COVID-19 Weekly Newsletter: New Vaccine EUA Expected

Updates on vaccines for young children and a massive study on the efficacy of mask-wearing in schools headline this week’s COVID-19 news.

Vaccine for Children

This week, one mRNA COVID-19 vaccine manufacturer announced it will seek an emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its vaccine to be given to children between the ages of 6 months and 6 years. When the vaccine’s trials were conducted during the Omicron wave, children 6 months to 2 years were 43.7% protected and kids between the ages of 2 and 6 were 37.5% protected against the virus.

Mandatory Masking in Schools Shown to Reduce COVID-19

With mandatory masking starting to end in some schools in the United States, data from large studies seeking to examine the effects of masking should be of high interest and value to states and districts. A recent study of over 1 million students and more than 150,000 staff across 61 K-12 districts and 9 states found SARS CoV-2 transmission events in schools with universal masking was significantly reduced, by about 72%, compared to schools with optional or partial masking policies. The study focused not on total transmission (which includes non-school specific cases), but rather only on cases of transmission within schools, or secondary transmission. The study was conducted during the timeframe when the Delta variant was dominant in the U.S.

Fewer Tuberculosis Cases Found During COVID-19 Pandemic

The U.S. Centers for Disease Control and Prevention (CDC) released a statement this week in which the number of cases of tuberculosis (TB) reported in 2020 and 2021 fell 20% and 13% respectively compared to TB diagnoses made before the pandemic. This is a sharp decline from reported cases which typically fall only 1-2% each year. While this reduction can be attributed to efforts such as mask wearing and social distancing, missed or delayed TB diagnoses may have also played a factor due to disruptions and strains to the health care system and an evaluation and testing bias focused on COVID-19 versus TB. While these two diseases have overlapping symptoms, it is critical that health care providers understand the differences to properly detect and diagnose both diseases.

Second Antigen Test Improves Detection Accuracy of SARS-CoV-2 Infection

Rapid antigen tests are convenient for checking asymptomatic individuals for a possible SARS-CoV-2 infection in a workplace or at home. A single test, however, can give a false positive result in over 60% cases. Repeating the antigen test, however, increases the accuracy: if both tests are positive, the chances that the person is really infected with the virus is more than 90%.

Vaccinations and Boosters Reduce Risk of Hospitalization and Death

The latest Morbidity and Mortality Weekly Report from the Centers for Disease Control and Prevention (CDC) presents yet another set of data demonstrating that those who have completed mRNA vaccinations have a significantly lower risk of ending up in a hospital, requiring mechanical ventilation, or dying following infection with SARS-CoV-2 including the Omicron variant. The protection was highest for those who also received boosters. As of March 20, less than half of the U.S. population has been boosted. The highest rate of boosting was reported in the state of Vermont (nearly 60%). On April 6, 2022, an FDA Advisory Committee will be discussing an updated framework for future boosters and variant-specific vaccines.

Clusters of Long-COVID Symptoms

Clinicians have identified several clusters of symptoms associated with long COVID. Each cluster was characterized by high frequency of particular symptoms, such as musculoskeletal and joint pains, or cardiorespiratory deficiencies. The occurrence of long COVID was not related to the mildness or severity of the original disease. The authors stress that long COVID is not a single disease, and that there is a need to further study this condition in order to improve its diagnosis and treatment.

How Low Should Case Numbers Go To Protect The Immunocompromised?

Those who cannot develop an appropriate immune response to vaccinations have to rely on other measures to avoid a SARS-CoV-2 infection. Patients with immune diseases or patients taking immunosuppressive medications for other conditions fall into that category. A simplified model of what would be needed to protect such individuals when everyone goes “back to normal” yielded a threshold: about 50 cases per 100,000 people per week.

With that many SARS-CoV-2 detections in the general population, the immunocompromised would have less than 1% chance of contracting COVID-19 over a four-month period. In the U.S., many communities are already below that threshold. That specific number, however, was calculated under certain assumptions (e.g., the immunocompromised would always wear a high-quality face mask when around other people, and they would always have access to the monoclonal antibody treatment providing passive immunity). A SARS-CoV-2 infection could have devastating consequences for individuals with a compromised immune system. Moreover, prolonged infection in such patients has been shown to lead to the emergence of new viral variants, as various studies (including studies by Nature; the New England Journal of Medicine (also here); American Society for Microbiology; Nature Communications; International Journal of Infectious Diseases; and Oxford Academic) have confirmed, including drug-resistant variants. Preventing SARS-CoV-2 infection in the immunocompromised remains an important public-health goal.

Children and COVID-19

A recent study showed that a previous infection with SARS-CoV-2 induces fewer antibodies in children compared to adults, leaving them vulnerable to re-infection. Even though children have lower rates of severe COVID-19 compared to adults, during the Omicron wave, the rates of hospitalizations among the very young was several fold higher than in the previous waves. While young children still lack an authorized vaccine, reducing virus circulation through immunization of the vaccine-eligible population indirectly protects the kids.

Pandemic’s Lessons for Data Management and Knowledge Communication

The COVID-19 pandemic has forced individuals, communities and organizations to re-think what they do and how they do it. One such area that has undergone a profound change has to do with gathering and sharing of scientific data to advance the goals of promoting public health. A recent Nature article reflects on the lessons that could be drawn from that explosion of data-sharing practices and tools for data management and visualization. The authors note that the cauldron of the past two years has also allowed data-communicators to test what works and to identify best approaches, which now could be deployed in the service of other pressing social issues.

Additional Resources

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.