Category: Covid-19 Vaccine

When Luisa Moore went to get a COVID-19 vaccination in April, she wished that her longtime partner, David Kelsey, had joined her.

But Kelsey, she said, adamantly refused to seek a vaccination.

Four months later, as Kelsey lay on a bed in the intensive care unit at Winter Haven Hospital, struggling to breathe after a diagnosis of COVID-19, he texted Moore to share his regrets.

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He said, As soon as I get out of the hospital, Im going to get the vaccine, Moore said.

But Kelsey never had the opportunity. He died Sept. 13 at age 50.

What I would like to tell to people is that they should get vaccinated because otherwise theyre risking lives, Moore said. Theyre risking to lose a loved one or their own lives.

Kelsey spent 22 years as an employee with the Florida Department of Corrections in its probation services division. He worked as a correctional probation senior supervisor at the Winter Haven office.

Moore said she and Kelsey had been a couple for 15 years. Though not legally married, they shared a home in Winter Haven and possessions and regarded each other as spouses, said Moore, a native of Venezuela.

Kelsey was a veteran of the U.S. Army, serving for six years as a unit supply specialist in Saudi Arabia. He received a Kuwaiti Liberation Medal and other awards, according to an obituary prepared by family members. After his discharge he spent six years in the U.S. Army Reserves, assigned to the 418th Military Police Detachment in Daytona Beach.

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Kelsey, who had a bachelors degree in math from the University of Central Florida, rose through the ranks of the Department of Corrections after beginning his employment in 1999. He became a supervisor after earning a masters degree in 2009 in administration of justice and security from the University of Phoenix.

For 16 years, he worked a second job as a security officer for the Mountain Lake Corporation in Lake Wales.

He used to work every single day, Moore said.

Kelsey also served as a guest lecturer for a criminology class at Polk State College, according to his LinkedIn profile. In his limited free time, Kelsey hiked and camped, collected guns and made frequent trips to a local firing range.

Moore said she tried to convince Kelsey to seek a vaccination against COVID-19 after they became available to the public last spring.

In other news: Polk County seeks applications for remaining $10.5 million in COVID-19 relief funds

He wanted to wait, Moore said. He didnt trust the vaccine. He said he wanted to see more studies.

She added: I had a conversation about it, that he should do that, that that could save his life, but he was very stubborn. He didnt want to do anything with the vaccine.

Moore said she and Kelsey both began feeling possible COVID-19 symptoms in early August. They went to the emergency room at Winter Haven Hospital on Aug. 9, and Kelsey was admitted. Moore said she grew tired of waiting and left after about three hours.

Moore endured what she called a mild case of COVID, with coughing, fatigue and dizziness that lasted about three weeks.

Winter Haven Hospital, like most hospitals during the latest surge of the pandemic, does not allow routine visits to patients in COVID units. Moore said she called Kelsey often, even after he was intubated, sedated and placed on a mechanical ventilator about two weeks after being admitted.

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Moore said a nurse held the phone near Kelseys ear, and she told him that she loved him.

I used to call him, and the nurses used put the phone on his ear and I used to talk to him, Moore said. And the nurse told me that he used to move his hand and he smiled, and the ventilator moved, so he reacted to my talking.

Kelseys condition worsened, and he developed double pneumonia and a blood infection, Moore said. A nurse called on the afternoon of Sept. 13 and urged Moore to come to the hospital, where she was allowed into Kelseys room for an end-of-life visit.

At about 11 p.m., Kelseys heart stopped, and a team of what Moore described as about 30 workers crowded in the room and attempted to revive him, without success.

I was there with him when he passed away, Moore said. It was horrible. I dont wish that to anybody. It was very hard to see that. I still have flashbacks about it.

Another loss: Polk County Sheriffs Office loses another to COVID-19

Kelsey had no relatives living in Florida. Moore said she plans to hold a memorial service for Kelseys friends, and she said the Department of Corrections will conduct a tribute for co-workers on Oct. 1.

Kelseys family plans a private ceremony on Nov. 14, which would have been his 51st birthday.

Moores disappointment that her partner chose not to get a vaccination doesnt dim her admiration for him.

He was a very good man, she said.

Gary White can be reached at gary.white@theledger.com or 863-802-7518. Follow on Twitter @garywhite13.

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Change of heart on COVID-19 vaccination comes too late for David Kelsey of Winter Haven - The Ledger

US COVID deaths reach 675,000, matching death toll of 1918 Spanish flu

The U.S. has surpassed 675,000 COVID-19 deaths. That's roughly the same amount of Americans killed by the 1918-19 Spanish flu.

Staff Video, USA TODAY

Three times in the past week and a half, Record Searchlight print editions included an ad rife with dangerous disinformation about the COVID-19 vaccines and our local public health department.

This ad should never have been published. It relies on a mischaracterization of the national Vaccine Adverse Event Reporting System (VAERS) and a variety of false and unsupported statements.

Most importantly, the ad turns the truth on its head. Let me start there: Vaccines are saving lives. COVID-19 is killing people in our community every week. Every credible source of information shows this. Shasta County Public Health employees go to work every day trying to protect the local community and have been straight-up heroic in their resilience over the course of this pandemic.

Since the ads author relied heavily on references to VAERS, I spoke with Dr. John Suat the Centers for Disease Control and Preventions Immunization Safety Office. Su is the lead for the VAERS safety monitoring system. I asked him to review the claims and set the record straight.

I think this (ad) is a good example of how VAERS data can be misunderstood, or worse, misrepresented, Su told me. VAERS is designed to detect potential problems. It is not designed to determine if the vaccine is the cause of the adverse event.

A series of things went wrong. Our company has a process for ads like this and this ad rightly was flagged. Even so, human error allowed it to reach the page. Then, after running twice and being flagged a second time, it ran a third and final time.

What publishes in the Record Searchlight is ultimately my responsibility. I pledge to do what I can to set this right.

First, as Su noted, it misuses VAERS data by claiming it shows a cause and effect. Its just a surveillance system meant to pick up as many signals as possible so the real science of interpretation can begin.

In addition, the ad gets the VAERS data wrong. It claims 14,000 deaths have been documented in the system. In actuality, the VAERS database includes 7,899 reports of death in the U.S. (the 14,000 figure likely came from the CDC briefly and mistakenly including foreign cases at one point in July an error that was quickly corrected).

Anyone can report an adverse event to VAERS. And, as Su pointed out, I could go in for my vaccine and then walk across the street and be hit by a bus. The death would qualify for inclusion because it occurred after my shot. Its a bit of a stretch to say the vaccine killed me.

In fact, of those 7,899 reported deaths, only three have been fully studied and found to be the direct result of vaccine injection. Those were extremely rare reactions to the Johnson & Johnson vaccine.

The ad builds on the 14,000 error by multiplying it claiming without basis that only 1% to 5% of adverse vaccine events are reported to VAERS. That statement may come from an outdated study on the rate at which rashes were reported after vaccination, but more recent research has shown a much higher rate of reporting for more serious events.

Kerri Schuette of Shasta County Public Health has written a lengthy point-by-point response to the ad that we are publishing in full in the Sunday edition of the Record Searchlight as well as online. I urge you to read it.

In short, the ad accused local officials of failing to investigate and report injuries and deaths due to COVID-19 vaccines. As Schuette notes, there has not been evidence of even a single Shasta County death from these vaccines. And the public health department reports everything it is supposed to. The ads author seems to misunderstand the agencys role.

As for COVID-19 itself, it has caused 290 deaths in Shasta County.

To compound all of this, the ad was what we refer to as issue-based. Our policies require that even if they are acceptable for publication (which this wasnt), issue-based and political ads must be clearly labeled so they cannot be confused with news content. That did not happen in this case.

First, write this column. I want to personally say Im sorry this happened and urge our readers to examine critically any claims they encounter especially those that contradict the vast body of expertise that has developed around this pandemic. If youre interested in tracking actual VAERS data on these vaccines, go to the source: bit.ly/3kDDv4w.

Second, we are running the response from public health in its entirety.

Related: A recent Record Searchlight ad contained disinformation about COVID-19 vaccines. These are the facts.

Finally, we will donate the amount of money received from that ad toward the COVID-19 response in our community.

This pandemic is a life and death situation and falsehoods about it are killing people. Too many have been lured by the dark corners of the internet and some authoritative-sounding YouTube and Instagram videos into believing conspiracy theories. Our best chance of getting through this is sticking to the truth and to verified facts from actual experts and scientists.

These vaccines have been under the greatest scrutiny of any vaccine in history, arguably, Su said. You can see that these vaccines are very safe from all the data weve been able to accumulate.

I couldnt be prouder of the work our local news team has done to cover the pandemic. It has been timely, accurate and informative. The publication of this ad pains me because it distracts from that work. But our mission is, and will always be, to tell you the truth.

Silas Lyons is executive editor for USA TODAY Network newsrooms in Northern and Central California and Nevada. He supports dedicated teams of reporters that investigate wrongdoing, swarm breaking news and tell stories of triumph and human kindness. If you believe in this work, please consider a subscription.

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Setting the record straight: Ad repeated lies about safety of COVID-19 vaccine - Record Searchlight

Erie, Pennsylvania (WJET/WFXP/YourErie.com) On Friday, Governor Tom Wolf announced that 85% of Pennsylvanians aged 18 and older have received their first COVID-19 vaccination.

On Friday, September 24th, vaccine providers across the commonwealth have administered 12,645,207 COVID-19 vaccines. The commonwealth ranks 9th nationally in first doses administered, according to a news release from Governor Wolfs office.

The Pennsylvania Department of Health announced last week that, since January 2021, 97% of COVID-19 related deaths and 95 percent of reported hospitalizations due to COVID-19 were in unvaccinated or not fully vaccinated people, the release reported.

The data is clear: COVID-19 vaccinations save lives. In fact, the data shows that compared to unvaccinated people, fully vaccinated individuals are seven times less likely to get COVID-19 and eight times less likely to due from COVID-19. We cannot stress the importance of getting vaccinated enough. Vaccines are safe and effective. Please, get yours today.

Click here to visit Your Local Vaccination Headquarters to find out more information on scheduling your vaccine.

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Governor Wolf reports 85% of Pennsylvanians received first COVID-19 vaccination - WOWK 13 News

So what are different governments doing to encourage those who have not been vaccinated, for whatever reason, to get the shot?

While 72% of Belgium's population is fully vaccinated against Covid-19, rates vary widely across the country of about 11.5 million people.

Authorities are now increasing pressure on vaccine holdouts in the capital in the hope of boosting vaccination rates.

While restrictions such as the mandatory wearing of face masks indoors have been eased elsewhere in the country, they remain in place for Brussels because of its lower vaccination rate and the strain that Covid-19 cases are placing on the city's hospitals.

And from October 1, the regional government in Brussels will also require residents to show a "Covid pass" to prove that they have been vaccinated or have recently tested negative for the virus before they can enter restaurants, bars or fitness clubs, according to Reuters.

This may go some way to encourage reluctant younger residents to get the shot. According to official figures, only 46% of those aged 18 to 24 in Brussels have received at least one vaccine dose, compared with 86% for the same age group in Flanders and 72% in Wallonia.

Belgian Prime Minister Alexander De Croo had harsh words for the nation last Friday.

"Those who do not get vaccinated are responsible for the fact that stricter rules remain necessary in some places," he said. "Intensive care is rapidly becoming a gathering place for the unvaccinated. We cannot accept that as a society. No one has the right to voluntarily put other people at risk."

Kenneth Coenye, chief medical officer at the Sint-Jan Clinic in Brussels, told CNN that during the last weekend of August, only four out of 70 patients being treated in Covid ICUs in the city were vaccinated. "It's very painful, of course, because they don't only get sick, they die. And that is so completely preventable," he said.

Speaking Saturday, the leader of Wallonia -- Belgium's largest region -- urged citizens who have not yet received their Covid-19 vaccination "to understand the consequences of their inaction and procrastination."

"We are not done with this damned virus because vaccination coverage remains insufficient," Minister-President Elio Di Rupo said. "The unvaccinated bear a heavy responsibility for themselves, and those close to them. The time has therefore come for everyone to examine their conscience."

France: Health pass boosts vaccine uptake

Measures proposed by French President Emmanuel Macron this summer have had a marked impact on vaccine hesitancy.

Under legislation announced by Macron on July 12, people in France have since August been required to carry a Covid health pass, or "pass sanitaire," to enter premises including bars, restaurants, cinemas and theaters, and many outdoor public spaces.

The pass -- which shows proof of either vaccination, a negative Covid-19 test or of past infection -- is also required for travel on long-distance public transport and to visit medical facilities.

From September 30, children aged 12 and above will also have to comply with health pass rules. Workers in sites under the health pass mandate have themselves needed to be inoculated since August 30, and from October 15 this will also apply to health workers.

Macron's July 12 announcement prompted tens of thousands of protesters to take to the streets, calling for the government to scrap the new rules. However, it was also followed by an immediate spike in demand for vaccine appointments.

French government spokesman Gabriel Attal hailed what he called a "French success" on Wednesday. "We surpassed at the end of last week the threshold of 50 million vaccinated individuals and this number continues to rise," he said, adding that 14 million individuals had been incentivized to be vaccinated since July 12.

But despite this, Attal warned that vigilance was still needed.

Some areas, particularly in the south and east of the country, still have relatively lower Covid-19 vaccination rates, including the northern half of Corsica, where 59.7% of the population has received at least one dose, according to Ameli, France's national health insurance body. The next lowest ranking are Seine-Saint-Denis, outside Paris, at 59.8%, Alpes de Haute Provence at 64.7% and Bouches-du-Rhne, home to the city of Marseille, where 64.9% of the population have received at least one dose.

Meanwhile, figures for France's overseas territories are significantly lower than for the mainland.

"In several territories -- notably Guyana, French Polynesia, and New Caledonia -- the situation remains extremely concerning and requires both the continuation of preventative measures and reinforcements," Attal said.

Only 18.4% of the population in Guyana has received at least one vaccine dose, according to figures from Ameli.

Some 587,000 people in France have already received a Covid-19 booster shot, Attal added. "I implore the French citizens who have not been vaccinated to do so, just as I implore our elderly to resort to the booster option," he said.

Italy: All workers will have to show a health pass

Italy's government extended its mandatory health pass to all workers on September 16 in a bid to improve vaccine coverage. The measure is due to come into force on October 15.

The country had already required all health workers to be vaccinated. And, since August 6, a "certificazione verde," or green pass, has been needed to enter cultural sites such as museums or galleries, entertainment and sports venues, theme parks, spas, and to eat indoors. This was extended to include domestic flights, train travel between regions, as well as sea travel on September 1.

The latest measure was introduced to "make the vaccination campaign even stronger," said Health Minister Roberto Speranza.

Just two days later, on September 18, the government commissioner in charge of the vaccination campaign recorded a countrywide increase in bookings of first Covid-19 vaccine doses of between 20% and 40%, compared to the previous week.

According to government figures, over 76% of the population aged 12 and over is fully vaccinated, while around 82% has received at least one shot.

But take-up still lags in some parts of Italy.

According to the Gimbe Foundation, based on the data provided by the Health Ministry and the National Institute of Statistics, the areas with the lowest Covid-19 vaccination rates are the Autonomous Province of Bolzano, in the South Tyrol Alps, and the regions of Calabria and Sicily, in the far south of the country.

In Bolzano, 61.3% of the total population has had two doses, while the figure stands at 63.7% for Calabria and 62.7% for Sicily.

Thomas Widmann, who heads the Bolzano health department, told CNN in a written message that a variety of factors contributed to South Tyrol's lower vaccination rate.

"The hypotheses range from a greater propensity to homemade remedies, like medicinal herbs used in peasant tradition; there are those who assume a more marked anti-authoritarian tendency than elsewhere, for historical reasons; but I think more practical hypotheses should also be considered, such as logistical difficulties," he said.

"For those who live at the bottom of a mountain valley, going to a city vaccination center can mean wasting a lot of time."

A vaccine bus service was launched in July to reach the more remote areas of South Tyrol.

Meanwhile, Sicily's regional president, Nello Musomeci, has made frequent appeals for its population to get vaccinated, describing it as a "civic duty" in a message to the island's mayors last month. "How unfair it would be to make everyone pay the hard price of those who do not want to get vaccinated!" he said.

Despite such exhortations, the announcement of the mandatory health pass for all workers led to an increase of only 5% in the number of people aged 20 and 59 booking vaccinations in Sicily in the week September 15-21.

Germany: No more compensation for unvaccinated workers who lose pay

Vaccinations in Germany are not compulsory. But authorities have been stepping up measures that make life increasingly inconvenient for people who remain unvaccinated against Covid-19.

On Wednesday, the German Health Ministry announced new rules that mean unvaccinated workers will no longer receive compensation for lost pay if coronavirus measures forced them into quarantine.

The new rules will come into force from November 1 and will affect people who test positive for Covid-19 and those returning from countries designated as "high risk" Covid-19 areas, Health Minister Jens Spahn told reporters.

These countries currently include the United Kingdom, Turkey and parts of France, according to Germany's public health agency, the Robert Koch Institute (RKI). Unvaccinated travelers from these "high risk" areas are required to quarantine for at least five days. Those who are fully vaccinated or have recently recovered from Covid-19 are not.

Spahn defended the new rules, asking: "Why should others pay for the fact that someone has decided not to be vaccinated?"

He stressed, however, that the new rules were a matter of fairness to everyone. "Some people will say this means pressure for the unvaccinated. I think we have to look at it the other way around -- it is also a question of fairness," he said.

The German trade union confederation (DGB) criticized the move, saying it dumped responsibility for the fight against the pandemic onto employees. "We still reject mandatory vaccination through the back door," DGB chairman Reiner Hoffmann told Editor Network Germany.

Germany's Health Ministry had previously announced that Covid-19 tests, which the unvaccinated must undertake to be allowed to dine inside restaurants, for example, will stop being free of charge from October 11.

A total of 63.6% of the German population had been fully vaccinated against Covid-19 as of Thursday, according to the RKI -- under the 85% threshold deemed necessary by the RKI for herd immunity.

CNN's Joseph Ataman contributed to this report.

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Pockets of low vaccine uptake remain in Europe. Here's how 4 countries are dealing with them - CNN

New Hampshire Democratic lawmakers are pushing to add COVID-19 vaccines to the list of immunizations required for all children provided the vaccines become approved by the U.S. Food and Drug Administration.

In a bill set to be introduced in 2022, eight Democrats, led by newly converted member Rep. William Marsh, aim to add COVID-19 vaccines to the current requirements.

State statute mandates that all children residing in New Hampshire be immunized against diphtheria, mumps, pertussis, poliomyelitis, rubella, rubeola, and tetanus. Children are not allowed to be admitted to public or private schools or child care centers unless they can demonstrate that they have received an immunization or partial immunization, or that they qualify for an exemption, according toRSA 141-C:20-a.

The existing statute allows children to be exempted from the vaccine only if a physician certifies that it would be detrimental to their health, or if their parent or guardian objects because of religious beliefs.

Marshs proposed bill would add COVID-19 to the list. And it would expand the definition of school to include colleges and universities, extending the existing vaccine mandate.

No virus in the history of mankind has ever been brought under control without vaccine mandates, said Marsh, a retired physician, in an interview Monday.

Under Marshs proposed bill, the mandate for children would not apply to all COVID-19 vaccines; it shall only apply to individuals whose age exceeds the minimum for a vaccine fully approved by the FDA, and not just available under emergency use authorization, according to a copy of a first draft shared with theBulletin.

Were not forcing anyone to have experimental vaccines, Marsh said.

The FDA has not formally approved the Pfizer COVID-19 vaccine for children under 16, but it has given emergency authorization for children 12-15. Medical experts recommend children 12-15 get the shot.

Marsh, a Brookfield representative who last week converted from a Republican to a Democrat after criticizing Republican House leadership for its opposition to vaccine and mask mandates, said he would introduce the bill to the Health and Human Services and Elderly Affairs Committee in January.

But the proposal comes at a time of deep division around vaccine mandates and skepticism among Republicans specifically, who currently control the House and Senate.

Some Republican House members have indicated they want to push the states child vaccination laws in the other direction; several bill requests filed last week would prohibit COVID-19 vaccination requirements and broaden the exceptions available to parents.

In that environment, Marsh said he didnt expect the bill to receive support in the Health and Human Services committee. But he said he would put his hopes into winning support for the effort on the House floor, even if the committee recommended the bill be killed.

A series of Democratic wins in House special elections have narrowed the Republican majority in the House which started in January as the slimmest of either partys hold over the chamber in several decades.

I fully expect this bill to be [recommended inexpedient to legislate] by the stacked HHSEA committee, Marsh said. Then it comes to the House floor, and I intend to flip it on the House floor.

It is unclear whether support exists for a COVID-19 school vaccine mandate in the New Hampshire Senate or in the governors office. Speaking to reporters Sept. 15, Gov. Chris Sununu, a Republican, did not explicitly endorse a vaccine mandate for COVID-19, but suggested the Legislature might support it in the future.

If the New Hampshire Legislature says, You know, were gonna mandate the COVID vaccine for school, they have every right to do so, he said. I imagine thatll probably happen at some point.

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Lawmakers to push for COVID-19 vaccine to be added to list of required immunizations for kids - Monadnock Ledger Transcript

The highly infectious Delta variant of SARS-CoV-2 has spread to more than 140 countries and accounts for 98% of U.S. Covid-19 cases. While U.S.-authorized vaccines provide strong protection against severe illness, they arent 100% effective and breakthrough infections, though rare and generally mild, do occur.

With this in mind, scientists are working to develop shots that would target the Delta variant specifically. The mRNA platform behind some vaccines might make this process relatively straightforward, according to Matthew Johnson, senior director of product development at the Duke Human Vaccine Institute.

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Covid-19 Vaccines Can Be Updated for the Delta Variant. Heres How. - The Wall Street Journal

A vaccine advisory panel voted Thursday to recommend that a wide swath of Americans should be offered Covid-19 vaccine booster shots, given at least six months after their second vaccination. But a vote that would have ensured access to boosters for health care workers and others in high-risk occupations did not pass, leaving many of them for now out of the eligibility pool.

The recommendations which pertain at this time only to people who were previously vaccinated with the Pfizer-BioNTech vaccine now go to Rochelle Walensky, director of the Centers for Disease Control and Prevention. She is not bound to follow recommendations from the Advisory Committee on Immunization Practices but it would be highly unusual for a CDC director to reject the ACIPs advice.

Walensky is expected to approve the recommendations on Thursday, opening the door for the booster shot program to begin soon, potentially in the week that the Biden administration had set as its target.

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The ACIP voted on a series of questions, each of which cast a broader net in terms of who in this country would be eligible to get a booster shot at this point. The committee agreed unanimously to recommend to boosters for people 65 and older as well as people living in nursing homes.

With each successive vote, however, the committees support for recommending boosters ebbed, with increasing numbers of members questioning the strength of the evidence supporting the need. A vote to recommend boosters for people aged 50 to 64 with medical conditions that raise the risk of severe Covid infection passed 13 to 2. A vote to recommend boosters for people aged 18 to 49 with medical problems passed with a 9 to 6 vote.

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But the committee drew the line at a recommendation that would have given access to boosters to people aged 18 to 64 who are at elevated risk because they live in a setting or work in an occupation where the risk of catching Covid-19 is significant. This would include health workers, prisoners and prison guards, and people who live in or work in homeless shelters.

The recommendation was defeated by a 9 to 6 vote.

We might as well give it to everybody, Pablo Snchez, a professor of pediatrics at Ohio State University and committee member, said of the last vote. Sarah Long, a pediatrics professor at Drexel University College of Medicine, who voted no on all but the first recommendation, called a very slippery slope that seemed uncharacteristically open-ended given the lack of data supporting both the benefit and the need.

Snchez said he was concerned offering booster shots so broadly at this point would send the wrong message about how well the Covid vaccines are working. This is like saying the vaccine isnt working. And it is working.

But Helen Keipp Talbot urged colleagues to vote for the recommendation as a way to boost the immunity of health workers. Hospitals are struggling under the crush of Covid patients, she said, and when health workers get sick, theres no one to step in.

Having the option to give health care workers a third dose helps us to maintain our staffing, said Talbot, who voted yes on all four recommendations.

Some outside experts who have been skeptical of offering boosters broadly said they supported ACIPs vote against including the last group even though the Food and Drug Administration expressly included them in its explanation of who it felt should be eligible for Covid booster shots in an emergency use authorization issued late Wednesday.

Supporting boosters based on occupation would have in effect opened up the shots to all adults who wanted to go out and get one, said Norman Baylor, a vaccine industry consultant who formerly ran FDAs vaccines program office.

Baylor noted most Covid vaccines are being administered by pharmacists, a group not equipped to check bona fides beyond age if an individual showed up for a booster saying they worked or lived in one of the named settings. You might have asked the question, 18 and above, period, he said.

Paul Offit, a pediatric infectious diseases specialist at Childrens Hospital of Philadelphia, agreed. Offit, who serves on the FDAs vaccine advisory body, said he was planning on waiting a bit before he gets a third shot hes 70 because as of now, there was not much data about booster shots and that the data showed that two doses were continuing to offer excellent protection against severe disease.

Im going to wait to see how this plays out, Offit said.

The FDA authorization issued Wednesday covers a Pfizer booster shot for those 65 and older and a wide array of people who are at higher risk of severe Covid because of health conditions or because they have frequent and unavoidable exposure to the SARS-CoV-2 virus in institutional or occupational settings.

Despite the fact that ACIP voted not to make the final recommendation, many Americans will now find themselves eligible to for a booster shot if they received the Pfizer and BioNTech vaccine as their primary vaccination series. So far only Pfizer and BioNTech have secured FDA authorization for a booster shot. Nearly 100 million people in the United States have received two doses of the Pfizer vaccine. The third shots should be given sometime after six months have elapsed from receipt of the second dose.

A number of ACIP members were clearly unhappy they could not recommend the Pfizer booster be made available to all people who fall into the groups that qualify for a booster shot, regardless of their initial doses. But the FDA said it did not have evidence on which to recommend that people who got Modernas two-dose vaccine or the one-dose Johnson and Johnson vaccine should get a Pfizer jab as their third or second shot respectively.

Peter Marks, director of FDAs vaccines division, told the committee FDA understands the frustration about not being able to give boosters at this point to people who did not get the Pfizer vaccine. The agency is working with manufacturers and will try to fill this gap as quickly as possible, he said.

While most members of the committee supported the use of boosters, several raised concerns that this step wont fix the countrys Covid problem. Talbot said hospitals are full of people with Covid-19 who arent vaccinated. Boosting fully vaccinated people wont change that.

I feel like were putting lipstick on frogs, she said. This is not going to solve the pandemic.

Thursdays ACIP vote punctuates a rocky five-week period in which the Biden administration found itself at odds with many in the scientific community and those who value drug and vaccine approvals playing out according to regulatory pathways.

Rather than asking the FDA and the CDC to advise it on whether it was time to make booster shots available to Americans, the administration announced a booster shot campaign would begin the week of Sept. 20. The announcement was made before any booster shots had been authorized for use and before two of the three manufacturers had even filed an application to the FDA for approval of a booster.

Whether most fully vaccinated people need a booster shot at this point remains a point of heated debate. While data from Israel one of the first countries to rapidly vaccinate a large portion of its population suggests the Pfizer vaccines ability to protect against serious disease subsides within months, many questions remain about the interpretation of those data. And as Israel only used the Pfizer vaccine, the countrys experience tells the world nothing about other vaccines in use.

The FDAs vaccine advisory committee, the Vaccines and Related Biological Products Advisory Committee, or VRBPAC for short, voted at a meeting last Friday not to recommend boosters for everyone 16 years of age and older who had received the Pfizer vaccine. Instead, it recommended a smaller group of individuals be offered boosters people 65 and older and people at high risk of severe disease.

Pfizer had applied for approval of a booster that would be offered to anyone aged 16 and older, to be given six months after the second dose of vaccine. But Pfizers application included no data to support the safety of giving 16- and 17-year olds a booster and members of VRBPAC objected strongly to their inclusion without safety data. In the end, the FDA did not include them.

Andrew Joseph contributed reporting.

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Advisory committee recommends many be offered Covid vaccine boosters - STAT

When it comes to fighting vaccine misinformation online, does calling it out actually work? Pool/Getty Images hide caption

When it comes to fighting vaccine misinformation online, does calling it out actually work?

A now-infamous tweet by rapper Nicki Minaj is the latest example of false messaging about the COVID-19 vaccines.

It's reignited a conversation about how to fight vaccine misinformation online and whether calling it out actually works.

And it's not just those outside the medical establishment who are hesitant or actively spreading false information. A small percentage of doctors are, too.

According to The Washington Post; Facebook, YouTube, and Twitter have all enacted stricter rules against coronavirus misinformation. This includes posting outright lies about vaccines. But much of the misinformation is spread by those who say they are simply asking questions, something the platforms have been hesitant to police.

We talk with experts about the tangled web of vaccine misinformation online and how to fight it.

Ben Collins, Dr. Sonja Rasmussen, Neil Johnson, and Lauren Culbertson join us for the conversation.

Like what you hear? Find more of our programs online.

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Extremely Online: The Fight Against COVID-19 Vaccine Misinformation : 1A - NPR

As more employers require their workers to get vaccinated against COVID-19, more workers are finding religion. Or rather, sincerely held religious beliefs that, they say, prevent them from getting the shots.

Hundreds of Los Angeles firefighters have sought exemptions from the citys vaccine mandate for religious or medical reasons, and thousands of Los Angeles Police Department employees are expected to do the same. And they may be the leading edge of the wave of workers seeking exemptions, as the federal government is preparing to require employers with 100 or more workers to order vaccinations or weekly coronavirus testing for all employees. Federal employees are already required to be vaccinated even if they work from home, with no testing alternative, and a similar requirement is being developed for federal contractors and subcontractors.

Nicholas De Blouw, an employment attorney and partner at Blumenthal Nordrehaug Bhowmik De Blouw in Los Angeles, said hes getting calls every single day from people facing a vaccine mandate including three in about 20 minutes on Wednesday morning.

But what are the rules surrounding religious exemptions? What constitutes a sincerely held belief? And how much leeway do employers have when faced with a torrent of exemption claims based on religion? The Times talked to experts in employment law and religious rights, and here are their answers to these and other questions.

The Supreme Court upheld the constitutionality of vaccine mandates more than 100 years ago, but has made it clear that employers cant run roughshod over their workers religious beliefs. The protections for religious objectors are in California law, the U.S. Constitution and federal law, particularly Title VII of the Civil Rights Act of 1964, which requires private companies to make reasonable accommodations for workers who have sincerely held religious beliefs that conflict with vaccination.

Employers hoping to stand on firm legal footing need to look at each employees request and go through an interactive process with the employee to seek a reasonable accommodation for sincerely held beliefs.

That process is really key, said Mark Phillips, a partner at the Reed Smith law firm in Los Angeles. Employers cant dismiss a request for a religious exemption out of hand, even if it may initially seem ridiculous, Phillips said. The employer has to engage with the worker not only to find out the nature of the request, but also to find out if accommodation is possible and reasonable.

Angel James Horacek, an attorney in Culver City, said Californias ban on religious creed discrimination applies not just to beliefs based on an organized religions teachings, but also to beliefs, observances, or practices, which an individual sincerely holds and which occupy in his or her life a place of importance parallel to that of traditionally recognized religions.

Theres still a limit to what constitutes a religion, Horacek said in an email. In a 2002 decision holding that veganism was not a religious belief, a California appeals court laid out three factors: a religion addresses fundamental and ultimate questions, consists of a belief-system as opposed to an isolated teaching, and often can be recognized by the presence of certain formal and external signs.

Employers can ask for the details of the religious conviction behind the request for an accommodation and explore whether the objection is based on politics, ideology or medical concerns. And if the employer denies the request and the worker sues, the burden will be on the worker to establish that he or she was motivated by a sincere religious belief.

Nevertheless, said Phillips, its not a good idea to question the sincerity of somebodys religious belief. Horacek agreed, saying theres very little an employer can do to test whether a workers claim is sincere.

Nor does it matter whether the person is following the teaching of his or her faith leaders of the vast majority of organized religions have endorsed at least some of the COVID-19 vaccines that are available. You dont go by what their organized religion believes, Phillips said. An individuals personal religious conviction can differ from their organized religion.

Added Douglas Laycock, Robert E. Scott distinguished professor of law at the University of Virginia, Courts are in no position to adjudicate the official teaching of the church anyway. There are lots of issues on which members of a church disagree, and lots of cases in which the objector takes the teaching further than the church does.

The issue here is what it would take to minimize the risk posed by an unvaccinated employee. Could the person work from home, or do the job in a private office, or otherwise maintain minimal contact with other workers and the public? Is there another, similar job that the person could do remotely?

For private employers, the accommodation isnt reasonable if it imposes an undue financial or operational burden on the company. Thats an ill-defined standard, so the answer will depend on such things as the nature of the accommodation and the size of the company.

Its important to bear in mind that if your employer mandates COVID-19 vaccinations, your religious objection, no matter how sincerely held, is no guarantee that you can keep your job. The employer is obligated to try to find a way to keep you at work unvaccinated, but whether thats possible depends on what you do.

For example, if you cant work from home, cant socially distance from co-workers or customers, and cant be tested frequently enough to assure the safety of those you come into contact with, your employer may have reason to replace you. If you cant perform the essential functions of the job even with accommodation, then theres no accommodation thats going to help you, Phillips said.

Two other factors are the extent to which workers interact with co-workers and the public and the nature of those interactions, he said. Another is the rate of coronavirus transmission among people in that workforce the higher the rate, the greater the argument against an exemption.

De Blouw noted that employers have a legal obligation to maintain a safe and healthy workplace. If they dont require vaccinations and an employee gets infected at work and dies, De Blouw said, they could be held liable.

Laycock, who described himself as one of the strongest academic defenders of religious exemptions in the country, nevertheless argues that Los Angeles officials would be on solid legal footing if they rejected all exemptions from the vaccine mandate except those needed for medical reasons.

It has a compelling government interest in requiring vaccination against a deadly infectious disease. The court cases are essentially unanimous about that, he wrote in an email. The unvaccinated are overwhelming our hospitals and depriving other folks of needed medical care, and because no vaccine is 100% effective, they are spreading the disease to folks who are vaccinated, causing minor problems for many of them and killing a few of them.

Other attorneys disagree, arguing that like any other employer, the city would have to meet individually with each of the hundreds of employees seeking exemptions to determine whether they could be reasonably accommodated.

In addition, the Biden administration has muddied the waters when it comes to what employers need to do to protect the public, mandating vaccinations for federal workers and contractors regardless of their size, but allowing a testing alternative for private employers with 100 or more workers, and requiring neither testing nor vaccinations for workers at other private companies.

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What is a religious exemption from the COVID vaccine? - Los Angeles Times

A non-peer-reviewed retrospective paper, released as a pre-print, analyzed the rate of post-vaccination cardiac myocarditis in children aged 1215 and 1617 years who had received mRNA COVID-19 vaccines.

The researchers did so by searching the Vaccine Adverse Event Reporting System (VAERS) for reports of children aged 12-17 years from January 1, 2021, to June 18, 2021. They searched using the words myocarditis, pericarditis, myopericarditis, chest pain, and a troponin lab, which identifies a heart attack and other heart conditions.

They then inferred a diagnosis of cardiac adverse events (CAE) in these children.

The Centers for Disease Control and Prevention (CDC) announced in June 2021 that it is actively monitoring for the occurrence of myocarditis and pericarditis after the COVID-19 vaccination. The CDC still recommends that everyone aged 12 years and older receive a COVID-19 vaccination.

Researchers stratified the reports they had identified as CAE rates by age, sex, and vaccination dose number. They conducted a harm-benefit analysis based on available literature concerning COVID-19-related hospitalization risk in the age group.

The study identified 257 CAEs in total and reported rates (in cases per million after the second dose) of 162.2 in boys aged 1215 years, 94 in boys aged 1617 years, 13 in girls aged 12-15 years, and 13.4 in girls aged 1617 years.

The study estimated that CAE incidence was between 3.7 and 6.1 times higher than their 120-day COVID-19 hospitalization risk (August 21, 2021) in healthy boys aged 1215 receiving their second mRNA dose. They estimated that the CAE incidence was 2.13.5 times higher in healthy boys aged 1617.

The paper appears on the pre-print server MedRxiv.

Stay informed with live updates on the current COVID-19 outbreak and visit our coronavirus hub for more advice on prevention and treatment.

Inflammation may occur in the heart due to infections, medicines, autoimmune diseases, or environmental factors, which may cause damage and lead to health problems. Inflammation may occur in the heart muscle (myocarditis) and tissue that forms the sac around the heart (pericarditis).

Cases of myocarditis and pericarditis reported to the VAERS occurred mainly in male adolescents and young adults, usually within 7 days following the second dose of an mRNA COVID-19 vaccine (Pfizer-BioNTech and Moderna), with most resolving after conservative management.

VAERS is a post-marketing safety program in the United States that collects reports of adverse events after vaccination from patients, family members, healthcare providers, vaccine manufacturers, and the general public in the U.S.

in an interview with MNT, Dr. Danelle Fisher, pediatrician, and Chair of Pediatrics at Providence Saint Johns Health Center in Santa Monica, CA, explained: All myocarditis causes symptoms, including chest pain, difficulty breathing, and palpitations [and] we usually [admit] children who have myocarditis [to] the hospital to monitor them.

However, theres no specific treatment for myocarditis we use supportive care which means things such as ibuprofen for chest pain or discomfort, intravenous fluids [for hydration], and just watching and waiting and these kids get better.

She added, Now, there is a small subset of myocarditis patients that will go on to have cardiac dysfunction, but it is incredibly rare. The [number] of cardiac issues that [we see] from COVID-19 disease [will] probably outweigh the [number] of kids who got the vaccine and ended up with vaccine-associated myocarditis.

The study has limitations regarding the inappropriate use of VAERS reporting data to calculate the CAE rate. VAERS serves to rapidly detect safety signals or unusual or unexpected patterns of vaccine-related adverse reactions, but the publically available database has some fundamental limitations:

Dr. Fisher commented about the studys limitations: The first thing that jumped out to me is that this is an evaluation of the VAERS database. [] I look at this data as being [] self-reported or [] not necessarily reviewed by physicians.

Using unverified VAERS data to calculate the incidence of heart inflammation is not recommended in the VAERS data disclaimer, limiting the accuracy and applicability of the studys findings.

She added, Now, on top of that, the instance of myocarditis that has been seen after the Pfizer vaccination is still a very rare number. []. So, Im not exactly sure that Im ready to draw conclusions or tell my patients that Im very concerned about myocarditis after [the] Pfizer vaccine if they are in the risk group of 1218 years old; this is not the study that Im going to hang my hat on as a physician.

Scott Pauley, Press Officer, News Media Branch, Division of Public Affairs, Office of the Associate Director for Communications for the CDC, commented to MNT: [The] CDC was not involved in the study, which used reports with limited information from a publicly accessible VAERS database [and] is not able to verify the validity of [the] methods used or the results obtained.

However, a CDC analysis of reports to the VAERS of myocarditis after COVID-19 vaccines is currently under review at a major peer-reviewed journal.

He added, This analysis describes reports that have been verified to meet the CDC working definition for myocarditis or myopericarditis, by an interview with a provider involved in the patients care, as well as a review of available medical records associated with these reports.

Dr. Fisher commented:

I have a young child myself who is a boy; hes 9.5 years old. [] Im not worried about my son getting the Pfizer vaccine if it is indeed released by October 30 or 31. Im still going to [] get him the vaccine because I still feel that the vaccine is truly the safest thing we can do to protect our children and our adult population from COVID disease.

She elaborated, I am so much more concerned about COVID disease than I am about [the] COVID vaccination, and I want to be sure that when people look at studies, they know what theyre looking at.

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Heart inflammation after COVID-19 vaccine: Are boys at higher risk? - Medical News Today