•   
  •   
  •   

US Overnight Health Care — Presented by EMAA — Pfizer requests FDA authorize COVID-19 vaccine for 5 to 11 year olds

02:30  08 october  2021
02:30  08 october  2021 Source:   thehill.com

Overnight Health Care — Presented by Altria — Merck's COVID-19 pill reduces hospitalization risks by half

  Overnight Health Care — Presented by Altria — Merck's COVID-19 pill reduces hospitalization risks by half Welcome to Friday's Overnight Health Care, where we're following the latest moves on policy and news affecting your health. Subscribe here: thehill.com/newsletter-signup.It's been nearly a month, and the dazzle of zebras are still roaming the Maryland suburbs. Can they survive and thrive? Merck announced it is seeking authorization for a new anti-COVID pill. It's a treatment that could be a significant boost for the effort to treat patients infected with the coronavirus.For The Hill, we're Peter Sullivan (psullivan@thehill.com), Nathaniel Weixel (nweixel@thehill.com) and Justine Coleman (jcoleman@thehill.com).

WASHINGTON — Pfizer and BioNTech asked federal regulators on Thursday to authorize emergency use of their coronavirus vaccine for children ages 5 to 11 , a move that could help protect more than 28 million people in the United States. The companies say they are submitting data supporting the “With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against Covid - 19 ,” Pfizer said on Thursday. Parents across the United States are anxiously awaiting the regulators’ decision, which could affect family life and the operation of schools.

Pfizer said Thursday it asked the Food and Drug Administration to authorize its Covid - 19 vaccine with BioNTech for kids ages 5 to 11 . The news couldn't come any sooner for parents anxious to get their children vaccinated as kids start the new school year with the delta variant surging across The company's request Thursday may mean the shots won't be available until around November if the FDA spends as much time reviewing the data for that age group as it did for 12- to 15- year - olds . Pfizer and BioNTech requested expanded use of their shot in adolescents on April 9 and were authorized by

Welcome to Thursday's Overnight Health Care, where we're following the latest moves on policy and news affecting your health. Subscribe here: thehill.com/newsletter-signup.

Overnight Health Care — Presented by EMAA — Pfizer requests FDA authorize COVID-19 vaccine for 5 to 11 year olds © The Hill Overnight Health Care — Presented by EMAA — Pfizer requests FDA authorize COVID-19 vaccine for 5 to 11 year olds

More zebras escaped - but this time from a pumpkin farm in Illinois. But unlike the zebras in Maryland who have been on the loose for more than a month, these two were captured in about two hours.

Five to 11 year olds are one step closer to getting a COVID-19 vaccine after Pfizer finished submitting an application for an emergency use authorization Thursday morning.

California to require COVID-19 vaccines for schoolchildren

  California to require COVID-19 vaccines for schoolchildren SAN FRANCISCO (AP) — California will become the first U.S. state to require COVID-19 vaccinations for children to attend public and private schools in person in a mandate that could effect millions of students. Gov. Gavin Newsom on Friday announced that the coronavirus shot will be added to 10 other immunizations already required for school kids, including those for measles and mumps. Exemptions would be granted for medical reasons or because of religious or personal beliefs but the exemption rules haven't been written yet pending public comment.Any student without an exemption who refuses to get the vaccine would be forced to do independent study at home.

Pfizer -BioNTech asked the FDA to expand emergency use of its COVID - 19 vaccine to Americans between ages 5 and 11 . The vaccine is currently fully approved for those aged 16 and older and authorized for teens aged 12-15. The FDA is meeting on October 26 to discuss and a decision is However, children between ages five and 11 were given 10 μg doses and kids from six months to four years old received three μg doses. Unlike the larger clinical trial conducted in adults, the pediatric trial did not measure efficacy by comparing the number of COVID - 19 cases among the vaccine group to

Pfizer and BioNTech have asked the Food and Drug Administration to authorize their vaccine for Covid - 19 for children aged 5 to 11 , the companies announced Thursday. © Michael Loccisano/Getty Images Teachers give a lesson to their masked students in their classroom in New York City. The filing could clear the way for roughly 28 million children in the United States to be vaccinated against the virus, beginning in a matter of weeks.

For The Hill, we're Peter Sullivan (psullivan@thehill.com), Nathaniel Weixel (nweixel@thehill.com) and Justine Coleman (jcoleman@thehill.com). Write to us with tips and feedback, and follow us on Twitter: @PeterSullivan4, @NateWeixel and @JustineColeman8.

Let's get started.

Pfizer applies for COVID-19 vaccine authorization in children 5-11

  Overnight Health Care — Presented by EMAA — Pfizer requests FDA authorize COVID-19 vaccine for 5 to 11 year olds © Provided by The Hill

There's a potential light at the end of the tunnel for parents worried about their children under 12.

Pfizer said Thursday that it had submitted an application to the Food and Drug Administration (FDA) for emergency use authorization of its COVID-19 vaccine in children ages 5 to 11.

The application has been highly anticipated, as millions of parents are eager to vaccinate their kids. No vaccine is currently available for children under 12.

NY man charged with felony, could face 7 years in prison after being accused of faking COVID-19 vaccine card

  NY man charged with felony, could face 7 years in prison after being accused of faking COVID-19 vaccine card A New York man was charged with showing his employer a plagiarized COVID-19 vaccine card. If convicted, he could face up to seven years in prison.David R. Kemp, 24, of Eaton, N.Y., was charged with a second-degree possession of a forged instrument, which qualifies for a Class D felony in the state. The unauthorized use of a government agency’s seal is a federal crime.

US drugmaker Pfizer said Thursday it has formally requested emergency use authorization for its Covid - 19 vaccine in children age five to 11 . © DOMINICK REUTER The Pfizer -BioNTech vaccine has been granted full FDA approval for those age 16 and up. Children have been infected in greater numbers in the latest coronavirus wave driven by the Delta variant, and inoculating young people is seen as key to keeping schools open and helping end the pandemic. © Patrick T. FALLON The Pfizer vaccine could soon be available for children as young as five in the United States.

FDA to authorize Pfizer 's Covid - 19 vaccine for 12-to-15- year - olds by early next week, official says. The company's vaccine safety and efficacy study in children age 6 months to 11 years old is still going. "We expect to have definitive readouts and submit for an EUA for two cohorts, including children age 2- 5 years of age and 5 - 11 years of age, in September," Pfizer CEO Albert Bourla said, adding that the readout and submission for children 6 months to 2 years is expected in the fourth quarter of 2021.

The FDA has previously said it would move quickly to review the application, "likely in a matter of weeks rather than months."

An FDA advisory committee is meeting to discuss the application on Oct. 26, and the agency will decide whether to accept the recommendation. A Centers for Disease Control and Prevention panel will meet shortly after.

Children generally do not get severely ill with COVID-19 as much as older people do, but there were still almost 175,000 cases among children in the week ending Sept. 30, according to the American Academy of Pediatrics (AAP).

Between 0.1 percent and 1.9 percent of COVID-19 cases in children resulted in hospitalization, according to AAP.

Pfizer has tested a dose for children that is one-third the amount used in adults. Late last month, it announced positive results from its studies, pointing to a "favorable safety profile and robust neutralizing antibody responses."

Overnight Health Care — Presented by EMAA — Administration to up at-home COVID-19 testing

  Overnight Health Care — Presented by EMAA — Administration to up at-home COVID-19 testing Welcome to Wednesday's Overnight Health Care, where we're following the latest moves on policy and news affecting your health. Subscribe here: thehill.com/newsletter-signup.It's been busy around Washington, so you may have missed Fat Bear Week. Meet your chonky champion, Otis, whose fans named him the winner for the fourth time. The Biden administration is aiming to boost the number of rapid, at-home coronavirus tests with a $1 billion investment, which officials said will quadruple the available supply by the end of the year. For The Hill, we're Peter Sullivan (psullivan@thehill.com), Nathaniel Weixel (nweixel@thehill.

Pfizer has submitted an emergency use authorization to the FDA for use of its vaccine in children ages 5 to 11 . © Genaro Molina/Los Angeles Times via Getty Images First grade students of teacher Marcela Tiscareno return to the classroom at the 9th Street Elementary School in Los Angeles, April 13, 2021. New York nurse Sandra Lindsay, the first person in the U.S. to get a COVID - 19 vaccine outside a clinical trial, received her Pfizer booster dose Wednesday at Long Island Jewish Medical Center in New York. Lindsay was joined by other health care workers who also got their first shots in

Pfizer Inc and BioNTech SE have asked U.S. regulators to authorize emergency use of their COVID - 19 vaccine for children ages 5 to 11 , a group for whom no shot is currently allowed, Pfizer said on Thursday. The two drugmakers are also testing the vaccine in children ages 2 to 5 years old and children ages 6 months to 2 years , with data expected in the fourth quarter. The vaccine could be ready for roll out as early as November pending approval from federal regulatory health agencies, White House COVID - 19 response coordinator Jeffrey Zients said on CNN.

Read more here.

A MESSAGE FROM EMAA

  Overnight Health Care — Presented by EMAA — Pfizer requests FDA authorize COVID-19 vaccine for 5 to 11 year olds © Provided by The Hill published in Pediatrics, estimated that another 22,000 lost a secondary caregiver, or a co-residing grandparent that provides housing, also died from COVID-19-associated deaths. In total, about 1 in 500 children experienced the COVID-19-associated death of a parent or caregiver.

Researchers defined COVID-19-associated deaths as fatalities spanning from April 1, 2020, to June 30, 2021, that were caused both directly by the virus and indirectly by the pandemic, such as due to lockdowns or less access to health care.

Call for action: The study, conducted by the CDC, Imperial College London and several universities, highlights the "ongoing secondary tragedy" among children and calls for the public health response to encompass the growing issue, the National Institutes of Health said in a release.


Video: Advocates For People Living With HIV Are Asking For Certain Laws To Be Changed (CBS Philadelphia)

"Effective action to reduce health disparities and protect children from direct and secondary harms from COVID-19 is a public health and moral imperative," the paper reads.

More than 40% of Americans may not get a flu shot this year. That could spell trouble during COVID.

  More than 40% of Americans may not get a flu shot this year. That could spell trouble during COVID. The main reason cited for not getting a flu shot is a belief that it isn't effective. Experts say flu shots prevent thousands of deaths every year.Last year's worries around a "twindemic" of influenza and COVID-19 overwhelming hospitals around the nation luckily went unfounded after a historically mild flu season.

Read more here.

Biden on the road to push benefits of vaccine requirements

  Overnight Health Care — Presented by EMAA — Pfizer requests FDA authorize COVID-19 vaccine for 5 to 11 year olds © Provided by The Hill

President Biden on Thursday aggressively lobbied for vaccine requirements as an effective tool to end the pandemic, arguing mandates had become necessary to turn the corner on the pandemic.

"These requirements work. And as the Business Roundtable and others told me when I announced the first requirement, that encouraged businesses to feel they could come in and demand the same thing of their employees. More people are getting vaccinated. More lives are being saved."

Biden traveled to Illinois, where the state's governor and the mayor of Chicago have implemented vaccine requirements for some workers, to lay out the case for why his administration has gotten more forceful in pushing for mandates.

Government officials had exhausted various other options to nudge people to get vaccinated, Biden argued. He said steps officials had taken included purchasing enough vaccines to ensure every American could get the shot, expanding eligibility and access, and offering incentives for those who were still holding out during the summer.

"We have to beat this thing," Biden said. "So while I didn't race to do it right away, that's why I had to move toward requirements that everyone get vaccinated where I had the authority to do that."

New FDA Chief Will Need to Ease Burnout, Repair Agency's Public Credibility, Experts Say

  New FDA Chief Will Need to Ease Burnout, Repair Agency's Public Credibility, Experts Say Dr. Janet Woodcock has been serving as acting commissioner since January and the White House faces a legal deadline of mid-November to name a replacement. Administration officials say Biden will make a decision before November 15. The news this week that Dr. Francis Collins will be stepping down from his post leading the National Institutes of Health has added new urgency to resolve the question of FDA leadership.Acting agency heads serve mainly as caretakers and generally cannot set new goals or priorities for their agencies.

Biden was in Elk Grove Village, a suburb of Chicago, where he toured a construction site being run by Clayco. The company announced Thursday it would be implementing a vaccination or testing requirement for its employees moving forward.

Read more here.

CDC DIRECTOR URGING FLU SHOTS AHEAD OF POTENTIALLY 'SEVERE' SEASON

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky urged Americans aged six months and older to get their flu shots as health officials prepare for a potentially "severe" flu season.

The CDC is preparing for the return of the flu after last year saw a "near absence" of it, Walensky said as she advocated for the vaccine during a National Foundation for Infectious Disease (NFID) news conference on Thursday.

The low levels of flu last year, likely due to COVID-19 prevention measures, could contribute to a worse season this year, public health experts have said.

"Because of so little disease last year, population immunity is likely lower, putting us all at increased risk for disease this year especially among those most vulnerable, including our children," Walensky said.

"This is why it is doubly important this year that we build up community immunity with vaccination as we head into the fall and winter," she added.

Current status: The U.S. is on track to match last season when 52 percent of those older than six months for the flu shot, she said.

Read more here.

A MESSAGE FROM EMAA

  Overnight Health Care — Presented by EMAA — Pfizer requests FDA authorize COVID-19 vaccine for 5 to 11 year olds © Provided by The Hill   Overnight Health Care — Presented by EMAA — Pfizer requests FDA authorize COVID-19 vaccine for 5 to 11 year olds © Provided by The Hill Texas will appeal a court order blocking the state's restrictive abortion law after a federal judge called it an "offensive deprivation of such an important right."

In public statements and court filings issued just hours after the ruling from U.S. District Judge Robert Pitman, Texas officials said they intended to take the case to an appeals court.

Texas Tea Party gubernatorial candidate Allen West has pneumonia; infection rates falling - for now: Live COVID-19 updates

  Texas Tea Party gubernatorial candidate Allen West has pneumonia; infection rates falling - for now: Live COVID-19 updates Tea Party favorite and Texas gubernatorial candidate Allen West says he has tested positive for COVID-19 and probably will be hospitalized.West, 60, said he is not vaccinated and that his wife Angela West, who is vaccinated, also tested positive. Both have completed monoclonal antibody injections, West said on  Twitter. He also said he is "taking hydroxychloroquine and ivermectin protocols." Neither drug has received FDA approval for use against COVID.

"We disagree with the Court's decision and have already taken steps to immediately appeal it to the Fifth Circuit Court of Appeals," Texas Attorney General Ken Paxton (R) said on Twitter Thursday morning. "The sanctity of human life is, and will always be, a top priority for me."

Pitman, who was appointed by former President Obama, sided with the Biden administration late Wednesday in blocking the enforcement of the law, known as S.B. 8, saying that Texas lawmakers purposely designed a legislative scheme to bypass constitutional protections for women seeking abortions.

"From the moment S.B. 8 went into effect, women have been unlawfully prevented from exercising control over their lives in ways that are protected by the Constitution," Pitman wrote. "That other courts may find a way to avoid this conclusion is theirs to decide; this Court will not sanction one more day of this offensive deprivation of such an important right."

Read more here.

WHAT WE'RE READING

  • Young, pregnant and unvaccinated: Hospitals confront a wave of severe illness and death (The Washington Post)
  • Where Biden's vaccine mandate will hit and miss (Politico)
  • Faced with losing their jobs, even the most hesitant are getting vaccinated (NPR)

STATE BY STATE

  • NC schools ordered to cooperate with health officials over contact tracing, quarantines (The Charlotte Observer)
  • More Wyoming children are being hospitalized for COVID-19, some facilities near rationing care (Casper Star Tribune)
  • Abortions resume in some Texas clinics after judge halts law (The Associated Press)

That's it for today, thanks for reading. Check out The Hill's healthcare page for the latest news and coverage. See you Friday.

US to reopen land borders to vaccinated tourists; Florida county faces fine for vaccine requirement: COVID updates .
Starting next month, the United States will allow fully-vaccinated foreign nationals to cross its land borders for non-essential purposes.The change would allow foreign tourists to enter the U.S. through land or ferry ports for the first time since March 2020. Government officials have not yet announced a date for the policy change but said it will take place in "early November," in tandem with the country's updated international air travel system.

usr: 2
This is interesting!