Top Three
Questions About the FDA's Rolling Authorization Plan for Covid Vaccine for Under 5s:
First up, Stat:
"In emailed comments, the FDA said that given the recent increase in infections among children, it felt holding a public discussion about the risks and benefits of vaccination of this critical age group was important."
"The surge of the Omicron variant has rapidly facilitated the collection of important additional clinical data impacting the potential benefit-risk profile of a vaccine for the youngest children,” spokeswoman Abby Capobianco wrote. “In light of these new data and the rise in illnesses and hospitalization in this youngest age group, FDA believed that it was prudent to request that Pfizer submit the data it had available, including the data that it has recently collected during the Omicron surge.”
"None of the experts STAT spoke to for this article could recall a precedent for this approach. And several are worried going down this path could erode willingness on the part of parents of young children to get them vaccinated."
“I think already it’s kind of a disaster for vaccine uptake in kids,” Malia Jones, an epidemiologist who teaches at the University of Wisconsin-Madison and who specializes in vaccine hesitancy said of the prospects for persuading parents to vaccinate their children against Covid and whether the FDA’s approach here will influence them. “Is it throwing gasoline on a dumpster fire? Maybe. But it was already a dumpster fire.”
Next up, Katelyn Jetelina
"Pfizer doesn’t have data from the third dose among this cohort yet because this takes time (they’re continuing trials to get this data eventually). If there is no new data since the last press release (December 2021), then what changed? I don’t know. But, if we read in-between the lines, we can assume it centers around Omicron."
"Before Omicron, neutralizing antibodies were working really well. With Omicron, though, our first line of defense is largely eroded without a booster. Thankfully, our secondary line of defense (T-cells) still works. This is largely why partially-vaccinated people continue to stay out of the hospital. So this begs the question: Are neutralizing antibodies still a fair measure to indicate that a vaccine is useful? Or, should we evaluate T-cell activation or, more broadly, efficacy against hospitalization and death? Discussions have likely been happening behind closed doors at the 'FDA."
"As you can tell, there is very limited data and little transparency thus far. So, going forward, we all need the following four key questions answered:"
"What was the original Phase III data for <5s? How far off were the neutralizing antibodies for 2-<5 year olds? If this was very far off, how comfortable do we feel with just vaccinating and hoping that the third dose will work?"
"Is there a new goalpost, like T-cells or hospitalizations? And, why was it chosen? If it’s hospitalizations, does Pfizer have enough sample size to measure effectiveness confidently given that hospitalizations are more rare for kids?"
"What is the safety profile of the proposed dose for kids under 5?"
"What is the plan if a third dose does not work? Is Pfizer concurrently testing other doses? And, what are the implications for long COVID and MIS-C, in particular, if the third dose doesn’t work?"
Secondary Transmission of COVID-19 in K–12 Schools: Study published in Pediatrics.
"During the study period, 1,102, 039 students and staff attended in-person instruction in 100 North Carolina school districts, 13 Wisconsin school districts, and 14 North Carolina charter schools."
"Students and staff had 7865 primary infections, 386 secondary infections, and 48 313 quarantines."
"For every 20 community-acquired infections, there was 1 within-school transmission event."
"Relaxed distancing practices (<3 ft, 3 ft) and increased children per bus seat were not associated with increased relative risk of secondary transmission."
"With universal masking, in-person education was associated with low rates of secondary transmission, even with less stringent distancing and bus practices."
"...all districts included in our analysis implemented layered mitigation strategies, including a mask mandate for K–12 schools for the duration of the study period. As a result, we cannot estimate the impact that masking alone or any other individual mitigation factor had on secondary transmission rates. Furthermore, distancing may play a larger role in the unmasked environment."
Parent Polling: Via Morning Consult and EdChoice.
"In November and December, about a quarter of parents said they had a child who had to quarantine. But in January that number jumped to 37%."
"In January, three out of five school parents supported moving back to remote learning due to the Omicron variant. Democrats, Blacks, urbanities, and younger generations were the most supportive of shifting to remote learning. Republicans and those living in small town/rural areas were least supportive."
Federal
NTIA: April McClain-Delaney (previously with Common Sense Media) will serve as deputy assistant secretary for comms and information and former Chattanooga Mayor Andy Berke will be a special representative for broadband.
Senate Majority: Sen. Ben Ray Luján (D-N.M.) suffered a stroke yesterday. We all wish him a speedy and complete recovery.
But it is also important to note how this changes the dynamics in the Senate since it means Sen. Schumer will not have a working majority for what could be the next several 6-8 weeks.
It means only bills and nominations with clear bipartisan support will be able to proceed. Several nominations, including Gigi Sohn as commissioner to the FCC, and the expected competitiveness conference committee (depending on if the House votes on the COMPETES bill this week) might be delayed.
COVID-19 Research
Comparing Omicron to Delta: CDC released new data today. Cases 5x higher; Hospitalizations 1.8x higher; Deaths at similar counts.
Ten Billion COVID Vaccinations: World hits new milestone, Nature reports. Largest vaccination program in history.
"But — as researchers warned last year when the first one billion doses had been administered — there are still huge inequities in access, with just 5.5% of people in low-income nations having received two doses."
What Made Some Countries Better Prepared for COVID: Trust: Study and Washington Post article.
"The aim of the study was to answer a question that has been dubbed the “epidemiological mystery” of the pandemic: Why did the coronavirus hit some countries so much harder than others?"
"In reviewing data from across the world, the study’s authors found that traditional models for pandemic preparedness didn’t fit what they were seeing."
“We found no links between covid outcomes and democracy, populism, government effectiveness, universal health care, pandemic preparedness metrics, economic inequality or trust in science,” said Bollyky who is a senior fellow for global health at the Council on Foreign Relation
“Trust in your government or your trust in others is strongly associated with vaccination rates,” Bollyky said. “It is associated with decreased mobility, which is an indicator of social distancing policies."
"The Lancet study estimated that if every country had the same level of trust in government as Denmark, one of the countries with more trust among high-income nations, 13 percent fewer people would have been infected with the coronavirus globally. If the same were true for one’s trust in others, the reduction would be even larger: 40 percent, or 440 million fewer infections over the 21-month period assessed in the study,” Bollyky said."
Meta Analysis on Effects of Lockdown: New report which has yet to be peer reviewed. I was hesitant to share it yesterday due to several methodological issues but it's been getting a lot of attention.
Their analysis of 24 papers suggests lockdowns only reduced Covid mortality by 0.2%.
Closing nonessential stores was found to be the most effective intervention, leading to a 10.6% drop in virus fatalities. School closures were linked to a smaller 4.4%.
Critics have suggested the studies were cherry picked given the universe of studies that could be included is more than 18,590. It's not unusual to have a selection criteria that filters out studies not meeting certain conditions. But going from this large of a number to just 24 raises questions.
COVID Vaccine-elicited T Cells Provide Robust Protection Against Omicron: Reports CIDRAP on two studies: University of Cape Town study and BIDMC study.
Another Misunderstood Study About Ivermectin: Reuters mistakenly reported Tuesday that a Japanese study showed the anti-parasitic drug ivermectin to be “effective” against omicron in Phase III clinical trials, which are conducted in humans.
"While the drug may someday prove to have some value in treating COVID-19, this study didn’t say it is “effective.” The study, which was done in a Japanese lab and did not involve humans, found ivermectin had an “antiviral effect” against omicron and other coronavirus variants. And that is all the company, Kowa Co. Ltd., said about its findings."
U.S. Has Far Higher Covid Death Rate Than Other Wealthy Countries: Via the NYT, "Two years into the pandemic, the coronavirus is killing Americans at far higher rates than people in other wealthy nations."
Gottlieb on Masks in Schools: Via this appearance on CNBC: "If they hold out and wait for communities to reach 10 cases per 100,000 per day we may be waiting a very long time and well past the point where immediate risk has subsided."
State
Alabama: Schools lay out $2 billion federal COVID relief spending plans.
Colorado:
Launches new test-and-mask program to cut down on school quarantines.
Cherry Creek School District, Adams 12 Five Star Schools, Denver, and others dropping mask mandate beginning Monday.
Indiana: The Indiana Department of Education has launched a public database showing how much schools are spending in federal pandemic relief funding.
Related: WFYI created a database of all school district spending plans.
Nebraska: Eyes loan forgiveness program for teacher shortage.
New Jersey: To fill shortage, Camden will sponsor teachers from other countries.
North Carolina: NC educator creates mobile tutoring bus to reach students at home.
Virginia: Governor’s mask order prompts dueling lawsuits.
"Parents of children with disabilities filed a federal lawsuit, arguing that forcing schools to repeal their mask mandates effectively excludes those students from public schools, in violation of the Americans With Disabilities Act."
"A separate suit was filed by three parents against the Loudoun County School Board for ignoring Younkin’s order and continuing the school district’s mask mandate."
Economic Recovery
Revenue Windfall Pushes States to Cut Taxes: “Soaring tax revenue and billions in pandemic aid from the federal government have left many states with an unusual problem — too much money,” the AP reports.
“The result is one of the most broad-based movements in recent memory toward giving consumers and taxpayers a break. In red states and blue, lawmakers and governors are proposing to cut taxes and fees, create tax credits, or delay tax and fee hikes that had been planned before the Covid-19 pandemic struck.”
Resources
The Pandemic and Student Engagement: Trends, Disparities, and Opportunities: 2021 National Survey of Student Engagement.
First-year students taking mostly remote courses were more likely than others to feel that the pandemic interfered with their college plans and their preferred living situation.
First-year students taking most courses in person were more likely to feel their instructors were substantially (“very much” or “quite a bit”) responsive to the needs of students, compared to those taking most courses remotely and in hybrid formats (73% versus 62%).
First-year students taking their courses in remote or hybrid formats were also somewhat more likely to feel an increase in mental health issues such as inability to concentrate (51% of remote and 52% of hybrid, compared to 40% of in-person), as well as depression, feeling hopeless, and difficulty sleeping
Tutoring Partnerships Take Shape to Address Learning Loss: Via K12 Dive.
As Schools Push for More Tutoring, New Research Points to Its Effectiveness — and the Challenge of Scaling it To Combat Learning Loss: Via The 74.
Some Schools Are Having Second Thoughts About ‘Test-to-Stay’ Policies: Via The Baltimore Sun.
NJ's Famous Groundhog, Milltown Mel, Has Died: This year's Groundhog Day event now stands canceled.
"Six more weeks of
COVID-remote learningwinter is on the way. Punxsutawney Phil made his prediction around 7:25 a.m. ET Wednesday at Gobbler's Knob."
Here's The Story Behind Black History Month: And why it's celebrated in February.
Stunning Light Display Illuminates Skies for Lunar New Year: China welcomed the Year of the Tiger with an epic light show illuminating the skylines of four cities: Beijing, Wuhan, Chongqing and Qingdao.
This video from Shenzhen is also amazing.
Related: China's Mars probe sends video selfie from Red Planet's orbit to welcome the Lunar New Year.