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FDA To Authorize Pfizer for Children 12 to 15 Years Olds as Adolescent Cases Spike

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  • FDA officials told reporters Monday that the agency will approve Pfizer’s coronavirus vaccine for children 12 to 15 years old by next week.
  • Last month, Pfizer said a clinical study found its vaccine to be just as effective in the adolescent age group as it is for adults. The shot is already approved for 16- and 17-year-olds.
  • The statement from FDA officials comes as the American Academy of Pediatrics reported that children now account for more than a fifth of new coronavirus cases in states that provide data on age.
  • While those higher percentages are partially due to the drop in infections among adults who have been vaccinated, experts also said the easing of restrictions on school activities has contributed to the spikes in child COVID cases, meaning wider vaccine approval ahead of summer activities will help curb the spread.

FDA To Expand Pfizer

The U.S. Food and Drug Administration is set to approve Pfizer’s COVID-19 vaccine for use among children 12 to 15 years old by next week, according to officials who spoke to reporters Monday.

The expected move comes just a month after a clinical trial found that the vaccine — which is already the only one approved for 16- and 17-year-olds — was just as effective, if not even more effective, in adolescents aged 12 to 15 as it is for adults.

According to Pfizer, none of the teens who received the vaccine developed symptomatic infections, a sign of powerful protection. The youths also produced strong antibody responses and had about the same side effects as people 16 to 25, the company said.

As far as what happens next, the FDA clearance could come as early as late this week, according to The New York Times, which first reported the alleged regulatory change. The clearance will be in the form of an amendment to the current emergency authorization.

From there, the Center for Disease Control and Prevention’s vaccine advisory panel will likely meet the next day to review the clinical trial data and make recommendations.

The anticipated decision is highly significant because it would expand the country’s vaccination campaign ahead of summer activities and the next school year. Vaccinating adolescents and children is essential to raising the level of immunity in the country and bringing down hospitalizations and deaths.

Child COVID-19 Cases Rise

The alleged expansion also came the same day the American Academy of Pediatrics reported that children now account for more than a fifth of new coronavirus cases in states that release data by age.

According to that data, over 22% of new infections reported in the past week, compared to just 3% last year.

Notably, experts have said a big reason for this trend is simply due to the fact that cases among adult Americans are falling as more people become vaccinated. Because kids cannot get the vaccine, it makes sense they would make up a larger share of the pie.

But public health officials also say that the spikes are due at least in part to the easing of restrictions on school activities, and as more of those restrictions are eased, the need to vaccinate children becomes heightened.

At the same time, the expansion will also pose another challenge to public health officials and policymakers who are struggling to encourage a large population of hesitant people to get the shot and are likely to express the same reservations to inoculating their children despite the proven benefits and safety.

See what others are saying: (The New York Times) (The Washington Post) (NPR)

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Mother and Boyfriend Charged After Abandoning 3 Children in Apartment With Sibling’s Remains

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Authorities said the malnourished children had been living in the unit without their parents for months.


Abandoned Children Discovered in Houston

Police in Texas arrested a mother and her boyfriend on Tuesday after finding the woman’s three children abandoned in an apartment unit with the remains of their sibling.

Authorities found the 7-, 10-, and 15-year-old boys on Sunday when the teen called police to report that his brother had been dead for a year and that his body was in the unit.

When authorities arrived at the scene, they found the children living in “deplorable conditions.” Police also found the skeletal remains of an 8-year-old, who they emphasized had been decomposing for an extended period of time.

Harris County Sheriff Ed Gonzalez said the boys were fending for each other, with the eldest doing his best to care for the younger ones. According to the teen, his parents hadn’t been living in the apartment with them for months.

Gonzales called it one of the most shocking cases he had ever seen in all his years in law enforcement, and many are now asking how these kids could have been suffering for so long without anyone ever noticing.

Signs That Went Unnoticed

The Daily Beast reported that the kids hadn’t been attending school since May 2020, claiming that the school even conducted an unsuccessful home visit in September of that year.

On top of that, the children had been without power for several weeks, with one neighbor telling local reporters that the teen would often charge his phone at her place.

Another neighbor, Erica Chapman, said she had once found the teen sleeping on a playground slide, so she gave him some food and drinks.

I asked him if he was hungry. He said, ‘Yeah,’ and I brought him out some food and some drinks,” Chapman told KHOU.

She said he “wouldn’t talk about his parents,” and she didn’t push because she wanted him to feel safe coming to her if he needed food. Chapman added that she would drop off food at the apartment sometimes but said it was hard to tell what was going on inside.

Police also described a foul odor coming from the unit, which a different neighbor said she complained to management about more than once. That woman claimed the smell was so vile, she could not turn on her air conditioning.

Dianne Davis, who lived in the complex for two years, told The Houston Chronicle that the building manager performs regular inspections on the units, with the most recent one happening last week.

“How come they couldn’t detect this?” Davis told the paper. “How could that not have been found?”

Mother and Boyfriend Face Charges

According to Child Protective Services (CPS), the agency does have a history with the family, but there was no active investigation at the time the kids were discovered.

After they were found, the boys were treated at a hospital and placed with CPS while the agency seeks emergency custody of them.

At the hospital, doctors discovered fractures in the 7-year-old face and said two of the three boys were malnourished. Meanwhile, the medical examiner’s office said the deceased child suffered multiple blunt force injuries and ruled his death a homicide.

Police located the mother, 35-year-old Gloria Williams, and her boyfriend, 31-year-old Brian Coulter, on Sunday. They were interviewed and initially released without charges.

ABC13 reported that the teen texted his mother, who lived just 15 minutes, before calling the police.

On Tuesday, the couple was finally arrested while allegedly reading articles about themselves at a library. Williams, faces multiple charges, including injury to a child by omission and tampering with evidence involving a human corpse.

Meanwhile, Coulter was charged with murder over the death of the child, though both he and Williams are expected to face more charges as investigators continue to unpack the details of this case.

See what others are saying: (The Houston Chronicle) (The Daily Beast) (The Washington Post)

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Man Spent COVID Relief Loan on $58,000 Pokemon Card, Feds Say

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The man is facing a wire fraud charge, which carries a max sentence of up to 20 years in federal prison, along with a $250,000 fine.


COVID Relief Funds Used on Pokemon Card

Authorities have accused a man in Georgia of misusing COVID-19 relief funds, claiming that he spent $57,789 on a single Pokemon card.

Prosecutors said Vinath Oudomsine made false statements about the gross revenue his business earns and the number of workers he employs when he applied for aid authorized under the CARES Act.

On his July 2020 application, Oudomsine allegedly claimed he had 10 employees and 12-month gross revenues of $235,000.

The following month, he was given about $85,000 from the Small Business Administration (SBA), which means he spent nearly all of the money on the rare card.

Authorities have given few details about the specific card purchased, though they have said Oudomsine was charged with wire fraud and is expected to appear in court on Thursday.

The charge carries a max sentence of up to 20 years in federal prison, along with a $250,000 fine.

Misuse of COVID Relief Funds

Oudomsine is far from the first person to face charges for fraud related to small business loans issued amid the pandemic. Others who received relief funds have been accused of spending the money on Lamborghinis, nights at strip clubs, and even an alpaca farm, among other purchases.

In fact, the first person to be charged with fraudulently seeking a pandemic relief loan was recently sentenced to 56 months in prison following a nationwide search after the man faked his own death.

According to The Washington Post, a federal watchdog said this month that the SBA overpaid $4.5 billion in grants to self-employed people and that “no system of controls was in place to flag applications with flawed or illogical information.”

On top of that, the SBA inspector general determined earlier this year that the agency rushed to send out billions of dollars in loans through the Paycheck Protection Program (PPP) “at the expense of controls” that could have blocked inappropriate aid.

In a statement on Sunday, the agency said that under the Biden administration, it has worked with Congress and the inspector general to add antifraud measures. Meanwhile, defenders of pandemic relief programs have argued that flagged loans and grants represent only a small fraction of the distributed aid that has been critical to small businesses and their pandemic recovery.

See what others are saying: (NPR)(USA Today)(The Washington Post)

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FDA Authorizes Moderna and J&J COVID Vaccine Boosters, Approves Mix-and-Match Doses

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The approval will allow at-risk Americans who received Pfizer and Moderna vaccines to get any booster six months after their initial series and all Johnson & Johnson recipients 18 and older to do the same two months after their single-shot dose.


New FDA Authorization

The U.S. Food and Drug Administration (FDA) on Wednesday authorized boosters shots of Moderna and Johnson & Johnson COVID-19 vaccines and approved a mix-and-match strategy that will allow people who got one company’s shot to get a booster from a different maker.

The decision paves the way for millions of more at-risk Americans to get extra protection, and not just certain Pfizer recipients as previously approved by the FDA.

Under the authorization, people who received Moderna or Pfizer can get any one of the three booster shots six months after completing their initial series if they are 65 and older, at high risk of severe COVID, or face increased exposure because of their work.

Meanwhile, all J&J recipients 18 and older can get any of the approved vaccines two months after they received the one-shot jab.

Hazy Recommendations, For Now

Notably, the FDA did not recommend a certain combination of vaccines, nor did the agency say whether or not it would be more effective for people to stick with their original vaccine maker for their booster.

The new authorizations draw on a study from the National Institutes of Health (NIH), which found that there are no safety concerns with mixing boosters and that vaccine combinations were at least as effective in stimulating antibodies as matched vaccines.

In the case of J&J recipients, the NIH found that people actually had a higher boost from mixing either Moderna or Pfizer boosters.

However, some of the scientists who worked on the study said it should not be used to recommend one combination over another because the research was limited.

The Centers for Disease Control and Prevention (CDC), which determines vaccine recommendations, could issue more guidance on when and whether people should switch vaccine makers for their booster shots.

An advisory panel for the agency is meeting Thursday to discuss the new FDA authorizations and recommendations.

Once the panel makes its decision, the CDC director has the final say on the guidelines. If the agency agrees with the FDA’s decisions, the booster shots could be rolled out as soon as this weekend.

See what others are saying: (The New York Times) (NPR) (The Washington Post)

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