Study suggests link between COVID-19 and risk of pregnancy complications
A National Institutes of Health (NIH)-funded study published in the Journal of the American Medical Association (JAMA 2022;327:748-59) suggests that pregnant women with COVID-19 appear to be at greater risk for pregnancy complications than those without COVID-19. The study included more than 13,000 pregnant people, approximately 2,400 of whom were infected with COVID-19, who delivered between March and December 31, 2020, before vaccines were available. Researchers found that, compared with uninfected people, those with moderate to severe COVID infection were more likely to experience death from any cause or a serious illness or condition related to common obstetric complications. They were also more likely to deliver via cesarean section or to deliver preterm. Mild or asymptomatic infection was not associated with adverse outcomes. These findings highlight the need for people who are pregnant and those who may become pregnant to be vaccinated against COVID-19 to avoid pregnancy complications.
WHO broadens mRNA vaccine technology transfer to more countries to counter pandemic
The World Health Organization (WHO) has added five new countries to the list of those receiving technology from the WHO's mRNA vaccine technology hub located in Cape Town, South Africa. The hub shares vaccine technology with low- and middle-income countries and provides training and support to bring mRNA COVID vaccines to production. Bangladesh, Indonesia, Pakistan, Serbia, and Vietnam will now be receiving support from the hub. The WHO plans to expand the technology transfer to other low- and middle-income countries, with priority given to those that do not currently have mRNA technology but already have some infrastructure in place to support the technology and subsequent vaccine production.
Researchers report COVID-19-related discrimination among racial and ethnic minority groups
In a study measuring the prevalence of COVID-19-related discrimination in the U.S., researchers found that people from all major racial and ethnic minority groups reported experiencing more discrimination than white adults. The report, published in the American Journal of Public Health (Am J Public Health 2022;112:453-66), detailed findings from a survey of 5,500 American Indian/Alaska Native, Asian, Black/African American, Hawaiian/Pacific Islander, Latino (English and Spanish speaking), white, and multiracial adults. Participants completed an online survey administered from December 2020 to February 2021 and were asked whether they had experienced COVID-19-related discrimination, such as being threated or harassed, because someone thought they had COVID-19. The study had some limitations, including the fact that it was administered online, so those with limited internet access were less likely to be included. It was also a self-reported survey, so discrimination was based on perceived behaviors.
According to the survey, when compared to white adults, people from all minority groups were more likely to have experienced discriminatory behaviors. Those who identified as Asian or American Indian/Alaska Native were the most likely to report discrimination, followed by those who identified as Hawaiian or Pacific Islander and Latino. The authors noted that the study results highlight the need for careful messaging during public health crises to prevent and address discrimination against marginalized groups.
Manufacturer of NIH-supported pain management nasal spray reports favorable preclinical safety data
Virpax Pharmaceuticals, Inc. has announced favorable preclinical data for its endogenous enkephalin intranasal spray for acute and chronic pain. The studies for the drug are being performed under a Cooperative Research and Development Agreement with the NIH's National Center for Advancing Translational Sciences (NCATS). The NIH entered into the agreement in 2020 as part of its efforts to support the development of nonaddictive pain treatments.
The NCATS conducted a 14-day study of the drug in rats, which showed no adverse related findings in hematology, coagulation, and serum chemistry and no treatment-related toxicity findings or mortality. Similarly, a 14-day study conducted in dogs showed no adverse toxicology findings. Additional preclinical studies will be conducted to support submission of an Investigational New Drug to the U.S. Food and Drug Administration (FDA) for eventual initiation of a phase 1 study of the drug in humans.
FDA expands clearance of brain function monitoring device to pediatric patients
Masimo announced that the FDA has expanded clearance of its SedLine® brain function monitoring system for use in patients 1-17 years of age. The system is used to monitor brain activity in patients under anesthesia to help physicians maintain appropriate depth of anesthesia and detect potential adverse reactions. The system had previously been cleared only for use in adult patients. Along with the announcement, Masimo introduced a new version of the system designed for use in pediatric patients, including smaller sensors to better fit children's foreheads.
Teladoc Health partners with Amazon to provide voice-activated virtual care
A new partnership between Teladoc Health and Amazon will provide on-demand medical care through Alexa-enabled devices. Using one of Amazon's voice-activated Echo devices (e.g., Echo, Echo Dot, Echo Show), customers can ask to speak to a doctor for nonemergency medical care, and the device will connect them to a Teladoc's call center. A doctor will then call the customer back for the telehealth visit.
The service will be available to all U.S. customers 24/7, and visits will be free with insurance or $75 without insurance. Only audio visits will be available initially, but the companies plan to expand to video appointments as well. The partnership is designed to limit barriers to health care access by providing a convenient way to connect with a doctor quickly from one device.
Magnets in smartphone accessories may interfere with implanted cardiac devices
According to new research published in Circulation: Arrhythmia and Electrophysiology (Circ Arrhythm Electrophysiol March 2022), magnets in small portable electronic devices and smartphone accessories, such as the Apple AirPods Pro charging case, Apple Pencil 2nd Generation, and Microsoft Surface Pen, may interfere with implanted cardiac devices (ICDs) and pacemakers. The accessories are often carried in the chest pocket and could deactivate ICDs if they come too close to the heart. The maximum distance for a possible interaction with ICDs was around 2 cm for the Apple products and 2.9 cm for the Microsoft Surface Pen. The study was conducted on ICDs that were not implanted in patients, but researchers recommend keeping magnetic devices at least one inch away from the heart to prevent any interactions.
Previous research has found that the iPhone 12 Pro Max can also interfere with ICD operation. The FDA recommends that consumer electronic devices be kept at least six inches away from implants during use.