Health Care — FDA halts authorization of last COVID antibody drug
RIP to Christine McVie, the singer-songwriter responsible for some of Fleetwood Mac’s biggest hits.
Today in health, the rise of new COVID-19 omicron subvariants BQ.1 and BQ.1.1 has led to the one remaining monoclonal antibody treatment no longer being authorized by the FDA.
Authorization for COVID antibody treatment paused
The Food and Drug Administration (FDA) said on Wednesday that the COVID-19 monoclonal antibody treatment bebtelovimab from Eli Lilly is no longer authorized for emergency use in the U.S. as it is not expected to be effective at neutralizing the two most dominant omicron subvariants in the country right now.
The omicron subvariants BQ.1 and BQ.1.1 collectively account for 57.3 percent of COVID-19 cases in the U.S. right now, having pushed the BA.5 omicron subvariant out as the dominant subvariant earlier this month.
Unsuited to newer mutations:
- “Given that a COVID-19 infection is likely to be caused by a non-susceptible SARS-CoV-2 variant, and consistent with the terms and conditions of the Letter of Authorization, bebtelovimab is not currently authorized for emergency use in any U.S. region at this time,” the FDA said in a statement.
- “Lilly and the FDA agree that it is not medically appropriate, at this time, to treat high-risk patients with mild-to-moderate COVID-19 with bebtelovimab in the US,” Eli Lilly said in a statement, confirming that its monoclonal antibody treatment does not appear to neutralize the BQ.1 and BQ.1.1 subvariants.
The agency stated that Eli Lilly and its distributors have paused distribution of bebtelovimab until further notice and the Administration for Strategic Preparedness and Response has also paused the fulfillment of any pending requests for the drug.
Bebtelovimab was the last monoclonal antibody authorized for treating COVID-19. Other previous antibody treatments have been withdrawn from the market.
With this treatment no longer being distributed or authorized for use, the FDA advised that health care providers choose “appropriate” treatments including the authorized antivirals Paxlovid, Veklury and Lagevrio.
CDC testing Mich., Pa. wastewater for polio
The U.S. Centers for Disease Control and Prevention is expanding its wastewater testing for polio in parts of Michigan and Pennsylvania, officials announced Wednesday.
The CDC will begin wastewater testing in Michigan’s Oakland County and an unspecified area around Philadelphia.
- “Wastewater testing can be an important tool to help us understand if poliovirus may be circulating in communities in certain circumstances,” said José R. Romero, director of the CDC’s national center for immunization and respiratory diseases.
- “Vaccination remains the best way to prevent another case of paralytic polio, and it is critically important that people get vaccinated to protect themselves, their families and their communities against this devastating disease.”
Polio outbreaks once caused panic in the United States, but those concerns died once a vaccine was created and widely distributed in the 1950s and 1960s.
Concerns over the spread of polio have been renewed this year, however, after the first case of paralytic polio in nearly a decade was diagnosed in an unvaccinated man in Rockland County, N.Y., in July.
Since then, New York health officials have detected 89 “cases of interest,” 82 of which have been linked to the infected Rockland man. The virus has been found in sewage water in New York City, Orange County, Sullivan County, Queens County and Nassau County.
INDIANA AG FILES COMPLAINT AGAINST DOCTOR WHO PERFORMED ABORTION ON 10-YEAR-OLD
Indiana Attorney General Todd Rokita (R) on Wednesday said he filed a complaint with the state’s medical licensing board, asking it to investigate an Indianapolis doctor who provided an abortion to a 10-year-old rape victim from Ohio.
The complaint alleges Caitlin Bernard violated federal and Indiana law related to patient privacy and the reporting of child abuse by sharing the girl’s story with the press “to further her political agenda.”
Rokita said Bernard also failed to immediately report to state authorities the abuse and rape that led to the girl’s pregnancy.
Bernard is suing Rokita to stop his office from accessing confidential medical records it requested as part of an investigation into her medical practice.
In a statement, Bernard’s attorney called the complaint “a last-ditch effort to intimidate Dr. Bernard and other providers of abortion care.”
GOP GOVERNORS, SENATORS TAKE AIM AT PENTAGON VAX MANDATE
Nearly all Republican governors and 13 GOP senators are taking aim at the Biden administration’s military COVID-19 vaccine mandate, with the two groups on Wednesday urging congressional leadership to try to alter or altogether dismantle the ruling.
The 21 GOP governors, led by Tennessee Gov. Bill Lee, issued a joint letter to top lawmakers asking them to “take immediate action to remove and prohibit” the mandate.
- “The Biden vaccine mandate on our military creates a national security risk that severely impacts our defense capabilities abroad and our state readiness here at home,” the governors argue, claiming that “current servicemembers are leaving our ranks, and new recruits are not signing up to join.”
- The 13 Republican senators want to insert language in the annual defense authorization bill that would prohibit any service member from being removed from the ranks should they refuse the coronavirus vaccine, as well as reinstate those already discharged with back pay.
Flashback: The Pentagon in August 2021 required COVID-19 vaccinations for all service members — including those in the National Guard and Reserve — with those who do not comply facing loss of days they accrue toward retirement, loss of pay or even dismissal from the ranks known as involuntary separation.
The U.S. military in February began to discharge service members for refusing the vaccine, with Pentagon officials in April telling Congress about 3,400 troops had been involuntarily separated from service.
Companies ask SCOTUS to nix flavored-tobacco ban
A group of tobacco companies have asked the Supreme Court to issue an injunction on California’s ban on flavored tobacco products, which was voted into law at the ballot box earlier this month.
Companies including the R.J. Reynolds Tobacco Company, the Santa Fe Natural Tobacco Company and Modoral Brands Inc. submitted a request for an injunction to the Supreme Court arguing that sales bans in the 9th Circuit Court of Appeals, of which California is a part, have been reversed by the court on prior occasions.
On Election Day, 62 percent of California voters chose “Yes” on the proposition to prohibit the sale of flavored tobacco products. The ban affects products with non-tobacco flavors, such as fruit, mint and vanilla. Vending machines or stores that are found to be in violation face a $250 fee.
The ban is set to go into effect beginning on Dec. 22.
The question: The tobacco companies are asking that the Supreme Court consider whether the Family Smoking Prevention and Tobacco Control Act, a 2009 bill that gives the secretary of Health and Human Services the power to restrict or allow the sale of tobacco products, preempts the ban issued in California.
- The companies cited a previous cases where the Supreme Court overturned the 9th Circuit’s findings on bans regarding the sale of meat from “downer” animals, ones that are unable to walk. Federal law requires that downer cows not be slaughtered for human consumption.
- In this earlier case, the court had ruled that federal law explicitly preempted the California law, which sought to include other livestock into the downer slaughter ban.
WHAT WE’RE READING
- The chase is on: Regulators are slowly cracking down on vapes aimed at teens (NPR)
- Older adults face Medicare hurdles for substance use treatment (Roll Call)
- Newest Alzheimer’s drugs take large but fraught step toward approval (Wall Street Journal)
- COVID hit HIV detection in Europe, threatens eradication progress (Reuters)
STATE BY STATE
- New Mexico sues over a dozen tobacco companies (KVIA)
- Texas’ rural hospitals are — once again — at grave risk of closing (Texas Tribune)
- Minnesota’s medical cannabis program adds qualifying conditions: IBS and OCD (MPR News)
That’s it for today, thanks for reading. Check out The Hill’s Health Care page for the latest news and coverage. See you tomorrow.