Overnight Health Care — Presented by March of Dimes — FDA advisers back first at-home COVID-19 pill
Welcome to Tuesday's Overnight Health Care, where we're following the latest moves on policy and news affecting your health. Subscribe here: thehill.com/newsletter-signup.
Tomorrow, Roe v. Wade will hang in the balance as the Supreme Court hears arguments on Mississippi's 15-week abortion ban. Read our colleague John Kruzel's preview here.
On the COVID-19 front, FDA advisers backed a treatment from Merck, but only narrowly. The vote came as experts work to determine how effective existing vaccines are against the new omicron variant of the virus.
For The Hill, we're Peter Sullivan (psullivan@thehill.com), Nathaniel Weixel (nweixel@thehill.com) and Justine Coleman (jcoleman@thehill.com). Write to us with tips and feedback, and follow us on Twitter: @PeterSullivan4, @NateWeixel and @JustineColeman8.
Let's get started.
FDA advisers endorse Merck COVID-19 pill
An advisory group for the Food and Drug Administration (FDA) narrowly voted to recommend Merck's COVID-19 antiviral pill for infected adults at high risk for severe coronavirus illness, hospitalization or death.
The panel endorsed Merck's five-day oral treatment in a 13-10 vote on Tuesday.
The advisers recommended the FDA authorize the pill, developed with Ridgeback Biotherapeutics, for adult patients enduring mild-to-moderate COVID-19 who face a higher risk of serious illness, including due to underlying health conditions.
Split vote: The close vote came as experts considered concerns about updated data showing the pill linked to a 30 percent reduction in hospitalizations, a decrease in effectiveness from previous research.
Advisers also discussed the potential risks the drug could present for pregnant people and worries that the treatment could spark the virus to mutate into a more dangerous strain.
But several who backed the pill for high-risk infected adults pointed to the ongoing state of emergency amid COVID-19 and the limited treatments for the virus.
Significance: Antiviral COVID-19 drugs have been considered a potential game changer in the pandemic, since all current drugs require an injection or IV.
Approval of these pills could expand accessibility with at-home COVID-19 treatments, pending FDA authorization and Centers for Disease Control and Prevention (CDC) approval.
A MESSAGE FROM MARCH OF DIMES
The U.S. remains among the most dangerous developed nations for childbirth. Help prioritize the health of our nation's moms and babies by joining the #BlanketChange movement today at BlanketChange.org.
REGENERON SAYS ITS ANTIBODY TREATMENT 'MAY BE' LESS EFFECTIVE AGAINST OMICRON
Regeneron said Tuesday that its COVID-19 antibody treatment "may be" less effective against the new omicron variant, though tests are ongoing.
Big picture: The statement shows how the new variant is shaking up the response to COVID-19, though there is still much that is unknown. Experts worry that the current vaccines could also be less effective against the omicron variant, though that has not been confirmed and it is likely some effectiveness will still be maintained.
Regeneron said in a statement that preliminary analyses "indicate that there may be reduced neutralization activity" from its antibody treatment.
"Further analyses are ongoing to confirm and quantify this potential impact using the actual Omicron variant sequence," the company added.
The company added that research is ongoing on other antibody formulations that could maintain effectiveness against the new variant.
On the other hand, Pfizer's pill could still work well: On a separate treatment front, Pfizer CEO Albert Bourla said Monday that he has a "high level of confidence" that the company's antiviral treatment will still be effective against the omicron variant.
Pfizer's treatment is in pill form, which could make it easier to administer, while the Regeneron treatment requires infusion.
BioNTech co-founder: Vaccinated unlikely to become seriously ill from omicron
BioNTech co-founder Ugur Sahin said in an interview published Tuesday that while the omicron variant may result in more breakthrough cases of COVID-19, most vaccinated individuals who contract the strain will likely experience mild illness.
Speaking to The Wall Street Journal, Sahin said, "Our message is: Don't freak out, the plan remains the same: Speed up the administration of a third booster shot."
Although no studies on the new variant have been released yet, Sahin said he believed vaccinated people will still be protected from severe illness based on how the vaccine he helped develop has protected against past variants that are more contagious.
As an example, Sahin pointed to the delta variant. It has been shown to infect vaccinated individuals at a higher rate than previous strains, but immunized people have still been shown to be protected against severe cases of the coronavirus.
BioNTech's vaccine, which was produced alongside Pfizer, works by creating antibodies that prevent infection from occurring in the first place as well as T lymphocytes, white blood cells that attack cells in the body that have already been infected. According to Sahin, even if the virus evades antibodies, it should still be vulnerable to T lymphocytes.
A MESSAGE FROM MARCH OF DIMES
The U.S. remains among the most dangerous developed nations for childbirth. Help prioritize the health of our nation's moms and babies by joining the #BlanketChange movement today at BlanketChange.org.
VIRTUAL EVENT ANNOUNCEMENT
Investing in Maternal & Infant Health--Thursday, December 2 at 1:00 PM ET
According to the CDC, over 700 women die of pregnancy complications annually and nearly two-thirds of these deaths are preventable. U.S. maternal mortality rates are moving in the wrong direction, and disparities run rampant, with Black women being up to three times more likely to die from pregnancy-related causes than White women. On Thursday, December 2, Rep. Alma Adams (D-N.C.), Rep. Jaime Herrera Beutler (R-Wash), CDC Division of Reproductive Health Director Dr. Wanda Barfield, and more join The Hill for a discussion on improving access to quality maternal and infant health care throughout the country. RSVP today.
BIDEN GLOBAL COVID-19 RESPONSE COORDINATOR STEPS DOWN
The head of the Biden administration's global COVID-19 pandemic response is stepping down from her role after eight months, Secretary of State Antony Blinken announced Tuesday.
Gayle Smith will return to her position as leader of the ONE Campaign, an organization focused on ending extreme poverty and preventable disease, with a focus on Africa. Smith's departure comes as the omicron variant of COVID-19 is spreading, triggering new fears about a surge in cases worldwide.
"As Gayle heads back to the ONE Campaign, she leaves behind a phenomenal set of accomplishments, a robust team and network who are prepared to carry our important work forward, and a comprehensive set of next steps to build on our progress," Blinken said in a statement. "As Gayle has said many times, our work to defeat this pandemic and prevent future health threats is not over."
Mary Beth Goodman, a senior member of the State Department's pandemic response team who previously served as the department's senior director for global development and humanitarian response, will serve as the acting coordinator in Smith's absence, Blinken said.
Blinken touted that the U.S. has donated more than 260 million COVID-19 vaccine doses since April. That figure is far shy of the Biden administration's commitment of 1.2 billion doses, but still puts the U.S. as the top giver of shots to both the global COVAX effort and to individual countries.
Pfizer requests authorization for booster shot in teens 16 and 17
Pfizer on Tuesday said the company and its partner BioNTech submitted a request to expand authorization of its coronavirus booster shot for teens aged 16 and 17
The move to expand eligibility comes as the Biden administration is exhorting everyone currently eligible to get vaccinations and booster shots to protect against the delta and omicron variant.
Currently, only adults over the age of 18 are eligible to receive a booster dose of either the Pfizer-BioNTech, Moderna or Johnson & Johnson vaccine. They can receive the Johnson & Johnson booster two months after getting the single-shot vaccine, and receive a booster of Moderna or Pfizer's shot six months after the second dose.
"It is our hope to provide strong protection for as many people as possible, particularly in light of the new variant," Pfizer CEO Albert Bourla tweeted Tuesday in announcing the move.
The White House is grappling with how to respond to omicron, which has garnered much attention and anxiety, but without much information about it. Still, administration officials are continuing to urge vaccinations as the first line of defense, and then boosters.
WHAT WE'RE READING
Doctors hope Omicron causes milder cases of Covid - but it's still too early to say (Stat)
The inside story of the Pfizer vaccine: 'a once-in-an-epoch windfall' (Financial Times)
With federal Covid sick leave gone, workers feel pressure to show up at work (Kaiser Health News)
STATE BY STATE
A growing number of Texas Republicans want a fourth special session to pass COVID-19 vaccine mandate ban (Texas Tribune)
New Hampshire becomes first state to provide free at-home rapid COVID test kits to residents statewide (Mass Live)
Federal COVID Task Force Team Providing Backup For Burned-Out Hospital Workers In St. Cloud (CBS Minnesota)
OP-EDS IN THE HILL
Texas abortion ban foreshadows the potential fate of half the nation
Five reasons for concern about Democrats' drug price control plan
That's it for today, thanks for reading. Check out The Hill's health care page for the latest news and coverage. See you Wednesday.
