COVID-19 Situation Report
New from the Center: The CommuniVax Coalition, led by the Johns Hopkins Center for Health Security and the Department of Anthropology at Texas State University, released 4 new reports that share findings from local rapid research within Black and Hispanic/Latino communities in Alabama, California, Idaho, and Maryland. The reports highlight the urgent need to humanize delivery and communication strategies for SARS-CoV-2 vaccines, develop heterogenous messaging, and implement anchor vaccination efforts in severely affected communities in a holistic “whole person” recovery process.

EPI UPDATE The WHO COVID-19 Dashboard reports 226 million cumulative cases and 4.65 million deaths worldwide as of September 16.

Global Vaccination
The WHO reported 5.63 billion cumulative doses of SARS-CoV-2 vaccines administered globally as of September 15. A total of 3.25 billion individuals have received at least 1 dose, and 2.34 billion are fully vaccinated. Analysis from Our World in Data indicates that the overall trend in global daily vaccinations continues to decline. After peaking 3 times at more than 42 million doses per day between late June and early September, the average has fallen to fewer than 30 million. In mid-July, between the 2 highest peaks, the averaged dropped to 20 million before rebounding, so the longer-term trend remains uncertain*. The global trend continues to closely follow Asia.

Our World in Data estimates that there are 3.37 billion vaccinated individuals worldwide (1+ dose; 42.8% of the global population) and 2.45 billion who are fully vaccinated (31.1% of the global population). Since mid-August, China has updated its cumulative 1+ dose vaccination totals every 7-14 days, which causes a substantial jump in the global totals. Oceania (43.7%) surpassed the global average in terms of 1+ dose coverage. At 5.9% coverage, Africa is now the only continent below the global average, by a factor of more than 7, illustrating the stark disparity in access to SARS-CoV-2 vaccines.
*The average daily doses administered may exhibit a sharp decrease for the most recent data particularly over the weekend, which indicates effects of reporting delays. In an effort to reflect the longer-term trends, the numbers reported here may not correspond to the most recent data.

The US CDC reports 41.6 million cumulative COVID-19 cases and 666,440 deaths. After decreasing following the US Labor Day holiday weekend (September 4-6), daily incidence over the past 5 days. The US appeared to be approaching a peak or plateau prior to the holiday weekend, so it is unclear how the trend over the coming week will compare to the pre-holiday trend. The current average (146,182 new cases per day) is still approximately 13,000 fewer new cases per day than the most recent high on August 31. A similar trend is evident for daily mortality as well, although the current average has already surpassed the pre-holiday peak. With 1,447 deaths per day, the US is at its highest daily mortality since March 1*. The US reported more than 1,900 deaths each of the last 2 days, the highest single-day totals since February 19. The US surpassed 660,000 cumulative deaths on September 13, which corresponds to 1 death for every 500 people in the US. The US surpassed 1 death per 1,000 population on December 18, 2020.
*Changes state-level reporting may affect the accuracy of recently reported data, particularly over the weekend. In an effort to reflect the longer-term trends, the numbers reported here may not correspond to the most recent dates.

If California continues on its current trajectory, it could soon drop from the High community transmission (≥100 new weekly cases per 100,000 population) to Substantial (50-99.9). It was briefly categorized as Substantial this week, but it moved back up to High as surveillance data caught up from the Labor Day holiday weekend. Connecticut has also been holding relatively steady at slightly more than 100 and could fall to the Substantial category as well. The CDC also includes test positivity in its community transmission determination, but test positivity is not reported for either California or Connecticut.

California passed its most recent peak in mid-August, but unlike many other states, its current surge was far smaller than its winter 2020 surge. In fact, California’s most recent peak was less than one-third of its highest peak. In contrast, numerous states, particularly in HHS Regions 4 (Southeast), 6 (South Central), and 7 (Central), have approached or surpassed their previous highest peaks during the current surge. For example, Florida spent nearly 3 weeks at its highest peak, reporting more than 21,000 new cases per day from August 10-29—approximately 40% higher than its previous record—before its epidemic began to recede. Louisiana set a new record high of 5,839 new cases per day on August 13, more than 50% higher than its January 2021 peak. And Alabama, Georgia, and South Carolina peaked at 96%, 97%, and 93% of their previous records, respectively.

Texas’ surge continues to increase, up to nearly 20,000 new cases per day on September 14, 86% of its record peak in January 2021. Kentucky, Tennessee, and West Virginia are all setting new records with their current surges as the Delta wave moves north from Alabama, Florida, and Louisiana. Continuing north into Regions 1, 2, and 3, daily incidence trends are increasing in most states, but most are nowhere near their current records. Several states already appear to be approaching or passing their respective peaks—including Connecticut, Massachusetts, New York, New Jersey, and Rhode Island—and Region 2, as a whole appears, to be peaking. The muted impact of the Delta variant in these states is likely driven by a combination of higher vaccination coverage and reinstituting various protective measures. In fact, with the exception of West Virginia (#50, 40.0%), all states in Regions 1, 2, and 3 are in the top 20 nationally in terms of full vaccination coverage, ranging from 56% (Pennsylvania) to 69% (Vermont).

In addition to California, other states on the West Coast (in Regions 9 and 10) were affected early in the Delta wave as well. The West Coast states have leveled off or peaked already, but moving east, Idaho’s epidemic is currently at 77% of its record high and still increasing sharply, mirroring trends in neighboring Region 8 (Mountain) states. Unlike states in the Southeast, however, most of the West Coast states remained well below their record highs. Oregon is the exception, peaking at 50% higher than its previous record daily incidence, even with nearly 60% full vaccination coverage (#12 nationally).

The Delta wave appears to be spreading inward from the coasts. The states in Region 5 (Midwest) are generally exhibiting increasing trends in daily incidence, with most currently around 50% of their highest peak and still accelerating. In Region 7 (Central), Missouri—which was affected very early in the surge—passed its peak in early August, but it did not peak as high as the states in the Southeast region (~57% of its highest peak). Iowa is exhibiting an accelerating trend, but it is still less than 40% of its highest peak. A number of other states in Regions 5 and 7 were exhibiting accelerating trends prior to the Labor Day holiday weekend, but do not appear to have caught up from delayed holiday reporting, including Indiana, Illinois, Kansas, Nebraska, and Wisconsin. States in Regions 5 and 7 generally fall between 47% and 57% full vaccination coverage (ranking #17-39). Considering the accelerating trajectories and low-to-moderate vaccination coverage in some states, Regions 5 and 7 could potentially face a severe COVID-19 surge in the coming weeks.

In Region 6 (South Central), New Mexico appears to have passed its peak as well, although the timing suggests that delayed holiday reporting could be a factor in its recent decrease. Notably, New Mexico only reached approximately 30% of its record high, which could be a result of the state having highest full vaccination coverage outside of Regions 1, 2, and 3 (#11; 62%). All of the states in Region 8 (Mountain) are exhibiting accelerating trends in daily incidence. Most of these states are currently at approximately 30% of their record highs, but Montana and Wyoming are closer to 60%. The accelerating trends indicate that these states may still be early in their respective surges, and most of these states are reporting less than 50% full vaccination coverage—including #49 Wyoming (40%) and #45 North Dakota (43%).

US Vaccination
The US has administered 383 million cumulative doses of SARS-CoV-2 vaccines. Daily vaccinations peaked at 837,000 doses per day on August 29 and then began to decline going into the Labor Day holiday weekend. The 7-day average window still includes delayed holiday weekend reporting, so it will be at least another several days before we can get a clearer picture of the longer-term trend*. There are 210.7 million individuals who have received at least 1 dose, equivalent to 63.5% of the entire US population. Among adults, 76.1% have received at least 1 dose, as well as 14.2 million adolescents aged 12-17 years. A total of 180.1 million individuals are fully vaccinated, which corresponds to 54.2% of the total population. Approximately 65.4% of adults are fully vaccinated, as well as 11.2 million adolescents aged 12-17 years.
*Due to delays in reporting, estimates for the average daily doses administered are less accurate for the most recent 5 days. The most current average provided here corresponds to 5 days ago.

UK VACCINE EFFECTIVENESS New real-world data from England offer additional evidence that full vaccination can significantly reduce the risk of COVID-19 mortality. The UK Office of National Statistics (ONS) reported 51,281 COVID-19 deaths in England from January 2-July 2, 2021. Of these, only 256 (0.5%) were classified as “breakthrough deaths”—ie, occurring in individuals who were fully vaccinated at least 14 days before diagnosis*.
*A total of 640 deaths were in individuals who received all necessary doses of the vaccine, including those who were infected prior to receiving the second dose.

The ONS also provides weekly age-standardized mortality rates (ASMRs) for COVID-19 deaths as well as additional information on the overall health of breakthrough deaths. The median age of breakthrough deaths was 84 years, which is 2 years older than the average for other COVID-19 deaths. Among breakthrough deaths, 61.1% were male, compared to 52.2% for other COVID-19 deaths. Notably, 13.1% of breakthrough deaths occurred in individuals who were immunocompromised, compared with 5.4% of other COVID-19-related deaths.Additionally, 76.6% of breakthrough deaths occurred among individuals who were classified as “clinically extremely vulnerable”—based on age, underlying health conditions, and other factors associated with elevated risk of severe COVID-19 disease and death. In comparison—which was slightly higher than for other COVID-19 deaths (74.5%). While experts cautioned the data need to be interpreted in context—considering trends in COVID-19 mortality during the study period and the emergence of the Delta variant in June—the ONS analysis provides additional evidence that full vaccination offers very high protection against death from COVID-19.

UK AUTUMN/WINTER PLAN On September 14, the UK government published its COVID-19 Autumn and Winter Plan 2021, an effort to mitigate impacts on the National Health System (NHS) and mitigate the need for future “lockdowns.” The plan is separated into 2 parts: Plan A lays out a comprehensive approach to pandemic preventive efforts, and Plan B outlines measures that would only be enacted if epidemiological trends illustrate a need for additional risk mitigation. Most notably, Plan A includes a booster shot program for approximately 30 million individuals, despite the WHO’s call for a moratorium on such initiatives in higher-income countries so that additional doses can be allocated to low- and middle-income countries (LMICs). 

Beginning next week, the UK government plans to provide booster doses—primarily of the Pfizer-BioNTech vaccine, regardless of which vaccine was administered first—to adults aged 50 years and older, those with underlying health conditions, and healthcare workers, following a recommendation from the UK Joint Committee on Vaccination and Immunization (JCVI) that additional doses be administered at least 6 months after the second dose. According to data published this week by Public Health England (PHE), the level of protection provided by 2-dose vaccines against severe disease and death begins to wane approximately 3 months after the second dose. While the science underpinning the need for booster doses remains unclear, most experts generally agree that additional doses are warranted for individuals who may not have mounted a strong immune response to the initial doses, such as the immunocompromised. The UK has no plans to offer the additional doses to the general population under age 50 this year.

Plan A also includes offering 1 dose of vaccine to adolescents aged 12 to 15 years, after a unanimous recommendation by the Chief Medical Officers (CMOs) from the 4 UK nations that children in this age bracket receive their first dose of the Pfizer-BioNTech vaccine. Additionally, Plan A includes promoting SARS-CoV-2 vaccination for those currently unvaccinated, keeping in place associated travel restrictions and providing additional funding to the NHS to support its COVID-19 response over the next 6 months. If enacted, Plan B would involve requesting the public to act more carefully, instituting mandatory vaccine passports for certain events and settings, and requiring mask use in some settings.

US FDA MEETING ON VACCINE BOOSTERS The US FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) is meeting today, in part, to discuss a proposed plan to administer a third dose of the Pfizer-BioNTech vaccine 6 months after the initial 2-dose course. Last month, the Biden Administration announced plans to initiate booster dose campaigns for the Pfizer-BioNTech vaccine starting September 20. While the plan was announced weeks ago, the vaccine has not been authorized for a third dose for most people. The CDC’s Advisory Committee on Immunization Practices (ACIP) is scheduled to meet next week to explore the same issue. If either the FDA or CDC advisory bodies push back on the need for booster doses, it would put the country’s leading health authorities at odds with the White House.

The Biden Administration initially announced plans for booster doses after unpublished data from a study in Israel suggested that the Pfizer-BioNTech vaccine demonstrated reduced efficacy months after the initial inoculation. Pfizer’s company leadership echoed these claims, suggesting that a booster dose would be able to counteract waning immunity in individuals who received their full vaccine regimen months earlier. Pfizer released additional data from a booster dose campaign in Israel, in which a third dose increased effectiveness against symptomatic COVID-19 back to approximately 95%, similar to the initial efficacy after 2 doses demonstrated in clinical trials. Moderna also released data suggesting that an increase in breakthrough cases made the idea of booster doses more reasonable. Despite these early claims, Moderna’s president released a statement questioning the necessity of future vaccine doses. Documents released by the FDA earlier this week in advance of the VRBPAC meeting showed that FDA scientists questioned the necessity of booster doses, considering that the vaccines are still exhibiting high levels of protection against severe disease and death in the US. Several FDA scientists published a commentary in The Lancet arguing that there is not enough evidence to indicate waning protection from SARS-CoV-2 vaccination.

VACCINE MANDATES A federal judge in New York state blocked a statewide vaccine mandate for healthcare workers late Tuesday. Former New York Governor Andrew Cuomo issued the mandate last month, and it was scheduled to take effect September 27. Plaintiffs in the lawsuit argue that the absence of a religious exemption violates the US Constitution, the New York State Human Rights Law, and New York City Human Rights Law. The 17 healthcare workers who filed the lawsuit have objected to the vaccine requirement on the grounds that the cell lines of aborted fetuses were used in the vaccine’s development. No major religious denomination has taken an opposing stance to vaccination, and Pope Francis has encouraged vaccination, calling it the “moral choice.” The defendants in the lawsuit have until September 22 to respond, and an additional hearing is scheduled for September 28. 

An Arkansas hospital is allowing religious exemptions for employees, but it is also asking them to validate their objections to show it is a “sincerely held belief.” Conway Regional Hospital requires employees to complete a form attesting that they “do not use or will not use” any of more than 30 medications and other vaccines that also utilized fetal cell lines in their development in order to demonstrate their conviction. Notably, some of the medications listed include common pain killers such as aspirin, ibuprofen, Tylenol, and Motrin; antihistamines such as Claritin and Benadryl; antacids such as Pepto-Bismol, Maalox, and Tums; and the MMR vaccine. 

LIMITING PUBLIC HEALTH AUTHORITY At least 29 US states have passed laws, enacted other initiatives, or succeeded in lawsuits that permanently weaken state and local government authority to protect public health, and similar efforts are pending in multiple other states. The analysis was published by Kaiser Health News and the Associated Press as part of their ongoing series “Underfunded and Under Threat,” which examines how US public health systems were unprepared to confront the COVID-19 pandemic and face ongoing politicization, funding cuts, and other hindrances. Legislators in at least 16 states have limited public health authorities’ ability to issue mask mandates or quarantines or isolation orders, and in some cases, legislatures gave themselves that authority or shifted it to other elected officials. In at least 17 states, lawmakers passed legislation banning SARS-CoV-2 vaccine mandates or passports or facilitated opt-out options. And in at least 14 states, new laws, executive orders, or court rulings ban or limit mask mandates. 

Proponents of the new measures argue that they are a necessary check on executive powers, particularly for appointed officials, and give lawmakers a voice in public health emergencies. Public health officials and experts have expressed frustration with these efforts and warned that the consequences of these actions will extend far beyond the current pandemic. These new limits could also impact public health officials’ ability to prevent and contain future outbreaks for any number of communicable diseases. At least 303 state and local public health department leaders have resigned, retired, or been fired during the pandemic, according to the analysis.

US HOSPITALIZATION COSTS Preventable costs for treating hospitalized, unvaccinated COVID-19 patients in the US reached US$5.7 billion between June and August, with US$3.7 billion of that spending happening during a surge in hospitalizations in August alone. The analysis was conducted by the Kaiser Family Foundation and the Peterson Center on Healthcare. According to the report, which uses data from the US Department of Health and Human Services (HHS) and the US CDC, there were an estimated 287,000 preventable COVID-19-related hospitalizations during the study period—specifically, those among unvaccinated individuals—which cost an average of US$20,000 each to treat. The authors note that the costs are likely an underestimate of the overall burden, if publicly funded programs and private insurance premiums are considered. Recent US CDC data show that vaccinated people are 10 times less likely to be hospitalized with COVID-19 than unvaccinated individuals.

GLOBAL VACCINE ACCESS Ahead of a global COVID-19 summit, many researchers and health advocacy organizations are amplifying their calls to increase support for low- and middle-income countries (LMICs) to manufacture their own SARS-CoV-2 supplies. On September 14, WHO Director-General Dr. Tedros Adhanom Ghebreyesus and a group of global health leaders issued an urgent call for global vaccine equity, with a focus on Africa, which accounts for approximately 17% of the global population but only 2% of the SARS-CoV-2 vaccine doses administered thus far. Speaking at a press conference, Dr. Tedros said African nations “have been left behind by the rest of the world,” with only 2 countries thus far surpassing 40% coverage. He warned that the longer the virus is allowed to persist among unvaccinated populations, the greater the risk of new variants emerging and the greater the risk of further disruption to social and economic systems. Additionally, the Gates Foundation, in its fifth annual Goalkeepers report, urged more investment in health infrastructure—including vaccine research, development, and manufacturing capacities—especially in LMICs, where such investments will help future responses to public health emergencies.

Meanwhile, efforts to develop an African base for manufacturing SARS-CoV-2 vaccines have reportedly stalled. According to a report by Reuters, a senior WHO official recently indicated that negotiations with Moderna regarding the technology transfer necessary to manufacture mRNA vaccines in Africa are not making sufficient progress. Although Moderna has said it will not enforce patents related to its vaccine during the pandemic, officials from a WHO-supported technology transfer hub in South Africa said it could take more than a year to develop the capability to manufacture an mRNA vaccine without Moderna’s assistance. The WHO reportedly is in negotiations with Indonesia to establish a second technology transfer and manufacturing hub for mRNA vaccines. And in a potentially more positive development, a source told Reuters that India could soon resume exporting SARS-CoV-2 vaccines, including to Africa. Additionally, the EU recently committed to donate an additional 200 million doses of vaccine for Africa and LMICs, on top of previous commitments of 250 million, and reiterated its pledge to invest €1 billion (US$1.2 billion) to improve vaccine manufacturing capabilities in Africa. 

VACCINATION FOR YOUNGER CHILDREN Many countries have approved vaccinations for children 12 years and older, and expanded eligibility to younger children may be on the horizon. Cuba has reportedly started vaccinating children as young as 2 years old, the only country thus far to vaccinate children that young. The Cuban Ministry of Health has not yet released data on how many children have been vaccinated, but pediatric vaccination efforts are reportedly ongoing in Cienfuegos, where the healthcare system is strained under the burden of a surge driven by the Delta variant. Two Cuban-made vaccines currently in use have not yet been recognized by the WHO, and clinical trial data have not yet been published publicly or been subjected to peer review; however, Cuban researchers say the vaccines are safe and effective, and they will eventually seek an Emergency Use Listing (EUL) and prequalification from the WHO. Children aged 2-18 years will receive the Soberana-2 vaccine, and adults will receive Abdala, according to a state-run media source.

A number of other countries are also expanding vaccination eligibility to younger children. El Salvador will begin vaccinating children aged 6 years and older, and the UAE approved Sinopharm for children aged 3 years and older, but noted that vaccination will be optional.Chile authorized the Sinovac vaccine for children aged 6 years and older, based on data provided by China. Researchers are initiating Phase 3 trials of the Sinovac vaccine in children aged 6 months to 17 years. The trials will be coordinated from South Africa, but trial sites include Chile, the Philippines, Malaysia, Kenya, and South Africa. 

US SPORTS Approximately 85% of NBA basketball players have received the SARS-CoV-2 vaccine, but the league announced that, like other US professional sports leagues, it will not mandate vaccinations. Protocol negotiations for the 2021-22 are ongoing, but sources say vaccine mandates remain a “non-starter.” Current protocols keeping vaccinated and unvaccinated players separate in locker rooms as well as while eating and transporting to and from games. NBA referees and NBA staff are required to be vaccinated. 

Spectators for Buffalo Bills (NFL) and Sabres (NHL) games will be required to be vaccinated for home games this season. Starting September 25 (Sabres) and 26 (Bills), fans aged 12 years and older attending games at Highmark Stadium and KeyBank Center must have received at least 1 dose of a SARS-CoV-2 vaccine, and they must be fully vaccinated by the end of October. Notably, the 2 venues will not offer a testing option in order to opt out of vaccination, and according to the Buffalo Bills website, no exceptions will be made to the vaccination mandate, including for medical or religious exemptions. Spectators under the age of 12 must wear a mask while inside the venues, but older individuals are not subject to a mask mandate. Unvaccinated fans were allowed at the Bills home game on September 12 while masked, but county health officials reported that fewer than half of stadium attendees wore masks. All events held in the 2 venues are subject to the new rules, including concerts.