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Saturday, January 1, 2022

Moderna creates twice as many antibodies as Pfizer, study shows

 Moderna Inc.’s COVID vaccine generated more than double the antibodies of a similar shot made by Pfizer Inc. and BioNTech SE in research directly comparing immune responses to the inoculations.

A study of almost 2,500 workers at a major Belgium hospital system found antibody levels among individuals who hadn’t been infected with the coronavirus before getting two doses of the Moderna vaccine averaged 2,881 units per milliliter, compared with 1,108 units/mL in an equivalent group who got two jabs of the Pfizer shot.

The results, published Monday in a letter to the Journal of the American Medical Association, suggested the differences might be explained by the:

higher amount of active ingredient in the Moderna vaccine -- 100 micrograms, versus 30 micrograms in Pfizer-BioNTech
longer interval between doses of the Moderna vaccine -- four weeks, versus three weeks for Pfizer-BioNTech

Moderna’s vaccine was associated with a two-fold risk reduction against breakthrough SARS-CoV-2 infections compared to Pfizer’s in a review of people in the Mayo Clinic Health System in the U.S. from January to July. The results were reported in a separate study released ahead of publication and peer review on Aug. 9.

https://www.bnnbloomberg.ca/moderna-creates-twice-as-many-antibodies-as-pfizer-study-shows-1.1700253

Buttigieg, FAA chief request delay in 5G rollout over airlines' concerns

 Transportation Secretary Pete Buttigieg and the administrator for the Federal Aviation Administration sent a letter addressed to Verizon and AT&T requesting that they delay their rollout of 5G services amid airlines’ concerns over flight disruptions.

“We ask that your companies continue to pause introducing commercial C-Band service for an additional short period of no more than two weeks beyond the currently scheduled deployment date of January 5,” Buttigieg and FAA Administrator Steve Dickson wrote to the two companies in a letter dated Friday.

The two federal officials said “commercial C-band service would begin as planned in January with certain exceptions around priority airports. The FAA and the aviation industry will identify priority airports where a buffer zone would permit aviation operations to continue safely while the FAA completes its assessments of the interference potential around those airports.”

Buttigieg and Dickson noted that 5G wireless services would be allowed to roll out on a rolling basis around priority airports “such that C-Band planned locations will be activated by the end of March 2022, barring unforeseen technical challenges or new safety concerns.”

The letter noted that the FAA would make assessments as quickly as possible, noting that their goal was to prioritize flight safety.

The letter comes one day after Airlines for America, an airlines trade group, expressed concerns over AT&T’s and Verizon’s 5G rollout, which is expected to start on Jan. 5. Citing a potential for flight disruptions as a result of the 5G rollout's technology, an emergency request was filed to the Federal Communications Commission (FCC) on Thursday.

In November, both cell phone carriers, in an attempt to address regulatory concerns, had made a proposal to limit their 5G services for the first half of 2022.

AT&T and Verizon confirmed to The Hill on Saturday that they had received the letter and were reviewing it.

“Years of research by the government and private industry has proven that 5G and aviation can safely coexist, just as it does in over 40 other nations. There is absolutely no reason why there should or will be any difference in the U.S. Assertions to the contrary are baseless and make absolutely no sense,”  Verizon said in a statement.

https://thehill.com/policy/technology/587860-buttigieg-faa-chief-request-delay-in-5g-rollout-over-airlines-concerns

Michigan shifts, will follow CDC isolation guidance

 The Michigan Department of Health and Human Services (MDHHS) announced on Friday that it would be changing its quarantine guidance to follow recommendations from the Centers for Disease Control and Prevention (CDC), a shift from earlier in the week.

Michigan's state government initially said it would not be following the CDC's new guidelines until it received further information. The new guidance shortened the recommended length of quarantine to five days for asymptomatic individuals regardless of vaccinations status.

The CDC also left out a recommendation to get a negative COVID-19 test before leaving isolation.

On Friday, the MDHHS said in a statement that it would be updating its guidance to "reflect the recent recommendations" from the CDC. 

MDHHS chief medical executive Natasha Bagdasarian said, "We have safe and effective tools for preventing the spread of COVID-19."

"Getting vaccinated continues to be the best protection against severe illness and hospitalization, and we urge all Michiganders over age 5 to get vaccinated as soon as possible," Bagdasarian said.

"These most recent updates to the quarantine and isolation guidelines are a reflection on our progress as we learn more about COVID — but we are not in the clear as variants like omicron continue to create new challenges in the fight to end this pandemic."

The CDC's new recommendations have been criticized by public health experts who warned that the new guidelines may encourage people to leave isolation while still capable of spreading infection. Some experts, like former President Trump's surgeon general Jerome Adams, advised people to still get an antigen test before leaving isolation if possible.

White House chief medical adviser Anthony Fauci defended the updated guidelines, saying this week that they were designed to "balance" the pandemic response.

"The reason is that now that we have such an overwhelming volume of cases coming in, many of which are without symptoms, there's the danger that this is going to have a really negative impact on our ability to really get society to function properly," Fauci said.

https://thehill.com/homenews/state-watch/587826-michigan-updates-guidelines-following-cdc-guidance-after-previous-delay

iTeos Therapeutics Set to Join S&P SmallCap 600

  iTeos Therapeutics Inc. (NASD: ITOS) will replace Magellan Health Inc. (NASD: MGLN) in the S&P SmallCap 600 effective prior to the opening of trading on Wednesday, January 5. S&P 500 constituent Centene Corp. (NYSE: CNC) is acquiring Magellan Health in a deal expected to be completed soon pending final conditions.

Following is a summary of the changes that will take place prior to the open of trading on the effective date:

Effective Date

Index Name

Action

Company Name

Ticker

GICS Sector

January 5, 2022

S&P SmallCap 600

Addition

iTeos Therapeutics

ITOS

Health Care


S&P SmallCap 600

Deletion

Magellan Health

MGLN

Health Care

For more information about S&P Dow Jones Indices, please visit www.spdji.com

https://finance.yahoo.com/news/iteos-therapeutics-set-join-p-224400392.html

Friday, December 31, 2021

Ivermectin's Days in Court

 On May 4, 2021, MedPage Today first reported on an Illinois judge's order for a hospital to give ivermectin to a comatose COVID-19 patient. As part of our review of the year's top stories, we look back on what has happened since this decision and the numerous cases that followed in its wake.

At the beginning of 2021, the anti-parasitic medication ivermectin took off in popularity as a treatment for COVID-19 after a campaign from the physicians at the helm of the Front Line COVID-19 Critical Care Alliance (FLCCC) touted its efficacy. Despite lack of evidence and recommendations against its use from the CDC, FDA, and NIH, some doctors and family members of COVID patients have taken the issue to court, suing hospitals that have refused to administer ivermectin in serious COVID cases.

New York

The first of these cases cropped up in January 2021, when a judge ordered Millard Fillmore Suburban Hospital in Buffalo, New York, to give ivermectin to 80-year-old Judith Smentkiewicz. She had been on a ventilator battling COVID-19 when her family members pleaded with one of the hospital's physicians to try ivermectin. Smentkiewicz received her first dose before another doctor at the hospital refused to continue the treatment.

Smentkiewicz's family maintained that even the first dose of the experimental drug made rapid improvements to her condition, which subsequently declined after the second dose was refused. The hospital insisted that doctors -- not the courts -- should be at the forefront of these decisions. State Supreme Court Judge Henry Nowak, however, went the way of Smentkiewicz's family members.

It is reported that Smentkiewicz recovered after resuming her treatments, but the connection between ivermectin and her turnaround remains unclear. Some clinicians have argued that patients might just be getting better, with or without this particular drug.

Illinois

The same was seen in May 2021, when Judge James Orel, of DuPage County, Illinois, ordered Edward-Elmhurst Hospital to allow 68-year-old Nurije Fype to receive ivermectin as a treatment for her acute COVID illness.

Fype's daughter, Desareta, learned of the drug after reading about Smentkiewicz's situation months prior. When her own mother was placed on a ventilator, she sought out ivermectin. Doctors refused, given the drug's experimental status for COVID-19 and potential side effects, including nausea, vomiting, diarrhea, sudden drops in blood pressure, and liver injury.

Bending to the judge's orders, the hospital granted internist Alan Bain, MD, credentials to give Fype ivermectin. According to some reports, she was discharged from the hospital after her condition improved. Still, whether ivermectin was what prompted Fype's recovery has yet to be proven.

In September 2021, the American Medical Association (AMA) issued a statement strongly opposing the use of ivermectin to treat COVID-19, adding that "calls to poison control centers due to ivermectin ingestion have increased five-fold from their pre-pandemic baseline."

Not all of the legal battles against hospitals in the fight for ivermectin have been successful, though. In September, MedPage Today reported that a judge sided in favor of Memorial Medical Center in Springfield, Illinois, which stood firmly against allowing ivermectin treatments for COVID patients. Anita Clouse, wife of 61-year-old Randy Clouse, took to the courts to force Memorial Medical Center to give her husband ivermectin.

Randy Clouse, who wasn't vaccinated against COVID-19, was on a ventilator and dialysis as a result of his COVID infection, the State Journal-Register reported. But in a legal response, the hospital said that Clouse's condition was improving at the time of their filing and he no longer had an active COVID diagnosis.

Chicago internist Bain had prescribed ivermectin to Clouse and testified in a hearing for the case. The lawyer representing the Springfield hospital maintained that Bain did not properly review Clouse's medical history before prescribing the drug and that he refused to acknowledge the widespread medical advice regarding the use of ivermectin for COVID-19 patients.

Attorney Ralph Lorigo, who represented Clouse and a number of other patients, told MedPage Today that, as of Nov. 3, Clouse was taken off the ventilator and later discharged from the hospital.

Lorigo also represented Man Kwan Ng, the daughter of 71-year-old Sun Ng, in a case against Edward Hospital in Naperville, Illinois. Sun Ng ended up on a ventilator with COVID-19 in mid-October, the Chicago Tribune reported. Despite the hospital's refusal to turn to ivermectin -- citing the same safety and efficacy concerns as health officials -- a DuPage County Judge ruled that Bain, who is unvaccinated, could prescribe Ng with ivermectin.

According to the Daily Herald, Lorigo said Ng removed his breathing tube himself after 5 days of ivermectin treatment. The lawyer for Edward Hospital, however, said Ng was improving before the treatment even started.

Ohio

At the beginning of September, what at first looked like a win for ivermectin proponents turned out to be a loss in the case of Julie Smith, who filed suit against West Chester Hospital, located near Cincinnati, to allow the use of ivermectin after her husband, Jeffrey Smith, 51, was placed on a ventilator and diagnosed with a secondary infection, the Ohio Capital Journal reported.

Although a Butler County judge originally ruled in favor of the Smith family against the hospital's wishes, the ruling was flipped a week later by a different judge after physicians told the court that ivermectin was not helping Smith get better, NPR reported.

Fred Wagshul, MD, who is affiliated with the Front Line COVID-19 Critical Care Alliance, had prescribed ivermectin to Smith before the hospital's refusal. At the follow-up hearing, Wagshul testified that he wasn't sure if the drug would help Smith, ultimately convincing the judge to reverse the order.

"After considering all of the evidence presented in this case, there can be no doubt that the medical and scientific communities do not support the use of ivermectin as a treatment for COVID-19," Judge Michael Oster ruled.

According to reports, Smith died a few weeks later.

Kentucky

In a similar decision from mid-September, Jefferson Circuit Court Judge Charles Cunningham overruled a previous ruling from a different judge, ultimately permitting a hospital to deny the prescription of ivermectin to a COVID patient.

Angela Underwood had filed a suit against Norton Brownsboro Hospital in Louisville, Kentucky, claiming that the hospital prohibited one of its physicians from administering ivermectin to her husband, Lonnie, 58, despite a previous agreement.

"[The internet] is rife with the ramblings of persons who spout ill-conceived conclusions if not out-right falsehoods," Cunningham said, according to a report by the Washington Post. "If [Angela Underwood] wants to ask the Court to impose her definition of 'medically indicated' rather than the hospital's, she needs to present the sworn testimony of solid witnesses, espousing solid opinions, based on solid data."

https://www.medpagetoday.com/special-reports/exclusives/96447

Vir: New Research Describes Structure of SARS-CoV-2 Omicron Immune Evasion, Receptor Engagement


– Growing body of evidence validates Vir’s approach of targeting a highly conserved region of the spike protein –

– Together with recent pseudo- and live virus results, additional preclinical data reinforce sotrovimab retains in vitro neutralizing activity against all known variants of concern, including the highly divergent Omicron variant –

https://www.biospace.com/article/releases/vir-biotechnology-announces-new-research-describing-the-structural-basis-of-sars-cov-2-omicron-immune-evasion-and-receptor-engagement/

Missouri to lift COVID-19 state of emergency

 Missouri Gov. Mike Parson (R) has lifted the state’s COVID-19 state of emergency for the first time since March 2020. 

"Thanks to the effectiveness of the vaccine, widespread efforts to mitigate the virus, and our committed health care professionals, past needs to continue the state of emergency are no longer present," Parson said in a statement on Thursday.

"Over the last 22 months, we have coordinated with local, state, and private partners to mitigate COVID-19 and work towards returning to normalcy. We all now know how to best fight and prevent serious illness from this virus. The State stands ready to provide assistance and response, but there is no longer a need for a state of emergency."

Parson previously extended the state’s COVID-19-related state of emergency five times before issuing the final executive order for health care needs in August. 

According to the statement, all of the state’s remaining COVID-19 related waivers authorized under EO 21-09 will be terminated on Dec.31. 

Also, all state agencies, boards, commissions, and departments are allowed to pursue rule-making if permanent changes to regulations are needed after Dec.31  to improve long-term outcomes for residents, healthcare facilities, and businesses. 

"In Missouri, we never had mandates or forced lockdowns," Parson said. "The main focus of our state of emergency was to provide regulatory flexibility to support and assist Missourians, health care facilities, and businesses and coordinate a COVID-19 response that saved lives and livelihoods.” 

“We encourage all Missourians to consider COVID-19 vaccination and to stay diligent, but we can work together to fight COVID-19 while living our normal lives. It is time to take this final step and move forward as a state."

The U.S. is currently dealing with a winter surge of COVID-19 infections as the omicron variant has taken hold across the nation.

State authorities have administered over 565,000 vaccine doses with 42 percent of residents being a part of a primary vaccine series.

Nearly 94 percent of state residents over the age of 65 have received one dose of the vaccine and 62 percent of residents have chosen to get vaccinated against the virus, according to the statement.

https://thehill.com/homenews/state-watch/587845-missouri-to-lift-covid-19-state-of-emergency