FDA panel mulls Covid vaccines for kids

From: POLITICO Pulse - Tuesday Oct 26,2021 02:04 pm
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Quick Fix

— An FDA advisory committee takes up the Covid-shots-for-kids question today, with the potential of childrens’ risk looming large.

Sen. Joe Manchin’s Sunday meeting with the president might not have moved the needle on budget expectations or key Medicare priorities.

Speaking of Manchin: Other lawmakers confronted him Monday about Medicaid priorities, but it’s unclear whether the arguments made an impression.

WELCOME TO TUESDAY PULSESomething for the spooky season: People who don’t get a Covid-19 vaccination can expect to be reinfected every 16 to 17 months, according to a study in The Lancet. Send tips to sowermohle@politico.com and acancryn@politico.com.

 

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Driving the Day

FDA PANEL TALKS COVID SHOTS FOR KIDS — FDA’s vaccine advisory committee kicks off its meeting today on whether to recommend the Pfizer-BioNTech Covid vaccine for kids ages 5 to 11. Should the panel give the thumbs-up, expect the FDA to act later this week, POLITICO’s Lauren Gardner writes.

The CDC’s vaccine committee is scheduled to meet Nov. 2 and 3 to finalize clinical recommendations for Director Rochelle Walensky’s approval. That means the 28 million children in that age group could be getting their initial shots by the first full week of November.

But it’s not smooth sailing. The FDA’s panel members, largely vaccine experts, pediatricians and other scientists, are sure to grill Pfizer and BioNTech on their shot’s safety in the youngest set of people considered so far. While no one in the clinical trials developed myocarditis, an inflammatory heart condition linked to the messenger RNA vaccines, Pfizer acknowledged the trial size — doubled at the FDA’s behest — was not large enough to detect the rare side effect.

The FDA posted the companies’ data late Friday night — luckily, Lauren was around to assess. The gist is that the agency thinks benefits outweigh risks for kids, but that could change if case numbers drop — especially because myocarditis risk looms for younger people.

States are eager. Governors and public health agencies are prepping for the kid rollout. Case in point: Illinois announced Monday it already has more than 2,200 locations and vaccine providers across the state registered to vaccinate children. Its initial allocation is expected to include about 500,000 doses.

 

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THE STATE OF RECONCILIATIONWest Virginia Democrat Joe Manchin — who met with President Joe Biden this weekend to settle some agenda priorities — doesn’t seem to be settled on the path forward.

A deal is unlikely this week. The moderate Democratic senator told POLITICO’s Burgess Everett on Monday that, even if the text is complete, “that would be difficult from the Senate side because we have an awful lot of text to go through.”

What is the holdup? “I'm concerned about an awful lot of things,” Manchin said. “It expands programs ... we don't even have programs we’re paying for properly.” (A major contention point, of course, has been expanding Medicare for dental, vision and hearing coverage to the tune of $350 million.)

Speaking of that: “My big concern right now is the 2026 deadline, when we hit insolvency,” the senator said. “You've got to stabilize that first before you look at basically expansion, so if you're not being fiscally responsible that's really concerning.”

Parting words: “I've always said that I believe that government should be your best partner, but it shouldn't be your provider. We have a moral obligation to provide those who have incapacity … physical or mental, but everyone else should be able to help and chip in,” Manchin told Burgess.

Manchin also underscored Monday that his budget line is $1.5 trillion. It’s a stark reminder that the Senate is at a standstill … and Biden’s Sunday breakfast meeting with Manchin and Majority Leader Chuck Schumer may not have broken ground.

MEDICAID BACKERS CONFRONT MANCHIN — It’s drama: Congress’ two biggest champions of closing the Medicaid gap cornered Manchin on Monday after he came out in opposition to the provision and lobbied him to preserve at least short-term coverage for people in the 12 remaining holdout states.

House Majority Whip Jim Clyburn (D-S.C.) and Sen. Raphael Warnock (D-Ga.) confirmed to reporters they spoke to Manchin, Alice reports. “I wasn’t making any arguments with him,; I just laid out what I think we ought to do,” Clyburn said. Warnock said he and other members are fighting to protect the provision from being dropped from the bill and bristled at Manchin’s assertion that a federal expansion wouldn’t be “fair” to states that expanded years ago.

“What’s unfair is for the people of Georgia to be paying for health care in other states that they have no access to because they woke up in the wrong state,” Warnock told Alice. “People are literally dying because they can’t get health care.” The Georgia senator said Manchin seemed receptive to his arguments, but no agreement has yet been reached.

SPOTTED: TOP HEALTH STAFF CONVENE FOR GOTTLIEB — Health experts, lobbyists and officials came together Monday night for a Friends of Cancer Research event featuring former FDA commissioner Scott Gottlieb in conversation with anoher FDA veteran, Mark McClellan, to discuss Gottlieb's new book, Uncontrolled Spread.

In attendance: Sen. Roy Blunt (R-Mo.), former Trump adviser Joe Grogan, Council on Foreign Relations fellow Luciana Borio, former HHS deputy chief of staff Judy Stecker, and a slew of former FDA officials including past commissioner Peggy Hamburg, former deputy commissioner Anna Abram, former chief of staff Keagan Lenihan, former principle associate commissioner for policy Lowell Schiller and Gottlieb's former chief of staff Lauren Silvis. BIO's Michelle McMurry-Heath, once floated for the commissioner post, also attended.

BIDEN LOOSENS LIMITS FOR VAXXED INTERNATIONAL TRAVELERS — The administration Monday rolled out new details on U.S. travel rules for foreign nationals, which take effect in early November.

Starting Nov. 8, fully vaccinated adults must show proof of vaccination before boarding their flight to travel to the U.S. Only vaccines approved or authorized by either the FDA or the World Health Organization will be accepted, according to senior administration officials.

Fully vaccinated individuals will also have to show proof of a negative Covid-19 test taken within three days before boarding an airplane, POLITICO’s Nick Niedzwiadek reports. That documentation will fall to airline companies.

“We have taken the deliberate step of taking this time to ensure implementation goes as smooth as possible, particularly with something this wide-ranging,” a senior administration official told reporters Monday.

The rules include an exemption for people hailing from a country with limited vaccine availability, which the Biden administration is defining as a place where less than 10 percent of the population is fully vaccinated “due to lack of vaccines,” according to one senior administration official. Roughly 50 countries fall under that threshold, including much of Africa.

 

BECOME A GLOBAL INSIDER: The world is more connected than ever. It has never been more essential to identify, unpack and analyze important news, trends and decisions shaping our future — and we’ve got you covered! Every Monday, Wednesday and Friday, Global Insider author Ryan Heath navigates the global news maze and connects you to power players and events changing our world. Don’t miss out on this influential global community. Subscribe now.

 
 


TELEHEALTH ADVOCATES PUSH FOR INTERNET ACCESS — More than 40 groups led by the Connect Americans Now coalition sent letters to Congressional leaders this week pressing for better broadband access to improve telehealth services, which have become critical during the pandemic.

Organizations — including groups from rural Oregon, Montana and Wisconsin — rallied for Congress to pass the infrastructure package that would release millions of dollars for better internet access in pockets of the country.

“Now more than ever, creating good jobs, lifting wages, reducing poverty, improving health outcomes and strengthening education depends on affordable, reliable broadband connectivity and access to digital devices and skills in every American community,” the groups said in their letter to House and Senate leaders.

 

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Names in the News

Gina Drioane will be senior director of health communications at Waxman Strategies. Drioane previously was associate director of federal policy and advocacy comms at Planned Parenthood Federation of America.

Hayley Alexander is now senior manager of U.S. government affairs and public policy at BeiGene. She previously worked for the Senate Appropriations Committee and was director of federal government relations at BIO.

Nick Przybyciel was promoted to SVP for PR at GCI Health, a health communications agency. He most recently was VP at GCI.

What We're Reading

Nearly 40 companies, including retail giants Walmart and Costco, said Monday they are launching a new pharmacy benefit initiative, circumventing PBMs that counted them as some of the biggest clients, Reuters reports.

The White House cannot share Moderna’s Covid-19 vaccine production process with others despite putting billions toward its production, Dan Diamond reports in The Washington Post.

Widespread pandemic lockdowns delayed cancer screenings and treatments. Experts now predict more than 10,000 excess cancer deaths because of the coronavirus, Medscape’s Victoria Stern writes.

 

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