Healthcare - FDA Suspends Authorization of Latest COVID Antibody Drug

Healthcare – FDA Suspends Authorization of Latest COVID Antibody Drug

RIP to Christine McVie, the singer-songwriter responsible for some of Fleetwood Mac’s greatest hits.

In healthcare today, the rise of the novel COVID-19 omicron BQ.1 and BQ.1.1 subvariants has led to the only remaining monoclonal antibody therapy no longer being cleared by the FDA.

Welcome to night health care, where we follow the latest developments in policies and news concerning your health. For The Hill, we are Nathaniel Weixel and Joseph Choi.

Authorization of COVID antibody treatment suspended

The Food and Drug Administration (FDA) said Wednesday that Eli Lilly’s COVID-19 monoclonal antibody treatment, bebtelovimab, is no longer authorized for emergency use in the United States because it is not expected to be effective in neutralizing the two most dominant omicron subvariants in the country right now.

The omicron BQ.1 and BQ.1.1 subvariants collectively account for 57.3% of COVID-19 cases in the United States right now, after making the BA.5 omicron subvariant the dominant subvariant in the Beginning of the month.

Unsuitable for new mutations:

  • “Given that a COVID-19 infection is likely to be caused by a non-susceptible variant of SARS-CoV-2, and in accordance with the terms and conditions of the letter of authorization, bebtelovimab is currently only authorized for emergency use in any part of the United States. right now,” 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 United States,” Eli Lilly said in a statement. statement, confirming that its monoclonal antibody treatment does not appear to neutralize the BQ.1 and BQ.1.1 subvariants.

The agency said Eli Lilly and its distributors have suspended distribution of bebtelovimab until further notice and the Administration for Strategic Preparedness and Response has also suspended fulfillment of any pending requests for the drug.

Bebtelovimab was the last monoclonal antibody authorized for the treatment of COVID-19. Other earlier antibody treatments have been taken off the market.

Since this treatment is no longer distributed or authorized, the FDA has advised health care providers to choose “appropriate” treatments, including the authorized antivirals Paxlovid, Veklury and Lagevrio.

Learn more here.

CDC tests sewage in Michigan, Pennsylvania for polio

The U.S. Centers for Disease Control and Prevention is expanding sewage polio testing in parts of Michigan and Pennsylvania, officials said Wednesday.

The CDC will begin testing sewage in Michigan’s Oakland County and an unspecified area around Philadelphia.

  • “Sewage testing can be an important tool in helping us understand whether poliovirus can circulate in communities under 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 extremely important that people get vaccinated to protect themselves, their families and their communities from this devastating disease.

Polio outbreaks once caused panic in the United States, but those worries died down once a vaccine was created and widely distributed in the 1950s and 1960s.

Concerns about 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, NY, in July.

Since then, New York health officials have identified 89 “cases of interest,” 82 of which have been linked to the infected Rockland man. The virus has been found in sewage in New York, Orange County, Sullivan County, Queens County and Nassau County.

Learn more here.


Indiana Attorney General Todd Rokita (right) said Wednesday he had filed a complaint with the state Medical Licensing Board, asking it to investigate an Indianapolis doctor who had performed an abortion on a 10-year-old rape victim from Ohio.

Complaint alleges Caitlin Bernard violated federal and Indiana laws relating to patient privacy and reporting child abuse by sharing the girl’s story with the press “to further her agenda.” Politics”.

Rokita said Bernard also failed to immediately report to state authorities the abuse and rape that led to the girl’s pregnancy.

Bernard sues Rokita to block his office from accessing confidential medical records he requested as part of an investigation into his medical practice.

In a statement, Bernard’s attorney called the complaint “a last-ditch effort to intimidate Dr. Bernard and other abortion care providers.”

Learn more here.


Nearly all Republican governors and 13 GOP senators are taking aim at the Biden administration’s military COVID-19 vaccine mandate, with both groups urging congressional leaders on Wednesday to try to change or completely dismantle the decision.

The 21 GOP governors, led by Tennessee Gov. Bill Lee, sent a joint letter to key 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 has serious implications for our defense capabilities abroad and our state’s preparedness here at home,” the governors say, saying “the current soldiers leave our ranks and new recruits do not enlist”. join.”
  • The 13 Republican senators want to insert language into the annual defense authorization bill that would prohibit any service member from being removed from the ranks if they refuse the coronavirus vaccine, as well as reinstating those already discharged with salary arrears.

Rollback: The Pentagon in August 2021 required COVID-19 vaccinations for all service members – including those in the National Guard and Reserve – those who do not comply with the loss of days they accumulate towards retirement, loss of pay or even dismissal from ranks known as involuntary separation.

The U.S. military began firing service members in February for refusing the vaccine, with Pentagon officials telling Congress in April that about 3,400 soldiers had been involuntarily cut from service.

Learn more here.

Companies Call on SCOTUS to Lift Ban on Flavored Tobacco

A group of tobacco companies have asked the Supreme Court to issue an injunction on California’s ban on flavored tobacco products, which passed at the polls earlier this month.

Companies such as RJ Reynolds Tobacco Company, Santa Fe Natural Tobacco Company and Modoral Brands Inc. have filed for an injunction with the Supreme Court arguing that sales bans in the 9th Circuit Court of Appeals, including California is part, have been overruled by the court on previous occasions.

On Election Day, 62% of California voters voted “yes” to the proposal to ban the sale of flavored tobacco products. The ban applies to products with flavors other than tobacco, such as fruit, mint and vanilla. Vending machines or stores in violation are subject to a $250 fee.

The ban is expected to come into effect from December 22.

The question: Tobacco companies are asking the Supreme Court to review 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 authorize the sale of tobacco products, warns the ban issued in California. .

Possible previous:

  • The companies cited previous cases in which the Supreme Court overturned 9th Circuit findings on bans on the sale of meat from “lower” animals, those unable to walk. Federal law requires that slaughtered cows not be slaughtered for human consumption.
  • In that earlier case, the court ruled that federal law explicitly prevailed over California law, which sought to include other animals in the ban on slaughter.

Learn more here.


  • The lawsuit is on: Regulators are slowly cracking down on vapes aimed at teens (NPR)
  • Older adults face Medicare hurdles for drug treatment (roll call)
  • New Alzheimer’s drugs take important but difficult step toward approval (Wall Street Journal)
  • COVID has hit HIV detection in Europe and threatens eradication progress (Reuters)


  • New Mexico sues over a dozen tobacco companies (KVIA)
  • Rural Texas hospitals are – once again – under serious threat of closure (Texas Tribune)
  • Minnesota medical cannabis program adds qualification requirements: IBS and OCD (MPR News)

That’s all for today, thanks for reading. Check out The Hill’s healthcare page for the latest news and coverage. Until tomorrow.

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