Category: Covid-19 Vaccine

Update: The Department of Veterans Affairs released a preliminary COVID-19 vaccine distribution plan Thursday morning on Dec. 10, 2020. The plan lists the 37 VA sites that will administer the Pfizer vaccine once it receives approval from the Food and Drug Administration. The list can be found here.

The Department of Veterans Affairs is preparing to distribute a COVID-19 vaccine as soon as its approved, but the agency acknowledged Wednesday it may initially struggle to reach healthcare workers and veterans in remote and rural locations.

VA so far has ordered 73,000 doses of the Pfizer vaccine and another 122,000 doses from Moderna, said Richard Stone, the departments acting undersecretary for health. Both COVID-19 vaccines require two shots per person.

The Pfizer vaccine, which is currently under review at the Food and Drug Administration, may receive emergency-use authorization by the end of the week.

Once it does receive authorization, VA is expecting a shipment of Pfizer doses nationwide, possibly as soon as this weekend, Stone said.

Can you handle the distribution, and then is that an adequate amount for the largest healthcare system in the nation? Jon Tester (D-Mont.), ranking member of the Senate Veterans Affairs Committee, said Wednesday at a hearing on VAs COVID-19 response.

It is not an adequate amount, and this will be a long process for us to reach all 7 million veterans who we believe will want vaccination from us, as well as all 400,000 employees of the agency, Stone told the committee. We do anticipate weekly distribution, and it remains to be seen how robust that weekly distribution will be.

VA hasnt yet released a comprehensive COVID-19 vaccine distribution plan, but it has offered a few details in a series of frequently-asked-questions for veterans posted on its website. VA health care employees at highest risk of contracting COVID-19 will receive the vaccine first.

Committee members are especially interested in VAs distribution plan, with some expressing some concern that the department hadnt released one publicly.

The Pentagon on Wednesday described its plans under a pilot program to distribute an initial 44,000 doses to 16 military sites, where mostly defense health workers will be first line to receive them.

Our vaccine plan is with the CDC, Stone said. That vaccine plan is still dependent on our ability to move the Pfizer vaccine, which requires a -70 degrees Fahrenheit refrigeration and freezing, across the nation.

As of Wednesday, 37 VA sites were equipped with the proper freezers needed to support the Pfizer vaccine. Stone said hes expecting a shipment of another 36 freezers, meaning VA may eventually have a total of 73 sites that are equipped to receive an initial shipment of Pfizer vaccines, once its approved.

We do anticipate that shipment will occur across the nation, and then it will depend upon on whether we can secondarily ship that -70 degree vaccine further, Stone said of the Pfizer doses. That decision has not been made by CDC, which is why you havent seen our really robust vaccine distribution plan.

The department also has 188 sites that can accept the Moderna vaccine once its approved, Stone added.

All VA medical centers have completed simulation exercises, where theyve walked through how they might distribute, receive and then administer the COVID-19 vaccine. The department does have some practice in distributing and administering new vaccinations, Stone reminded senators.

VA has annual influenza inoculation program, and its administered 1 million flu shots to veterans so far this year.

Still, Stone said hes especially concerned about VAs ability to deliver the COVID-19 vaccine to rural and remote locations. The 73 sites VA anticipates it will have to administer an approved vaccine from Pfizer arent nearly enough, and Stone said the department will have to rely on the Moderna supply to reach more remote facilities.

This morning I had a conversation about our ability to obtain short-runway aircraft to go into rural areas, where we could bring small amounts of vaccine into those rural areas where theres 20, 30, 50 or 100 veterans, Stone said. I believe were going to need to have that kind of creativity and innovation in order to deliver this effectively.

Like the rest of the country, VA is experiencing a surge in active COVID-19 cases, though Stone said the department had beds and spots within its intensive-care units open and available for veterans and members of the public.

VA on Wednesday was tracking 16,449 active cases, including 1,300 employees. A total of 77 employees within the Veterans Health Administration have died from complications due to COVID-19 since the start of the pandemic, according to the departments public data.

To respond to the pandemic, VHA received $17.4 billion through the Coronavirus Aid, Relief and Economic Security (CARES Act) back in March. VAs health administration has spent about $8 billion of that so far, but Stone said he anticipates needing more resources.

Well consume the rest of that through the rest of this fiscal year, but I do believe that theres a lot we cant see about vaccine distribution, he said. I think were still probably three-to-four weeks ahead of the peak of what were going to see in this escalation of cases across the nation.

Beyond the additional funding, VA is hopeful Congress will also extend additional authorities that helped the department more quickly hire new health professionals.

Stone described the hiring waivers VA received from the Office of Personnel Management as absolutely critical in helping the department bring on more than 66,000 new employees since the pandemic began.

Should we expire in those authorities, it will make it very difficult for us to sustain this workforce in the manner that we have, he said.

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VA warns of long process to distribute COVID-19 vaccine to employees and veterans - Federal News Network

Days before her 91st birthday, Margaret Keenan became the first person in the world to receive the Pfizer-BioNTech COVID-19 vaccine outside of clinical trials.

Keenan, who was sporting a polka-dot cardigan over a festive shirt, was given the first dose of a two-dose vaccine at the University Hospital Coventry in England, setting off the first mass vaccination effort against a virus that has now infected at least 70 million people worldwide and killed 1.5 million. An 81-year-old named William Shakespeare was next in line for the vaccine.

Keenan and Shakespeare are also the first humans, outside of a trial setting, to be given a vaccine that harnesses "mRNA" technology. This relatively new tech, which relies on a synthetic strand of genetic code called messenger RNA (mRNA) to prime the immune system, had not yet been approved for any previous vaccine in the world.

Related: Coronavirus live updates

But the COVID-19 pandemic served as an unexpected proof of concept for mRNA vaccines, which, experts told Live Science, have the potential to dramatically reshape vaccine production in the future. In fact, two COVID-19 vaccines developed by Pfizer and Moderna, are 95% and 94.1% effective, respectively, at preventing an infection with the novel coronavirus causing COVID-19.

On Thursday (Dec. 10), a panel of experts voted and recommended that the Food and Drug Administration (FDA) grant emergency approval to Pfizer's vaccine, or permission for it to be distributed prior to full approval under emergency situations like a pandemic. The panel is set to assess Moderna's vaccine on Dec. 17. Healthcare workers and vulnerable individuals in the U.S. could receive the Pfizer vaccine as early as next week.

COVID-19 has really "laid the foundation" for rapid production of new vaccines, such as mrNA vaccines, to fight future pathogens, said Maitreyi Shivkumar, a virologist and senior lecturer in molecular biology at De Montfort University in Leicester, England. "With the technology that we've developed for SARS-CoV-2, we can very easily transfer that to other emerging pathogens."

Here's how mRNA vaccines work, and why they could make such a difference for vaccine development.

mRNA vaccines are inspired by basic biology.

Cells store DNA that holds coded instructions for making proteins. When a cell needs to make a protein, it copies the appropriate instructions onto a messenger RNA molecule a single strand of genetic material. A cellular machine called a ribosome then runs along this code, reads it, and shoots out the correct building blocks to make the protein. Proteins are the essential workers of the body, forming the structure of cells, making tissue, fueling chemical reactions and sending messages: Without them, everything would shut down.

Around three decades ago, scientists realized that they could synthesize mRNA in the lab, deliver it into human cells and use the body to make any protein they wanted, such as proteins that could help fight a range of diseases in the body from cancers to respiratory illnesses. In 1990, researchers at the University of Wisconsin and biotech company Vical Incorporated figured out how to make mRNA that could direct mice cells to create proteins, according to Business Insider.

In the 1990s, Hungarian-born scientist Katalin Karik started building on this work, but ran into major roadblocks, the biggest being that the mice's immune system would deem synthetic mRNA foreign and destroy it, sometimes even creating a dangerous inflammatory response. A decade later, while working at the University of Pennsylvania, Karik and her collaborator Dr. Drew Weissman, figured out that they could create an invisibility cloak for synthetic mRNA by swapping out a piece of the mRNA code for a slightly altered one, according to STAT News. That tiny edit allowed synthetic mRNA to slip right into cells without rousing the immune system, a finding that the researchers published in multiple papers starting in 2005, according to STAT News. These results caught the attention of two key scientists: one who later helped found Moderna and another who helped found BioNTech.

Neither company initially set out to develop mRNA vaccines against infectious diseases, but eventually started to expand into that field with mRNA flu, cytomegalovirus and Zika virus vaccines in development or clinical trials. But then a deadly virus presented a unique opportunity to test, in large groups of people, just how powerful the technology could be.

On Jan. 10, Chinese researchers first published the genetic sequence of the novel coronavirus on a preprint online; within a week, Weissman and his team at the University of Pennsylvania were already developing synthetic mRNA against the virus and both Moderna and Pfizer licensed this team's formulation from The University of Pennsylvania, according to a perspective posted on Sep. 3 in the journal JAMA.

Within 66 days of the sequence being published, Moderna, in collaboration with the National Institute of Allergy and Infectious Diseases, developed a vaccine and kickstarted the first U.S. clinical trial to test it against COVID-19.

Five of the vaccines currently in clinical trials are mRNA vaccines; though they are made from different recipes, they use the same underlying concept.

Both Moderna's and Pfizer's vaccines are made up of synthetic mRNA that carries the code for the spike protein. The mRNA is enveloped inside a fatty nanoparticle that acts as a Trojan horse, infiltrating human cells and delivering the spike-building instructions without awakening the immune system. Once cells have gotten hold of the mRNA, they create the spike protein, which in turn triggers the immune system to produce an arsenal of cells to fight the spike protein and thus protect the body against SARS-CoV-2.

The vaccines developed by Moderna and Pfizer are likely so successful because they're "mimicking a viral infection," by activating two major immune responses in the body, said Dr. Otto Yang, a professor of medicine in the division of infectious diseases and of microbiology, immunology, and molecular genetics at the University of California, Los Angeles.

The better-known response involves antibodies: The cells expel the spike proteins they make; these trigger the immune system to create antibodies against them, Yang told Live Science. Antibodies are found in blood, tissues and fluids but they can't access a virus that's already inside the cell, "so the immune system evolved a way to deal with that," Yang said.

Related: 14 coronavirus myths busted by science

That response involves killer T cells, also known as CD8 T cells. These killers scan cell surfaces cells display small pieces of all the proteins they make on their surface and destroy the ones that are infected by a virus. SARS-CoV-2 vaccines can also wave a warning flag for killer T cells: after the mRNA prompts cells to make the spike protein, cells display processed fragments of it on its surface.

This gives mRNA vaccines an advantage over more traditional vaccines such as those for flu or rabies, that are made from killed versions of the actual pathogen or their target proteins. Killed virus vaccines can't get into cells, so they trigger antibodies but not the killer T-cell response, Yang said.

But mRNA vaccines aren't the only ones that trigger both these immune responses; the University of Oxford vaccine, made from a weakened cold virus called an adenovirus that infects chimpanzees, also does, Yang said. This adenovirus is genetically modified to not be able to replicate in the body and to include the genetic code for the spike protein. These vaccines also prompt the cells to create the proteins themselves, rather than providing already-made ones; and because the cells make the proteins, they display fragments of them on their surfaces.

Vaccines like the Oxford vaccine also show great promise in the future of vaccine development, experts told Live Science. And such vector vaccines have been studied extensively when compared to mRNA vaccines, according to the JAMA perspective. But the Oxford vaccine, developed with AstraZeneca, showed less efficacy than the mRNA vaccines did; in late-stage clinical trials, the Oxford vaccine was 62% effective at protecting against COVID-19 in participants who were given two full doses and 90% effective at protecting those who were first given a half dose and then a full dose, according to findings published on Dec. 8 in the journal The Lancet.

It's not yet clear why, but one major possibility is that the Oxford vaccine could be overwhelming the immune system when people are given an initial full dose. In addition to the spike protein, the adenovirus also has its own proteins. Because all of these proteins are foreign to the body, the immune system creates defenses against all of them. "There's no way that the immune system has any sort of guidance that 'OK, I'm only supposed to make a response against spike,'" Yang said. On the other hand, the mRNA vaccines are more targeted, telling the immune system to respond only to the spike protein.

But before we can say that mRNA vaccines are fundamentally better than other options, Yang said, scientists need to see detailed data from the trials, rather than gleaning information from "snippets from press releases." It's also not yet known how long mRNA vaccine-induced immune responses will last. That being said, mRNA vaccines are the "first technology that allows us to [make killer T cell responses] without giving a whole live virus," Yang said. Though rare, live but weakened virus vaccines have a slight risk of causing a more serious disease, whereas mRNA vaccines, as far as we know, do not, he added.

mRNA vaccines do not integrate into our DNA (the DNA is stored in a cell's inner core called the nucleus, a place that the synthetic mRNA doesn't go) and the mRNA generally degrades after a few days, Shivkumar said.

In the first day that Pfizer's vaccine was administered to several thousand people, two people who had a history of severe allergic reactions had anaphylaxis-like symptoms, prompting the U.K.'s regulatory agency to warn people with severe allergies to avoid getting that particular vaccine. But experts say the general population shouldn't be anxious about getting this vaccine and it isn't totally unexpected as allergic reactions can occur with a number of vaccines, Live Science reported.

"I do not believe that mRNA vaccines pose any significant greater chance of a severe allergic reaction than other vaccines," said Justin Richner, an assistant professor in the department of microbiology and immunology at the University of Illinois (who previously, as a postdoctoral fellow, collaborated with Moderna on their as-of-yet unapproved mRNA vaccine to fight the Zika virus), noting that the safety data from the mRNA vaccine trials looked very similar to other vaccines. "If anything, I would predict that there is less likely to be an allergic reaction in the mRNA vaccines as the production does not require eggs like other vaccines," he said. (Most flu-vaccines are made using eggs so they can contain bits of egg protein, according to the CDC).

Another huge advantage of mRNA vaccines is how quickly and easily they can be developed.

"The beauty of the mRNA platform is that you can easily swap out the genetic code," Richner said. In theory, if scientists know what proteins to target on a virus to stop it from infecting human cells, such as the spike protein for SARS-CoV-2, they can use the same platform that was developed for other vaccines such as the COVID-19 vaccine and just swap out the code for the spike protein with the code for the new protein.

The real problem lies in finding the correct target, Richner said.

Because scientists had previously conducted research on similar coronaviruses those that caused severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) they knew early on that the spike protein was probably the optimal target, Richner said. But they may not get so lucky with other viruses, as previous failures, such as with HIV, have revealed.

mRNA vaccines are cheaper, easier and faster to develop, and in theory, scale up more easily when compared to traditional vaccines. That's because older vaccine technologies rely on growing the virus or the proteins in the lab, Shivkumar said. Traditional vaccines are often grown in eggs or cells and then weakened or killed.

"After obtaining knowledge of the pathogen," researchers can synthesize and have an mRNA vaccine ready for delivery in about a week, Richner said. "For traditional vaccine development, this process would take at a minimum one month and usually several months."

mRNA is a chemical that can be made in a factory setting (such as in a test tube or tank) "relatively easily" once a pipeline is established, Richner said. "Manufacturing is going to be a big advantage going forward." Pfizer recently experienced production delays, but those delays are only "because it's the first time making an mRNA vaccine to this scale," he added.

Still, this easy genetic swap isn't a sole capability of mRNA vaccines, as the adenovirus vector vaccines also have this advantage. "The Oxford vaccine is more traditional, but it is, again, slightly sort of a jump from the traditional ones because it has the same backbone," Shivkumar said. Prior to the pandemic, the group that was developing the Oxford vaccine was working on a vaccine against the coronavirus that causes MERS so "they actually just swapped in the SARS-CoV-2 sequence into that same backbone," she said. But with the adenovirus vector vaccines, scientists still have to rely on the slower biological processes, namely, growing an adenovirus in the lab.

Theoretically, mRNA vaccines can tackle any virus and one day, might even be able to tackle multiple pathogens at once, according to the JAMA perspective. But practically, we won't know how universal these vaccines can become when confronted with a variety of new viruses. SARS-CoV-2 is "not a particularly difficult virus," said Dennis Burton, a professor of immunology and microbiology at the Scripps Research Institute in California. There will likely be "more severe tests and then you'll be better able to judge how universal RNA vaccines could be. Still, there's "every chance" mRNA can be truly revolutionary, but we need more information before we can be sure, he told Live Science.

Either way, no matter how quickly genetic information can be swapped in and out of mRNA vaccines, "you can't skip all the safety data," Richner said. The "slowdown is always going to be the clinical trial," Richner said.

Despite their promise, mRNA vaccines still have some limitations. For instance, right now, Pfizer's mrNA vaccine must be stored at polar temperatures of minus 94 degrees Fahrenheit (minus 70 degrees Celsius). "Especially in developing countries and countries where it's impossible to have minus-80 freezers everywhere, I think it's still not ideal, so you would still need to rely on the more traditional vaccines," Shivkumar said.

Moderna's vaccine can be stored at freezer temperatures of minus 4 F (minus 20 C). The difference in storage requirements between the two vaccines likely comes down to the recipe that the company used to make them; the ultra-cold temperature may keep either the nanoparticle shell or the mRNA more stable, Yang said.

But if those mRNA vaccines could be stored and delivered at higher temperatures, with the impressive efficacy that they showed, "I can imagine that they will sort of be a game-changer globally," Shivkumar added. In the future, Pfizer may be able to improve their vaccine to be more stable at higher temperatures, Richner said.

Related: The most promising coronavirus vaccine candidates

In the past, mRNA vaccines didn't produce a strong enough response compared to more traditional vaccines, Shivkumar said. "Because with the mRNA you use such low levels and it degrades so quickly, the amount of protein produced will be relatively lower than if you were to be given either a protein or an attenuated virus," she said. But clearly scientists have figured out how to make mRNA stable enough to trigger a strong protective response. While this would need to be checked with every pathogen, it's clear the technology has "definitely improved," Shivkumar added.

"It's very exciting to have these mRNA vaccines," said Dr. Octavio Ramilo, the chief of infectious diseases at Nationwide Children's Hospital, Columbus, Ohio. But "it will be good to have more than just one strategy," because you never know which one will stick, he said. Not all platforms will necessarily work as well for every pathogen, especially since each virus might have a unique strategy to hide from the immune system, he added.

It's also important to understand how these vaccines will work in children and the elderly, Ramilo said. Though many of the trials have included elderly participants, children have been absent. Children can respond to vaccines differently than adults, Ramilo told Live Science.

Especially babies' immune systems change "dramatically in the first year," Ramilo said. The flu virus tends to impact children and the elderly more severely than other age groups, Ramilo said. But vaccines don't work as well in those groups, he said. So having multiple platforms and understanding how they work "is going to be fundamental to leverage and to make them work in different situations," he added.

And if another new virus comes along years from now, we'll hopefully have learned lessons from 2020. The pandemic served as a "proof of concept" that mRNA experts had been waiting for, Yang said. The fastest vaccine developed to date prior to the COVID-19 pandemic was the Mumps vaccine, which took four years to develop and license it in 1967. Not counting the years it took to develop the vaccine, the Ebola vaccine was the fastest ever tested in clinical trials which took less than a year during the Ebola outbreak across West Africa. That is, until the world was faced with a deadly pandemic.

Just nine months into the pandemic, the fact that new vaccines are already finished clinical trials "is pretty impressive," Yang said. "When you're talking about a vaccine possibly being FDA-approved only a few months after it was first tried in a human that is amazingly fast."

"I'm not sure that it could actually be much quicker than this."

Originally published on Live Science.

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COVID-19 vaccines: The new technology that made them possible - Livescience.com

Tribal leaders on the Rosebud Reservation in South Dakota say they plan to hold the Indian Health Service accountable as the first vaccines are set to be delivered to Indian Country. Kirk Siegler/NPR hide caption

Tribal leaders on the Rosebud Reservation in South Dakota say they plan to hold the Indian Health Service accountable as the first vaccines are set to be delivered to Indian Country.

These last few days have been chaotic at the Nimiipuu Health Clinic on the Nez Perce Reservation in Idaho.

The director, Dr. R. Kim Hartwig, is trying to manage testing and treating patients for COVID- 19 and other diseases, while also racing to get a plan in place to distribute a vaccine.

"It's not something that we have a timeline [for], it's like, I got a call and was told, 'You're gonna get a vaccine in two weeks, get a plan together,' " she says.

Only a handful of Hartwig's frontline workers are expected to get the initial Pfizer vaccine because the tribe doesn't have the special refrigeration and storage it requires. But she's OK with waiting a few more weeks for the expected second Moderna vaccine that won't need that. It's a feat in and of itself to be getting a vaccine this fast to rural Lapwai, Idaho, population 1,000.

"I'm thankful for that," Hartwig says. "If I have to scramble some to make sure my community is safe, that's what I've committed my life to."

On the Nez Perce Reservation, Dr. R. Kim Hartwig is scrambling to manage testing and treating patients for COVID-19 and other health issues, while also racing to get a vaccine distribution plan in place. R. Kim Hartwig hide caption

On the Nez Perce Reservation, Dr. R. Kim Hartwig is scrambling to manage testing and treating patients for COVID-19 and other health issues, while also racing to get a vaccine distribution plan in place.

The federal government has designated an allocation of the first coronavirus vaccines to hard-hit Indian Country. Native Americans have long endured health care inequities, and they're four times as likely to be hospitalized by COVID-19.

Still, reaching everyone who needs it will be a monumental challenge, and there is plenty of skepticism about the federal government's ability to deliver, after a century's worth of broken treaties and failures to meet government to government obligations with sovereign tribes.

"We're treating this as any other challenges we're faced with," says Commander Andrea Klimo of the Indian Health Service.

Tribes had the option of getting the vaccine shipments from their state or the IHS. More than half of the 574 federally recognized tribes are doing what the Nez Perce are, and opting for the IHS, says Klimo.

Klimo, an enrolled member of the Chickasaw Nation in Oklahoma, is leading the government's task force in charge of distributing the vaccines to tribes.

"We're tackling it head-on and working through things such as hesitancy or any sort of perceived trust issue, as they come along," Klimo says.

There will be a lot of scrutiny on the IHS as the first vaccines are expected to begin being distributed in the next couple of days. Congress has long underfunded tribal health care, and consequently, Native people aren't always confident in the IHS's ability to deliver.

"We're going to hold their feet to the fire because it's their trust responsibility, their treaty obligation," says Rodney Bordeaux, president of the Rosebud Sioux Tribe.

At the IHS hospital in Rosebud, S.D., only 10 of the 30 beds are even being used right now because of staff shortages. The tribe has had some of the highest COVID-19 rates of infection in the region. Curfews, mask mandates and other lockdowns have been enforced, Bordeaux says, unlike in the surrounding state.

If the IHS fails to distribute the vaccine as planned, Bordeaux says that hopefully, Congress will provide another round of stimulus as a backup.

"It's very bad, we've tried working with Congress to get more funding, but we have not [yet] been able to do that," he says.

Already CARES Act funds helped pay for mobile units that his tribe will use to deliver the vaccine to communities across its 2,000-square-mile reservation.

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'Hold Their Feet To the Fire': Getting A COVID-19 Vaccine To Hard-Hit Indian Country - NPR

Michigans health department leaders announced their prioritization plans for distributing the coronavirus vaccines Friday afternoon, Dec. 11.

Health care workers will be first in line, along with residents and staff of long-term care facilities. Other essential workers will come next, followed by people at high risk for severe COVID-19 illness due to underlying medical conditions and people 65 years and older.

While distribution has been divided among four phases, Dr. Joneigh Khaldun, chief medical executive for the Department of Health and Human Services, said some phases will have overlap, depending on dose availability.

The COVID-19 vaccine will help all our communities eliminate the virus, Khaldun said. Because initial allocations of vaccine will be limited, we must prioritize how the vaccine will be distributed across the state and will use the guidance and principles outlined by the CDC and national experts. We want every adult to be planning now for how they will get their vaccine once it becomes available to them.

MDHHS estimates the first phase of distribution will begin later this month and span about five weeks. The timeline estimates the fourth grouping -- all remaining individuals 18 and older -- to begin receiving the vaccine in weeks 15-20, or in late March/early April.

Khaldun said the health departments goal is to vaccinate 70% of Michigan adults, or about 5.4 million people, by the end of 2021.

Prioritization is based on recommendations from the U.S. Centers for Disease Control and Prevention, and the national Advisory Committee on Immunization Practices, which is made up of medical and public health experts who develop recommendations on the use of vaccines in the U.S.

The phases are as follows:

The first COVID-19 vaccine, from Pfizer and BioNTech, is expected to be approved for emergency use authorization by the Food and Drug Administration in the coming days following a Thursday vote by the FDAs advisory panel in favor of the authorization.

Related: FDA panel recommends approval of Pfizers coronavirus vaccine for emergency use

Meanwhile, Modernas vaccine is a step behind and is expected to receive FDA approval before the end of the year. Both vaccines showed better than 90% effectiveness during Phase 3 trials.

Distribution of vaccines will be handled by hospitals, local health departments, pharmacies, EMS, the Michigan National Guard, and outpatient clinics. The initial allocation of the Pfizer vaccine will send doses to 56 Michigan hospitals and 16 local health departments.

The minimum age for receiving Pfizers vaccine is 18, though the FDAs advisory panel recommended emergency use authorization for individuals 16 and older. Khaldun said she was aware of the recommendation, and shed base Michigans recommendations on official guidance from the FDA.

The states top doctor said it is important to note that while scientists worldwide are working to develop a COVID-19 vaccine faster than any vaccine before, they are still following the proven process. Scientists had already begun research for coronavirus vaccines during previous outbreaks caused by related coronaviruses such as SARS (Severe Acute Respiratory Syndrome) and MERS (Middle East Respiratory Syndrome). That earlier research provided a head start for rapid development of vaccines to protect against infection with COVID-19.

The process for approval of a COVID-19 vaccine is scientifically sound, and no steps have been skipped, Khaldun said. People should know what to expect when they get a vaccine- such as mild side effects like a sore arm or low-grade fever. They should also plan on making sure they get their second dose to make sure they get the full benefit of the vaccine.

The Pfizer vaccine doesnt contain the actual coronavirus. Instead, theyre made with a piece of genetic code for the spike protein that studs the virus. That messenger RNA, or mRNA, instructs the body to make some harmless spike protein, training immune cells to recognize it if the real virus eventually comes along.

Khaldun noted that many people will get mild symptoms like a sore arm, low-grade fever or general malaise, which indicates that your immune system is responding to the vaccine. Other symptoms reported during trials include chills, fatigue, headache, and muscle or joint pain.

Four individuals in Pfizers Phase 3 trial reported Bells palsy, which causes temporary weakness or paralysis of the muscles in the face, and two individuals with histories of allergic reactions in the UK reported having allergic reactions to the vaccine.

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How Michigan will prioritize who gets the first COVID-19 vaccines - MLive.com

Ashley Nerbovig, For the Detroit Free Press Published 8:00 a.m. ET Dec. 11, 2020

The United Kingdom began nationwide distribution of Pfizer/BioNTech's highly anticipated COVID-19 vaccine with this woman. Associated Press

As health providers prepare to distribute the coronavirus vaccine, we should be ready for an onslaught of disinformation.

Social media users are already attempting to circulate false claims about people who got the vaccine. Rumors are also swirling about the ingredients used to create the vaccine.

Some disinformation questions the need for the vaccine or attempts to paint vaccination efforts as nefarious, according to research by First Draft, a non-profit that investigates online information. People who spread misinformation are also taking advantage of the many unknowns about the vaccines, according to the report.

And as we know, people dont like ambiguity, the authors, Rory Smith and Seb Cubbon, wrote in thereport. This is when the rumor mill kicks into gear and misinformation runs rampant.

Misinformation is an umbrella term for misleading or false information. Disinformation refers to false facts that bad actors spread on purpose to confuse people and sow distrust in information sources.

[ Read the 2020 report: Americans decided their own truth this election season ]

In May, the Department of Homeland Securitys cybersecurity agency, CISA, laid out some simple steps you can take to reduce the likelihood of unknowingly spreading false or misleading information related to COVID:

The more shocking the information is, the more likely it is to be false.

Ashley Nerbovig covers mis- and disinformation. Follow or DM her at@AshleyNerbovig.

Read or Share this story: https://www.freep.com/story/news/health/2020/12/11/covid-vaccine-disinformation-misinformation/3879269001/

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As COVID-19 vaccine rollout nears, disinformation already circulating: What to watch for - Detroit Free Press

Economists hold that a good is most efficiently allocated when it goes to the people who value it the most and hence are willing to pay the most for it.

Its for that very reason that bioethicists and infectious-disease doctors worry that initial doses of a coronavirus vaccine, once granted an emergency-use authorization, will make its way into the arms of wealthier Americans first.

An independent group of medical experts voted Thursday to recommend that the Food and Drug Administration issue an EUA for BioNTech BNTX and Pfizer Inc.s PFE vaccine candidate. (The advisory panel is set to meet on Modernas MRNA vaccine candidate on Dec. 17.)

Health-care workers and nursing-home residents should be the first to get vaccinated, the Centers for Disease Control and Preventions Advisory Committee on Immunization Practices, or ACIP, recommended on Dec. 1.

States arent required to follow the committees recommendations, but health experts are urging governors to stick to ACIPs recommendations going forward because it gives them a science-based framework to follow that can ultimately help end the pandemic more swiftly.

That said, wealthy Americans who are accustomed to flying in private jets and can afford to pay steep annual fees for personalized care through concierge medical practices arent too keen on waiting in line for a vaccine.

Speaking to Stat News, bioethicist Arthur Caplanof New York University did not hold back his feelings on well-connected individuals with the money and/or connections to get a vaccine if and/or when one or more become available.

There absolutely will be a black market. Anything thats seen as lifesaving, life-preserving and thats in short supply creates black markets, he said.

Dr. Ehsan Ali of Beverly Hills Concierge Doctor Inc. said he has been receiving phone calls and texts from patients all day long inquiring about when they can get the vaccine. His practice, unlike many other concierge practices, accepts some insurance plans.

Andrew Olanow, co-founder of the concierge service Sollis Health, which serves patients in Beverly Hills, Manhattan and the Hamptons, said he started fielding questions from patients as to when they can get a coronavirus vaccine as soon as the pandemic took off in early March.

His practice charges $3,000 a year for adults under the age of 45, plus $2,000 a year for each additional adult. For people above 45 years of age, the membership fees start at $5,000 a year plus $3,000 for each additional adult above 45.

Once you started seeing trial data become available, particularly from Pfizer PFE, -1.46%, thats when we started getting much more pointed questions from patients, Olanow said. They want to know exactly when there will be a vaccine, he said.

People ask, When specifically is that vaccine going to be available?

He tends to respond to these types of questions by assuring patients that he and his staff are taking all the appropriate steps now, such as procuring ultralow-temperature freezers to store the Pfizer vaccine, so that if/when its approved, Sollis Health be ready to get its patients vaccinated.

Dont miss: The perils of transporting millions of COVID-19 vaccines with dry ice across the U.S.

Well be working hard to get access to the vaccine for the members of our practice when it becomes available to a certain risk profile, Olanow told MarketWatch. My guess is that we, as members of the private sector, will be able to move quicker than the public sector.

As Gillian Tett wrote in the Financial Times: Definitions of pre-existing conditions may vary. As could the concept of essential worker. In states such as New York and Illinois, for example, financiers and bankers were defined as essential workers during COVID-19 (which gave them the right to go into the office). So were journalists.

The net result, then, will be numerous loopholes which could be exploited or, to use the language of Wall Street, be prone to arbitrage.

Ideally, the distribution of a coronavirus vaccine would follow the same principles and framework that informs organ-donation registries, saidGovind Persad, a professor of health law and bioethics at the University of Denver.

At the United Network for Organ Sharing (UNOS), that framework is based on medical utility and justice, said Joel Newman, who has served as a staff liaison on the ethics committee at UNOS, a private nonprofit organization that manages the nations organ-transplant system under contract with the federal government.

Justice, he said, refers to fairness, while medical utility refers to all the evidence-based criteria that we know would point to good treatment outcome.

The key in our experience is to strike a balance between these factors, he said.

If medical utility were the only factor determining who receives an organ transplant , that could mean that we treat more people who may be relatively healthy and who havent been waiting as long, he said.

In contrast, overemphasizing justice would mean that we treat many very sick patients, but many may die soon afterward or need a repeat transplant, thus removing the chance for better-matching people to get a successful transplant.

To overcome these challenges, UNOS relies on a computerized matching system that scores an individual and takes into account other factors including the location of the donor and blood type.

However, an individuals financial or social status is never taken into account, Newman, a senior spokesman for UNOS, told MarketWatch. Not only would that be illegal; it would also go against UNOSs ethical code of conduct.

That said, wealthier people who may require an organ transplant are more likely to expedite the waiting process compared to lower-income people, Persad said.

Affluent patients can sometimes do this by getting on multiple organ waitlists in multiple facilities or multiple states, traveling to a foreign country, or convincing a doctor to misstate exactly how at risk somebody is to move them up in line.

Well-resourced Americans could potentially use those same strategies to receive some of the earliest doses of a coronavirus vaccine, said Persad, who co-wrote a paper titled Fairly Prioritizing Groups for Access to COVID-19 Vaccines with Dr. Ezekiel Emanuel, a member of President-elect Joe Bidens coronavirus task force, and Dr. Monica Peek, a professor at the University of Chicagos medical school.

For instance, because different states likely will follow different allocation models after health-care workers and long-term-care residents are inoculated, it could create an opportunity for arbitrage where theyll go where they think they have the best chance.

Having some kind of residency requirement could make shopping around more difficult, he added, but ultimately there need to be vaccine-allocation criteria that health-care providers internalize as an ethical obligation.

Ideally youd also want to have one that makes sense to people, he said.

When it comes to college admissions another area where the wealthy often have the upper hand, for various reasons one could make the case that an upper-income family donating money to boost their childs chances of getting accepted indirectly benefits other students by potentially adding funds to scholarship programs, Persad said.

That likely is not true for COVID-19 vaccines because there are hard short- and medium-term manufacturing constraints rich people paying Pfizer or some other supply-chain actor more wont make more vaccines available.

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Americas 1% will be pulling out all the stops to get their hands on the COVID-19 vaccine - MarketWatch

SYDNEYAs they prepare to roll out Covid-19 vaccines, governments world-wide are grappling with how to keep track of those who have been immunized.

Many developed countries maintain lists of who has received vaccines, but those registries can rely on incomplete data provided voluntarily by doctors, pharmacies and even health-care providers that distribute flu shots to corporate clients in winter. The U.S. doesnt have a national database, but states and some localities maintain their own.

Health experts say it will be crucial for governments to monitor accurately who gets inoculated, particularly because many vaccines are under development and some are expected to require multiple doses. Widespread tracking would also enable health officials to detect any adverse reactions, which is important because the vaccines are being developed much faster than usual.

It is mandatory to have this kind of information to protect the health of the population, said Terry Slevin, chief executive of the Public Health Association of Australia. Government health officials there plan to require health-care providers to report who gets a coronavirus vaccine to that countrys register.

Requiring reporting presents several challenges to authorities, including the security of patient health data. Early in the pandemic, an Australian government initiative to develop an app that would record whether someone was in contact with anyone infected with the coronavirus foundered when many people avoided it on privacy grounds.

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Governments Will Want to Track Who Has Had a Covid-19 Vaccine - The Wall Street Journal

The Shawnee Mission Post is making much of its local coverage of the coronavirus pandemic accessible to non-subscribers. (If you value having a news source covering the situation in our community,we hope youll consider subscribing here).

Kansas is expected to receive its first shipment of the COVID-19 vaccine sometime between Monday and Wednesday of next week, health officials at the University of Kansas Health System said Friday.

The University of Kansas Health System, located in Kansas City, Ks., is one of five storage facilities throughout the state that will be receiving initial shipments of the vaccine, which must be stored at extremely cold temperatures.

Dr. Tim Williamson, vice president of quality and safety at KU Medical Center, said during the University of Kansas Health Systems daily COVID-19 briefing that while the timeline is a bit of a moving target, the system will be prepared when doses arrive.

This is going to be a game changer, Willamson said.

Some of the first doses are expected to go to frontline healthcare workers who treat COVID-19 patients.

However, health care workers at the University of Kansas Health System will not be required to get the COVID-19 vaccine, said Williamson.

They are required to get the annual influenza vaccine, but Williamson said some of the reasoning behind the differing mandates is that the flu vaccine has a long history of FDA approval, while the COVID-19 vaccine is available through an Emergency Use Authorization.

After frontline health care workers and nursing home staff are vaccinated, doses will become available to the general public, though it is difficult to say exactly when that will be, said Dr. David Wild, vice president of performance improvement at health system. Individuals living with chronic illnesses and residents of long-term care homes will be first in line to get the vaccine.

I think it is probably safe to say no sooner than the spring time for the general public and probably the summer, Wild said.

Dr. Dana Hawkinson, medical director of Infection Prevention and Control at the University of Kansas Health System, said the system was noticing an upward trend in COVID-19 patients and currently had 101 patients with active COVID-19, including 45 in the ICU.

Hawkinson said they expected to see the need for hospitalizationscontinue to increase as infections following Thanksgivinggatherings present in the general public.

Read more here:

'Game changer' COVID-19 vaccine to arrive in KC metro early next week - Shawnee Mission Post

Austin Sarat, Opinion contributor Published 4:30 a.m. ET Dec. 11, 2020 | Updated 8:28 a.m. ET Dec. 11, 2020

Former FDA Commissioner Scott Gottlieb talks pandemic, vaccines and recovery with USA TODAY's Editorial Board. USA TODAY

With theimpending approvalof COVID-19 vaccines, the United Stateswill soon have some difficult choices to make about who gets priority for receiving inoculation. Debate among federal and state health officials about vaccine distributionis heating up, andlobbying efforts are intensifying.

Perhaps the most controversial question of priority concerns inmates in American jails and prisons. Given this country's generally unforgiving attitude toward the incarcerated, putting them toward the head of the vaccine line would not be an easy political choice.

Yet there are compelling reasons to do so.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) issued guidelines on Nov.23 that recognized the distinctive situation for prisons. It listed correctional officersas essential workerswho would be among the segment of the population to get the vaccine in the second wave of Phase 1, immediately following health care workers and residents of long-term care facilities. Those guidelines recognized that, like other essential workers, people who work in jails and prisons are "at increased risk and should be given the opportunity to be vaccinated early on."

A correctional officer escorts a group of recently arrived inmates through the Deuel Vocational Institution in Tracy, California.(Photo: Rich Pedroncelli/AP)

In line withthe ACIP recommendation, the Federal Bureau of Prisons quicklyannouncedthat it will give vaccine priority to its prison staff, according to a report by The Associated Press. The bureau already has started working to secure the vaccine. Wardens and prison staff could receive the vaccine within weeks.

But neither the ACIP guidelines nor the Bureau of Prisons said anything aboutinmates, even though their living conditions can pose even greater risks than conditions innursing homes and long-term care facilities. This silence raises what aNew York Times reportcalled the "chilling prospect"of"anotherprison outbreak thatkills scores ofinmates after the only preventive was reserved forstaff."

COLUMN: Message to Biden-Harris: Follow through on justice promises. Our brother deserves no less

State and local governments across the country face similar prospects as they decide the fates of jail inmates and prisoners held in state penitentiaries. They, too, are making choices and announcing plans.

The Marshall Projectreportsthat at leastsix states have decided that inmates and prisoners will be among the earliest vaccine recipients. North Carolina is one of them, treatingpeople who live in close quarters (including migrant farm camps and homeless shelters)equally.

Elsewhere, resistance is emerging. ColoradoGov.Jared Polis, a Democrat, recentlyannouncedhis opposition to recommendations that his state should follow North Carolina's example. Referring to the distribution of the COVID-19 vaccine, Polis said, "That won't happen. ...There's no way it's going to go to prisoners before it goes to the people who haven't committed any crime. That's obvious."He assured the state's residents that thepublic health department will deprioritize prisoners when it finalizes its vaccination plan.

His stance won plaudits from people across the state. As one newspaperexplained, the vaccine should go to Coloradans "who simplyneed a vaccination even more. Some of them are teaching school or running our schools ... while others are keeping various federal, state and local public services functional. Police and firefighters of course provide fundamental services we can't do without. ... Prison inmates, by contrast, contribute little to any of that activity. Their lives are on hold. The rest of us do not depend on them."

COLUMN: Cops shouldn't be first at scene in mental health crises. NYC pilot program needed nationwide

The issue in Colorado and elsewhere is whether vaccine distributionshould focus onsaving the lives of those most at risk or should be based on the contributions of various segments of the population to the general welfare.

Such choices are by no means easy ones.

But the CDC guidelines rightly articulate the principle thatpriority should be given to saving the lives of those at highest risk. While those guidelines don't recognize it, people confined in the nation's prisons and jails are certainly in the high-risk category.

In fact, the likelihood of getting COVID-19 in prison is5.5 times higherthan for the general population. As of Thursday, nearly 252,000prisoners hadtested positive for the virus.

Some of the worst outbreaks in the USA have been in prisons, such as at California's San Quentin state facility, where the coronavirus infected 75% of the incarcerated population.

Because incarcerated people have higher rates of underlying conditions than the general population, prisoners are also more likely to experience severe complications or death if they contract the virus. Their COVID-19 mortality rates are higher than in the general population.

POLICING THE USA: A look at race, justice, media

The reasons are not hard to find. Many of America's correctional facilities are antiquated and notoriouslyovercrowded. InCalifornia, for example, more than a thirdof the state's institutions are operating overcapacity. In New York City, inmatessleep 40 people to a room, making social distancing an implausible form of protection.

Sanitation in jails and prisons is frequentlypoor. In many facilities, the plumbing regularly fails, ventilation is inadequateand food preparation fails to meet minimum standards of safety.

And given the disproportionate number of persons of color serving time in U.S. jails and prisons, delaying vaccine distribution will exacerbate COVID-19's alreadydisparate racial effects.

Life behind bars is hard enough without a deadly virus on the prowl. When COVID-19 strikes,additional restrictionsmake it even harder. Family visitation is often suspended, as are visits by lawyers. To prevent the spread of the virus, prison authorities order inmates locked down in their cells. Delay in vaccine distribution means that such restrictions and deprivations will continue.

The Supreme Courthaslong recognizedthat "when the State takes a person into its custody and holds him there against his will, the Constitution imposes upon it a corresponding duty to assume some responsibility for his safety and general well-being."

What this means is that we have an obligation to attend to the health needs of those whom we incarcerate and cannot treat them as less deserving of disease prevention measures like the COVID-19 vaccine.

Recognizing this obligation, last month the American Medical Associationsaidthat people behind bars "should be prioritized in receiving access to safe, effective COVID-19 vaccines in the initial phases of distribution."

Political leaders in Washington, D.C., and across the country need to muster the political courage necessary to heed that wise and humane recommendation.

Austin Sarat is associate provost and associate dean of the faculty andWilliam Nelson Cromwell Professor Jurisprudence andPolitical Science atAmherst College. He is the co-editor of "Life Without Parole: America'sNew Death Penalty?"Follow him on Twitter:@ljstprof

Read or Share this story: https://www.usatoday.com/story/opinion/policing/2020/12/11/heres-why-inmates-should-get-covid-19-vaccine-before-rest-us-column/3871449001/

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Here's why inmates should get vaccinated against COVID-19 before the rest of us - USA TODAY

Its official: The COVID-19 vaccine will be free for all, regardless of whether you have private health insurance, are uninsured, or are on Medicare.

That is, people in the United States wont need to shell over any cash for a coronavirus vaccine.

Many have wondered if the vaccine will come with unexpected costs, such as copays or administration fees. But private insurers and the Health Resources and Services Administration (HRSA) have confirmed the vaccine and appointment will be free, at least throughout the pandemic.

Its unclear how much the vaccine could cost on the other side of the pandemic, but health insurance experts suspect people privately insured or on Medicare will still be able to get vaccinated at no cost.

After the pandemic, there may be a higher price for uninsured individuals.

Heres what to know about paying for a coronavirus vaccine:

The vaccine will be covered for people with private insurance, according to guidelines released by the Centers for Medicare and Medicaid Services (CMS).

Health insurers whose plans are subjected to the coverage of preventive services without cost-sharing requirement under the Public Health Service Act are not allowed to bill patients for the administration of the COVID-19 vaccine, said Anh Nguyen, PhD, a health economics expert and assistant professor of economics at Carnegie Mellon Universitys Tepper School of Business.

Nguyen noted that this applies to both in-network and out-of-network providers.

Private insurers such as Blue Cross Blue Shield (BCBS) and Oscar Health confirmed members will pay $0 for the vaccine.

If the primary purpose of a patients visit is to receive the COVID-19 vaccine, BCBS companies will cover the vaccine, administration services, and the office visit at no cost-share to the patient, even if the appointment is out-of-network, per regulations issued by CMS, a BCBS spokesperson told Healthline.

If the doctors visit includes health services unrelated to COVID-19, the person may be charged.

If a patient receives additional, non-COVID-19 care at the same appointment, patients will be covered for those services in accordance with their health plan, the BCBS spokesperson said.

Oscar Health, too, has committed to providing the vaccine for free to its members. There will be no charge for the vaccine itself or for the doctors visit associated with the immunization, Oscar Health confirmed.

People receiving the COVID-19 vaccine will not be billed with copays or unexpected administrative fees, an Oscar Health spokesperson said. Based on guidance so far from the federal government, plans and issuers must cover COVID vaccines without cost sharing.

According to Nguyen, this coverage benefit doesnt apply to certain alternative healthcare plans, such as short-term limited duration insurance. Individuals on alternative plans may be subjected to copay or administration costs related to the vaccine.

Some states may require these plans to cover costs related to COVID-19 similarly to how they did with testing for the disease.

The CMS also states there will be no vaccine costs, administration fees, or deductibles for people on Medicare.

Any COVID-19 vaccine that receives Food and Drug Administration (FDA) authorization will be covered under Medicare as a preventive vaccine at no cost to beneficiaries, the CMS states on its website.

Uninsured people will also be able to get vaccinated for free during the pandemic.

People without health insurance or whose insurance does not provide coverage of the vaccine can also get COVID-19 vaccine at no cost, the CMS states.

Healthcare providers that administer the vaccine to uninsured people will need to submit a reimbursement claim to the Provider Relief Fund. The fund is handled by the U.S. Department of Health and Human Services (HHS), which will reimburse healthcare providers.

Providers who participate in and are reimbursed by the Provider Relief Fund, a part of the HRSA COVID-19 Uninsured Program, arent allowed to bill people without insurance.

Uninsured patients may be hit with a fee if the provider doesnt submit a claim to the relief fund.

If the provider doesnt submit a bill for COVID-19-related testing and/or treatment to the HRSA COVID-19 Uninsured Program, or the care was not eligible for reimbursement from the program, the patient may be responsible for full payment of the bill, an HRSA spokesperson said.

There are no steps uninsured people will need to take prior to getting vaccinated, the HSRA spokesperson confirmed.

Though its unclear what the COVID-19 vaccine will cost when the pandemic is over, itll likely be handled similarly to other important vaccinations, such as the flu shot and measles-mumps-rubella (MMR) vaccine.

For health insurance plans that are subjected to the coverage of preventive services without cost-sharing requirement, the CARES Act ensures that the COVID-19 vaccine will be added to the list of required preventive care coverage without the 1-year delay, Nguyen said.

People on private health insurance plans or Medicare Part B will most likely be able to get the vaccine for free.

After the federal public health emergency period ends, insurers will cover the COVID-19 vaccine in line with essential health benefit coverage rules, the Oscar Health spokesperson said.

The future vaccine costs for uninsured people is less concrete, but Nguyen suspects it may be pricier than other routine vaccinations.

For the uninsured, I expect the cost to be higher than that of a flu vaccine due to the cold storage requirement of the vaccine, Nguyen said. Furthermore, there is no regulation on how much providers can charge uninsured patients once the pandemic status is lifted.

During the pandemic, the COVID-19 vaccine will be free for all, regardless of whether you have private health insurance, are uninsured, or are on Medicare.

Administration fees for immunization-related appointments will be free as well.

After the pandemic, the vaccine will likely be covered as a preventative service for people on Medicare or private insurance. However, those who are uninsured may see a bigger price tag.

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You Won't Have to Pay for a COVID-19 Vaccine During the Pandemic - Healthline