Overnight Health Care — Presented by Rare Access Action Project — Pfizer wants boosters for everyone

Overnight Health Care — Presented by Rare Access Action Project — Pfizer wants boosters for everyone
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Welcome to Tuesday’s Overnight Health Care, where we’re following the latest moves on policy and news affecting your health. Subscribe here: thehill.com/newsletter-signup.

Pfizer wants you to know that science is the solution to misinformation and conspiracy theories... and they have a meme showing the “human brain” and “science” to make the case. 

Booster shots could soon be broadened out to all adults, as Pfizer asks the FDA to authorize its vaccine for everyone 18 and over. 

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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 to FDA: Authorize booster shots 

Pfizer and BioNTech on Tuesday said they had asked the Food and Drug Administration (FDA) to authorize booster shots of their COVID-19 vaccine for all adults 18 and over, seeking to broaden who is eligible for a third shot.

The move comes as part of a long-running debate among experts over who should be eligible for booster shots. An FDA advisory panel voted against a request for all adults to have a booster in September, in what was a blow to the Biden administration's earlier announcement of widespread shots.

But the eligibility has been gradually widening as experts point to concerns that the vaccines' efficacy wanes over time.

The debate: Part of the discussion over boosters for younger adults has centered on whether the goal is to prevent people from being hospitalized with COVID-19 or whether the goal is to prevent them from getting sick at all, even if it is milder.

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Some experts have said given that the initial doses of the vaccine have still been holding up very well against hospitalization or death, there is no need for widespread boosters for younger adults.

Anthony FauciAnthony FauciPublic health expert: Biden administration needs to have agencies on the 'same page' about COVID Trump slams Biden, voices unsubstantiated election fraud claims at first rally of 2022 DeSantis says he disagreed with Trump's decision to shut down economy at start of pandemic MORE is one of the experts who has argued that preventing any illness from COVID-19 should be the goal, an argument that speaks more in favor of widespread booster shots.

"I think we should be preventing people from getting sick from COVID even if they don’t wind up in the hospital," Fauci told The Atlantic Festival in September.

Read more here.

A MESSAGE FROM RAAP

The End of Innovation:

Treatments and cures for rare disease patients are under threat from Congress. Find out more at RareAccessActionProject.org.

 

PFIZER CEO CALLS PEOPLE WHO SPREAD VACCINE MISINFORMATION 'CRIMINALS'

Pfizer CEO Albert Bourla on Tuesday described people who spread false information about the coronavirus vaccines as “criminals.”

“Those people are criminals,” Bourla said to Atlantic Council CEO Frederick Kempe, CNBC reported. “They’re not bad people. They’re criminals because they have literally cost millions of lives.”

Bourla said a “very small” group of people has been spreading misinformation about the vaccines.

Millions in the United States have yet to be vaccinated despite the fact the COVID-19 vaccines have been available to people above the age of 12 for months. 

“The only thing that stands between the new way of life and the current way of life is, frankly, hesitancy to vaccinations,” Bourla said.

Bourla’s comments come after a Kaiser Family Foundation poll found that 8 in 10 Americans believe or are unsure of at least one false statement about COVID-19.

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Read more here.

 

More than 360,000 children under 12 have gotten at least one vaccine dose 

More than 360,000 children under age 12 have received at least one dose of the COVID-19 vaccine, according to Centers for Disease Control and Prevention (CDC) data, as the country scales up pediatric vaccinations.

The preliminary data as of Monday evening shows at least 156,000 children younger than 12 have started their vaccination regimen within the past two weeks, as doses first began to become available to those within that younger age group. 

Children under 12 represented 5.2 percent of those who got their first dose within the past 14 days.

Despite making up 14 percent of the American population, those younger than 12 currently make up 0.2 percent of Americans who received at least one dose, since the vaccines have only been available for days.

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Follows: The CDC officially recommended the Pfizer vaccine for 5- to 11-year-olds last week, marking the first time Americans younger than 12 became eligible for a COVID-19 vaccination. 

The move, following the Food and Drug Administration’s emergency authorization for the age group late last month, opened up vaccinations to 28 million children across the U.S. 

Caveat: The CDC noted that the vaccination data was available by age for about 205 million recipients, cautioning that the numbers ”only represent the geographic areas that contributed data” and therefore are “not generalizable to the entire US population.”

Read more here.

 

DOJ ASKS COURT TO LIFT ORDER BLOCKING VACCINE RULES

The Biden administration in a filing late Monday said it has the legal authority to mandate COVID-19 vaccines or tests for larger companies, and that the GOP-led states and businesses challenging the law have not shown their claims will outweigh the harms of stopping the rule.

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In a filing to the 5th U.S. Circuit Court of Appeals, which temporarily blocked the mandate with a nationwide stay last week, the Department of Justice (DOJ) said the rule is firmly grounded in law and necessary to keep people safe.

Stopping the mandate from taking effect "would likely cost dozens or even hundreds of lives per day," the DOJ wrote. 

Wait your turn: The DOJ also argued there is no need to address the challenges immediately, because there is a congressionally mandated process for judicial review of Occupational Safety and Health Administration standards. Since the challenges were filed in separate courts, there is going to be a lottery on Nov. 16 to determine which court will hear the lawsuit. Nov. 16 is also well ahead of the Dec. 4 deadline for people to get their first shot, if they want to be vaccinated ahead of the Jan. 4 effective date. 

Read more here.

A MESSAGE FROM RAAP

The End of Innovation:

Treatments and cures for rare disease patients are under threat from Congress. Find out more at RareAccessActionProject.org.

State high court overturns J&J opioid verdict 

Opioids

Oklahoma's Supreme Court overturned a landmark ruling against drugmaker Johnson & Johnson on Tuesday, finding a lower court incorrectly applied the state's public nuisance law.

The 5-1 decision reversed a district court's $465 million judgement against Johnson & Johnson for its role in the state's opioid epidemic. 

The district court's 2019 decision was the first to hold a drugmaker liable for the epidemic. Cleveland County Judge Thad Balkman found Johnson & Johnson and its subsidiary Janssen Pharmaceuticals liable under Oklahoma's public nuisance statute for conducting "false, misleading, and dangerous marketing campaigns" about prescription opioids that helped lead to thousands of overdose deaths. 

"In reaching this decision, we do not minimize the severity of the harm that thousands of Oklahoma citizens have suffered because of opioids. However grave the problem of opioid addiction is in Oklahoma, public nuisance law does not provide a remedy for this harm," Justice James Winchester wrote for the majority. 

“J&J no longer promotes any prescription opioids and has not done so for several years,” Winchester wrote. “Even with J&J’s marketing practices these ... medications amounted to less than 1% of all Oklahoma opioid prescriptions.”

The justices also found that Johnson & Johnson had no control over how patients used its products once they reached the market.

Impact: It's murky. Tuesday's ruling from Oklahoma's highest court could be a blow to the lawsuits brought by more than 3,000 state, tribal and local governments, which argue opioid manufacturers, marketers and distributors created a public nuisance by flooding communities with highly addictive drugs. But every judge, and jury, is different and may not follow the same logic.

Read more here.

 

WHAT WE'RE READING

 

STATE BY STATE

  • South Carolina reports lowest single-day total of COVID cases since July (The State)
  • Miami public schools: all students can opt out of wearing masks (Miami Herald)
  • Kansas lawmakers closer to special session on COVID mandates (The Associated Press)



OP-ED IN THE HILL

Understanding the barriers between scientists, the public and the truth

That’s it for today, thanks for reading. Check out The Hill’s health care page for the latest news and coverage. See you Wednesday.