Covid-19 vaccine 80.3 percent effective in kids under 5- POLITICO

With help from Katherine Foley and Carmen Paun

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—A Covid-19 vaccine for the youngest kids gets a little closer as Pfizer and BioNTech announce plans today to submit data to the FDA for their three pediatric doses.

—Biden calls monkeypox something “everyone should be concerned about,” as the WHO confirms more than 90 cases in North America, Europe, the U.K., and Australia.

—A judge blocks the Biden administration from lifting Title 42, keeping in place a public health policy the nation’s public health agency says is no longer necessary.

WELCOME TO MONDAY PULSE — Singer Billie Eilish talks with David Letterman for his Netflix series about what it’s like living with Tourette’s syndrome. Send news and tips to [email protected] and [email protected].

INCHING CLOSER TO THE UNDER-5 VACCINE — This morning, Pfizer and BioNTech announced they plan to finish submitting data to the Food and Drug Administration on three doses of their Covid-19 vaccine for the 19 million children in the U.S. under 5 and still ineligible for any Covid-19 vaccine, Katherine reports.

The companies released top-line results showing that three pediatric doses of their Covid-19 vaccine generated a comparable immune response in children ages 6 months to under 5 years as two full doses did in young adults — the primary end goal the FDA set for pediatric vaccine manufacturers. Three doses of the vaccine also appeared to reduce cases of symptomatic disease by 80.3 percent within the age group.

The companies collected data on three doses of their vaccine in 1,678 children at least two months after they received their second vaccine dose. Omicron was the dominant variant of Covid-19 circulating at the time. No children in the trial had any serious side effects.

Background: Pfizer and BioNTech initially asked the FDA to authorize their two-shot Covid-19 regimen for kids 6 months to under 5 in February. The agency delayed the advisory committee meeting that would discuss the vaccine for this population, choosing to wait for more data on a third dose. Two doses of the vaccine generated immune responses in children 6 to 24 months old comparable to that in young adults but not in those between 2 and 5 years old.

What’s next: The FDA will schedule an advisory committee meeting to discuss the companies’ application when they complete their data submission.

WHY ARE WE ALL TALKING ABOUT MONKEYPOX? — Before leaving South Korea on Sunday, President Joe Biden referred to monkeypox, the contagious virus that’s spreading quickly in some countries, as endemic to West Africa and “something that everyone should be concerned about.”

The same day, White House Covid-19 response coordinator Ashish Jha tried to draw a clear line between monkeypox and Covid-19 on the Sunday shows, reports POLITICO’s David Cohen. “We have vaccines against it; we have treatments against it,” he said. “And it is spread very differently than SARS-CoV-2.”

Monkeypox by the numbers: On Saturday, the World Health Organization reported 92 lab-confirmed cases and 28 suspected cases in 12 countries in North America, Australia, Europe and the U.K. So far, the CDC has only confirmed one case in the U.S. in the Boston area, health and senior administration officials said on Friday, though other suspected cases have been reported.

The officials said the cases have been spreading primarily — but not exclusively — among men who have intimate contact, including but not limited to sexual activity, with other men.

Why public health officials are watching this so closely: The reported cases, including the U.S. case, aren’t linked to any of the 12 countries in West and Central Africa where monkeypox is endemic.

“This case is highly unusual, and we do have a degree of scientific concern about it,” a senior U.S. health official told reporters Friday. “So far, it doesn’t have any direct link to any of the countries in West and Central Africa where monkeypox is commonly found.

The official cautioned that while additional cases may be reported in the coming days, the virus still poses a “low risk” to Americans at this time.

TITLE 42, IN THE NAME OF PUBLIC HEALTH NO MORE — On Friday, a federal judge blocked the Biden administration from lifting the public health order Title 42 today, continuing the expulsion of migrants from the U.S. on public health grounds the CDC says is no longer necessary.

More than 20 states had sued the administration over the way it ended the policy, first enacted in March 2020 during the early days of the pandemic, and the impact a potential surge in migrants would have on states. The administration said the Department of Justice will appeal the decision but would continue to enforce the order during the appeal process.

This will evidently be welcome news to the majority of Americans who oppose the Biden administration’s decision to end Title 42, according to a new POLITICO-Harvard survey, underscoring how a law designed to stop the spread of disease is now widely seen as the best way to control immigration.

The survey found that 55 percent of American adults oppose ending the use of the order, known as Title 42, to prevent migrants from entering the U.S., compared to 45 percent who think the order should end.

Among those who said they think there should be less immigration into the U.S., opposition to ending the order rose to 77 percent, while 72 percent of people who support more immigration think the order should end.

BECERRA INVOKES DPA TO EASE BABY FORMULA SHORTAGE … Health and Human Services Secretary Xavier Becerra invoked the Defense Production Act on Sunday to help manufacturers get the materials they need to ramp up production of infant formula during the national shortage.

Two manufacturers — Abbott Nutrition and Reckitt — can now “add legally binding language to their orders with suppliers that will give them priority over other customers,” the administration said in a statement.

The DPA order will authorize Abbott, which requested federal government assistance, to obtain “priority fulfillment” over the next three months for goods needed to manufacture formula like corn syrup and sugar and Reckitt to access products like filters that are held up in the supply chain.

Earlier in the day, 35 tons of Swiss baby formula arrived via cargo plane in Indianapolis, enough to feed 9,000 babies and 18,000 toddlers for a week.

… AND RESPONDS TO WHO CONSPIRACY THEORY — Claims that revising international health rules would diminish U.S. sovereignty “are categorically false and dangerous,” Becerra wrote on social media Friday, Carmen reports.

The message was in response to a conspiracy theory that’s been picked up online claiming the U.S. is planning to hand over sovereignty to the World Health Organization at a meeting this week in Geneva. At least one Biden-Harris administration official received thousands of emails about it.

The conspiracy stems from a U.S proposal to revise the International Health Regulations, which govern how the world responds to a disease outbreak. Conspiracy theorists seized on a proposal to delete current wording noting that a country should agree that an outbreak poses international concern before convening a committee to declare so. They claim this would give the WHO unchecked control over the U.S. and other countries.

Fox News commentator Tucker Carlson mentioned it during his show Thursday. Media personalities in the U.K. and politicians in Australia have amplified the theory.

For the record, the WHO is not plotting a global takeover. The regulations, which in theory should be respected by all 194 WHO member countries, have no way to punish a government for not following them.

STATE DEMS WANT MORE EXECUTIVE ACTION ON ABORTION — Democrats in states want to see the White House swing into action to secure access to abortion, POLITICO’s Megan Messerly and Alice Miranda Ollstein report.

Since the draft opinion overturning Roe v. Wade became public, national Democrats have largely highlighted what they can’t do in the Senate and focused on fueling midterm-election turnout instead of taking executive action that could increase access to abortion pills or help protect people’s medical information.

The lack of federal action is forcing members of Congress and national reproductive-rights groups to concede that state and local action is their best and possibly only option — even if it means tens of millions of people could be left without access to abortion.

“At this juncture, the state is going to be the lead,” Michigan Democratic Gov. Gretchen Whitmer told POLITICO. “We’re not waiting for someone else to solve this. We’re moving forward.”

A new report from Stat News’ Casey Ross details how HIPAA allows companies to traffic in Americans’ health data without their knowledge or consent.

Insider’s Madison Hall and Walt Hickey dig into how tobacco giant Reynolds American is spending millions of dollars in state-level politics.

A patient who needed back surgery after a car accident was told the procedure would cost $1,337. The hospital charged her $229,112.13, The New York Times reports.