Top Three
FDA Advisory Panel Narrowly Recommends Authorization of First Antiviral Pill to Treat COVID: Stat covers today's FDA advisory meeting on Merck's Molnupiravir:
"During the panel, discussions frequently turned to whether or not panelists trusted the effectiveness data on the drug, even when they were discussing other topics"
"I think we need to stop and acknowledge that the whole reason we’re having this discussion is because the efficacy of this product is not overwhelmingly good,” said W. David Hardy of Charles Drew University School of Medicine and Science during a discussion about the drug’s use during pregnancy. “And I think that makes all of us feel a bit uncomfortable about the fact whether this is an advance therapeutically because it’s an oral medication, not an intravenous medication.”
"Concerns have also been raised about whether molnupiravir, which works by inhibiting the ability of the virus to replicate its DNA, might cause birth defects or even long-term effects from damaging patients’ DNA, potentially causing long-term harms like cancer. Both Merck and FDA scientists said such outcomes were unlikely for a medicine that would only be taken for only five days, although they faced tough questions from panelists about the specific animal studies that indicated the treatment was safe."
The vote: "Do known/potential benefits outweigh known/potential risks in treatment of mild-moderate COVID-19 in adults within 5 days of symptom onset and at high risk of severe COVID19, including hospitalization or death?" Yes: 13; No: 10; Abstain: 0
CDC Expands Eligibility for COVID-19 Booster Shots to All Adults: Announced last evening.
"The recent emergence of the Omicron variant (B.1.1.529) further emphasizes the importance of vaccination, boosters, and prevention efforts needed to protect against COVID-19," said CDC Director Dr. Rochelle Walensky.
Before yesterday, the graphic below represented the recommendation. The "may" is now changed to "should."
School Closures Tick Up: From The 74
Last week, 621 schools across 58 districts announced new closures for a variety of reasons including teacher burnout, staffing shortages and virus outbreaks, according to counts from Burbio."
"Since the start of the academic year, 9,313 campuses across 916 districts nationwide have added extra days off. The numbers suggest that nearly 10% of the nation’s roughly 98,000 K-12 schools have experienced closures this year.
"In Maryland, more than 3 in 10 schools have been affected by at least one day of disruption this academic year. In North Carolina, where such events have been most frequent, the number is above 4 in 10."
More via US News
Omicron
Cases: 242 confirmed cases in 19 countries
Four countries have confirmed cases in individuals with no travel history: Germany, UK, Portugal, and Israel.
“Dutch health authorities announced on Tuesday that they found the new Omicron variant of the coronavirus in cases dating back as long as 11 days, indicating that it was already spreading in western Europe before the first cases were identified in southern Africa,” CBS News reports.
Reports from South Africa:
According to the director of South Africa's communicable disease institute. "The fact that cases have started to rise rapidly, especially in the most populated Gauteng province, is a sign that some displacement might already be happening."
"Children under the age of 2 account for about 10% of total hospital admissions in the Omicron epicenter Tshwane in South Africa."
"Rudo Mathivha, head of the intensive care unit at Baragwanath Hospital in Soweto, South Africa, told a news conference, “Young people, in their 20s to just over their late 30s, are coming in with moderate to severe disease, some needing intensive care. About 65% are not vaccinated and most of the rest are only half-vaccinated.”
WHO: Issued a new statement that included:
"Blanket travel bans will not prevent the international spread, and they place a heavy burden on lives and livelihoods.”
"Persons who are unwell or at risk of developing severe COVID-19 disease and dying, including people 60 years of age or older or those with comorbidities (e.g. heart disease, cancer and diabetes), should be advised to postpone travel."
Vaccines Could Provide Some Protection:
Via WSJ, "Based on current knowledge about the mechanisms behind the vaccines and the biology of variants, Dr. Sahin (co-founder of BioNTech) said he assumed that immunized people would have a high level of protection against severe disease even if infected by the Omicron variant."
Moderna CEO Stéphane Bancel told the Financial Times that existing vaccines will be much less effective at tackling Omicron than earlier strains of coronavirus. Said Bancel: “There is no world, I think, where the effectiveness is the same level… I think it’s going to be a material drop... I just don’t know how much because we need to wait for the data. But all the scientists I’ve talked to . . . are like, ‘This is not going to be good.’”
Regeneron: “Preliminary tests indicate the Covid-19 antibody drug cocktail from Regeneron Pharmaceuticals Inc. loses effectiveness against Omicron, a sign that some products in an important class of therapies might need modifying if the new strain becomes widespread,” the WSJ reports.
Federal
Reconciliation:
Senate Majority Leader Schumer is planning to bring Build Back Better to the floor as soon as the week of Dec. 13, The Hill reports.
But... Sen. Manchin said he won’t commit yet to Senate Majority Leader Chuck Schumer’s timetable for moving ahead before the end of the year, Bloomberg reports.
ED: The White House is considering Richard Cordray to serve as the Federal Reserve’s top banking regulator.
Vaccine Mandate:
A federal court in Missouri granted a preliminary injunction on Monday blockin the enforcement of the Biden administration’s CMS rule mandating health care workers at federally funded facilities be vaccinated against COVID-19. "
"The nature and breadth of the CMS mandate requires clear authorization from Congress—and Congress has provided none," U.S. District Judge Matthew Schelp said.
"Federal employees who have not complied with the coronavirus vaccine mandate will not face aggressive discipline, including unpaid suspensions or firing, until at least early next year, according to guidance the White House sent to unions," reports the Washington Post.
COVID-19 Research
See Where Covid Is Surging Across Europe: Great interactive visualization from the New York Times.
We Don’t Need Universal Booster Shots. We Need to Reach the Unvaccinated: Argues three FDA officials in this Washington Post oped.
"Two of us — Krause and Gruber — were co-authors of a recent article in the Lancet, a medical journal, that summarized all of the available data on boosting and concluded that the data did not support widespread boosting; the other — Offit — is a member of the FDA vaccine advisory committee that voted against boosting for all adults last month."
"We continue to think that while boosting can improve immune responses and can even further increase already very high levels of protection in some people, the need for a boost remains restricted to people who are at high risk of serious disease (including the elderly) or those at risk of exposing vulnerable household or workplace contacts if they get infected."
"Indeed, the push for boosters for all could actually prolong the pandemic. First, such a campaign diverts focus away from the goal of persuading the unvaccinated to get their shots (and persuading parents to get their eligible children shots). Second, and relatedly, exaggerated descriptions of the waning efficacy of the vaccines undermine public confidence in them, and some people may be less likely to accept vaccines that they regard as less effective than originally advertised."
Two Long-Term Public-Policy Lessons of the Pandemic: Good piece by Matthew Slaughter and Matthew Rees.
"The first, optimistic long-term lesson is that the dynamic forces of globalization continue to generate very large gains for America."
"Vaccines have appeared only thanks to the worldwide flows of ideas, people, capital, and products in elaborate global supply networks."
"The second, sobering long-term lesson is that the poor state of public health continues to generate very large costs for America."
"As pointed out by Dariush Mozaffarian, dean of Tufts University’s Friedman School of Nutrition Science and Policy, COVID-19 has been “a fast-moving pandemic overlaid on a slow-moving pandemic” that’s been driven by poor metabolic health."
State
California:
75% of Sacramento City Unified School District students have not shown proof of vaccination.
A COVID-19 vaccine mandate for students in the San Diego Unified School District has been blocked following a decision by the Ninth Circuit Court of Appeals.
Iowa: Johnston, Iowa schools end COVID-19 mask mandate.
Michigan: The number of patients in hospitals for COVID-19 has surpassed the spring wave and has reached a new record high.
More than one-fifth of COVID patients in Michigan hospitals were in intensive care. Only Minnesota had a higher seven-day rate of new infections than Michigan.
About 20% of tests statewide were positive, a level not seen since the early days of the pandemic when there was a testing shortage.
New Hampshire: Some schools reinstate mask rules, go remote as COVID-19 cases rise.
Oregon: Portland teachers union proposes self-taught Fridays for high schoolers, says educators need more planning time.
Tennessee: "The state will spend $200 million to initiate a three-year tutoring project called Tennessee Accelerating Literacy and Learning Corps (TN ALL Corps), serving 150,000 students in either math or English language arts in 79 districts."
Economic Recovery
Cyber Monday: Online sales drop 1.4% from last year to $10.7 billion, falling for the first time ever.
The Pandemic's Unequal Impact: Morning Consult/Axios economic inequality index
Resources
Promising Practices for Reconnecting Recent High School Graduates to Postsecondary Education: New report from Strada.
More Momentum Behind Learning Pods: Via Michael Horn.
There's a Laptop on Every Desk. Now What?: Via NEA
Education Policy Playbook: From ExcelinEd including:
Close learning gaps
Bridge the digital divide
Empower families with opportunity
Strengthen pathways to college and career
Reimagine learning
New Research Shows Homeschool Growth across All Race, Income Categories: Via HSLDA
New Data Show School Staffing Shortages Disproportionately Hitting High-Poverty Districts During Pandemic: The 74 covers new CEDR research.
A Boy Thinks His Dad Forgot His Birthday: But his dad didn't forget…