HEALTH CARE BRIEFING: Vaccine Arguments Readied for High Court

Covid-19 is a societal health problem and not a workplace hazard that the Occupational Safety and Health Administration can regulate with its vaccinate-or-test rule for large employers, a coalition of states and an alliance of business groups told the U.S. Supreme Court.

The Republican-led states and industry organizations filed their final briefs yesterday in advance of Friday’s oral arguments at the high court. The justices will consider the states’ and business groups’ bid for an order blocking OSHA’s emergency rule, a key part of the Biden administration’s efforts to vaccinate the country out of the nearly two-year-long coronavirus pandemic.

The Supreme Court also will hear oral argument on the same day in a challenge to the administration’s vaccine mandate for health-care workers.

The practical impact of the shot-or-test rule may depend on the Supreme Court’s view of the stay requests. If the justices freeze the measure while litigation over its merits continues, it may not be in effect for long even if it survives judicial review at the circuit court level. The regulation is set to expire in May. Read more from Robert Iafolla.

• Meanwhile, many state safety agencies have until Jan. 24 to enact OSHA’s emergency temporary standard requiring Covid-19 shots or weekly testing for large private employers, two weeks longer than employers in other states who must comply by Jan. 10. After that extra time for state plans to adopt the standard, employers in those states will have another 30 days to comply. The Supreme Court case, to be argued Jan. 7, adds a layer of complication to state adoptions. Read more from Bruce Rolfsen.
• Minnesota yesterday became the first state to announce it had adopted federal OSHA’s Covid-19 shot or weekly testing emergency standard for employers with 100 or more workers. Minnesota’s Occupational Safety and Health Administration in a written statement said it won’t issue citations before Jan. 10 and won’t issue citations for noncompliance with the rule’s testing requirements before Feb. 9 if the employer is “exercising reasonable, good faith efforts” to comply, Rolfsen reports.

Meanwhile, the partial halt on the Biden administration’s vaccine mandate for health-care workers should be lifted because it is an imminent risk to the safety of patients and staff, the U.S. Solicitor General told the Supreme Court yesterday. “The rule has never been more necessary than it is now,” U.S. Solicitor General Elizabeth Prelogar said in a brief replying to those states contesting the rule, which is now unenforceable in half the country. “Absent stays, the preliminary injunction will likely result in hundreds or thousands of deaths and serious illnesses from COVID-19 that could otherwise be prevented,” Prelogar told the high court, which is scheduled to hear arguments Friday.

The Supreme Court filing comes amid a debilitating surge in the omicron variant of the virus that causes Covid-19. Although people infected with the variant are less likely to require hospitalization, the sheer quantity of sick people is overwhelming short-staffed hospitals. Read more from Allie Reed.

Happening on the Hill

Capitol Has ‘Explosive’ Covid-19 Cases: The U.S. Capitol has seen an “explosive” growth of coronavirus infections, with more than 13% of those tested turning up positive over a seven-day period, up from from less than 1%, the chief doctor for Congress told lawmakers and staff yesterday. Attending Physician Brian P. Monahan said in a letter to member offices obtained by Bloomberg News that hundreds people have been infected and he urged maximum use of teleworking and better masking.

“The daily case rates will increase even more substantially in the coming weeks,” Monahan wrote, urging greater precautions. “Blue surgical masks, cloth face masks and gaiter masks must be replaced by the more protective KN95 or N95 masks.” Read more from Billy House and Steven T. Dennis.

Facebook Temporarily Suspends Greene: Facebook suspended Rep. Marjorie Taylor Greene (R-Ga.) for 24 hours, the congresswoman said yesterday, after she posted misleading data about deaths related to the Covid-19 vaccine. The suspension follows Twitter’s decision yesterday to permanently ban Greene for repeated violations of the platform’s policy against medical misinformation. Read more from Anna Edgerton.

Drug Pricing Group Launches Ads Targeting Manchin: Another Democrat-aligned group is launching ads in West Virginia to pressure Sen. Joe Manchin (D) to back the party’s social spending plan, known as the Build Back Better Act. Patients for Affordable Drugs Now will have ads in West Virginia and Washington D.C. calling on Manchin to support the legislation to get drug pricing provisions into law, Alex Ruoff reports.

The Coronavirus Pandemic

FDA Clears Pfizer Booster for Younger Teens: The Food and Drug Administration granted an emergency-use authorization for Pfizer and BioNTech’s Covid-19 booster for people ages 12 to 15 yesterday. The agency also reduced the recommended interval between the second and third doses of the Pfizer vaccine for all ages to five months. In addition to clearing Pfizer boosters for younger teens, the FDA also said that immune-compromised children age 5 to 11 could receive a third primary-series Pfizer shot at least 28 days following their initial two-dose immunization. Recently, the U.S. has seen an increase in hospitalized children with Covid-19. New hospital admissions of those below the age of 18 with the disease have increased 86% to 521 per day on average for the week ending Dec. 31, according to data from the CDC.

Next, a Centers for Disease Control and Prevention expert panel is expected to discuss the authorization and make further recommendations about how to dispense the shots. The group, the Advisory Committee on Immunization Practices, is scheduled to meet tomorrow. Read more from Timothy Annett and Riley Griffin.

• In New York City, Mayor Eric Adams tried to reassure parents of 1 million public school students that it was safe to return to classes yesterday after the winter break despite a surge in Covid cases, staffing shortages and no testing requirement to come back. “Our city and school system must open,” Adams said on Bloomberg Television. “We cannot lose more years of education for our children.” Read more from Laura Nahmias, Amanda Gordon and Fola Akinnibi.

Head Start Shot, Masking Mandates Halted by Courts: The Biden administration’s requirements that Head Start staff be fully vaccinated against Covid-19 and that program participants wear masks were halted in large swaths of the country by a pair of federal courts in Texas and Louisiana, which said the executive branch likely exceeded its authority. HHS and other agencies in November announced that all Head Start staff, volunteers working in classrooms or directly with children, and contractors whose activities involve contact with families must be fully vaccinated by Jan. 31. It also required immediate masking by all individuals two years of age or older in indoor settings where Head Start services are provided, as well as certain crowded outdoor settings. A number of states challenged the mandates. Read more from Brian Flood.

Weekly Covid Cases Pass 10 Million, Doubling Previous Record: Almost twice as many people were diagnosed with Covid-19 in the past seven days as the pandemic’s previous weekly record thanks to a tsunami of omicron that has swamped every aspect of daily life in many parts of the globe. The highly mutated and infectious variant drove cases to a record 10 million in the seven days through Sunday, almost double the previous record of 5.7 million seen during in a week in late April, Jinshan Hong reports.

• Still, a string of new studies has confirmed the silver lining of the omicron variant: Even as cases soar to records, the numbers of severe cases and hospitalizations have not. The data, some scientists say, signal a new, less worrying chapter of the pandemic, although they caution there’s still plenty of time for the situation to change. “We’re now in a totally different phase,” said Monica Gandhi, an immunologist at the University of California, San Francisco. “The virus is always going to be with us, but my hope is this variant causes so much immunity that it will quell the pandemic.” Kristen V. Brown has more.
• Related: What We Know About the Omicron Variant Now: QuickTake

More Headlines:

• Starbucks to Require Vaccine or Weekly Testing for U.S. Workers
• McDonald’s Workers Win Jobs Back in Covid-19 Layoff Case

What Else to Know

N.Y. Requires Pharmacy Middlemen to Get Licenses: Pharmacy benefit managers in New York will be required to get a license and conform to state standards under legislation signed on Friday, in an effort to increase transparency on how drug prices are negotiated and whether savings are actually passed on to the insured. The measure (S.3762/A.1396) requires pharmacy benefit managers, the third-party administrators of prescription drug plans for health insurers, to register with the state and obtain a license by Jan. 1, 2023. Read more from Keshia Clukey.

• Meanwhile, New York State will ban the sale of mattresses, upholstered furniture, and certain electronics containing carcinogenic flame retardant chemicals under legislation signed by Gov. Kathy Hochul (D). A growing body of research has connected the chemicals with adverse health effects, including negative impacts on the immune system, infertility, cancer, and adverse effects on fetal and child development, according to the National Institute of Environmental Health Sciences. Read more from Keshia Clukey.

Holmes Found Guilty of Theranos Fraud: Elizabeth Holmes was found guilty of criminal fraud after she built her blood-testing startup Theranos into a $9 billion company only to see it collapse in scandal. A jury in California returned the verdict after hearing three months of testimony that was often technical, heavily contested and, from Holmes herself, shocking. Unless the decision is overturned on appeal, the 37-year-old new mother faces as long as 20 years in prison, though she’s likely to be sentenced to far less than that. Read more from Joel Rosenblatt and Joe Schneider.

More Headlines:

• Prescription Weight Loss Drugs Are Working, If You Can Get One
• Purdue, Sacklers Seek Appeal of Order Killing $4.5 Billion Deal
• Ex-Glaxo Scientist Pleads Guilty to Stealing Trade Secrets: DOJ
• Washington Top Court Asked to Weigh in on Birth Defect Damages
• Novartis Fends Off Copycat of MS Drug Gilenya at Federal Circuit
• Monsanto, Pfizer’s Pharmacia Avoid Claims in Pennsylvania’s PCB Suit

With assistance from Alex Ruoff

To contact the reporter on this story: Michaela Ross in Washington at mross@bgov.com

To contact the editors responsible for this story: Zachary Sherwood at zsherwood@bgov.com; Giuseppe Macri at gmacri@bgov.com; Brandon Lee at blee@bgov.com