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More People Are Getting Unapproved Fourth Doses of the Covid-19 Vaccine

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When asked to show her vaccination card, Stacey Ricks has three to choose from.

Ms. Ricks, 49, a kidney transplant recipient taking immunosuppressive drugs, did not develop antibodies after her first two Moderna shots.

In June, without disclosing that she had already received the Moderna syringes, she received a dose of the Johnson & Johnson vaccine before federal health officials approved anyone for a third injection.

It was more difficult to get their fourth and fifth shots. In July, pharmacy records in the Houston area where she lives finally showed her previous shots. Armed with a medical certificate stating that she had developed no antibodies, Ms. Ricks convinced a pharmacist to give her two doses of the Pfizer vaccine over the summer.

“She kept saying, ‘There is no clinical data here,’” recalls Ms. Ricks. “And I said, ‘Hey, I’m the clinical data.'”

Ms. Ricks is one of many immune-compromised people in the United States who have bypassed government guidelines and received unauthorized fourth or fifth injections.

The Food and Drug Administration and Centers for Disease Control and Prevention are responsible for determining when additional doses should be given, but some patients and their doctors feel that federal agencies have acted too slowly to protect the most vulnerable.

Israel has already started rolling out the fourth vaccination – Prime Minister Naftali Bennett announced on Sunday that the country would offer additional vaccinations to people aged 60 and over and medical workers, making it the first country to introduce an additional booster vaccination so widely.

By comparison, the CDC updated its guidelines in late October to say that immunocompromised groups are eligible for a fourth dose six months after a third dose. For those who followed the rules, the earliest eligibility would be for a fourth in late February.

But as new varieties like Omicron emerge and vaccination rates remain sluggish in many areas, worrying those with weak immune systems, many of them are getting extra vaccinations without being sure whether they are safe or effective.

Usually, it is at the discretion of doctors to use approved drugs outside of the recommended uses – so a fully approved vaccine like Pfizer’s could normally be prescribed at the discretion of the doctors.

However, in order to receive and administer Covid-19 vaccines, providers must sign a legal agreement with the CDC – meaning that if they breach the agency’s rules, they risk being kicked off the vaccination program and face criminal prosecution be able. The CDC also previously warned that providers who administer unapproved shots may not have protection from patients’ legal claims if something goes wrong.

Legal experts say the government has done little to enforce compliance and it is unlikely that most providers will be penalized.

The people who do the extra shots aren’t doing anything illegal. You could face civil lawsuits if vaccine providers decide to prosecute you for lying, but that’s extremely unlikely, according to Govind Persad, assistant professor at the University of Denver’s Sturm College of Law.

The FDA and CDC did not respond to questions.

For some, taking additional shots seems to have worked – to some extent. After Ms. Ricks’ fifth shot, her doctor sent her a note stating that she had developed a “moderate” antibody response, but “still not a typical response”. She continued to take extra precautions as if she were not vaccinated.

Researchers say that some immunocompromised people – depending on their condition and the drugs they are taking – may never trigger an immune system response no matter how many shots they are given. Doctors and advocates of the extra doses say the United States has an excess of vaccines, so often the alternative is to throw them away.

Higher antibody levels seem to correlate with better protection against the virus, but researchers aren’t sure what level of protection different numbers of antibodies offer, and the FDA doesn’t recommend using antibody tests to measure immunity.

Updated

Jan. 3, 2022, 10:27 p.m. ET

The CDC estimates that there are around seven million immunocompromised people in the country, but it’s difficult to know who will benefit from extra doses, according to Dr. Robert Wachter, chairman of the medical school at the University of California, San Francisco.

“This is probably more improvisation than science at this point,” he said.

With the blessings of his transplant team, Chris Neblett, who recently moved to Indiana, Pennsylvania, received a third syringe in April.

Mr Neblett, 44, had no idea if it could help him – the drugs he was taking for his kidney transplant suppressed his immune system and prevented him from making antibodies after two shots of the Pfizer vaccine.

“Of course we bypassed the rules, but what were the effects? There weren’t really any, ”he said.

He produced low levels of antibodies after his third injection in Pfizer, but it was not until his fourth injection in November that his antibody levels matched the response of a normal, healthy person.

Mr Neblett believes his gambling was for the greater benefit – he is participating in a study at Johns Hopkins Hospital of organ transplant patients’ responses to the vaccine. According to Dr. Dorry Segev, a transplant surgeon at Johns Hopkins University working on the study, his data and those of those who acted outside of official guidelines helped convince the CDC and FDA to approve third shots for groups at risk. He said hundreds of patients in his study were given unauthorized syringes.

“You’re acting out of desperation,” he said.

“Instead of saying ‘ashamed of them’, I would say ‘too bad about the system we created’.”

While additional syringes could bring some risks, such as: B. Overstimulating the immune system, said Dr. Segev that the risks could be carefully monitored. In general, he said his data showed that extra doses of the vaccine should be safe and can work in some cases.

The Coronavirus Pandemic: Important Things You Should Know

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The global upswing. The coronavirus is spreading faster than ever in early 2022, but the final days of 2021 brought encouraging news that the Omicron variant is causing fewer serious illnesses than previous waves. As a result, governments are focusing more on expanding vaccination than limiting its spread.

Back to the office. For many businesses, the recent surge has resulted in a rapid reversal of return to office plans. In the past few days, companies like Goldman Sachs and Chevron have started to scale back their workplace guidelines. Some tell staff to only have a few days or even hours to stay home before their scheduled return.

“If three doses didn’t work at all, we should probably consider something else for this fourth dose,” said Dr. Segev.

One example, he said, is to try to reduce or stop immunosuppressive drugs before giving additional doses if possible. He is one of many doctors who complain that the CDC’s guidelines are too rigid and prevent medical professionals from treating patients on a case-by-case basis.

Karen Pearce’s doctor wrote her a note that the timing of her booster vaccination “must be before her next infusion of chemotherapy,” a treatment she needs every six months to control a life-threatening inflammatory blood vessel disease.

But Ms. Pearce, 69, of Gettysburg, Pennsylvania, won’t be eligible for a fourth syringe until February, right after she is due to receive her next IV, which she and her doctor believe will render her fourth syringe useless. This booster has become more important at Omicron, but so far no provider has agreed to give it a month earlier.

“More flexibility in their leadership could save lives, maybe mine,” she said.

Other experts say there is a limit to the flexibility of advice. Adding an extra dose too early could be counterproductive, according to Shane Crotty, professor at the Center for Infectious Diseases and Vaccine Research at the La Jolla Institute for Immunology.

This is because the immune system’s long-term memory seems to function better when it can rest between vaccines, he explained, and it takes the body months to perfect its antibody-making process after an initial vaccination.

A possible alternative to more syringes is to use monoclonal antibodies to protect patients, said Dr. Lianne S. Gensler, rheumatologist at the University of California, San Francisco. Most monoclonal antibody treatments were scarce – that is, they were only used as post-exposure treatment and not as a preventive measure. To make matters worse, Omicron made some existing monoclonal antibody treatments ineffective.

The FDA approved long-term preventive monoclonal antibody treatment specifically for vulnerable populations in December, but doses may be limited initially.

Meanwhile people with weakened immune system think about their imperfect options.

Patrick VanHorn, 67, of Ventura, Calif., Has chronic leukemia and needs his immunosuppressive drugs to stay alive. He did not produce antibodies after his fourth dose of the Moderna vaccine in August.

He discusses a fifth injection with his doctors, but is not sure whether he will pull it through.

“Right now I think why bother? Nothing happened in these first four shots, why do I think a fifth shot would do something different? ”He asked.

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Pandemic

During COVID-19, even psychiatrists need self-care

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It’s no secret that the events of the past two years have taken an extraordinary toll on most people’s mental health and well-being. COVID-19 has caused distress and grief for many people and likely contributed to higher reported levels of anxiety and depression compared to pre-pandemic years.

A 2020 American Psychiatric Association public opinion poll found that 62% of American adults were more anxious than the year before. Then another APA poll this year found that a third of Americans rated their mental health as fair or poor. As we head into the new year, it’s likely that the ongoing uncertainty means general anxiety, frustration and fatigue will also persist.

Despite these challenges, the start of a new year is always an opportunity to reflect, to leave the past behind and work toward positive change. However, it’s important to realize that most meaningful changes don’t happen overnight.

So as you ponder your goals for 2022, try not to forget that it’s easy to get overwhelmed. Realistic goals may be smaller, but they’re no less valuable and can feel just as good as those big goals when they’re accomplished.

Here are my goals for the new year. I’ll try to focus on the things I can control. Yes, even a psychiatrist can work to improve their own mental health.

And as it turns out, I’m not alone with this plan, the APA reported that one in four Americans is planning a mental health New Year’s resolution, from DIY steps like taking time to meditate or journaling to seeking help a therapist or psychiatrist.

Building resilience and improving mental health and well-being are big tasks that require small but very important steps to get started. Some of the key things I do and advise my patients to do to support their mental health are:

• Take time each day to think. Just a few minutes can make a difference.

• Practice self-care.

• Reach out to others—via email, SMS, phone, or in person. Remember you are not alone.

• Volunteer, donate, be altruistic.

• Spend less time looking at screens.

• Keep a schedule and plan ahead.

• Embark on a creative project or revive a hobby you’ve neglected.

• It’s okay not to be okay. Get professional help if needed.

My primary resolution is to conduct my profession by focusing on the prevention of public health issues that negatively impact mental health. We refer to these as the social determinants of mental health.

With large groups of people, we can avoid the need to treat the aftermath of years of violence, poverty and trauma. I believe it can be easier to address the big issues, like our history of structural racism, misogyny, disregard for indigenous culture, and many other equally important issues, if we can improve our approach to public health individually.

But just like with personal goals, meaningful cultural change doesn’t usually come quickly. We must have patience – both with ourselves and with others as we work to make the future better.

There’s no denying that the last two years have been tough. But taking individual steps to take care of ourselves and our mental health can be the first steps to addressing some of these long-standing difficulties this country faces.

Vivian Pender is President of the American Psychiatric Association. She wrote this column for the Dallas Morning News.

See the full opinion section here. Do you have an opinion on this topic? Send a letter to the editor and you might get published.

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Multiple COVID-19 outbreaks reported at Denver metro schools as omicron spreads

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DENVER — The omicron variant continues to spread in Colorado, accounting for 100% of all new cases, according to CDPHE.

It has made its way into schools as counties are now reporting multiple outbreaks, even those with measures.

As demand for safer learning environments grows, a group of students at Denver’s Thomas Jefferson High School plan to drop out next week if Denver Public Schools fail to meet their demands.

“[We have] 545 signatures so far. I think it’s amazing,” said 10th grader Haven Coleman on Saturday.

She is one of five students who helped create a petition on Change.org. Students are demanding that the district equip schools with N95 or KN95 masks, improve filtration in classrooms, conduct COVID-19 testing twice a week, improve and integrate virtual learning, and add weather-protected outdoor areas.

“We can see that tons of kids are still getting sick, still tons of outbreaks, and we have to change things,” Coleman said.

Though DPS is implementing a vaccination mandate for teachers and staff and requiring masks for everyone regardless of vaccination status, the district reports that at least 58 schools have five or more active cases. These schools meet the CDPHE definition of an outbreak.

Coleman’s school has at least 20 reported cases, but she worries that number could be higher.

“I know that our district has many more mandates than other districts. But that’s not enough,” she said.

In Douglas County, where there is no vaccination or mask requirement for teachers or students, the district is reporting outbreaks in at least five schools. However, some parents say more may be added to this list soon.

“We don’t know the nature of the exposure. We don’t know the true risk to our child because there are so many cases at the school at this point, so it’s upsetting,” said parent Amy Winkler.

She received an email from her child’s middle school, Mountain Ridge, on Friday notifying her that there was also an outbreak and more than 10 people reported having COVID-19.

“My kids wear masks to school, but the kids around them don’t wear masks, so we know they’re at risk of catching COVID from them,” Winkler said.

She and other parents are calling for universal masking regardless of immunization status, which the district deviated from on Dec. 8 when it lifted the mask mandate.

But in a video to the county this week, the health department president said all restrictions are being considered based on severity metrics such as hospitalizations and deaths, rather than case counts.

“Rather than responding to case numbers, we will respond to severity, rather than responding with fear-driven mandates and restrictions,” said Doug Benevento, president of the Douglas County Board of Health.

It’s unclear how sick students get with COVID-19, especially those who are vaccinated, but Coleman says even with safety measures like a vaccination mandate and mask requirements at her school, it’s not worth the risk.

“This really sucks. We don’t want to catch COVID, and we don’t want to risk our lives just to get a decent education,” she said.

DPS Superintendent Dr. Alex Marrero says that as omicron spreads, some schools need to go remote. At least 13 had done so this week through Friday, according to district data.

Similarly, the Douglas County School District is warning on its website that if teachers or school staff are affected by COVID-19, some classes, classes or schools may need to be remotely controlled for at least five days. A spokesman confirmed Saturday that no schools or classes will be removed.

In lieu of conditionality, the district has purchased 3,750 air purifiers to be installed in every classroom. It also offers N95 and surgical masks, but doesn’t require them.

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Partisan COVID-19 divide continues as Oklahoma schools, parents make tough decisions

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OKLAHOMA (KFOR) — Metro hospitals are on the verge of a slump as staff shortages continue and a surge in patients arrive, but health systems and first responders are not alone in their struggle. The latest surge is also affecting schools and workplaces across Oklahoma as state lawmakers continue to debate how to protect Oklahomaans from COVID-19 weeks ahead of the 2022 legislative session. Republicans are pushing back on federal vaccination mandates and want to translate these views into state law.

“Trying to debate with the federal government about who is in charge is not productive,” said Sen. Julia Kirt, D-OKC.

“It’s so politicized that more than ever I think it needs to be put in the hands of the individual citizen,” said Sen. Rob Standridge, R-Norman.

“Prior to 2020, vaccines were good,” said Sen. Mary Boren, D-Norman.

OSDH: COVID-19 hospitalizations, cases across Oklahoma steadily increasing

Debate rages on at the Oklahoma State Capitol about how best to protect Oklahomaners from COVID-19. A day after the US Supreme Court lifted a federal vaccination mandate for large companies, Oklahoma lawmakers are working to do the same here.

“I’ve seen several bills that certainly just eliminate the mandates,” said Standridge, a pharmacy owner.

The COVID-19 vaccine is administered.

Standridge has authored one of at least seven bills restricting vaccination mandates. His bills allow employees to file claims against companies if they are injured after being asked to get the shot.

“If you force someone to put something, a chemical, into their body, you should be held accountable for the results,” he said.

Data: ICU beds are not available in major Oklahoma City metro hospitals

Senator David Bullard, R-Durant, also filed a bill Friday that would make it “unlawful for any federal or state agency, political subdivision, or corporation contracted with the state to require any Oklahoma resident.” , a COVID-19 vaccine or a variant thereof.”

Senate Democrats say this sounds more like political theater and pushing back on the federal government.

“They’re really taking advantage of the political climate regarding COVID,” Boren said.

“We need to stop the spread of COVID instead of arguing about who has control of what part,” Kirt said.

Meanwhile, school districts across the Sooner State have closed their doors or switched to virtual learning because so many teachers have contracted COVID.

4. COVID-19 vaccine being offered to some immunocompromised Oklahoma residents

Mid-Del Schools said Tuesday its students will be back in class but will be required to wear masks. However, the district said mask opt-outs filed earlier this year will continue to be honored.

Oklahoma City public schools previously announced that students would return to in-person study Tuesday. On Friday, the district said students will study virtually that day instead. However, OKCPS said there’s always a chance they’ll have to stick with online learning if there are still staffing issues next week.

“You know, when the school is closed, we have problems,” said Angelica Johnson, a parent at Norman Public Schools.

Norman Mayor tests positive for COVID-19 while teaching in Costa Rica

Johnson is just one of several parents who are being forced to choose between working or staying at home with their child. Luckily, the Norman Parks and Rec Department has stepped up and given parents at three locations $25 per child relief. The parents felt the care was worth the money.

“It was immeasurable how important it was to have her here to support me as a single parent,” Johnson said.

“We’re all a community that’s working on this right now,” said Mitchell Richardson, the supervisor of the 12th Avenue Parks and Rec Center.

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