Booster shot debates are here — J&J preps for teen vaccine studies — FEMA changes Covid-19 aid policy

From: POLITICO Pulse - Thursday Jul 01,2021 03:00 pm

Jul 01, 2021

Presented by

With Katherine Foley and Alice Miranda Ollstein

PROGRAMMING NOTE: Morning PULSE will not publish on Monday, July 5. We'll be back on our normal schedule on Tuesday, July 6.

Quick Fix

— Theoretical discussions about Covid-19 boosters are becoming a reality as countries move into action for winter vaccines.

— J&J is slated to begin four vaccine studies in children, but unlikely to chip in by fall for mass back-to-school vaccination efforts.

— FEMA is softening rules for Covid-19 funeral assistance after mourning families argued it was impossible to prove early cases.

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Driving the Day

DELTA VARIANT RENEWS BOOSTER CONCERNS — With the Delta variant quickly spreading, scientific discussions about when and how to roll out Covid-19 booster shots are kicking into overdrive — and some countries are already planning for the possibility.

The U.K.’s vaccine committee Wednesday advised the government to prepare to start vaccinating vulnerable people with a third shot in September, potentially alongside flu shots, in a bid to protect them through the winter, Politico Europe’s Helen Collis reports.

In the U.S., top health officials are doubling down on the message that if you’re are vaccinated, you’re are safe, even with existing strains. “We have no information to suggest that you need a second shot after J&J, even with the Delta variant,” CDC Director Rochelle Walensky told the Today show’s Savannah Guthrie, referring to some concerns that immunity from J&J’s single-dose vaccine could wear down before others. There is no evidence as of yet to suggest when immunity from the J&J vaccine (or the others) could begin to fade.

But scientists are openly wondering whether the U.S. should begin preparing the booster message, especially with vaccine-hesitant people. “Scientifically, it would make sense that getting a second dose of an mRNA vaccine could boost the immune response for those who got the one-dose J&J vaccine,” Leana Wen, an emergency physician and public health professor at George Washington University, told our Prescription Pulse colleagues (who did a great deep dive on the topic earlier this week.)

The backdrop: Delta variant cases in the U.S. doubled last month and now account for roughly 20 percent of U.S. cases, while experts project that a quarter of global cases are from the more contagious and severe strain first found in India. Anthony Fauci last week called the Delta variant the “greatest threat” to reopening the U.S.

J&J PREPS FOR VACCINE STUDIES IN CHILDREN — The single-dose Covid-19 vaccine manufacturer announced plans Wednesday to conduct four separate clinical trials in children from under 2 months old to 17 years.

J&J is working with the FDA and other regulators to design each of these trials, starting with one including 12- to 17-year-olds, Katherine Ellen Foley writes. The studies spring off of promising data from safety trials that showed that 16- and 17-year-olds tolerated the vaccine well and developed antibody protection, Macaya Douoguih, the head of clinical development and medical affairs for Johnson & Johnson's vaccine branch Janssen, told listeners in a Johns Hopkins and University of Washington webinar.

Data from those trials will be made public "in the near future," she said.

Reality check: Those vaccines likely won’t be cleared for kids anytime soon. At the same event, FDA vaccine chief Peter Marks said at the same event that health officials are likely to rely on Pfizer and Moderna vaccines through the fall because of how long it takes to collect data.

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FEMA CHANGES FUNERAL-AID RULES AFTER BLOWBACK — The agency changed its pandemic funeral assistance policy to allow reimbursement for lost family members even if the certificate doesn’t specifically identify Covid-19 as the cause of death, Erin Banco reports.

The update comes after months of talks with the CDC, Sen. Chuck Schumer and Rep. Alexandria Ocasio-Cortez (D-N.Y.) about how to make it easier for people to apply.

The change could assist thousands of people whose relatives died early in the pandemic, before reliable testing was commonplace, to access the funeral-aid program — the largest FEMA has ever run. The agency had struggled to find a balance between helping people in need and warding off potential scammers, Erin writes.

Under the new rules, families don’t need to get death certificates amended — something medical examiners are loath to do without definitive proof — but they do need a signed letter from those examiners linking the death to the virus.

RARE COMMON GROUND: LAWMAKERS LOOK TO KEEP VIRTUAL CARE — Congress is poised to let millions of Medicare recipients continue to video chat with their doctors after the pandemic by making pandemic-era telemedicine policies permanent, Ben Leonard writes.

The telehealth measures — which would make payments easier to a range of doctors, especially in rural areas — are an unexpected bipartisan rallying point. Yet telehealth lobbyists so far have failed to get extensions into Covid relief packages, partly because of concern over how they could drive up health spending and potentially invite fraud.

From apathy to enthusiasm: A Senate plan, S. 1512 (117) , by Brian Schatz (D-Hawaii) that would permanently enshrine many of the measures has attracted 59 co-sponsors, while private insurers are also moving to broaden coverage.

“We've gone from the point where if I talked about telehealth to someone their eyes would start to glaze over,” Schatz said. “Now when I start to talk about telehealth, their head nods vigorously up and down.”

Except: Skeptics warn a rapid expansion of telehealth could trigger a surge of new health spending. Watchdogs warn that health care fraud could rise: the HHS Office of Inspector General estimates $4.5 billion of telehealth-related fraud last year.

In Congress

PROGRESSIVE GROUP HITS SENATE MODERATES WITH DRUG-PRICING ADS — Patients For Affordable Drugs Now is out with a new six-figure ad campaign to pressure moderate Democrats in the Senate who haven’t yet endorsed Finance Chair Ron Wyden’s plan to empower Medicare to negotiate drug prices.

The ads target Sens. Michael Bennet (D-Col.), Tom Carper (D-Del.), Bob Menendez (D-N.J.) and Bob Casey (D-Penn.), lawmakers who have long been friendly to the pharmaceutical industry and have expressed reservations about price reforms, Alice Miranda Ollstein writes.

COALITION PRESSES CONGRESS FOR BIOSIMILAR REFORM — More than two dozen patient and provider organizations penned a letter to lawmakers this week voicing support for the BIOSIM Act, H.R. 2815, a bill that would boost reimbursements for biosimilars.

The measure, sponsored by Reps. Kurt Schrader (D-Ore.) and Adam Kinzinger (R-Ill.), is aimed at incentivizing prescriptions for lower-cost versions of expensive biologics. “Misaligned financial incentives within the Medicare program continue to encourage the use of high-cost brand biologics even when a lower-cost biosimilar medicine is available,” wrote the groups, which include advocacy organizations for people with asthma, lupus and arthritis.

Around the Nation

DRUG COMPANIES, DISTRIBUTORS HIT BACK IN OPIOID TRIAL — Drug companies and distributors fought back against allegations that they helped fuel the opioid epidemic Wednesday as they began their rebuttals in the first jury trial to target major corporations in the opioid supply chain, our Shannon Young writes.

Attorneys representing the defendants — including Teva, Allergan, Endo Pharmaceuticals, McKesson and their affiliates — urged jurors in a New York court to examine each defendant’s alleged actions and refrain from looking at them as a monolith.

Among the various arguments, Allergan’s lawyer argued that his clients were “too little, too late to have caused or contributed to any kind of issue or problem with regard to addiction in the communities.”

What’s next: The trial, which state Supreme Court Justice Jerry Garguilo is presiding over, will resume opening statement this morning. The trial is expected to last at least six weeks.

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Around the Agencies

BIDEN SIGNS MENTAL HEALTH LAW FOR VETS — The president on Wednesday signed into law the Sgt. Ketchum Rural Veterans Mental Health Act of 2021, which requires Veterans Affairs to expand rural access to mental health care.

What We're Reading

Long-haul Covid-19 is “our next public health disaster in the making,” Steven Phillips and Michelle Williams write in the New England Journal of Medicine.

The Biden administration's efforts to distribute 80 million coronavirus vaccines worldwide have been stymied by a series of bureaucratic hurdles , Noah Weiland writes for The New York Times.

Providers are diagnosing more advanced cancers and other diseases after the pandemic put a pause on routine screenings and treatments, Modern Healthcare reports.

A message from UnitedHealth Group:

UnitedHealth Group believes that all individuals should have access to high-quality, affordable health care that meets their unique needs. We are committed to advancing health equity by delivering personalized care, building a diverse health workforce, improving the health of underserved communities and providing insights and analyses to address disparities in care. Learn more about our commitment to sustainability in our recently released 2020 Sustainability Report.