HEALTH CARE BRIEFING: FDA Authorizes Booster Shots for Elderly

By Brandon Lee

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People over age 65 and those at high risk of severe Covid-19 can receive a booster dose of the Pfizer-BioNTech vaccine, the Food and Drug Administration said, opening a new and more controversial phase of the U.S. immunization campaign.

The emergency-use authorization also allows boosters for people 18 and older whose occupational exposure to the SARS-CoV-2 virus puts them at elevated risk of serious complications. Booster doses can be given any time at least six months after a person received their second shot, the FDA said in a statement.

Acting FDA Commissioner Janet Woodcock said the authorization would allow people such as teachers and day-care staff, as well as health-care and grocery workers, to get the third shot.

The authorization applies only to the Pfizer-BioNTech shot, the agency said.

While less broad than some had hoped, the authorization leaves the door open for the FDA to consider broader use of boosters, including in younger adults, as more data on their safety and efficacy become available. And it assures that many of the older Americans who were first in line for the initial shots will be among the earliest to get additional protection. Read more from Robert Langreth and Josh Wingrove.

Happening on the Hill

Sanders Proposes $1,000 for Seniors in Budget Bill: Seniors could get $1,000 loaded onto a debit card for dental visits, hearing aides or eye glasses, under a plan from Sen. Bernie Sanders (I-Vt.). The debit cards, which Sanders has called vouchers, would be means-tested for Medicare beneficiaries. The funds would be available to individuals making less than $75,000 per year and families with incomes under $150,000, similar to the rules used for stimulus funds during the pandemic.

The money would be given out to seniors before planned new benefits can be rolled out, Sanders said. That would ensure people in Medicare can pay for health services sooner than the government can offer them as a central part of the public health program. He wants to tack the funding onto Democrats’ reconciliation bill, through which lawmakers want to expand Medicare. Read more from Alex Ruoff.

  • Also in the House’s reconciliation bill is $3 billion to establish the Advanced Research Projects Agency for Health. Yesterday, National Institutes of Health Director Francis Collins offered an ambitious timeline to stand up the agency, which would be an incubator for biomedical discoveries. Speaking at the Rally for Medical Research, Collins said he’s hoping that “we can see this also get launched in the course of the next few months,” Jeannie Baumann reports.
  • Related: Biden Battles for Budget Deal in Face of Democratic Infighting

More on the Pandemic

Biden Calls On Rich Nations to Hasten Vaccine Donations: Biden called on other nations to help vastly expand production of coronavirus vaccines and therapies in order to end the Covid-19 pandemic in a virtual summit he held yesterday. Biden said the U.S. will buy another 500 million doses of Pfizer-BioNTech’s vaccine for donation abroad, pushing the total U.S. donation pledge beyond 1.1 billion doses. The Pfizer shots will be produced in the U.S. and be shipped through Covax, the global vaccine sharing system, to low-income and lower-middle-income countries, beginning in January and running through next September. Josh Wingrove has more.

Alaska Joins Idaho in Rationing Health Care: Alaska became the second place in the U.S. to activate statewide crisis standards of care, as a surge in Covid-19 patients strains hospital capacity in parts of the country that have resisted vaccination the most. Idaho last week extended health care rationing statewide as authorities there said they didn’t have enough resources to adequately treat patients in its hospitals. Some Montana health providers have done the same. A common thread in all three states? Less than half the population has been fully vaccinated, according to data compiled by Bloomberg. That’s also well below the U.S. national average for full vaccination, about 55%. Read more from Derek Wallbank.

Vaccinated Pregnant Women Pass Protection to Babies: Pregnant women who get mRNA vaccines pass high levels of antibodies to their babies, according to a study published in American Journal of Obstetrics & Gynecology – Maternal Fetal Medicine yesterday. The study—one of the first to measure antibody levels in umbilical cord blood to distinguish whether immunity is from infection or vaccines—found that 36 newborns tested at birth all had antibodies to protect against Covid-19 after their mothers were vaccinated with shots from Pfizer-BioNTech or Moderna. Read more from Anushree Dave.

Gilead’s Remdesivir Averts Hospitalization in Study: Early treatment with Gilead Sciences’ remdesivir kept higher-risk Covid-19 patients out of the hospital in a late-stage international trial that supports administering the medicine to individuals recovering at home. A three-day course of the injectable antiviral, also known as Veklury, was associated with an 87% drop in hospitalizations in a randomized, placebo-controlled trial with 562 patients, the drugmaker said in a release yesterday. Read more from Jason Gale.

When Is Covid-19 a Disability?: Several cases percolating in courts are testing a gray area over coronavirus’s interplay with the federal disability bias law. The Biden administration has guidance about how “long-haul” Covid-19 symptoms may qualify as a disability. However, whether the ADA also protects workers who contract the virus—prior to the onset of long-term symptoms—remains an open question. Read more from Erin Mulvaney.

Births Are Back on Rise After Pandemic Slump: Births have bottomed out in some states earlier this year, suggesting Americans were more optimistic about starting a family after the depths of the pandemic in 2020. The number of births in Arizona, California, Connecticut, Florida, Hawaii, Iowa, Ohio and Oregon hit their lowest since at least 2018 around February, reflecting the decrease in babies conceived during the lockdown restrictions of 2020, state health departments show. Molly Smith and Alex Tanzi have more.

More Headlines:

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What Else to Know Today

Drugmakers Referred to HHS Office Over Discount Policy: The Health Resources and Services Administration said yesterday it reported six drugmakers to an HHS watchdog agency for limiting product discounts in a program geared for low-income people, claiming the companies are running afoul of government policy. Lilly, Novartis, and Novo Nordisk are among the companies that HRSA called out for their “continued refusal to comply” with statutory obligations under the 340B program. Ian Lopez has more.

Hospitals Concerned About Surprise Billing Networks: The White House’s first rule implementing a landmark 2020 law aimed at protecting patients against costly hospital and doctor bills in emergencies and other situations will lower costs for patients, a group that represents large employers said. But hospitals say they are worried the No Surprises Act’s rules won’t get at the real problem driving high bills—inadequate health-care networks—and also worry about its Jan. 1 deadline. Sara Hansard has more.

Florida Proposal Would Ban Most Abortions, Mimicking Texas: A Florida legislator has proposed banning most abortions in the state and allowing lawsuits against doctors who violate it, mirroring a law that recently enacted in Texas. The bill, proposed by state Representative Webster Barnaby, a Republican, would require doctors in Florida to perform tests to determine if a fetus has a detectable heartbeat before performing an abortion. Read more from Michael Smith and Jonathan Levin.

Meth-Related Deaths Almost Triple, NIH Finds: Deaths linked to methamphetamine overdoses nearly tripled in recent years, indicating the public health crisis of substance misuse that takes tens of thousands of lives in the U.S. annually extends beyond opioids. A study released yesterday in JAMA Psychiatry found the number of overdose deaths involving psychostimulants other than cocaine—largely meth— rose 180% from 5,526 in 2015 to 15,489 in 2019. Meth use grew by 43%, Jeannie Baumann reports.

Greater Scrutiny Pushed for Medicare Advantage: A government watchdog agency is calling for greater oversight of 20 private Medicare Advantage plans that received a disproportionate share of $9.2 billion in enhanced payments in 2016 that were based on suspicious patient diagnoses. The HHS Office of Inspector General’s report follows a similar OIG report last year that called on the Medicare program to tighten oversight of Medicare Advantage payments based on health risk assessments. Tony Pugh has more.

Health Issues in the Courts:

More in Industry & Regulation:

With assistance from Jeannie Baumann

To contact the reporter on this story: Brandon Lee in Washington at blee@bgov.com

To contact the editors responsible for this story: Zachary Sherwood at zsherwood@bgov.com; Giuseppe Macri at gmacri@bgov.com; Michaela Ross at mross@bgov.com

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