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EPI UPDATE The WHO COVID-19 Dashboard reports 610.4 million cumulative cases and 6.51 million deaths worldwide as of September 21. Global weekly incidence remained stable, increasing 2% over the previous week. Global weekly mortality continued to decrease, for the fifth consecutive week—down 15% from the previous week.
Weekly incidence declined in most WHO regions, ranging from -8% in South-East Asia to -32% in the African region. As predicted last week, the decreasing trend in Europe reversed, with the region recording a 10% increase in weekly incidence. Weekly incidence in the Western Pacific region remained relatively stable, increasing 3% from the previous week.
UNITED STATES
The US CDC is reporting 95.6 million cumulative cases of COVID-19 and 1,049,101 deaths. Daily incidence continues to decline, down to 55,332 new cases per day. Daily mortality appears to have plateaued, with an average of 356 deaths per day. **
**Changes in state-level reporting may affect the accuracy of recently reported data, particularly over weekends. In an effort to reflect the longer-term trends, the numbers reported here may not correspond to the most recent dates.
Both new hospital admissions and current hospitalizations continue to exhibit downward trends, with decreases of 6.8% and 11.1%, respectively, over the past week. Both trends peaked around the last week of July, similar to trends in daily incidence.
The BA.5 sublineage continues as the dominant strain in the US, accounting for 84.8% of sequenced specimens. Since last week, however, several other Omicron sublineages show evidence of possible growth advantage over BA.5, including BA.4.6 (10.3%), BF.7 (1.7%), and BA.2.75 (1.3%). The prevalence of BA.4 continues to fall, down to 1.8% the week of September 17.
EMERGING VARIANTS As the Northern Hemisphere moves into its colder months, scientists and officials are following the evolution of SARS-CoV-2 more closely than ever, watching for new variants of interest (VOI) and variants of concern (VOC). As of now, Omicron subvariants are capturing the most international attention, and experts remain uncertain as to which variant will be dominant going into fall. More specifically, the sublineages of the Omicron subvariants BA.2, BA.4, and BA.5 are beginning to show growth advantages compared to their parents. In the United States, prevalence of BA.4 and BA.5 appears to be decreasing, while Omicron sublineage cases have been rising. BA.4.6, a sublineage of BA.4, is now estimated to make up 10.3% of new cases. BF.7, a BA.5 sublineage, now is estimated to make up 1.7% of new cases. BA.2.75, a BA.2 sublineage, is estimated to make up 1.3% of new cases. BF.7 has garnered particular concern among the scientific community, as it has recently made up more than 10%, and even over 25%, of new cases in some Western European nations. However, some experts have argued that BQ.1, a BA.5 sublineage, and BA.2.75.2, a sublineage of BA.2.75 that demonstrates additional immune evasion, also pose a threat. While still too early to tell which sublineage might become predominant, and where, the continuously evolving SARS-CoV-2 promises to keep the attention of scientists and public health practitioners, even as much of the world wants to move on.
BIVALENT BOOSTER FOR YOUNG CHILDREN According to an updated Fall Vaccination Operational Planning Guide released by the US CDC on September 20, bivalent SARS-CoV-2 vaccine boosters could be available for children ages 11 years old and younger starting in October, pending authorization from the US FDA. Dr. Peter Marks, Director of the FDA Center for Biologics Evaluation and Research (CBER), confirmed that the updated boosters for 5- to 11-year-olds are expected to receive emergency use authorization in the next few weeks. The boosters for younger children aged 6 months to 5 years are “a few months away,” according to Dr. Marks.
Currently, the updated bivalent booster shots from Pfizer-BioNTech are authorized for anyone aged 12 years and older who has completed their primary vaccination series, and Moderna’s bivalent booster is available to those aged 18 years and older who have completed the primary series. Pfizer-BioNTech and Moderna are working on bivalent vaccines for children aged 5 to 11 years and 6 to 17 years, respectively. While children aged 6 months and older can now receive primary vaccinations against COVID-19 (3 doses of Pfizer-BioNTech and 2 doses of Moderna), they remain ineligible for booster doses.
More than 1,400 children and teens have died of COVID-19 in the US, according to CDC data, but vaccination rates for the youngest children remain low, worrying health officials. Only 38% of children aged 5-11 and 8% of those aged 6 months to 4 years have received at least one dose of vaccine. Correspondence published today in the New England Journal of Medicine discusses a study showing that immunity from vaccination and previous infection provided considerable protection against hospitalization and death among children 5 to 11 years of age, but that protection rapidly waned over 16 weeks, particularly against the Omicron variant. The authors note that the rapid decline in protection against Omicron infection conferred by vaccination and previous infection provides support for booster doses among this age group. However, children will first need to finish their 2- or 3-dose primary series before becoming eligible to receive an updated booster when authorized.
MODERNA BIVALENT BOOSTER SUPPLY Providers across the US have reported supply shortages of Moderna’s new bivalent SARS-CoV-2 booster, leading pharmacies and local health groups to offer limited appointments for receiving the shot. A Moderna spokesperson anticipated that availability constraints would be resolved in a few days and assured that the company is committed to delivering 70 million doses of the updated bivalent vaccine by the end of the year. No supply issues have been reported for the Pfizer-BioNTech bivalent booster.
The shortage is being attributed to delays in Moderna receiving vaccine supply from its production facility operated by Catalent Inc. in Bloomington, Indiana. The facility was not cleared by the FDA to make Moderna’s new booster shots until recently. The FDA conducted a routine inspection of the facility amid concerns that it was not sufficiently sterile. In its Form 483 notice, the FDA cited observations related to quality control, recordkeeping, failure to follow procedures and address discrepancies in certain batches, misuse of equipment, and contamination in vials packaged at the Catalent facility. The FDA shared that it plans to include doses produced in the Catalent facility in the emergency use authorization (EUA) of the Moderna bivalent vaccine. The FDA also inspected a second production facility, which is operated by Thermo Fisher Scientific, and found no safety issues at that site.
Meanwhile, health officials recommend those eligible to receive Pfizer-BioNTech’s booster shot. The companies have shipped more than 21 million doses of their booster and plan to provide 100 million doses by the end of November. To accommodate locations that cannot switch to the Pfizer-BioNTech shots and need immediate supplies of Moderna’s, the federal government is adjusting ordering thresholds in the coming weeks. Efforts to maintain production of all available booster shots are a crucial component of the fall booster campaign in the US, with the federal government strongly encouraging US residents to receive boosters as new cases are expected to rise this fall and winter.
US FDA TEST AUTHORIZATION The US Department of Health and Human Services’ Office of Inspector General (OIG) on September 21 released a report criticizing the use of the emergency use authorization (EUA) mechanism by the US FDA during the early months of the pandemic. The report cited changing standards for new EUAs for COVID-19 tests from January 2020 to May 2020, sometimes allowing flawed diagnostic and serology tests—such as the initial US CDC assay which was unusable for weeks—to be used to increase testing availability at the cost of quality. Additionally, failure of the FDA to engage with public health laboratories, who were responsible for initial testing efforts, also led to testing challenges. These critiques echo those in a recent study published in the Journal of Public Health Management & Practice describing the experience of public health laboratories in 27 states during the pandemic from 2020 through early 2021. Furthermore, test developers interviewed by OIG noted that, despite FDA support for EUA requests, the EUA process for new COVID-19 tests remained frustrating and confusing to navigate. To help prevent similar issues during future health emergencies, the OIG report recommended that the FDA revise EUA guidance, improve resources for test developers and tracking of EUA submission monitoring, establish better communication between FDA and the lab community, and incorporate lessons learned into a national testing strategy beyond the EUA process.
DATA COLLECTION & ANALYSIS Outmoded and underfunded public health information and data systems in the US are crippling epidemiologists’ and other experts’ ability to fully understand the COVID-19 pandemic and subsequently harming federal, state, and local responses. With state and local health departments having to resort to communicating data through antiquated fax machines, spreadsheets, emails, and phone calls, a lack of interconnected data systems has forced US health officials to extrapolate and make educated guesses about who is being hospitalized with COVID-19, how well vaccines are working, and who is being infected with which variants.
As new SARS-CoV-2 bivalent vaccine boosters are being rolled out in the US, this type of data is more important than ever. Understanding the demographics of the 400-500 people dying of COVID-19 each day in the US would help public health officials better target resources to help prevent these deaths. While we know that vaccination reduces the risk of severe illness and death from COVID-19, there is little data on whether people who end up in intensive care units (ICUs) have been vaccinated or boosted, which shots they received, when they got them, and if they had an immune response. Nor are there data on the COVID-19 treatments they received.
Overall, people are less likely to die of COVID-19 now because of collective immunity from vaccinations or natural infections. But the disease is a leading cause of death and likely will remain so indefinitely. Older adults continue to be at an increased risk of severe illness and death nationwide, and racial and ethnic disparities persist. A recent study published in PNAS suggested that while racial and ethnicity-related mortality disparities among Whites and 6 other groups worsened with the onset of the COVID-19 pandemic, most of those disparities evolved to pre-pandemic levels after the first year. Notably, however, 2 years into the pandemic mortality disparities remained exacerbated for American Indian or Alaska Native people and for Native Hawaiian or other Pacific Islander people when compared to the White population, driven by mortality among those under aged 65 years. The study authors call for new policies and community investments addressing the pandemic’s unequal impacts.
Still, knowing who is dying of COVID-19 will help best target resources to prevent these deaths. Since the beginning of the pandemic, the US CDC has received more funding to help modernize its data and analysis systems, but experts worry the nation’s lawmakers could once again slip into a boom-or-bust funding pattern, leaving the country's public health data systems weak and underfunded.
PANDEMIC FRAUD The US Department of Justice announced charges against 47 people accused of carrying out what officials said is the largest COVID-19 fraud scheme to date. Federal prosecutors said the alleged scheme involved the creation of fake entities that claimed to be providing meals to tens of thousands of children. After being reimbursed more than US$250 million from a US Department of Agriculture child-nutrition program, those charged used the money to purchase luxury items and real estate instead of feeding children, according to prosecutors. The 47 defendants are facing charges related to conspiracy, wire fraud, money laundering, and paying and receiving kickbacks. The Justice Department has recently stepped up its efforts to identify and prosecute those involved in theft from programs meant to provide aid during the COVID-19 pandemic.
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