U.S. toes the line on monkeypox vaccine donations

From: POLITICO Pulse - Thursday Jun 02,2022 02:01 pm
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By Sarah Owermohle and Krista Mahr

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With help from Daniel Lippman and Ben Leonard

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QUICK FIX

The World Health Organization has asked for monkeypox shots, but the U.S. may not be ready to part with its stockpile.

A longtime CDC official talks Covid-19 and coming crises as he departs.

We’re one step closer to a shot for the youngest kids after Pfizer and BioNTech’s filing.

WELCOME TO THURSDAY PULSESomething we’re reading: Gynecology has a pain problem. Send news and tips to sowermohle@politico.com and kmahr@politico.com.

 

A message from PhRMA:

Nearly half of insured Americans who take prescription medicines encounter barriers that delay or limit their access to medicines. In a new report, learn more about the abusive insurance practices that can stand between patients and the care they need.

 
Driving the Day

Monkeypox illustration

Global health officials have asked to pool monkeypox vaccines as cases spike in hotspots. | Jakub Porzycki/NurPhoto via AP

THE NEW VACCINE DIPLOMACY DEBATE — The U.S. hasn’t decided whether it will answer the WHO’s call to pool monkeypox vaccinations as case numbers continue to rise around the world.

Why it matters: Last week, WHO officials asked countries with stockpiles of monkeypox and smallpox vaccines to distribute them to countries based on their need, nodding to a 20-year-old vaccine-sharing agreement designed for a smallpox emergency.

The WHO has reported more than 550 confirmed monkeypox cases since May 13 in 30 countries where the virus isn’t endemic.

“Given that the current situation involves monkeypox, it is premature to comment on what steps related to this previous commitment might be taken in the current situation,” an HHS official said in a statement to our Daniel Payne and Krista on Tuesday. “No decisions have been made at this point.”

In the states: The CDC has reported 18 cases of monkeypox or orthopox, the group of viruses that monkeypox belongs to, in nine states: California, Colorado, Florida, Georgia, Massachusetts, New York, Utah, Virginia and Washington.

The CDC said last week that the federal government’s Strategic National Stockpile contained some 100 million doses of ACAM2000, an older live smallpox vaccine that can be used to treat monkeypox but that has significant potential side effects, as well as about 1,000 doses of Jynneos, a newer vaccine approved by the Food and Drug Administration for monkeypox and smallpox.

Bavarian Nordic, the manufacturer of Jynnoes, told POLITICO last week it had received calls from “many, many countries” wishing to purchase its shot.

Most vaccines in the global supply are old, said Rosamund Lewis, the WHO’s technical lead for monkeypox, said at a press briefing Wednesday. “Most of the vaccines in these reserves are in fact what we call first-generation vaccines, and they are from the eradication era,” she said — adding that the older versions don’t fit the current needs well. “They don’t at the present time meet the standards we have today.”

DEPARTING CDC OFFICIAL ON COVID, TRUST AND THE NEXT CRISISThe Centers for Disease Control and Prevention’s chief medical officer, Mitchell Wolfe , is leaving the agency after 21 years, Daniel Lippman reports. Wolfe will be transitioning to a role in the private sector overseas. His successor at the CDC hasn’t been announced yet.

In an interview with Daniel and Krista, Wolfe talked about the CDC’s global strategy, the agency’s image overseas and the importance of international cooperation to protect Americans’ security.

How concerned are you that Americans are done with the pandemic, but the pandemic isn't done with Americans?

It's important that we keep people focused on where the pandemic is and what we need to be doing. It’s important for the government to do that, it's important for academic institutions, it's important for health care providers. It’s going to be with us for a long time, so it's going to be important to transition to a long-haul mentality of how we're going to be dealing with the pandemic.

Public trust in the CDC has taken a beating in the U.S. during the pandemic. Do you see the same thing happening in terms of the CDC’s global leadership in public health?

In the past two or three months, I have been to many countries. I've been to India, Guatemala, Panama, Korea, Japan and Georgia. In every country, the host country Ministries of Health or host country CDC equivalents have a huge respect for CDC and are looking to us for collaboration and as a model. So, I feel that our global brand and global reputation is as strong as it's ever been.

Considering the multiple public health crises facing the U.S., what are you most worried about looking five years down the road? 

It’s critical that we maintain close engagement with as many countries as possible to help them not just with Covid, but really building capacity to be able to prevent, detect and respond to future threats. We have this pandemic, but we're always at risk for additional outbreaks or another pandemic.

What do you feel like you’ve accomplished in your career? 

I'm most proud of my work overseas and being able to contribute to the mission of the CDC of protecting Americans from health, safety and security threats, through improving the capacity of other countries to address their health threats. … We have established a strategy to have a longer-term, more stable, reliable overseas presence that involves a mix of country and regional offices. … It’s critical that we’re involved in and we’re collaborating with as many countries as possible of all income levels because, you know, the threats can come from anywhere.

 

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A classroom is pictured.

Federal advisers will soon review administering Covid-19 vaccines to the country's youngest children. | AP Photo

PFIZER, BIONTECH FILE VAX FOR YOUNGEST KIDS — Pfizer and BioNTech finished submitting data to the Food and Drug Administration for their three-dose Covid-19 vaccine for children 6 months to 4 years old.

Background: In May, the companies announced that three pediatric doses — about one-tenth the size of adult doses — of their mRNA Covid-19 vaccine produced immune responses in that age group comparable to young adults who received two full doses. The companies also reported preliminary data that suggested their vaccine reduced symptomatic Covid-19 infections by 80.3 percent. The data was collected when Omicron was the primary variant circulating.

What’s next: The FDA’s vaccine advisory committee will meet on June 15 to discuss Pfizer and BioNTech’s request to authorize their vaccine for the youngest kids, Katherine Ellen Foley reports. The committee will also discuss Moderna’s emergency use authorization request for its vaccine for children 6 months to 5 years old.

 

DON'T MISS DIGITAL FUTURE DAILY - OUR TECHNOLOGY NEWSLETTER, RE-IMAGINED:  Technology is always evolving, and our new tech-obsessed newsletter is too! Digital Future Daily unlocks the most important stories determining the future of technology, from Washington to Silicon Valley and innovation power centers around the world. Readers get an in-depth look at how the next wave of tech will reshape civic and political life, including activism, fundraising, lobbying and legislating. Go inside the minds of the biggest tech players, policymakers and regulators to learn how their decisions affect our lives. Don't miss out, subscribe today.

 
 
Industry Intel

CYBERATTACK ATTEMPT AT BOSTON CHILDREN’S — Iranian government-sponsored hackers unsuccessfully attempted to launch a cyberattack against Boston Children's Hospital last summer, FBI Director Christopher Wray said Wednesday at a cybersecurity conference at Boston College, Ben reports.

Wray called it “one of the most despicable cyberattacks” he had seen. The agency was tipped off to the plans targeting the hospital and helped hospital officials protect against the threat, Wray said.

Background: Health care organizations have seen more sophisticated threats in recent years, experts say, and have braced for Russian cyber threats amid the war. The industry is a ripe target for ransomware because an attack stopping care delivery could threaten patients' lives, leaving organizations feeling forced to pay ransoms.

The U.S. faces threats from nations such as Iran and North Korea as well as Russia and China, Wray said.

“We can’t let up on China or Iran or criminal syndicates while we’re focused on Russia,” Wray said.

At the Agencies

HHS ISSUES SPECIAL NEEDS GUIDANCE — The agency’s Health Resources and Services Administration on Wednesday released a national framework, “The Blueprint for Change,” aimed at care and equity for the roughly one in five American children with special health care needs.

The framework would press existing programs for those children to train a lens on health inequities and disparities and address administrative barriers to access.

Names in the News

Donald Yealy is the new editor-in-chief for the Annals of Emergency Medicine. Yealy, a professor and chair of the University of Pittsburgh’s Department of Emergency Medicine, has been with the journal for more than two decades and became a deputy editor in 2006.

Liz Goodman joins the Commonwealth Care Alliance as chief legal and public affairs officer. Goodman most recently was executive vice president of government affairs and innovation at America’s Health Insurance Plans.

Maureen Bartee has left the National Security Council, where she served as senior adviser and director for emerging biological threats in the global health security and biodefense directorate. Bartee, an epidemiologist, is returning to the CDC to work on global health, Daniel Lippman reports.

Chris Holt is now vice president of policy at the Alliance for Health Policy. He previously was director of health care policy at the American Action Forum.

 

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.

 
 
What We're Reading

In the wake of the Roe v. Wade draft opinion, reports have swirled that Native American tribes could provide safe havens for abortion care. But that’s unlikely to be a reality amid existing health barriers in the reservations, writesNational Journal’s Erin Durkin.

Ukraine is bracing for more losses, including amputations that will beset the health care and social care systems with new challenges amid the war,The New York Times’ Erika Solomon reports.

Babies born to vaccinated mothers were less likely to catch Covid-19 even amid the Omicron surge, according to a Norwegian study covered by MedPage Today’s Molly Walker.

 

A message from PhRMA:

According to data just released, insurance isn't working for too many patients. Despite paying premiums each month, Americans continue to face insurmountable affordability and access issues:

  • Roughly half (49%) of insured patients who take prescription medicines report facing insurance barriers like prior authorization and “fail first” when trying to access their medicines.
  • More than a third (35%) of insured Americans report spending more in out-of-pocket costs in the last 30 days than they could afford.
Americans need better coverage that puts patients first. Read more in PhRMA’s latest Patient Experience Survey.

 
 

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