NIH-sponsored mix-and-match trial finds additional COVID-19 dose safe and immunogenic
A new report published in The New England Journal of Medicine (N Engl J Med January 2022) found that for adults who had previously received a full COVID-19 vaccine regimen of either Moderna, Pfizer, or Johnson & Johnson, an additional booster of any of these vaccines was safe and immunogenic. The study assessed adults who had been fully vaccinated with any of the three vaccines at least 12 weeks prior and who had no previous COVID-19 infection. A single booster was administered to each participant; depending on which initial vaccine the participant had received, the booster was either different than (heterologous) or the same as (homologous) the original vaccine. Participants reported side effects such as headache, pain at injection site, and muscle aches, but no serious adverse events. All combinations were found to increase neutralizing antibody levels, strongly suggesting that both heterologous and homologous COVID-19 booster combinations will increase protection against infection. Investigators will continue to follow participants to study longer-term responses to the booster vaccines.
Researchers highlight effects of COVID-19 on the brain and the need for further studies
Acute COVID-19 infection can affect many areas of the body, including the nervous system. Reported neurological symptoms include loss of taste and smell, headaches, impaired concentration, and psychological effects. These symptoms sometimes persist months after infection, a condition known as long COVID-19. In a Viewpoint published in Science (Science January 2022), researchers outline what is currently known about the effects of COVID-19 on the brain, noting that the virus does not seem to infect brain cells but that neurological symptoms may be caused by immune activation and damage to blood vessels. The authors also note there is a wide variability of long COVID symptoms from person to person, and little is known about the long-term neurological complications. They call for increased research into long COVID, including close studies of sufferers based on specific symptoms, indicating that such studies are necessary to develop diagnostic and therapeutic tools to address long COVID.
The U.S. Food and Drug Administration (FDA) expanded approved use of the antiviral drug remdesivir to include adults and pediatric patients 12 years of age and older who are not hospitalized and have mild to moderate COVID-19 but are at high risk for disease progression. Use of the drug had previously been limited to hospitalized patients. This new group of approved patients is authorized to receive the drug via intravenous infusion for a total of three days outside of a traditional inpatient hospital setting. Though remdesivir provides another treatment option to reduce the risk of hospitalization from COVID, the FDA cautions that remdesivir is not a substitute for vaccination and recommends vaccination and a booster dose for those eligible.
CMS commits funds to connect eligible children, parents, and pregnant people to health care coverage
The Centers for Medicare & Medicaid Services (CMS) committed $49.4 million to connect eligible children, parents, and pregnant people to coverage through Medicaid and the Children’s Health Insurance Program (CHIP). The funds will be distributed to organizations to provide enrollment and renewal assistance to children and their families, as well as pregnant people. Each awardee organization will receive up to $1.5 million for a three-year period, and applicants are encouraged to consider a range of activities, including engaging schools and youth activities, targeting communities with low coverage rates, and using social media for outreach.
This is the first year that pregnant people have been included as a target population for these grants, a move designed to increase access to prenatal care and improve birth outcomes. The funding is also aimed to ensure more children are enrolled in coverage, especially those who are eligible but not yet enrolled; many parents do not realize their children are eligible for coverage, a disparity that is especially profound in certain demographic groups. The funds are an effort to enroll some of these hard-to-reach populations and advance health equity.
CVS Health and Uber Health collaborate to reduce health disparities
A new partnership between CVS Health and Uber Health will provide free transportation support for people seeking access to medical care, work, or educational programs in high-risk areas. The collaboration, part of CVS Health’s Health Zones initiative, is designed to address unreliable access to transportation, which can limit a person’s ability to receive medical care and can lead to adverse health outcomes. The rides will be coordinated by Uber’s health care arm, Uber Health, and will be available to target populations in Atlanta, Columbus, Ohio, and Hartford, Connecticut, with plans to expand to more locations later in the year.
New software aims to expand diversity in clinical trial recruitment
Clarify Health, a health care and life sciences analytics company, recently launched its Clarify Trials software, designed to increase diversity in clinical trial recruitment. The software uses more than 400 social determinants of health insights, including income level, education level, transportation access, housing stability, and health literacy, and links to government and commercial claims and prescription and dispensing data that cover more than 300 million patients. Researchers can use this data to expand the diversity of patients enrolled in their trials and proactively reduce health disparities.
The need for increased clinical trial diversity has been addressed by the FDA, which released a guidance document in 2020 urging the enhancement of diversity in clinical trial populations (asamonitor.pub/3GjgA6g). The document highlights the importance of recruiting patients who better reflect the population most likely to use the drug and recommends researchers broaden eligibility criteria and take steps to increase enrollment of underrepresented populations.