October 12: Johns Hopkins COVID 19 Report

COVID-19 Situation Report

Editor: Alyson Browett, MPH

Contributors: Clint Haines, MS; Natasha Kaushal, MSPH; Amanda Kobokovich, MPH; Christina Potter, MSPH; Matthew Shearer, MPH; Marc Trotochaud, MSPH; and, Rachel A. Vahey, MHS.

WEBINAR: Please join the Johns Hopkins Center for Health Security for a webinar, Lessons from eMed: COVID-19 At Home Testing and Verifying the Results, on October 19, 2021 at 10am ET. We will discuss the ongoing importance of COVID-19 testing and the verification of testing results at-home. Please register here.

EXTENDED PRIMARY VACCINE SERIES On October 11, the WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization recommended additional doses of SARS-CoV-2 vaccines for immunocompromised individuals. The recommendation applies to all 7 vaccines that have received an Emergency Use Listing (EUL) from the WHO and to all individuals who are moderately or severely immunocompromised individuals. SAGE also recommended a third dose of the Sinopharm and Sinovac vaccines for individuals aged 60 years and older. The advisory group emphasized that countries should initially prioritize administering the full original vaccine regimen to increase vaccination coverage, but an additional dose would provide extra protection for individuals at the highest risk for severe disease.

Notably, SAGE clearly distinguished its updated guidance from booster dose policies being implemented in some countries, including several in Europe, Israel, and the US. Specifically, the additional doses recommended under the new SAGE guidance are intended “as part of an extended primary series since [immunocompromised] individuals are less likely to respond adequately to vaccination” rather than as a general boost to protection for otherwise healthy individuals. The SAGE experts met for 4 days to discuss myriad vaccine-related issues, including non-pandemic topics such as the world’s first malaria vaccine, and the full meeting report is expected to be published in December. Reportedly, SAGE will address waning immunity and the need for broader booster doses in healthy individuals at a meeting scheduled for November 11.

MOLNUPIRAVIR EUA REQUEST Merck and Ridgeback Biotherapeutics on October 11 submitted an application with the US FDA for Emergency Use Authorization (EUA) of molnupiravir, an investigation oral antiviral medication, for the treatment of mild-to-moderate COVID-19 in adults at high risk of severe disease. Notably, if authorized by the FDA, the drug would be the first COVID-19 treatment to be administered orally, as all other authorized or approved medications are delivered intravenously or via injection. The companies’ submission is based on a Phase 3 clinical trial interim analysis showing molnupiravir reduced the risk of hospitalization or death by about half when compared with people who received a placebo. The data are not yet published or peer-reviewed. An effective therapeutic that is taken by people recovering at home could relieve some pressure on hospitals, particularly in areas with low vaccination rates.

Two Indian generic drug manufacturers last week requested permission to end late-stage clinical trials of generic versions of molnupiravir, after the drug did not show “significant efficacy” among people with moderate COVID-19 disease. A Merck spokesperson noted that the Indian studies defined moderate disease differently than the FDA and included patients with more severe disease. The Indian companies are continuing to research the treatment among people with mild COVID-19.

COVID-19 IN PREGNANCY Echoing guidance by the US CDC, England’s National Health Service (NHS England) on October 11 encouraged pregnant people to get vaccinated against SARS-CoV-2 and released data showing that, since July, nearly 1 in 5 of England’s most critically ill COVID-19 patients—those who required intensive care unit support including extracorporeal membrane oxygenation (ECMO)—have been unvaccinated pregnant women. Notably, of all women between the ages of 16 and 49 who have required ECMO in an intensive care unit, 32% of them have been pregnant, up from 6% at the beginning of the pandemic. NHS England is working to dispel misinformation and fears surrounding SARS-CoV-2 vaccines, pointing to safety data showing the shots are safe for pregnant individuals and their fetuses. According to data from the CDC, COVID-19 poses a significantly higher risk to pregnant people compared with non-pregnant people.

Several other recently released studies suggest that pregnant people with symptomatic COVID-19 are at a higher risk of emergency complications and other adverse perinatal and neonatal outcomes. A not-yet-peer-reviewed study presented over the weekend at the Anesthesiology 2021 Annual Meeting and a peer-reviewed study published October 10 in the Journal of Maternal-Fetal & Neonatal Medicine showed that pregnant people with COVID-19 who were symptomatic had an increased risk of giving birth in emergency circumstances and were more likely to have complications endangering their newborns, compared with those who had asymptomatic COVID-19 or who were not infected. Researchers writing in the American Journal of Obstetrics and Gynecology found that the recent surge of the Delta variant was associated with increased morbidity among pregnant people with COVID-19, particularly in underserved populations with low vaccine acceptance, prompting them to highlight the urgency of preventive measures during pregnancy, including vaccination. Additionally, experts attending the recent American Academy of Pediatrics (AAP) virtual meeting discussed neonatal outcomes, an apparent increase in preterm birth incidence among infected pregnant people compared with the 2019 incidence, as well as higher-than-expected maternal mortality among pregnant people testing positive at or around the day of delivery. All of the studies support emerging trends showing that COVID-19 can severely impact pregnant people and neonates, and provide evidence that vaccination is critically important for this population.

MENTAL HEALTH Prior to World Mental Health Day on October 10, a study published online on October 8 in The Lancet documented a grim and startling rise in cases of major depressive disorder (53.2 million new cases; 27.6% increase) and anxiety disorders (76.2 million new cases; 25.6% increase) globally from January 1, 2020 to January 29, 2021. The study was a systematic review of the prevalence of major depressive disorder and anxiety orders during the COVID-19 pandemic across various comprehensive sources, culminating in a meta-regression to estimate the rise in these 2 disorder types during the pandemic associated with COVID-19 impact indicators (e.g. mobility, daily SARS-CoV-2 infection rate). Impact indicators were found to be associated with increased prevalence of major depressive disorder and anxiety disorders, particularly among women and younger age groups.

The US CDC Morbidity and Mortality Weekly Report (MMWR) also published a similar study last week on national and state trends related to anxiety and depression during the pandemic. Findings noted that anxiety severity scores and depression severity scores increased from August 2020 to December 2020 before decreasing until June 2021.

RACIAL/ETHNIC DISPARITIES American Indian/Alaska Native (AI/AN), Black, and Latino individuals in the US have been disproportionately affected by the COVID-19 pandemic, with the disease causing more deaths by population size—both directly and indirectly—among these groups when compared with White or Asian populations. In a study published last week in the Annals of Internal Medicine, researchers reported that during the first 10 months of the pandemic (March-December 2020), an estimated 477,200 excess deaths occurred in the US than would have been expected based on 2019 data. Of these deaths, about 74% were directly attributable to COVID-19. After adjusting for age, overall excess deaths per 100,000 persons in 2020 were 2 to 3 times higher among AI/AN, Black, and Latino individuals compared with White and Asian individuals. Although the reasons for excess mortality are unknown, the researchers noted that “structural and social determinants of health with established and deep roots in racism”—including an increased risk of occupational exposure and lack of access to healthcare, possibly caused by fear during the pandemic—or misattribution of causes of death could have played roles.

The racial and ethnic disparities in COVID-19-related deaths spill over into the pandemic’s impacts on children. According to a modeling study published last week in Pediatrics, children of racial and ethnic minorities accounted for 65% of the more than 140,000 children who experienced orphanhood or lost a caregiver due to COVID-19 between April 2020 and June 2021. Compared to White children, AI/AN children were 4.5 times more likely to lose a caregiver, Black children were 2.4 times more likely, and Hispanic children were 1.8 times more likely. The highest burden of caregiver deaths due to COVID-19 occurred in states on the Southern US border, in the Southeast, and those with tribal areas. The researchers concluded there is an “urgent need” to provide affected children access to support services. An October 8 analysis from the Kaiser Family Foundation using CDC data shows that racial disparities in COVID-19 cases and death rates persist among Black, Hispanic, and AI/AN individuals, but data suggest the gap has recently narrowed for Black and Hispanic people. Notably, AI/AN individuals remain at disproportionate risk for COVID-19 disease and death, despite having the highest vaccination rate across racial/ethic groups. While the narrowing disparity in some groups could be due to increasing vaccination rates, other factors definitely play a role in ongoing disparities, and more research is needed to understand and address them.

AUSTRALIA On October 11, Australia began to emerge from its strict pandemic lockdown when New South Wales (NSW) began to allow fully vaccinated residents to return to restaurants, bars, hair salons, and gyms after nearly 4 months of restrictions. About 74% of NSW residents aged 16 and older are fully vaccinated, enabling the state—including Sydney, Australia’s most populous city—to ease its lockdown despite an ongoing outbreak. NSW State Premier Dominic Perrottet called it a “freedom day” and pledged to lead the nation out of the pandemic, but not without challenges. He warned that the number of new COVID-19 cases will rise following reopening, as virus-free Western Australia and Queensland and other so-called “zero COVID” countries in the Asia-Pacific region watch closely to see whether NSW can adapt to living with COVID-19.

ITALY’S GREEN PASS From October 15 through the end of 2021, Italian workers will be required to present a digital or printed “Green Pass” certificate upon entering their workplace, demonstrating that they have recovered from COVID-19 in the last six months, received a negative COVID-19 rapid antigen test result in the last 48 hours, received a negative COVID-19 molecular test result in the last 72 hours, or have been at least partially vaccinated. Workers who do not comply with the new mandate risk fines or suspension. Both civil and violent protests have broken out in response to the September 16 announcement regarding the new mandate in Italy, including reported clashes over the weekend between neo-fascists or other individuals associated with the far right and police. Some employees and policymakers are concerned that a rise in vaccinations may not occur, instead leading to worker shortages due to a lack of available tests.

The Green Pass already is required in Italy in order to access schools and universities, utilize public transport, participate in gatherings related to civil or religious ceremonies, visit medical facilities or long-term care facilities, access certain public gathering events or spaces, and pass through areas with higher COVID-19 risk—so-called “red” or “orange” zones. The Green Pass also is recognized by the European Union to help travelers avoid COVID-19 travel restrictions.