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Wednesday, December 1, 2021

NYC Prisons Face Crippling Staff Shortages As Thousands Defy Mayor's Vaccination Mandate

 Outgoing NYC Mayor Bill de Blasio has been widely criticized for seeming and acting out of touch with New Yorkers. And during his final weeks in Gracie Mansion, the intensely unpopular Democratic candidate may unwittingly handicap the already struggling NYC jail Riker's Island.

To wit, the AP reports that hundreds of city department of corrections' workers might soon be fired after missing a Tuesday deadline to either get vaccinated or see their waiver approved. The city's DoC reported 77% of its staff had gotten at least one vaccine dose as of 1700ET on Monday. That's the lowest rate of any city agency, meaning about 1,900 employees have yet to comply with the mandate or apply for the waiver.

The deadline for compliance was delayed a month for jail workers because of existing staffing shortages.

Jail workers who have applied for religious or medical exemptions can continue to work while their cases are reviewed, officials said. They plan to release data on Wednesday detailing how many workers sought for an exemption. But they already know that the number who have obstinately refused to do either is unsustainably high.

Those who don't comply are supposed to be placed on unpaid leave and asked to surrender any badges or city-issued firearms (or other equipment).

What is the mayor doing about this? Well, in anticipation of the looming mandate, Mayor de Blasio on Monday issued an emergency executive order designed to beef up jail staffing by authorizing a transition to 12 hour from 8 hour shifts. Faced with a revolt over vaccine mandates, the mayor is asking remaining workers to take on more hours in a poorly paid, highly dangerous job.

The workers and their union representatives are unsurprisingly pushing back: The president of the union for jail guards balked at de Blasio's decision to move to 12-hour shifts, calling it "reckless and misguided."

The union said it would sue to block the mandate, the same tactic an NYC police union tried in late October as the vaccine requirement for officers neared. The police union lost and the mandate went into effect as planned.

To be sure, Benny Boscio Jr., the president of the Correction Officers’ Benevolent Association, told the AP that staffing in the city’s jails is as bad or worse than it was in October, when the mayor announced jail workers would have extra time to meet the vaccine mandate.

Resignations and retirements are already piling up, Boscio warned. Asking more able-bodied workers to go on unpaid leave would be like "pouring gasoline on a fire", Boscio said.

"To move forward with placing what little staff we do have on leave tomorrow would be like pouring gasoline on a fire, which will have a catastrophic impact on the safety of our officers and the thousands of inmates in our custody," Boscio said Tuesday.

NYC's jails, which includes the notorious Rikers Island complex, have been plagued by surging violence, self-harm and deaths since the start of the pandemic. At least 14 deaths have been recorded in NYC's jails so far this year, the highest number since 2013.

But de Blasio doesn't seem to care; he's preoccupied with adopting a new plan that would ban horse-drawn carriages and replace them with electric cars. And on Monday he imposed a new vaccination mandate on child-care workers in the city. You almost couldn't make this up.

https://www.zerohedge.com/political/nyc-prisons-face-crippling-staff-shortages-thousands-defy-mayors-vaccination-mandate

Invacare gets FDA warning letter

 Invacare Corp. said it received a warning letter from the U.S. Food and Drug Administration.

The maker of medical equipment used in non-acute care settings said in a U.S. Securities and Exchange Commission filing that the letter related to observations in a Form FDA-483 issued in June following an inspection of the company's Elyria, Ohio, facilities.

The warning letter relates to procedures involving complaint handling, corrective and preventive action and medical device reporting associated with oxygen concentrators.

The FDA issues a Form 483 at the conclusion of an inspection when an investigator observes any conditions that may constitute violations of the Food Drug and Cosmetic Act and related acts.

Invacare said in the filing it intends to respond in a timely manner and work to adequately address the FDA's concerns.

The company said there has been no impact on the its ability to produce and market its products.

https://www.marketscreener.com/quote/stock/INVACARE-CORPORATION-13127/news/Invacare-Gets-Warning-Letter-From-FDA-37182238/

Amgen: FDA Approves Kyprolis Combination to Treat Multiple Myeloma

 Amgen Inc. said Wednesday the U.S. Food and Drug Administration approved Kyprolis in a combination regime to treat certain adult patients with relapsed or refractory multiple myeloma.

The company said the FDA expanded Kyprolis' prescribing information to include its use with Darzalex Faspro, or daratumumab and hyaluronidase-fihj, and dexamethasone to treat adults with relapsed or refractory multiple myeloma who have received one to three lines of therapy.

Amgen said the expansion was supported by an ongoing Phase 2 trial evaluating Darzalex Faspro in combination with four standard-of-care treatment regimens in patients with multiple myeloma.

https://www.marketscreener.com/quote/stock/AMGEN-INC-4847/news/Amgen-Says-FDA-Approves-Kyprolis-Combination-to-Treat-Multiple-Myeloma-37184855/

CVS started at Buy by Seaport

 Target $110

https://finviz.com/quote.ashx?t=cvs

AstraZeneca to Scrap Plan for U.S. Covid Booster Study

 

AstraZeneca Plc is dropping plans to test its Covid-19 vaccine as a booster in the U.S., according to a letter sent to participants in the clinical trial that urged volunteers to seek a third dose elsewhere.

After discussions with the U.S. government, it became clear that the U.K. drugmaker was unlikely to pursue plans to assess a third dose of its vaccine, New York’s Montefiore Medical Center told trial participants on Tuesday.

“We learned this not long ago, and were hoping that there would be a formal announcement from AstraZeneca,” the letter said. “In the absence of a formal announcement, we are sending this information in the interest of your health.”

Astra, one of the first vaccine developers out of the gate, has yet to win clearance to sell the shot in the U.S. after facing questions about its clinical trial results and side effects. As a result, the product has taken a back seat to messenger RNA rivals made by Moderna Inc. as well as Pfizer Inc. and its German partner, BioNTech SE

Barry Zingman, the doctor overseeing the trial at Montefiore, advised participants in Astra’s vaccine trial who haven’t gotten a third shot to seek one outside the study, mentioning immunizations from Pfizer, Moderna and Johnson & Johnson. Volunteers who take one of these shots can still remain in the study, he said.

The performance of Astra’s vaccine, which was developed with the University of Oxford, as a booster will become clearer in coming days when the U.K. releases a study comparing the performance of seven different Covid shots administered as a third dose. 

A spokesperson for Astra declined to comment. It was unclear whether there would be an Astra booster, Montefiore said, and the hospital therefore encouraged patients to get a booster off-site in light of immunization recommendations from health authorities. 

https://www.bloomberg.com/news/articles/2021-12-01/astra-to-scrap-plan-for-u-s-booster-study-participants-told

    Moderna could have Omicron booster ready in March

     Moderna Inc could have a COVID-19 booster shot targeting the Omicron variant tested and ready to file for US authorization as soon as March, the company's president said on Wednesday.

    Moderna President Stephen Hoge said he believes booster shots carrying genes specifically targeting mutations in the newly-discovered Omicron variant would be the quickest way to address any anticipated reductions in vaccine efficacy it may cause.

    The company is also working on a multi-valent vaccine that would include up to four different coronavirus variants including Omicron.
    That could take several more months, he said.
    The United States identified its first COVID-19 case caused by the Omicron variant in California, the US Centers for Disease Control and Prevention said on Wednesday.
    Omicron, dubbed a "variant of concern" by the World Health Organization, is being studied to see if it is more contagious or causes more severe illness than other variants, and if it can evade current vaccines.
    Given prior guidance from the US Food and Drug Administration, which has required mid-stage clinical testing, Hoge said the process could take three or four months.
    "The Omicron-specific boosters, just realistically, are not before March and maybe more in the second quarter," Hoge said, unless the FDA changes its guidance for what data would be needed for authorization.
    Moderna would be able to manufacture the vaccine as it was conducting the testing, Hoge said, to have it ready to roll out as soon as possible.
    He said the FDA is currently assessing the threat to vaccine protection posed by the Omicron variant. The agency could provide a faster timeline, akin to the way it approves vaccines for influenza, by approving changes in the flu strains, which would shorten the three- to four-month timeline.
    In the United States, licensed flu vaccines can be updated each season by substituting in new strains of the virus that are believed to be most likely to cause illness in the upcoming flu season, without the need for large, randomized clinical trials.
    Based on the pattern of mutations seen in the Omicron variant, which include mutations that have already been shown to reduce the efficacy of its vaccine in lab studies, Hoge said, "we expect there will be an impact."
    It is not clear yet how big of a drop in efficacy the Omicron variant will cause for current vaccines, but it could be significant, Hoge surmised.
    "The mutations that had previously led to the biggest drops in efficacy were seen in Delta and Beta. And all of those mutations have shown up in Omicron," Hoge said.
    "And so the question here is, are we going to see a Delta-like performance? Are we going to see a Beta-like performance? Or are we going to see some cross multiple of the two? I think it's that last scenario that has people most concerned," he said.
    Hoge said the company is testing to see whether fully vaccinated recipients of Moderna's vaccine are protected against the variant, as well as those who received the 50-microgram and 100-microgram booster doses of the shot.
    "I still believe that the existing vaccines will be able to at least slow down, if not completely stop, the Omicron variant," he said.

    NYC private schools now mandating COVID-19 vaccines for all students

     Some of the city’s most exclusive private schools are leading the charge in mandating COVID-19 vaccines for all students, The Post has learned.

    Elite bastions including Spence, Chapin, and Horace Mann have all sent out letters in recent weeks informing parents of the requirement and issuing deadlines for students to get the jab.

    “The expectation is now for all Spence students ages 5-11 to have received their first dose of COVID vaccine before January 7, 2022, and to be fully vaccinated by February 11, 2022,” Spence’s Principal Bodie Brizentine wrote to parents last month.

    The school said it would field medical and religious exemption requests that were formally sought before this upcoming Monday.

    “No consideration of exemptions will be accepted after this date,” Brizentine cautioned.

    Horace Mann Head of School Thomas Kelly issued a similar letter mandating the vaccine for all students.

    Horace Mann Head of School Thomas Kelly told parents that they shouldn't be surprised by the school's new vaccine mandate.
    Horace Mann Head of School Thomas Kelly told parents that they shouldn’t be surprised by the school’s new vaccine mandate.
    James Messerschmidt

    “No one with children ages five through eleven should be surprised by the school’s decision to mandate the new Pfizer vaccine,” Kelly wrote in a November 5 email to parents.

    The Chapin School has also elected to require students to get the jab in order to maintain enrollment with a deadline of January 14.

    Most city private schools are expected to follow suit if they have not already established the mandate.

    “There is a lot of support for this and some dissenters as well,” a Chapin parent said. “There are definitely parents here who are hesitant. It will be interesting to see how it plays out.”

    The Chapin School will require all students to be vaccinate for COVID-19 by January 14.
    The Chapin School will require all students to be vaccinated for COVID-19 by January 14.
    J.C. Rice

    Mayor Bill de Blasio declined to require doses for students this academic year, arguing that his focus was on getting Department of Education employees vaccinated.

    Mayor-elect Eric Adams said in October that he would back mandatory student vaccinations shortly before they received FDA approvals.

    “We already have a system in place that states before you start school, you receive your vaccination. It is to protect the child and the student population,” Adams told WCBS Newsradio 880.

    City Catholic schools have encouraged parents to get their kids vaccinated against the coronavirus but have stopped short of requiring them.

    California Gov. Gavin Newsom was the first official to require the vaccine for public school students, with the mandate expected to take effect later this year.

    https://nypost.com/2021/12/01/some-nyc-private-schools-now-mandating-covid-vaccines-for-students/