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Pfizer to enroll kids as young as 12 in COVID-19 vaccine study

(Reuters) – Pfizer Inc will enroll participants as young as 12 in its large, late-stage COVID-19 vaccine trial to understand how it works in a wider age group.

While severe COVID-19 symptoms are extremely rare in infected children, they can pass on the virus to high-risk groups such as the elderly.

That makes determining the effectiveness of a potential vaccine in children crucial, as vaccines work differently in kids and adults, the FDA said in its guidelines https://www.fda.gov/media/139638/download in June.

The U.S. Food and Drug Administration (FDA) granted permission to the drugmaker and German partner BioNTech SE to enroll younger participants this month, according to an update on the U.S. company’s website https://www.pfizer.com/science/coronavirus/vaccine on Monday.

Last month, Pfizer scaled up its trial to about 44,000 participants, from up to 30,000, to enroll people as young as 16 and those with chronic, stable HIV, hepatitis C and hepatitis B.

The company said on Tuesday it would enroll children in its study based on satisfactory safety data in older adolescents and young adults, but did not specify a timeline.

Pfizer is racing to develop a safe and effective vaccine for the new coronavirus with rivals such as Moderna Inc, AstraZeneca Plc and Johnson & Johnson.

Late-stage vaccine trials initiated by Moderna, J&J and Novavax Inc are testing their respective candidates only in adults.

AstraZeneca’s U.K. vaccine trial, targeting more than 12,000 volunteers, will have one out of 11 subgroups with children 5 to 12 years of age. Chief Executive Officer Pascal Soriot said last month that tests on children had not yet started.

(Reporting by Manojna Maddipatla in Bengaluru and Ludwig Burger in Frankfurt; Editing by Sriraj Kalluvila and Shinjini Ganguli)

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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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Wisdom tooth removal: Young woman spends two nights in ICU after failures by dentist

A dentist made multiple failures in treating an infection following her wisdom tooth extraction. Photo / 123rf

A woman in her 20s spent two nights in a New Zealand intensive care unit (ICU) after getting one of her wisdom teeth removed.

Today, a Health and Disability Commission report revealed the hospital stay came after a dentist made multiple failures in treating an infection following her wisdom tooth extraction, including allowing his patient to self-medicate and mistaking it for a dry socket.

The woman – who has not been named for privacy reasons – had her lower right wisdom removed in April 2018.

In the days following, she developed a painful mouth and “was finding it difficult to eat or open her mouth”, the report said. She visited the dental service on three occasions to discuss her symptoms.

She also began taking an antibiotic not prescribed by the dental clinic, which she had obtained overseas. She disclosed this with her dentist, who did not advise her to stop self-medicating, the investigation found.

Deputy Health and Disability Commissioner Kevin Allan criticised this, saying “a patient who is taking self-prescribed medication is a significant ‘red flag'”.

The report said the dentist diagnosed a dry socket and prescribed a course of the antibiotic amoxicillin.

Her infection worsened and she was admitted to hospital, where pus was drained from her socket and she was treated in the intensive care unit for two nights.

In the report, Allan said the dentist failed to recognise that the woman’s presenting complication was an infection and not a dry socket.

The dentist also did not provide appropriate treatment even if it was a dry socket, and missed an opportunity to recommend that she stop taking her own antibiotic and take amoxicillin instead, Allan said.

He said the dentist failed to comply with the Dental Council’s documentation standards and that the dental service had inadequate policies for ascertaining the medications being taken by clients, and that poor record-keeping and missing records indicated broader systems issues at the practice.

“Neither dentist ascertained what antibiotic [the woman] was taking. I am not satisfied that the dental service had adequate policies to deal with the situation when a patient is known to be taking medication that has not been prescribed by the practice to treat dental conditions.”

As a result of the investigation, the Deputy Commissioner recommended that the dental service audit its clinical records and develop further policies on the management of patients who are taking medications not prescribed by the clinic.

He also advised that both dentists involved undertook further training, and that the dentists and the dental clinic apologise to the woman.

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CDC Study Details ‘Urgent Need’ to Address Coronavirus Spread Among Young Adults | National News

Coronavirus cases among young adults are on the rise, and the Centers for Disease Control and Prevention said there is an “urgent need” to address the trend.

In a study released on Friday, the CDC examined 767 hotspot counties identified during June and July and found that increases in the percent of positive tests among people 24 and younger were followed by several weeks of increasing positivity rates in those aged 25 and older. The trend was particularly true in the South and West.

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Making the findings even more concerning is the fact that a jump in the positivity rate of older age groups is “likely to result in more hospitalizations, severe illnesses, and deaths,” according to CDC.

“There is an urgent need to address transmission among young adult populations, especially given recent increases in COVID-19 incidence among young adults,” the study said.

CDC published a separate, small study on Friday that identified common drivers of behavior that might influence risk for COVID-19 exposure among young adults in Wisconsin. The list included: social or peer pressure, perceived severity of disease outcome and exposure to misinformation, conflicting messages or opposing views regarding masks.

During interviews, young adults said they felt social or peer pressure to not wear a mask and reported receiving “negative reactions” or “odd looks” from people while wearing a mask.

The study said the finding “further underscores the importance of providing clear and consistent messages regarding need for and effectiveness of masks.”

Last week, CDC reported that coronavirus infections among young adults jumped from August to September, with the agency concluding that some of the increase was likely due to colleges and universities resuming in-person classes.

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CDC study: ‘Urgent need’ to slow spread of coronavirus among young adults

A Centers for Disease Control and Prevention (CDC) study released Friday warned that there is an “urgent need” to address the spread of the coronavirus among young adults. 

The study found that increases among transmission in younger people are often a precursor to transmission among older, higher-risk people. 

The study examined 767 counties in June and July that were “hot spots,” meaning they had high levels of virus spread. The study found that the spread of the virus, measured by the percentage of positive tests, began rising first in people aged 24 and under, before later rising in older, more vulnerable age groups. 

The findings “provide evidence that among young adults, those aged 18–24 years demonstrate the earliest increases in percent positivity; and underscore the importance of reducing transmission from younger populations to those at highest risk for severe illness or death,” the study said 

“Addressing transmission among young adults is an urgent public health priority,” it added.

The CDC study’s emphasis on slowing the spread of the virus among young people stands in contrast to the strategy often articulated by President TrumpDonald John TrumpBiden campaign raises over M on day of VP debate Trump chastises Whitmer for calling him ‘complicit’ in extremism associated with kidnapping scheme Trump says he hopes to hold rally Saturday despite recent COVID-19 diagnosis MORE to “protect the vulnerable” while allowing younger, lower-risk people to go on with their lives. 

“We are aggressively sheltering those at highest risk, especially the elderly, while allowing lower-risk Americans to safely return to work and to school,” Trump said in his Republican National Convention speech in August. 

Many experts have warned that given that young people can transmit the disease to older people, the best way to protect the vulnerable is to reduce the spread of the virus overall. 

“As we often say in public health: there is no peeing section of the swimming pool,” tweeted Ashish Jha, dean of the Brown University School of Public Health, tweeted last month. “We’re in this together.”

The study found that positivity rates began increasing for people aged 24 and under 31 days before a county was identified as a hot spot. Older groups’ positivity only started rising later and also peaked after the spread of the virus had already peaked among younger people. 

There was regional variation, as the South and West saw more of the trend of transmission among the young later becoming transmission among the old than the Northeast and Midwest. 

A separate CDC study released Friday found that young people reported “social or peer pressure to not wear a mask,” as well as “exposure to misinformation” and “conflicting messages” about the importance of masks. 

“Exposure to misinformation and unclear messages has been identified as a driver of behavior during an outbreak, underscoring the importance of providing clear and consistent messages about the need for and effectiveness of masks,” the study states. 

Treatment Reverses Young Man’s Type 1 Diabetes. Will It Last? | Health News

By Serena Gordon
HealthDay Reporter

(HealthDay)

WEDNESDAY, Oct. 7, 2020 (HealthDay News) — After starting a drug that’s officially approved to treat a type of blood cancer, a young man with type 1 diabetes was able to stop using insulin.

He’s been off insulin since August 2018 — more than two years.

Dr. Lisa Forbes — his doctor and co-author of a letter describing his case in the Oct. 8 issue of the New England Journal of Medicine — stopped short of calling the drug a cure for type 1 diabetes.

But Forbes, an assistant professor of pediatrics, immunology, allergy and rheumatology at Baylor College of Medicine in Houston, said the patient’s diabetes appears to have been reversed. She hopes it will stay that way as long as he keeps taking the oral medication called ruxolitinib (Jakafi). It’s in a class of medications known as JAK inhibitors.

Whether this drug can help others with type 1 diabetes isn’t yet known. This patient had a genetic mutation that ruxolitinib is known to work on. Forbes said it’s not clear if other people with type 1 diabetes also have this specific genetic mutation.

Type 1 diabetes is believed to be an autoimmune disease, though the exact cause is unknown. It develops when the immune system mistakenly attacks insulin-producing beta cells in the pancreas. Insulin is a hormone that ushers the sugars from foods into the body’s cells to be used as fuel.

People with type 1 diabetes produce little to no insulin and must take multiple daily injections of insulin (or use an insulin pump) to survive. No treatments are approved for reversing type 1 diabetes.

At 15, Forbes’ patient had been experiencing chronic yeast infections (of skin, nails, mouth and throat), chronic diarrhea, oral and rectal ulcers, recurrent sinus and lung infections and another autoimmune condition called hypogammaglobulinemia. At 17, he was diagnosed with type 1 diabetes.

Because he had multiple conditions, his doctors ordered whole genome sequencing to see if they could pinpoint a root cause. They saw one particular genetic mutation and thought ruxolitinib might help. He started the drug nine months after being diagnosed with type 1 diabetes.

“The drug had an unbelievable effect on his type 1 diabetes,” Forbes said. “A year after starting ruxolitinib, we took him off insulin, and he’s been insulin-free ever since.”

The patient is in college now, and Forbes said he calls the drug a “game-changer” because it’s a pill and so easy to take.

Forbes said this case provides potentially important information into a pathway that leads to type 1 diabetes. But more research is needed, she added.

Because ruxolitinib acts on the immune system, patients have a higher risk of certain infections. And their white blood cells, liver function and kidney function have to be checked every few months, according to Forbes.

She isn’t the only one excited about the potential of JAK inhibitors in type 1 diabetes.

JDRF (formerly the Juvenile Diabetes Research Foundation) has been funding research into

Europe’s Second Covid Wave Starts to Spill Over From Young to Old

Since the summer, Europe’s second wave of the coronavirus has mainly affected young people, who usually have mild or no symptoms. But infections are beginning to leak into older age groups, the latest data show, often spreading from younger to older members of the same family.

Cases among those aged over 65 are increasing in most European countries, according to data from the European Centre for Disease Prevention and Control. As a result, hospitalizations and deaths—which stayed low for much of the summer while infections spread among young people less likely to fall severely ill—are starting to rise too.

Many European countries are now recording more cases than they did in the spring, but that is partly because of better detection. The health emergency isn’t as serious as it was at the time, when only a fraction of infected people were tested for the virus, and some hospitals in countries such as Italy were overrun by severely sick Covid-19 patients.

Still, in the U.K., infections among older age groups rose sharply in late September, according to research by Imperial College London. Hospitalizations of Covid-19 patients more than doubled during September, to more than 2,000, according to official data. Deaths reached 588 in the month through Sept. 28, more than twice the number in August.

In Spain, which is struggling to contain one of Europe’s biggest outbreaks, 547 people died in the first week of October alone. In the week that ended Sept. 1, by comparison, only 159 had died.

When Carmen Pallarolas and her husband tested positive for the coronavirus in August, they blamed their 26-year-old son, who lives with them, leads an active social life and tested positive too.

“Generally young people move around more than us older people do, and they are less careful,” said Ms. Pallarolas, a 60-year-old from the Spanish town of Argentona, who suffered mild Covid-19 symptoms such as a fever and a cough, and who has since recovered.

Even in Germany, where the rise in infections is relatively slow, increasing admissions to intensive-care wards have prompted the Robert Koch Institute, Germany’s center for disease control, to warn that the virus is likely spreading to the older generations.

Like other nursing-home guests, Nilda Nari is allowed to see her son for just 15 minutes every two weeks, while keeping a distance.

Health officials are advising the elderly to do more to protect themselves, above all by limiting social interactions, avoiding crowds and wearing face masks. They are also urging them to get vaccinated against the flu to prevent overcrowding in hospitals during the winter. Some research suggests that flu vaccinations might also reduce the severity of Covid-19 infections.

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Family members are also being asked to reduce contact with older relatives. “Don’t kill your gran by catching coronavirus and then passing it on,” U.K. Health Secretary Matt Hancock said in a broadcast interview

COVID-19 cases among young adults in U.S. rise 55% in August: CDC

(Reuters) – Coronavirus cases among young adults rose steadily across the United States in recent weeks as universities reopened, suggesting the need for this group to take more measures to prevent the spread of COVID-19, a U.S. health agency said.



a group of people standing around a bench: Testing site for returning students and staff at NYU campus in New York


© Reuters/MIKE SEGAR
Testing site for returning students and staff at NYU campus in New York

Universities that want to reopen for in-person learning need to implement mitigation steps such as mask wearing and social distancing to curb the spread of the virus among young adults, researchers from the Centers for Disease Control and Prevention (CDC) said in the report.



a group of people on a stage in front of a building: Tulane University in New Orleans prepares for reopen


© Reuters/CATHERINE KOPPEL
Tulane University in New Orleans prepares for reopen

Between Aug. 2 and Sept. 5, weekly cases of COVID-19 among people aged 18 to 22 rose 55.1%. The Northeast region recorded a 144% increase in COVID-19 cases, while Midwest cases rose 123.4%, the report said.

The uptick in cases was not solely attributable to increased testing and could be linked to some universities resuming in-person attendance, the CDC researchers said. They also said transmission could also be among young adults not attending college.

Previous reports identify young adults as being less likely to adhere to prevention measures, the report said.

In a separate study published in CDC’s Morbidity and Mortality Weekly Report (MMWR) on Tuesday, researchers reported a rapid rise of COVID-19 cases two weeks after a North Carolina university opened its campus to students.

The study found that between Aug. 3 and Aug. 25, the university reported 670 laboratory-confirmed cases of COVID-19, with preliminary investigations finding that student gatherings and congregate living settings likely contributed to the spread.

On Aug. 19, classes moved online and the school began to reduce density of on-campus housing. No COVID-19 patient from the university was hospitalized or had died, the researchers said.

The authors of both studies suggest the need for enhanced measures to reduce transmission among young adults and at institutes of higher education.

(Reporting by Vishwadha Chander in Bengaluru; Editing by Caroline Humer and Amy Caren Daniel)

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Coronavirus cases among young adults jumped by more than 50 percent in August nationally, the CDC says

New research from the Centers for Disease Control and Prevention (CDC) says coronavirus infections among young adults increased significantly from August to September as colleges and universities reopened around the country. 

The CDC study released Tuesday found that between Aug. 2 and Sept. 5, weekly COVID-19 cases among adults aged 18-22 increased 55 percent nationally. 


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The Northeast region experienced a 144 percent increase in coronavirus cases among young adults, while the Midwest recorded a 123.4 percent increase, according to the report. 

The health agency emphasized that the jump in cases was not solely attributable to increased testing. 

As about 45 percent of young adults in the age range are enrolled in colleges and universities, the CDC said it is likely the resumption of in-person classes is part of the reason for the rise in cases. 

The CDC notes previous reports showed young adults are less likely than any other age group to adhere to health guidance meant to curb the spread of the coronavirus. 

While young adults are at lower risk for severe disease and death if they contract the virus compared to older adults and those with preexisting conditions, they can certainly transmit the virus to those at higher risk and can also become seriously ill themselves. 

“Young adults, including those enrolled in colleges and universities, should take precautions, including mask wearing, social distancing, and hand hygiene, and follow local, state, and federal guidance for minimizing the spread of COVID-19,” the CDC said in its report. 

“Institutions of higher education should take action to promote healthy environments,” the agency said. 

In a separate study published by the CDC on Tuesday, researchers looked at an unnamed North Carolina university that experienced a rapid increase in COVID-19 cases and clusters within two weeks of opening the campus to students, forcing the school to transition to online classes. 

Between August 3 and 25, nearly 700 coronavirus cases were identified and most cases occurred in people aged 22 or younger. 

“Student gatherings and congregate living settings, both on and off-campus, likely contributed to the rapid spread of COVID-19 within the university community,” researchers wrote in the report. 


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COVID-19 Cases Among Young Adults in U.S. Rise 55% in August: CDC | Top News

(Reuters) – Coronavirus cases among young adults rose steadily across the United States in recent weeks as universities reopened, suggesting the need for this group to take more measures to prevent the spread of COVID-19, a U.S. health agency said.

Universities that want to reopen for in-person learning need to implement mitigation steps such as mask wearing and social distancing to curb the spread of the virus among young adults, researchers from the Centers for Disease Control and Prevention (CDC) said in the report https://www.cdc.gov/mmwr/volumes/69/wr/mm6939e4.htm?s_cid=mm6939e4_w.

Between Aug. 2 and Sept. 5, weekly cases of COVID-19 among people aged 18 to 22 rose 55.1%. The Northeast region recorded a 144% increase in COVID-19 cases, while Midwest cases rose 123.4%, the report said.

The uptick in cases was not solely attributable to increased testing and could be linked to some universities resuming in-person attendance, the CDC researchers said. They also said transmission could also be among young adults not attending college.

Previous reports identify young adults as being less likely to adhere to prevention measures, the report said.

In a separate study published in CDC’s Morbidity and Mortality Weekly Report (MMWR) on Tuesday, researchers reported https://bit.ly/33iBtON a rapid rise of COVID-19 cases two weeks after a North Carolina university opened its campus to students.

The study found that between Aug. 3 and Aug. 25, the university reported 670 laboratory-confirmed cases of COVID-19, with preliminary investigations finding that student gatherings and congregate living settings likely contributed to the spread.

On Aug. 19, classes moved online and the school began to reduce density of on-campus housing. No COVID-19 patient from the university was hospitalized or had died, the researchers said.

The authors of both studies suggest the need for enhanced measures to reduce transmission among young adults and at institutes of higher education.

(Reporting by Vishwadha Chander in Bengaluru; Editing by Caroline Humer and Amy Caren Daniel)

Copyright 2020 Thomson Reuters.

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