Category: Covid-19 Vaccine

Media Advisory

Tuesday, August 10, 2021

Trial will assess antibody response in people who did not respond to two-dose regimen.

A pilot study has begun to assess the antibody response to a third dose of an authorized COVID-19 mRNA vaccine in kidney transplant recipients who did not respond to two doses of the Moderna or Pfizer-BioNTech COVID-19 vaccine. The Phase 2 trial is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

The lifelong immunosuppressive therapy that organ transplant recipients must take to prevent organ rejection blunts their immune response to both pathogens and vaccines. Research has shown that many organ transplant recipients do not develop antibodies against SARS-CoV-2, the virus that causes COVID-19, after receiving an authorized COVID-19 vaccine regimen. The purpose of the new study is to determine whether a third dose of one of the mRNA COVID-19 vaccines could overcome this problem for at least some kidney transplant recipients. This is particularly important because this population has a high prevalence of conditions that are risk factors for severe COVID-19, such as cardiovascular disease and diabetes.

The pilot study also aims to identify characteristics that could help distinguish those kidney transplant recipients who would benefit from a third dose of an mRNA vaccine from those who will require a different approach to achieve protection. The pilot study findings will inform a subsequent, larger phase of the trial that includes higher-risk strategies to induce a protective immune response against SARS-CoV-2 in solid organ transplant recipients who do not respond to a third dose of an mRNA vaccine.

The third-dose vaccine intervention was chosen because of the demonstrated safety of the two-dose mRNA vaccine regimen in solid organ transplant recipients as well as the efficacy of additional doses of other vaccines, such as those for hepatitis and influenza, in immunocompromised people.

The pilot study, called COVID Protection After Transplant (CPAT), is being conducted at Johns Hopkins University in Baltimore under the leadership of Dorry Segev, M.D., Ph.D. Dr. Segev is the Marjory K. and Thomas Pozefsky professor of surgery and epidemiology, associate vice chair of the department of surgery, and director of the Epidemiology Research Group in Organ Transplantation at Johns Hopkins University.

The CPAT study team will enroll up to 200 adults ages 18 years or older who received a kidney transplant a year or more prior to enrollment and have had no recent organ rejection or change in immunosuppression. Between 50 and 100 participants will have had no detectable antibody response to two doses of an mRNA COVID-19 vaccine, and 50 to 100 participants will have had a low response. All participants will receive a third dose of the same COVID-19 vaccine that they received previously. Thirty days later, investigators will measure participants antibody response to the third dose. The goal is to determine the proportion of participants who achieve a designated antibody response at the 30-day mark. The study team will follow participants for one year after enrollment. Preliminary results are expected in September 2021.

People who would like to enroll in the CPAT pilot study should contact Johns Hopkins University using the email address dose3@jhu.edu. More information about the trial is available at ClinicalTrials.gov under study identifier NCT04C969263.

NIAID Director Anthony S. Fauci, M.D., and Daniel Rotrosen, M.D., director of the NIAID Division of Allergy, Immunology, and Transplantation, are available to discuss the CPAT pilot study.

To schedule interviews, please contact the NIAID News & Science Writing Branch, (301) 402-1663, niaidnews@niaid.nih.gov.

NIAID conducts and supports researchat NIH, throughout the United States, and worldwideto study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

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NIH launches study of third COVID-19 vaccine dose in kidney transplant recipients - National Institutes of Health

GETTING BETTER AND WHEN HE IS FULLY RECOVERED, HE SAYS HE WILL GET VACCINATED. LARA: I REMINDER FOR , MISSOURIANS. YOURE RUNNING OUT OF TIME TO ENTER TO WIN TEN GRANDFO, R GETTING YOUR CORONAVIRUS VACCINE. TOMORROW IS THE DEADLINE TO ENTER, INTO THE STATES DRAWING. ,SO IF YOURE INTERESTED, FLIL OUT THE FORM AT COVID-VACCINE.MO.GOV/WIN. THERE WILL BE PRIZE DRAWINGS FOR 3-CATEGORIES, BASED ON WHEN YOU GOT THE VACCINE, AND F 1OR2 TO 17-YEAR-OLDS WANTING MONEY FOR COLLEGE. THE DRAWINGS WILL HAPPENVE ERY TWO WEEKS. THEY START FRIDAY AND WILL GO THROUGH OCTOBER 8. THERE WILL

More than 375,000 Missourians have entered the states COVID-19 vaccine lottery program

State officials say the first of five drawings will be Friday.

Updated: 4:36 PM CDT Aug 10, 2021

More than 375,000 Missourians have entered the states COVID-19 vaccine lottery program, but vaccinations continue to lag, especially in rural areas of the state. State officials say the first of five drawings will be Friday. All told, 800 adults will win $10,000 cash prizes, and 100 people ages 12-17 will win education savings accounts worth $10,000. Only those who have initiated vaccination are eligible.Republican Gov. Mike Parson announced the incentive program on July 21. State officials say that vaccinations have risen nearly 50% in the past month. Missouri continues to lag far behind most states in vaccinations.

More than 375,000 Missourians have entered the states COVID-19 vaccine lottery program, but vaccinations continue to lag, especially in rural areas of the state.

State officials say the first of five drawings will be Friday. All told, 800 adults will win $10,000 cash prizes, and 100 people ages 12-17 will win education savings accounts worth $10,000. Only those who have initiated vaccination are eligible.

Republican Gov. Mike Parson announced the incentive program on July 21. State officials say that vaccinations have risen nearly 50% in the past month.

Missouri continues to lag far behind most states in vaccinations.

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More than 375,000 Missourians have entered the states COVID-19 vaccine lottery program - KMBC Kansas City

PARISJulien Zerbos turned away some would-be diners on Monday from the brasserie on Pariss Champs-lyses where he works because they didnt have the European Unions new digital health certificate.

France began requiring the passes, which certify that somebody has been vaccinated against Covid-19, on Monday for people seeking to dine at a restaurant, whether indoors or outdoors. The pass is now also necessary to take domestic flights and long-distance buses and trains. France already made the pass mandatory last month for a host of other activities such as entrance to museums, pools, gyms and large sports events.

Some customers say they got the vaccine but didnt come with the health pass, and we have to say sorry, we cannot accept you, said Mr. Zerbos, who works as a host at Fouquets in Paris. We can get in serious trouble if we accept someone without the health pass.

French establishments that dont check the health passes risk a 1,500 fine, the equivalent of about $1,763, which can rise to 9,000 and a year in prison following the third violation within a month.

Italy also made the digital health pass mandatory for a range of activities last Friday, although the unvaccinated can still dine at restaurants if they sit outdoors.

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France, Italy Require Proof of Covid-19 Status for Restaurants, Bars - The Wall Street Journal

Hundreds of people have gathered outside of St. Elizabeth Healthcare in Edgewood, protesting the requirement of COVID-19 vaccinations for employees throughout the Greater Cincinnati Health Systems. St. Elizabeth's was one of 11 hospital systems in Kentucky that announced last week they will require its workforce to be vaccinated for COVID-19. "None of us want to lose our job...the reason I came out here, is because, well, I've been a nurse for 13 years, and I've never taken a vaccine," registered nurse Crystal Real said.The new policy will help health systems respond to a surge in COVID-19 cases driven by the delta variant, health officials said. But on Tuesday afternoon, hundreds of people gathered outside in protest of the hospital's policy. "I think it's absolutely beautiful, I'm touched, I got chills just walking in here," Real said.The grouping was made up of a variety of people: Some who work at the hospital, and some that do not. Many in the group are speaking out, saying it's their right to choose if they want to be vaccinated or not. "It's not about the vaccine, there's plenty of people here who have had the vaccine and there's plenty of people who haven't, and the choice should be yours to make without being threatened with your job," registered nurse Darlene Miller said.All Greater Cincinnati Hospital systems decided to require the vaccine as the delta variant continues to spread, causing COVID-19 cases and hospitalizations to rise.

Hundreds of people have gathered outside of St. Elizabeth Healthcare in Edgewood, protesting the requirement of COVID-19 vaccinations for employees throughout the Greater Cincinnati Health Systems.

St. Elizabeth's was one of 11 hospital systems in Kentucky that announced last week they will require its workforce to be vaccinated for COVID-19.

"None of us want to lose our job...the reason I came out here, is because, well, I've been a nurse for 13 years, and I've never taken a vaccine," registered nurse Crystal Real said.

The new policy will help health systems respond to a surge in COVID-19 cases driven by the delta variant, health officials said.

But on Tuesday afternoon, hundreds of people gathered outside in protest of the hospital's policy.

"I think it's absolutely beautiful, I'm touched, I got chills just walking in here," Real said.

The grouping was made up of a variety of people: Some who work at the hospital, and some that do not. Many in the group are speaking out, saying it's their right to choose if they want to be vaccinated or not.

"It's not about the vaccine, there's plenty of people here who have had the vaccine and there's plenty of people who haven't, and the choice should be yours to make without being threatened with your job," registered nurse Darlene Miller said.

All Greater Cincinnati Hospital systems decided to require the vaccine as the delta variant continues to spread, causing COVID-19 cases and hospitalizations to rise.

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Hundreds gather outside of St. Elizabeth Edgewood, protesting required vaccinations - WLWT Cincinnati

Tyson Foods, United Airlines, CNN, the U.S. military.

A wide variety of employers, including those four, impose COVID-19 vaccine mandates on their workers, and experts said theyll have a lot more company soon after the Food and Drug Administration gives the shots its full approval.

Some employers arent ready to impose mandates but may penalize workers for not getting vaccinated, possibly by requiring them to pay an insurance surcharge costing several hundred dollars a year.

I think theyve decided that in order to get that needle to move, they need to do something more, said Wade Symons, leader of the regulatory resources group at Mercer, an employee benefits consultancy.

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Other employers just ask nicely or stick with incentives, hoping not to scare workers off amid what HR leaders call The Great Resignation a pent-up flood of people quitting after holding onto their jobs during the pandemic.

The hodgepodge of vaccination strategies coincides with the surge of the delta variant, which is more contagious than earlier versions of the coronavirus and threatens to derail efforts to return to the office.

Here are some of the issues with vaccine mandates, which experts agree are legal as long as workers are provided accommodations for legitimate medical or religious objections:

If you work in a field that requires you to interact with the public, you are among those most likely to be required to be vaccinated, said Michael C. Schmidt, vice chair of law firm Cozen O'Connors labor and employment department.

This is particularly true of health care providers such as hospitals, many of which have historically required flu vaccinations.

It may be true of other industries with workers in harms way such as meatpacking plants. Those facilities faced criticism over COVID-19 outbreaks in the early months of the pandemic because the employees typically work side by side. Tysons Food, which sells meat, ordered vaccinations for its workers.

Story continues

In the travel sector, United Airlines is among the first major companies to issue a vaccine mandate to its employees. Flight attendants and gate agents are among workers who work directly with the public, putting themselves and travelers at risk.

What youre seeing is employers realizing that that resistance is softer than it might have been a few months ago as the delta variant gets more extreme, said Denise Rousseau, professor of organizational behavior and public policy at Carnegie Mellon University's Heinz College.

Yet many companies whose employees interact with the public don't require vaccination. Major retailers such as Walmart and Target havent issued mandates for store workers. Walmart requires vaccinations for employees at its headquarters in Arkansas and for some workers who travel regularly.

"We have an important role to play and believe the requirement for vaccinations for our leaders is key to driving toward an end to this pandemic," Walmart CEO Doug McMillon said in a memo to employees.

Yes. This could include a surcharge on your health insurance.

Mercers Symons said clients have asked him about how to charge unvaccinated employees more for their insurance to cover the costs of massive hospital bills.

Its something weve just started getting questions about in the last couple of weeks, Symons said. The number of questions has been surprising in the volume. This is something theyre more willing to take on. Its less than a mandate.

Symons estimated that some workers could face an additional $20 to $50 per paycheck, though he said he would expect it to be on the lower end of that scale.

That would translate into several hundred dollars annually in extra costs.

Unvaccinated folks have the potential to cost employers more from a health care cost perspective, so theyre feeling theyre justified in that additional surcharge, he said.

It would be akin to how some employers tack on a surcharge for workers who smoke cigarettes, Symons said, though he acknowledged that surcharges for the unvaccinated would probably be more controversial.

Insurance surcharges could turn out to be more effective than mandates, Carnegie Mellons Rousseau said.

People are loss-sensitive, she said. Losses are more painful than gains are good. If the incentives are experienced as a loss, theyll act to correct that loss.

Its highly likely. For now, COVID-19 vaccines remain authorized under emergency use regulations.

If the FDA grants full approval, it may lead to a flood of employers mandating shots since the agency's signoff would remove one of the arguments against requirements, experts speculated.

Emergency use status isnt enough to block mandates. A federal judge in Houston ruled against hospital employees who argued that they should not be subject to a mandate because the vaccine had been only authorized for emergency deployment.

The judge pretty handily rejected that claim, said Schmidt, the employment lawyer.

Tyson Foods team members receive COVID-19 vaccines Feb. 2 from health officials in Wilkesboro, N.C. Tyson Foods requires all of its U.S. employees to get vaccinated against COVID-19.

Some employers have been reluctant to order vaccines until the shots have the same authorization as, say, over-the-counter medicine.

Theres no question there were some employers that recognized the uneasiness of the (emergency) status and were waiting and might still be waiting for approval, Schmidt said.

Possibly. In some cases, unions support mandates, including the AFL-CIO, which represents 56 unions accounting for more than 12 million workers.

Others, such as unions representing teachers, sheriffs deputies and state workers, have spoken up against mandates.

We have a right to bargain over a new work rule," said Debbie White, president of Health Professionals and Allied Employees, New Jerseys largest health care union.

Most union contracts will prevent employers from imposing mandates without negotiating, Schmidt said.

Definitely. Employers recognize that resistance is particularly strong in some quarters. Nearly 3 in 10 American adults havent gotten at least one dose of vaccine.

Because vaccinations have become a political issue for a portion of Americans who refuse them, employers could face mass resignations if they require shots. (Other employees are hesitant because of safety concerns and other fears.)

Thats particularly concerning for bosses since many are struggling with The Great Resignation a widespread departure of workers who held onto their positions during the pandemic but are ready to leave for something else now that the economy is picking up.

Given how many employers are grappling with worker shortages, they may want to avoid upsetting their staff.

Workers could be bluffing when they threaten to quit, but employers might still fold their cards.

What people say and what people do theres always a disparity, said Theresa McEndree, global head of marketing for Blackhawk Network, which consults with employers about worker incentives.

Employers may have to accept the inevitability that some people are as good as gone.

Ive heard employers saying that if this is a reason why someone is unwilling to come to work, then maybe we just have to live with them working somewhere else, Symons said, because some employers feel like they just need to get back to functioning as close to the way they did before.

This is also possible. Research shows that many vaccinated Americans are concerned about working alongside unvaccinated colleagues.

More than 62% of American workers want at least 8 in 10 of their co-workers to be vaccinated before theyll feel comfortable returning to the office, according to Blackhawk Network research.

In many cases, the answer is probably yes. For companies that dont want to force their workers to get vaccinated, incentives may do the trick.

History and data have shown that its more positive to reward good behavior than impose a punishment, McEndree said.

Of unvaccinated workers, 51% say a financial incentive from their employer would motivate them to start and complete the vaccine process, she said, summarizing Blackhawks research.

In this case, she said, money works.

Contributing: Lindy Washburn of NorthJersey.com

You can follow USA TODAY reporter Nathan Bomey on Twitter @NathanBomey and subscribe to our free Daily Money newsletter here for personal finance tips and business news every Monday through Friday morning.

This article originally appeared on USA TODAY: Health insurance charge for not getting COVID vaccine? It could happen

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Won't get a COVID-19 vaccine? Some bosses may charge you $20 to $50 more for health insurance on every paycheck - Yahoo! Voices

Some people are reportedly disguising themselves while getting the Covid-19 vaccine so that their ... [+] friends and families don't know. This isn't an example of that. It's a nurse injecting a performer in a bear costume with the Sputnik V vaccine in Russia. (Photo by Gavriil GrigorovTASS via Getty Images)

There havent been any high school genre movies entitled The Fully Vaccinated Breakfast Club or Mean Antivaxxers just yet. But apparently some people who want to get vaccinated against Covid-19 may be facing high school-type peer pressure or even bullying. In the following video, Priscilla Frase, MD, the chief medical information officer for Ozarks Healthcare, described how her patients said they actually had to don disguises while getting vaccinated so that their family members and peers wouldnt find out:

Ozarks Healthcare is based out of West Plains, Missouri. As of today, only 42.1% of the total Missouri population and 49.3% of the 12 years and older population are fully vaccinated, according to Missouris Covid-19 Dashboard. So if you are fully vaccinated in Missouri, you still may be in the minority in your community.

Welcome to the High School Musical thats America 2021, where grown adults actually have to hide doing something that may benefit themselves and others. Were in the middle of a Covid-19 coronavirus pandemic, a public health emergency. The more contagious Delta variant is spreading. And there are people actually judging and stigmatizing others who get vaccinated?

OK, its not clear how many people have actually had to resort to wearing a disguise. Its also not clear how elaborate these disguises may have been. Wearing a hat or some glasses a la Clark Kent or Kara Danvers is one thing. Dressing up as a hot dog and telling others that your first name is Hot and your last name is Dog is something completely different.

Nonetheless, its not surprising that people may resort to disguising themselves. After all, political leaders and others pushing anti-vaccination messages have politicized and culturalized vaccination to a rather high schoolish degree. Its been sort of like how high school bullies try to arbitrarily label some activities as cool and others as loserish. Theyve turned getting vaccinated and taking Covid-19 precautions into us versus them cliques.

United States Representative Matt Gaetz has sidestepped questions about whether he's been vaccinated ... [+] against Covid-19. (Photo by Chelsea Guglielmino/Getty Images)

So as a result, some people may be reluctant to admit whether theyve been vaccinated, sort of like how jock Mike Dexter hid that he hung out with nerdy guy William Lichter in the movie Cant Hardly Wait. On July 22, Annie Grayer, Lauren Fox and Sarah Fortinsky reported for CNN that nearly half of Republicans in the U.S. House of Representatives have not revealed publicly whether theyre vaccinated against Covid-19. They quoted Rep. Matt Gaetz (R-Florida) as responding that's very nosy of you, when asked about his vaccination status, and saying, I think we should be talking more about freeing Britney. So essentially, Gaetz seemed to be saying dont hit me baby one more time with that question.

Then theres Fox News host Tucker Carlson, whos been called a superspreader of Covid-19 vaccine fears by HBO TV host John Oliver, as I described previously for Forbes. Hes been quite a Tucker when talking about vaccines. Yet, as Charlotte Alter reported for Time, when she asked Carlson about his vaccination status, he wasnt exactly forthcoming. He reportedly replied: Because I'm a polite person, I'm not going to ask you any supervulgar personal questions like that. Supervulgar? Its not as if the reporter was asking Carlson whether he has autoplushophilia, which according to a HuffPost article is arousal to oneself dressed as a giant cartoon-like stuffed animal. Or xylophilia, which is arousal to wood and not the kind of wood that you might expect.

Tucker Carlson has sidestepped questions about whether he's been vaccinated against Covid-19. (Photo ... [+] by Janos Kummer/Getty Images)

As with high school cliques and bullies, you cant always tell if someone is taking a stance because he or she actually believes in that position or because it portrays a certain image.

Its one thing to not get vaccinated yourself because you have questions about the Covid-19 vaccine or dont want to feel pressured into getting vaccinated. Thats understandable. Not everyone has the same knowledge and level of comfort with the Covid-19 vaccine. In such a situation, it make sense to talk to a real legitimate medical expert to better understand the risks that you may face. After all, you dont want to be putting yourself in danger of getting Covid-19 just because you have a misconception about the vaccine.

However, its something completely different to pressure others to not get vaccinated. Someone around you getting vaccinated does not pose a risk to you. Theres no evidence that a Covid-19 vaccine alone will cause someone to shed the virus, despite what some anonymous social media accounts are trying to tell you. If you want others around you to not get the vaccine just because you dont want to, thats high schoolish. And if youre telling others to not get vaccinated even though you yourself got vaccinated? Well, theres plenty of high schoolish names for that with none of them being very nice.

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Some May Be Getting Covid-19 Vaccines In Disguise To Hide Vaccination Status - Forbes

CNN

Pfizers Covid-19 vaccine is currently only authorized for emergency use in the United States, but its full approval by the US Food and Drug Administration could happen within weeks.

The ramifications could alter the course of the pandemic in several ways.

First, full approval of a Covid-19 vaccine could persuade more people to get vaccinated.

More than 30% of the eligible population in the United States still hasnt gotten a vaccine.

To qualify for emergency use authorization, Covid-19 vaccine makers submitted about three months of clinical trial data. This included at least 2 months of safety data on fully vaccinated participants, since most vaccine side effects occur 2-3 months after the vaccination.

For some Americans, that hasnt been enough data to convince them to get the shot.

Full approval of a Covid-19 vaccine requires much more data, including safety and efficacy data generated in the real-world, outside of a clinical trial. The CDC has been tracking real-world data on the vaccines and more than 165 million people in the US are now vaccinated against the virus.

The extra data may help convince more people that the vaccines are not dangerous.

For some, getting a full FDA approval will help allay that fear. Even if its just a relatively small number of people. Every little bit helps against this virus, Dr. David Dowdy, an associate professor in the division of infectious disease epidemiology at Johns Hopkins Bloomberg School of Public Health, said.

Three in ten unvaccinated adults said they would be more likely to get vaccinated if one of the vaccines moves to full approval, according to a survey from the Kaiser Family Foundation.

However, Kaiser cautioned that some people it surveyed were confused about the shots. Two-thirds thought the vaccines already had full approval or they were unsure about it. This finding may just mean that full approval is a proxy for general safety concerns.

Dr. Michael Wolf, the Associate Vice Chair for Research, Department of Medicine at Northwestern Feinberg School of Medicine expects approval would get about 5-10% more individuals worried about safety to get vaccinated.

The FDA is currently working around the clock on approval of the Covid-19 vaccine, according to Dr. Paul Offit, a prominent member of the FDAs vaccine advisory committee and director of the Vaccine Education Center at the Childrens Hospital of Philadelphia.

I think from the standpoint of the public, it really shouldnt matter, Offit said. Its been given to half of the American population. We have more than 300 million doses out there. This is far from experimental. We have a tremendous safety and efficacy portfolio on these vaccines I mean, its more than most licensed products that are out there now.

And yet he recognized that, at least for some, it does matter. He said the FDA knows that, too.

I think they realize that at least theres a psychological issue with how these vaccines are viewed, in terms of whether theyre a licensed product or just approved through EUA, Offit said.

Full approval of a Covid-19 vaccine could also make workplace mandates easier. Many unvaccinated people would face a financial reason to get one; theyll need it to keep their jobs.

FDA approval alone is not going to make many individuals run out and get it now, but youre going to start seeing health systems and employers feel more emboldened to require them, Wolf said. Theres precedent for mandatory vaccinations and immunizations.

Workplaces already have the legal authority to mandate the Covid-19 vaccine, according to the US Equal Employment Opportunity Commission. But full approval could give any legal challenge less potency.

FDA approval is the gold standard. The worlds regulators look to our FDA as the beacon when it comes to such issues as this, George Karavetsos, a legal expert who had worked at the FDA and now provides strategic advice to FDA regulated companies as an attorney at Buchanan Ingersoll Rooney, said. I can assure you, theyre going to make sure they got this right.

Erik Nisbet, the Owen L. Coon Endowed Professor of Policy Analysis & Communication and director of the Center for Communication & Public Policy in the School of Communication at Northwestern University, agreed.

If you ever want to get beyond 70% threshold of people who have gotten a vaccination so far, you need to have carrots and you have to have sticks, Nisbet said. The only way to do that is the mandate. Authorization takes out one of the impediments to more widespread mandates.

Full approval may also provide political cover to get more people vaccinated. On Wednesday, Louisianas Governor John Bel Edwards said he would not consider requiring the vaccine for state employees unless and until the FDA grants full licensure to one of more of the Covid vaccines. The state has the highest per capita number of cases of any state and one of the lowest vaccination rates.

San Francisco announced that it would require all city employees to be vaccinated no later than 10 weeks after FDA full approval.

Full approval may even be able to override laws like the one in Ohio that bans vaccine mandates under emergency use authorization, according to Nisbet.

Approval kicks that out of the way, he said.

Full approval may also mean that the fully vaccinated could get an additional vaccine, even before boosters are approved.

Approval will make it easier for physicians to give the vaccine off label, Dowdy explained. If people can convince their doctor they need one.

Many scientists hope people wont do that. While a number of clinical trials are underway, boosters are not yet recommended by the FDA and the CDC.

Trials have shown immunocompromised people may not respond as well to the vaccines and may need a booster. There is an effort to make boosters for that population available very soon, Dr. Anthony Fauci, head of the National Institutes for Allergies and Infectious Diseases, said on Tuesday.

Right now, what we really want to do is get the patient population here in the US to at least get one shot and not get ahead of the data, said Melissa Tice, program director of regulatory affairs and assistant professor of clinical research and leadership at George Washington University School of Medicine & Health Sciences. Hopefully, approval will at least get more people to get their first dose.

It remains unclear how having a fully licensed coronavirus vaccine may impact the timeline of authorizing or approving the coronavirus vaccines for children younger than 12 if at all, Offit said.

The Pfizer/BioNTech Covid-29 vaccine is currently authorized for ages 12 and older, whereas the Moderna and Johnson & Johnson vaccines are authorized only for adults 18 and older.

Does getting full approval for an adult vaccine, does that matter in terms of speeding up the process for approval for the childhood vaccines? I think the answer to that question is probably no, Offit told CNN on Friday.

Overall, this is all sort of new territory the notion of emergency use authorization obviously is new, certainly for vaccines that have been used to this extent. We had EUAs for anthrax vaccines, but thats not this, he said. Im not sure how the FDA views this.

CNNs Jacqueline Howard contributed to this report.

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FDA approval of the Covid-19 vaccine could mean more people will get vaccinated for an unexpected reason - CNN

After a Sunday service at the Church of God Christian Life Center in Dorchester, parishioners trickled into a pop-up clinic in the back room, where a nurse from Boston Medical Center prepared a dose of the Johnson & Johnson COVID vaccine for Irlande Aime, who fidgeted nervously in a folding chair. The 34-year-old Dorchester resident said the vaccines fast-tracked development had made her hesitant about getting the shot for over a year now even as the virus tore through her community and she was treating COVID patients last year as a nurse at Carney Hospital.

Tori Bedford / GBH News

I wanted to wait because it was something that just happened so suddenly, it was too rapid, too fast, Aime said. Before theres new medication, you must have research, and the research must be for a period of time.

After the state's mass-vaccination clinics shut down in May, health officials focused on targeting harder-to-reach populations, opening pop-up clinics in houses of worship, senior centers, YMCAs and other community organizations. As of last week, the DPH Mobile Vaccination Program has delivered more than 85,000 doses via 1,577 community-based and state-sponsored vaccination clinics across the state, including the Vax Express, Market Basket clinics, school-based clinics, community-based clinics with centers of worship, community-based organizations and cultural groups all hosting events, according to the Office of Health and Human Services.

A spokesperson for the citys mobile vaccination effort told GBH News that the Boston Public Health Commission does not have public data on the number of people who have been vaccinated at clinics across the city.

At pop-up clinics like the one at the Church of God, Boston Medical Center has distributed 1,223 vaccine doses. Over a slightly longer period, since February, BMC has distributed roughly 41,000 vaccines at mobile clinics across Boston. Black and Latino residents have made up 68% percent of those vaccinated at the clinics.

The effort has been a slog in a hard-hit section of Dorchester and in Mattapan, the neighborhood with the lowest percentage of fully vaccinated residents in the city, 40.9%. In those neighborhoods, the clinics have fought against misinformation circulating among Haitian immigrants and a longstanding distrust of the health care system among Black Americans rooted in a history of mistreatment.

The Mattapan Community Health Center has been running a small vaccination clinic out of its Blue Hill Avenue facility since December and offers free walk-in vaccinations. More than 2,000 people have received their first dose of the vaccine, and unvaccinated patients are offered on-site doses during their doctors visits.

We find that most people say no, said Guale Valdez, the centers CEO. The majority of our patients, over 90%, identify as either Black or brown, and thats where the greatest hesitancy is.

The health center hosts town halls and distributes public service announcements that include testimonies from clinic staff who give their reasons for getting vaccinated: to protect family members, travel and visit their elderly relatives. Still, Valdez says hesitancy is pervasive and difficult to combat.

What were being told is, its going to cause infertility, that there are trackers in the vaccine, that not enough time has been was given to develop the vaccine, that its not safe, Valdez said. We counter that with very rational, very supportive facts. We always approach whoevers interested, whoever were talking to, in a culturally respective way also, in the languages that we speak here, English, Haitian Creole and Spanish.

Tori Bedford / GBH News

Emmanuel Dieujuste, a Dorchester resident who like Aime is Haitian, got his first shot at the Dorchester pop-up clinic after reports of rising cases of the Delta variant. But for over a year, he said he was frightened by what he saw on social media sites.

I saw on social, it was scary, Dieujuste said. People got different reactions and were warning about it.

In Mattapan, Rev. Dieufort Keke Fleurissaint runs a small clinic out of the Immigrant Family Services Institute on Blue Hill Avenue. The clinic has vaccinated 312 people, and an outreach team regularly fans out across Mattapan Square, urging people to come in and get the vaccine but Fleuressant says some residents are uncomfortable with the idea.

People say the vaccine was developed too fast, the AIDS epidemic has been happening for decades and they still dont have a vaccine to combat that, Fleurissaint said. People say the vaccine is designed to reduce the Black race, that it contains a tracking system. Some people say the vaccine is the mark of the beast, in the apocalypse, people who took the vaccine will be identifying with the beast. There are many myths about the vaccine.

Misinformation on social media exists in every culture, but Fleurissaint says hes wary of misinformation coming out of Haiti, which has the lowest COVID-19 vaccination rate of any country in the world, and its impact on Mattapan, which has the largest Haitian community in the state.

Tori Bedford / GBH News

We are facing many patients who definitely get the misinformation regarding the vaccine, especially information coming from Haiti regarding the vaccine, he said.

Another factor thats holding Mattapan back is a more general mistrust of the medical system within the predominately Black community, one thats rooted in history, including an infamous 1932 study of syphilis that left Black men in Tuskegee, Ala., suffering with the disease.

But it can make a difference if people see and hear leaders from their community advocating for the vaccine.

Trusted voices are extremely important, leaders in the community, pastors, priests, Fleurissaint said. I call into Haitian radio and invite people to join me, and then Ive had three or four people say, I wasnt going to take the vaccine, but the fact that you said, Come right now, Im taking the vaccine.

In a recent interview on a community station called Boston Praise Radio, Claudine Bruff-Lopes, a nurse from the New England Regional Black Nurses Association, spoke with local activist and City Council candidate Leonard Lee about the more general racial disparity in health care treatment that she says has affected the vaccine rollout.

We see disparities and the gaps in care with Black and brown people going to the emergency room, not receiving timely care in the emergency room and not getting the adequate care or medication as our Caucasian brothers and sisters, Bruff-Lopes said. That is real. It does happen. Cultural competency in health care providers definitely needs to be improved and not just with a Black and brown community, but also Asians and Guatemalans. We need to really be sensitive and educate ourselves on other cultures.

State officials say the roughly 900 small mobile clinics focusing on the 20 hardest-hit communities is also an effort to make getting vaccinated convenient for people like Cherlie Noel, a 35-year-old Brockton resident who doesnt speak English. Noel says she struggled to schedule and access a vaccine appointment until last month.

I just couldnt find the time, Noel said through a Spanish translator.

Tori Bedford / GBH News

Last month, Massachusetts state health officials reported a record-breaking uptick in COVID-19 vaccinations with more than 19,000 new doses administered. About 65% of the states residents have received at least one dose.

As long as its needed, state health officials and community leaders plan on operating smaller mobile clinics as a way to reach out to non-English speakers, immigrants and communities of color.

We have to make sure that every person who should get a vaccine has a vaccine available to them, Valdez said. Were just going to continue. We dont have a time frame. Were just, were just going to keep doing it for however long it takes.

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Bringing The COVID-19 Vaccine To Boston's Hardest-Hit Communities Is A Battle Against Hesitancy, Misinformation - wgbh.org

WILMINGTON, Del. The U.S. governments top infectious disease expert, Dr. Anthony Fauci, said Sunday that he was hopeful the Food and Drug Administration will give full approval to thecoronavirus vaccineby months end and predicted the potential move will spur a wave of vaccine mandates in the private sector as well as schools and universities.

The FDA has only granted emergency-use approval of the Pfizer PFE, +0.02%, Moderna MRNA, -0.61% and Johnson & Johnson JNJ, -0.33% vaccines, but the agency is expected to soon give full approval to Pfizer.

The Biden administration has stated that the federal government will not mandate vaccinationsbeyond the federal workforce, but is increasingly urging state and local governments as well as businesses to consider such mandates. Fauci, who is President Joe Bidens chief medical adviser, said mandates at the local level need to be done to help curb the spread of the virus.

I hope I dont predict I hope that it will be within the next few weeks. I hope its within the month of August, Fauci said of FDA approval of the vaccine. If thats the case, youre going to see the empowerment of local enterprises, giving mandates that could be colleges, universities, places of business, a whole variety and I strongly support that. The time has come. Weve got to go the extra step to get people vaccinated.

Faucis comments come as the Biden administration is weighing what levers it can push to encourage more unvaccinated Americans to get their shots as thedelta variant continues to surgethrough much of the United States.

Biden recently approved rules requiring federal workers to provide proof of vaccination or face regular testing, mask mandates and travel restrictions. Biden is alsoawaiting a formal recommendation from Defense Secretary Lloyd Austinon potentially requiring U.S. troops to get vaccinated.

The administration has become more vocal in its support of vaccine mandates at a moment when high-profile companies have informed employees that coronavirus vaccination requirements are in the works, and some localities have adopted or are contemplating vaccine requirements to dine indoors.

United Airlinesinformed its employeesthat they will need to be fully vaccinated by Oct. 25 or five weeks after the FDA grants full approval to one of the vaccines whichever date comes first.

Disney and Walmart have announced vaccine mandates for white-collar workers, and Microsoft MSFT, -0.02%, Google GOOGL, -0.38% GOOG, +0.07% and Facebook FB, +0.15% said they will require proof of vaccination for employees and visitors to their U.S. offices. Tyson Foods TSN, +1.40% has also announced it will require all U.S. employees to get vaccinated by November.

Theres also been pushback.

The U.S. Supreme Court last weekwas asked to block a planby Indiana University to require students and employees to get vaccinated against COVID-19. Its the first time the high court has been asked to weigh in on a vaccine mandate and comes as some corporations, states and cities are also contemplating or have adopted vaccine requirements for workers or even to dine indoors.

Randi Weingarten, president of American Federation of Teachers union, said on Sunday that she personally supports a vaccine mandate for educators.

As a matter of personal conscience, I think that we need to be working with our employers not opposing them on vaccine mandates, said Weingarten, who estimated about 90% of AFT members are already vaccinated.

Dr. Francis Collins, director of the National Institutes of Health, on Sunday all but endorsed vaccine mandates, saying, I celebrate when I see businesses deciding that theyre going to mandate that for their employees.

Yes, I think we ought to use every public health tool we can when people are dying, Collins said.

Fauci and Weingarten spoke on NBCs Meet the Press, and Collins appeared on ABCs This Week.

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Fauci hopeful COVID-19 vaccine will get FDA's full approval within weeks - MarketWatch

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A nurse in Athens, Ohio, loads a syringe with a Covid-19 vaccine on March 9, 2021.

CNN

An Ohio man says he will not get vaccinated despite a judge ordering him to get a Covid-19 vaccine shot as a condition of his probation.

Judge Christopher Wagner ordered defendant Brandon Rutherford to get vaccinated within 60 days of his court appearance August 4 or face jail time, Rutherfords attorney, Carl Lewis, told CNN on Sunday.

Wagner said in a written statement to CNN that his role in the court is to rehabilitate the defendant and protect the community.

Im not taking the vaccine, Rutherford told CNN.

Rutherford said he was kind of shocked when the judge told him he had to get vaccinated as a condition of his probation. He said he wore a mask to court because hes unvaccinated. While masks are not required at the Hamilton County Courthouse, non-vaccinated individuals are encouraged to mask up inside, the courts website shows.

This defendant was in possession of fentanyl, which is deadlier than the vaccine and COVID 19, Wagner said. The defendant expressed no objection during the proceedings and stated no medical concerns, and his attorney did not object.

It isnt uncommon for judges to make decisions to protect a defendants health, Wagner added, which can include ordering various health treatments.

Lewis said that they are going to wait until the 60 days are up to see what the judge does before requesting a hearing or filing any opposition to the order. This is the first time hes heard of a person being ordered to get the vaccine as a condition of their probation, he added.

Rutherford was sentenced to two years probation for possession of fentanyl, court records show.

CNNs Raja Razek and Alaa Elassar contributed to this report.

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An Ohio judge ordered a man to get a Covid-19 vaccine as a condition of his probation - CNN