 doses very quickly” before it spoiled, she said.

She added that all front-line staff from the health system, including the clinics, were given the opportunity to get the shots.

Jupiter is not the only hospital in the nation facing questions about its handling of the vaccines. The initial rollout — aimed at health care workers and nursing home residents — has been uneven at best because of a lack of a federal strategy on how it should work, with states, hospitals, nursing homes and pharmacies often making decisions on their own about who gets vaccinated and when.

In some hospitals, administrators and other personnel who have no contact with patients or face no risk at work from the virus are getting shots, while patients — and even front-line staff — who are at heightened risk for covid complications are being passed by. Some administrators who have been working remotely throughout the pandemic have been vaccinated, especially at hospitals that decided to allocate doses by age group rather than exposure risk.

Although states and federal health groups laid out broad guidelines on how to prioritize who gets the vaccine, in practice what’s mattered most was who controlled the vaccine and where the vaccine distribution was handled….”

Arthur Caplan, a bioethicist at NYU Langone Medical Center in New York City, said hospitals should not be inoculating board members ahead of hospital workers unless those people have a crucial role in running the hospital.

“That seems, to me, jostling to the head of the line and trying to reward those who may be potential donors,” he said. But he acknowledged that the hospitals’ vaccination systems are not always rational or equitable.

Covid vaccines need to get out as quickly as possible, he added, but hospitals can give them only to people they are connected with.

Caplan noted he was vaccinated at an NYU outpatient site last week, even though his primary care doctor hadn’t yet gotten the vaccine because his clinic had not received any doses.” (I)

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• A.U.S. to change Covid vaccine allocation to favor states that quickly administer shots, by Berkeley Lovelace Jr., https://www.cnbc.com/2021/01/12/covid-vaccine-us-to-change-allocation-to-favor-states-that-quickly-administer-shots.html
• B.CDC expands Covid vaccination guidelines to everyone 65 and older, by Berkeley Lovelace Jr., https://www.cnbc.com/2021/01/12/covid-vaccine-trump-administration-to-expand-eligibility-to-everyone-65-and-older.html
• C.’States should move on’: Federal officials push states to speed up COVID-19 vaccinations, announce major changes to distribution, by Adrianna Rodriguez, https://www.usatoday.com/story/news/health/2021/01/12/covid-vaccine-states-speed-up-vaccinations-hold-back-second-dose/6635995002/
• D.After Unused Vaccines Are Thrown in Trash, Cuomo Loosens Rules, By Dana Rubinstein, https://www.nytimes.com/2021/01/10/nyregion/new-york-vaccine-guidelines.html?referringSource=articleShare
• E.New York needs minor miracle to meet new CDC guidance for COVID-19 vaccine: Cuomo, By Robert Pozarycki, https://www.amny.com/news/new-york-needs-minor-miracle-to-meet-new-cdc-guidance-for-covid-19-vaccine-cuomo/
• F.New York Gov. Cuomo to propose law making it a crime to skip the line for Covid vaccine, by Noah Higgins-Dunn, https://www.cnbc.com/2021/01/04/covid-vaccine-ny-gov-cuomo-to-propose-law-making-it-a-crime-to-skip-the-line-for-shots.html
• G.Hospitals say syringes supplied by feds waste vaccine doses, By SUSANNAH LUTHI and RACHEL ROUBEIN, https://www.politico.com/news/2021/01/10/hospitals-syringes-vaccine-waste-doses-457017
• H.Operation Warp Speed chief resigns at Biden team’s request, will stay through transition, sources say, by Meg Tirrell, https://www.cnbc.com/2021/01/12/operation-warp-speed-chief-resigned-at-biden-teams-request-sources-say.html
• I.Hospitals’ Rocky Rollout of Covid Vaccine Sparks Questions of Fairness, By Phil Galewitz, https://khn.org/news/article/hospitals-rocky-rollout-of-covid-vaccine-sparks-questions-of-fairness/
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