Category: Covid-19 Vaccine

Every day, COVID-19, which has taken more than 300,000 American lives, exposes the great divide between the powerful and powerless. The poor and people of color suffer the most from the disease, while small businesses continue to take a big economic hit. To control the spread of the virus, states mandate assorted business lockdowns. But the NBA can still create a bubble so basketball can be played. In California, a restaurant owner must shut down an outdoor patio, while next door, a television production crew dines under tents. In Massachusetts, gyms must cut back service, but casinos can still operate.

The pandemic also reveals Americas willingness to accept the basic unfairness that is baked into our health care system. Medical ethics begins with the assumption that all people are equal, that every life has value, Charles E. Binkley, a surgeon and director of bioethics at the Markkula Center for Applied Ethics at Santa Clara University, said in an interview. But in real life, theres plenty of wiggle room. Anybody can get COVID-19, but not everyone gets access to the same treatment. Some people, because of what they do to keep society moving, get priority, said Binkley. Who these special people are is a judgment call. A president and his cabinet members? A president-elect and his incoming staff? And whats the difference between jumping the line and instilling confidence by taking the vaccine publicly, as former presidents Bill Clinton, George W. Bush, and Barack Obama plan to do?

When it comes to national vaccine distribution, the Centers for Disease Control and Prevention has designated front-line health workers and people in nursing homes as the first recipients. But its also a given that some people who fall outside those categories are going to use their power and privilege to game the system and try to get what others cant, said Binkley. Can such gaming be stopped? Only by the conscience of the individual, said Binkley, which today seems to be in short supply.

Rudy Giuliani is the face of privilege: Trumps lawyer freely acknowledged his celebrity status got him access to treatment that others did not have. But privilege is also the difference between the quick service available, for a price, through private testing, versus the lines that stretch for hours at public sites and the delayed results that go with them. Its the safety that comes with being able to work remotely from home in contrast to the risk of having to show up for work in a restaurant, grocery store, or classroom. Its the comfort of being able to travel by car, versus the need to rely on public transit, and the threat of losing that service to cuts as white-collar workers abandon commuter rail and subway systems.

With the vaccine comes the opportunity for even sharper divisions between the haves and have-nots. Massachusetts, like other states, has a vaccine distribution plan that promises safe, equitable, and effective delivery. Phase One covers health care workers; long-term care facilities; first responders; congregate care facilities, including corrections facilities and shelters; and home-based health care workers and health care workers doing non-COVID care. How will that play out in reality? Will prison staff and prisoners get equal access?

During a pandemic, these are not theoretical questions. They are a matter of life and death.

Joan Vennochi can be reached at joan.vennochi@globe.com. Follow her on Twitter @joan_vennochi.

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Power, privilege, and the COVID-19 vaccine - The Boston Globe

Former Presidents Barack Obama, George W. Bush, and Bill Clinton announced earlier this month their intentions to get vaccinated against Covid-19 potentially on live television to bolster trust and confidence in the shots among Americans. Following their lead, President-elect Biden said he too would take a vaccine on camera, as did Anthony Fauci, the nations most visible virologist. Ivanka Trump also signaled her willingness to get inoculated publicly.

Celebrities and other influential people leveraging their star power to promote a medical product is nothing new in America, not even for vaccines. Elvis Presley famously rolled up his sleeves to receive the polio vaccine on national television in 1956. The quick needle jab into the King of Rock n Rolls arm was among the most memorable moments from the robust teenager-led vaccine campaign. The crusade against the crippling disease helped immunizations skyrocket across the country, and by 1960, yearly cases of polio plummeted by 90% in the U.S. compared with a decade earlier, according to the University of Cambridge.

Now, as the first Covid-19 vaccine has been authorized for emergency use in the U.S., some polls suggest only about half of Americans are willing to get vaccinated against the scourge that is claiming two lives every minute in this country. The challenges of vaccine hesitancy thrust into the spotlight questions about the role, if any, celebrities should play in boosting public support for Covid-19 vaccines: How much can VIPs sway peoples opinions about getting vaccinated, which celebs would be best to tap, and is it ethical for a big name to jump the line to get a vaccine in exchange for an endorsement?

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I think its going to be harder to have an Elvis Presley moment with Covid, said Timothy Caulfield, a health policy professor at the University of Alberta in Canada.

Pop culture in the U.S. is much more fragmented now than in the 50s, he said, making it tougher to rally the public behind any particular influencer. (Dolly Parton, though, has received wide praise as a sort of Covid-19 vaccine ambassador after it was reported she helped fund the Moderna vaccine.) Caulfield suggested The Rock, Tom Hanks, or Beyonc might make good ambassadors because they are beloved and hold a neutral place in pop culture. He also said a public health campaign that seeks to enlist A-listers should focus on finding celebrities who resonate with particular communities in order to build trust within those groups.

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He added that any vaccine campaign using celebrities should aim to create a memorable, shareable, and engaging message that also explains the science of the vaccine and addresses concerns people hold, like how quickly it was developed. That means developing strategies that connect with people of different age groups that reach them where they are, like on Twitter, Facebook, and TikTok.

For a good chunk of people, they wont get a vaccine and there will be no changing their minds. Some may dabble in conspiracy theories and claim that celebrities purporting to get a vaccine are actually getting placebos and tricking the masses, as some people claimed on social media after the former presidents made their announcement. Caulfield said public health officials should not focus their energy on this subset of people who accounted for 1 in 4 of those polled this month by the Associated Press-NORC Center for Public Affairs Research and instead look towards those who are on the fence about getting vaccinated. Some 27% of Americans fall into the not sure category, the poll found.

Caulfield, who has spent much of his time debunking celebrity vaccine myths, advises public health officials to take a page out of the anti-vaxx movements playbook. Jenny McCarthy, an actress and anti-vaccine advocate, was successful at perpetuating the falsehood that vaccines cause autism, he said, because she was able to center the story around her autistic son and resonate her struggles as a parent with other parents.

They use these powerful anecdotes in order to push misinformation, said Caulfield. Weve got to flip that on its head and start using narratives and creative communication strategies to get across the good stuff.

A celebrity who lost a loved one to the disease and understands the grief that comes with mourning during a pandemic could make for a potent partner in helping the public understand the altruism in getting vaccinated and how it protects their loved ones. Such a message could connect with people on the fence, he said.

Steven Hoffman, a professor of global health, law and political science at York University in Toronto, said if public health officials can partner with a variety of celebrities, such as former politicians, religious leaders, movie stars, singers, and athletes, it could be a powerful way of normalizing and encouraging the use of the Covid-19 vaccine. But he warned that careful vetting is key.

Sometimes it can present a risk, if one chooses the wrong celebrity, he said, or a celebrity who might have a tendency to veer off message or who might be open to mixing gobbledygook with science.

Other experts question whether celebrities acting as ambassadors for the Covid-19 vaccines could budge the needle on alleviating peoples fears. Its one thing for celebrities like Gwyneth Paltrow to promote unproven and potentially harmful health products, but quite another to overcome entrenched ideas about vaccines; in fact, research into the influence of celebrities on creating anti-vaccine sentiment far eclipses research on celebrities promoting vaccine use.

If I say celebrities will help, do I know thats really true? I dont. I think its true, but I dont really know, said Arthur Caplan, a bioethicist at New York University. We spent a ton of money making these vaccines, but we didnt spend anything on the social science about how to persuade people to take them.

A small study in Indonesia published earlier this year offers some support for the idea of using celebrity ambassadors: It recruited actors, pop stars, television personalities, and motivational speakers to tweet or retweet vaccine endorsements as a part of a nationwide Twitter immunization campaign. It found that vaccine tweets celebrities wrote themselves garnered much more attention than tweets written by someone else and posted from the celebritys account. The researchers concluded that celebrities could be effective partners for vaccine campaigns, especially when theyre just acting like themselves.

Other research has shown that celebrities can inspire people to take other actions to prevent illness: In whats become known as the Angelina Jolie effect, many women followed the movie stars lead after she disclosed in a New York Times op-ed in 2013 that she had a double mastectomy after learning she carried a BRCA1 mutation that put her at high risk for cancer. And researchers also documented the Katie Couric effect an increase in the number of people who underwent colonoscopies after the news anchors televised procedure.

Vaccine hesitancy is of great concern in communities of color, especially Black communities that have a long legacy of mistrust of medical research due to historical and present-day racial injustices. Only 24% of Black adults would get a Covid-19 vaccine, and some 37% are not sure, according to the AP-NORC poll.

Malika Fair, senior director of health equity partnerships and programs for the Association of American Medical Colleges, is skeptical celebrity endorsements would appreciably change those numbers. I dont think it matters who is taking the vaccine, she said. I do not think that its going to remove the hesitancy and the mistrust of the medical system, of the public health system, of politicians around the vaccine.

One reason, she said, is that celebrities have access to the greatest medical care in case something goes wrong. People are not just thinking about what happens on day one. Theyre thinking, what happens a month from now? What happens a year from now? And what if I have a horrible reaction and I dont have backup? Fair said. Faith leaders and local physicians would likely have more success in building community confidence in Covid-19 vaccines, she added.

Thomas LaVeist, dean of the Tulane University School of Public Health and Tropical Medicine, echoed those sentiments. But he added that some athletes like Serena Williams and LeBron James, who are seen as trusted voices within many Black communities, are good examples of celebrities that could potentially lend credibility to the Covid-19 vaccines.

I dont think that theres any one messenger, and I dont know who would be the Elvis Presley of today, he said. I think you need Elvi, or multiple Elvises, to reach the population.

There are also ethical considerations that need to be taken into account if celebrities are used to promote the vaccine. Under no circumstances should they jump the priority line to get vaccinated, said Lawrence Gostin, professor of global health law at Georgetown University. That would mean that during the early months of the vaccine rollout, any PR campaign should not attempt to televise athletes and young, healthy celebrities getting a vaccine out of turn. Instead, they should set their sights on partnering with celebrities who fall into those groups designated as high-risk. Obama and spokespersons for Bush and Clinton have said the former presidents would receive their vaccinations only within their priority groups, according to CNN.

President Trump, who will be a former president for much of the vaccine rollout, will play a pivotal role in whether or not the vaccination efforts are successful, said LaVeist.

Doses of the Pfizer-BioNTech vaccine will be offered to Trump and other White House officials beginning Monday, according to Reuters. Though it is unclear whether he will try to have an Elvis moment and get vaccinated on live television when he does get the shot, according to People Magazine, Trump could be a useful vaccine ambassador if he stressed to his supporters to get vaccinated, said LaVeist.

There are a lot of people that have followed him down the path of not wearing masks, not taking this pandemic seriously, and putting themselves and their communities at risk, said LaVeist. I think a lot of those people, he can turn around. He can reach people who I dont know could be reached by anyone else.

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Can celebrities spur acceptance of the Covid-19 vaccine? - STAT - STAT

Minnier said an expert panel of clinicians across the organization are guiding the implementation of the vaccination plan, which will continue to move forward. Those vaccinated today will return in 21 days for a second round of shots, and will continue taking all precautions to keep the staff and patients safe, she said.

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Pennsylvania slated to receive over 100,000 doses of COVID-19 vaccine - WPXI Pittsburgh

As essential workers, education employees will be included in Phase 1B of the state's vaccine rollout plan. (Jack Flagler/Community Impact Newspaper)

We know that the vaccine is here, but we know it is still months away from when we will all be able to benefit, Elizalde said during the districts Dec. 14 board meeting. We did get news that our teachers will be in the second phase because [the state knows] how important our teachers are to our schools. The lobbying that we did collectively, our voices were heard.

AISD spokesperson Eddie Villa told Community Impact Newspaper on Dec. 15 that, as essential workers, education employees will be included in Phase 1B of the state's vaccine rollout plan.

According to the Texas Department of State Health Services, Phase 1A includes getting the vaccine to health care workers. A draft of a Phase 1B plan includes teachers, long-term care residents, law enforcement, firefighters, adults age 65 and older and those individuals with medical conditions that put them at a greater risk.

Phase 1B is expected to begin in early 2021, depending on the availability of vaccines after Phase 1A is completed, Villa said. According to DSHS, there are 1.6 million health care workers in the state that make up Phase 1A.

Once available, Elizalde said the district will work with health officials to prioritize vaccines within its staff based on an employee's proximity to students and AISD families.

The way it was explained to us was it would be any of our staff members that have the most direct contact with students, and that we are to help provide that prioritization, she said. The districts are actually being given the autonomy to help tier within the organization.

Villa said the district is not a vaccine distributor, but it will continue to partner with local health experts regarding the rollout.

The first doses of the Pfizer's COVID-19 vaccine approved for emergency use by the U.S. Food and Drug Administration began arriving in Texas Dec. 14. UT Health Austin and Dell Medical School were the first Austin institutions to receive the vaccine, and began administering doses the morning of Dec. 15.

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Austin ISD: Teachers will be able to take COVID-19 vaccine alongside other essential workers after health care professionals receive doses - Community...

With the FDAs approval of Pfizers COVID-19 vaccination on Dec. 11, thousands of health care workers may soon receive immunization shots in Santa Clara County within the next week.

Health officials expect 17,550 doses of the Pfizer vaccine and 39,300 doses of the Moderna vaccine to be available in the county over the next few weeks.

However, only a fraction of health care workers will have access to the vaccine.

Doses are so scarce that state health officials have broken down their first phase of vaccine distribution into multiple tiers. In the first tier are health care workers at acute care and skilled nursing facilities and hospitals within jails and prisons.

The first bit of vaccine coming to our county will not even be enough to get us through the first two bullets in tier one, said Public Health Officer Dr. Sara Cody. Thats a very large group of individuals that fall into tier one.

COVID-19 Testing Officer Dr. Marty Fenstersheib said the county will receive about 6,000 of the 17,550 Pfizer doses by mid-December, which will all go to acute care and skilled nursing staff. Fenstersheib said the county has about 75,000 acute care hospital workers, and the first round will only be available for 10% to 12% of them.

Urgent care workers and community health workers will be in the second tier of the first phase. Health officials expect the general public wont have access to COVID-19 vaccines for several months.

How will the county track who receives the vaccine and any adverse reactions to it?

County health officials encourage private and public health care providers to collect dataon peoples immunizations, vaccination dates and inventory to share with the state.

Vaccine providers can transmit data to the California Immunization Registry a database tracking immunizations of California residents via electronic health records or software that tracks patients immunizations, according to the countys vaccination plan.

Hospitals may use software such as PrepMod online software that tracks when people are vaccinated to alert patients when they need to receive a second dose of the Pfizer vaccine 28 days after the first. Both vaccines require a second booster shot and patients will be notified via email and texts.

The states immunization registry is confidential and can only be accessed by authorized medical staff and health officials.

Reactions to the vaccine

California requires every provider to report reactions from the vaccine to the federal Vaccine Adverse Events Reporting System (VAERS).

VAERS is a database and early warning system run by the FDA and Centers for Disease Control and Prevention to detect possible safety problems with U.S. licensed vaccines.

While the FDA has approved the vaccines under emergency authorization, three patients in the United Kingdom reported severe allergic reactions to the vaccine. British health officials said any person with a history of anaphylaxis or severe allergies to vaccines, medicine or food should not be immunized. However, they noted those conditions are rare.

The county will update its website to provide instructions on how health care providers should report any incidents to VAERS, though no guidance was listed as of Dec. 13.

Patients can report reactions to the vaccine directly to VAERS as well.

County leaders said they may come up with more requirements for private health care providers to prevent hoarding of vaccinations and to ensure theyre immunizing sufficient numbers of people within the county.

Its unclear how the county will ensure hospitals are distributing proper amounts of vaccinations.

Santa Clara County Supervisor Joe Simitian last week said he lacks confidence in private health care providers after they failed to conduct enough COVID-19 tests.

The hope and expectation is that responsibility will be undertaken by folks in the health carearena, who are in the private (and) nonprofit sector outside the governmental sphere, Simitian said. But we had that hope and expectation with testing only to be disappointed, frankly.

County Executive Jeff Smith said the county could imposevaccination requirements on private companies or take legal action against them for not complying with state and county vaccine regulations.

However, county leaders said collecting too much data could spark distrust among immigrant communities. A federal data sharing plan drew the ire of Smith, who said the plan could dissuade people from getting vaccinated if they are undocumented.

Were very concerned about the fact that any information transfer may discourage people from participating in the vaccine program, Smith said.

Contact Mauricio La Plante at [emailprotected] or follow @mslaplantenews on Twitter.

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COVID-19 vaccines are coming to Santa Clara County. Here's how they'll be distributed and tracked - San Jos Spotlight

YORK, Pa. (WHTM) Pfizers COVID-19 vaccine doses arrived at WellSpan Good Samaritan Hospital in Lebanon, PA, Tuesday morning. Health professionals will be administering the vaccine to care team members this week.

WellSpan was among the states first 100 hospitals to receive a vaccine shipment from Pfizer. In alignment with the PA Department of Healths phased approach to vaccination, the initial doses of the vaccine will be given to caregivers at the highest risk for exposure to COVID-19. As additional doses become available,vaccines will be offered to all WellSpan employees and patients.

The COVID-19 vaccine represents a bright spot for our teams who have tirelessly cared for their friends and neighbors with COVID-19, said WellSpan Health President and CEO Roxanna Gapstur, Ph.D., R.N. We are encouraged by the available data, which tell us the Pfizer vaccine is 95 percent effective in lowering a persons risk for developing COVID-19.

The vaccine has been through a rigorous process before receiving approval as safe and effective by theFood and Drug Administration (FDA). Based on the available research data, WellSpan Health endorses the COVID-19 vaccine.

We areconfident that this vaccine will slow the spread and help our community turn the corner in this pandemic, said Dr. Eugene Curley, Infectious Disease Specialist at WellSpan Health, who reviewed the available research data with his team members. We support the vaccine as safe and effective. WellSpan is encouraging team members to get vaccinated, and as additional doses become available, will encourage our community members to receive the vaccine.

Six other WellSpan hospitals are expected to receive their shipments this week, including WellSpan Chambersburg Hospital, WellSpan Ephrata Community Hospital, WellSpan Gettysburg Hospital, WellSpan Surgery and Rehabilitation Hospital, WellSpan Waynesboro Hospital and WellSpan York Hospital. Each of them is prepared to begin administering the vaccine to team members this week.

It will take several months until the vaccine is widely available for the general public. In the meantime, WellSpan encourages everyone to continue to follow safety precautions: wear a mask, wash your hands, and stay six feet apart from others.

Community members seeking additional information about the COVID-19 vaccine should visit WellSpans dedicated COVID-19 Information web page: https://www.wellspan.org/covid19/covid-19-vaccine/

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WellSpan Health receives first doses of COVID-19 vaccine - ABC27

TIJUANA (Border Report) The first doses of the COVID-19 vaccine are expected to arrive in Tijuana by Dec. 21, but residents are being told the vaccination wont be the final solution.

Baja Californias Secretary of Health Alonso scar Prez Rico said the vaccine takes time to generate antibodies and those who receive the shot still need between three and four weeks to see a benefit.

Prez Rico said when its all set and done, they expect vaccinations for only 60 percent of the population.

The amount were getting wont be enough to cover all residents, he said. Even by the first quarter of 2021, we wont have enough.

Prez Rico stressed the best way for people to protect themselves is to continue wearing facemasks and to practice social distancing by avoiding gatherings of more than 10 people.

Tijuana, and the rest of Mexico, plan on distributing the vaccine to health workers first, followed by senior citizens

In Tijuana, according to Prez Rico, 33 people died as a result of COVID-19 on Monday.

If we cant get this under control this week, were going to start the new year under more restrictions, he said. Everyone, especially those who cross the border between Mexico and the United States, must use facemasks and use them correctly to protect everyone.

According to statistics, 73 percent of patients in area hospitals are COVID-19 patients, with 164 new reported cases. And the number of cases is at its highest since the pandemic began, according to Baja health officials.

Visit theBorderReport.com homepagefor the latest exclusive stories and breaking news about issues along the United States-Mexico border.

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COVID-19 vaccine is not an end-all, Tijuana residents are told - WAVY.com

KANSAS A western Kansas mayor announced Tuesday that she is resigning, effective immediately, because of threats she has received after she publicly supported a mask mandate.

Dodge City Mayor Joyce Warshaw said she was concerned about her safety after being met with aggression, including threats via phone and email, after she was quoted on a USA Today article on Friday supporting the mandate, The Dodge City Globe reported.

I understand people are under a lot of pressure from various things that are happening around society like the pandemic, the politics, the economy, so on and so forth, but I also believe that during these times people are acting not as they normally would, Warshaw said.

The commission voted 4-1 on Nov. 16 to impose a mask mandate, with several exceptions.

Ford County, where Dodge City is located, has recorded 4,914 cases of COVID-19 since the pandemic began, according to the state health department. The county has about 33,600 residents.

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THE VIRUS OUTBREAK:

Poor countries face long wait for vaccines despite promises

Over-the-counter home test for COVID-19 gets U.S. green light

French theater, cinema workers protest against virus closure

Pandemic backlash jeopardizes public health powers, leaders

Swedens prime minister says health officials misjudged new infection wave

U.S. COVID-19 deaths top 300,000 just as vaccinations begin

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Follow APs coverage at https://apnews.com/hub/coronavirus-pandemic and https://apnews.com/UnderstandingtheOutbreak

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HERES WHAT ELSE IS HAPPENING:

BOISE, Idaho A proposed public health order that would have included a mask mandate for Idahos most populated region was voted down on Tuesday as hundreds of protesters again gathered outside the Central District Health building in Boise.

A previous attempt to vote on the order was abruptly halted last week after Boise city police asked the board to end the meeting early amid protest-related safety fears.

During Tuesdays meeting, three board members from Elmore, Valley and Boise counties the more rural counties in the region all voted against the mask mandate, saying theyd heard from constituents who were deeply opposed to the rule. But three board members from Ada County the most populated county in the state were in favor of the mask mandate, noting that Boise-area hospitals are reaching capacity because of an influx of COVID-19 patients, including many who are coming from neighboring counties.

The order lacked the required majority to pass.

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SACRAMENTO, Calif. California is distributing 5,000 body bags mostly to the hard-hit Los Angeles and San Diego areas and has 60 refrigerated trailers standing by as makeshift morgues in anticipation of a surge of coronavirus deaths.

The precautions come from hospitalizations that now are double the summertime peak and threaten to soon overwhelm the hospital system.

Gov. Gavin Newsom said Tuesday that the number of average daily deaths has quadrupled from a month ago. The surge is forcing an urgent scramble for more staff and space, a crush that might not abate for two months despite the arrival of the first doses of vaccines this week.

In Orange County, health officials said they plan to send large tents to four hospitals to help handle their patient caseloads.

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ATLANTA The first coronavirus vaccines were administered Tuesday in Georgia as new infections continued to soar and many schools closed in-person classes for the remainder of the last week before Christmas.

Gov. Brian Kemp and Public Health Commissioner Kathleen Toomey visited Savannah as the first four shots were administered to local health care workers.

The Republican governor warned the state is not out of the woods. The state is now averaging nearly 6,000 new infections a day, far above its summer peak. At least 14 Georgia school districts have sent all students home. Nearly 3,000 people are hospitalized statewide with confirmed cases of COVID-19.

Kemp continues to encourage people to maintain social distance, wear masks, wash hands and avoid large gatherings. But Kemp indicated again Tuesday that he will rely on voluntary compliance instead of trying to order businesses to close.

As Ive said from the beginning, no government mandate is going to make this virus go away, he said.

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TALLAHASSEE, Fla. -- Floridas largest hospital system said it was on track to immunize nearly 20,000 health care workers against COVID-19 as Gov. Ron DeSantis on Tuesday announced a delay in hundreds of thousands of doses of the Pfizer vaccine.

But DeSantis said the first batch of the Moderna vaccine 370,000 doses could begin heading to his state as soon as this weekend and would allow wider distribution of the medicine to hospitals across the state, pending federal authorization.

Florida began receiving its share of the coronavirus vaccine on Monday, and the state was expected to get about 450,000 doses produced by Pfizer over the next two weeks. But production issues could prevent them from being delivered.

Were just going to have to wait. Obviously, it would be shipped relatively soon if we got it, DeSantis said at a news conference in West Palm Beach. We dont know if were going to get any or not.

The state will take what it can get, DeSantis said, as it attempts to take control of a pandemic that has infected more than 1.1 million Floridians since COVID-19 made its first appearance in the state in March.

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WASHINGTON, D.C. -- Acting Defense Secretary Christopher Miller was among the first Cabinet members to get the vaccine. He traveled to Walter Reed National Military Medical Center in Bethesda, Md., on Monday and was given the first dose of Pfizer-BioNTechs coronavirus vaccine.

While Miller was there, a number of the medical centers front-line healthcare staff were also receiving the first of the two-shot regimen. It was the first day of the vaccines nationwide rollout.

Other high-ranking Pentagon military service leaders are expected to get the vaccine as soon as next week, in an effort to encourage the military force to also get shots, and to show that it is safe. Currently, getting the vaccine is voluntary within the military.

In a message to his force on Tuesday, Adm. Mike Gilday, chief of naval operations, urged service members to strongly consider getting the vaccine, not just for themselves but to help protect their shipmates. Saying he will receive the vaccine shortly, Gilday called the vaccine a proven effective measure to better protect the troops.

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MONTREAL Quebecs premier is closing all non-essential businesses across the Canadian province from Christmas until at least Jan. 11.

Premier Francois Legault says that big box stores will be prohibited from selling any goods that are deemed non-essential. The premier is also forcing all office towers to empty starting Thursday and requiring employees to work from home until at least Jan. 11.

Legault says elementary and secondary schools will close Dec. 17 and can reopen at the earliest on Jan. 11. He says hospitals across the province are under too much pressure because of the COVID-19 pandemic to allow non-essential businesses to stay open during the holidays.

Quebec reported 1,741 COVID-19 infections on Tuesday.

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SALT LAKE CITY -- An intensive care nurse in Salt Lake City became the first person in Utah to receive the COVID-19 vaccine.

Utah hospitals began administering vaccinations to front-line healthcare workers with the highest risk of exposure. Hospital leaders expect about a total of 100 doses to be administered across the state on Tuesday.

Christy Mulder, a nurse at University of Utah Hospital, was the first person in the state to receive the vaccine.

State Epidemiologist Dr. Angela Dunn says she is thrilled that vaccines are finally being distributed in Utah. But she urges people to continue public health measures like wearing masks and social distancing.

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CHARLESTON, W.Va. The death toll from the coronavirus pandemic in West Virginia pushed past 1,000 with the announcement Tuesday of a record 34 deaths.

Health officials said the deaths broke the one-day mark of 31 deaths reported last Wednesday.

At least 1,012 people in West Virginia have died from the virus since the pandemic began. The number of deaths has more than doubled since early November, along with virus-related hospitalizations.

The number of virus patients in hospitals reached 774 as of Monday. Thats up 124, or 19%, in the past week alone. That includes a record 207 patients in hospital intensive care units, up from 180 a week earlier.

There are more than 21,000 active cases in the state, where officials began administering a vaccine for the virus on Monday.

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RENO, Nev. -- A federal appeals court has ruled in favor of two Nevada churches that say the states COVID-19 restrictions violate their First Amendment rights.

The 9th U.S. Circuit Court of Appeals agrees with the churches in Las Vegas and rural Lyon County that the states limits are unconstitutional because they place harsher attendance limits on religious gatherings than casinos and other secular businesses.

The appellate court reversed earlier federal court rulings Tuesday that upheld Nevadas hard cap on the size of worship services. It instructed the district judges to preliminary enjoin Nevada from imposing attendance limits for churches stricter than those for other gatherings or businesses.

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PHOENIX -- Arizona on Tuesday reported more than 60 additional deaths as the current coronavirus surge saw the rolling seven-day averages of additional cases and deaths more than double over the past two weeks.

The state on Tuesday reported 4,134 additional known cases and 64 deaths, increasing the states totals to 424,382 cases and 7,422 deaths. The rolling average of daily new cases rose from 3,499 on Nov. 30 to 7,772.1 on Monday while the rolling average of daily deaths rose from 25 to 58.3.

The number of COVID-19-related hospitalizations reached 3,702 on Monday, setting another record.

Arizona on Friday exceeded the summer surges peak of 3,517 hospitalizations.

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PIKEVILLE, Ky. The new COVID-19 vaccine arrived at an Appalachian hospital in Kentucky, and medical workers received the first injections.

The Pikeville Medical Center was one of a handful of regional hospitals to receive the Pfizer-BioNTech vaccine on Tuesday.

Dr. Fadi Al Akhrass, Pikeville Medicals infectious disease specialist, received the first injection during a live-streamed news conference Tuesday afternoon. Al Akrass urged the public to have confidence in the vaccine.

Im a true believer that this is going to be our only option, and its going to be an amazing option to turn around this pandemic, he said.

The hospital, which was required to have facilities for ultra-cold storage, received 975 doses meant for medical workers. A Louisville hospital received the first Kentucky shipment of the vaccine on Monday.

Health care workers are first in line for the vaccine, but about 25,000 doses from the first batch to Kentucky will be dedicated to vaccinating people in long-term care facilities. Gov. Andy Beshear said he hopes to have the entire long-term care population vaccinated within two months.

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INDIANAPOLIS A coalition of some of Indianas top hospital systems is warning that facilities are struggling to cope with the surge in COVID-19 patients a sobering reminder that the coronavirus is still spreading quickly in the state despite the arrival of a vaccine.

With COVID-19 patient numbers hovering above 3,000 for nearly a month, Indiana hospitals are treating more than four times as many as they were in September and are worried they soon could get overwhelmed.

Local hospitals are fast approaching crisis, the Indianapolis Coalition for Patient Safety, which represents several central Indiana health-system systems, said Monday in a statement.

During an online news conference Monday, members of the hospital coalition painted a grim picture of what has been unfolding in their emergency rooms and intensive care units. They also pleaded with members of the public to continue wearing masks and socially distancing and to forgo in-person holiday gatherings.

The state Department of Health on Tuesday added another 129 COVID-19 deaths to the states death toll, pushing the overall figure of confirmed or presumed coronavirus deaths to 6,968 since the start of the pandemic.

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CHEYENNE, Wyo. A registered nurse who does coronavirus testing and contact tracing got Wyomings first COVID-19 vaccination Tuesday.

Terry Thayns regular job is overseeing maternal and child health matters for the Cheyenne-Laramie County Health Department, but this year, she has been busy working to contain the virus.

I was excited for the vaccine, Thayn said after getting the shot at a health department news conference. Whenever it was here, I was taking it.

Thayn is set to get a follow-up shot of the Pfizer vaccine in three weeks.

Her initial dose came from a shipment of 975 in a box that arrived Monday at the health department. Small glass vials of the vaccine came packaged in a box within a box and were kept cold by dry ice.

Almost 35,000 people have tested positive for the coronavirus and 321 have died of the virus in Wyoming since the pandemic began, according to state health officials.

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WASHINGTON Vice President Mike Pence says he looks forward in the days ahead to receiving a vaccine for COVID-19 and will do so without hesitation.

Pence is speaking Tuesday at a Catalent Biologics plant in his home state of Indiana. The plant is producing a vaccine developed by Moderna and the National Institutes of Health.

He is trying to inject confidence in the vaccine a day after the rollout of Pfizer-BioNTechs coronavirus shots and as the Food and Drug Administration says in a preliminary report that the Moderna vaccine is also safe and effective.

Pence declared, we have come to the beginning of the end of the coronavirus pandemic.

Pence is also stressing the need for Americans to stay focused on limiting the spread of the virus before a vaccine is in widespread use. He says cases and hospitalizations are continuing to rise in many parts of the country. The death toll from the coronavirus topped 300,000 Monday.

Its been a marathon this year. Its been a marathon of heartbreak for many American families, he said.

___

WASHINGTON Senate Majority Leader Mitch McConnell is urging elected officials to step up and encourage wary Americans to be vaccinated against COVID-19.

The Republican leader said that as a childhood polio survivor, hes a huge supporter of being vaccinated.

Whenever my turn comes, Im going to be anxious to take the vaccine and do my part to reassure those who are doubtful about this, McConnell said at a press conference in Washington, D.C.

For those who say they will resist the vaccine, he said its not good news.

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The unprecedented effort to identify one or more safe and effective vaccines for COVID-19 includes more than 180 candidates in development (1), with at least 12 in phase 3 trials (2). The testing of so many vaccine candidates, in a pandemic of a disease for which there are to date limited treatment options, raises a critical challenge: What should researchers do if a vaccine candidate is judged to be safe and efficacious? Guidance from the U.S. Food and Drug Administration (FDA) states that in the event that a COVID-19 vaccine candidate is judged to be safe and effective, discussion may be necessary to address ethical arguments to break the blind and offer vaccine to placebo recipients (3). We consider here two questions raised by this guidance: First, if a vaccine candidate is found to be safe and efficacious in a placebo-controlled trial, should the researchers continue that trial as designed? Second, should researchers continue to test other vaccine candidates using placebo-controlled trials? These two questions are especially timely given recent announcements by Pfizer and Moderna that their vaccine candidates have been found to be efficacious in preventing symptomatic COVID-19 (4, 5).

A finding of efficacy occurs when a vaccine candidate being tested in a phase 3 trial meets its efficacy end point, either during an interim analysis or after study completion. The primary efficacy end point of current phase 3 trials is whether the vaccine candidate prevents symptomatic COVID-19 in individuals newly infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (6). A finding of efficacy in these trials thus implies that the vaccine candidate protects infected individuals from experiencing symptoms. A finding of safety occurs when there is sufficient data on the impact of the vaccine candidate to conclude that its potential benefits justify its risks in the target population.

A single finding of safety and efficacy may not be sufficient for a vaccine candidate to receive FDA approval. Depending on the strength of the data, it may be important to conduct additional research to learn more about the vaccine candidate and gain greater confidence in its safety and efficacy before offering it to millions of people. For example, the FDA frequently requires a finding of efficacy in two phase 3 trials before approving medical interventions for marketing to the public.

Still, a finding of safety and efficacy in a phase 3 trial is an ethically critical point in the vaccine development process. From that point, receiving the vaccine candidate is known to offer protection to many individuals. Hence, receiving a placebo instead is contrary to their interests, even though it may be necessary to collecting socially valuable data.

This tension between protecting research participants and gathering data that may benefit others is common to clinical research, and there is substantial literature on how to address it (7). Although this literature applies to the ethics of vaccine trials, the present situation is unparalleled.

There is a global crisis for which there are currently limited treatment options. Hence, billions of individuals could benefit from a safe and efficacious vaccine. And having so many vaccine candidates in development substantially increases the chances that one or more will be found to be safe and efficacious while others are still being tested. Limitations on current treatment options mean that it is in each individual's interests to receive the first vaccine found to be safe and efficacious, rather than participate in vaccine trials where they might receive placebo or an unproven vaccine candidate.

In addition, given the challenges of manufacturing sufficient supply for so many people, and given that different vaccine candidates may be efficacious in different populations, several vaccines may be needed to meet the global need. This highlights the potential social value of conducting additional trials after one or more vaccine candidates are found to be safe and efficacious.

Moreover, vaccine candidates typically have not been widely available until after they receive marketing approval by the FDA. However, the FDA has indicated that it may take the unprecedented step of making a vaccine candidate that is found to be safe and efficacious widely available through an emergency use authorization (EUA) before marketing approval. An EUA involves the FDA commissioner allowing unapproved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved, and available alternatives (8).

Pfizer recently announced that at the first interim analysis, its vaccine candidate was found to be 95% effective at preventing symptomatic COVID-19 (4, 5). A week later, Moderna announced that its vaccine candidate was found to be 94.5% effective. At that point, the trials had enrolled more than 43,000 and 30,000 participants, respectively, of whom 94 and 95 developed symptomatic disease. If these findings are confirmed, they will represent an important public health advance, and provision of the vaccine candidates would be in the interests of many individuals. The FDA may thus grant an EUA, making either or both vaccines available before each study's completion and also before FDA marketing approval.

Some commentators argue that clinical trials are ethically acceptable only as long as there is insufficient evidence that the intervention offered in one arm is superior to what is offered in another arm, or to what is available outside the trial (9). This view implies that it would be unethical to continue Pfizer's and Moderna's placebo-controlled trials given the findings of efficacy. It also implies it would be unethical to test other unproven vaccine candidates against placebo.

Proponents defend this view on the grounds that it provides a way to protect participants from excessive risks. They argue further that researchers conducting clinical trials are obligated to treat participants consistent with their clinical interests and conclude that it is unethical to give participants a placebo once a safe and efficacious vaccine has been identified.

We disagree. This view fails to recognize that the obligations researchers have to their participants are distinct from the obligations that clinicians have to their patients (9). It further ignores the existence of other mechanisms, including independent review and informed consent, to protect research participants from excessive risks. The differences between the ethics of clinical research and clinical care are reflected in the consensus that it can be ethically appropriate to invite research participants to accept some risks to collect socially valuable data. In particular, codes and guidelines around the world permit researchers to expose participants in clinical trials, including vaccine trials, to some risks to collect socially valuable data that cannot be obtained in a less risky way (10).

These guidelines have a critical implication for COVID-19 vaccine trial ethics: Researchers are not obligated to provide placebo recipients with a safe and efficacious vaccine once one has been identified. Instead, researchers are obligated to ensure that any plans to conduct placebo-controlled trials remain ethically appropriate given current evidence. Such plans must be reviewed and approved by an independent board, known as an institutional review board (IRB) in the United States, which must find that a number of conditions are satisfied (11). Two of these conditions are particularly important for determining the acceptability of conducting placebo-controlled trials after a vaccine candidate has been found to be safe and efficacious: Is the trial's risk-benefit profile still acceptable? Do participants consent?

Continuing a blinded, placebo-controlled trial after the vaccine candidate being tested has been found to be safe and efficacious is justified only when the trial's risk-benefit profile remains acceptable. Making this determination requires answering three questions: (i) What is the social value of continuing the trial? (ii) What are the risks to participants of continuing the trial? (iii) Are the risks to participants sufficiently low and justified by the social value of continuing the trial?

Continuing a trial after the vaccine candidate has been found to be safe and efficacious can provide an opportunity to collect several types of socially valuable data. Of greatest importance, it can provide greater confidence in and a more precise point estimate of the vaccine's efficacy and offer an opportunity to collect additional safety data, including data on any uncommon or delayed side effects. It can also help to assess how long the vaccine's protective effect lasts; offer insight into the vaccine's impact in various subgroups, such as older individuals or those with comorbidities; and evaluate whether the vaccine candidate protects against infection itself.

Once a vaccine candidate is found to be efficacious, participants in the placebo arm are known to be at higher risk of symptomatic disease than those in the active arm. The degree of risk depends on the chances that participants in the placebo arm will become infected, the risks they face if they are, and how much protection the vaccine candidate offers.

A volunteer receives an injection as part of a phase 3 trial of the vaccine candidate developed by Pfizer and BioNTech.

The chances that participants in the placebo arm will be infected depends on the local transmission rate, preventive measures they adopt, and the amount of time they remain on placebo. When participants are on placebo for a short time, the chances of infection are correspondingly low. For example, Moderna plans to continue its placebo-controlled trial until 151 cases of symptomatic disease are identified (5). Given current transmission rates, this may take as little as a few weeks.

Remaining on placebo for a few weeks, rather than accessing an efficacious vaccine, poses a low chance of substantial harm. Continuing on placebo for even longer periods also poses a low chance of substantial harm to individuals at low risk for severe disease.

Remaining on placebo for an extended period can pose considerable risks to individuals at high risk of severe disease. The extent of these risks depends critically on what options are available to them. In the setting of few effective treatments and potentially strained hospital systems, receiving placebo for an extended period rather than a safe and efficacious vaccine can pose substantial risks. However, if high-risk individuals would not have access to a safe and efficacious vaccine outside of researchfor example, there is only enough supply for the trial or they are not part of a prioritized group that will receive the vaccine during the time of the trialreceiving placebo in a clinical trial poses few additional risks to them.

There is no algorithm for determining how much social value a given clinical trial has and whether its social value justifies the risks participants face. As a result, IRBs tend to focus on ensuring that a trial has the potential to collect important data and that the risks of substantial harm are low.

Trials with the potential to collect data helpful for addressing a global pandemic have considerable social value. Inviting competent adults to participate in such trials can be ethical when doing so poses a small increase in their risk of experiencing substantial harm. This suggests that it can be ethically acceptable to continue a placebo-controlled trial for a short period after the vaccine candidate has been found to be safe and efficacious, even when participants might be able to access the vaccine candidate outside the trial, for example, through an EUA (12). By contrast, if continuing the trial does not offer the opportunity to collect socially valuable data, or comparable data can be obtained in less risky ways, continuing the trial with a placebo arm for any length of time would be ethically problematic.

Inviting participants who are at low risk of severe disease to remain blinded and stay in the trial for a longer period can be acceptable when it offers the potential to collect data that might be helpful for addressing the pandemic. In most cases, continuing a blinded, placebo-controlled design with high-risk individuals for longer periods will not yield data of sufficient value to justify it. Exceptions might include when the individuals cannot access an efficacious vaccine outside the trial and their participation is needed to collect valuable data, or they are in a group for whom no efficacious vaccine candidate has been identified. Otherwise, individuals at high risk of severe disease should be unblinded and those on the placebo arm offered the vaccine within a redesigned study or given the opportunity to seek the vaccine outside the trial.

When the value of the data to be collected does not justify the risks of continuing the trial as designed, researchers have several options. They can unblind participants; offer placebo recipients the vaccine, possibly as part of an expanded access program; and follow them to collect additional data (13). Alternatively, researchers might redesign the trial, for example, to include a crossover in which the blind is maintained and those on the placebo arm receive the vaccine after they complete the placebo arm. Finally, in some cases, it may make sense to simply stop the trial and unblind participants, thus allowing those in the placebo arm to seek the vaccine elsewhere.

Even when a vaccine candidate is found to be safe and efficacious, there are likely to be good reasons to study others. Another vaccine candidate might be more effective, generate longer-lasting immunity, work better in certain subpopulations, provide greater protection against severe disease, or prevent infection better. Other candidates may also be superior with respect to cost or other practical considerations. For example, Pfizer's vaccine candidate must be stored at very low temperatures until 5 days before administration, a requirement which will reduce its availability in many parts of the world.

When there are safe and effective interventions available, the default is to use them rather than placebo as the comparator in clinical trials. Thus, if the Pfizer or Moderna vaccine candidates, or others, are confirmed to be safe and efficacious, researchers should consider whether their trials can be redesigned as a comparison between the vaccine candidate they are testing and a safe and efficacious vaccine. When making this decision, researchers and IRBs should take into account that an active comparison trial is likely to require larger sample sizes and extend the duration of the trial.

Redesigning ongoing trials to include an efficacious vaccine as an active comparator may not always be feasible or valuable. If continuing to evaluate the vaccine candidate nonetheless offers important social value, participants at low risk of severe disease might be invited to stay blinded and remain in the placebo-controlled trial. If continued participation appreciably increases participants' risk of severe disease, researchers should discuss participants' options for obtaining an efficacious vaccine outside research.

Researchers are ethically obligated to inform participants of developments that might influence their willingness to remain in a clinical trial. Clearly, that a vaccine candidate has been found to be safe and efficacious meets this standard. Hence, investigators should inform participants in all trials of such a finding. This information should include the vaccine's safety record, the level of protection it provides, the populations for which it has been found to be safe and efficacious, and whether it might be available through an EUA or other means.

Researchers should then explain the plans for their trial going forward and solicit participants' consent. To minimize potential confusion and distrust (14), participants should understand the rationale behind the plan and that their prior consent does not obligate them to continue to participate. If researchers intend to continue with a placebo-controlled design, participants can be encouraged to remain in the trial. However, once a safe and efficacious vaccine candidate is available, knowing whether they received placebo or vaccine becomes relevant to a participant's decision whether to seek the vaccine outside research. Hence, participants who choose to leave the trial should be informed whether they received the vaccine candidate or placebo.

If one or more efficacious vaccines become widely available outside research, continuing a blinded, placebo-controlled trial might result in participants in both the active and placebo arms dropping out and seeking the vaccine elsewhere. Researchers should anticipate this possibility and consider whether they might unblind participants, offer an efficacious vaccine to the placebo recipients, and follow everyone. Alternatively, it might make sense to continue the blinded, placebo-controlled trial with a guarantee that individuals in the placebo arm will receive an efficacious vaccine once their participation in the study is completed. With careful planning and systematic assessment of the social value and risks, we believe it can be ethical to conduct some placebo-controlled trials of vaccine candidates for COVID-19 even after we have an efficacious vaccine. Doing so may be necessary to effectively address a pandemic that is causing so much harm around the world.

Acknowledgments: Thanks to E. Erbelding for valuable discussion of this issue. This work was funded by the Intramural Research Program at the U.S. National Institutes of Health Clinical Center. The authors declare no competing interests. Disclaimer: The opinions expressed are the authors' own. They do not represent the position or policy of the National Institutes of Health, the U.S. Public Health Service, or the U.S. Department of Health and Human Services.

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COVID-19 vaccine trial ethics once we have efficacious vaccines - Science

PHOENIX (3TV/CBS 5) -- The first doses of the Pfizer vaccine are expected to arrive in Arizona between Monday, Dec. 14 and Wednesday, Dec. 16. The first doses of the Moderna vaccine, once approved, should arrive the week of Dec. 21.

Arizona is expected to get 384,350 doses of the vaccine, but not all at once, and only the first dose. The second doses will arrive later.

Dr. Cara Christ, Director of the Arizona Department of Health Services (AZDHS), said the planned turnaround times from the doses arriving in Arizona to patients given the vaccine would be 24-48 hours.

A: While there have been a couple of cases in Britain in which patients had an allergic reaction to the vaccine, Pfizer, the manufacturer, says it appears to be safe.

Dr. Christ said when people get the vaccine, they will need to stay put with their provider for about 15 minutes to make sure they do not have an adverse reaction.

Neither Pfizer nor Moderna reported any serious side effects during their clinical trials. The most common side effects, according to the manufactures, are not unusual with vaccines.

"We need to let everybody know that the vaccine is safe, effective, and it's for everyone's benefit," Dr. Christ said.

There are several things, however, that cannot be known yet, including what, if any, long-term effects the vaccine might have.

It's also not clear if the vaccine can prevent transmission of the coronavirus that causes COVID-19 or if it only prevents people from getting sick.

An expert committee endorsed the Pfizer vaccine on Thursday. Dec. 11. The Food and Drug Administration was expected to quickly green-light the vaccine for emergency use based on the panel's recommendations.

The FDA is scheduled to look at the Moderna vaccine on Dec. 17.

A: Two. The second dose comes 21 or 28 days after the first.

A: Not fully.

"While some protection will be obtained two weeks after the first dose, full protection will not be achieved until one to two weeks after the second dose," Dr. Christ said. "That second dose is very important."

A: There's no certain answer to that yet, but medical experts seem to be leaning toward an annual shot like the flu vaccine. Viruses mutate over time and vaccines have be adjusted to be as effective as possible against current strains. It's probably not a one-vaccine-fixes-everything-forever approach. Medical researchers are still learning about the body's responses to the coronavirus and how the antibodies to it work. There's still quite a bit that's unknown.

A: The short answer is possibly.

If you have an underlying medical condition, you might be exempt under the Americans with Disabilities Act. Title VII of the Civil Rights Act provides similar protection for people with "sincerely held" religious believes against vaccines.

If you are exempt, you and your employer would need to work together to come up with "reasonable accommodations." What that looks like varies. It could be remote work or it could be using personal protective equipment (PPE) at the workplace.

Absent those two exceptions, you will be taking a risk against your employer's mandate. Employers have the right to enforce their requirements.

"If your employer requires it, and you don't do it, then it is likely you'll lose your job," said attorney Logan Elia with Rose Law Group.

A: The vaccine is being rolled out in phases before it becomes available to the general population.

A: It depends. The first doses will go to frontline workers, essential workers, and people at high risk for developing complications from COVID-19. The vaccine will likely not be available to the general public until spring of 2021.

The Maricopa County Health Department created a COVID-19 Vaccine Prescreen for health care workers and others in Phase1A to register. To learn more, click here.

The New York Times created a tool to help people determine their "place in line" to get the vaccine. It looks at at four specific factors -- your age, where you live, your profession, and underlying conditions. This is not a reservation or registration for the vaccine. It's merely meant to give you and idea where you might fall in what's going to be a massive vaccination effort.

A: Nothing is certain except death and taxes, but Pfizer says its vaccine is 95% percent effective at preventing COVID-19. Moderna puts its vaccine's efficacy at 94.5%.

If you do develop the disease, you probably will not get as sick as you might have otherwise.

A: "There are no clinical trials yet conducted in children or pregnant women," Dr. Christ said. "As we get more information, will be adding more information about kids and pregnant women."

A: Medical experts say yes. While Pfizer says its vaccine is effective at preventing people from getting COVID-19, it's not clear yet if it has any effect on transmitting the virus. So, even if you do not get sick, you could still be contagious.

"It will be important for everyone to continue taking precautions, even after being vaccinated, to ensure that we are protecting our loved ones and those around us," according to Dr. Christ.

Medical experts worldwide have made it clear that masks are not just to protect the wearer but also to protect everyone around them.

A: It's free.

A: No

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FAQ: What you should know about getting the COVID-19 vaccine in Arizona - AZFamily