Fla. gov’s office releases policy goals for COVID-19 special legislative session

 Following Gov. Ron DeSantis’s announcement in Clearwater of a special COVID-19 legislative session to be called, the Governor’s Office released a list of the main topics that state lawmakers will focus on during the coming legislative gathering.

The main goal of the session is to bolster existing laws or draft new ones that will provide additional protections for Floridians regarding COVID-19 vaccine mandates and employees who face what the Governor’s Office calls “unfair, discriminatory” actions by employers.

DeSantis, and state leaders, promised further action both in the legislature and in court to contest vaccine requirements and mask mandates as a federal vaccination deadline for employees of the United States government looms closer, particularly for various branches of the U.S. military.

The following items are proposed protective goals for lawmakers to consider during the coming special session of the Florida General Assembly:

• If someone is fired from their job for refusing an employer-required COVID-19 vaccine, then that person should be eligible for reemployment assistance.
• If someone has an adverse medical reaction from an employer-required COVID-19 vaccine, then that person should be eligible for workers compensation coverage.
• If an employer fires someone based on an arbitrary COVID-19 vaccine mandate, then the employer should not receive the benefits of current COVID-19 liability protections.
• If an employer fires someone solely based on COVID-19 vaccine status, then that business may not enforce a non-compete agreement against the employee.
• Employers must provide notice to employees of religious and health exemptions. Fired employees should have a right to sue if employers fail to provide such notice.
• DEO shall establish a program to connect employees terminated based on COVID-19 vaccine status with other employment opportunities.
• Reaffirm that government entities, including school districts, may not fire any employee based on COVID-19 vaccine status. Violating government entities should be held accountable.

Additionally, the governor stated in Clearwater that he would be working with the legislature to strengthen the protections for parents’ rights set forth in the Parents’ Bill of Rights.

In the information released by the Governor’s Office, those protections are described as focusing on parents’ freedom to manage healthcare decisions for their children, despite “several school districts [who] continue to violate state law.”

The release also said that additional protections are needed to hold districts accountable for violating those laws, citing data on COVID-19 infections over the past 12 to 14 months that show no correlation between mask requirements and infection rates in the state of Florida.

Soon after the announcement from the governor about the special session, Florida Speaker of the House released the following statement, confirming that state lawmakers were in communication with the governor about the proposed session.

This morning Governor DeSantis announced that he plans to call the Legislature into a Special Session. At this time, we have not received the dates or details regarding any proposed call. We are in communication with the Governor’s Office and our partners in the Senate, and we will share details with you as they emerge.

STATEMENT FROM HOUSE SPEAKER CHRIS SPROWLS ABOUT SPECIAL LEGISLATIVE SESSION FOR COVID-19 LAWS

https://www.wfla.com/community/health/coronavirus/florida-governors-office-releases-list-of-policy-goals-for-covid-19-special-legislative-session/

Court Holds COVID Not 'Transitory and Minor' Disability Exempt From ADA Protections

 In a case of first impression, the federal court in Matias v. Terrapin House, Inc., denied an employer’s motion to dismiss an employee’s suit that alleged she was terminated in violation of the Americans with Disabilities Act (ADA) and the Families First Coronavirus Response Act (FFCRA) after testing positive for COVID-19—providing a potential roadmap for future COVID “regarded as” ADA claims. 

What You Need to Know:

• Employee had plausibly alleged a “regarded as” disability claim under the ADA where she claimed that her employer knew that she was suffering a loss of taste and smell due to COVID-19 and terminated her shortly thereafter.
• Employer could not rely on the “transitory and minor” exception because COVID-19, even if transitory, was not “minor” where the hospitalizations and deaths were significantly higher in comparison to the average seasonal flu. 

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The Court reached two key conclusions concerning COVID-19 that may impact future ADA disability claims:

1. The plaintiff sufficiently alleged a claim for “regarded as” disability discrimination under the ADA where days prior to her termination she informed her employer that she was COVID-19 positive and was losing her sense of taste and smell; and
2. The employer had failed to establish that COVID-19 was transitory and minor and therefore not a disability under the ADA.

To state a prima facie case of discrimination under the ADA, a plaintiff must allege that: (1) they are a disabled person within the meaning of the ADA; (2) they are otherwise qualified to perform the essential functions of the job, with or without reasonable accommodations by the employer; and (3) they have suffered an otherwise adverse employment decision as a result of discrimination. “Disability” is defined in the ADA as: (a) a physical or mental impairment that substantially limits one or more major life activities, (b) a record of such an impairment, or (c) being regarded as having such an impairment.  42 U.S.C. § 12102(1).

The Court in Matias determined that the plaintiff had plausibly alleged that her employer “regarded her” as having an impairment. In so holding, the Court focused on the allegations that in the days immediately prior to her termination Matias had informed her employer that she was losing her sense of taste and smell, and that she had also tested positive for COVID-19. It pointed to the recent guidance from the Department of Justice and Department of Health and Human Services that “long COVID” (new or ongoing symptoms that last weeks or months after infection) may be considered a disability. Although Matias did not allege she suffered from long COVID or that her employer regarded her as having long COVID, the Court still held she had plausibly alleged a “regarded as” disability claim. The fact that she had informed her employer that she was losing her sense of taste and smell—which is one symptom of long COVID—and the temporal proximity between Matias’s disclosure of her symptoms and positive test result was enough for the Court to conclude she had plausibly alleged that Terrapin House regarded her as disabled. Based on this, it denied Terrapin House’s motion to dismiss.

The Court then rejected Terrapin House’s affirmative defense that COVID-19 is “transitory and minor” and, thus, excepted from the ADA. Citing the length of the COVID-19 pandemic, the number of cases, and the total deaths in the United States, the Court concluded that, even if COVID-19 was “transitory,” it was not “minor.” It contrasted another respiratory disease, H1N1, which some federal district courts had determined was “minor” where the number of cases of H1N1 was on par with seasonal flu, and the number of deaths was less than the seasonal flu. Because “the hospitalization and mortality profiles of the seasonal flu pale in comparison to those associated with COVID-19,” COVID-19 “is not ‘minor’” under the ADA.  

This is the first time a federal district court has addressed the issue of whether COVID-19 is “transitory and minor” head on and it remains to be seen whether other courts will follow suit. See Burbach v. Arconic Corp., No. 2:20-CV-00723, 2021 WL 4306244, at *6 (W.D. Pa. Sept. 22, 2021) (rejecting defendant’s motion to dismiss “regarded as” disability claim because coronavirus was “transitory and minor” because at the motion to dismiss stage, based on the pleadings in the complaint, it was “reasonable to infer that Plaintiff's impairment in treating and recovering from COVID-19 could have lasted longer than six months”); Payne v. Woods Servs., Inc., 520 F. Supp. 3d 670, 679 (E.D. Pa. 2021) (holding that plaintiff had not sufficiently alleged facts in his complaint that he was “regarded as” disabled due to his COVID-19 diagnosis, and not reaching the questions of whether COVID-19 was “transitory and minor”).

https://www.jdsupra.com/legalnews/court-holds-covid-19-is-not-a-3267585/

Apple will require unvaccinated employees to test for COVID-19 daily

 Apple has yet to issue a mandate similar to Google's that would require all employees to be vaccinated, but it's tightening its COVID-19 protocols nonetheless. According to Bloomberg, the tech giant will start requiring all unvaccinated corporate employees to be tested for COVID-19 every time they have to work in the office instead of working from home. Back in September, Bloomberg reported that Apple asked employees to share their vaccination status voluntarily. Those who refuse to share their vaccine status will also have to undergo daily testing, while vaccinated office workers will only have to do rapid testing once a week. 

The company's retail store employees, however, won't be subjected to daily tests despite having consumer-facing jobs. Unvaccinated staff members are required to be tested twice a week. Like Apple's office workers, vaccinated staff will only have to undergo weekly rapid testing. It's unclear if the tech giant will ever issue a COVID-19 vaccine mandate, but the Biden administration previously gave all federal contractors a December 8th deadline to require all their employees to be inoculated against the virus. As Bloomberg notes, Apple sells products to the US government.

For now, Apple has reportedly given employees an October 24th deadline to report and show proof of their vaccination status, so it could implement the new rules starting on November 1st. Unvaccinated employees will have to pick-up at-home rapid tests from Apple offices and stores, do the test themselves and then report their results through an internal app.

https://www.engadget.com/apple-require-unvaccinated-employees-covid-19-daily-test-093357015.html

Some Myeloma Patients Also Lack T-Cell Responses After COVID Vaccine

 In multiple myeloma patients unable to mount a sufficient antibody response following COVID-19 vaccination, roughly one-third also failed to mount T-cell responses, an important and durable source of protection, researchers determined.

Among 26 myeloma patients who were seropositive after COVID vaccination, 25 (96%) had a CD4+ T-cell response versus just six of 17 seronegative patients (35%), reported Samir Parekh, MBBS, and colleagues of the Icahn School of Medicine at Mount Sinai in New York City.

In addition, fewer patients on active anti-B-cell maturation antigen (BCMA) bispecific therapy or anti-CD38 antibody therapy mounted SARS-CoV-2-specific CD4+ T-cell responses compared with patients on other therapeutics or anti-BCMA CAR T-cell therapy, they noted in Cancer Cell.

Because vaccination failed to induce anti-SARS-CoV-2 spike (anti-S) antibody responses in seronegative patients, Parekh and colleagues also investigated whether the lack of response reflected an inability of the vaccines to induce spike-reactive B cells.

They found that spike-reactive B cells were detected in almost all seropositive patients (again in 96%), as well as in all 12 of the healthy individuals without myeloma included in the study, compared with only 40% of the seronegative myeloma patients, who also had lower B-cell numbers in their peripheral blood compared with the seropositive group.

Immunologists have suggested that patients with undetectable anti-S IgG antibody response after vaccination may still mount T-cell protection from severe disease, Parekh and colleagues noted.

However, "the unexpected lack of T-cell responses, coupled with an absence of anti-S antibodies following SARS-CoV-2 vaccination, particularly in multiple myeloma patients actively receiving anti-CD38 and anti-BCMA antibody-based therapies, is of concern, and it emphasizes the need for serological testing after vaccination to identify this specific subgroup of multiple myeloma patients," they wrote.

With the spread of the Delta variant, continuing safety precautions, passive antibody treatments, and booster vaccinations should be considered in order to prevent morbidity and mortality from COVID-19 in patients with suboptimal responses to vaccination, they added.

"If you don't have antibodies, you can't assume you have protection," Parekh told MedPage Today. "We've been counseling our patients to get their booster vaccinations as soon as they can."

"And now that these patients are getting boosters, the results have been encouraging," he noted. "We are seeing that about 90% of patients actually mount a phenomenal response to the booster, including about two-thirds of patients who had no response to the standard vaccines."

In the study, Parekh and colleagues profiled B-cell and T-cell responses in 44 patients with multiple myeloma who were treated at Mount Sinai (17 seronegative and 27 seropositive), as well as 12 healthy individuals, at least 2 weeks after their second vaccine dose. Most patients received the Pfizer-BioNTech vaccine, while 14 received the Moderna vaccine. Thirteen of 17 seronegative patients were either on anti-BCMA or anti-CD38 therapies.

"There seems to be a very strong biological connection between antibody responses and T-cell responses, and it seems the common underlying reason that we uncovered was that patients on some of these treatments were actually depleted of B cells, and that both their B cell and CD4 counts were low," Parekh said. "I think there is still biology to be discovered where the lack of B cells not only compromises the ability to make antibodies, but also the ability to educate T cells and form sufficient T-cell response."

Disclosures

The Icahn School of Medicine at Mount Sinai has filed patent applications relating to SARS-CoV-2 serological assays and NDV-based SARS-CoV-2 vaccines.

Parekh is supported by National Cancer Institute grants, and reported receiving research funding from Amgen, Celgene/Bristol Myers Squibb, and Karyopharm, and consulting fees from Foundation Medicine.

Several co-authors also reported multiple relationships with industry.

Primary Source

Cancer Cell

Source Reference: Aleman A, et al "Variable cellular responses to SARS-CoV-2 in fully vaccinated patients with multiple myeloma" Cancer Cell 2021; DOI: 10.1016/j.ccell.2021.09.015.

https://www.medpagetoday.com/infectiousdisease/covid19vaccine/95183

Texas clinical trial to examine ivermectin in fight against COVID-19 symptoms

 A Texas university clinical trial is examining the effectiveness of ivermectin in fighting against COVID-19 symptoms, with hopes of determining if the controversial drug can be a helpful tool in combating the pandemic.

The National Institutes of Health granted Texas Tech University's Health Sciences Center El Paso $1.7 million to spearhead clinical trials that include two projects: ACTIV-6, a nationwide study that includes ivermectin, and a local initiative planned by the university, The Washington Post reported Thursday.

The ACTIV-6 study, which started June 8, is examining the effectiveness of three drugs, including ivermectin, the antiparasitic medication that has sparked controversy in the U.S. over some unauthorized use to treat the coronavirus.

While ivermectin is approved by the Food and Drug Administration (FDA) to treat humans for parasitic worms, lice and skin conditions including rosacea, it is more often used to help animals, including cattle and horses.

The study is also examining fluvoxamine, a drug that has been prescribed for depression, and fluticasone, a steroid that is sometimes used to treat asthma and chronic obstructive pulmonary disease, according to the Post.

The project, which is being led by the Duke Clinical Research Institute, aims to evaluate the effectiveness of repurposed medications in reducing COVID-19 symptoms in non-hospitalized patients who are experiencing mild to moderate illness.

Edward Michelson, the chairman of the Texas university’s Department of Emergency Medicine, told the Post that the results of the school's study are needed right away.

“Usually treatments for diseases take many years to develop, and everything we’re doing is on a fast track because people need it now,” Michelson said.

He also said the project will “hopefully put the debate to rest” regarding ivermectin’s effectiveness, and shine light on the proper ways to use the drug.

“People like Dr. Google, and they don’t really know how to safely take ivermectin,” Michelson told the Post. “Some people are probably overdosing. With this trial, we will give them the appropriate number of pills so that the amount of drug is appropriate for their individual weight.”

The debate over ivermectin and its effectiveness in treating COVID-19 sparked after the FDA in August warned against using the drug at home following reports that some coronavirus patients were treating themselves with the drug.

https://thehill.com/policy/healthcare/577844-texas-clinical-trial-to-examine-ivermectin-in-fight-against-covid-19

GOP senators join call on Biden to back down from vaccine mandates

 A group of Republican senators on Thursday sent a letter to the White House calling on President Biden to back down from his COVID-19 vaccine mandate policies.

The group, led by Sens. Dan Sullivan (R-Alaska) and Tommy Tuberville (R-Ala.), said the administration's executive order requiring all federal employees and contractors to be vaccinated, as well as a forthcoming Labor Department rule that will require many companies to implement coronavirus vaccination or testing protocols for their workers, are unconstitutional.

"While the Supreme Court has upheld the ability of states to mandate vaccines during a pandemic, there is no precedent for the federal government to mandate vaccines for contractors, private employers, or individual Americans," the GOP senators wrote. 

Republican opposition to vaccine mandates has come from both the federal and state level. Thursday's letter comes on the same day Florida Gov. Ron DeSantis (R) announced that he is calling a special session of the state legislature to pass bills aimed at fighting COVID-19 vaccine mandates.  

In September, every GOP senator voted for an amendment to block Biden's regulation on businesses.  

The White House has sought to argue that GOP governors like DeSantis and Texas's Greg Abbott are putting politics ahead of health, while opponents of mandates have cast the White House as abridging personal freedoms and of overreach.

"Vaccines are important in slowing the spread of the coronavirus, however, the decision on whether or not to get vaccinated is a personal choice and should not be unilaterally decided by the President. These unconstitutional actions are not only unprecedented, but they are also a vast federal overreach into individual liberties, personal health decisions, and private enterprise," the senators wrote. 

Health experts have praised mandates as an effective way to get people vaccinated, and the White House has fully leaned into them as a way to turn the tide of the pandemic, after initially steering clear of federal intervention.

In speeches, Biden has argued that government officials exhausted various other options to nudge people to get vaccinated. 

The administration purchased enough vaccines to ensure every American could get the shot, expanded eligibility and access, and offered incentives for those who were still holding out during the summer, but a part of the U.S. population did not get the shot.

https://thehill.com/policy/healthcare/577899-gop-senators-call-on-biden-to-back-down-from-vaccine-mandates

FDA Proposes to Make OTC Hearing Aids Accessible: Who Sells Them

 Hearing aids amplify sound and benefit people with hearing issues. If you struggle with hearing loss, you generally can purchase hearing aids after undergoing a medical exam, which sometimes requires a fitting with an audiologist.

With medical costs soaring, making it impossible for some to afford the visit(s) needed to purchase hearing aids, the FDA has proposed a rule to make over-the-counter hearing aids accessible. What companies will be offering over-the-counter hearing aids, and how soon can they be purchased?

What is the FDA proposing in its over-the-counter hearing aid rule?

The FDA is looking to establish a new category, specifically for over-the-counter hearing aids, and to amend “the regulatory framework for hearing aids.” This includes repealing the current conditions that are set for selling and purchasing these devices.

If approved, the rule would give “millions of Americans” access to over-the-counter hearing aids at a more affordable price, according to an FDA press release. The rule was also created to help “increase competition in the market.” The FDA’s proposed rule addresses President Joe Biden’s executive order on promoting competition in the U.S. economy.

How many people would the FDA’s over-the-counter hearing aid rule help?

Data shows that nearly “37.4 million American adults 18 and over struggle with hearing,” but only about “one-fifth of people who could benefit from a hearing aid use one.” Hearing aids are expensive devices, often ranging between $399 and $3,000. With this new proposed rule, individuals requiring the use of hearing aids might be able to afford them when purchasing the device over the counter.

To ensure that hearing aid users or those in need of the device are protected from being injured by “overamplification of sound,” the FDA’s proposed rule includes a volume limit for OTC hearing aids.

What companies will sell over-the-counter hearing aids?

The FDA stated that over-the-counter hearing aids will be sold in brick-and-mortar retail stores and online rather than purchasing them directly from a doctor or a store that specializes in hearing aid sales.

Bose, Audien Hearing, and Eargo Store are a few retailers that currently sell hearing aids. They require patients to submit medical documentation before closing a sale.

Any hearing aids sold over-the-counter will be required to comply with any new regulations issued by the FDA along with those outlined in section 709 of the FDA Reauthorization Act of 2017 (FDARA). Physical and online stores that currently sell PSAPs (personal sound amplification products) might soon be able to market their devices as OTC as long as they comply with the FDA’s regulations.

PSAPs deliver a similar experience that someone would have if they were to wear a hearing aid. However, the FDA doesn't classify these devices as hearing aids.

“Hearing loss has a profound impact on daily communication, social interaction, and the overall health and quality of life for millions of Americans,” according to Dr. Janet Woodcock, the acting FDA commissioner.

With the passing of this rule, millions of people will have access to a selection of hearing aids, offered at a more affordable price and without having to schedule a visit with their doctor.

While it isn’t clear when over-the-counter hearing aids will be available without needing a prescription or fitting, the public is open to comment on the proposed rule up until January 18, 2022.

https://marketrealist.com/p/who-sells-over-the-counter-hearing-aids/