Morning Consult Health Presented by the Better Medicare Alliance: FDA Review Declines to Take Position on Need for Moderna Booster Shot


Essential health care industry news & intel to start your day.
October 13, 2021
Twitter Email

New Data: Where the Public Stands on COVID-19 Booster Shots

With the COVID-19 booster shot rollout well underway, new Morning Consult polling indicates 10 percent of vaccinated adults have already gotten an extra dose — and many more could join them if regulators clear boosters of Moderna Inc. and Johnson & Johnson’s vaccines. An advisory group meets tomorrow and Friday to set off that process.


If the extra doses are authorized, we’ll be keeping an eye on whether booster eligibility for Moderna and J&J will mirror the guidance for Pfizer Inc.-BioNTech SE’s vaccine, which wasn’t quite as broad as the Biden administration had hoped. We’ve got more data and details — check it out.


Top Stories

  • The Food and Drug Administration stayed neutral on whether booster shots are needed for Moderna Inc.’s COVID-19 vaccine, according to documents released ahead of an advisory meeting tomorrow. Moderna is asking regulators to authorize another half-dose of its shot in order to bolster protection against mild and moderate illness, and the FDA’s data review suggests the third dose increases antibody levels when given at least six months after the second shot. (The New York Times)
  • The Centers for Medicare and Medicaid Services approved Colorado’s request to require individual and small-group health plans to cover gender-affirming care for transgender patients beginning in 2023, a first for the federal government under a Trump-era policy that grants states more flexibility with their Obamacare exchanges. CMS Administrator Chiquita Brooks-LaSure said she hopes “that other states look to Colorado as a model” and “follow suit.” (The Washington Post)
  • The FDA authorized an e-cigarette for the first time, saying the Vuse Solo vape from Reynolds American Inc. can help smokers curb their use of traditional cigarettes, a move that comes after a major review of which vaping products should be allowed to remain on the market. The FDA said it rejected another 10 requests for flavored products from Vuse, the No. 2 e-cigarette brand in the United States behind Juul Labs Inc. (The Associated Press)
  • The Biden administration moved forward with its plan to require roughly 80 million private-sector workers to get a COVID-19 vaccine, with the Occupational Safety and Health Administration submitting the initial text of the rule to the White House for approval. The Labor Department’s announcement came shortly after Texas Gov. Greg Abbott (R) banned businesses and private groups from requiring that their employees get vaccinated. (The Wall Street Journal)

Chart Review


Events Calendar (All Times Local)


What Else You Need to Know


Biden lifting land border travel restrictions for fully vaccinated

Stef W. Kight, Axios

The Biden administration will open up U.S. land borders with Canada and Mexico to non-essential travel starting in November — but only to those fully vaccinated against COVID-19.


W.H.O. Will Announce New Team to Study Coronavirus Origins

Benjamin Mueller, The New York Times

“This new group can do all the fancy footwork it wants, but China’s not going to cooperate,” one expert said.


J&J booster confusion ahead

Caitlin Owens, Axios

Data collected by the National Institutes of Health show that people who received a shot of Johnson & Johnson’s coronavirus vaccine have a stronger neutralizing antibody response if they receive an mRNA shot instead of a second J&J one, according to a person who has seen the data.


Philip Morris-backed group to launch first plant-based Covid vaccine

Kana Inagaki, Financial Times

A unit of a Japanese company backed by Philip Morris International is planning to launch the world’s first plant-based Covid-19 vaccine that is potentially cheaper and easier to transport and store than conventional jabs.


WHO backs extra jab for Chinese-made vaccines, despite resistance to coronavirus boosters over supply strain

Adam Taylor, The Washington Post

When the World Health Organization gave its backing to two coronavirus vaccines produced by Chinese companies early this year, global health experts greeted the move as a much-needed boost to international vaccine supply.


Harvard Immunologist Champions At-Home Covid Tests to Beat the Pandemic

Emma Court and Jason Gale, Bloomberg Businessweek

Michael Mina says the U.S. should be following in the footsteps of Germany and the U.K. in making low-cost, rapid tests readily available to consumers.


Southwest, American airlines workers will have to get vaccinated, despite Texas order

Oriana Pawlyk, Politico

Texas Gov. Greg Abbott on Monday signed a sweeping order effectively banning vaccine mandates for private businesses with 100 or more employees.


Vaccines Could Have Spared 22,000 Lives in Texas and Florida

Augusta Saraiva, Bloomberg

More than 22,000 lives could have been spared in Texas and Florida, states where governors have spoken out against mask and vaccine mandates, if they had vaccinated three-quarters of their adult populations.


Why Some Nations Have Deadlier Outbreaks With the Same Vaccines

Jinshan Hong et al., Bloomberg

While it’s clear vaccines led to a drop in fatalities during the most recent delta variant-driven waves compared with earlier bouts with the virus, some countries saw deaths fall to a greater degree than others, an outcome scientists still don’t have answers for.


Divided Supreme Court considers who can defend abortion restrictions

Alice Miranda Ollstein, Politico

A divided Supreme Court on Tuesday weighed which state officials can defend abortion bans in court — a procedural question with implications that extend beyond reproductive health in states where the governor and attorney general hail from opposing parties.


Democrats Debate Eligibility for Reconciliation Bill’s New Social Programs

Andrew Duehren, The Wall Street Journal

Choosing which Americans should be eligible for benefits in a proposed expansion of the social-safety net is one of the main challenges vexing Democrats, who are attempting to slim down their healthcare, education, child-care and climate bill in the coming weeks.


New FDA guidance aims to drastically cut salt in food supply

Erika Edwards, NBC News

The recommendations are intended to cut rates of heart disease, the No. 1 killer in the U.S.


New Medicare Benefits Must Stay in Biden Bill, Progressives Say

Alex Ruoff, Bloomberg Law

New vision, dental, and hearing benefits under Medicare must be included in Democrats’ social spending package if it’s going to win support from progressives, two vocal lawmakers said Tuesday.


Democrats Eye Medicare Managed-Care Plans to Fund New Benefits

Tony Pugh, Bloomberg Law

Medicare managed-care plans say they’ll have to increase premiums and reduce benefit offerings if Democrats cut their program reimbursements to help pay for new dental, vision, and hearing benefits in traditional Medicare.


The Hunt for the Riskiest, Most Lucrative Patients

John Tozzi, Bloomberg Businessweek

Privately run Medicare Advantage programs are squeezing money from the Medicare risk-adjustment system by coding sicknesses for maximum payout.


BCBS CEOs received bigger raises in 2020 than execs at for-profit insurers, report says

Nona Tepper, Modern Healthcare

The CEOs of Blue Cross and Blue Shield insurers received larger compensation increases in 2020 compared with their for-profit counterparts, a recent report found.


AmeriHealth Caritas enters ACA exchange as Medicaid redeterminations loom

Nona Tepper, Modern Healthcare

Medicare and Medicaid managed-care provider AmeriHealth Caritas will enter the Affordable Care Act exchange market in 2022, the Philadelphia-based insurer said Tuesday.


Concerns grow over home health care as Democrats debate funding

Lauren Clason, Roll Call

Advocates are concerned that a proposed boost to Medicaid and home health care for the elderly and disabled in Democrats’ $3.5 trillion budget bill will be pared back so much that it wouldn’t deliver on its promise to increase jobs and wages.


Physicians Press Lawmakers to Forestall Medicare Payment Cuts

Tony Pugh, Bloomberg Law

Physician groups on Tuesday called for congressional action by year’s end to stop a series of potential Medicare payment cuts from taking effect in 2022.

Pharma, Biotech and Devices

Older Adults Shouldn’t Take Aspirin in Effort to Prevent First Heart Attack, Panel Says

Brianna Abbott, The Wall Street Journal

People in their 60s or older shouldn’t take aspirin to prevent a first heart attack or stroke because risks likely cancel out the potential benefits, according to a government-backed panel of medical experts.


Covid success of mRNA vaccines opens way to a new generation of drugs

Nikou Asgari, Financial Times

Personalised cancer treatments are among those being developed using a technology once distrusted by big pharma.


Bristol-Myers Is Said to Have Weighed Offer for Acceleron

Michelle F Davis, Bloomberg

Acceleron Pharma Inc. engaged with several companies including Bristol-Myers Squibb Co. to gauge their interest in a potential acquisition before Merck & Co. agreed to buy the company for $11.5 billion in the biggest biotechnology deal of 2021, according to a person familiar with the matter.


Axial Therapeutics Grabs $37.3 Million for Autism Clinical Trials With Teens

Brian Gormley, The Wall Street Journal

Biotechnology startup Axial Therapeutics Inc. has raised $37.3 million in new venture capital to run clinical trials of a medication designed to help children with autism who exhibit serious mood swings and aggressive behavior.


New data on CRISPR Therapeutics’ off-the-shelf CAR-T cancer therapy shows more remissions, no major safety issues

Adam Feuerstein, Stat News

More of the cancer patients who received CRISPR Therapeutics’ experimental, off-the-shelf CAR-T cell therapy showed complete remissions compared to the drug’s initial study results, according to a company update Tuesday. Some of the remissions are lasting six months or more, an important measure of durability.

Health Technology

Apple Studying Potential of AirPods as Health Device

Rolfe Winkler, The Wall Street Journal

Apple Inc. is studying ways to make AirPods into a health device, including for enhancing hearing, reading body temperature and monitoring posture, according to documents reviewed by The Wall Street Journal and people familiar with the plans.


Big Health scores a novel deal to bring its digital therapeutics to an entire country

Mario Aguilar, Stat News

Part of the allure of software-based medical treatments is the possibility of reaching people in need at scale. And there’s no scale as compelling as absolutely everyone.


Best Buy ramps up focus on home health care by acquiring Current Health

Heather Landi, Fierce Healthcare

Current Health provides an enterprise remote care management platform that combines connected health devices, telehealth and patient engagement into a single solution for healthcare organizations.

Opinions, Editorials and Perspectives

Drug Companies Say We Can Have Innovation or Lower Prices. That’s a False Choice.

Ezekiel Emanuel, Politico

The debate in Congress over negotiating drug prices is based on a phony premise that higher prices are needed to fund pharmaceutical R&D.

Do NOT follow this link or you will be banned from the site!