Monday, April 4, 2022

POLITICO NIGHTLY: The kiddie vax may finally be here

 


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BY MYAH WARD

Presented by Human Rights Watch

With help from Renuka Rayasam

A child under 12 years old receives a dose of Pfizer vaccine as part of the Covid-19 immunization campaign in Belo Horizonte, Brazil.

A child under 12 years old receives a dose of Pfizer vaccine as part of the Covid-19 immunization campaign in Belo Horizonte, Brazil. | Pedro Vilela/Getty Images

FAST VAX FACTS — The parents of very young children have waited for well over a year for a vaccine that protects their kids from Covid. Their hopes have been repeatedly dashed. Now, it seems like that vaccine may finally be here — except it doesn't work as well as expected.

Moderna announced last month that it would ask the FDA to approve its vaccine for children 6 and under for emergency use. But the vaccine’s efficacy — how effective these shots are at keeping young children from catching Covid — wasn’t as exciting. It is expected to prompt an active debate at the FDA, as regulators decide whether the data is enough to greenlight the shot for kids.

In children 6 months to 2 years, 43.7 percent were protected against any form of disease. In the 2 to 6 years group, Covid cases decreased even less, by 37.5 percent. Despite those disappointing numbers, the company said the protection was similar to a two-dose vaccine in adults against the Omicron variant, which predominated during Moderna’s trial with young children.

To help break down the research and discuss what could come next once the data moves to the FDA in the coming weeks, Nightly talked with Chandy John, a pediatric infectious diseases expert at Indiana University. This conversation has been edited.

What stood out to you about Moderna’s data? 

With the caveat that it would be so much nicer to have full details, what stood out to me was that the efficacy wasn’t great, but there was efficacy. And that very importantly, there were no negative safety signals. Kids seemed to do really well with this.

And just a note they made: The incidence of high fevers above 104 were really quite rare, but it did happen every now and then. It was less than 1 in 1,000 that your child may have a high fever but usually that’s well tolerated. As a pediatric infectious diseases doctor, I always think that transparency and acknowledgment of any problem there may be is important.

Is there anything else the efficacy rate fails to capture? 

They didn’t have any severe disease or hospitalization or death in the study, which is great. But it means you can’t study that outcome.

On the one hand, one group will say: Well, they had, you know, 6,700 kids, and they didn’t have any hospitalizations or deaths. So why do you even need this vaccine?

But we have the numbers: Tens of thousands of children, including many under 6, were hospitalized during the Omicron wave with Covid-19. Even a relatively rare outcome like hospitalization, that’s tens of thousands of kids who may be affected if you have millions of them getting the infection.

So it couldn’t be studied in this study, but it’s likely that its efficacy is even better for protecting against severe disease, just based on what we’ve seen in every other study in adults and children. That’s to me another strong reason for thinking it is worthwhile to get young children vaccinated.

What have we learned about how Covid affects children below the age of 6?

The data shows a much higher risk of death in children below 1, which goes down dramatically between ages 1 and 14, and then starts climbing again after 16.

But among children younger than 18, the highest rate of death is in children under age 1. The number of these children as a fraction of the population is relatively small, but the data clearly show they are at highest risk for death among children, and I think highest risk of hospitalization as well.

The risk of death, 60 per 1 million, is still lower than adults, especially older adults. But it’s the highest among children.

It’s unclear why, but probably has to do with a less well-developed immune system in children less than 1 year, as is true for other respiratory viruses like RSV, and possibly also lack of exposure to other coronaviruses, as compared to older children.

During Omicron, the under-6 age group bore a lot of disease, and I think part of that is because there was no vaccine available. It was far from all of it, because the vaccination rates in 6- to 11-year-olds in particular are not great in the U.S. overall, but I think having no vaccine available for those younger kids did shift a larger brunt of the infection to them.

Myocarditis, or inflammation of the heart, has been a concern when it comes to vaccinating children. What do we know about how it affects this younger age group? 

For young adults, data shows that spacing out the second dose to be eight weeks or more after the first substantially reduced the rate of myocarditis to where it’s really no more prevalent than it is in the general population. The CDC did recommend children 12 to 17 could get the eight-week spacing, and I think that’s what most of us are recommending now to essentially take the risk of myocarditis out of the equation.

In 5 to 11, there really has not been a myocarditis signal at all so far, so that’s really good news. For very young children — which you need a larger study to definitively say anything about myocarditis — but in this first Moderna study, there was no myocarditis.

The question then becomes, could it have been a 70 percent or 80 percent effective vaccine if we had a higher dose? But if we did, would we have more myocarditis? These are the things that make these trials so difficult to do.

Welcome to POLITICO Nightly. In an hour and change from Nightly's publish time, the college basketball national title game will tip off, featuring editor Chris Suellentrop's Kansas Jayhawks vs. Myah Ward's North Carolina Tar Heels. Despite the bad blood, we still managed to get a newsletter out today, possibly because Tyler Weyant hasn't thought much about his Maryland Terrapins in months. Reach out with news, tips and ideas at nightly@politico.com. Or contact tonight’s author at mward@politico.com, or on Twitter at @MyahWard.

 

A message from Human Rights Watch:

There is food in the market, but families have no cash to buy it. Health workers are ready to save lives, but there are no salaries or supplies. Learn More.

 
WHAT'D I MISS?

A view of a mass grave by a church in Bucha, Ukraine.

A view of a mass grave by a church in Bucha, Ukraine. | Anastasia Vlasova/Getty Images

— Ukraine massacre has U.S. and allies seeking new ways to punish Putin: The United States and its allies began ramping up economic, diplomatic and legal pressure on Russia today to punish the Kremlin for apparent massacres of Ukrainian civilians . Ukrainian leaders welcomed the moves but urged their global supporters to do more, going for the “most severe sanctions” possible. Images and videos posted over the weekend showed dozens of Ukrainian civilians, some with their hands bound, laying dead in Bucha — a suburb of the capital, Kyiv — after Russian forces retreated. There also were reports and images of mass graves containing hundreds of civilians.

— Biden admin plots fix to Obamacare’s ‘family glitch,’ expand coverage: The Biden administration is planning on Tuesday to propose a long-sought change to the Affordable Care Act aimed at lowering health insurance costs for millions of Americans, four people with knowledge of the matter told POLITICO . The new policy is designed to close a loophole in the ACA known as the “family glitch” that’s prevented an estimated 5 million people from qualifying for subsidized health plans — even when they can’t find affordable coverage elsewhere.

— Senate strikes $10B Covid deal: Senate negotiators struck a deal on $10 billion in Covid aid today, setting the chamber on a potential course to clear the bill this week. The compromise would reprogram billions in unused money from other coronavirus bills to deliver funding for therapeutics, testing and vaccine distribution. However, it does not include global pandemic aid sought by Democrats and a handful of Republicans, the people said, which could become a sticking point when the package comes before the House.

— Trump’s new social media site sees a top staffer exodus: Top executives from former President Donald Trump’s social media venture, Truth Social, have departed the company as the site has struggled to gain traction with users.

— NYC mayor uses ‘Don’t Say Gay’ law to recruit LGBTQ Floridians with billboards: Mayor Eric Adams announced the placement of billboards denouncing the “Don’t Say Gay” law in five major Florida cities to bring state residents opposed to the legislation to New York City.

 

SUBSCRIBE TO NATIONAL SECURITY DAILY : Keep up with the latest critical developments from Ukraine and across Europe in our daily newsletter, National Security Daily. The Russian invasion of Ukraine could disrupt the established world order and result in a refugee crisis, increased cyberattacks, rising energy costs and additional disruption to global supply chains. Go inside the top national security and foreign-policymaking shops for insight on the global threats faced by the U.S. and its allies and what actions world leaders are taking to address them. Subscribe today.

 
 
FROM THE TECHNOLOGY DESK

BACK TO THE (DIGITAL) FUTURE — There’s a new newsletter in the POLITICO corral: Digital Future Daily . Here’s a snippet by Konstantin Kakaes from the first edition:

Congress isn’t the most tech-savvy institution, but we got curious: When did it first start thinking about AI?

You’d be surprised. The term first shows up in the Congressional Record in April 1964, when Hubert Humphrey, in a speech to the Eastern Spring Computer Conference, spoke of a new breed of machines “that read, that remember, that improve their performance, that respond to sound — including human voices — to touch, to scent — machines which incorporate almost every facet of artificial intelligence.”

Humphrey envisioned that AI would bring about “a revolution for permanent prosperity” by analyzing “mountains of largely unused, unsynthesized information” held by government agencies.

Today, those mountains of information are much, much higher — and in a twist Humphrey could not have fully anticipated, are now filled with our personal data. Nearly 60 years after Humphrey warned that “history’s most profound revolutions have been underestimated by their contemporaries,” it remains just as hard to foresee where this one will go. And Congress is still struggling to sort it out.

 

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NIGHTLY NUMBER

254 feet

The length of Tango, a sanctioned oligarch’s super yacht that was captured by authorities in Spain in an operation today, marking the country’s first seizure since sanctions against Russia’s elite class were announced in retaliation for Moscow’s invasion of Ukraine.

 

STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president’s ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today.

 
 
PARTING WORDS

SWEET SORROW — Renuka Rayasam emails:

Today is my last edition of Nightly. I will still write about Covid, and you’ll still get Nightly in your inbox, but I probably won’t get the chance to write so intimately about the dissonance of pandemic life at my new job. In the newsletter’s earliest months, it was clear that translating public health guidance into thousands of daily life decisions would be confusing and conflicted. In Nightly I shared advice from researchers based on the latest Covid science, but I also got to record my own attempts to figure out how to balance that advice with the demands of my family and frankly, my own sanity.

During those first months, when attitudes on safety were just hardening, writing about that balance felt like a release valve. A Covid journalist got a haircut and got on a planeand sent her kids to day care. Following expert guidance was a challenge, and I didn’t want to pretend otherwise. Still, I was lucky — I’ve gotten colds and the flu during the past two years, but I haven’t gotten Covid, that I know of anyway.

What I didn’t realize was that the dissonance would still be with us two years later.

I traveled to Washington, D.C., last week to moderate a panel at POLITICO’s Health Summit about the pandemic’s impact on mental health. It was POLITICO’s first in-person public event in two years, and it came after an Omicron surge and perhaps just before a BA.2 wave. Public health experts filled the room, but few wore masks. Covid cases have been falling, but at least one person had to bow out of the summit because of a positive Covid test.

I flew back to Texas the following day, which happened to be April Fool’s Day and the anniversary of both my wedding and my first Covid shot. After experiencing basically no Covid restrictions in Washington, the trip felt surreal: I wore a mask during the entire eight-hour journey, through two planes and three airports. I finally ripped it off when I stepped outside the El Paso airport, into the dry, dusty heat, not sure when I would have to put it on again — still not sure whether — or when — my luck will run out.

 

A message from Human Rights Watch:

This is Afghanistan today. The Taliban are carrying out extrajudicial killings and abductions, repressing media, and imposing draconian restrictions that violate the rights of women and girls. On March 23, they reneged on promises to allow girls to go back to secondary school.

At the same time, the US government has cut off Afghanistan's economy from the rest of the world and suspended support for salaries for teachers and health workers.

The country is on the brink of economic collapse. Millions are at risk of starvation - especially women and girls, who face greater obstacles to getting food. Without a functioning economy, most families have lost their ability to feed themselves. Their most basic rights - to food, health, and life itself - are under assault.

Learn More.

 

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