COVID-19 Weekly Newsletter: Pediatric COVID-19 Patients
A number of recent studies have sought to identify commonalities among COVID-19 patients under the age of 18 who have required hospitalization. In addition, many new studies have worked to measure the impact of the COVID-19 pandemic — including its economic cost both within the U.S. and globally.
New Vaccine Filed for EUA
This week a biotechnology company filed its emergency use authorization to the Food and Drug Administration (FDA) for its protein-based COVID-19 vaccine. The vaccine was one of the recipients of the $2 billion investment made by the U.S. government in funding COVID-19 vaccine development, an initiative called Operation Warp Speed. The vaccine is already authorized to be used in Indonesia and the U.K. In addition, it has conditional marketing authorization in the European Union and is on the emergency use listing from the World Health Organization.
Second Vaccine Granted Full Approval
As of this week, both mRNA vaccines have received full FDA approval. One mRNA vaccine manufacturer received its full approval in August 2021, and this week, the other mRNA vaccine did as well. The vaccine has been authorized for emergency use since December 2020 and has been authorized in more than 70 countries. According to the Centers for Disease Control and Prevention (CDC), more than 204 million doses of the vaccine have been administered in the U.S., accounting for 38% of all doses given. It currently is only authorized to be used for individuals 18 years of age and older, but leaders expect to have data on teens and children in the coming month.
Free Tests for Medicare Beneficiaries
President Biden announced on Thursday, February 3, that starting in the early spring, the approximately 64 million people with Medicare will be able to obtain up to eight free over-the-counter COVID-19 tests a month. Per the Centers for Medicare and Medicaid Services (CMS), “This new initiative will enable payment from Medicare directly to participating pharmacies and other participating entities to allow Medicare beneficiaries to pick up tests at no cost.”
Vaccine Data Submitted for Under 5 Population
One mRNA vaccine maker is requesting an emergency use authorization (EUA) for its two-dose vaccine for children age 6 months to 5 years. FDA's Vaccines and Related Biological Products Advisory Committee’s (VRBPAC) will meet on February 15 to review the submission and make a recommendation to regulators. According to the American Academy of Pediatrics, over 3.5 million children have tested positive for COVID-19 in January alone and at least 11.5 million cases since the pandemic began.
Study Deliberately Infects Individuals With SARS-CoV-2
A “human challenge” study was conducted by researchers at Imperial College London in which healthy volunteers were exposed to a low dose of SARS-CoV-2, the virus that causes COVID-19. Half of those infected displayed COVID-19 symptoms and became infectious in only two days and remained infectious for nine days on average. This timeframe is accelerated from previous estimates of five days. It was shown that viral levels peaked at five days, with the virus still detectable in the nose 12 days after exposure. Researchers observed that high levels of viral shedding occurred regardless of the severity of symptoms, which explains the high transmissibility of COVID infections, suggesting that symptom severity does not correlate with transmission risk.
Omicron’s Evasiveness and T-Cells’ Effectiveness
T-cells have been demonstrated to recognize Omicron as well as the previous variants of SARS-CoV-2. By contrast, memory B-cells and neutralizing antibodies show reduced ability to respond to Omicron — possibly because of its conformational changes in the molecular regions targeted by antibodies induced by current vaccines.
Vaccination Leads to Broader Variant Recognition Than Infection
Another good reason to get vaccinated: compared to a SARS-CoV-2 infection, vaccination with any type of the currently available vaccines produced antibodies with a broader variant recognition and therefore better protection against different variants.
Multi-Omics Blood Analysis Can Forecast COVID-19 Progression
Dysregulation of the immune system plays a critical role in a person’s progressing from mild SARS-CoV-2 infection to a severe disease. A newly developed tool analyzes various blood markers to predict the likelihood that a given person would develop severe COVID-19. The new approach relies on a detailed characterization of the person’s genome and proteome, using advanced data processing methods involving machine learning, systems analysis and integrative biology.
Commonalities of Hospitalized Pediatric COVID-19 Patients
According to a CDC report published on December 31, 2021, hospitalized COVID-19 patients under 18 years of age were often co-infected with another respiratory virus or had high body-mass index (BMI). The most critical common feature was their vaccination status: Less than one percent of hospitalized patients who were eligible for vaccines were in fact vaccinated against SARS-CoV-2. The CDC report was based on the data gathered during the period when the Delta variant was prevalent in the U.S. and before Omicron became widespread.
More recently, the American Academy of Pediatrics reported that pediatric COVID-19 cases further increased during the Omicron wave. Hospitalization rates with Omicron were analyzed in a January 2022 bulletin from South Africa, where Omicron started circulating earlier than in the rest of the world. Worryingly, it shows that those younger than 18 years old have a higher proportion of hospitalizations with Omicron compared to the previous variants.
Vaccinations are the surest and safest way to protect kids from SARS-CoV-2. Unfortunately, as late as February 2022, only two-thirds of all eligible U.S. residents have been fully vaccinated, and community transmission in the U.S. remains “high” by CDC standards. The situation in the rest of the world is not much better, with only about 60% of the world population having received at least one dose, and very few having received boosters. This leaves many children unprotected and vulnerable to the infection and potential hospitalization. Moreover, with non-pharmaceutical interventions being loosened, both SARS-CoV-2 and other respiratory virus infections are likely to rise in children and other susceptible populations.
Cost of the Pandemic Exceeds Ten Trillion Dollars
In October 2020, Harvard economists warned that the pandemic could cost the U.S. upward of $16 trillion, due to losses in health and production. The good news is that thanks to the highly effective vaccines, robust testing programs, non-pharmaceutical interventions and other public health measures, as well as an increasing number of efficacious medical treatments for those who do catch the virus, the U.S. losses haven’t come close to that number. The global economic cost, however, is likely to land in the same ballpark — over $ 12 trillion by 2024, according to the updated International Monetary Fund (IMF) estimates. The most devastating price was paid in human lives lost to the disease -- over 5 million worldwide so far, with millions more in excess deaths.
Mixed Effect of the Pandemic on Cultural Sector
A review in the Business Journal suggests that the effects of the pandemic on creative industry and cultural institutions have been mixed. Self-employed artists have been hardest hit, although larger organizations may have seen a boost in funding.
A Surprising Effect of Lockdowns
A paper presented at the December 2021 meeting of the American Geophysical Union (AGU) showed that during lockdowns of March-May 2020, a 10-20% reduction in the amount and intensity of atmospheric lightning has been observed globally. The authors suggest that the explanation lies in the reduced air pollution during the widespread lockdowns, which led to fewer crystallization centers in the clouds. According to the leading theory, lightning starts when ice crystals get electrostatically charged through turbulent mixing.
It’s Not Too Early for a Museum Exhibition on COVID-19!
The American Museum of Natural History has created a freely accessible online collection of videos explaining the science of viruses, vaccines and much more. Fun and educational, these short segments could supplement school curricula and improve our fluency in all things COVID.
Additional Resources
Global COVID-19-Related Patent Office Status and Deadline Extension UpdatesInformation regarding the status of each foreign patent office and the availability of extensions of time in each jurisdiction.
Government Actions: COVID-19Tracking 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.The material contained in this communication is informational, general in nature and does not constitute legal advice. The material contained in this communication should not be relied upon or used without consulting a lawyer to consider your specific circumstances. This communication was published on the date specified and may not include any changes in the topics, laws, rules or regulations covered. Receipt of this communication does not establish an attorney-client relationship. In some jurisdictions, this communication may be considered attorney advertising.