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Should the FDA move faster on COVID-19 vaccines for young children?

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Should the FDA move faster on COVID-19 vaccines for young children?

Whether or not you’re the guardian of a younger youngster, a faculty worker or simply somebody who pulls your masks up slightly tighter on the sight of an approaching gaggle of youngsters, you’re in all probability asking your self this query with a rising sense of urgency:

How quickly can the youngest People safely get their jab?

Prepare to listen to requires endurance and the oft-repeated mantra of pediatric medical professionals: Children aren’t small adults.

In different phrases, don’t assume that as a result of COVID-19 vaccines have been proven to guard adults and adolescents fairly safely that the identical vaccines in the identical doses will work simply as properly for youthful youngsters.

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Kids’s our bodies — their organs, their muscular tissues and bones, and their metabolic and immune programs — perform otherwise than these of adults. Meaning they will reply very otherwise to grownup medicines in grownup doses.

So earlier than COVID-19 vaccines will be cleared for the 28 million American youngsters between the ages of 5 and 11 and the 20 million who’re even youthful, regulators want strong proof that the pictures are protected and that they scale back the danger of illness.

That proof must come from scientific trials that can be scrutinized by the specialists at Meals and Drug Administration. That’s usually an exacting and deliberate course of, typically taking years.

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However within the midst of a pandemic despatched into overdrive by the Delta variant, “exacting and deliberate” is starting to sound extra like “gradual and bureaucratic.”

Between late June and mid-August, because the Delta variant solidified its grip on the nation, the speed at which youngsters have been hospitalized for COVID-19 surged virtually fivefold. The nation’s pediatricians have been rising impatient.

“The Delta variant has created a brand new and urgent threat to youngsters and adolescents throughout this nation,” the American Academy of Pediatrics wrote in an Aug. 5 letter to the FDA. The docs exhorted the company “to fastidiously contemplate the affect of its regulatory choices on additional delays within the availability of vaccines for this age group.”

The FDA is keenly conscious of the stress. It responded Friday with the discharge of an uncommon public assertion that acknowledged the urgency of its mission and promised to evaluation scientific trial knowledge “as rapidly as attainable, possible in a matter of weeks relatively than months.”

Right here’s a better take a look at the place we go from right here.

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Aren’t some COVID-19 vaccines already accessible to American youngsters?

Sure. The one made by Pfizer and BioNTech has acquired full approval for folks 16 and older and has been licensed for emergency use in 12- to 15-year-olds.

That’s it?

Up to now. Pfizer stated it expects to get the primary outcomes from its trial in youthful youngsters to the FDA later this month or in early October. As soon as these knowledge are submitted, the FDA can start to guage it.

A second vaccine made by Moderna has gained provisional approval for adolescents 12 to18 in Canada, Europe and Japan. The corporate has filed to realize the FDA’s blessing for emergency use in youngsters within the U.S. as younger as 12, saying that its scientific trial outcomes have been “in keeping with a vaccine efficacy of 100%.” A complicated-stage trial in 4,000 youngsters ages 5 to 11 has simply accomplished enrollment.

The Johnson & Johnson vaccine continues to be being examined on adolescents 12 to 17.

What’s holding issues up?

Anxious over the emergence of a few uncommon negative effects, the FDA in midsummer went again to vaccine makers and informed them so as to add extra youngsters to their trials. Regulators additionally proposed that the trials observe them for longer than that they had initially deliberate. That will give security specialists a greater probability of detecting uncommon negative effects, in addition to very delayed reactions to vaccine.

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Pfizer and Moderna responded by roughly doubling the dimensions of their trials for youthful youngsters.

The sudden shift alarmed Stanford pediatrician Dr. Yvonne Maldonado, who chairs the American Academy of Pediatrics’ Committee on Infectious Illnesses and is engaged on one in every of Pfizer’s pediatric scientific trials.

“It might have prolonged the timeline by a number of months,” she stated. And as a statistical matter, a trial with twice as many youngsters would in all probability nonetheless miss a uncommon aspect impact. Plus, since post-vaccine reactions are most definitely to happen within the two months after a shot, lengthening the follow-up was unlikely so as to add any perception, she stated.

Why would regulators threat a delay?

The problem with scientific trials is that “you’re primarily attempting to foretell the security of a vaccine in billions of youngsters by its security in hundreds of youngsters,” stated Dr. Paul Offit, a vaccine professional at Kids’s Hospital of Philadelphia.

It’s essential to attempt to detect uncommon antagonistic results, stated Offit, who has suggested each the FDA and the Facilities for Illness Management and Prevention. Even when a dreadful aspect impact occurred in only one in 1 million youngsters, it may imply vaccine-related hospitalizations or demise for as many as 120 youngsters within the U.S. alone.

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However throughout a raging pandemic by which youngsters are being hospitalized at rising charges, it’s expensive to increase trials in hopes of catching faint security alerts. “It’s irritating that youngsters are again at school and that they’re not vaccinated,” Offit stated.

Is the FDA searching for one thing particular?

Sure. Regulators are significantly eager to know extra a couple of situation known as myocarditis, which is swelling or irritation of the guts muscle.

In early June, only a month after the Pfizer vaccine turned accessible to 16- and 17-year-olds, the CDC documented a slight rise in circumstances of myocarditis in just lately vaccinated folks.

Seen largely in boys and males youthful than 30, the signs have been typically gentle and went away in a number of days both on their very own or with over-the-counter remedy. The long-term results of a gentle case of myocarditis aren’t clear.

On the similar time, myocarditis is commonly seen in youngsters and younger adults who’re hospitalized with COVID-19 — so stopping the illness with a vaccine could also be a internet achieve. Analysis is ongoing, and pediatricians are not sure whether or not youthful boys can be as susceptible to the negative effects as their older brothers.

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After an in depth briefing in June, a CDC advisory panel beneficial the vaccine for all eligible adolescents. However the panel cautioned that individuals who developed myocarditis after their first dose ought to contemplate delaying their second dose till that they had recovered or the situation was higher understood.

Is that it?

There’s at all times the potential for a completely unexpected aspect impact, such because the blood clots that emerged in a vanishingly small variety of youthful girls who acquired the J&J vaccine. Though administration of that vaccine was briefly paused whereas the danger was investigated, pictures have been rapidly resumed.

In the course of a pandemic, detecting uncommon or unexpected negative effects is a process greatest left till after a vaccine is allowed and huge numbers of numerous folks start to get it, Maldonado stated.

“This wait-and-see strategy assumes that you realize what you’re ready for,” Maldonado stated. “We don’t have the luxurious of ready three to 5 years for no matter that magical endpoint is perhaps.”

So long as youngsters stay unvaccinated, they’ll proceed to transmit the virus and maintain the pandemic alive, she added.

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With vaccines — particularly ones for youngsters — medical ethicists demand a very excessive normal of security. In spite of everything, vaccines are given to wholesome individuals who, in the event that they’re fortunate, would possibly by no means be uncovered to the disease-causing pathogen within the first place.

That’s why, in the perfect of instances, tolerance for dangerous vaccines could be very low. However now, regulators face a quandary.

Public distrust continues to suppress vaccine uptake and to drive COVID-19 hospitalizations. If the FDA redoubles its efforts to detect vaccine-related negative effects, will it shore up public confidence of their oversight? Or will it erode religion in vaccines by chasing issues that will show innocent?

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Cluster of farmworkers diagnosed with rare animal-borne disease in Ventura County

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Cluster of farmworkers diagnosed with rare animal-borne disease in Ventura County

A cluster of workers at Ventura County berry farms have been diagnosed with a rare disease often transmitted through sick animals’ urine, according to a public health advisory distributed to local doctors by county health officials Tuesday.

The bacterial infection, leptospirosis, has resulted in severe symptoms for some workers, including meningitis, an inflammation of the brain lining and spinal cord. Symptoms for mild cases included headaches and fevers.

The disease, which can be fatal, rarely spreads from human to human, according to the U.S. Centers for Disease Control and Prevention.

Ventura County Public Health has not given an official case count but said it had not identified any cases outside of the agriculture sector. The county’s agriculture commissioner was aware of 18 cases, the Ventura County Star reported.

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The health department said it was first contacted by a local physician in October, who reported an unusual trend in symptoms among hospital patients.

After launching an investigation, the department identified leptospirosis as a probable cause of the illness and found most patients worked on caneberry farms that utilize hoop houses — greenhouse structures to shelter the crops.

As the investigation to identify any additional cases and the exact sources of exposure continues, Ventura County Public Health has asked healthcare providers to consider a leptospirosis diagnosis for sick agricultural workers, particularly berry harvesters.

Rodents are a common source and transmitter of disease, though other mammals — including livestock, cats and dogs — can transmit it as well.

The disease is spread through bodily fluids, such as urine, and is often contracted through cuts and abrasions that contact contaminated water and soil, where the bacteria can survive for months.

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Humans can also contract the illness through contaminated food; however, the county health agency has found no known health risks to the general public, including through the contact or consumption of caneberries such as raspberries and blackberries.

Symptom onset typically occurs between two and 30 days after exposure, and symptoms can last for months if untreated, according to the CDC.

The illness often begins with mild symptoms, with fevers, chills, vomiting and headaches. Some cases can then enter a second, more severe phase that can result in kidney or liver failure.

Ventura County Public Health recommends agriculture and berry harvesters regularly rinse any cuts with soap and water and cover them with bandages. They also recommend wearing waterproof clothing and protection while working outdoors, including gloves and long-sleeve shirts and pants.

While there is no evidence of spread to the larger community, according to the department, residents should wash hands frequently and work to control rodents around their property if possible.

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Pet owners can consult a veterinarian about leptospirosis vaccinations and should keep pets away from ponds, lakes and other natural bodies of water.

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Political stress: Can you stay engaged without sacrificing your mental health?

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Political stress: Can you stay engaged without sacrificing your mental health?

It’s been two weeks since Donald Trump won the presidential election, but Stacey Lamirand’s brain hasn’t stopped churning.

“I still think about the election all the time,” said the 60-year-old Bay Area resident, who wanted a Kamala Harris victory so badly that she flew to Pennsylvania and knocked on voters’ doors in the final days of the campaign. “I honestly don’t know what to do about that.”

Neither do the psychologists and political scientists who have been tracking the country’s slide toward toxic levels of partisanship.

Fully 69% of U.S. adults found the presidential election a significant source of stress in their lives, the American Psychological Assn. said in its latest Stress in America report.

The distress was present across the political spectrum, with 80% of Republicans, 79% of Democrats and 73% of independents surveyed saying they were stressed about the country’s future.

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That’s unhealthy for the body politic — and for voters themselves. Stress can cause muscle tension, headaches, sleep problems and loss of appetite. Chronic stress can inflict more serious damage to the immune system and make people more vulnerable to heart attacks, strokes, diabetes, infertility, clinical anxiety, depression and other ailments.

In most circumstances, the sound medical advice is to disengage from the source of stress, therapists said. But when stress is coming from politics, that prescription pits the health of the individual against the health of the nation.

“I’m worried about people totally withdrawing from politics because it’s unpleasant,” said Aaron Weinschenk, a political scientist at the University of Wisconsin–Green Bay who studies political behavior and elections. “We don’t want them to do that. But we also don’t want them to feel sick.”

Modern life is full of stressors of all kinds: paying bills, pleasing difficult bosses, getting along with frenemies, caring for children or aging parents (or both).

The stress that stems from politics isn’t fundamentally different from other kinds of stress. What’s unique about it is the way it encompasses and enhances other sources of stress, said Brett Ford, a social psychologist at the University of Toronto who studies the link between emotions and political engagement.

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For instance, she said, elections have the potential to make everyday stressors like money and health concerns more difficult to manage as candidates debate policies that could raise the price of gas or cut off access to certain kinds of medical care.

Layered on top of that is the fact that political disagreements have morphed into moral conflicts that are perceived as pitting good against evil.

“When someone comes into power who is not on the same page as you morally, that can hit very deeply,” Ford said.

Partisanship and polarization have raised the stakes as well. Voters who feel a strong connection to a political party become more invested in its success. That can make a loss at the ballot box feel like a personal defeat, she said.

There’s also the fact that we have limited control over the outcome of an election. A patient with heart disease can improve their prognosis by taking medicine, changing their diet, getting more exercise or quitting smoking. But a person with political stress is largely at the mercy of others.

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“Politics is many forms of stress all rolled into one,” Ford said.

Weinschenk observed this firsthand the day after the election.

“I could feel it when I went into my classroom,” said the professor, whose research has found that people with political anxiety aren’t necessarily anxious in general. “I have a student who’s transgender and a couple of students who are gay. Their emotional state was so closed down.”

That’s almost to be expected in a place like Wisconsin, whose swing-state status caused residents to be bombarded with political messages. The more campaign ads a person is exposed to, the greater the risk of being diagnosed with anxiety, depression or another psychological ailment, according to a 2022 study in the journal PLOS One.

Political messages seem designed to keep voters “emotionally on edge,” said Vaile Wright, a licensed psychologist in Villa Park, Ill., and a member of the APA’s Stress in America team.

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“It encourages emotion to drive our decision-making behavior, as opposed to logic,” Wright said. “When we’re really emotionally stimulated, it makes it so much more challenging to have civil conversation. For politicians, I think that’s powerful, because emotions can be very easily manipulated.”

Making voters feel anxious is a tried-and-true way to grab their attention, said Christopher Ojeda, a political scientist at UC Merced who studies mental health and politics.

“Feelings of anxiety can be mobilizing, definitely,” he said. “That’s why politicians make fear appeals — they want people to get engaged.”

On the other hand, “feelings of depression are demobilizing and take you out of the political system,” said Ojeda, author of “The Sad Citizen: How Politics is Depressing and Why it Matters.”

“What [these feelings] can tell you is, ‘Things aren’t going the way I want them to. Maybe I need to step back,’” he said.

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Genessa Krasnow has been seeing a lot of that since the election.

The Seattle entrepreneur, who also campaigned for Harris, said it grates on her to see people laughing in restaurants “as if nothing had happened.” At a recent book club meeting, her fellow group members were willing to let her vent about politics for five minutes, but they weren’t interested in discussing ways they could counteract the incoming president.

“They’re in a state of disengagement,” said Krasnow, who is 56. She, meanwhile, is looking for new ways to reach young voters.

“I am exhausted. I am so sad,” she said. “But I don’t believe that disengaging is the answer.”

That’s the fundamental trade-off, Ojeda said, and there’s no one-size-fits-all solution.

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“Everyone has to make a decision about how much engagement they can tolerate without undermining their psychological well-being,” he said.

Lamirand took steps to protect her mental health by cutting social media ties with people whose values aren’t aligned with hers. But she will remain politically active and expects to volunteer for phone-banking duty soon.

“Doing something is the only thing that allows me to feel better,” Lamirand said. “It allows me to feel some level of control.”

Ideally, Ford said, people would not have to choose between being politically active and preserving their mental health. She is investigating ways to help people feel hopeful, inspired and compassionate about political challenges, since these emotions can motivate action without triggering stress and anxiety.

“We want to counteract this pattern where the more involved you are, the worse you are,” Ford said.

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The benefits would be felt across the political spectrum. In the APA survey, similar shares of Democrats, Republicans and independents agreed with statements like, “It causes me stress that politicians aren’t talking about the things that are most important to me,” and, “The political climate has caused strain between my family members and me.”

“Both sides are very invested in this country, and that is a good thing,” Wright said. “Antipathy and hopelessness really doesn’t serve us in the long run.”

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Video: SpaceX Unable to Recover Booster Stage During Sixth Test Flight

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Video: SpaceX Unable to Recover Booster Stage During Sixth Test Flight

President-elect Donald Trump joined Elon Musk in Texas and watched the launch from a nearby location on Tuesday. While the Starship’s giant booster stage was unable to repeat a “chopsticks” landing, the vehicle’s upper stage successfully splashed down in the Indian Ocean.

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