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Health Care — Moderna seeks FDA nod for young kids’ vaccine

According to new research, your pup’s personality might be all its own and have nothing to do with its breed.

Today in health care, there’s a new movement on a vaccine for young children, but authorization still could be a few weeks away.

Welcome to Overnight Health Care, where we’re following the latest moves on policy and news affecting your health. For The Hill, we’re Peter Sullivan, Nathaniel Weixel and Joseph Choi. Someone forward you this newsletter? Subscribe here.

Moderna asks FDA to OK vaccine for kids under 6

Moderna on Thursday asked the Food and Drug Administration (FDA) to authorize its vaccine for children under 6 years of age, becoming the first company to submit an application for young children.

There are currently no vaccines authorized for children under 5, which has led to some frustration among parents over the pace as they are eager to see a vaccine become available.

Moderna’s move is a step forward on that front, but it still could be a few weeks before the vaccine is authorized.

The company said the application would become fully complete next week, and there still needs to be time for the FDA to review it and for an outside advisory committee to meet, which could be in June.

Pfizer has previously said that authorization for its vaccine in children under 5 could be in June, though previous timelines have been pushed back before.

“We are proud to share that we have initiated our EUA submission for authorization for our COVID-19 vaccine for young children,” said Stéphane Bancel, Moderna’s CEO. “We believe [the vaccine] will be able to safely protect these children against SARS-CoV-2, which is so important in our continued fight against COVID-19 and will be especially welcomed by parents and caregivers.”

The company had previously announced that its vaccine for children under 6 produced a similar antibody response as the adult vaccine, a positive sign.

Read more here.

FDA seeks ban on menthol in cigarettes

The Food and Drug Administration (FDA) on Thursday proposed a ban on menthol cigarettes and flavored cigars after a very public debate on whether to prohibit them.

Under the ruling, menthol would be prohibited as a “characterizing flavor in cigarettes.” Additionally, all characterizing flavors, with the exception of tobacco, would be banned in cigars.

The proposed ban stands to have an impact on the tobacco market as a whole. Menthol cigarettes make up over one-third of the cigarette market in the US, according to the Kaiser Health Foundation.

Supporters of the ban argue that it will save lives by lowering smoking rates across the board.

“The proposed rules would help prevent children from becoming the next generation of smokers and help adult smokers quit,” Health and Human Services Secretary Xavier Becerra said in a statement.

However, the ban’s critics argue that it will result in the illegal selling of the cigarettes, stretching law enforcement thin. Various civil rights figures, including the Rev. Al Sharpton and attorney Ben Crump, have warned that it could result in negative interactions between police and the Black community. Black and Hispanic smokers tend to prefer menthol cigarettes to other types.

Read more here.

SERVERS NOT APPROACHED ABOUT TESTING, VACCINES: UNION

A union representing the servers for the upcoming White House Correspondents’ Dinner reportedly said they have not been approached about COVID-19 testing and vaccine requirements for the event.

The White House Correspondents’ Association (WHCA) said earlier this month that it will require attendees to be vaccinated against COVID-19 and to show a same-day negative test to attend the April 30 dinner.

Unite Here Local 25 representative Benjy Cannon told Axios on Wednesday that the Hilton hotel, where the event will be hosted, hadn’t approached servers about those requirements.

Cannon also noted the union could bargain over the issue if it was raised, noting it had agreed to one-off COVID-related work rules for other events.

“Throughout the pandemic, Washington Hilton has hosted a number of large-scale events with COVID-19 protocols in place, including offering our team members the flexibility to choose if they work in large group settings, based on their comfort level,” the Hilton spokesperson told The Hill.

Read more here.

WEIGHT LOSSES TOPPING 20 PERCENT WITH NEW DRUG: REPORT

Eli Lilly in a statement to investors is saying that its new experimental anti-obesity drug has caused patients in a clinical trail to lose up to 20 percent of their weight.

The test group included 2,539 participants, and was meant to test the safety and efficacy of the drug tirzepatide, according to the statement released by the company on Thursday.

Eli Lilly said people in the test group who used the drug lost up to roughly 50 pounds, or 22.5 percent of their weight in its first phase 3 global registration trial.

The drug is intended for people with obesity or who are overweight with at least one comorbidity, but who do not have diabetes, according to the statement.

Eli Lilly shares were up nearly 5 percent on the news while the Dow Jones index was up just more than 2 percent late Thursday afternoon.

Read more here.

Probe finds Medicare plans deny needed care

Medicare Advantage Organizations (MAOs) delayed or denied payments and services to patients, even when these requests met Medicare coverage rules, according to a report released by federal investigators on Thursday.

The Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) reviewed a random sample of 250 prior authorization denials and 250 payment denials that were issued in 2019 by 15 of the largest MAOs.

The 15 selected MAOs accounted for almost 80 percent of beneficiaries enrolled in Medicare Advantage in June 2019.

“Our case file reviews determined that MAOs sometimes delayed or denied Medicare Advantage beneficiaries’ access to services, even though the requests met Medicare coverage rules,” the OIG said. “MAOs also denied payments to providers for some services that met both Medicare coverage rules and MAO billing rules.”

According to the report, 13 percent of prior authorization requests that were denied met Medicare coverage rules, which MAOs are required to follow, meaning they would likely have been approved under original Medicare. Among the payment requests that were denied, 18 percent met Medicare coverage rules with most of the denials caused by human error.

In one specific case, post-acute services were denied for a beneficiary who was experiencing pain and swelling due to a serious bacterial skin infection and bed sores. The patient’s condition impacted their ability to lead a daily life without assistance, which met Medicare rules for skilled nursing facility care. Ultimately, this specific patient’s denial was appealed and reversed.

Read more here.

WHAT WE’RE READING

  • Climate Change Will Accelerate Viral Spillovers, Study Finds (New York Times)
  • AI gone astray: How subtle shifts in patient data send popular reeling algorithms, undermining patient safety (Stat)
  • The masks, the CDC and the judge—a battle brewing since 1944 (NPR)

STATE BY STATE

THE HILL OP-EDS

The next COVID mandate? Focus less on masks and more on those behind them

That’s it for today, thanks for reading. Check out The Hill’s Health Care page for the latest news and coverage. See you tomorrow.

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