Overnight Health Care — Presented by Altria — FDA advisers endorse Pfizer vaccine for kids

Overnight Health Care — Presented by Altria — FDA advisers endorse Pfizer vaccine for kids
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Younger children are one step closer to being able to get vaccinated against COVID-19 after an FDA advisory panel endorsed the safety and effectiveness of Pfizer-BioNTech's shot. 

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.

 

FDA panel endorses vaccines for younger children

A key Food and Drug Administration (FDA) expert advisory panel on Tuesday recommended the agency authorize Pfizer's COVID-19 vaccine for use in children between the ages of 5 and 11, bringing those children one step closer to getting a shot.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) found that the benefits of the vaccine outweighed its risks and voted nearly unanimously 17-0 — with one abstention — to recommend the agency authorize the shot.

The FDA is not bound to follow the panel's recommendation, though it often does. 

Significance: Extending vaccine eligibility to children younger than 12 has been a major goal of public health officials and has been eagerly awaited by many pediatricians and families. The FDA has been under pressure for months to move quickly to authorize vaccines for younger children, one of the final barriers to overcome in the country's historic vaccination campaign.  

Safety: There were some concerns about monitoring the safety profile of the vaccine, because of the potential for an extremely rare but serious condition called myocarditis, or heart inflammation. Cases of myocarditis are generally more common in teenagers between the ages of 16 and 19. It's less common in adolescents, and even more rare in young children. 

Patrick Moore, a professor at the University of Pittsburgh Cancer Institute, said the potential risks of myocarditis are important, but theoretical. The risks of COVID-19 to children are much more tangible.

Moore noted that 94 children in the 5- to 11-year-old age group have died of COVID.

"All of them had names. All of them had mothers," he said.

Next up: ​​A decision by agency regulators is expected in the coming days, and a Centers for Disease Control and Prevention (CDC) panel is scheduled to meet Nov. 2-3 to recommend how the vaccines should be used. If the panel gives favorable recommendations and CDC Director Rochelle WalenskyRochelle WalenskyCDC working to tighten testing requirement for international travelers Overnight Health Care — Presented by March of Dimes — Omicron sets off a flurry of responses CDC strengthens recommendation to say all adults should get booster shot MORE accepts them, the vaccination campaign would begin.

Read more here.

A MESSAGE FROM ALTRIA

Altria’s companies are leading the way in moving adult smokers away from cigarettes – by taking action to transition millions towards potentially less harmful choices. Learn how at Altria.com.

Health care at the center of final social spending talks

Majority Leader <span class=Charles SchumerChuck SchumerProgressive groups urge Schumer to prevent further cuts to T plan Collins says she supports legislation putting Roe v. Wade protections into law Biden should seek some ideological diversity MORE (D-N.Y.) speaks to communication director Justin Goodman as Senate Democrats address reporters after the weekly policy luncheon on Tuesday, October 26, 2021." width="645" height="363" data-delta="21" />

Senate Majority Leader Charles Schumer (D-N.Y.) told reporters Tuesday that negotiators still haven’t reached agreement on language to expand Medicare benefits and lower the price of prescription drugs, two major pieces of their agenda, but insisted “a final deal is within reach.”

Schumer signaled to reporters that Democrats are much closer to agreement on climate provisions, which he promised would make a “robust” contribution to addressing global warming.

But he acknowledged that two of Senate Budget Committee Chairman Bernie SandersBernie SandersGOP ramps up attacks on SALT deduction provision Symone Sanders to leave the White House at the end of the year Briahna Joy Gray says Chris Cuomo will return to CNN following scandal MORE’s (I-Vt.) top priorities — expanding Medicare and cutting the cost of prescription drugs — remain unresolved.

The other holdups are a disagreement over creating a Medicaid-type program to expand health care coverage in states that opted out of expanding Medicaid under the Affordable Care Act, the length of a national paid family leave program and a proposal to empower the IRS to broadly review banking activity to find unreported tax obligations.

“I believe that we will get this done and we will get it done soon,” Schumer said after a caucus meeting. “No one ever said that passing transformational legislation like this would be easy, but we are on track to get it done.

“There is universal consensus in our caucus that we have to come to agreement despite the differences in views on many issues,” he added. “I believe a final deal is within reach.”

Read more here.

RELATED: SANDERS DRAWS HIS RED LINES

Senate Budget Committee Chairman Bernie Sanders (I-Vt.) said on Tuesday that a deal on President BidenJoe BidenManchin to vote to nix Biden's vaccine mandate for larger businesses Congress averts shutdown after vaccine mandate fight Senate cuts deal to clear government funding bill MORE’s spending bill must expand Medicare and include a plan to lower the cost of prescription drugs.

“Bottom line is that any reconciliation bill must include serious negotiations on the part of Medicare with the pharmaceutical industry, lower the cost of prescription drugs. That's what the American people want,” Sanders said. 

He added that a “serious reconciliation bill must include expanding Medicare to cover dental, hearing aids and eyeglasses.”

Sanders’s decision to draw red lines, while speaking with reporters on Capitol Hill, underscores the headache facing Democratic leadership as they try to reach a deal that can unify their various factions.  

On the other side: Joe ManchinJoe ManchinManchin to vote to nix Biden's vaccine mandate for larger businesses Congress averts shutdown after vaccine mandate fight Senate cuts deal to clear government funding bill MORE. The West Virginia Democrat, speaking to reporters on Monday, reiterated he doesn’t support expanding Medicare amid concerns about the program's solvency. 

“My big concern right now is the 2026 deadline [for] Medicare insolvency and if no one’s concerned about that, I’ve got people — that’s a lifeline. Medicare and Social Security is a lifeline for people back in West Virginia, most people around the country,” Manchin warned.

Read more here.

 

Birx: Trump White House prioritized politics 

Former President TrumpDonald TrumpBaldwin calls Trump criticism following 'Rust' shooting 'surreal' Haley hits the stump in South Carolina Mary Trump files to dismiss Trump's lawsuit over NYT tax story MORE and other White House officials were "distracted" by the 2020 election and prioritized campaigning over any COVID-19 mitigation strategies, the administration's former coronavirus adviser Deborah BirxDeborah BirxFeehery: The honest contrarian Documents reveal new details of Trump political interference in COVID-19 response The Hill's Morning Report - Presented by Facebook - Democrats insist budget consensus close as talks drag on MORE told House investigators earlier this month.

In excerpts from closed-door testimony conducted Oct. 12-13 by the House Select Subcommittee on the Coronavirus Crisis shared with The Hill, Birx said she felt the White House focus on campaigning took people’s time away and distracted them from focusing on the pandemic.

"I felt like the White House had gotten somewhat complacent through the campaign season, and I wanted to make sure that as soon as everyone was back the day after the election, that people would comprehensively reengage," Birx told the panel.

A big number: Birx said the administration's resistance to promoting basic public health mitigation resulted in more than 100,000 avoidable deaths. She said former President Trump did not do everything he could to try to stop the spread of the virus and save lives.

"I believe if we had fully implemented the mask mandates, the reduction in indoor dining, the getting friends and family to understand the risk of gathering in private homes, and we had increased testing, that we probably could have decreased fatalities into the 30 percent less to 40 percent less range," Birx said.

More than 735,000 Americans have died from COVID-19, including more than 300,000 since President Biden took office.

Read more here.

A MESSAGE FROM ALTRIA

Altria’s companies are leading the way in moving adult smokers away from cigarettes – by taking action to transition millions towards potentially less harmful choices. Learn how at Altria.com.


MODERNA PLANS TO SEND 110M VACCINE DOSES TO AFRICA

Moderna has reached a deal to sell as many as 110 million coronavirus vaccine doses to the African Union, the company announced.

The deal will involve the U.S. government deferring delivery of 33 million doses of the company's vaccine so that they can be purchased by the African Union. 

The company announced the deal on Tuesday morning, saying it would deliver 15 million doses in the fourth quarter of 2021, 35 million in the first quarter of 2022 and up to 60 million in the second quarter of 2022.

White House role: The White House, which later took credit for helping to broker the deal, said the U.S. would defer delivery of roughly 33 million Moderna vaccine doses it had already purchased so that the African Union can instead purchase and distribute them. 

White House press secretary Jen PsakiJen PsakiOvernight Health Care — Presented by March of Dimes — Biden's winter COVID-19 strategy Biden lays out multi-pronged plan to deal with evolving pandemic White House defends travel ban on African countries MORE told reporters that the doses were originally supposed to be delivered to the U.S. between December and February. 

“This deal will get the continent Moderna doses that have been long awaited and in high demand,” Psaki said during a press briefing.

Read more here.


WHAT WE'RE READING

  • Enforcement of indoor vaccine mandates proves uneven in US (The Associated Press)
  • Covid-19 vaccine rates for kids echo regional disparities, worrying doctors (NBC News)
  • Democratic senators raise concerns with potential FDA pick (Stat News)

 

STATE BY STATE

  • Colorado prepares for possible mask, vaccine mandate as COVID hospitalizations grow (Boulder Daily Camera)
  • Gov. John Bel Edwards lifts Louisiana mask mandate, except for certain K-12 schools (The Advocate)
  • Lawmakers want to restrict schools, businesses and health officers during COVID-19 legislative session (The Tennessean)

 

OP-EDS IN THE HILL

 

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

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