New guidance and pandemic preparedness strategies from the federal government highlight this week’s COVID-19 news.
Biden Administration New Measures To Combat COVID-19
The Biden administration released a 96-page strategy — the National COVID-19 Preparedness Plan — aimed at protecting people from the virus, reopening schools and regaining economic movement. The plan focuses on four areas: protecting against and treating COVID-19, preparing for new variants, preventing economic and educational shutdowns, and continuing to lead the effort to vaccinate the world and save lives. The administration wants to create a “Test-to-Treat” initiative, which would allow people who test positive at pharmacy clinics to immediately be prescribed anti-viral treatments. In addition, the administration plans to launch a new website to help Americans find up-to-date public health guidance and COVID-19 risk assessments. This is to ensure schools and businesses have necessary guidance and resources to avoid shutting down. The administration will also prioritize bolstering surveillance and data collection and accelerating the FDA review of authorized vaccines for use against new variants. Lastly, health officials are working with companies to ensure variant-tailored covid vaccines could be available to the public within 100 days of the discovered threat. The administration is still hesitant to declare the pandemic as an endemic part of life, but is hopeful these new measures will enhance the nation’s health and economic security as it pertains to COVID-19.
Vaccine Effectiveness in Reducing Hospitalization Less Effective for Children Than Teens
According to the Centers for Disease Control and Prevention (CDC) and based on a study of New York children, one of the mRNA COVID-19 vaccines is not nearly as effective at preventing urgent care visits and hospitalizations among children ages 5-11 compared with fully vaccinated teenagers. Vaccine effectiveness among children dropped the most during the Omicron surge, with many kids age 5-11 being hospitalized. A possible reason cited for this observation is younger children only receive 1/3 of the dose as adults, which may lead to decreased immunity. However, the CDC released a report today from additional studies suggesting the reduced effectiveness was indeed related to the Omicron variant, which was found circulating in the population shortly after vaccinations began for this age group. This report also demonstrates the importance of booster shots in protecting against severe COVID-19 and supports extending the booster eligibility to children ages 5-11, as well.
Potential New COVID-19 Therapeutic Identified
The RECOVERY Trial reported that an arthritis drug has been shown to reduce the risk of death in hospitalized patients with severe COVID-19 by 13%, which correlates with a similar study conducted by the drug manufacturer last August. The Randomized Evaluation of COVID-19 Therapy (RECOVERY) trial is an international clinical trial working to identify potential treatments for hospitalized patients with severe COVID-19. This trial has identified positive results for new treatments for COVID (such as dexamethasone) and also confirmed the ineffectiveness of other treatments (such as hydroxychloroquine) in treating COVID.
CDC Revises Mask Guidelines
On February 25, 2022, the CDC announced that mask-wearing guidance will now be based on the burden experienced by local health care systems rather than on the number of cases. Under this new guidance, 90% of the U.S. population no longer needs to wear masks, with masks still required under federal law on planes, trains and other public transportation. Mask-wearing will only be recommended in indoor public spaces within communities with “high” hospitalizations and hospital-bed utilization rates. The CDC also changed its guidance to recommend testing only in symptomatic individuals. Regardless of the area’s risk status, however, CDC recommends completing SARS-CoV-2 vaccination. The American Medical Association (AMA) also stressed that decisions regarding mask-wearing and other non-pharmaceutical interventions should take into account personal circumstances. For example, the immunocompromised, those unable to get vaccinated, or those exposed to someone with COVID-19 should take appropriate precautions, including wearing well-fitted masks, especially when physical distancing is impractical.
Long COVID Risk Factors Clarified
A Mayo Clinic study (also summarized in a Mayo Clinic editorial) identified several factors common to those suffering from long COVID, also known as post-acute sequelae of SARS-CoV-2 infection (PASC). Women and those with higher levels of the inflammatory cytokine interleukin 6 (IL-6) were in particular linked with the increased risk of developing PASC. Unfortunately, clinicians have seen an uptick in health problems for former COVID-19 patients even if the symptoms are not currently considered within the definition of PASC. For example, researchers found an increased risk of cardiovascular problems a full year past a SARS-CoV-2 infection. Having had COVID-19 seems to be an independent risk factor for developing cardio-vascular diseases leading to myocardial infarction, stroke, atrial fibrillation and other disorders.
Susceptibility to Re-Infection Likely Has Genetic Component
A 2020 study of recurring infections with endemic coronaviruses other than SARS-CoV-2 found that the severity of symptoms had more to do with the person’s genes than their immunity developed in response to the previous infections.
Allergic Reactions to Second Vaccine Are Rare
A retrospective analysis of data published for mRNA vaccine recipients found that among those who experienced an immediate allergic reaction to the first dose, only a small number (less than 1 percent) had an allergic reaction to the second dose. The authors conclude that completing the mRNA vaccination course is safe, even for those who may have experienced side effects from the initial dose.
Unvaccinated Still at Risk
A social gathering in Minnesota last summer provided an unintended case study of the SARS-CoV-2 transmission and infection. Three quarters of the attendees were fully vaccinated but there were no masking or social-distancing rules observed. A symptomatic unvaccinated child with a SARS-CoV-2 infection was among the guests. As a result, almost half of the attendees and some staff servicing the event caught the virus, including one unvaccinated adult who required hospitalization. The hospitalized person was younger than 65 years of age and had no underlying health conditions prior to this COVID-19 illness. The state CDC investigation of the outbreak associated with this social event found that for the unvaccinated attendees, the risk of getting infected was more than 2.5 higher than for the vaccinated.
COVID-19 ICU Patients’ Long Road to Recovery
A study of COVID-19 patients who had been admitted to the largest temporary intensive care unit (ICU) in Italy between April 2020 and June 2021 showed that it takes more than two weeks, on average, for the patients to be able to sit up in bed. ICU patients are often too weak to move on their own, and may be connected to ventilators or other equipment restricting motion. The physical-therapy interventions that facilitated a safe transition to the “active sitting position” milestone on the road to recovery included airway clearance techniques and targeted muscle-strengthening exercises.
Telehealth Can Enhance Equity and Safety of Patients
A Viewpoint in JAMA advocates a broader access to telehealth services for COVID-19 patients. The authors highlight the benefits that accrue from enabling more consistent remote monitoring of patients’ condition and care. To strengthen the use of remote health care tools, the authors recommend identifying effective technical protocols, creating a dedicated service line for coordinating remote care, arranging suitable billing mechanisms, integrating related technologies to maximize their value, and designing systems for matching specific patient’s needs and available services, since not everything “on the menu” would necessarily be optimal for every patient. In a separate development, an international group of experts published a consensus statement exhorting governments and other stakeholders to leverage digital technologies in order to better prepare for, and prevent, future pandemics. The statement advises countries to prioritize digital health, improve digital health infrastructure and cultivate “a health care workforce with the knowledge, skills, and training in data and digital technologies required to address current and future public health challenges,.” The authors also stress the importance of surveillance systems and developing “digital personal tools and services to support comprehensive health programs (in disease prevention, testing, management and vaccination) globally.”
FDA Updates FAQs for COVID-19 Testing
The Food and Drug Administration (FDA) updated its Frequently Asked Questions page related to COVID-19 Tests. In particular, the agency explained that antibody test results cannot be used to assess a person’s immunity against SARS-CoV-2. In a separate “FDA Roundup,” FDA also warned consumers against using unauthorized tests, which may yield false results.
Designing More Efficient Masks
The physics of airflow and particle filtration, combined with the science of the microscopic structure and properties of materials, provide useful insights that enable informed choices and design of more efficient yet comfortable masks. A recent modeling study also explained why woven cloth masks are suboptimal. When no specialized masks are available, however, and cloth must be used, the wearer could at least improve their protection by multiple layering.
Global COVID-19-Related Patent Office Status and Deadline Extension Updates
Information regarding the status of each foreign patent office and the availability of extensions of time in each jurisdiction.
Government Actions: COVID-19
Tracking executive orders, legislation, and other government actions related to COVID-19 by state and major locality across the U.S.
Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.