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Friday, February 11, 2022

Wall Street begins to drop mask mandates

 Mask mandates on Wall Street are becoming a thing of the past as some of the biggest players in finance are relaxing stringent requirements for vaccinated employees, FOX Business has learned.   

As omicron infections are slowing across the country, Goldman Sachs, JPMorgan, Morgan Stanley and the New York Stock Exchange are no longer requiring masks for fully-vaccinated employees.

Management at the New York Stock Exchange announced at an internal town hall Thursday that masks are no longer mandatory on the trading floor for fully-vaccinated employees as of Friday, people with direct knowledge of the matter confirmed to FOX Business. NYSE is not requiring booster shots to be considered fully vaccinated at this time. However, people who visit the Big Board as guests will need to show proof of vaccination status as well as a negative COVID-19 test within 24 hours of visiting, before entering without a mask. Management said they would revisit that policy in the coming weeks.  

"I’m pleased we’re taking another step forward to returning to a sense of normalcy," one trader told FOX Business. "It’s been a very long two years."  

An internal memo sent out by JPMorgan management Friday morning stated that masks are now completely voluntary in all U.S. offices for individuals who have been fully vaccinated unless there are more stringent local restrictions in place. Those local restrictions refer to branch offices in areas of the country where mandates remain in effect and where local guidelines will override company policy.  

The memo also outlines the company’s definition of "fully vaccinated," which is an employee who has received at least the first two shots and updated their vaccine status in the company’s database. Booster shots are not required for employees at this time.   

Workers who have not received a vaccine or have not reported their status will still be required to wear a mask in public spaces and participate in twice-weekly mandatory testing, the JPMorgan memo stated.  

The memo also noted that many employees have now returned to the office with a "large percentage" of its workforce vaccinated.   

Goldman Sachs is also dropping its mask mandates, making them optional starting Monday, a Goldman spokesperson confirmed to FOX Business.  

A spokesperson for Morgan Stanley confirmed to FOX Business that as of February 1st, masks are no longer required at vaccine-only locations unless otherwise mandated. 

The move to ease mandates come as the number of new COVID-19 cases are slowing, and according to data from the CDC, the number of people in hospital with the virus has dropped more than 63% over the past month.  

Dr. Anthony Fauci, chief medical adviser for President Biden, said in an interview published Tuesday that the U.S. is almost past the "full-blown" pandemic phase of the coronavirus.  

New York Governor Kathy Hochul dropped her statewide mask mandate that impacts both private and public sector employees on Wednesday, citing "tremendous progress" battling the virus in New York State.  

https://www.foxbusiness.com/markets/wall-street-mask-mandates

California extends COVID-19 paid sick leave, expands small business relief

 Millions of California workers are now eligible for two weeks of paid sick leave if they are infected with COVID-19 under a new bill that Gov. Gavin Newsom signed into law this week.

The legislation provides up to two weeks of paid sick leave for those recovering from COVID-19, on top of the three days of paid sick leave that employers are already required to give workers. California had previously extended its paid sick leave earlier in the pandemic, but the program expired in September. 

"By extending sick leave to front-line workers with COVID and providing support for California businesses, we can help protect the health of our workforce while also ensuring that businesses and our economy are able to thrive," Newsom said in a statement. 

The reinstated sick leave program is retroactive to Jan. 1 and officially ends on Sept. 30. It applies to businesses with 26 or more employees. The program also provides 40 hours – or eight days – of paid time off for workers who are: experiencing symptoms that are consistent with COVID-19, subject to quarantine requirements or taking care of a sick relative or child whose school or day care is closed because of the virus. Finally, workers can use up to 24 hours of paid time off to get the COVID-19 vaccine or recover from vaccine-related side effects. 

Newsom signed the measure along with several other bills included in a COVID-19 emergency package, including a law that will give new tax cuts to businesses and new relief to restaurants. The bills will provide roughly $6 billion in relief for small businesses; most of the money – about $5.5 billion – stems from tax credits and deductions for the businesses. Restaurants alone will receive about $500 million in tax cuts. 

"This much-needed tax relief is not only essential for the immediate help of employers, but it also creates a pathway and lays the foundation for long term economic recovery for our employers," said Jennifer Barrera, president of the California Chamber of Commerce.

The relief package also includes $150 million in grants for small businesses on the waitlist for a separate grant program. Newsom estimated that the money will provide relief for about 13,500 businesses in the state. 

Newsom also signed a bill allocating another $1.9 billion to combat COVID-19, including ramping up testing and vaccination efforts.

https://www.foxbusiness.com/politics/california-covid-paid-sick-leave

There’s no autism epidemic. But there is an autism diagnosis epidemic

 Is there an autism epidemic? No. The increase in the autism rate recently reported by the Centers for Disease Control and Prevention represent an autism diagnosis epidemic.

Writing in the weekly journal MMWR, CDC researchers reported that autism rates in the United States increased from 1 in 150 children in 2000 to 1 in 54 in 2016, and the rate now stands at 1 in 44 children.

Some argue that autism’s prevalence is rising because of environmental causes like vaccines. There is no evidence, though, for that explanation. Others argue that the rate is increasing because of the rising age of parents, especially fathers. This doesn’t explain the whole story, however, as increased paternal age accounts for only about 3% of the increase.

I believe that the rise in the autism rate is social, not biological. It’s not that more children are developing symptoms of autism, but multifaceted sociological and political factors are increasing the diagnoses and documentation of this condition.

The first of these factors was the rise of the deinstitutionalization movement. Starting in the 1960s, parent groups such as the National Association of Retarded Children advocated for the deinstitutionalization and normalization of children diagnosed with what was then called mental retardation. (The phrase “mental retardation” is offensive today, but I use it here because it was the technical diagnosis at the time). These parent groups partnered with therapists to develop new treatments for children that took place outside of institutions.

In his book “The Autism Matrix,” sociologist Gil Eyal explained that a diagnosis of autism fit the message of the deinstitutionalization movement better than mental retardation because the public believed that children with autism lagged behind only in some areas and could improve with behavioral therapies. In contrast, children with mental retardation were believed to lag behind in all areas and could not improve with therapy, justifying banishing them to institutions away from society.

As the deinstitutionalization movement took off, many children who would have been diagnosed with mental retardation were instead diagnosed with autism, not because the diagnosis was more accurate but because its treatment was preferable. As autism diagnoses increased, diagnoses of mental retardation and other learning disabilities decreased. More diagnoses and more patient advocacy led to more money dedicated to autism therapy and research, which in turn led to even more diagnoses. This trend has continued today as the number of psychiatric beds continues to decrease and parent advocacy groups successfully lobby to raise billions for autism research.

Another powerful factor behind the rise in autism rates is the passing of insurance mandates. Since 2001, all 50 states have instituted mandates requiring non-self-funded private insurance plans to cover behavioral therapies for autism. These mandates can save families up to $50,000 a year on treatment. The prevalence of autism increased an average of 10% directly following a state’s mandate implementation and 18% after a mandate had been place for a few years.

Insurance mandates increase autism rates because, in borderline cases, practitioners and parents push for a diagnosis that ensures a child receives coverage for the help the child and family need. The families of children with developmental disorders other than autism must often rely on broad laws such as the Individuals with Disabilities Education Act (IDEA), which vaguely states that each child must receive a “free and appropriate public education in the least restrictive environment.” IDEA’s implementation is underfunded by Congress and largely depends on each state’s interpretation of it. With such limited options for children with special needs, it makes sense that caring practitioners might push for a diagnosis that guarantees children receive the help they need.

These factors were crystalized by the CDC’s changing methodology to measure autism rates. In 2013, the American Psychiatric Association narrowed its criteria for an autism diagnosis. In its 2018 and 2020 reports, however, the CDC used both the psychiatric association’s older broad diagnostic criteria and its newer narrow criteria, inflating rates. In its December 2021 report in MMWR, the agency went a step further, including not only children with autism diagnoses but also those with an autism billing code or a special education classification of autism. That meant a child didn’t even need a formal diagnosis of autism to be counted as a datapoint in the “autism epidemic.”

It’s easy to believe that disease categories simply report divisions in nature. But political and social factors also affect disease rates, as well as who receives treatment. Autism rates aren’t spiking because more children are developing this condition, but instead because of the deinstitutionalization movement, insurance legislation, and data collection methods. These social factors control which conditions receive more funding for treatment and research. They are even powerful enough to fuel an “epidemic.”

Rachel Burr Gerrard is a first-year medical student at the University of Pennsylvania. This essay stems from research she conducted for a master’s degree in philosophy from the University of Cambridge’s Health, Medicine and Society program.

https://www.statnews.com/2022/02/10/theres-no-autism-epidemic-but-there-is-an-autism-diagnosis-epidemic/

WHO adds Roche’s arthritis drug tocilizumab to COVID-19 medicines list

 The World Health Organization said on Friday it had added its first monoclonal antibody tocilizumab to its so-called pre-qualification list, an official list of medicines used as a benchmark for procurement by developing countries.

The WHO recommended the drug, manufactured by Roche and typically used to treat arthritis, only for patients diagnosed with severe or critical COVID-19.

https://wtvbam.com/2022/02/11/who-adds-roches-arthritis-drug-tocilizumab-to-covid-19-medicines-list/

Does Any Monoclonal Antibody Work Against BA.2?

 Sotrovimab, the only monoclonal antibody currently authorized to treat Omicron, appeared to lose its neutralizing activity against the Omicron subvariant, BA.2, lab data showed.

Neutralization activity for sotrovimab was 27-fold lower against BA.2 than against the original Omicron variant, BA.1, reported David Ho, MD, of Columbia University in New York City, and colleagues in a pre-print in bioRxiv.

BA.2 has blanketed COVID cases in Europe, and according to the latest CDC data, it comprises 3.6% of COVID cases in the U.S.; prior pre-print research found it to be more transmissible than the original Omicron.

Manufacturer Vir Biotechnology fired back against the study from Ho's group, saying its own lab data suggest sotrovimab sufficiently retains neutralizing activity against BA.2; the company plans to publish its own pre-print in bioRxiv shortly.

Importantly, Vir CEO George Scangos noted in the statement that the "500 mg dose of sotrovimab is sufficient to retain activity against the BA.2 variant." While this is the dose authorized by the FDA, Ho's group did not indicate the dosing in their pre-print.

They looked at neutralizing activity of the Omicron sublineages, first using convalescent sera. They found "a marked and significant loss of neutralizing activity" against both BA.2 and sublineage, BA.1+R346K, with "neutralizing titers dropping below the limit of detection."

They added that this drop in neutralizing activity was "less prominent" among sera from individuals who received a booster dose of vaccine, where the mean titer was "slightly lower" for BA.2, but the difference was non-significant compared to BA.1.

Ho's team then used 19 neutralizing monoclonal antibodies, where all but three had their emergency use authorization (EUA) altered by the FDA for being ineffective against Omicron.

Interestingly, while the group noted that all class 3 antibodies "lost greater neutralizing potency against BA.2 versus BA.1 sublineages," cilgavimab/tixagevimab (Evusheld) "retained activity against BA.2."

However, as they noted, this combination is only authorized for pre-exposure prophylaxis, not treatment.

"Presently, no authorized therapeutic monoclonal antibody could adequately treat all sublineages of the Omicron variant," they concluded.


Disclosures

FDA Puts COVID Vaccine for Toddlers in Timeout

 FDA is postponing their scheduled advisory committee meeting on Pfizer's COVID-19 vaccine for children ages 6 months to 4 years, which now may not happen for a few more months, agency officials said on Friday.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) was slated to meet on Tuesday, February 15, to discuss Pfizer's application for their COVID vaccine in this age group. However, an FDA media briefing indicated that it could take months to get the new data needed to go forward.

statement from FDA noted that Pfizer recently told them about "additional findings from its ongoing clinical trial," which led the agency to postpone the meeting. As previously reported, a two-dose vaccine series failed to meet immunobridging criteria among the youngest children.

Pfizer itself released a statement, explaining that a third dose "may provide a higher level of protection in this age group," based on findings from booster dose studies that showed that three doses boosted neutralizing antibody levels and "real-world protection."

In a hastily arranged media briefing on Friday, Peter Marks, MD, PhD, director of FDA's Center for Biologics Evaluation and Research, noted that the Omicron variant has sickened a large number of children, which compelled the agency to act with urgency. However, they ultimately came to the conclusion that "additional time regarding a third dose should be considered."

Prior media reports indicated this was all but a done deal, and that the vaccine could be authorized for this age group by President's Day.

When reporters pressed Marks for details, he explained that "the data that we saw made us realize that we needed to see data from a third dose in the ongoing trial in order to make the determination that we could proceed with doing an authorization."

Marks added that it was a safe assumption that when the additional data are reviewed, they will be clinical data on infection and not merely immunobridging data.

He promised that FDA would review the data "in an expeditious manner" as it came in.

"For the next few months, while these additional data are gathered, parents will have to rely on what they've come to do well," including the use of masks and ensuring that all other family members are vaccinated, Marks said.

https://www.medpagetoday.com/infectiousdisease/covid19vaccine/97159

FDA authorizes Eli Lilly's new COVID-19 antibody drug

 he U.S. Food and Drug Administration on Friday authorized Eli Lilly and Co's COVID-19 antibody drug for people aged 12 and older at risk of severe illness, adding a tool that has been found to work against the highly contagious Omicron variant.

The FDA authorized bebtelovimab for emergency use in patients with mild-to-moderate COVID-19 who are at high risk of progression to severe disease, including hospitalization or death.

Bebtelovimab should be used when alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate, the agency said.

The U.S. health regulator had in January revised the emergency use authorizations for Lilly's antibody combination treatment and a rival therapy from Regeneron after the drugs were found to be ineffective against the Omicron variant.

Lilly has said bebtelovimab retains activity against Omicron as well as its BA. 2 subvariant, which is said to be more transmissible.

The company on Thursday signed a supply deal with the U.S. government for up to 600,000 doses of bebtelovimab to be delivered by the end of March.

https://finance.yahoo.com/finance/news/1-u-fda-authorizes-eli-195338320.html

Bebtelovimab was originally discovered by AbCellera Biologics and later licensed and developed by Eli Lilly.