Miami, FL – The Florida Department of Health in Miami-Dade County (DOH-Miami-Dade) is offering appointments for the Pfizer- BioNTech and Johnson & Johnson’s Jannsen COVID-19 vaccine. The Pfizer BioNTech vaccine is available to individuals 12 years of age and older while the Johnson & Johnson’s Jannsen vaccine is available to individuals 18 years of age and older. The vaccines will be offered by appointment at the following locations:

Health District Center – DOH-Miami-Dade site

Little Haiti Clinic – DOH-Miami-Dade site 300 NE 80 Terrace, Miami Florida 33138

West Perrine Clinic – DOH-Miami-Dade site 18255 Homestead Avenue, Miami Florida 33157

West Dade Clinic – DOH-Miami-Dade site 11865 SW 26th Street, Miami, Florida 33175

City of Sweetwater

250 SW 114th Avenue, Sweetwater, Florida 33174

Hialeah Gardens Library

13451 NW 107th Avenue, Hialeah Gardens, Florida 33018

City of Miami Springs

1401 Westward Drive, Miami Springs, Florida 33166

To schedule an appointment, follow the attached link on google chrome https://public.domo.com/cards/v2mAg

All individuals under the age of 18 receiving a vaccine must be accompanied by a parent or guardian and must complete the COVID-19 vaccine screening and consent form.

As per State Surgeon General Dr. Scott Rivkees’ Public Health Advisory issued on April 29, 2021, vaccine access and eligibility is expanded to any individual in Florida who is present in Florida for the purpose of providing goods or services for the benefit of residents and visitors of the state.

About the Florida Department of Health

The department works to protect, promote and improve the health of all people in Florida through integrated state, county and community efforts.

Follow us on Twitter at @HealthyFla and on Facebook. For more information about the Florida Department of Health please visit www.FloridaHealth.gov.

Trial also will test pausing immunosuppressive medication to improve antibody response.

The National Institutes of Health has begun a clinical trial to assess the antibody response to an extra dose of an authorized or approved COVID-19 vaccine in people with autoimmune disease who did not respond to an original COVID-19 vaccine regimen. The trial also will investigate whether pausing immunosuppressive therapy for autoimmune disease improves the antibody response to an extra dose of a COVID-19 vaccine in this population. The Phase 2 trial is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, and is being conducted by the NIAID-funded Autoimmunity Centers of Excellence.

“Many people who have an autoimmune disease that requires immunosuppressive therapy have had a poor immune response to the authorized and approved COVID-19 vaccines, placing these individuals at high risk for the disease,” said NIAID Director Anthony S. Fauci, M.D. “We are determined to find ways to elicit a protective immune response to the vaccines in this population. This new study is an important step in that direction.”

An estimated 8% of Americans have an autoimmune disease, including a disproportionate number of people in the minority communities most severely impacted by COVID-19. Researchers have reported higher rates of severe COVID-19 and death in people with autoimmune disease than in the general population. It is unclear whether this is attributable to the autoimmune disease, the immunosuppressive medications taken to treat it, or both.

The results of recent studies indicate that giving an extra dose of an authorized COVID-19 vaccine to solid organ transplant recipients, who must take immunosuppressive medications, can improve the immune response to the vaccine in many of these individuals. A NIAID study is underway to investigate this further. The recent findings in solid organ transplant recipients also suggest that an extra dose of a COVID-19 vaccine may help some people with autoimmune disease who take certain immunosuppressive medications. The Food and Drug Administration recently amended(link is external) the emergency use authorizations for the Pfizer-BioNTech and Moderna COVID-19 vaccines to allow the administration of an additional dose to solid organ transplant recipients and other people who have an equivalent level of immunocompromise.

The new NIAID trial, called COVID‐19 Booster Vaccine in Autoimmune Disease Non‐Responders, initially will include people with one of five autoimmune diseases: multiple sclerosis, pemphigus, rheumatoid arthritis, systemic lupus erythematosus or systemic sclerosis. The immunosuppressive therapies commonly taken by people with these diseases have been associated with poor immune responses to vaccines.

The study team will enroll approximately 600 participants ages 18 years and older at 15 to 20 sites nationwide. Participants must have had a negative or suboptimal antibody response to two doses of the Moderna COVID-19 vaccine, two doses of the Pfizer-BioNTech COVID-19 vaccine, or one dose of the Johnson & Johnson COVID-19 vaccine, all received prior to enrollment. Participants also must be taking one of three immunosuppressive therapies: mycophenolate mofetil (MMF) or mycophenolic acid (MPA); methotrexate (MTX); or B cell- depleting drugs.

All participants will receive an extra dose of the same COVID-19 vaccine as they received originally. Then those participants who are taking MMF/MPA or MTX will be assigned at random either to continue taking their immunosuppressive medication without alteration or to pause taking their medication for a short period before and after receiving the extra vaccine dose. The main goal of the study is to determine the proportion of participants who have a significantly better antibody response four weeks after receiving the extra vaccine dose than they did after their original vaccinations.

Study participants will be followed for a total of 13 months. Preliminary results are expected in November 2021.

The COVID‐19 Booster Vaccine in Autoimmune Disease Non‐Responders trial is being led by Judith James, M.D., Ph.D., Meggan Mackay, M.D., M.S., Dinesh Khanna, M.B.B.S., M.Sc., and Amit Bar-Or, M.D., F.R.C.P.C. Dr. James is vice president of clinical affairs and program chair of the Arthritis & Clinical Immunology research program at the Oklahoma Medical Research Foundation in Oklahoma City. Dr. Mackay is a professor in the Institute of Molecular Medicine at the Feinstein Institutes for Medical Research in Manhasset, New York. Dr. Khanna is the Frederick G.L. Huetwell professor of rheumatology and the director of the scleroderma program in the department of internal medicine at University of Michigan in Ann Arbor. Dr. Bar-Or is the director of the Center for Neuroinflammation and Neurotherapeutics, chief of the multiple sclerosis division, and the Melissa and Paul Anderson President’s Distinguished Professor at the University of Pennsylvania in Philadelphia.

Additional information about the COVID‐19 Booster Vaccine in Autoimmune Disease Non‐Responders trial, including the locations of study sites, is available in ClinicalTrials.gov under study identifier NCT05000216.

NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing, and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

TALLAHASSEE, FL – The Florida Hospital Association, the state’s leading voice for hospitals and health systems, provided the following update today on COVID-19 in the state. Statewide data is derived from the federal Department of Health and Human Services (HHS).

HHS Statewide COVID-19 Update:

Current Confirmed COVID-19 Hospitalizations: 16,163

7-Day Change in COVID-19 Hospitalizations: -3.9%

Total New COVID-19 Cases: 27,584

Inpatient Bed Availability (all patients): 14.8%

Inpatient ICU Bed Availability (adults): 5%

Percent of Inpatients with Confirmed COVID-19 (all patients): 33%

Source: COVID-19 Reported Patient Impact and Hospital Capacity by State

FHA Hospital Update:

The following information is being released by the Florida Hospital Association from a survey of hospitals completed Thursday, August 26, 2021. This survey reflects responses from hospitals representing 82% of Florida’s acute care hospital beds.

COVID-19 patients in ICU: 22.9% (steady from 8/23)
COVID-19 patients on ventilators: 17.4% (steady from 8/23)
COVID-19 patients transferred from nursing homes/long-term care: 2.4% (steady from 8/23)
Hospitals expecting critical staffing shortage in next 7 days: 75.7% (1.1% decrease from 8/23)
Hospitals expanding into non-care areas in next 7 days: 27.3% (1.1% decrease from 8/23)

“Fingers crossed, we may be seeing the beginning of a downward trend in COVID-19 hospitalizations, but new cases remain near all-time highs, so it is much too early to declare victory,” said Mary C. Mayhew, President and CEO, Florida Hospital Association. “We must remain vigilant, not let our guard down against the virus, and continue to encourage more people to get the vaccine. In the last week we have seen a 4 percent decline in COVID-19 hospitalizations. Hopefully better days are ahead.”

The Florida Hospital Association will continue communicating with all Florida hospitals and state officials and provide additional updates as events warrant.

About the Florida Hospital Association Founded in 1927, the Florida Hospital Association is the leading voice for health care in the State of Florida. Through representation and advocacy, education and informational services, the Florida Hospital Association supports the mission of more than 200 hospitals and health care systems to provide the highest quality of care to the patients we serve. Led by President and CEO Mary Mayhew, the Florida Hospital Association has offices in Tallahassee and Orlando and is governed by a Board of Trustees and officers elected by the member institutions. For more information, visit www.fha.org.

Patients with symptoms of PCCD being treated with Ampligen in the ongoing AMP-511 Early Access Program have reported consistent improvements in cognitive function

Aug. 25, 2021 (GLOBE NEWSWIRE) — AIM ImmunoTech Inc. (NYSE American: AIM) today provided an update on the company’s efforts to develop its drug Ampligen as a potential intranasal therapeutic for COVID-19, including the announcement of a new provisional patent application for Ampligen as both an intranasal and an intravenous therapy for what AIM describes as Post-COVID-19 Cognitive Dysfunction (PCCD).

AIM has been working steadily to expand its COVID-19 patent portfolio. In addition to the new provisional patent application addressing compositions and methods for treating PCCD, in February 2020 the company filed multiple COVID-19-related provisional patient applications, which are now patent pending worldwide, for Ampligen as a COVID-19 therapy and as a vaccine adjuvant. Developing an effective therapy is critical for relieving the socioeconomical impact of PCCD and its medical burden on the population. The people suffering from PCCD, including some young adults, are afflicted with severe difficulties in concentrating, serious memory problems and inability to live an active lifestyle, unable to work, and even unable to perform everyday tasks.

Early data has demonstrated that patients with symptoms of PCCD being treated with Ampligen in the ongoing AMP-511 Early Access Program (EAP) have reported improvements in cognitive function, according to Charles Lapp, MD, at Hunter-Hopkins Center in Charlotte, N.C.

“The results of some individual symptoms are very dramatic,” said Lapp, the EAP’s lead investigator. “The results clearly show a significant reduction of one or more symptoms of PCCD in patients after the administration of Ampligen.”

Also, as recently noted in the Wall Street Journal, intranasal immunity to the SARS-Cov-2 virus may be a key to controlling the spread of COVID-19, especially the more contagious and deadly Delta variant, which can accumulate in nasal tissues even in individuals who have been vaccinated with currently available vaccines. AIM’s leadership and scientific experts reached a similar conclusion in the early days of the COVID-19 outbreak, deciding then to make the development of intranasal Ampligen a major R&D goal.

“There is a growing and significant need for effective therapies to treat COVID-19, both in the acute phase and its longer-term effects,” said AIM CEO Thomas K. Equels. “We believe that Ampligen has the potential to activate the body’s innate immune system to fight COVID-19 through its use as a front-line, early-onset therapeutic — which includes potentially reducing intranasal viral load, potentially curbing the spread of the disease and lessening its severity. We believe Ampligen also can play a role in treating Post-COVID-19 Cognitive Dysfunction. PCCD is one of the most common and disabling immediate after effects of acute COVID-19 infection.”

AIM’s approach has been strategic and methodical:

In August 2020, AIM identified an effective in vitro model using human tracheal, bronchial epithelial cells at The Institute for Antiviral Research at Utah State University which showed that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels.
In November 2020, AIM disclosed positive pre-clinical results from a test by Japan’s National Institute of Infectious Diseases (NIID) This pre-clinical work determined that Ampligen, when used as a vaccine adjuvant, provided 100% survival in a pre-clinical rodent model of SARS-CoV as a surrogate model of SARS-CoV-2, in contrast to the control group, which demonstrated 100% mortality. The preclinical findings suggested Ampligen was generally well-tolerated by the experimental cohort.
In early 2021, AIM launched a Phase 1 intranasal safety study of Ampligen, testing the safety, tolerability and biological activity of Ampligen at increasing doses, in anticipation of testing its potential as an intranasal therapy. A total of 40 healthy subjects received either Ampligen or a placebo in the trial, with Ampligen given at four escalating dosages across four cohorts, to a maximum level of 1,250 micrograms. In June 2021, AIM announced that there were no Severe Adverse Effects observed in the study at any dosage level, thus establishing that Ampligen was well-tolerated when administered intranasally in humans.
A June 2021 article in the medical journal Cancers stated that Ampligen has the potential to reduce the severity of COVID-19 by “activating the innate and the adaptive immune systems by activating a cascade of actions in human pancreatic cancer cells.” The study’s authors include Prof. C.H.J. van Eijck, MD, PhD, the lead investigator for an Early Access Program at Erasmus Medical Center in the Netherlands, where Ampligen is being used to treat patients with late-stage pancreatic cancer.
In July 2021, AIM announced significant progress toward a Phase 2a Human Challenge Trial to test the intranasal prophylactic effect of Ampligen in separate Rhinovirus hRV and Influenza cohorts. The study is part of AIM’s work to develop Ampligen as a potential therapy against SARS-CoV-2 and other respiratory viruses. The trial is expected to commence in Q4 2021.

About AIM ImmunoTech Inc.

AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

Medtech industry delivers for workers in Florida, thanks to policies that value innovation

August 26 2021 – New data released by the Advanced Medical Technology Association (AdvaMed) found that the medical technology (medtech) industry is a critically important employer in Florida and contributes billions of dollars to state revenues and payroll. AdvaMed commissioned a new economic research report by Macro Policy Advisors to study the industry’s economic impact on states across the country, and the results were overwhelmingly positive for Florida.

The 2019 repeal of the medical device excise tax has enabled the Florida medtech industry to excel. As a result of policies that value growth and innovation, medtech revenues have had countless benefits for Florida state revenues and payroll. These economic benefits are particularly important as Florida experiences reduced tax revenues caused by lockdowns during the coronavirus pandemic. For example:

In 2020, the medtech industry contributed more than $1.2 billion in state payroll, which generated an additional over $1.1 billion in payroll across the state.
In 2020, the medtech industry created more than $6.09 billion in Florida revenues, generating an additional over $4.3 billion in indirect revenues.
Florida’s medtech industry employed 19,200 workers, generating an additional 26,100 jobs.
In 2020, the medtech industry’s pay premium was higher than the average pay premium in 38 states, including Florida.

“This new data clearly shows that our industry not only creates lifesaving medical technologies but also generates tremendous economic benefit to Florida and its workers,” said Scott Whitaker, President and CEO of AdvaMed, the leading global trade organization for medical device manufacturers. “Repeal of the federal tax on medical devices has allowed the medtech industry to grow and employ more than 19,200 Florida workers, not to mention expand the critical research and development necessary to improve and save patients’ lives. As we begin to emerge from the coronavirus pandemic, we encourage state leaders to continue supporting policies that recognize the critical role medical innovation plays in the state and its workers’ lives.”

“This new report reaffirms the medtech sector’s leadership role in Florida’s manufacturing economy and the creation of high-wage, high-value-added jobs,” said John Ray, Executive Director of the Florida Medical Manufacturers Consortium (FMMC). “The vast majority of Florida medical device manufacturers are small, entrepreneurial firms, employing fewer than 25 people. These are the companies driving Florida’s job creation and innovation in patient care, and policymakers should continue to nurture them through sound public policy and business climate improvements.”

“Florida is a leader in the MedTech industry driving Florida’s economy forward with high-paying jobs while providing valuable innovation to improve patient health,” said Nancy K. Bryan, President and CEO of BioFlorida, the voice of Florida’s life sciences industry, representing 6,700 establishments and research organizations. “Florida’s life sciences ecosystem is large, growing, and contributing to groundbreaking research and discoveries led by a strong base of MedTech, BioPharma, and some of nation’s most highly regarded research institutions and universities.”

The study also finds that the medtech industry has had overwhelmingly positive impacts on workers across the nation. The economists determined:

Nationally, medtech employed 438,000 people, at an average annual salary of $88,096—49% higher than the average across all industries and 18% higher than the corresponding premium of all manufacturing jobs.
Every 5 medtech industry jobs create an additional 7 jobs across the country.
Between 2014-19, national medtech employment grew by 4.1%, compared to a 3.3% increase in overall manufacturing employment.
Of the nearly 15,000 medtech establishments across the nation, 94% were small businesses that employed fewer than 100 employees.

The report was produced by The Macro Policy Institute (MPI)—an independent nonprofit organization that partners with private think tanks, academic institutions and policy advocacy organizations to develop unbiased investigations and reasoned responses to the macroeconomic policy concerns of today.

AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.