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Thursday, August 11, 2022

FDA recommends repeat at-home Covid tests to reduce risk of false negatives

 The Food and Drug Administration (FDA) issued guidance on Thursday recommending that people testing themselves for COVID-19 at home take a repeat test within 48 hours to rule out a potential false negative.

In its guidance, the FDA noted that at-home tests are less likely to detect the coronavirus than PCR lab tests. This inaccuracy is more likely to occur early on in the infection in people who display no symptoms.

“Currently, all at-home COVID-19 antigen tests are FDA-authorized for repeat, or serial use. This means people should use multiple tests over a certain time period, such as 2-3 days, especially when the people using the tests don’t have COVID-19 symptoms,” the FDA said.

People should keep multiple tests on hand for the purpose of this new guidance, the agency said. Most over-the-counter, at-home COVID-19 tests are sold in multipacks.

The FDA recommended that people take one initial test if they suspect they may be infected or exposed to COVID-19. If they test negative and have some symptoms, then they should test again 48 hours after the first test. If the second test is still negative, a laboratory molecular-based test should be considered.

If a person has no COVID-19 symptoms but believes they have been exposed to the virus, the FDA said they should also test themselves a second time, also 48 hours after their first at-home test. If the second test is negative, they should take an additional third test another 48 hours afterward.

If any of these at-home tests come back positive, then the individual likely has COVID-19 and should follow guidance from the Centers for Disease Control and Prevention.

The agency said these most recent recommendations were based on “the latest study results from people with likely omicron infection showing that repeat testing after a negative at-home COVID-19 antigen test result increases the chance of an accurate result.”

Around a dozen at-home COVID-19 tests have been authorized by the FDA.

Many community health centers across the country have been giving out free at-home COVID-19 tests. Individuals with health insurance can usually either receive free tests at stores and pharmacies or receive reimbursements through their insurers. The Department of Health and Human Services is also distributing free tests through Medicare-certified health clinics.

https://thehill.com/policy/healthcare/3597306-fda-recommends-repeat-at-home-covid-tests-to-reduce-risk-of-false-negatives/

'USPS planning temporary price hike for holiday season'

 United States Postal Service customers may have to temporarily dole out more money this holiday season to send mail and ship packages.

A planned hike, which is similar to adjustments made by the agency in previous years, has been approved by the Governors of the Postal Service and would impact the price of commercial and retail domestic competitive parcels sent through Priority Mail Express (PME), Priority Mail (PM), First-Class Package Service (FCPS), Parcel Select and USPS Retail Ground. International products will be unaffected.

If approved by the Postal Regulatory Commission, the temporary rates would go into effect at 12 a.m. CT on Oct. 2 and remain in place until 12 a.m. CT on Jan. 22, 2023.

For Priority Mail and Priority Mail Express, price increases will range between 75 cents and $6.50 for commercial mail and 95 cents and $6.45 for retail mail. 

For First-Class Package Service, Parcel Select Ground and USPS Retail Ground, price increases will range between 25 cents and $5.50 for commercial mail and 30 cents and $5.85 for retail mail. 

"The Postal Service has some of the lowest postage rates in the industrialized world and continues to offer great values in shipping," USPS said in a statement. "These temporary rates will keep USPS competitive while providing the agency with the revenue to cover extra costs in anticipation of peak-season volume."

The latest move, which is part of the agency's 10-year Delivering for America plan to achieve financial sustainability and service excellence, comes after USPS upped the price of First-Class mail by 6.5% in July.

The Postal Service notes that it generally receives no tax dollars for operating expenses and relies on the sale of postage, products and services to fund its operations.

The Labor Department reported on Wednesday that consumer prices rose 8.5% year over year in July, cooling slightly but still near the highest level in 40 years.

https://www.foxbusiness.com/lifestyle/usps-planning-temporary-price-hike-for-holiday-season

Electric Vehicles May Present Major Problem During Natural Disaster Evacuations

 by Katie Spence via The Epoch Times,

The push to transition the national road fleet to electric vehicles (EVs) is on and while increasingly popular with buyers, experts in the transportation space are examining potential problems with mass EV adoption.

One such issue involves EVs and evacuations during natural disasters.

report from Transportation Research published in ScienceDirect headlined “Can we evacuate from hurricanes with electric vehicles?” found that Florida—which often bears the force of hurricanes—may not have enough power to cope during an evacuation.

“If the majority of the evacuating vehicles were EVs, Florida would face a serious challenge in power supply,” the report said.

First responders work together in extinguishing the flames of a wildfire near the Irvine Cove neighborhood in Laguna Beach, Calif., on Feb. 10, 2022. (John Fredricks/The Epoch Times)

It added that could affect six out of the nine main power authorities, especially those in mid-Florida, and “could induce cascading failure of the entire power network” throughout the state.

In California, the two main natural disasters are earthquakes and wildfires.

Both are short-notice events that have the potential to knock out the power grid with no warning, making it especially difficult, if not impossible, to charge a Battery Electric Vehicle (BEV),” a case study from California Polytechnic State University found.

In 2020, sales of electric vehicles (EVs) reached a record 3 million, according to the International Energy Agency (IEA). And, EV sales could increase to 23 million by 2030, thanks partly to the Biden administration’s stated goal of half of all new vehicles sold in 2030 being zero-emissions vehicles.

The increase in EV adoption makes the issue of natural disaster evacuations more pressing.

However, according to a panel of experts at the 2022 National Conference of State Legislatures (NCSL), the problem has yet to be solved.

Posing the Question

“What happens when people … run out of battery on the side of the road [during an emergency evacuation]?” an NCSL conference attendee asked.

“Early adoption is less than one percent. But when its 2035 or 2040 and we’re at 15–20 percent, it’s a whole new level of problem to deal with.

“What’s your vehicle evacuation plan at that point?”

State Sen. Jeff Brandes (R-Fla.), one of the panelists for “The Promise and Challenges of Electric Vehicles” at NCSL, acknowledged the problem and said Florida was examining the issue. It did not yet have a solution.

State Sen. Faith Winter (D-Colo.) said a “really creative company” in Colorado was examining the feasibility of putting chargers in crates and deploying them “like we deploy water, like we deploy firefighters.” Winter said Colorado is aware of this issue and is looking for a solution.

Alex Schroeder, interim executive lead for the Joint Office of Energy and Transportation, didn’t attempt to answer the question.

During a Hurricane

In 2020, Dr Kairui Feng, a researcher at the Department of Civil and Environmental Engineering at Princeton University, along with her colleagues Dr Ning Lin and Dr Siyuan Xian, released a report with Dr Mikhail Chester, the director of the Metis Center for Infrastructure and Sustainable Engineering at Arizona State University, on the problem of evacuating from hurricanes with EVs.

The team used Hurricane Irma (2017) for its evacuation model,

“Hurricane Irma created the largest-scale evacuation in U.S. history, involving about 6.5 million people in Florida on mandatory evacuation orders and, consequently, 4 million evacuating vehicles.

“Severe travel delays happened throughout the state due to traffic jams; some highways [with a 75 mph speed limit] were experiencing a 15 mph peak traffic speed under a tripled traffic volume, compared to the usual conditions.”

Evacuations from major cities could prove problematic during major natural disasters. (Chip Somodevilla/Getty Images)

Assuming the movement of the cars would be the same, researchers examined the electricity demands if the evacuating vehicles were EVs and compared that to the power providers in Florida.

The simulation result found that in some areas “the power demand would significantly exceed the capacity,” but others areas would hold up better in the short-term due to drivers charging at home.

As batteries drained and needed to recharge, however, the simulation showed concerning results.

“When the exodus reached inland Florida and batteries are depleted, the power service companies there would face enormous electricity pressure, and the EV power demand would rapidly exceed their safety margins.”

Indeed, the report found that some power companies would experience a power shortage of 400 megawatts to 1000MW, meaning between 35 to 45 percent of vehicles would receive power, and 55 to 65 percent wouldn’t.

Further, while power companies in cities such as Tallahassee and Gainesville would initially be capable of supplying power, once demand on other grids surpassed supply, there would be a “larger-scale cascading failure in the power network” lasting up to three days.

People leave with supplies outside a Home Depot store in Miami, Fla,, as they prepare for Hurricane Irma, Sept. 7, 2017. (Saul Loeb/AFP via Getty Images)

The report’s abstract states, “The increasing usage of electrical vehicles might not meet the safety requirement of massive hurricane evacuations, which may happen more frequently in the future climate.

“Policymakers need to consider the evacuation problem as EVs are increasingly adopted in disaster-prone regions. Potential solutions include developing centralized charging strategies, improving battery technology, and adopting hybrid vehicles in addition to EVs.”

In response to the critique of EVs not being suitable for evacuations during hurricanes, the EV advocacy site EV Resource wrote, “While power outages are a problem during and after hurricanes, there aren’t electricity shortages before the storm.”

In EV Resource’s opinion, people can charge before a storm, and that charge should be sufficient to reach safety.

“EVs don’t sit and burn fuel. The horror stories of people being stuck in traffic for 12 hours and running out of gas simply aren’t a problem for EVs and hybrids. Even for long stays in traffic, EVs can run for a long time by shutting off non-essentials like air conditioning.”

Neither the Electrification Coalition nor the Eclectic Vehicle Association returned The Epoch Times’ request for comment on evacuation solutions.

Fires or Earthquakes

EV Resource didn’t provide data to back up the above assertions on their site. Moreover, while hurricanes usually have advanced warnings, fires and earthquakes often don’t, as pointed out in “The Use of Electric Cars in Short-Notice Evacuations: A Case Study of California’s Natural Disasters.”

Further, the case studies’ authors—Roxanne Peterson and Mohamed Awwad of the Industrial and Manufacturing Engineering Department at California Polytechnic State University—point out, “Short-notice evacuations, such as those caused by wildfires and earthquakes, may lead to stall-outs, resulting in increased traffic and accidents.”

Traffic is diverted off of the 71 freeway during the Blue Ridge Fire in Chino Hills, Calif., on Oct. 27, 2020. (David McNew/Getty Images)

According to the case study, EVs have a range of 100 to 200 miles, and full recharging can take anywhere from three to 12 hours. Fast charging is quicker, but still takes up to 30 minutes.

In the case of an emergency evacuation charging delays “can create serious problems in evacuations” leading to increased traffic and traveling delays as EVs potentially block lanes.

The report said, “California’s two main natural disasters are earthquakes and wildfires.

“Both are short-notice events that have the potential to knock out the power grid with no warning, making it especially difficult, if not impossible, to charge a Battery Electric Vehicle (BEV).

“More than 2 million properties in California are at extreme risk from wildfires, making up about half of all properties at extreme risk from wildfires.”

https://www.zerohedge.com/technology/electric-vehicles-may-present-major-problem-during-natural-disaster-evacuations-experts

Novartis: 2 Children Died From Liver Failure After Treatment With Zolgensma Gene Therapy

 NOVARTIS REPORTS TWO CHILDREN DIED FROM ACUTE LIVER FAILURE AFTER TREATMENT WITH ITS ZOLGENSMA GENE THERAPY

https://www.marketscreener.com/quote/stock/NOVARTIS-AG-9364983/news/Novartis-Reports-Two-Children-Died-From-Acute-Liver-Failure-After-Treatment-With-Its-Zolgensma-Gene-41285899/

CDC Drops Quarantine Recommendations for Unvaccinated Americans Exposed to COVID

 The Centers for Disease Control and Prevention on Thursday updated its COVID-19 guidance to allow Americans who are unvaccinated or not up to date on their shots to skip quarantine after exposure to the virus.

Instead, those people should wear a high quality mask for 10 days and get tested on day five or sooner if they have symptoms, according to the CDC. It’s the same guidance for people who are up to date on their shots. The agency previously recommended that undervaccianted individuals quarantine for five days.

The agency cited the availability of coronavirus treatments, high levels of immunity against the coronavirus as well as a desire to “limit social and economic impacts” in a report published alongside its decision. But COVID-19 immunity – both from infection and from vaccination – has proved fleeting in the face of ever-changing variants, making the concept of herd immunity likely unattainable for the virus.

“These circumstances now allow public health efforts to minimize the individual and societal health impacts of COVID-19 by focusing on sustainable measures to further reduce medically significant illness as well as to minimize strain on the health care system, while reducing barriers to social, educational and economic activity,” the CDC wrote in its report.

Isolation guidance from the CDC mostly remained unchanged, recommending that people who test positive isolate for at least five days. If after the fifth day the person has no symptoms or symptoms are improving, they can end isolation but continue to wear a mask through day 10. However, regardless of when someone’s isolation ends, they should avoid being around people who are more likely to get very sick from COVID-19 until at least day 11.

The update also clarifies that if a person has ended their isolation but their symptoms worsen, they must restart their isolation period.

The changes highlight the agency’s efforts to shift COVID-19-related decisions to the individual level as states, cities and the federal government have ended most coronavirus mitigation measures. Still, the majority of the country is undervaccinated, and coronavirus cases, deaths and hospitalizations remain elevated.

https://www.usnews.com/news/health-news/articles/2022-08-11/cdc-drops-quarantine-recommendations-for-unvaccinated-americans-exposed-to-covid-19

Poseida Therapeutics results and update

 Announced strategic collaboration with Roche, with a $110 million upfront payment, to focus on the research and development of allogeneic CAR-T cell therapies directed to hematologic malignancies

Completed an underwritten public offering adding multiple quality institutional shareholders with gross proceeds of $80.5 million

Well capitalized with cash runway into at least mid-2024

https://finance.yahoo.com/news/poseida-therapeutics-provides-updates-financial-200500053.html

Graphite launches sickle cell study

 Graphite Bio 

 announced the initiation of patient dosing in the Phase 1/2 CEDAR trial with its asset GPH101 (nulabeglogene autogedtemcel) in people with sickle cell disease (SCD).

Nula-cel is an investigational next-gen gene-editing autologous hematopoietic stem cell (HSC) therapy designed to directly correct the genetic mutation that causes sickle cell disease (SCD).

The CEDAR Phase 1/2 single-dose clinical trial is evaluating the safety, preliminary efficacy and pharmacodynamics of nula-cel in approximately 15 patients at multiple sites in the United States with severe SCD.

Josh Lehrer, Chief executive officer, said, For decades, the goal of gene editing has been to precisely correct genetic mutations that cause disease. Today, we took an important step toward achieving that goal by dosing our first patient with nula-cel, the first investigational therapy designed to correct a mutated gene to normal. This first use of high-efficiency precision DNA repair to correct a genetic mutation is an important milestone not only for our company but also for the gene editing field and, hopefully, for the sickle cell community.”

The company is planning to announce initial proof-of-concept data readout from the CEDAR trial in mid-2023.

https://www.benzinga.com/general/biotech/22/08/28458313/graphite-bio-shares-soar-as-initial-stage-blood-cell-disorder-study-launched