Overnight Health Care — Presented by Emergent Biosolutions — Boosters for all

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.

President BidenJoe BidenChina eyes military base on Africa's Atlantic coast: report Biden orders flags be flown at half-staff through Dec. 9 to honor Dole Biden heading to Kansas City to promote infrastructure package MORE’s doctor on Friday released a report on his health, finding he is healthy and fit for office, while also highlighting his throat clearing and stiffened gait. 

Today we'll look at expanded eligibility for booster shots, with the CDC and FDA signing off on booster doses for all adults — something the Biden administration originally pushed for months ago.

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.

CDC signs off on boosters for those 18+ 

A Center for Disease Control official is seen as Afghans displaced from their homes due to the Taliban takeover arrive at Washington Dulles International Airport in Chantilly, Va. on Monday, August 30, 2021.

Booster shots of COVID-19 vaccines are now available to anyone over the age of 18, after Centers for Disease Control and Prevention (CDC) Director Rochelle WalenskyRochelle WalenskyNIH director says it's 'possible' omicron will not be last emerging variant CDC director confirms FDA in talks to streamline authorization of omicron-specific vaccine Sunday shows preview: Multiple states detect cases of the omicron variant MORE signed off on the recommendations of an agency advisory panel.

Effective immediately, tens of millions of people who are at least six months past their last Pfizer or Moderna shot are now eligible for a booster dose. 

Friday's action represents the culmination of a long-running debate among experts over who should be eligible for booster shots and belatedly delivers on President Biden's promise of widespread boosters for all adults by September.

Earlier in the day, the Food and Drug Administration (FDA) authorized boosters of both the Pfizer-BioNTech vaccine and Moderna's vaccine.

Biden administration officials have been encouraging anyone eligible to get a booster as soon as possible, and authorizing wide availability of both shots ahead of Thanksgiving reflects the administration's concern about the growing numbers of COVID-19 infections.


CONFUSION AND LOWER NUMBERS

State officials and infectious disease experts have argued the previous federal guidelines on boosters were confusing and preventing some of the most vulnerable people from getting another dose.

While eligibility was fairly broad, it was still technically limited to certain populations. Less than 40 percent of people over the age of 65 have received a booster dose, according to CDC data. Broadly, only about 18 percent of all adults have received a booster. The new guidelines are meant to make it simpler.

"After thorough review of the data, we are following the science, which shows boosters can help increase people’s protection from COVID-19 and help us reduce infections and severe outcomes. This is especially important ahead of the winter months, where we all spend more time indoors. I am grateful to the hard-working scientists at the FDA and CDC for their rigorous, independent decision-making on booster shots and their ongoing commitment to keeping us all safe," HHS Secretary Xavier BecerraXavier BecerraThe Hill's 12:30 Report: Trump's pre-debate COVID-19 test sparks criticism Biden unveils updated strategy to end HIV epidemic by 2030 Buttigieg has high name recognition, favorability rating in Biden Cabinet: survey MORE said in a statement. 

Read more here.


NUANCES IN CDC PANEL'S RECOMMENDATIONS

​​A key outside advisory group to the Centers for Disease Control and Prevention (CDC) endorsed the use of COVID-19 booster shots for all adults earlier on Friday, a one-size-fits-all approach designed to simplify eligibility.

But there was some nuance in the recommendations: the panel voted that all adults are eligible, but in a separate, last-minute vote they explicitly recommended that everyone over the age of 50 should get a booster.

Older adults have the clearest benefit from a booster dose of an mRNA vaccine, panelists said, and also less risk of severe side effects like myocarditis, a rare inflammation of the heart that's been found in younger men.

The recommendations were made in an effort to keep things simple.

"The current guidelines, though well-intentioned and thoughtful, generate an obstacle to uptake of boosters. In pursuit of precision, they create confusion," Nirav Shah, president of Association of State and Territorial Health Officials, told the panel.  "Simplifying eligibility will allow staff across the states, territories and local health departments to focus on making vaccination— primarily the primary vaccination series— as easy and accessible as possible." 

But some public health experts said afterwards they felt the recommendations were still too confusing by parsing out people who "should" get a booster versus people who "may" get a booster.

Read more here.



A MESSAGE FROM EMERGENT BIOSOLUTIONS


Emergent has produced over 100 million Covid-19 vaccine dose-equivalents. Today, these critically important doses are deployed around the world to help fight the pandemic. Get the latest on Emergent’s Covid-19 response.



House advances drug pricing, health provisions 

Speaker <span class=Nancy PelosiNancy PelosiUS expected to announce diplomatic boycott of Beijing Olympics soon: report Pressure grows to remove Boebert from committees Lawmakers remember Bob Dole: 'Bona fide American hero' MORE (D-Calif.) addresses reporters during a press conference on Friday, November 19, 2021 after the Build Back Act vote." width="645" height="363" data-delta="3" />

After a marathon speech by House Minority Leader Kevin McCarthyKevin McCarthyPressure grows to remove Boebert from committees Senate leaders face pushback on tying debt fight to defense bill News reporting in an age of rampant mendacity MORE (R-Calif.) late into the night, the House finally passed the massive Build Back Better package early this morning. 

On health care, that means measures to extend enhanced ObamaCare subsidies, provide coverage to low-income people in the 12 states not yet expanding Medicaid, and lower drug prices have advanced. 

Democrats have pressed ahead to pass popular legislation in the face of rising inflation, an ongoing COVID-19 crisis and a disastrous showing in state elections around the country earlier in the month, including a stunning loss in the high-profile Virginia governor’s race. 

"I thank Speaker Pelosi and the House leadership and every House member who worked so hard and voted to pass this bill," President Biden said in a statement Friday morning. "For the second time in just two weeks, the House of Representatives has moved on critical and consequential pieces of my legislative agenda."

The House vote, which sends the spending package to the Senate, comes just days after Biden signed into law a $1.2 trillion bipartisan infrastructure bill — back-to-back victories Democrats hope will demonstrate their governing chops and give them something to tout back home.

“This is the end of the beginning,” said Rep. Dean PhillipsDean PhillipsBiden touts infrastructure bill in Minnesota swing district Five takeaways: House passes Biden's sweeping benefits bill Overnight Health Care — Presented by Emergent Biosolutions — Boosters for all MORE (D-Minn.). “We all expect it will be further modified before coming back to us. But to keep the ball rolling, I think it's important” to advance it through the House.

Read more here.

FAUCI SAYS BABY VAX COULD COME IN 2022

Director of the National Institute of Allergy and Infectious Diseases Anthony FauciAnthony FauciMurthy says travel restrictions are 'temporary measures' Fauci calls Ron Johnson's AIDS comment 'preposterous': 'I don't have any clue of what he's talking about' Fauci: US 'hopefully' will lift African countries travel ban in 'reasonable period of time' MORE said Thursday that though he "can't guarantee it," babies and toddlers aged 6 months to 5 years could be eligible for COVID-19 vaccination by spring.

"Hopefully within a reasonably short period of time, likely the beginning of next year in 2022, in the first quarter of 2022, it will be available to them," Fauci told Insider in an interview, though he cautioned that he was speculating, adding, "you've got to do the clinical trial." 

Pfizer-BioNTech previously stated that results from their clinical trial in children in the age ranges of 2 to 5 years and 6 months to 2 years are expected as soon as the fourth quarter of this year.

The White House announced Wednesday that 10 percent of children ages 5 to 11 have received their first coronavirus shot, following the approval of the Pfizer pediatric dose.

Read more here.

Pregnant with COVID raises stillbirth risk 

Pregnant women infected with COVID-19 are more at risk for stillbirths, a Centers for Disease Control and Prevention (CDC) analysis found, providing further evidence supporting COVID-19 vaccines for those carrying a child.

The analysis released on Friday determined that 1.26 percent of deliveries between March 2020 and September 2021 among people infected with COVID-19 resulted in stillbirths, compared to 0.65 percent of deliveries among non-infected people.

Out of the 1.2 million deliveries across 736 hospitals in that time period, 21,653 occurred among people with COVID-19, amounting to about 1.73 percent.

Stillbirths are usually rare, but have been more strongly linked to COVID-19 since the delta variant became the dominant strain.

The reports’ authors emphasized the importance of preventive measures including vaccination, which the CDC recommends for pregnant women. Only about 30 percent of pregnant Americans are vaccinated, a rate far lower than the population as a whole.

“Most women with COVID-19 at delivery were likely unvaccinated," CDC said.

“Implementing evidence-based COVID-19 prevention strategies, including vaccination before or during pregnancy, is critical to reducing the impact of COVID-19 on stillbirths,” the report read. 

Read more here.



A MESSAGE FROM EMERGENT BIOSOLUTIONS


At Emergent, we develop, manufacture, and deliver protections against public health threats. Find out how we’ve enhanced and reinforced quality control and oversight practices on our vaccine bulk drug substance manufacturing in support of Covid-19 vaccine production.



WHAT WE’RE READING

  • Biden administration looks to expand access to Covid-19 antiviral pills (Wall Street Journal)
  • Colleges are turning to science to limit suicide contagion and help heal campuses (Kaiser Health News)
  • The new COVID war: Redefining vaccinated (Axios)

 

STATE BY STATE

  • VA stats show devastating Covid toll at vets’ nursing homes (Politico)
  • Public health advisory for Michigan amid COVID-19 surge: Wear a mask (Detroit Free Press)
  • Deadlocked Texas Board of Education fails to approve health textbooks for elementary schools (Dallas Morning News)

 

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

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