Emergent tries to repair its image after J&J fiasco — Aides ask Trump to promote a new product: Covid shots — Government watchdog urges better pandemic planning

From: POLITICO Pulse - Tuesday Apr 20,2021 02:03 pm
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Quick Fix

— Emergent BioSolutions is pouring money into lobbying and ads amid growing scrutiny over a manufacturing mishap that wasted 15 million vaccine doses.

— Aides to former President Donald Trump are urging him to promote coronavirus vaccines, as some conservatives remain stalwart skeptics.

— The Government Accountability Office is faulting federal officials for the U.S.’ chaotic attempts to repatriate Americans in the early days of the Covid pandemic.

WELCOME TO TUESDAY PULSE. It’s fine that Pfizer recipients see themselves as elites; as part of the J&J crowd, we’re feeling right now like the limited-time-only, collector’s edition crew. As always, send tips to sowermohle@politico.com and Adam at acancryn@politico.com.

 

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America’s unique R&D ecosystem delivered multiple COVID-19 medical breakthroughs in record-breaking time. Instead of breaking what works, let’s work together to improve health care – for everyone. We support common-sense, patient-centered reforms to build a stronger, more resilient, affordable and equitable health care system. And we are ready to do our part. Learn more about our plan.

 
Driving the Day

EMERGENT TURNS TO IMAGE REPAIR The embattled contract manufacturer for Johnson & Johnson’s vaccines is spending big amid increasing scrutiny of its vaccine production.

The Maryland-based company dropped $1.47 million on federal lobbying in the first three months of the year, a jump from $900,000 at the end of 2020 and $700,000 in the third quarter. Emergent has spent more than $1 million on Capitol lobbying in the past — most notably in the first quarter of 2019, — but that was around the time that Emergent was lobbying the Trump administration to give control of the the Strategic National Stockpile over to an official that company executives were friendly with, as the Washington Post’s Robert O'Harrow Jr., Jon Swaine and Aaron C. Davis reported last year.

This latest spending surge comes alongside a digital ad campaign, including a slick commercial featuring the company’s Baltimore facility. An Emergent spokesperson declined to say how much they were spending.

But Emergent’s troubles keep coming. Federal regulators told the company last week to stop producing vaccine substance for J&J’s shot until officials finish inspecting the vaccine plant that was the site of a disastrous ingredient mix-up earlier this year.

The Food and Drug Administration on April 16 ordered Emergent to halt making the J&J vaccine's active ingredient and quarantine its existing vaccine stock until agency staff complete an inspection of the troubled plant and deliver their findings.

It’s not clear yet when Emergent could start making Covid shots again — and that’s just the latest hurdle for J&J, which is now dealing with its own potential safety concerns tied to reports of rare post-vaccine blood clots.

J&J promised 100 million shots by June, and while Emergent isn’t cleared to release doses yet, it had been expected to eventually play a significant role in hitting that target. Meanwhile, J&J also enlisted Merck to help with producing vaccine substance. But the facility that Merck intends to use, located in North Carolina, is not expected to begin actually manufacturing vaccine doses until the second half of this year.

 

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TRUMPWORLD FRUSTRATION FESTERS OVER VACCINES — Vaccine skepticism among Trump supporters is making aides question what the former president could have done — or can still do — to raise Republicans’ confidence in the science behind the Covid shot, write Joanne Kenen and Meridith McGraw.

Former aides and senior officials saw a pro-vaccine messaging effort as both politically beneficial to Trump and key to increasing the vaccination rate among conservatives, Joanne and Meridith report.

“If he spent the last 90 days being the voice — and taking credit because he deserved to for the vaccine — and helping get as many Americans get vaccinated as he could, he would be remembered for that,” said a former senior administration official.

And yet: As recently as Monday night, Trump appeared resistant to endorse the shots. In an appearance on Sean Hannity’s Fox News show, Trump cast further doubt on the utility of the J&J vaccine, saying the vaccine pause is “so stupid” and could be politically motivated.

But Trump’s followers are also among the most vaccine-resistant blocs of Americans, with one-third to nearly half of Trump supporters, white evangelicals or Republicans expressing vaccine hesitancy or antagonism in various polls.

Frustrated Trump aides had planned on Trump using his well-honed salesmanship to drive reluctant Americans to vaccine clinics. Two former administration officials said there were even talks of getting Trump vaccinated publicly, but there was skepticism that he’d be open to the idea.

“Someone joked and said, ‘Have you ever seen him wear a short sleeved shirt in public? I don’t think that’s going to happen,’” one of those officials said.

WATCHDOG GIVES SCATHING REVIEW OF WUHAN EVACUATION — Efforts the federal government to repatriate Americans from Wuhan, China and other regions in the early days of the coronavirus pandemic suffered from bureaucratic confusion that put those citizens at risk, the Government Accountability Office concluded in a report released Monday.

Roughly 1,100 U.S. nationals were repatriated and subsequently quarantined at the start of the pandemic. But HHS officials were inconsistent about safety measures like donning personal protective equipment, causing mix-ups about which agency was in charge of health and safety protocols at quarantine sites, GAO found. At one point, the report said, an HHS official told staff to remove their protective gear because it created “bad optics.”

A whistleblower laid out concerns about these early evacuation efforts last year, in a complaint first reported by the Washington Post’s Lena H. Sun and Yasmeen Abutaleb. The GAO advised HHS to include repatriation plans in future pandemic planning.

 

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Around the Agencies

FIRST IN PULSE: SENATORS URGE DEVICE TRACKING REVAMP — Sens. Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) are urging a panel that advises Medicare on medical forms to finalize a change that could make it easier to track the use of implantable devices like pacemakers and knee replacements.

What it is: The letter, addressed to the Accredited Standards Committee, or X12, asks the group to push for a rule requiring these products’ serial numbers in Medicare claims forms. They argue that such a regulation — first floated by X12 in October 2019 — would make it vastly easier to figure out which patients are affected when a device fails or is recalled, and would also help researchers study long-term outcomes.

Names in the News

Ninio Fetalvo is now an associate at Brunswick Group. Fetalvo was previously the director of strategic communications at CMS and also did a stint in the Trump White House.

Demetrios Kouzoukas has joined the board of Clover Health. He spent four years at CMS under the Trump administration as a principal deputy administrator and director of the agency’s Center for Medicare.

Elyse Petroni joins the Healthcare Distribution Alliance as vice president of communications and marketing. She was previously vice president of public affairs for the Advanced Medical Technology Association.

Rachel Pollock is now vice president at ACT for NIH Foundation , an organization to prioritize biomedical research. She previously was deputy director at the NIH Executive Secretariat.

 

A message from PhRMA:

America's unique R&D ecosystem allowed the biopharmaceutical industry to develop COVID-19 vaccines and treatments at unprecedented speed. As we continue our work to help end the pandemic – from researching variants to seeking additional therapeutics – we are committed to common sense policy changes that will improve our health care system for everyone.

We have a plan built on three key pillars to help our country reach that goal: from ending the pandemic and building a more resilient system to making medicines more affordable and creating a more just, equitable health care system. We are ready to do our part. Let’s work together to get it done. Learn more about our plan.

 
What We're Reading

Three organizations — the Children’s Defense Fund, Every Texan and Texans Care for Children — were at the heart of a CMS decision last week to rescind Texas’s Medicaid waiver, according to Eli Kirshbaum of State of Reform. The Washington Post’s Dan Diamond first reported the recission.

How South Korea’s success against the virus — including fewer than 2,000 deaths and no official lockdowns — started on a bumpy road, by Vox’s Dylan Scott and Jun Michael Park.

Scientists are working to cure the physical symptoms of long-haul Covid-19, yet many people are struggling with the emotional burden of the pandemic, “languishing” in “the void between depression and flourishing,” writes New York Times’ Adam Grant.

 

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