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The 2021 Health Care Insights Study published by CVS Health® on July 8, 2021, reveals the impacts of the COVID-19 pandemic but also highlights the resilience of patients, providers, and the U.S. health care system.
The CVS Health study reveals people’s changing viewpoints toward their own health as well as generational and gender preferences in how they would like their health care delivered.
In fact, 77% of people said the COVID-19 pandemic has led them to pay more attention to their health in general, and 50% indicated previous stay-at-home orders helped them achieve their health goals.
Even as access to health insurance coverage (55%) and location of care (43%) remain among the top factors that influence consumer health care decisions, more people are exploring different avenues of care.
The Health Care Insights Study by CVS Health, first released in 2018 and called the Health Ambitions Study, then known as the Path to Better Health Study in 2019 and 2020, was conducted in March 2021 and included two surveys fielded by Market Measurement, a national market research consulting firm.
Australia-based Imugene Limited announced on July 2, 2021, the City of Hope, a world-renowned independent cancer research and treatment center near Los Angeles, has received US Food and Drug Administration (FDA) Investigational New Drug (IND) approval to initiate a Phase I clinical trial of its oncolytic virotherapy candidate, CHECKvacc (CF33-hNIS-antiPDL1).
The clinical trial is titled “A Phase I Study of Intratumoral Administration of CF33-hNIS-antiPDL1 in Patients with Advanced or Metastatic Triple-Negative Breast Cancer”.
The FDA approval of the IND enables Imugene and the City of Hope to start patient recruitment and dosing in Phase 1 clinical trial for triple-negative breast cancer patients.
The purpose of the study is to evaluate the safety and initial evidence of the efficacy of intra-tumoral administration of CF33-hNIS-antiPDL1 against metastatic TNBC. The trial will involve a dose escalation, followed by an expansion to 12 patients at the final dose, the recommended phase 2 dose.
CF33-hNIS-antiPDL1 is an immune checkpoint inhibitor armed chimeric vaccinia poxvirus.
The Principal Investigator leading the trial is Dr. Yuan Yuan MD, Ph.D. Principal Investigator said in a related press statement, “Our team is excited to be part of this important study and the search for effective new treatments for triple-negative breast cancer as there are limited options for patients.”
The JAMA Oncology published the results from a cohort study 'Serologic Status and Toxic Effects of the SARS-CoV-2 BNT162b2 Vaccine in Patients Undergoing Treatment for Cancer.'
On July 8, 2021, this Original Investigation concluded by saying, 'In this cohort study of 223 cancer patients, the SARS-CoV-2 BNT162b2 vaccine (Pfizer-BioNTech, Comrinaty) appeared to be safe and achieve satisfactory serologic status.'
'There was a pronounced lag in antibody production compared with the rate in noncancer controls.'
'However, seroconversion occurred in most patients after the second vaccine dose.'
Moreover, 'future real-world data are warranted to determine the long-term efficacy of the Pfizer-BioNTech vaccine concerning the type of anticancer treatment.'
After the first dose of the BNT162b2 vaccine, 29% (n = 25) of patients were seropositive compared with 84% (n = 220) of the controls (P < .001). After the second vaccine dose, the seropositive rate reached 86% (n = 187) in the patients.
Patients undergoing chemotherapy showed reduced immunogenicity. In seronegative patients, the rate of documented absolute leukopenia reached 39%.
Throughout the study period, no COVID-19 cases were documented. Of the 232 patients undergoing treatment for cancer, 57% were men; the mean age was 66 years.
In conclusion, these researchers stated, 'Our study lends credence to the widely adopted recommendation to prioritize patients with cancer for SARS-CoV-2 vaccination. Nevertheless, our results imply that a potential intention to decline a second vaccine by some jurisdictions owing to a shortage of vaccines warrants reevaluation of unique populations, such as patients with cancer, because of lagging immunogenicity.'
'Until additional prospective data regarding vaccine efficacy in patients with cancer are established, adherence to risk reduction health care strategies is prudent.'
Funding/Support: This study was partially supported by the Israel Cancer Research Fund grant 16-1276-CRCDA. Dr. Peer reported receiving Pfizer Lecture fees outside the submitted work. No other disclosures were reported.
Myocarditis in children is a rare yet challenging condition to treat. Many cases of myocarditis resolve on their own, according to a new scientific statement issued by the American Heart Association (AHA) on July 7, 2021.
The “Diagnosis and Management of Myocarditis in Children,” published in the AHA's Circulation journal, reviewed the latest research to develop guidance in diagnosing and treating myocarditis in children.
Myocarditis is inflammation of the middle layer of the wall of the heart muscle, the myocardium, and it can temporarily or permanently weaken the heart muscle and the heart’s electrical system, which keeps the heart pumping regularly. Approximately 10 to 20 per 100,000 people are diagnosed with myocarditis in the U.S. annually.
And in children, the incidence is 1 to 2 per 100,000.
“Myocarditis has distinct characteristics in children and a potential impact on their lifelong health,” said Yuk M. Law, M.D., FAHA, chair of the scientific statement writing group, director of Cardiac Transplant and Heart Failure Service at Seattle Children’s Hospital, and professor of pediatrics at the University of Washington School of Medicine in Seattle, in a press statement.
“We hope that this statement serves as an educational update as well as a unifying call for much-needed research to understand better and treat this important pediatric condition."
"And, in light of the recently recognized occurrence of myocarditis after COVID-19 infection, as well as the emergence of cases of suspected myocarditis after COVID-19 vaccination, this statement is a resource for clinicians and health care professionals in caring for these patients.”
Note: The U.S. CDC recently stated in the Morbidity and Mortality Weekly Report, 'within the Vaccine Adverse Event Reporting System, 1,226 reports of myocarditis after mRNA vaccination was received from December 29, 2020 - June 11, 2021. Among 1,194 reports for which patient age was known, 923 were male, and 76% of the adverse events occurred after receiving a second mRNA vaccine dose.
The Miami Herald reported on July 7, 2021, a federal judge denied a request from the U.S. Centers for Disease Control and Prevention (CDC) to keep its COVID-19 safety regulations for Florida cruises in effect. The CDC argues that cruise ships could exacerbate the spread of COVID-19 in the U.S without its regulations.
The judge stated the CDC’s argument ignores state, and local oversight and the improvements cruise companies have made to their operations since COVID-19 outbreaks began in early 2020.
On April 2, 2021, the CDC had issued the next phase of technical guidance under the Framework for Conditional Sailing Order requiring cruise lines to establish agreements at ports where they intend to operate, implement routine testing of the crew, and develop plans incorporating vaccination strategies to reduce the risk of introduction and spread of COVID-19 by crew and passengers.
The CDC lowered its Travel Alert to Level 3 status on June 16, 2021, and specified the notice is for travelers who are not fully vaccinated.
The CDC says, ‘COVID-19 vaccines play a critical role in the safe resumption of passenger operations. As more people are fully vaccinated, and more drug therapeutics are available, the phased approach allowed CDC to incorporate these advancements into planning for safe resumption of cruise ship travel.’
The states of Florida and Texas have endorsed relaunching the cruise ship industry this summer.
Copenhagen-based Evaxion Biotech A/S announced today results from its Phase 1/2a trial of cancer immunotherapy EVX-01 in metastatic melanoma and interim Phase 1/2a trial of cancer immunotherapy EVX-02 adjuvant melanoma.
Data from the trial of EVX-01, a novel patient-specific cancer neoepitope immunotherapy based on Evaxion’s PIONEER AI technology combined with a PD-1 checkpoint inhibitor, showed a safety profile with only Grade 1 and 2 adverse events observed.
Combined therapy with EVX-01 demonstrated an objective response rate of 67% across all nine patients compared with historical data of 40% with anti-PD1 treatment alone.
The study also demonstrated a complete response rate of 22%, compared with a historical 7% with anti-PD1 treatment alone, and a partial response rate of 44%, versus 33% compared with anti-PD1 treatment alone.
Among the four patients on the highest two doses, there was an objective response rate of 75%In addition, three patients with Stable Disease for 10, 8, and 9 months on anti-PD1 treatment alone achieved CR, CR, and PR respectively following EVX-01 administration and subsequent activation of a neoepitope-specific de novo T-cell response.
Evaxion Biotech A/S is a clinical-stage AI-immunology platform company decoding the human immune system to discover and develop novel immunotherapies to treat cancer and vaccines against bacterial diseases and viral infections.
Messenger RNA (mRNA) vaccines against COVID-19 were recently approved under various emergency use authorization issued by the U.S. FDA. However, there is a paucity of data regarding vaccine safety in pregnant or lactating individuals excluded from phase 3 clinical trials.
The journal JAMA Pediatrics published a Research Letter on July 6, 2021; vaccine-associated mRNA was not detected in 13 milk samples collected 4 to 48 hours after vaccination from 7 breastfeeding individuals.
The BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) vaccines were separately inoculated into prevaccination milk samples, processed by the same protocols, and used as positive controls for this assay, with prevaccination milk samples used as negative controls.
These results provide important early evidence to strengthen current recommendations that vaccine-related mRNA is not transferred to the infant and that lactating individuals who receive the COVID-19 mRNA-based vaccine should not stop breastfeeding.
In addition, any residual mRNA below the limits of detection would undergo degradation by the infant gastrointestinal system, further reducing infant exposure, stated these researchers. Clinical data from larger populations are needed better to estimate the effect of these vaccines on lactation outcomes.
The primary limitations of this study are the small sample size and the few participants who received the Moderna (SpikeVax, mRNA-1273) vaccine. In addition, milk storage conditions may have affected mRNA stability.
The World Health Organization (WHO) issued its bi-monthly influenza reported on July 5, 2021. Globally, despite continued or even increased testing for influenza in some countries, influenza activity remained at lower levels than expected for this time of the year, stated the WHO.
During early June 2021, the WHO Global Influenza Surveillance and Response System laboratories tested more than 146,816 specimens. Only 766 specimens were positive for influenza viruses, of which 682 (89%) were identified as influenza B. Of the type B viruses for which lineage was determined, all 624 (100%) were ascribed to the B-Victoria lineage.
The WHO added, 'the current influenza surveillance data should be interpreted with caution as the ongoing COVID-19 pandemic has influenced varying extents health-seeking behaviors, testing priorities, and capacities in the Member States.'
- In the Caribbean and Central American countries, there were no influenza detections reported.
- In tropical South America, no influenza detections were reported.
- In tropical Africa, a few influenza detections were reported in some countries in Western and Eastern Africa.
- In Southern Asia, a few influenza detections were reported from India.
- In Southeast Asia, no influenza detections were reported.
- In the temperate zone of the southern hemisphere, influenza activity remained at inter-seasonal levels.
- In the temperate zone of the northern hemisphere, influenza activity remained at inter-seasonal levels, though detections of influenza B/Victoria lineage slightly increased, especially in China.
The most common flu shot in the Northern Hemisphere are quadrivalent vaccines that protect people against four viruses: influenza A (H1N1) virus, influenza A (H3N2) virus, and two influenza B viruses, said the U.S. CDC. In addition, two new influenza vaccines have been licensed for use in people aged 65 and older; a quadrivalent high-dose influenza vaccine and a quadrivalent adjuvanted influenza vaccine.
Most people over 6-months of age are encouraged to get vaccinated every flu season since influenza infections can create severe consequences, said the CDC.
The US Department of State issued an update on July 2, 2021, regarding the status of US passport operations. The list below highlights what to expect during July 2021:
- Mail delays are impacting when we receive passport applications for processing. Our processing times begin the day we receive your application, not the day you mail it.
- Routine service can take up to 18 weeks from when an application is submitted to the day a new passport is received. The 18-week timeframe includes up to 12 weeks for processing and up to 6 weeks for mailing times on the front and back end.
- Expedite service (for an additional $60) can take up to 12 weeks from the day an application is submitted to the day a new passport is received. The 12-week timeframe includes up to 6 weeks for processing and up to 6 weeks for mailing times on the front and back end.
- Our processing times (up to 12 weeks for routine; up to 6 weeks for expedite) do not include mailing times. Mail times vary, and delays have been significant. Plan ahead.
The State Department suggests you:
- Please send your application to us via trackable mail, so you can track your application before it enters our system. This can be done whether applying at an acceptance facility or by mail.
- Pay an extra $17.56 for 1-2 day delivery for the return of your completed passport.
- More about Status Updates: It may take up to 6 weeks from the day you submit your application until your status is “In Process.” During these 6 weeks, your application is delivered to a mail facility, your payment is processed, and your application is entered into our system. So even if your passport status update says, “Not Available,” your application and supporting documents are safely on their way to us. Check online for your passport status.
- Use Self-Service Tools Online: Our call center is experiencing extremely high call volumes with longer-than-usual wait times. You can get your questions answered immediately by using one of the self-service tools available on our site 24 hours a day, 7 days a week. What you see online is the same information that call center representatives can share with you by phone.
- Planning to Travel? Apply Early! Apply at least six months before planned travel. Due to limited availability for urgent travel appointments, we cannot guarantee you can receive in-person service at a passport agency or center. We are prioritizing customers with life-or-death emergencies.
- Renew By Mail: Adults with 10-year passports can renew them by mail instead of appearing in person.
Visit our Passport Agency and Center page to learn more.
France-based Valneva SE announced that it had been awarded Breakthrough Therapy Designation for its single-shot chikungunya vaccine candidate, VLA1553, by the U.S. Food and Drug Administration (FDA).
FDA Breakthrough Therapy Designation intends to facilitate and expedite the development and review of new drugs for serious or life-threatening conditions where preliminary clinical data demonstrates that the drug may have substantial improvement for at least one endpoint over available therapies.
Previously, Valneva announced recruitment completion for its pivotal Phase 3 trial, VLA1553-301, and expects to report topline data during the summer of 2021.
Juan Carlos Jaramillo, Chief Medical Officer of Valneva, commented in a press statement, “Chikungunya is a major, growing public health threat, and VLA1553 targets long-lasting protection against the chikungunya virus with a single shot. We will continue to work closely with the FDA to bring a preventative solution to the market as soon as possible.”
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus, a Togaviridae virus transmitted by Aedes mosquitoes. An infection leads to symptomatic disease in 72-92% of humans after 4 to 7 days following the mosquito bite. While mortality is low, morbidity is high. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash, and chronic arthralgia, says the U.S. CDC.
In the USA, Chikungunya virus disease cases reported to ArboNET as of May 25, 2021, are published on this CDC webpage.
Saint Herblain, France-based Valneva SE, is a specialty vaccine company focused on developing and commercializing prophylactic vaccines for infectious diseases with significant unmet medical needs.
