Overnight Health Care — Presented by The National Council for Mental Wellbeing — FDA panel advises Moderna booster shot for high-risk people

by Tristan Lejeune - 10/14/21 6:02 PM ET

Welcome to Thursday’s Overnight Health Care, where we’re following the latest moves on policy and news affecting your health. Subscribe here: digital-staging.thehill.com/newsletter-signup.

What’s the best way to get Moderna to share its vaccine with poor countries? According to Jimmy Kimmel, the U.S. should buy the formula, and then give it to McDonald’s. “Sharing is caring!”

An FDA advisory panel voted to recommend a booster dose of Moderna’s COVID-19 vaccine for the vulnerable, but was less than enthusiastic about the idea of boosters for all.

For The Hill, we’re Peter Sullivan (psullivan@digital-staging.thehill.com), Nathaniel Weixel (nweixel@digital-staging.thehill.com) and Justine Coleman (jcoleman@digital-staging.thehill.com). Write to us with tips and feedback, and follow us on Twitter: @PeterSullivan4, @NateWeixel and @JustineColeman8.

Let’s get started.

FDA panel recommends authorizing Moderna booster shot

A key Food and Drug Administration (FDA) panel on Thursday voted in favor of recommending booster doses of Moderna’s COVID-19 vaccine for a large swath of the population.

Members of the Vaccines and Related Biological Products Advisory Committee voted unanimously, 19-0.

The agency’s vaccine advisory committee said boosters should be recommended for people over 65, people between the ages of 18 and 64 who are at high risk of severe COVID-19, as well as people who are at risk of serious COVID-19 because of their jobs, or living situation.

That’s the same population who is eligible for a booster from Pfizer, and 60 million Americans qualified when the decision was made last month. Fewer people have received Moderna, but the eligible population will still be significant.

Broadly, panel members said they felt the company did not present enough robust evidence to justify a booster shot, but FDA had already set a precedent by authorizing boosters for the Pfizer vaccine.

Details: Moderna is asking for authorization of a half dose of 50 micrograms, rather than a full dose.

Moderna argued that the potency of its vaccine wanes over time, with neutralizing antibody levels dropping six to eight months after a second dose. FDA reviewers found that while a booster did increase antibody levels, it wasn’t clear whether the protection of the initial vaccination had dropped substantially.

The vaccine offers robust protection against severe disease at least five months after initial dosing, but less against mild to moderate infections.

Not for everyone: Following the vote, panelists made it clear that while they voted in favor of boosters for the vulnerable, they were not comfortable with the possibility of widespread availability for either Pfizer or Moderna boosters — even though that was the Biden administration’s initial intention.

Next step: A final agency decision on Moderna boosters could come within days. A Centers for Disease Control and Prevention vaccine advisory committee is expected to vote on the proposal next week. The panel will meet again Friday to vote on Johnson & Johnson boosters and to discuss mixing and matching different vaccine boosters.

Read more here.

A MESSAGE FROM THE NATIONAL COUNCIL FOR MENTAL WELLBEING

This is our chance to expand access to care. Join us on October 19 for Hill Day at Home – the largest mental health and substance use advocacy event of the year. Learn more.

UPCOMING: FDA ADVISORY PANEL TO DISCUSS MERCK COVID-19 ANTIVIRAL PILL

The Food and Drug Administration (FDA) scheduled a meeting for late next month for its advisory panel to discuss Merck’s antiviral pill designed to treat mild-to-moderate COVID-19.

The federal agency announced on Thursday that the advisory committee will meet on Nov. 30 to review data on molnupiravir. If approved, the oral pill would be given to adults who recently tested positive for COVID-19 and are at high risk of severe illness, hospitalization and death.

Merck applied for an emergency use authorization for the drug, developed with Ridgeback Biotherapeutics, earlier this week after trials showed it reduced the risk of hospitalization by 50 percent.

Significance: The five-day oral treatment could be a game changer in the U.S.’s fight against the virus, potentially getting the country closer to the light at the end of the tunnel in the pandemic, experts have said.

The U.S. government has agreed to purchase 1.7 million doses of Merck’s treatment if the FDA grants it emergency use authorization, although former FDA Commissioner Scott Gottlieb said that amount is “not enough.”

Read more here.

Biden likely to tap Robert Califf to return as FDA head

President Biden is expected to nominate Robert Califf to lead the Food and Drug Administration (FDA), multiple sources familiar with the deliberations said Thursday.

Califf previously held the role of FDA commissioner during the Obama administration, where he served for less than a year.

One source said the pick was not fully finalized amid back and forth with Califf about the job, but he is the likely choice.

A second said that the nomination is expected, calling Califf the favorite, but noted that the decision is not firm yet.

Under federal law, Biden faces a Nov. 15 deadline to pick a leader for the agency or nominate the current acting commissioner, Janet Woodcock.

Woodcock has been leading the FDA since Biden was elected, but key Democrats have indicated they would not support her nomination because of what they view as her role in failing to control the opioid epidemic, and her ties to the pharmaceutical industry.

Baggage? The White House has stressed it wants its choice for the critical position to be someone with a smooth path to Senate confirmation, and it believes it has found that candidate in Califf. He was confirmed by a vote of 89-4 in 2016.

Senators at the time expressed concerns that he was too close to industry, because he had served as a consultant to drug and device firms.

Since he left the agency, Califf advised Google Health and later ran health policy at its spinoff, Verily Life Sciences. He is currently a professor of cardiology at Duke University School of Medicine.

Senators also expressed concern over opioids, but the opposition was focused more on the FDA’s role in regulating them as a whole than Califf specifically.

Challenges ahead: Califf would take the helm of an agency that has not had a confirmed leader since Biden took office in January. The FDA is in charge of leading the nation through the eventual end of the COVID-19 pandemic, and it faces key decisions in authorizing COVID-19 booster shots and vaccines for children.

Read more here.

Biden touts progress but warns US in ‘critical period’ as millions remain unvaccinated

President Biden touted the United States’ progress in the pandemic in a Thursday address but cautioned the country is in a “critical period” as millions of Americans remain unvaccinated.

In his speech, Biden expressed optimism about the momentum the U.S. has made against COVID-19, citing nationwide drops in cases and hospitalizations, but called on businesses to “step up” and back his vaccine requirements.

“My team and I are doing everything we can,” he said. “I’m calling on more businesses to step up. I’m calling more parents to get their children vaccinated, when they are eligible. And I’m asking everyone, everyone who hasn’t gotten vaccinated, please get vaccinated. That’s how we put this pandemic behind us.”

Focus on unvaccinated: Biden specifically cited the decrease of unvaccinated people from almost 100 million in July to about 66 million, he said, although noting that’s “still unacceptably high.”

“That’s important progress, but … now’s not the time to let up,” he said. “We have a lot more to do. We’re in a very critical period as we work to turn the corner on COVID-19.”

Biden called it “essential” to give doses to the unvaccinated and praised vaccine requirements, saying they are “working” and “should not be another issue that divides us.”

Read more here.

A MESSAGE FROM THE NATIONAL COUNCIL FOR MENTAL WELLBEING

This is our chance to expand access to care. Join us on October 19 for Hill Day at Home – the largest mental health and substance use advocacy event of the year. Learn more.

HOUSE DEMS PUSH FOR HEALTH PRIORITIES IN SOCIAL SPENDING PACKAGE

The House Democratic Caucus Task Force on Aging and Families is calling for a “significant investment” in at-home care for seniors, as well as Medicare negotiation to lower drug prices and paid family and medical leave to be included in Democrats’ Build Back Better package.

The focus on care for seniors and people with disabilities, known as Home and Community Based Services, comes as the provision could face cuts as Democrats look for ways to pare down the overall size of the package.

“As discussions for the Build Back Better Act continue, we urge you to include the highest possible level of funding for Medicaid home and community-based services,” the letter to congressional leadership and President Biden states.

The letter was signed by Reps. Jan Schakowsky (D-Ill.), Doris Matsui (D-Calif.), Conor Lamb (D-Pa.), Debbie Dingell (D-Mich.), Ayanna Pressley (D-Mass.) and Ted Deutch (D-Fla.).

It also calls for “expansive and effective” Medicare negotiation to lower drug prices, as lawmakers debate the scale of that provision given concerns from some moderates about going too far.

Read the letter here.

WHAT WE’RE READING

How the hunt for this deadly virus shaped the search for coronavirus’s origins (The Washington Post)
‘Lurching between crisis and complacency’: Was this our last Covid surge? (The New York Times)
Covid testing, turnaround times are still uneven this far into pandemic (Kaiser Health News)
Confusion clouds FDA’s approach to e-cigarettes (Politico)

STATE BY STATE

Michigan governor orders urgent response to lead crisis (The Associated Press)
Oregon Health Authority punts question of how to ration care in a crisis (Oregon Public Broadcasting)
Connecticut faces an ‘overwhelming’ pandemic induced crisis in pediatric mental health care. Here’s what experts say the legislature should do. (Hartford Courant)