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Feb 3, 2023 • 4:35 am CST
U.S. FTC Privacy Rule 2023

A leading online pharmaceutical discount company recently responded to a first-of-its-kind disciplinary civil action by the U.S. Federal Trade Commission (FTC).

The FTC alleged GoodRx was unauthorized when it shared health information with Meta Platforms Inc.'s Facebook and Alphabet Inc.'s Google, as well as other digital firms.

The FTC issued a $1.5 million fine as an enforcement action.

The FTC issued a policy statement in September 2021 warning health apps and others that collect or use consumers' health information that they must comply with the Health Breach Notification Rule.

"Digital health companies and mobile apps should not cash in on consumers' extremely sensitive and personally identifiable health information," said Samuel Levine, Director of the FTC's Bureau of Consumer Protection, in a press release.

"The FTC is serving notice that it will use all of its legal authority to protect American consumers' sensitive data from misuse and illegal exploitation." 

On February 1, 2023, GoodRx published the following response:

'GoodRx, protecting our users' privacy is one of our most important priorities. Therefore, we are thoughtful and disciplined about what information we gather and how and why we use it.

The settlement with the FTC focuses on an old issue that was proactively addressed almost three years ago before the FTC inquiry began.

We do not agree with the FTC's allegations and admit no wrongdoing. However, entering into the settlement allows us to avoid the time and expense of protracted litigation.

We believe the requirements detailed in the settlement will have no material impact on our business or our current or future operations.

In fact, almost three years ago, before the FTC reached out to us, we proactively made updates consistent with our commitment to being at the forefront of safeguarding users' privacy.

While we used vendor technologies to advertise in a way that we believe was compliant with all applicable regulations and that remains a common practice among many health, consumer, and government websites, we are proud that we took action to be an industry leader in privacy practices.

We are glad to put this matter behind us so we can continue focusing on being a trusted source for Americans to find affordable and convenient healthcare.

The complete unedited response is available at this link.

More information on compliance and reporting breaches under the Health Breach Notification Rule are available on the FTC's Health Privacy page.

Disclosures: Precision Vax LLC participated in GoodRx programs until 2019 when it discontinued all business relationships.

Feb 2, 2023 • 10:06 am CST
WHO - Uganda Sudan Ebola outbreak 2022

A biotechnology company today announced positive results from a limited clinical trial evaluating a DNA vaccine candidate as a booster targeting the Zaire Ebolavirus.

This placebo-controlled Phase, 1b trial assesses its safety, tolerability, and immunogenicity in healthy adult participants who previously received a single injection of Merck's Ervebo®, a vaccine approved by the U.S. Food and Drug Administration for the prevention of disease caused by Zaire ebolavirus.

In the trial, INOVIO Pharmaceuticals, Inc.'s INO-4201 vaccine candidate was well-tolerated and boosted humoral responses in 100% (36 of 36) of study participants.

INO-4201 is a DNA vaccine targeting Zaire Ebola virus (ZEBOV) glycoprotein, designed to prevent ZEBOV infection. It encodes for a synthetic consensus antigen encompassing ZEBOV genetic variability from various outbreak strains to broaden immune coverage for divergent ZEBOV virus variants.

The participants were dosed with 1 mg of INO-4201 injected intradermally, followed by electroporation using our investigational proprietary smart device, CELLECTRA®.

Dr. Angela Huttner, MD, Infectious Disease Consultant, Geneva University Hospitals, and the study's lead investigator, commented in a press release on February 2, 2023, "INO-4201 was well-tolerated and all treated participants responded to the booster vaccine."

"These are encouraging results since our participants were initially vaccinated with Ervebo three to seven years ago."

"We remain grateful to our participants for their critical role in developing this vaccine candidate, which we hope will be a key player in future Ebola Virus Disease prevention."

This news is essential since recent research suggests dormant Ebola virus in a previously infected survivor could re-emerge up to nearly five years later and again allow human-to-human transmission Keita et al. Nature (Sept. 15, 2021).

The Ebola virus is classified as a Category A Priority Pathogen by the U.S. Centers for Disease Control and Prevention (CDC). This designation indicates a national security risk.

The Ebola virus family includes four virus species that cause periodic outbreaks of a highly contagious and lethal human infectious disease – called Ebola Virus Disease (EVD).

The virus is transmitted from wild animals to people and then easily spreads via human-to-human transmission.

Ebola outbreak news from 2022 and 2023 are posted at Vax-Before-Travel.com/Ebola.

The trial was spearheaded by Global Urgent and Advanced Research and Development, sponsored by Geneva University Hospitals, and funded by the U.S. Defense Advanced Research Projects Agency.

INOVIO is a biotechnology company focused on developing and commercializing DNA medicines. For more information, visit www.inovio.com.

Feb 1, 2023 • 1:59 pm CST
WHO Marburg cases 2023

A Cincinnati-based biopharmaceutical company developing transformational vaccines today announced the development of vaccine candidates targeting Mpox and Marburg virus disease (“MVD”).

No vaccines or antiviral treatments are currently approved for MVD, which was first recognized in 1967.

As of 2023, Angola, DR Congo, Germany, Ghana, Guinea, Kenya, Serbia, South Africa, and Uganda have confirmed MVD cases.

Both candidate vaccines will utilize Blue Water Vaccines (BWV) Inc. norovirus shell and protrusion virus-like particle platform, which allows for the presentation of multiple antigens on the surface of either the S or P particle of a norovirus backbone.

In addition to monkeypox vaccine development, AbVacc will utilize its extensive expertise in MVD to develop a novel vaccine targeting the Marburg virus using BWV’s VLP platform.

“As various epidemics continue to emerge around the world, there has never been a better time to invest in the creation of preventative vaccines,” said Joseph Hernandez, Chairman and CEO of BWV, in a press release on February 1, 2023.

MVD is caused by either the Marburg or Ravn viruses, both from the same family as Ebola viruses and can cause outbreaks with high transmission and fatality rates.

According to the World Health Organization (“WHO”), Marburg spreads through human-to-human transmission via direct contact with the blood, secretions, organs, or other bodily fluids of infected individuals or contaminated surfaces.

Case fatality ratios of MVD can reach up to 88%, indicating a severe unmet need for preventative and therapeutic options, says the WHO.

Marburg vaccine candidates at listed on this webpage.  

Feb 1, 2023 • 9:39 am CST
U.S. CDC Mpox vaccinations Feb. 2023

According to reporting by The Hill, the public health emergency (PHE) for the mpox outbreak that began in May 2022 has been discontinued as of January 31, 2023. 

The U.S. administration announced in December 2022 that it was not expecting to renew the PHE for Mpox, which was initially declared in August 2022 and renewed in November.

During the outbreak in the U.S., the Centers for Disease Control and Prevention (CDC) reported 30,093 cases and 26 related fatalities.

And in Europe, the five countries reporting the most Mpox cases since the start of the outbreak are Spain (7,528), France (4,127), Germany (3,676), Netherlands (1,260), and Italy (954).

Furthermore, the CDC confirmed about one million first and second doses of Bavarian Nordic's JYNNEOS® (MVA-BN) vaccine had been administered during the emergency.

The CDC says that two doses of the U.S. FDA-approved vaccine provide the best protection (~70%), regardless of how the vaccine was administered.

One dose offers less than 40% protection from this sexually transmitted disease.

Other outbreak news is posted at MonkeypoxToday.com.

Feb 1, 2023 • 8:06 am CST
by Gerd Altmann

A biotechnology company focused on developing and commercializing DNA medicines today announced it has strategically redirected resources to advance DNA vaccine candidates.

INOVIO Inc. reconfirmed on January 31, 2023, its focus on treating Recurrent Respiratory Papillomatosis, such as the INO-3107 vaccine candidate.

"Today's announcement is a reflection of measured efforts INOVIO has undertaken to assess the portfolio and prioritize those programs with the greatest benefit for patients and commercial potential," said INOVIO's President and CEO, Dr. Jacqueline Shea, in a related press release.

"This decision followed thoughtful consideration and thorough diligence to position the organization better and ultimately realize the potential of DNA medicines."

INOVIO's lead programs include its treatments for HPV-associated diseases, such as INO-3107 and VGX-3100 for cervical high-grade squamous intraepithelial lesions.

The data readouts for INOVIO's Phase 3 REVEAL2 trial for VGX-3100 and the second cohort from the Phase 1/2 trial for INO-3107 are expected to be announced in the first quarter 2023.

INOVIO's DNA medicines in development are delivered using its investigational proprietary smart device, CELLECTRA®, to produce immune responses against targeted pathogens and cancers. For more information, visit www.inovio.com.

Note: This news article is not paid content.

Jan 31, 2023 • 4:01 pm CST
WHO Nipah Virus Outbreaks 2023

Bangladesh Health and Family Welfare Minister Zahid Maleque recently confirmed to local media eight people were infected with the Nipah virus in 2023. Of them, five people died.

".... drinking raw date juice, contaminated by bats carrying Nipah virus. And some Nipah virus-infected people can transmit the disease.

The minister said people should avoid eating fruits that are half eaten by birds and urged people not to drink raw date juice.

In 2022, Bangladesh reported three Nipah virus cases.

The World Health Organization (WHO) says Nipah virus infection is a zoonotic illness transmitted to people from animals and can also be transmitted through contaminated food or directly from person-to-person.

In infected people, it causes a range of illnesses.

During the first recognized outbreak in Malaysia and Singapore in 1999, most human infections resulted from direct contact with sick pigs or their contaminated tissues.

This outbreak resulted in nearly 300 human cases and more than 100 related fatalities.

In subsequent outbreaks in Bangladesh and India, consuming fruits or fruit products (such as raw date palm juice) contaminated with urine or saliva from infected fruit bats was the most likely source of infection.

As of January 31, 2023, no Nipah virus vaccines are available, says the U.S. CDC.

The CDC does recommend several vaccinations, such as dengue, before visiting Bangladesh in 2023.

Jan 31, 2023 • 1:34 pm CST
Pfizer Inc. Jan. 31, 2023

Pfizer Inc. today announced its 2022 year-end financial results reflecting the COVID-19 pandemic's diminishing impact on society. Excluding COVID-19 products, the Company continues to expect 7% to 9% operational revenue growth in 2023.

While 2022 revenues for the Comirnaty vaccine exceeded the previous year by 3% at $37.81 billion, the company expects this amount to decrease to $13.5 billion this year.

Today's data indicates a projected demand reduction of just 65 million vaccines, compared to 92 million in 2022.

And from its COVID-19 antiviral treatment known as Paxlovid, Pfizer expects a 58% reduction in 2023.

Dr. Albert Bourla, Chairman and Chief Executive Officer, stated in a related press release on January 31, 2023, "2022 was a record-breaking year for Pfizer, not only in terms of revenue and earnings per share, which were the highest in our long history, but more importantly, in terms of the percentage of patients who have a positive perception of Pfizer and the work we do."

"As proud as we are about what we have accomplished, our focus is always on what is next."

"As we turn to 2023, we expect to once again set records, with potentially the largest number of new product and indication launches that we've ever had in such a short period."

"We believe that the combination of these expected near-term launches, additional pipeline products that could potentially come to market in the medium-term, and anticipated contributions from business development, has the potential to set the company up for continued robust growth through the rest of this decade and beyond."

Jan 31, 2023 • 9:05 am CST
Mercy Ships’ Newest Hospital Ship 2023

The newest ship in the Mercy Ships fleet will soon lower her gangway in Dakar, Senegal, and welcome patients on board to receive life-changing surgery.

In 2023, Mercy Ships will serve patients in two countries – Senegal and The Gambia – from one port, with six operating rooms and 199 beds.

Since the new ship's construction was completed in mid-2021, she's been preparing to serve her first patients.

The Global Mercy hospital will bring new technology and larger spaces to the field service.

The new hospital has several advantages.

Many off-ship facilities, like the dockside medical tents, have been moved on board. This saves weeks of setup and tear-down, allowing more time for surgeries.

Built-in cameras will allow trainees to watch surgeries remotely, exponentially expanding training opportunities.

Jan 31, 2023 • 8:31 am CST
by Thorsten Frenzel

The first randomized, placebo-controlled, single-blind clinical study of Ondine Biomedical Inc.'s Steriwave™ nasal photodisinfection was published in Frontiers in Cellular and Infection Microbiology.

This limited study, announced on January 31, 2023, met its primary endpoint, with a highly significant decrease in viral infectivity recorded as early as two days after treatment (p<0.0001).

Steriwave therapy also significantly improved the immune-protective status of treated patients, as measured by PCR testing one week after treatment (over six times fewer PCR-positive patients compared to controls).

The study was conducted at the Clínica Universidad de Navarra in Spain during the sixth Omicron outbreak in late 2021 and early 2022. Over 90% of the patients recruited into the study were fully vaccinated.

Ondine is seeking to offer a therapeutic approach to those patients who test positive but are not yet symptomatic or to those individuals who have had known exposure to a COVID-19 patient.

Currently, there are no U.S. FDA-approved approaches for killing the coronavirus while it is still located in the nose and throat.

Ondine Biomedical Inc. is a Canadian life sciences company innovating in the field of photodisinfection therapies.

Jan 31, 2023 • 6:15 am CST
People Images - Hopkins

The American Pharmacists Association (APhA) today announced its perspective regarding the recent news that some pharmacies are reducing operating hours.

'Like other health care professionals, pharmacy teams across the country have been stressed and stretched delivering patient care that they are educated and trained to provide while being inadequately staffed or supported in some cases.

During the pandemic, the Federal Retail Pharmacy Program for COVID-19 Vaccination, a collaboration between the federal government, states, and territories, and 21 national pharmacy partners and independent pharmacies, increased access to COVID-19 vaccines for millions of people. 

Appropriate staffing and workplace conditions are essential for a pharmacy to deliver quality patient care safely.

Time will tell how reduced operating hours will impact patients and pharmacy teams.

For patients, reducing pharmacy operating hours will impact when they can pick-up prescriptions, get vaccines, and receive other pharmacist services.

For pharmacists, because prescribers must continue to write prescriptions, the workload remains unchanged ... while pharmacy personnel will now have less time to do the work.

Many pharmacists already work after closing to keep up with prescription volume.

It is essential that appropriate pharmacy staffing is addressed, and employers and the public recognize pharmacy personnel's well-being as an essential component for safe and effective patient care.

"Some are blaming reduced hours on a pharmacist shortage. It is incorrect that there is a shortage of pharmacists or pharmacy technicians. More accurately, there is a shortage of pharmacists and technicians willing to work under the current conditions. Pharmacy is a rewarding profession, and pharmacists are experts in medication use."

"Therefore, we need to stop conflating and blaming the current conditions on pharmacist or technician shortages when it's due to short-staffing and health care system faults," said Ilisa BG Bernstein, PharmD, JD, FAPhA, interim executive vice president and CEO of APhA, in a press release on January 30, 2023.

"APhA has been on the frontlines of this issue and is driving the urgent and critical change that is needed in the current pharmacy workplace model," she said.

"For pharmacy teams, APhA offers resources and tools to support pharmacy personnel and provide data to improve pharmacy team well-being across the country."

"APhA and NASPA's PWWR tool is first of its kind; it allows pharmacists and pharmacy personnel to anonymously and confidentially share positive and negative workplace and well-being issues as we work to make necessary changes."

For example, Texas-based pharmacies affiliated with the Texas Department of State Health Services are actively administering COVID-19 boosters and oral therapeutics. Use Vaccines.gov to search for vaccination sites by zip code. 

Jan 31, 2023 • 2:12 am CST
CDC Prevention and Treatment of SARS-CoV-2 Infection Jan. 2023

The U.S. Centers for Disease Control and Prevention (CDC) recently confirmed COVID-19 vaccination remains the most effective way to prevent SARS-CoV-2–associated serious illness, hospitalization, and death.

And everyone, including those who are immunocompromised and their household members and close contacts, should stay up to date with COVID-19 vaccination.

Although moderately to severely immunocompromised persons might not mount a strong vaccine-mediated immune response, staying up to date with COVID-19 vaccinations does provide some protection.

A recent CDC study of preliminary data showed that a bivalent booster dose provided additional protection against symptomatic SARS-CoV-2 infection among immunocompetent persons who had previously received 2, 3, or 4 monovalent vaccine doses.

Among persons with immunocompromise and their household members and close contacts, prevention measures, including wearing a high-quality and well-fitting mask, maintaining physical distance from others, improving indoor ventilation, practicing frequent handwashing, and developing a care plan, should be considered in addition to receipt of a bivalent booster dose.

Furthermore, early outpatient treatment of mild to moderate COVID-19 with a recommended first-line therapy, Paxlovid or Veklury, has been shown to reduce the risk for severe COVID-19.

These medications are expected to retain activity against the currently circulating Omicron sublineages.

Available COVID-19 treatment does not supplant the need for persons to stay current on their COVID-19 vaccinations, which are highly effective at preventing COVID-19–related morbidity and mortality, stated the CDC's Morbidity and Mortality Weekly Report on January 27, 2023.

Jan 31, 2023 • 1:32 am CST
by Gerd Altmann

Scientists are harnessing a new way to turn cancer cells into potent, anti-cancer agents. Researchers recently published data in Science Translational Medicine. that showed they had developed a new cell therapy approach to eliminate established tumors and induce long-term immunity, training the immune system to prevent glioblastoma, with promising results.

Cancer vaccines are an active area of research for many labs, but this innovative approach is distinct.

Instead of using inactivated tumor cells, the team repurposes living tumor cells, which possess an unusual feature.

Like homing pigeons returning to roost, living tumor cells will travel long distances across the brain to return to the site of their fellow tumor cells.

Taking advantage of this unique property, the team engineered living tumor cells using the gene-editing tool CRISPR-Cas9 and repurposed them to release tumor cell-killing agents.

In addition, the engineered tumor cells were designed to express factors that would make them easy for the immune system to spot, tag, and remember, priming the immune system for a long-term anti-tumor response.

“Our team has pursued a simple idea: to take cancer cells and transform them into cancer killers and vaccines,” said corresponding author Khalid Shah, MS, Ph.D., director of the Center for Stem Cell and Translational Immunotherapy and the vice chair of research in the Department of Neurosurgery at the Brigham and faculty at Harvard Medical School and Harvard Stem Cell Institute, in a related press release.

“Using gene engineering, we are repurposing cancer cells to develop a therapeutic that kills tumor cells and stimulates the immune system to destroy primary tumors and prevent cancer.”

“Our goal is to take an innovative but translatable approach so that we can develop a therapeutic, cancer-killing vaccine that ultimately will have a lasting impact in medicine.”

Shah and colleagues noted that this therapeutic strategy applies to a broader range of solid tumors and that further investigations of its applications are warranted.

CDC Influenza Surveillance Report Jan. 27, 2023
Jan 30, 2023 • 5:25 pm CST

According to the U.S. Centers for Disease Control and Prevention (CDC) Weekly Influenza Surveillance Report, a total of 91 influenza-associated pediatric deaths have occurred during the 2022-2023 flu season.

During week #3, six influenza-associated pediatric deaths were reported to CDC.

All six pediatric deaths were associated with influenza A viruses.

Four of the influenza A viruses had subtyping performed; one was an A(H1N1) virus, and three were A(H3) viruses.

As of January 27, 2023, the CDC stated the cumulative hospitalization rate was 1.4 times higher than the highest cumulative in-season hospitalization rate observed for week #3 during previous seasons going back to 2010-2011.

However, this in-season rate is still lower than end-of-season hospitalization rates for all but four pre-COVID-19-pandemic seasons going back to 2010-2011.

Most influenza viruses tested are in the same genetic subclade as and antigenically similar to the influenza viruses included in this season’s influenza vaccine.

As of January 14, 2023, about 171 million influenza vaccines had been distributed in the U.S.

All flu shots this flu season are quadrivalent and remain available at clinics and pharmacies. According to the CDC, these vaccines are authorized for most people over six months.

Jan 30, 2023 • 12:45 pm CST
U.S. CDC Disease Outbreaks Nigeria 2023

The Nigeria Centre for Disease Control (NCDC) recently reported its ongoing diphtheria outbreak had recorded 38 deaths in the country.

On January 20, 2023, NCDC confirmed it has responded to diphtheria cases in Lagos and Kano States and is monitoring the situation in Osun and Yobe States.

Diphtheria is a bacterial infection caused by the corynebacterium species that affect an individual's nose, throat, and sometimes, skin. It spreads quickly between people through:

  • Direct contact with infected people,
  • Droplets from coughing or sneezing,
  • Contact with contaminated clothing and objects.

Over the past five decades, diphtheria has reduced dramatically worldwide.

And since diphtheria is a vaccine-preventable disease, the NCDC childhood immunization schedule recommends three doses of pentavalent vaccine (diphtheria toxoid-containing vaccine) are recommended for children early in life.

Furthermore, the NCDC announced on January 23, 2023, all healthcare workers with a high level of exposure to diphtheria should be vaccinated.

The U.S. CDC stated in December 2022 to ensure you are up-to-date on all routine vaccines before visiting Nigeria, including for Diphtheria-Tetanus-Pertussis.

Additionally, the CDC has issued Travel Advisories regarding Nigeria's Mpox, yellow fever, polio, and measles outbreaks.

Vaccines available at travel clinics and pharmacies in the U.S. prevent these diseases.

Jan 30, 2023 • 9:57 am CST
from Pixabay

Moderna, Inc. today announced that its investigational mRNA vaccine candidate for the respiratory syncytial virus (RSV) mRNA-1345, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) in adults aged 60 years or older.

Moderna also confirmed it intends to submit a license application to the FDA for regulatory approval in the first half of 2023.

"The FDA's Breakthrough Designation for mRNA-1345 further emphasizes the significant health impact of RSV in older adults and the high unmet need," said Stéphane Bancel, Chief Executive Officer of Moderna, in a press release on January 30, 2023. 

Moderna's mRNA platform has demonstrated two positive Phase 3 infectious disease trial results."

This designation is granted to expedite the development and review of drugs intended to treat a serious condition and when preliminary clinical evidence indicates the drug or vaccine may demonstrate substantial improvement over available therapy on a clinically significant endpoint.

mRNA-1345 was previously granted Fast Track designation by the FDA in August 2021.

RSV can cause severe disease, with an estimated 5.2 million cases and nearly half a million hospitalizations in adults 60 years or older reported across high-income countries in 2019, says the U.S. Centers for Disease Control and Prevention.

Each year in the U.S., approximately 60,000-120,000 older adults are hospitalized, and 6,000-10,000 die due to RSV infection.

As of January 30, 2023, the FDA has not approved any RSV vaccine candidates but authorized RSV antibody treatments.