Category: Covid-19 Vaccine

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Even Some Health Care Workers Refuse To Get The COVID-19 Vaccine – NPR

September 19, 2021

Nurse Katrina Philpot (left) protests against COVID-19 vaccine and mask mandates in Santa Fe, N.M., in August. Cedar Attanasio/AP hide caption

Nurse Katrina Philpot (left) protests against COVID-19 vaccine and mask mandates in Santa Fe, N.M., in August.

As new data shows 1 in 500 Americans has died from COVID-19 and the delta variant continues to surge across the country, the next challenge many health care leaders face is within their own staffs: the 27% of of U.S. health care workers who have not been vaccinated against the disease as of July, according to a study by The COVID States Project.

On top of that, other research shows that since the vaccine first became available to health care workers in December 2020, the rate of vaccination among nurses and nursing home aides has been lower than that of physicians. This may be of particular concern because nurses and aides have such frequent and close contact with patients.

Data shows health care workers have gotten the COVID-19 vaccine at a higher rate than the general population: 73% versus 64% of non-health care workers. And many may assume that people who work in health care industry are more enthusiastic about the vaccine and less apprehensive.

But there are limits, says David Lazer of Northeastern University, the lead researcher on The COVID States Project report. The attitudes of health care workers toward the COVID-19 vaccine essentially mirror the rest of the country with those living in rural areas, are Republican and have less education and income more likely to be vaccine-resistant.

"The big takeaway for us is really that health care workers are like everyone else," Lazer tells NPR.

"The same things that predict vaccine resistance or reluctance among the general population is also predicted among health care workers," he says.

Melody Butler, a nurse at Long Island Community Hospital in New York and the executive director of the nonprofit Nurses Who Vaccinate, says she has heard from nurses across the country about why they don't want the vaccine.

Among the reasons: The research was done too quickly; it wasn't fully FDA-approved (at first); they already have antibodies from working the front lines of the pandemic or perhaps from getting the virus already. Many are concerned about how the vaccine affects fertility.

To be clear, all of these concerns have been addressed by scientific experts, and the overwhelming evidence is that the COVID-19 vaccines are safe and effective.

Demonstrators protest COVID-19 vaccine mandates in New York this week. Attitudes among health care workers about getting vaccinated have largely mirrored data from the general population, researchers have found. Bloomberg via Getty Images hide caption

Demonstrators protest COVID-19 vaccine mandates in New York this week. Attitudes among health care workers about getting vaccinated have largely mirrored data from the general population, researchers have found.

But Butler points out that widespread misinformation plays a role here, too. And nurses are not taught the ins and outs of vaccine research. The vaccination gap between physicians and nurses, she says, comes down to an education gap.

"When you have these new diseases popping up, it's really on nurses to educate themselves on what the research is," Butler says. "You had nurses who were floundering, looking for information. So now we see this educational gap."

"We are seeing the nurses who weren't trained to recognize poorly written studies; they weren't trained to recognize anti-vaccine propaganda," she says. "And it's very convincing. That's what our struggle is in the nursing community."

Butler says her concern for getting nurses across the country vaccinated is that she wants them to be safe and protected. The best way for health care leaders to get their colleagues inoculated against COVID-19, she says, is to operate from a place of compassion.

They need workplaces that "speak to individuals in a compassionate and kind manner," she says. "Knowing that the person talking to you wants you to get vaccinated not because it's the law, but because they care."

While a majority of nurses are vaccinated and more than half support vaccine mandates in the workplace, some are pushing back against requirements to get vaccinated or face mandatory testing and say they would rather leave their jobs. And hospitals are already feeling the effects.

One New York hospital announced that it would no longer be able deliver babies because dozens of staff members quit rather than get vaccinated. In Houston, 153 hospital workers resigned or were terminated over a recent vaccine mandate. It's a crisis on top of the widespread shortage of nurses that's been a problem since even before the pandemic.

Some hospital leaders like Alan Levine, CEO of Ballad Health based in Johnson City, Tenn. say they can't afford to implement a vaccine mandate for their staff of which about 63% are already vaccinated. Enough nurses would leave, Levine says, that the hospitals wouldn't be able to take care of patients.

"We have about 6,000 nurses in our system," he says. "If we are five or 10 nurses down in our system, we feel it."

Levine says that right now, all of the ICU beds in the hospital system are full at least half with COVID-19 patients.

McNairy Regional Hospital in Selmer, Tenn., is just one of the rural hospitals that has shut down in the state in recent years. The nursing shortages in the U.S. have long affected rural hospitals the hardest. The Washington Post via Getty Images hide caption

McNairy Regional Hospital in Selmer, Tenn., is just one of the rural hospitals that has shut down in the state in recent years. The nursing shortages in the U.S. have long affected rural hospitals the hardest.

The nursing shortages in the U.S. have long affected rural hospitals the hardest. In Tennessee, 14 rural hospitals have closed since 2012, leaving behind thousands in communities that already struggle to find care.

Levine says he's not yet sure how President Biden's national vaccine mandate for health care workers will impact his hospitals, but he has concerns about how it will affect rural health care providers.

"I understand why the president felt the need to announce these mandates nationally, but each region of the country is different," Levine says. "In rural areas, it's very difficult."

"I have to keep as many nurses as I can who are capable of taking care of our community," he says.

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Even Some Health Care Workers Refuse To Get The COVID-19 Vaccine - NPR

Is It Safe to Get a Flu Shot and COVID-19 Vaccine Together? – GoodHousekeeping.com

September 19, 2021

Americans may be wondering about flu shots as the future of how additional doses of the COVID-19 vaccine will be administered to millions of people. While officials at the Food and Drug Administration (FDA) decide when more than just immunocompromised people can receive another immunity-boosting dose, there's more than a good chance that flu shot season overlaps with your timeline for another COVID-19 vaccine.

FDA officials previously determined that anyone who received a two-dose mRNA vaccine should seek another dose around eight months after their final booster dose; for many, that will fall in November, December, and January, the peak of flu season here in the United States. On Friday, September 17, the FDA group known as the Vaccine and Related Biological Products Advisory Committee voted to move forward on this timeline for those over the age of 65.

Those in that age group wishing to plan a timeline for a third COVID-19 vaccine or, if you're hoping to begin the vaccination process now that the Pfizer shot has full FDA approval you may be wondering if there's a way to work in your seasonal flu vaccine. Officers at the Centers for Disease Control and Prevention (CDC) have planned to encourage Americans to indeed seek both, as they're both essential to lower health risks this winter (in fact, burgeoning news reports indicate teams at Moderna are working on a joint flu-and-covid shot).

CDC Director Rochelle Walensky, M.D., MPH, previously told Good Housekeeping that it's best to receive a flu shot by the end of October, as it takes at least two weeks for flu antibodies to build up within your immune system. Since many are acutely aware of the side effects associated with COVID-19 vaccines, they may be wary of getting a flu shot before getting another vaccine dose, or vice versa. But Dr. Walensky and other top federal health officials have indicated that this shouldn't be a concern here's why.

The short answer? Yes! You may be confused if you've heard advice against this tactic, though, as previously CDC officials recommended waiting at least two weeks between a COVID-19 vaccine and any other shot. After having almost a full year to monitor these new vaccines, the agency has updated its instructions to reflect the current understanding of vaccination in general, as immune responses are usually unaffected by receiving more than one vaccine at a time. "You can get a COVID-19 vaccine and other vaccines in the same visit," Dr. Walensky says. "CDCs recommendation has been updated so that you no longer need to wait 14 days between getting your COVID-19 vaccine and other vaccinations."

Currently, CDC officers are working to further educate professionals from physicians to pharmacists on administering the flu shot alongside other vaccines. "Based on our prior experience and knowledge of immunology, we do not anticipate any unusual or unexpected safety problems with receiving COVID-19 vaccines and flu vaccines at the same time," she adds.

The flu shot isn't expected to make any potential side effects associated with COVID-19 vaccines particularly arm tenderness or chills, fatigue, or fever worse than it would be if you had got them separately. Dr. Walenksy indicates that an immune system often responds to multiple vaccines with the same potential side effects that have already been well documented; getting vaccinated against the seasonal flu and COVID-19 won't create new side effects altogether.

It's true that there is a lack of robust research on administering COVID-19 vaccines alongside other vaccines, given how new they are to the scientific community. But doctors in the field aren't worried that a combination of the two vaccines will heighten any side effects the biggest concern, at best, could be two sore arms, says William Schaffner, M.D., the medical director for the National Foundation for Infectious Diseases.

"I personally wouldn't want two sore arms at the same time and so if you would wait at least a week between the two, you won't [face the possibility of] simultaneous adverse events," he tells us.

If you're someone who has a well-documented history of experiencing side effects after a flu shot such as a sore arm, or a bit of a fever on the day of you may wish to space the two out for your own personal comfort. All side effects are temporary, but the likelihood of you experiencing a potential side effect (and how mild or severe it may be) may be influenced if you decide to get both shots at the same time, Dr. Schaffner explains.

Currently, pharmacists at CVS and Walgreens, as well as retailers like Walmart and Target, are offering appointments for flu vaccinations online.

While the flu posed less of a threat to Americans during the socially distanced winter earlier this year, there's mounting evidence that influenza may pose more of a threat now than ever. "We know that antibodies that protect against flu wane over time; this means there may be many people, both children and adults, who have less immunity against flu this season than during previous seasons because they werent exposed to flu last year," Dr. Walensky warns.

It's crucial to ensure that you receive both vaccines, as they're equally important do not prioritize one over the other, especially if you are older than 65. "Everyone six months and older should get their flu vaccine each season," she says, adding that those at higher risk for severe flu complications should start planning their vaccine timeline now. "This includes adults 65 years and older, people with certain chronic health conditions asthma, diabetes, and heart disease pregnant people, and children younger than 5 years old."

This article is meant to be educational in nature and isn't a substitute for actual medical or treatment advice from a licensed professional. Please consult your primary health care provider to determine which vaccinations and vaccine schedules are best for you.

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Is It Safe to Get a Flu Shot and COVID-19 Vaccine Together? - GoodHousekeeping.com

A murky battle over religious beliefs and COVID-19 vaccination continues – The Boston Globe

September 19, 2021

There are thousands and thousands of people I have helped with religions exemptions, Corrigan calmly assured the people who kept listening to her advice well past 11 p.m. We are the majority and we have been silent.

None of the major religions officially oppose vaccination, but that hasnt stopped a growing cottage industry from helping people devise religious arguments to get out of taking a COVID-19 shot. Some try to link vaccine research to aborted fetal tissue, while others, including Corrigan, reference passages from the Bible that, they say, suggest vaccinations make sacred blood impure.

Now, in the wake of President Bidens recent order mandating COVID shots for roughly 80 million Americans, the push to vaccinate has grown more fervent. So, too, has the pushback by people who insist the shots violate their religious beliefs.

It started with a trickle earlier this year, maybe helping three or four people navigating mandates, but some days now we are getting 1,500 e-mails and our phone bank wont stop ringing, said Harry Mihet, chief litigation counsel at Liberty Counsel, a Florida-based evangelical organization that has filed lawsuits on behalf of people opposing abortion, same-sex marriage, and COVID vaccines.

As more and more people are having to deal with these mandates, the number of those opposed to them will increase, not because people are all of a sudden getting religious, Mihet said, but because they have to all of a sudden make decisions.

Federal civil rights law requires companies to accommodate religious beliefs that are sincerely held, putting employers at risk of a lawsuit if they dont make allowances for employees faith-based claims.

But determining sincerity in a country deeply divided over COVID mandates has become a tense exercise, a journey into uncharted territory. Employers and human resource officers are keenly aware of the growing number of lawsuits challenging mandatory shots.

A federal judge last month dismissed a lawsuit against the University of Massachusetts over its requirement that students be fully vaccinated against COVID-19 before returning to campus. One of the students had claimed a religious exemption, saying she is a Roman Catholic, yet acknowledged she received other vaccines in her late teenage years including flu shots.

But on Tuesday, another federal judge, this one in New York, temporarily blocked that state from forcing health care workers to be vaccinated against COVID after a group of workers sued because New Yorks mandate did not allow religious exemptions.

Corporate squeamishness on the subject is apparently widespread; several companies and universities contacted by the Globe for this story declined to comment about their process for granting religious exemptions.

Others, such as State Street Corp., a Boston-based global financial services company with about 9,000 Massachusetts employees, provided only general statements. State Street requires employees to be vaccinated, but doesnt ask questions if someone claims a religious exemption.

We are not asking employees for any documentation [for exemptions] but reserve the right to do so, read the State Street statement.

John Dooney, an adviser for the Society for Human Resource Management, said that before COVID, most companies rarely encountered requests for religious exemptions. Now, he said, the trade association for human resource leaders is receiving more calls seeking guidance on matters of faith, and is advising companies to be consistent, such as using a core group of reviewers, to ensure consistency in their decisions.

But Dooney also advises that each employees request be judged on its own merits.

It cant be everyone who is this religion gets this type of accommodation, he said.

During Corrigans recent late-night Zoom session, attendees from New York, Ohio, and other states sought tips on how to best word their responses on religious exemption request forms from their employer.

Corrigan suggested attendees not answer questions about their religion on the forms. Instead, she recommended people write on the document please see attached.

The forms, I strongly believe, are meant to trip you up, they ask you difficult questions, Corrigan told the group. Your employer, your school is trying to deny you, in many cases they are just trying to deny you.

Nearly two hours into the session, several attendees still had questions. Corrigan, meanwhile, promised two more online teach-ins the next week. They typically run three hours and cost $25 per person.

Corrigan, who was home-schooled from the age of 8 until college, told the Globe that she has never been vaccinated. She describes her own faith as Christian, but strongly values Buddhist principles. She traces her passion for religion to a long line of ancestors who, she said, fought for religious freedoms. Her goal is to be ordained as a minister and go to law school.

I am called to do this, to support people, she said And protect their right to bodily autonomy.

Corrigans teachings dont exactly mesh with the tenets of many religions that espouse an obligation to society, said Dr. Michael Grodin, an emeritus professor of health law, ethics and human rights at the Boston University School of Public Health. Grodin long taught a course on religious bioethics that examined the controversy inherent in major public health issues, including exemptions to mandatory vaccination.

The notion of protection of life is critical to this discussion, and the risk to others and not just to ourselves, Grodin said.

Most religions have no prohibition against vaccinations. A very few, such as Dutch Reformed Congregations and Faith Tabernacle, do have concerns, according to Vanderbilt University Medical Center research. Christian Science, which teaches that disease can be cured or prevented by prayer, does not prohibit the shots.

The church has made a point to let its members know there is no pressure or judgment for whether one chooses to vaccinate or not, said Kevin Ness, a church spokesman. Christian Scientists share a concern for public health and safety and remain mindful of the responsibility all citizens have to follow government requirements and respect the rights of others.

Among those who object to the COVID vaccine, some cite misconstrued information linking the shots to abortion. During testing or development of the three COVID vaccines available in the United States, researchers essentially reproduced cells that were originally obtained in the 1970s and 1980s from elective abortions. Many Catholic leaders, including Pope Francis, have said the COVID shots are morally acceptable. Historical fetal cell lines have been used to create vaccines for other diseases such as hepatitis A, rubella, and rabies.

The Rev. Laura Everett, executive director of the Massachusetts Council of Churches, argues that vaccines can be seen as a manifestation of Gods care and concern.

Its possible to understand Gods care for us at this moment as coming through the vaccines, as coming through God-given wisdom and hard work by those who have studied and developed the vaccines, she said. This is a gift from God, and I am not in the business of turning down gifts from God.

But Corrigan, the Boston University theology student, suggests otherwise

On her website, Students Against Mandates, she includes links to scriptural passages to include in applications for religious exemptions as well as detailed steps for writing one. Corrigan also advises that contamination of blood is usually the first problem for vaccines for all faiths.

While there are many passages about blood in the Bible, the one denomination that typically asserts concerns about purity, often regarding blood infusions, are Jehovahs Witnesses, said Grodin, the retired BU professor. But even they promote vaccination.

Corrigan founded Students Against Mandates in June, as colleges and universities were among the first to widely adopt COVID vaccine mandates.

Colleges have taken different approaches to exemptions, with some requiring a signed letter from a religious official that describes the religious tenet that precludes vaccination, while others accept personally written statements from a student or employee describing the religious basis for the objection.

A University of Massachusetts spokesman said theyre compiling numbers from their five campuses, but expect just over 1,000 student religious exemption requests out of 75,000 UMass students.

We expect that well over 80 percent of those student exemption requests to be granted, the spokesman said. Any student granted an exemption is required to undergo at least weekly testing.

For Corrigan, who calls COVID testing nasal rape, such rules are unfair.

People need to say no and take a stand, she said in closing her recent online class, with more than 140 people still on the session. As a stream of Amens and other comments wound down in the written chat section of the session, Corrigan concluded.

I will be praying for you all, she said.

Kay Lazar can be reached at kay.lazar@globe.com Follow her on Twitter @GlobeKayLazar.

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A murky battle over religious beliefs and COVID-19 vaccination continues - The Boston Globe

The Detroit Free Press’ Sunday edition is dedicated to COVID-19 vaccines. Here’s why – Detroit Free Press

September 19, 2021

At the Free Press, truth-telling is at the very heartof what we do.Although we live in a time when many are not willing to accept the truth, we have a duty as a news institution to keep delivering it. And that is our purpose today: to deliver the truth about COVID-19and vaccines.

The vaccines are safe andeffective, and supported by science. They are widely available, free of charge.

And they can help to end the pandemic and bring us closer to what was once normal.

Yet a large percentage of Americans and Michiganders are unvaccinated. To be sure, some have legitimate questions about the safety of vaccines. We answer those this week in a special reporting project. But many others have passed on vaccinations for reasons of ideology or buying into conspiracy theories. We ask you to consider the health of others, to read into what our reporting has found and to think deeply about it.

We lead today's newspaperwith a front-page editorial an expression of opinion which is a rare move for a news organization whose lifeblood is fact-based reporting. But this is an extraordinary time that calls for an extraordinary statement one that calls on all of us who are vaccinated to do more to get friends, family, acquaintances, co-workers and others vaccinated.

More:The truth about COVID-19 vaccines. Everything you need to know.

Editorial:An appeal to vaccinated Free Press readers

This package gives you all the facts about vaccinesand stories of how the virus has afflicted unvaccinated Michiganders as well as some who are vaccinated in what are calledbreakthrough infections. This project alsosheds light on whatdifferent communitiesacrossthe state are doing to fight COVID-19inschools and workplaces, and provides insight into the debates around vaccinesand masking.

The Free Press offers digital subscriptions to our readers, which gives access to our best and most insightful journalism. All of this package isavailable to anyone on freep.com because of the public service it provides.But digital subscriptions are essential to our ability to deliver news to you, especially work of depth like this COVID-19 project. To our subscribers, we thank you.You share our unrelenting passion for Detroit and Michigan and your support means everything. If you're not a subscriber, please consider it. It's a good deal. Go to freep.com/specialoffer.

And, remember, it is easy to get a vaccine. Text your ZIP code to 438829 for a quick response that tells you where you can get the shot nearby.

Peter Bhatia is editor and vice president of the Free Press and Michigan editor for the USA TODAY Network. You can reach him at pbhatia@gannett.com.

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The Detroit Free Press' Sunday edition is dedicated to COVID-19 vaccines. Here's why - Detroit Free Press

COVID-19 Vaccination Efforts Continue Saturday In Areas Of Baltimore Hit Hardest – CBS Baltimore

September 19, 2021

BALTIMORE (WJZ) The state health department reported 1,277 new cases of COVID-19 in Maryland Saturday and 12 new deaths from the virus.

But the positivity rate went down again, to 4.22 percent.

And its the sixth day that its decreased.

The vaccination effort continued Saturday across the state including in one of its zip codes hit hardest by COVID, 21215.

Saturday, the New Psalmist Baptist Church worked with the University of Maryland Childrens Hospital to offer more shots of the vaccine for kids who are going back to school so that more of this community is protected against the virus.

Dozens lined up for shots of the COVID-19 vaccine at this event.

It is critical that we do vaccinations. That we get the vaccine in persons bodies, said Bishop Walter Thomas, the churchs pastor.

More than 5,600 people in the 21215 zip code have been diagnosed with COVID-19.

The goal here was to get more people in the community vaccinated with the help of trusted church leaders.

It feels a lot more comfortable to receive the vaccination knowing that people you already know and trust are right at your side supporting you through it so we really have appreciated this collaboration, said Dr. Rebecca Carter, director of community outreach and engagement at the University of Maryland Childrens Hospital.

Thomas said he worked with the University of Maryland Childrens Hospital to host the event because he wants to get as many people vaccinated as quickly possible.

The only way were going to get back to some semblance of life and build upon it for the future is to stop this virus in its tracks, he said.

The state health department reports that almost 48 percent of the eligible population is fully vaccinated against covid-19 in 21215, meaning more than half the people in it dont have the extra layer of protection the vaccine offers.

Thomas says the only way to safely protect against the virus is with the vaccine.

It wont stop with rhetoric it wont stop with arguments. It will only stop with a vaccination, he said.

And as of Saturday, almost 58 percent of people eligible for the vaccine in Baltimore have been fully vaccinated.

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COVID-19 Vaccination Efforts Continue Saturday In Areas Of Baltimore Hit Hardest - CBS Baltimore

Does Everyone Need a Covid-19 Booster Shot? Heres What Scientists Say – The Wall Street Journal

September 19, 2021

Some people are trying to get Covid-19 booster shots. Others arent sure if they need them. Mixed public health messages arent making personal-health decisions any clearer.

So far, the U.S. has authorized booster shotsan extra dose of the mRNA vaccines made by Pfizer Inc. and its partner BioNTech SE, and by Moderna Inc. only for people who are immunocompromised, although others have managed to get them.

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Does Everyone Need a Covid-19 Booster Shot? Heres What Scientists Say - The Wall Street Journal

Vaccine mandate backlash sparks concerns of other health crises | TheHill – The Hill

September 19, 2021

Explosive disputes over COVID-19 vaccine mandates are prompting concerns in the public health community that previously low-level opposition to other required vaccines could quickly gain traction.

Health experts say that rejecting routine vaccines might spark preventable public health crises, including the reemergence of outbreaksof diseases such asmeasles and mumps.

In addition, rising criticism of President BidenJoe BidenSunday shows preview: Coronavirus dominates as country struggles with delta variant Did President Biden institute a vaccine mandate for only half the nation's teachers? Democrats lean into vaccine mandates ahead of midterms MOREs vaccine mandate from GOP governors is seen by some as giving more legitimacy and momentum to the anti-vaccine movement and its resistance to requiring shots of any kind, even for children and members of the military.

If more parents decide to refrain from getting routine vaccinations for their kids, experts warn, it could cause the childhood immunity rate for certain diseasessuch as measles to fall below the herd immunity threshold, allowing them to spread more easily.

Now we could potentially reenter an era where we have endemic transmission of these diseases that we're no longer transmitting in the population, said Jonathan Berman, an assistant professor in the department of basic sciences at the New York Institute of Technology (NYIT).

The anti-vaccine movement started long before COVID-19 took hold, but the pandemic presented activists with the opportunity to bolster their ranks by taking advantage of peoples anxieties and uncertainties amid the evolving nature of the coronavirus and the governments response.

The Center for Countering Digital Hates Anti-Vaxx Playbook, published last year, said vaccine opponents have promoted three key messages to circulate COVID-19 vaccine skepticism:that the virus is not dangerous, that vaccines are unsafe and that people shouldnt trust vaccine advocates.

The debate over vaccines has intensified over the past 10 days after Biden announced that all private employers with 100 or more employees would be required to mandate vaccines or weekly testing, a move that will impact millions of workers. The announcement faced immediate backlash from many Republicans who have slammed the policy as government overreach.

Rep. Tom McClintockThomas (Tom) Milller McClintockVaccine mandate backlash sparks concerns of other health crises The right fire to fight fire why limiting prescribed burning is short-sighted Hillicon Valley: House advances six bills targeting Big Tech after overnight slugfest | Google to delay cookie phase out until 2023 | Appeals court rules against Baltimore Police Department aerial surveillance program MORE (R-Calif.) commented directly on mandating other vaccines during a House Judiciary Committee markup last week.

So, in this brave new world of Big Brother Biden, what is to stop the government from forcing every American from getting a flu shot or a tetanus shot or a hepatitis shot or a shingles shot? he asked. The president warns his patience is wearing thin. Mr. Biden, our patience as Americans is wearing thin.

Such arguments are seen by some experts as casting vaccine mandates of any kind as government overreach.

That position also plays into the conservative narrative of left-wing authoritarianism, which Berman of NYIT said he expects will be exploited by anti-vaccine proponents to great effect.

The Supreme Court held up vaccine mandates more than a century ago, in 1905, for a Massachusetts smallpox immunization requirement, meaning any legislation outlawing the practice would clash with the long-held precedent.

Dan Salmon, director of the Institute for Vaccine Safety at the Johns Hopkins Bloomberg School of Public Health, said its difficult to predict whats going to happen in response to Bidens mandate because the U.S. doesnt have precedent in mandating a vaccine that a quarter of the population doesnt want.

Having worked in this area for decades, I do have concerns that it could create backlash, and it could spill over beyond COVID vaccines to other vaccines and other laws such as those for routinely childhood required vaccines, he said.

A majority of Americans have voiced approval for vaccine mandates in workplaces, schools and sporting events; 52 percent of respondents in a recent Economist-YouGov poll said they supported Bidens requirement.

Months after the vaccine became widely available, almost three-quarters of the eligible population has received at least one dose, and 63.6 percentis fully vaccinated, according to the Centers for Disease Control and Prevention (CDC).

But more than 70 million of those aged 12 and older have not yet gotten a shot, and those younger than 12 are still ineligible, leaving much of the population at risk of serious illness from COVID-19.

Meanwhile, the CDC said routine child and adolescent vaccinations fell significantly in the early months of the pandemic as people stayed at home. The rate picked up in the summer and fall of 2020 but not to high enough levels to offset the earlier drop-off, according to a study released in June.

Timothy Callaghan, an assistant professor of health policy at the Texas A&M School of Public Health, said its unclear at this point whether the decrease is attributable to vaccine hesitancy or to more people avoiding doctors offices during the pandemic.

But its certainly possible those who view Bidens mandate as overreach could question the governments ability to require vaccines in general, he said.

I think it's too soon to tell whether or not that specific pattern will take hold, but it is certainly a concern, Callaghan said. That said, the benefits of these mandates likely largely outweigh the risks, given the need to get as much of the population vaccinated against COVID-19 as possible to get us past the pandemic.

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Vaccine mandate backlash sparks concerns of other health crises | TheHill - The Hill

COVID-19 vaccines – Harvard Health

September 17, 2021

What you need to know before getting vaccinated

The FDA has granted full approval to one COVID-19 vaccine and has authorized two others. As more people get their shots and more time passes, we will learn how long protection lasts. And we will gain answers to important questions, including whether vaccinations protect against emerging variants. The vaccines offer hope for an end to this pandemic.

In August 2021, the FDA granted full approval to the mRNA COVID-19 vaccine developed by Pfizer and BioNTech. This vaccine had received emergency use authorization (EUA) in December 2020. The mRNA COVID-19 vaccine developed by Moderna also received EUA in December 2020. The Johnson & Johnson adenovirus vaccine was granted EUA by the FDA in late February 2021. Use of the Johnson & Johnson vaccine resumed on April 23, 2021, after a temporary pause.

In August 2021, the FDA granted full approval to the Pfizer/BioNTech COVID-19 mRNA vaccine for use in people ages 16 years and older. The transition from emergency use authorization (EUA) status to full licensure was based on additional data and longer follow-up showing that the vaccine met certain safety, effectiveness, and manufacturing quality standards. The Pfizer/BioNTech vaccine can now be marketed under the brand name Comirnaty.

In granting full approval, the FDA analyzed data from 44,000 study participants. Half received two doses of the Pfizer/BioNTech vaccine and the other half received the placebo. Over six months of follow-up, the vaccine was 91.1% effective at preventing symptomatic COVID-19 infection.

A subset of study participants was followed for six months to look at safety outcomes associated with the vaccine. A small but increased risk of two inflammatory heart conditions, myocarditis and pericarditis, was identified and will be noted in the FDAs prescribing information. The risk is higher in males under age 40, and highest in males ages 12 to 17. Safety data will continue to be collected and monitored.

Before granting full approval, the FDA also inspected vaccine manufacturing facilities to ensure vaccine quality. Full approval gives doctors some leeway to prescribe the vaccine for "off-label use."

In the US, more than 92 million people have been fully vaccinated with the Pfizer/BioNTech vaccine since it received EUA in December 2020. Children ages 12 to 15 years will continue to use the vaccine under EUA status.

EUA status may be granted by the FDA during public health emergencies when they determine that the known and potential benefits of a medical product in this case, the COVID-19 vaccine outweigh the known and potential risks.

On May 10, 2021, the FDA expanded its emergency use authorization (EUA) for the Pfizer/BioNTech COVID-19 vaccine to include adolescents 12 to 15 years old. Previously, the Pfizer vaccine was authorized for use in children 16 years and older. For now, this is the only vaccine authorized in the U.S. for anyone under age 18.

Pfizer has been conducting age de-escalation studies, in which its vaccine is tested in groups of children of descending age. The EUAs expanded authorization was based on results from a Phase 3 trial of children ages 12 to 15. The trial enrolled 2,260 adolescents; half received the Pfizer mRNA vaccine, the other received a saltwater placebo.

The immune response in the vaccinated adolescent group was even stronger than that in vaccinated 16- to 25-year-olds enrolled in an earlier study. In addition, a total of 16 symptomatic cases of COVID-19 were reported during the trial, all in the placebo group, which meant that the vaccine had been 100% effective in preventing COVID-19.

Vaccine-related side effects were mild and included pain at the injection site, tiredness, headache, chills, muscle pain, fever, and joint pain. Pfizer has also started testing the vaccine in children younger than 12 years.

Being fully vaccinated with a COVID-19 vaccine does reduce the risk of long COVID. Also called post-COVID-19 syndrome or post-acute sequelae of SARS-CoV-2 infection (PASC), long COVID is the term for symptoms that arise or persist more than 28 days after an initial COVID-19 infection.

Vaccination may reduce the risk of long COVID in two ways. The first is by reducing the risk of becoming infected with COVID in the first place. But what about people who experience breakthrough infections, becoming infected despite being vaccinated?

A study published in The Lancet shows that fully vaccinated people who experience breakthrough infections are about 50% less likely to develop long COVID than people who are infected without having been vaccinated. These results are based on self-reported data submitted via the COVID Symptom Study phone app in the United Kingdom between December 2020 and July 2021.

Minor side effects are common after COVID-19 vaccination. Almost everyone experiences arm pain at the injection site. Other symptoms can include low grade fever, body ache, chills, fatigue, and headache.

You can expect to feel better within 24 to 48 hours. Some people feel too unwell to go to work or perform their usually daily activities during this period. Contact your doctor if your symptoms have not improved by the third day.

Moving your sore arm around may help to relieve discomfort. If you have a fever, drink plenty of fluids. Over the counter pain relievers like ibuprofen or acetaminophen can also help with fever, pain, and other discomfort. However, its best to not take a pain reliever right before getting your shot, because there is a chance this could blunt your immune response.

The good news: These side effects are a sign that the vaccine is working and that your body is building an antibody response. The currently available vaccines require two shots, and side effects are more likely to occur after the second shot.

There have been rare cases of people having a severe allergic reaction after receiving the mRNA COVID-19 vaccine. As a result, everyone getting an mRNA vaccine in the US must be observed for at least 15 minutes after getting their shot, so they can receive immediate medical treatment if they experience a severe allergic reaction.

Despite the small risk, most people with a history of severe allergy can safely get the mRNA COVID-19 vaccine. This includes people who are allergic to food, pollen, bee stings, and medications taken by mouth. If you have a history of severe allergy, tell the person administering your vaccine. You will be observed for at least 30 minutes, instead of the usual 15 minutes.

If you have a history of allergic reactions to injectable medications or other vaccines, the CDC recommends asking your doctor if you should get one of the currently available mRNA vaccines.

There are some people who should not get an mRNA COVID vaccine. You should not get one if you are allergic to any components of the mRNA vaccine, which include polyethylene glycol (PEG) and polysorbate. And you should not get the second dose of an mRNA vaccine if you had an allergic reaction within the first 30 minutes after receiving the first vaccine dose.

If you have questions regarding the safety of the COVID vaccine for you, your best option is to talk to your doctor.

There are only a few groups of people who should not get the mRNA vaccine. They include people who

If you have a history of allergic reactions to other (non-COVID) vaccines or to injectable medications, ask your doctor if it is safe for you to get one of the currently available mRNA vaccines.

Finally, it is possible that convalescent plasma or monoclonal antibodies, both of which are used to treat COVID-19, could reduce the effectiveness of the vaccine. If you have received either of these treatments, wait 90 days before getting your vaccine.

The Delta variant is different from previous SARS-CoV-2 variants that have made their way to the US. Its highly contagious and may cause more severe disease. It is also more likely than previous variants to be spread by vaccinated people experiencing breakthrough infections.

Evidence presented to the CDC showed the Delta variant to be much more contagious than previous variants, with a risk of transmission similar to chickenpox. It also appears that people who are infected can spread the virus for longer periods of time.

In addition, people who are vaccinated and then get infected (breakthrough infections) can also spread the virus to others, perhaps to the same extent as those who are unvaccinated. This is also new; vaccinated people were much less likely to spread previous variants.

Finally, international studies point to the Delta variant being more likely to cause severe disease.

The good news is that while vaccination may be less effective at preventing infection and spread of the Delta variant, it is still highly protective against severe disease, hospitalization, and death. Get the COVID-19 vaccine if you have not already done so.

In July 2021, the CDC advised all people vaccinated and unvaccinated to wear masks in public indoor places, in areas of the country with substantial or high transmission of the virus. Given the threat posed by the Delta variant, its reasonable for everyone to start wearing a mask in indoor public spaces, regardless of the level of virus in your area.

Masks reduce the amount of virus we breathe in, and breathe out. Combined with the vaccine, masks provide a one-two punch that reduces the risk of spread to children who are not yet eligible for vaccines, to people with weakened immune systems, and to others who are unvaccinated. Masks also provide additional protection for the wearer, including who are fully vaccinated.

Three studies released by the CDC in August 2021 suggest that the COVID-19 mRNA vaccines (Pfizer/BioNTech and Moderna) become less effective over time. The studies, all published in MMWR, show that vaccine protection against mild to moderate infection begins to drop beginning several months after the second dose. However, the vaccines continue to be highly protective against severe illness, hospitalization, and death.

The increase in mild and moderate breakthrough infections may not be entirely due to a decrease in the immunity provided by the vaccines. Its possible the vaccines are not as effective against the Delta variant as they were against previous variants. And safety precautions such as mask wearing and physical distancing have also decreased in the past several months. All these factors may play into increased breakthrough infections in fully vaccinated people.

The MMWR studies did not address the effectiveness of the Johnson & Johnson vaccine over time.

A breakthrough infection is one that occurs after full vaccination.

In an article published in MMWR, the CDC reported 10,262 breakthrough infections through the end of April 2021. By that point, more than 100 million Americans had received the COVID-19 vaccine.

The vast majority of breakthrough infections were asymptomatic, mild, or moderate. About 1,000 people with breakthrough infections were hospitalized, and 160 died, though the hospitalizations and deaths were not always related to COVID-19.

These numbers tell us that the vaccines are doing a good job preventing infection and severe illness. None of the vaccines were 100% effective in clinical trials, so a small number of breakthrough infections was expected.

In August 2021, the FDA authorized a third dose of an mRNA vaccine (Pfizer/BioNTech or Moderna) for certain people who are immunocompromised. The third dose should be given at least 28 days after the second dose.

The COVID-19 vaccines, like other vaccines, work by stimulating a persons immune system to produce antibodies against the virus. If the antibodies later encounter the actual virus, they are ready to recognize and destroy it.

A person with a weakened immune system may not be able to produce a strong enough immune response to the standard, two-dose COVID mRNA vaccine regimen. This leaves them more likely to have a breakthrough infection, and increases the risk of more severe disease if they do become infected. A third vaccine dose may enhance the immune response in some people who are immunocompromised.

The FDA authorized a third dose for people who are moderately to severely immunocompromised. A person may have a weakened immune system for a variety of reasons. These include being born with an immunodeficiency, having advanced or untreated HIV, and having a chronic medical condition such as chronic kidney disease or lack of a spleen. Many types of medication also suppress the immune response, including some cancer treatments, TNF blockers, some biologic agents, and high-dose corticosteroids. Talk to your doctor if you think you may qualify for a third COVID vaccine dose.

The FDA and CDC further recommend that anyone with a weakened immune system should continue to wear masks, stay six feet apart from others, and avoid crowds and poorly ventilated indoor spaces.

In July 2021, the FDA warned that the Johnson & Johnson (J&J) COVID-19 vaccine may lead to a small but increased risk of Guillain-Barr syndrome (GBS). GBS is a disorder in which the body destroys its own nerve cells. It can lead to muscle weakness and sometimes paralysis, trouble breathing, or, rarely, death. The risk of developing GBS after receiving the J&J vaccine is very low, and benefits of vaccination still far outweigh the risks.

The FDAs warning was based on preliminary reports of about 100 cases of GBS that occurred in people who had received the J&J vaccine. To date, about 12.8 million people in the US have gotten the J&J vaccine. Most of the reported cases occurred in men ages 50 years and older, about two weeks after vaccination.

Almost all required hospitalization because GBS can affect the nerves to chest muscles and the diaphragm, making it difficult to breathe. Most people recover completely from GBS within a few months, but some never regain full strength.

Seek immediate medical attention if you experience any of the following symptoms after receiving the J&J COVID-19 vaccine:

On April 13, 2021, the FDA and CDC jointly recommended pausing use of the Johnson & Johnson COVID-19 vaccine until the agencies could review the cases of a rare but serious type of blood clot that were reported in six women who received the Johnson & Johnson vaccine. On April 23, the FDA and CDC recommended lifting the pause, and allowing use of the vaccine to resume. They made this decision after their medical and scientific teams examined the data and determined that the vaccines known and potential benefits outweigh its known and potential risks.

The Johnson & Johnson vaccine is once again available for use in the US, for anyone ages 18 and older. However, the vaccines label and factsheet will now warn of the rare risk of developing blood clots involving blood vessels in the brain, abdomen, and legs, along with low levels of blood platelets. (This combination is being referred to as thrombosis and thrombocytopenia syndrome, or TTS, an abbreviation of the medical terms for the two conditions.) The label and factsheet also list symptoms of TTS and urge anyone who experiences them after receiving the Johnson & Johnson vaccine to seek immediate medical attention.

Since the FDA granted emergency use authorization (EUA) for the Johnson & Johnson vaccine in late February, more than 8 million doses of the one-dose vaccine have been given. A total of 15 cases of TTS were reported through April 23rd; all occurred in women between the ages of 18 and 59, between six and 15 days after vaccination.

While the risk of experiencing a blood clot after vaccination is very low, anyone who experiences the following symptoms within three weeks of receiving the Johnson & Johnson vaccine should contact their doctor and seek immediate medical care:

The clotting issue reported with the Johnson & Johnson vaccine is similar to the rare cases of unusual blood clots that the European Medicines Agency linked to the AstraZeneca vaccine.

In a study published in MMWR in September 2021, the CDC reported that even after Delta became the dominant COVID variant in the US, full vaccination has effectively prevented against COVID hospitalizations and deaths. The study looked at more than 600,000 cases of COVID in 13 locations across the US between April and July 2021. Compared to people who were not vaccinated, those who were fully vaccinated were five times less likely to become infected, 10 times less likely to be hospitalized, and 11 times less likely to die of COVID. The effectiveness of vaccine protection against infection fell after Delta became the dominant variant in the US. But vaccination continued to effectively protect against COVID-related hospitalization and death.

In an earlier MMWR study published in April 2021, the CDC reported that people who had received both doses of either mRNA vaccine (Pfizer/BioNTech or Moderna) were 90% less likely to get infected with COVID-19 than people who were not vaccinated. In clinical trials, the vaccines were 95% (Pfizer/BioNTech) and 94.1% (Moderna) effective. Several viral variants were circulating during this study period, but the April study preceded the rise of the Delta variant in the US.

Two reports published in MMWR in September 2021 found that vaccine protection has declined in older adults. However, vaccinated older adults still enjoy significant protection compared to older adults who are unvaccinated.

One report describes the results of a study looking at the effectiveness of the COVID vaccines (Pfizer/BioNTech, Moderna, and Johnson & Johnson) in preventing COVID-related hospitalization at five Veterans Affairs Medical Centers in the US. It found that vaccines were 80% effective in preventing COVID-related hospitalization in people aged 66 years and older compared to 95% in people aged 18 to 65 years.

The second report is an interim analysis of ongoing data collection from medical sites in nine different states. The vaccines were found to be 89% effective at preventing COVID-related hospitalization in people ages 18 to 74 and 76% in people aged 75 or older. The researchers based their findings on an analysis of 32,867 medical encounters, including visits to hospitals, emergency departments, and urgent care sites. The data collection occurred during a time when Delta was responsible for more than half of infections.

A small study conducted earlier this year by the CDC and published inMMWRreported that the two mRNA vaccines (Pfizer/BioNTech and Moderna) had been as effective in older adults in the real world as they were in the clinical trials that led to authorization of their use. That study found that full vaccination reduced risk of COVID-related hospitalization by 94% compared to 95% (Pfizer/BioNTech) and 94.1% (Moderna) in the clinical trials. At the time of this study, the Delta variant was much less common.

This newest data does suggest that Delta variant is the primary reason for the decline in vaccine effectiveness. But the numbers still strongly support vaccine efficacy even during a period of Delta dominance.

Its natural to want to make an informed decision about the COVID-19 vaccine. Fortunately, the safety of the vaccine seen in the clinical trials has been verified by the real-world results. And in August 2021, the FDA granted full approval to the Pfizer/BioNTech COVID-19 mRNA vaccine for use in people ages 16 years and older. The transition from emergency use authorization (EUA) status to full licensure was based on additional data and longer follow-up showing that the vaccine met certain safety, effectiveness, and manufacturing quality standards.

Warp speed? Yes, the speed with which the COVID-19 vaccines were developed was incredibly fast. But the science and technology to make it happen came after decades of research.

COVID-19 mRNA vaccines are new, but scientists have been studying mRNA for many years. They cannot change your DNA. The mRNA sends a message to the bodys cells to make only a specific protein, not a virus, that stimulates the immune system to give you protection. Experts predict that most vaccines in the future will use mRNA technology.

If you still have doubts about the vaccine, we recommend this short video produced by the Black Womens Health Imperative.

Some communities, particularly communities of color, may have historical reasons to doubt the health care system. But these communities have also been among the hardest hit by this pandemic, and like all of us, have a lot to gain from vaccination.

The Black Womens Health Imperative is a national organization dedicated to improving the health and wellness of Black women and girls.

Fully vaccinated people can participate in most indoor and outdoor activities without a mask and without physical distancing. In July 2021, the CDC advised all people, including those who are fully vaccinated, to wear masks in public indoor places in areas of the country with substantial or high transmission of the virus.

In addition, youll still need to follow federal, state, tribal, and local laws, and workplace or business requirements around mask wearing and physical distancing.

For people who are not fully vaccinated, the CDC continues to recommend mask wearing and other preventive measures in some outdoors settings and in most indoor settings.

Mutations have led to several new, concerning coronavirus variants, including the B.1.1.7 (Alpha) variant, which was first detected in the United Kingdom; the B.1.351 (Beta) variant, which originated in South Africa; the P.1 (Gamma) variant, which originated in Brazil, and the B.1.617.2 (Delta) variant, which was first documented in India. Emerging evidence suggests that the current vaccines are effective against at least some of these variants.

Two peer-reviewed and published studies have found the Pfizer/BioNTech vaccine to be extremely effective against the Alpha and the Beta variants. The first study, published inNEJM, looked at data from more than 200,000 people from the country of Qatar between early February and late March 2021. During that time, the Alpha and Beta variants were responsible for nearly all COVID cases in that country. The researchers found that in people who were fully vaccinated, the Pfizer vaccine was 97.4% effective at preventing severe, critical, or fatal disease caused by the Alpha or Beta variants.

The second study, published in TheLancet, looked at more than 200,000 COVID infections in Israel from late January to early April 2021, when the Alpha variant accounted for more than 90% of infections. The researchers found that in fully vaccinated people, the Pfizer vaccine was nearly 97% or more effective at preventing symptomatic COVID-19, COVID-related hospitalization, severe or critical COVID-19, or COVID-related death.

Research has also found vaccination to be effective against severe disease, hospitalization, and death caused by the Delta variant, which is now the dominant variant in the US. A study from Public Health England found that full vaccination with the Pfizer/BioNTech vaccine was 88% effective at protecting against symptomatic illness caused by the Delta variant, and 96% effective at preventing hospitalization due to the Delta variant. However, the vaccines appear to be less effective at preventing all infection (including mild and asymptomatic infection). And the Delta variant is more likely than previous variants to be spread by vaccinated people experiencing breakthrough infections.

Studies on the effectiveness of the Moderna vaccine are ongoing. In the lab, it has performed well against the Alpha variant, compared to the original, unmutated virus. However, it was less effective against the Beta and Delta variants compared to the unmutated virus and the Alpha variant. More study is needed to see if the laboratory results hold up in real-world conditions.

It's important to remember that both the Pfizer/BioNTech and Moderna vaccines are extremely effective 95% and 94.1%, respectively. Even with some possible decrease in effectiveness against variants, they will still provide excellent protection against severe illness.

Another study, published inNature, looked at blood samples from people who received the Johnson & Johnson adenovirus vaccine. It found that the vaccine produced a less robust antibody response against the Beta and Gamma variants compared to the response to the original SARS-CoV-2 virus. However, the T cell immune response held up, particularly among the type of T cells that prevent the virus from spreading within the body. This immune response should protect against developing severe symptoms if a person does get infected. Johnson & Johnson also released data from a small, unpublished laboratory study, which found a strong neutralizing antibody response against the Delta variant in people who had received the single-shot J&J vaccine. The response was sustained for at least eight months, the duration of the study.

On December 18, 2020, the FDA granted emergency use authorization (EUA) to an mRNA COVID-19 vaccine developed by Moderna in collaboration with scientists from the NIH. The vaccine is approved for use in people 18 years and older. This is the second COVID-19 vaccine authorized for use in the US. (The Pfizer/BioNTech vaccine received EUA during the prior week.)

The FDA granted EUA based on their own analysis of efficacy and safety data, as well as on the recommendation made by the Vaccines and Related Biological Products Advisory Committee (VRBPAC). VRBPAC is a group of outside experts in infectious disease, vaccinology, microbiology, immunology, and other related fields.

In briefing documents submitted to the FDA, the Moderna vaccine showed an overall efficacy of 94.1% in preventing COVID-19. This study enrolled 30,400 adults; half received the vaccine, half received a saltwater placebo shot. There were 196 infections among the study participants. Of these, 185 were in the placebo group and 11 were in the vaccine group. All 30 cases of severe COVID occurred in the placebo group, strongly suggesting indicating that the vaccine reduces risk of severe illness.

The vaccine was similarly effective in people older and younger than 65, in men and women, in people with and without medical conditions that put them at high risk for severe illness, and in different racial and ethnic groups.

The most common vaccine side effects were pain at the injection site, fatigue, headache, muscle pain, joint pain, and chills.

This vaccine requires two doses, spaced four weeks apart. In January 2021, the CDC released guidance stating that while the second dose should be administered as close to the recommended four-week interval as possible, it may be scheduled for administration up to six weeks (42 days) after the first dose. We do not yet know how long immunity from this vaccine will last.

In August 2021, the FDA authorized a third dose of mRNA vaccine (Moderna or Pfizer/BioNTech) for certain people with a weakened immune response.

The Moderna vaccine contains synthetic messenger RNA (mRNA), genetic material that enters human cells and instructs them to produce the spike protein found on the surface of the SARS-CoV-2 virus. The body recognizes the spike protein as an invader and produces antibodies against it. Soon after, the cell breaks down the mRNA into harmless pieces. If the antibodies later encounter the actual virus, they are ready to recognize and destroy it before it causes illness.

Unlike the Pfizer vaccine, which requires ultracold storage, the Moderna vaccine can be stored at normal freezer temperatures. This may allow for wider distribution to pharmacies and other facilities that are not equipped for ultracold storage.

In August 2021, the FDA granted full approval to the Pfizer/BioNTech COVID-19 mRNA vaccine for use in people ages 16 years and older. The transition from emergency use authorization (EUA) status to full licensure was based on additional data and longer follow-up showing that the vaccine met certain safety, effectiveness, and manufacturing quality standards.

Previous milestones for the Pfizer/BioNTech COVID-19 vaccine include the following:

The FDA granted its original EUA based on their own analysis of efficacy and safety data as well as on the recommendation made by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on December 10th. VRBPAC is a group of outside experts in infectious disease, vaccinology, microbiology, immunology, and other related fields.

Results from the Pfizer/BioNTech vaccine trial were published in theNew England Journal of Medicine. The data showed that the vaccine reduced the risk of COVID-19 by 95%. The trial enrolled nearly 44,000 adults, each of whom got two shots, spaced three weeks apart; half received the vaccine and half got a placebo (a shot of saltwater). Of the 170 cases of COVID-19 that developed in the study participants, 162 were in the placebo group and eight were in the vaccine group. Nine of the 10 severe COVID cases occurred in the placebo group, suggesting that the vaccine reduced risk of both mild and severe COVID.

According to theNEJMarticle, the vaccine was similarly effective in study participants of different races and ethnicities, body weight categories, presence or absence of coexisting medical conditions, and ages (younger and older than 65). It's worth noting that the FDA felt comfortable authorizing the vaccine for 16- and 17-year-olds, even though the number of teens enrolled in the study was small.

None of the study participants experienced serious side effects. However, most did have pain at the injection site. Also, about half of those receiving the vaccine reported mild to moderate fatigue or headache or both. Chills and fever were also fairly common. Symptoms almost always resolved within 24 to 48 hours.

The expanded EUA was based on results from a Phase 3 trial testing the Pfizer vaccine in children ages 12 to 15. The trial enrolled 2,260 adolescents; half received the Pfizer mRNA vaccine, the other received a saltwater placebo. The immune response in the vaccinated adolescent group was even stronger than that in vaccinated 16- to 25-year-olds enrolled in an earlier study. In addition, a total of 16 symptomatic cases of COVID-19 were reported during the trial, all in the placebo group. Vaccine-related side effects were mild and included pain at the injection site, tiredness, headache, chills, muscle pain, fever, and joint pain.

In granting full approval, the FDA analyzed data from 44,000 study participants and found that over six months of follow-up, the vaccine was 91.1% effective at preventing symptomatic COVID-19 infection. A subset of study participants was followed for six months to look at safety outcomes. A small but increased risk of two inflammatory heart conditions, myocarditis and pericarditis, was identified and will be noted in the FDAs prescribing information. Before granting full approval, the FDA also inspected vaccine manufacturing facilities to ensure vaccine quality.

This vaccine requires two doses, spaced three weeks apart. In January 2021, the CDC released guidance stating that while the second dose should be administered as close to the recommended three-week interval as possible, it may be scheduled for administration up to six weeks (42 days) after the first dose. Although the vaccine appears to provide reasonable protection after the first dose, it provides stronger protection after two doses. We do not yet know how long immunity from this vaccine will last.

The Pfizer/BioNTech vaccine is an mRNA vaccine. The vaccine contains synthetic messenger RNA (mRNA), genetic material that contains instructions for making proteins. Inside the body, the mRNA enters human cells and instructs them to produce a single component of the SARS-CoV-2 virus the "spike" protein found on the virus's surface. The body recognizes the spike protein as an invader and produces antibodies against it. If the antibodies later encounter the actual virus, they are ready to recognize and destroy it before it causes illness. mRNA vaccines must be stored at very cold temperatures; improperly stored vaccines can become inactive.

On February 27, 2021, the FDA granted emergency use authorization (EUA) for Johnson & Johnson's single-shot adenovirus vaccine, following the recommendation from the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC). The vaccine is authorized for use in people 18 years and older.

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COVID-19 vaccines - Harvard Health

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