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Monday, September 13, 2021

MTA Yanks $500K COVID Death Benefit From Unvaccinated Transit Workers

 Struggling to get its workforce vaccinated, the MTA has pulled a $500,000 death benefit for any unvaccinated employees who succumb to COVID, THE CITY has learned.

The MTA this week will extend through the end of the year the lump-sum payment and three years of health insurance to the survivors of vaccinated workers who die from the virus, a senior official said.

But workers who opt out of getting their shots could relinquish the rights of their loved ones to secure the benefit should they die — unless they had a “valid documented exception” to vaccination, according to a notice sent to employees by Paul Fama, the MTA’s chief people officer.

The MTA, which has 68,200 employees, has lost 171 of them to the pandemic so far, according to an agency spokesperson.

“It is more important than ever to consider how getting vaccinated not only protects you, but also your family,” Fama wrote in the memo, which was shared with THE CITY.

“We highly encourage all our team members to get vaccinated — it’s safe, effective and one of the surest things we can all do to prevent serious illness or death from COVID-19.”

An MTA vaccination center in Vanderbilt Hall at Grand Central Terminal, March 9, 2021.
The MTA ran a COVID-19 vaccination center in Vanderbilt Hall at Grand Central Terminal.
 Marc A. Hermann/ MTA

The vaccine resistance battle is playing out beyond New York as the spread of the Delta variant drives up infection rates. On Thursday, President Joe Biden issued a sweeping order mandating vaccines or weekly testing for everyone from private-sector employees to health care workers to federal contractors.

With schools set to reopen and 300,000 city employees slated to return to their workplaces Monday, the MTA is still trying to get its workforce on board with vaccines that are mandated for state employees.

Approximately 70% of staffers agency-wide have received at least one vaccine dose, according to the MTA — although the figure falls to 55% for subway and bus workers.

Vaccination rates vary across the range of MTA divisions, from nearly 89% for workers at MTA Construction & Development to below 60% for employees of MTA Bridges and Tunnels, Long Island Rail Road and New York City Transit.

A Widow’s Wish

In the face of resistance from employees, the MTA recently pushed back a Labor Day mandate for workers to get vaccinated or agree to weekly COVID tests, which are now administered at 120 sites throughout the transit system. Testing remains voluntary for now.

“We are incentivizing people to get vaccinated, so we’ve made a lot of progress,” Janno Lieber, the MTA Chairperson and CEO, told THE CITY on Friday. “It’s just like the rest of society — there are people who have questions and, for whatever reason, have elected not to get vaccinated.”

After the MTA lost dozens of employees in the early days of the pandemic, the transit agency agreed in April 2020 to the death benefit pushed for by Transport Workers Union Local 100. The half-million dollar payment is in addition to traditional benefits provided by a pension or life insurance policy.

The agreement did not require proof that workers who were in active service on or after Feb. 1, 2020, had contracted the virus on the job — only that the death was preceded by a COVID-19 infection that was unresolved when they passed away.

The pact was extended in mid-April — even after vaccines became widely available earlier this year — through the end of August. Notice was given at the time that vaccinations would be required to access the benefit as of June.

“This was an unprecedented negotiated agreement. No other workforce that suffered COVID deaths in the city, probably the country, secured employer payments of $500,000 for the victims’ families,” Tony Utano, the president of TWU Local 100 told THE CITY in a statement. “While nothing can fill the void left from each coronavirus-related passing, this agreement put grieving families on solid financial ground and helped tremendously.”

MTA bus maintainer Joseph Fletcher with his family before passing away from the coronavirus.
MTA bus maintainer Joseph Fletcher with his family in a photo taken before his death last year.
 Courtesy of the Fletcher Family

Veronica Fletcher — whose bus-maintainer husband, Joseph, 60, died in April 2020 — said his 16- and 13-year old sons were vaccinated earlier this year “in honor of their papa.”

Statistics show that people who are vaccinated have far lower infection and death rates than those who haven’t gotten inoculated against a virus that’s killed about 34,000 New Yorkers.

“I wish that my husband had the opportunity to be vaccinated,” said Fletcher, whose family received the death benefit. “We’re trying to live in honor of him.”

‘Not Going to Sway Me’

But several employees told THE CITY they will continue to refuse the vaccine — even with the prospect of their families losing out on the death benefit should they die due to COVID.

“That’s not going to sway me,” said Andy Valentine, a 40-year-old subway operator. “That’s a benefit that is good for the family, I get it, but I feel like they’re trying to coerce you.”

Tiffany Nelson, a 37-year-old station agent, said she is planning to pass on vaccination “until this thing has been fully vetted,” even though the FDA approved the Pfizer vaccine last month.

“If you don’t mandate something like the flu vaccine that’s been around for years, how is it that you can mandate something that is literally being tested?” Nelson said. “I’m not taking it, period.”

Interim MTA New York City Transit President Sarah Feinberg views the launch of “Travels Far: A Memorial Honoring Our Colleagues Lost to COVID-19” at Bowling Green on Jan. 25, 2021.
The MTA debuted “Travels Far: A Memorial Honoring Our Colleagues Lost to COVID-19” at the Bowling Green station in January.
 Marc A. Hermann / MTA

Chaumtoli Huq, an associate professor at the CUNY School of Law, said it was “great” that the MTA has offered the death benefit to surviving family members throughout much of the pandemic, but added that it’s now “changing the rules sort of midway.”

“There could be other reasons for an individual not to seek vaccination — health and other personal reasons,” Huq told THE CITY. “So their death benefit should not be conditioned on that, especially when a family is dealing with the loss of a loved one.”

Lieber said the MTA is “redoubling” efforts to get its employees inoculated. The agency has offered workers up to four hours of pay — two hours per each injection — to receive shots.

“This is a public facility,” he said. “We need our customers to be comfortable, we need the workforce to be comfortable, we need their families to be comfortable.”

https://www.thecity.nyc/2021/9/12/22667777/no-covid-death-benefit-for-unvaccinated-mta-bus-subway-workers

Washington state troopers, firefighters sue over vaccine mandate

 Dozens of public employees in Washington state filed a lawsuit against Gov. Jay Inslee (D-Wash.) last week, claiming his COVID-19 vaccine mandate went beyond his legal authority and violated the state constitution.

As The Seattle Times reported, more than 90 plaintiffs were listed in the lawsuit against Inslee, including 53 state police employees as well as firefighters, state ferry system workers and corrections staff.

In August, Inslee issued multiple proclamations requiring most state employees, school workers and health care workers to get vaccinated against COVID-19. All state employees must be fully vaccinated against COVID-19 by Oct. 18 or be blocked from working.

Exceptions to the mandate were made for disability-related reasons or a "sincerely held religious belief."

In their lawsuit, the state workers argued that Inslee's proclamations violated "the authority of his office by the Washington Constitution statute, and, independently, violates the rights guaranteed to the state workers by the Washington constitution and applicable statutes."

They also accused Inslee of imposing "unconscionable" penalties on those who do not comply.

Mike Faulk, Inslee's deputy communications director, defended Washington's vaccine mandate in a statement to The Hill.

"These requirements are both legal and appropriate to protect the public," Faulk said. "It’s not unreasonable to ask public servants to help alleviate the public’s suffering in this pandemic."

The lawsuit claims that Inslee's office could not provide evidence that a COVID-19 vaccine offered greater immunity or lowered transmissibility better than "a natural immunity produced by the human immune system."

The COVID-19 vaccines created by Moderna and Pfizer have been shown to be at least 90 percent effective at preventing COVID-19 infection. The Pfizer vaccine was granted full approval by the Food and Drug Administration last month.

As the Times noted, Inslee's mandates are stricter than those that have been enacted by other states because his do not permit weekly COVID-19 testing in lieu of getting vaccinated.

According to the Washington State Department of Health, around 75 percent of the state's eligible population has received at least one dose of a COVID-19 vaccine and about 68 percent are fully vaccinated. Both figures are significantly higher than U.S. averages of 63 percent and 54 percent, respectively. 

https://thehill.com/homenews/state-watch/572047-washington-state-troopers-firefighters-sue-over-vaccine-mandate

Employers scramble to secure vaccine verification systems

 Businesses are scrambling to secure systems for verifying COVID-19 vaccinations and implementing weekly testing following President Biden’s vaccine-or-test order announced last week.

The White House has not yet clarified key details of the new requirements, such as how companies should verify an employee’s vaccination status or whether the federal government will pick up the tab on testing, creating uncertainty among employers on how to move forward.

Still, many companies are already eyeing digital platforms to ensure employees comply with the forthcoming rule.

ReturnSafe, a startup that helps companies track workers’ vaccination and testing status through a phone app, received a 76 percent increase in inquiries following Biden’s announcement, mostly from firms with more than 1,000 employees, according to CEO Jikku Venkat.

“More and more employers are thinking about testing and vaccine protocols and how they will implement them,” Venkat said. “If I have thousands of employees spread across the country, I need some systematic way of doing all of this from a human resources standpoint.”

The administration’s rule will require companies with 100 or more workers to mandate vaccinations or weekly testing. Businesses that don’t comply with the rule could face fines up to $14,000 per violation, raising the stakes for firms that have a large number of employees to keep track of.

Employers are also looking into digital vaccine cards that have been implemented in several states as part of the Vaccination Credential Initiative, a public-private partnership that includes tech and health care giants such as Microsoft Corp. and the Mayo Clinic.

A large number of firms that already mandate vaccines for employees have yet to impose verification measures, instead asking employees to attest that they got the shot. That standard likely won’t satisfy the Biden administration rule, experts said, but as of now it’s not clear.

Domenique Camacho Moran, an employment attorney at New York-based law firm Farrell Fritz P.C., said she is advising companies to provide multiple methods for employees to verify vaccine status by using a digital platform or the COVID-19 vaccine card they received after the shots.

The Labor Department’s Occupational Safety and Health Administration is expected to formally unveil the administration’s rule within weeks, according to Jeff Zients, coordinator of the White House COVID-19 response team. The agency didn’t respond to a request for comment Monday about any guidance on how employers should plan to enforce the vaccine rules.

The administration has not said whether employers or workers will have to pay for weekly COVID-19 testing or whether the government will reimburse them for the cost. It’s also unclear what kind of tests will be required, such as in-home test kits or more expensive lab tests, and if the rules also will apply to remote workers.

“Those are the kind of questions that, for employers, there’s a real wait and see, because they just don’t know what to mandate,” Camacho Moran said.

The uncertainty is causing angst among businesses that want to get ahead of the rule by purchasing testing kits or implementing a vaccine verification program.

The Consumer Brands Association, a trade group that represents packaged goods companies such as Coca-Cola, Clorox and General Mills, sent a list of questions to the White House on Monday about the specifics of the vaccine requirement.

In addition to inquiries about the cost of testing and vaccine verification, the group asked about how booster shots will factor in and whether employers will be liable if a worker is caught falsifying their vaccination status.

“Federal agencies must move quickly, anticipate challenges, promptly answer questions and partner with the private sector if we are to realize successful implementation of the administration’s COVID-19 Action Plan and achieve our shared goal of increased vaccination rates,” Geoff Freeman, Consumer Brands president and CEO, wrote in a letter to Biden.

National Association of Manufacturers President Jay Timmons said in a statement after Biden’s announcement Thursday that while he supports the White House effort to boost vaccinations, it is key that “undue compliance costs do not burden manufacturers, large and small alike.”

Some of the largest U.S. companies, including Google, Walmart, United Airlines and Amazon, have already mandated vaccines for some or all of their employees. The administration’s rule is expected to affect around 80 million U.S. workers.

About one-fifth of businesses already mandate vaccinations and another 29 percent were considering requiring the shot before the end of the year, according to a recent survey of large U.S. companies from advisory firm Willis Towers Watson.

The U.S. Chamber of Commerce and Business Roundtable, lobbying groups that are pushing to derail Biden’s $3.5 trillion spending plan, are not opposed to the administration’s vaccine requirement for businesses, even as GOP governors and conservative groups pledge to fight the measure in court.

Biden’s rule enjoys support from about 3 in 5 Americans, according to a Morning Consult-Politico poll released Monday.

The White House announced the new requirement last week as 25 percent of U.S. adults remained unvaccinated against COVID-19, which has spread rapidly through much of the nation over the last month.

https://thehill.com/business-a-lobbying/business-a-lobbying/572045-employers-scramble-to-secure-vaccine-verification

COVID-19 vaccine boosters not widely needed, top FDA and WHO scientists say

 Additional COVID-19 vaccine booster shots are not needed for the general population, leading scientists including two departing senior U.S. Food and Drug Administration officials and several from the World Health Organization (WHO) said in an article published in a medical journal on Monday.

The scientists said more evidence was needed to justify boosters. That view disagrees with U.S. government plans to begin offering another round of shots to many fully vaccinated Americans as soon as next week, contingent on approval from health regulators.

As COVID-19 cases caused by the Delta variant of the virus rise, President Joe Biden's administration is concerned that infections among those already vaccinated are a sign that their protection is waning and has pushed boosters as a way to rebuild immunity.

The WHO has argued that the vaccines are still needed for first doses around the globe.

"Any decisions about the need for boosting or timing of boosting should be based on careful analyses of adequately controlled clinical or epidemiological data, or both, indicating a persistent and meaningful reduction in severe disease," the scientists wrote in the Lancet medical journal.

The risk-benefit evaluation should consider the number of severe COVID-19 cases that boosting would be expected to prevent, and whether it is safe and effective against the current variants, they said.

"Current evidence does not, therefore, appear to show a need for boosting in the general population, in which efficacy against severe disease remains high," the scientists wrote.

Some countries have begun COVID-19 booster campaigns, including Israel, providing some of the data on which the Biden administration has made its case for additional shots.

The article's authors included the FDA Office of Vaccines Research and Review Director Marion Gruber and Deputy Director Phil Krause, both of whom plan to leave the agency in the next several months.

They acknowledged that some individuals, such as those who are immunocompromised, could benefit from an additional dose.

Broader use of boosters may be needed in the future if there is waning immunity to the primary vaccination or if new variants evolve so that the vaccines no longer protect against the virus, they said.

Boosters could also prove risky if introduced too soon or too frequently, the scientists wrote.

A panel of experts that advises the FDA on vaccines plans to meet on Sept. 17 to discuss additional doses of the Pfizer /BioNTech shot, the first step in a wider booster roll-out.

The article's authors included WHO top scientists Soumya Swaminathan, Ana-Maria Henao-Restrepo and Mike Ryan.

"Current vaccine supplies could save more lives if used in previously unvaccinated populations," the authors wrote.

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/news/Moderna-COVID-19-vaccine-boosters-not-widely-needed-top-FDA-and-WHO-scientists-say-36413933/

IQVIA, NRx Pharma Collaborate on Potential Medical Support for Novel COVID Treatment

 IQVIA™ (NYSE:IQV), a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry, today announced a transformative collaboration with NRx Pharmaceuticals (NRx) (Nasdaq: NRXP). NRx is a company dedicated to creating innovative, life-saving treatments and bringing hope to those facing life-altering conditions with no approved disease-modifying therapies or cures. IQVIA is excited to collaborate with NRx as its designated partner, to provide pharmacovigilance services and medical information in preparation for potential regulatory actions.

"As the world suffers yet another surge of COVID-19, thousands of patients require intensive care and too many succumb to this virus. New medicines with new mechanisms of action are urgently needed," said Robert Besthof, chief commercial officer and head of Operations of NRx. "As a small biopharma company preparing to launch a lifesaving medicine across multiple countries, we deeply appreciate the global reach that IQVIA is able to offer in support of patients, families, and those who care for them."

This collaboration will allow NRx to access IQVIA’s domain experience with COVID-19, our unparalleled data assets, and analytics to support potential emergency use authorization (EUA) of ZYESAMI. IQVIA will work closely with NRx to support key activities required for EUA activation, including the pharmacovigilance and medical information programs.

"We are honored by the opportunity to join with NRx on the EUA activation and compliance for ZYESAMI in treating some of the sickest patients suffering from COVID-19," said Susan Kitlas, vice president, Precommercial Business Unit, IQVIA. "IQVIA’s experience and expertise within the COVID-19 market will be a valuable component in helping make this treatment more widely available."

Walgreens COVID-19 Test Registration System Left Patient Data Unprotected

 Drugstore chain Walgreens Boots Alliance's COVID-19 test registration system exposed data of potentially millions of people, including their phone numbers and email addresses, Recode reported on Monday.

The data also exposed names, dates of birth and gender identities on the open web for potentially anyone to see and for the multiple ad trackers on Walgreens' site to collect, the report said. (https://bit.ly/3AdXgoE)

In some cases, the results of these tests could also be taken from the exposed data, the report added.

Matinas BioPharma Jumps After Meningitis Candidate Data

 

  • Matinas BioPharma Holdings Inc (NYSE: MTNB) has announced positive data from the first two cohorts of the Phase 2 EnACT trial of MAT2203 (oral amphotericin B) for cryptococcal meningitis.

  • The study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID).

  • In the second cohort, step-down therapy with MAT2203 achieved an effective clearance of fungal organisms was 0.38, significantly higher than the prespecified primary endpoint threshold of over 0.20. Cohort 2 evaluated stepdown to MAT2203 after two days of IV amphotericin.

  • There was no evidence of breakthrough or relapsed cryptococcal infections through 10 weeks. In Cohort 2, overall survival was 95% in 40 patients randomized to receiving MAT2203.

  • All 39 patients completing induction with MAT2203 achieved sterility, with no evidence of breakthrough or recurrent infections during the first ten weeks of antifungal treatment.

  • Enrollment in Cohort 3 of EnACT has commenced and is expected to complete by the end of 2021. Cohort 3 is the safety lead-in for Cohort 4, an all-oral MAT2203 treatment regimen.