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FDA says the Pfizer COVID vaccine looks effective for young kids

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FDA scientists concluded that in almost every scenario the Pfizer vaccine’s benefit for preventing hospitalizations and death from COVID-19 would outweigh any serious potential side effects in children. Pfizer via AP hide caption

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Pfizer via AP

Federal health regulators said late Friday that kid-size doses of Pfizer’s COVID-19 vaccine appear highly effective at preventing symptomatic infections in elementary school children and caused no unexpected safety issues, as the U.S. weighs beginning vaccinations in youngsters.

The Food and Drug Administration posted its analysis of Pfizer’s data ahead of a public meeting next week to debate whether the shots are ready for the nation’s roughly 28 million children ages 5 to 11. The agency will ask a panel of outside vaccine experts to vote on that question.

In their analysis, FDA scientists concluded that in almost every scenario the vaccine’s benefit for preventing hospitalizations and death from COVID-19 would outweigh any serious potential side effects in children. But agency reviewers stopped short of calling for Pfizer’s shot to be authorized.

The agency will put that question to its panel of independent advisers next Tuesday and weigh their advice before making its own decision.

If the FDA authorizes the shots, the Centers for Disease Control and Prevention will make additional recommendations on who should receive them the first week of November. Children could begin vaccinations early next month — with the first youngsters in line fully protected by Christmas.

Full-strength Pfizer shots already are recommended for anyone 12 or older, but pediatricians and many parents are anxiously awaiting protection for younger children to stem infections from the extra-contagious delta variant and help keep kids in school.

The FDA review affirmed results from Pfizer posted earlier in the day showing the two-dose shot was nearly 91% effective at preventing symptomatic infection in young children. Researchers calculated the figure based on 16 COVID-19 cases in youngsters given dummy shots versus three cases among vaccinated children. There were no severe illnesses reported among any of the youngsters, but the vaccinated ones had much milder symptoms than their unvaccinated counterparts.

Most of the study data was collected in the U.S. during August and September, when the delta variant had become the dominant COVID-19 strain.

The FDA review found no new or unexpected side effects. Those that did occur mostly consisted of sore arms, fever or achiness.

However, FDA scientists noted that the study wasn’t large enough to detect extremely rare side effects, including myocarditis, a type of heart inflammation that occasionally occurs after the second dose.

The agency used statistical modeling to try to predict how many hospitalizations and deaths from COVID-19 the vaccine would prevent versus the number of potential heart side effects it might cause. In four scenarios of the pandemic, the vaccine clearly prevented more hospitalizations than would be expected from the heart side effect. Only when virus cases were extremely low could the vaccine cause more hospitalizations than it would prevent. But overall, regulators concluded that the vaccine’s protective benefits “would clearly outweigh” its risks.

While children run a lower risk of severe illness or death than older people, COVID-19 has killed more than 630 Americans 18 and under, according to the CDC. Nearly 6.2 million children have been infected with the coronavirus, more than 1.1 million in the last six weeks as the delta variant surged, the American Academy of Pediatrics says.

The Biden administration has purchased enough kid-size doses — in special orange-capped vials to distinguish them from adult vaccine — for the nation’s 5- to 11-year-olds. If the vaccine is cleared, millions of doses will be promptly shipped around the country, along with kid-size needles.

More than 25,000 pediatricians and primary care providers already have signed up to get the shots into little arms.

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Source: https://www.npr.org/sections/coronavirus-live-updates/2021/10/23/1048660468/fda-pfizer-vaccine-kids-effective

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Tracking Social Determinants of Health During the COVID-19 Pandemic

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The public health and economic effects of the pandemic continue to affect the well-being of many Americans. The American Rescue Plan included funding not only to address the public health crisis of the pandemic, but also to provide economic support to many low-income people struggling to make ends meet. Millions have lost jobs or income since the start of the pandemic, making it difficult to pay expenses including basic needs like food and housing. These challenges will ultimately affect people’s health and well-being, as they influence social determinants of health. This brief provides an overview of social determinants of health and a look at how adults are faring across an array of measures as of September 2021 when a portion of the population remained unvaccinated, and hospitalizations and deaths due to the delta variant are surging in some areas even as they wane in others.

What are social determinants of health?

Social determinants of health are the conditions in which people are born, grow, live, work, and age. They include factors like socioeconomic status, education, neighborhood and physical environment, employment, and social support networks, as well as access to health care (Figure 1).

9812 - Figure 1

Figure 1: Social Determinants of Health

Though health care is essential to health, research shows that health outcomes are driven by an array of factors, including underlying genetics, health behaviors, social and environmental factors, and financial distress and all of its implications. While there is currently no consensus in the research on the magnitude of the relative contributions of each of these factors to health, studies suggest that health behaviors and social and economic factors are the primary drivers of health outcomes, and social and economic factors can shape individuals’ health behaviors. There is extensive research that concludes that addressing social determinants of health is important for improving health outcomes and reducing health disparities. Prior to the pandemic there were a variety of initiatives to address social determinants of health both in health and non-health sectors. The COVID-19 pandemic exacerbated already existing health disparities for a broad range of populations, but specifically for people of color.

How are adults faring across a range of social determinants of health during the pandemic?

Across a wide range of metrics, large shares of people are experiencing hardship. The Census Bureau’s Household Pulse Survey was designed to quickly and efficiently collect and compile data about how people’s lives have been impacted by the coronavirus pandemic. For this analysis we looked at a range of measures over the course of the pandemic. Unfortunately, the Household Pulse Survey does not provide pre-pandemic measures for comparison. While we have tracked data over time and there have been fluctuations at various points since March 2020, patterns of hardship remain largely consistent, and changes in measures do not necessarily follow economic indicators or pandemic trends. Data for the most recent period, September 1 – September 13, show that (Figure 2):

  • More than one in six adults (17.4%) reported that they or someone in their household had experienced a loss of employment income in the past four weeks;
  • More than half (50.9%) of adults reported difficulty paying for usual household expenses in the past 7 days, and 30.5% used credit cards or loans to meet household spending needs;
  • 5% of adults had no confidence in their ability to make next month’s housing payment (across renters and owners), and 8.8% reported food insufficiency in their household;
  • Nearly one in three (32.1%) adults reported symptoms of depression or anxiety.

Black and Hispanic adults fare worse than White adults across nearly all measures, with large differences in some measures. In September 2021, nearly seven in ten of Black and Hispanic adults (66.4% and 69.2%, respectively) reported difficulty paying household expenditures compared to 43.6% of White adults; 12.9% of Black adults and 10.6% of Hispanic adults reported no confidence in their ability to make next month’s housing payment compared to 4.1% of White adults; and 14.9% of Black adults and 14.2% of Hispanic adults reported food insufficiency in the household compared to 6.3% of White adults. Furthermore, around a quarter of Black and Hispanic adults reported living in a household that experienced a loss of employment income in the last four weeks (24.9% and 27.2%, respectively) compared to 13.1% of White adults.

While variation across age and gender was not as stark, younger adults (ages 18 to 44) fared worse on many measures compared to older adults. For example, higher shares of younger adults reported symptoms of anxiety and depression as well as difficulty paying for usual household expenses. In addition, higher shares of women reported symptoms of depression or anxiety and difficulty paying usual household expenses in the past seven days compared to men.

Across most measures, adults with children in their household fared worse compared to overall adults. For example, 22.0% of adults with children in the household experienced loss of employment income in the household in the last four weeks compared to 17.4% of adults overall, and six in ten (59.7%) adults with children in the household reported difficulty paying for household expenses in the past week compared to the overall population of 50.9%. Adults in households with children were also more likely to report food insufficiency, symptoms of depression or anxiety, and no confidence in ability to make next month’s housing payment than the general population.

Patterns of hardship over time indicate both effects of the pandemic and related policies as well as longstanding disparities in social determinants of health. Data indicate the shares of people experiencing hardships peaked in December 2020 but have otherwise remained largely stable (Figure 2). Trends across all measures have improved since December 2020, reaching lows during the pandemic in March and April 2021, likely reflecting the roll-out of the COVID-19 vaccines and new federal funding available during that period. However, differences in rates of hardship among certain populations has remained largely stable throughout the pandemic and to some extent reflect longstanding disparities that existed even before the pandemic. Still, understanding these disparities in the context of heightened levels of need over the past year highlights these differences and who may benefit most from government assistance.

What to watch going forward

The American Rescue Plan provides $1.9 trillion in funding to address the ongoing health and economic effects of the pandemic. Some of the provisions that provide key economic support for individuals include direct stimulus payments to individuals, an extension of federal unemployment insurance payments, a child tax credit of up to $300 per child per month from July through the end of the year, additional funding to address food insecurity, emergency rental assistance, and emergency housing vouchers. This federal support may have contributed to some improvements in metrics, but hardship is also affected by the trajectory of the pandemic (including a surge in cases and deaths due to the delta variant and any changes in vaccination rates). Looking ahead, the effects of some temporary federal support and the pandemic are likely to continue to be factors in future data releases; however, additional and extended federal support being debated in Congress that may seek to address underlying economic issues beyond the pandemic has the potential to change long-standing patterns of hardship across different demographic groups.

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Source: https://www.kff.org/coronavirus-covid-19/issue-brief/tracking-social-determinants-of-health-during-the-covid-19-pandemic/

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Memes about COVID-19 helped us cope with life in a pandemic, a new study finds

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Artist Jonas Never (@never1959) applies finishing touches to his mural of Sen. Bernie Sanders in Culver City, Calif., on Jan. 24. Standing out in a crowd of glamorously dressed guests, Sanders showed up for the presidential inauguration in a heavy winter jacket and patterned mittens — with an AFP photo of the veteran leftist spawning the first viral meme of the Biden era. Chris Delmas/AFP via Getty Images hide caption

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Chris Delmas/AFP via Getty Images

Does a meme a day keep the doctor away? Not quite, but it looks like it might help, according to one recent study.

Researchers with Pennsylvania State University and the University of California Santa Barbara found that memes helped people cope with life during the COVID-19 pandemic, according to a study published this week in the Psychology of Popular Media journal. Researchers found that those who viewed memes — a type of humor they described as funny or cute pictures that reference pop culture — reported “higher levels of humor” and more positive feelings, according to a news release from the American Psychological Association, which publishes the journal.

They surveyed 748 people online last December: 72% of those who responded were white, 54% identified as women, 63% didn’t hold a college degree, and their ages ranged from 18 to 88, the release states. They were shown a variety of meme types, with different kinds of photos and captions, and asked to rate the cuteness, humor and emotional responses prompted by the materials, as well as how much the memes in question made them think about COVID-19.

Those who viewed memes that specifically referenced the pandemic felt less stress than those who viewed non-pandemic-related memes. They also felt more capable of coping with the COVID-19 crisis and were better at processing information, according to the study. And they were also less likely to be stressed about the pandemic than those who didn’t view memes related to COVID-19 at all, researchers concluded.

The type of meme matters, too: People who viewed memes featuring cute babies or baby animals were overall less likely to think about the pandemic or the effects it has had on them, regardless of the type of caption, according to this week’s release. (And researchers also found that those who were surveyed found that memes with animals in them were cuter than those featuring humans, the APA said.)

The results of the study show that memes about stressful situations can potentially help the public deal with and process those situations, researchers said.

“While the World Health Organization recommended that people avoid too much COVID-related media for the benefit of their mental health, our research reveals that memes about COVID-19 could help people feel more confident in their ability to deal with the pandemic,” Jessica Gall Myrick, a lead author of the study and a professor at Pennsylvania State University, said in the APA release. “This suggests that not all media are uniformly bad for mental health and people should stop and take stock of what type of media they are consuming. If we are all more conscious of how our behaviors, including time spent scrolling, affect our emotional states, then we will better be able to use social media to help us when we need it and to take a break from it when we need that instead.”

So the next time you worry that you’re wasting time scrolling through memes, just think: It could be good for your health.

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Source: https://www.npr.org/sections/coronavirus-live-updates/2021/10/21/1047736825/memes-about-covid-19-helped-us-cope-with-life-in-a-pandemic-a-new-study-finds

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The U.S. is ready to roll out the COVID vaccine once it’s approved for kids age 5-11

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Safeway pharmacist Ashley McGee fills a syringe with the Pfizer COVID-19 booster vaccination at a vaccination booster shot clinic on Oct. 1, in San Rafael, Calif. Justin Sullivan/Getty Images hide caption

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Justin Sullivan/Getty Images

The White House said on Wednesday that it is ready to quickly roll out COVID-19 vaccines for kids ages 5 to 11, if the Pfizer-BioNTech vaccine for that age group is authorized by the Food and Drug Administration and recommended by the Centers for Disease Control and Prevention.

The administration has bought enough doses for all 28 million children in that age group and will provide it in smaller packages with essential supplies like smaller needles to make it easier to get to physicians, pediatricians and community health centers, Biden administration officials said.

“Should the FDA and CDC authorize the vaccine, we will be ready to get shots in arms,” said White House coronavirus response coordinator Jeff Zients during a news briefing Wednesday morning.

The vaccine could be cleared for use in children ages 5 to 11 within a couple of weeks, officials said. The FDA’s independent advisory committee meeting is scheduled for Oct. 26, and the CDC’s independent advisory committee meeting is set for Nov. 2 and 3.

The Pfizer vaccine currently has full approval for use in adults, and the federal government has authorized it for emergency use in children ages 12 to 17.

White House officials said they were announcing the plan to inoculate children ages 5 to 11 before the vaccine was approved for that age group so they could be “operationally ready” to deploy the doses as soon as the approval came.

Under the plan, the administration will work with state and local leaders to make the vaccine available at more than 25,000 pediatricians’ offices and primary care sites and 100 children’s hospital systems as well as pharmacies, schools and community health centers.

The administration also will roll out a national public education campaign to inform parents and guardians about the vaccine and solicit questions.

U.S. Surgeon General Vivek Murthy said the campaign would help head off one of the barriers to vaccinating both children and adults — misinformation about the drug.

“That’s why we’re making sure that it’s trusted messengers with scientific credibility who go out there and talk about these vaccines,” Murthy said. “But it is our collective responsibility — whether we’re in government, in the media, whether we’re individuals — to help prevent the flow and spread of misinformation online.”

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Source: https://www.npr.org/sections/coronavirus-live-updates/2021/10/20/1047587933/covid-19-children-kids-vaccine-coronavirus

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