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Pfizer to start testing its Covid-19 vaccine in kids as young as 12

It will be the first coronavirus vaccine trial to include children in the United States.

A team at Cincinnati Children’s Hospital will begin vaccinating teenagers aged 16 and 17 this week, and will move to enroll 12-to 15-year-olds later, said Dr. Robert Frenck, director of the Vaccine Research Center at the hospital.

The company confirmed on its website it has approval from the US Food and Drug Administration to enroll children as young as 12 in its trial.

“We really think a vaccine for adolescents and children is going to be critical for getting Covid under control,” Frenck told CNN in a telephone interview.

“I think one of the things that is important to remember is that although the death rate for children with Covid is lower than in older adults, it’s not zero,” he saId, noting that more than half a million children have been diagnosed with coronavirus in the US. “It is not a nonexistent infection in children.”

Children can develop serious illness and also die from coronavirus and there is no way to predict which ones will, he said. They also can spread it to other, more vulnerable people, including parents, grandparents, healthcare workers and others. And children can develop a rare but serious side-effect from coronavirus infection called multisystem inflammatory syndrome in children or MIS-C.
Kids struggle with Covid-19 and its months of aftermath

Frenck also believes more children have been infected with coronavirus than the official data show. “I think we are probably under detecting the number of kids that are infected because they are not getting sick enough to where a parent says they need to go to a doctor,” he said.

“Most of the time in kids, you have a young kid at home and they have a runny nose, they have a cough — you are not going to bring them to a doctor,” he added.

“And most of the time, what a coronavirus causes is a cold.”

Plus, the FDA has asked the companies working to make a coronavirus vaccine to test them in diverse groups — including in people usually missed in drug and vaccine trials, such as the elderly, Blacks, Hispanics and Native Americans.

New ads encourage minorities to roll up their sleeves and participate in coronavirus vaccine trials

Pfizer, one of four companies to have vaccines in advanced, Phase 3 clinical trials in the US, says it has enrolled close to 38,000 volunteers in its trial. More than 31,000 of them have received the second of two shots.

Frenck said more than 90 people have responded to an ad looking for volunteers to sign up teens for the trial.

Pfizer developed its two-dose coronavirus vaccine with Germany’s BioNtech. It uses pieces of viral genetic material to induce immunity to the coronavirus.

“If regulatory approval or authorization is obtained, the companies expect to manufacture globally up to 100 million doses by the end of 2020 and potentially 1.3 billion doses by the end of 2021,” the company said on its website.

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The VHSL needs to start playing because athletes are already competing

Maybe it’s just time.

Despite what doctors and scientists say about the coronavirus and its ability to easily spread between people, maybe it’s just time to start high school sports.

Damn the virus, go ahead, full speed!

It’s not that our children are any safer than they were in August – they aren’t. It’s that it really doesn’t matter if high school sports start – they’re already happening throughout Hampton Roads with pay-to-play programs.

You’ll find anything from football at Virginia Beach Sportsplex to field hockey at the U.S. Field Hockey Regional Training Center. Soccer programs are moving forward – with the blessing of the governor’s office – and recently a team tennis program and club cross country program were started for high school athletes.

About the only organization that isn’t moving forward is the Virginia High School League, and it’s not moving because it doesn’t have the blessing of the governor’s office. And this isn’t sitting well with high school athletes, coaches, parents or fans. As a matter of fact, there are some within the VHSL membership who have a sense of frustration over the fact that the league hasn’t received approval while pay-to-play programs are moving forward.

The VHSL put together its Championship + 1 schedule and is ready to move forward with high school sports in early December. The delay was established to allow schools to open, get students back in the classroom and to learn how to handle possible outbreaks, busing and any other coronavirus-related issues. This was smart and sports shouldn’t start before December.

But, as we sit here in October, the VHSL is still waiting for guidance. Unless the governor’s office gives its blessing, high school sports can’t happen in Phase 3. As of right now, the VHSL hasn’t heard it cannot play, but it hasn’t received permission either. The league is stuck in limbo.

There needs to be some resolution between the VHSL and the governor’s office, giving people a better picture of what’s going to happen or what needs to happen as we approach December.

If there isn’t any clarity as we enter November, it might be time for the VHSL to take the lead from the pay-to-play folks. The VHSL may need to say, “We’re playing if we have permission or not and if you don’t like it, enforce the rules across the board.” From that point, high school sports will open. The state will be forced to either let the schools play or stop the VHSL – along with everyone else.

In addition, the VHSL can establish state-wide regulations that could help hinder the spread of coronavirus while athletes compete. Will athletes, coaches and referees still get exposed to the virus? It’s a definite possibility. Will it cause spreading to parents or grandparents? It certainly could. Are there dangers to doing this? Undoubtedly. Could schools be forced to shutter again? Yep. But it doesn’t matter.

If the VHSL doesn’t start the kids are just going to sign up

Symptoms of Anxiety Have Doubled in the United States Since Start of COVID-19

Kantar Health finds that 46% of patients have cancelled scheduled appointments, leaving healthcare providers to seek other methods to reach Americans

Ahead of World Mental Health day on 10th October, Kantar Health, a leading global healthcare data, analytics and research provider, today announced that symptoms related to anxiety have doubled in the United States since the start of the COVID-19 pandemic, leading to a significant change in attitudes and behaviors of those impacted.

These findings are from Kantar Health’s National Health and Wellness Survey, the largest patient-reported outcomes survey in the world. Kantar Health revealed these findings in a recent episode of Health Heroes, a podcast series aimed to inform and educate life sciences companies on ways to get closer to patients to help drive improved health outcomes.

A ‘sobering’ mental health situation

Symptoms of anxiety can vary, as some patients reported change in sleep or the inability to care for themselves, while others reported forgoing scheduled appointments with their doctor or skipping doses of their medication.

Prior to the pandemic, America had a shortage in psychologists, psychiatrists, behavioral therapists and counselors. Now, with more Americans reporting symptoms related to anxiety, this gap has only been further exacerbated as mental health professionals struggled to meet the demands of the American public.

As such, there needs to be a workforce readjustment and more resources need to be made available for training of mental health professionals to meet the current and future anticipated challenges.

As a result, this will require a multi-year strategy, leaving a gap in the ability to deliver mental health services in the immediate future. To help in the short-term, it is essential that healthcare providers maintain communication with those that are most vulnerable to mental health issues and ensure that they are getting necessary treatment for their symptoms.

“COVID-19 has shined a glaring light on the inequities, disparities and poor funding of the US public health system,” stated Dr. David Nash of Thomas Jefferson University. “Despite this, I am optimistic about the future of the US health care system as it provides us with a once in a century opportunity to self-reflect and make the appropriate changes needed to make our system better and safer for all Americans.”

Kantar Health found that 46% of patients cancelled or delayed their appointments due to COVID-19, with 26% of those cancelling their appointment due to worries around contracting the virus. This can lead to worsening symptoms of chronic illness and increase mental health issues.

To reach patients who have decided to forego their regular appointments, Kantar Health suggests that doctors need to find ways to maintain regular communication with them, such as through the use of telehealth or in-home care. In order to treat these patients, doctors need to promote a “back to prevention” mindset. In this scenario, doctors encourage their patients to resume preventative measures such as mammograms and screenings along with monitoring of chronic illnesses, such as diabetes and hypertension.

“Healthcare providers need to proactively

CMS Gives Hospitals 14 Weeks to Start Daily COVID, Flu Reports

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

The federal government is giving hospitals 14 weeks to comply with daily reporting requirements for COVID-19.

Hospitals that fail to meet the requirements will be barred from participating in Medicare and Medicaid, as announced in late August in a final rule.

The Centers for Medicare & Medicaid Services (CMS) will send letters on October 7 to all 6200 hospitals that receive reimbursement from the two federal health programs informing them of how well they are doing now, said CMS Administrator Seema Verma on a press call. 

Verma would not give an estimate on how many hospitals are currently not compliant. But Deborah Birx, MD, a member of the White House Coronavirus Task Force, said on the call that 86% of hospitals are currently reporting daily.

Federal officials on the call also announced that hospitals would have the option to begin reporting certain data on influenza starting October 19, but that it would become mandatory a few weeks later.

The reporting is important “to really ensure that we’re triangulating all data to understand where this epidemic is, how it’s moving through different populations, and ensuring that we’re meeting the needs of specific hospitals and communities,” Birx said.

The federal government began a new hospital reporting system in April but did not require hospitals to participate until it quietly issued guidance in mid-July informing facilities that they should no longer report to the Centers for Disease Control and Prevention (CDC).

The move perplexed many public health experts and epidemiologists, who expressed concern that asking hospitals to use a new data system during a pandemic could result in delays and lost information. The new HHS data collection site, HHS Protect, is being managed by a private contractor, not the CDC, which also raised alarms.

The final CMS rule issued in August went into effect immediately, without any chance for comment or revision. CMS said at the time that the pandemic was reason enough to skip over the normal bureaucratic process.

Hospitals were not pleased. But Verma claimed that since then CMS had been working with hospital organizations on enforcement.

“We’re going to do everything we can to facilitate reporting, including an enforcement timeline that will provide hospitals ample opportunity to come into compliance,” she said.

Hospitals that do not comply will get a notice every 3 weeks. Three weeks after the second notice, they’ll get weekly notices for a month, and a final termination notice at 14 weeks.

The Federation of American Hospitals (FAH), however, said their members were still not happy. “It is both inappropriate and frankly overkill for CMS to tie compliance with reporting to Medicare conditions of participation,” said FAH President and CEO Chip Kahn in a statement. He called the CMS proposal “sledgehammer enforcement,” and said that the continuing data request might weaken hospitals’ response to the pandemic because it would divert time and money away from patient care.  

Rick Pollack, president and CEO of

Parents often clueless when teens start vaping, study says

Parents are often clueless when their kids start smoking e-cigarettes, a new study finds.

On the other hand, Mom and Dad usually can tell if their children take up traditional smoking, said researchers from the University of California, San Francisco.

Having strict household rules against any form of tobacco is the best form of prevention, researchers found. And those rules should apply to adults, too.

“Tobacco use by children is troubling, and dentists, like all health care providers, should be concerned about preventing youth tobacco use,” study co-author Dr. Benjamin Chaffee, an associate professor in the university’s School of Dentistry.

“We know that tobacco-free homes are a key tool to help prevent smoking by kids,” he said in a university news release.

The study included parents of more than 23,000 kids aged 12 to 17. Researchers found the parents were less likely to know or suspect that their child used e-cigarettes, non-cigarette tobacco products or smokeless tobacco, compared with traditional cigarettes or other tobacco products.

As traditional smoking declines among American youth, use of e-cigarettes is rising. The U.S. Centers for Disease Control and Prevention said last year that 1 in 4 high school students vapes.

The new research looked at cigarettes and e-cigarettes, and also cigars, pipes, hookahs and bidis. It also examined use of smokeless tobacco products such as snuff, chewing tobacco, snus and dissolvable tobacco.

Researchers found that parents were more likely to know or suspect a child was using tobacco if the child was older, male, white, lived with a smoker, and if parents were less educated. Mothers were more clued in than fathers.

Moreover, teens and tweens whose parents had the strictest rules against tobacco use were 20% to 26% less likely to start using tobacco, compared with kids in the most permissive homes.

To stop kids from using tobacco, the researchers suggest parents:

  • Not smoke themselves.
  • Insist on tobacco-free homes.
  • Maintain strict rules against all tobacco use by anyone in the home.
  • Have clear communication with your children about not smoking.

The report was published Oct. 5 in the journal Pediatrics.

More information

For more on children and smoking, see the American Lung Association.

Copyright 2020 HealthDay. All rights reserved.

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Russian COVID-19 vaccine trials have yet to start in Brazil, lagging rivals

BRASILIA (Reuters) – Testing of Russia’s “Sputnik-V” COVID-19 vaccine has not begun in Brazil, while its British and Chinese rivals have already begun to file partial results from clinical Phase III trials, the Brazilian health regulator Anvisa said on Tuesday.

Brazil’s Paraná and Bahia states, which have testing and production or distribution agreements for the Russian vaccine, have not yet filed requests for clinical trials in Brazil, a spokeswoman for Anvisa said.

“There have been numerous meetings, physical and online, with no documents on the Russian vaccine materializing yet,” she told Reuters.

The Russian Direct Investment Fund (RDIF), which is marketing the Sputnik, touted by Russia as the world’s first registered vaccine, did not immediately reply to a request for comment.

Meanwhile, trials for the vaccine developed by Oxford University and AstraZeneca Plc , and another potential vaccine by China’s Sinovac Biotech Ltd are being conducted at a dozen sites and initial data sent in to Anvisa.

“This is still not a formal request for registration of these vaccines. We will only consider that when all the documents have been filed,” the spokeswoman told Reuters.

To speed up the process, Anvisa last week started a process of continuous filing of paperwork and initial results so that they can be studied simultaneously.

With the second most deadly coronavirus outbreak after the United States, Brazil has become a key testing ground for the vaccines under development.

Anvisa has authorized trials in Brazil for four vaccines, including those under development by Pfizer Inc in partnership with BioNTech and Johnson & Johnson’s pharmaceutical subsidiary Janssen.

Brazil has had almost 5 million confirmed cases of coronavirus and the death toll reached 146,675 on Monday, the Health Ministry said.

(Reporting by Anthony Boadle; Editing by Lisa Shumaker)

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