COVID-19 Situation Report
EPI UPDATE The WHO COVID-19 Dashboard reports 202.6 million cumulative cases and 4.29 million deaths worldwide as of 1:00pm EDT on August 9. The global weekly incidence increased for the seventh consecutive week. Last week’s total is 3.3% higher than the previous week, but it appears as though case counts may have passed an inflection point and could be approaching a peak or plateau. Global weekly mortality increased again as well, up 1.3% compared to the previous week. Overall, the trend has increased steadily for 5 consecutive weeks, with the exception of a spike during the week of July 19, which was the result of 8,786 deaths reported by Ecuador on July 21.

Global Vaccination
The WHO reported 4.03 billion doses of SARS-CoV-2 vaccines administered globally as of August 9. The WHO reports that a total of 1.59 billion individuals have received at least 1 dose, and 798 million are fully vaccinated. Analysis from Our World in Data shows that the global daily doses administered has leveled off at approximately 41 million doses per day*. The global trend continues to closely follow the trend in Asia. Our World in Data estimates that there are 2.35 billion vaccinated individuals worldwide (1+ dose; 30.2% of the global population) and 1.22 billion who are fully vaccinated (15.6% of the global population).
*Average doses administered is exhibiting a sharp decrease for the most recent several days, which indicates effects of reporting delays. In an effort to reflect the longer-term trends, the averages reported here may not correspond to the most recent data.

The US CDC reported 35.8 million cumulative COVID-19 cases and 614,856 deaths. On August 5, the US surpassed 100,000 new cases per day for the first time since February 10. The current average of 102,413 is nearly 9 times the most recent low—11,486 on June 19—and still increasing rapidly. Daily mortality appears to continue its exponential increase up to 457 deaths per day. This is the highest average since May 27, and it is an increase of 46% over the past week and 79% over the past 2 weeks*
*Changes in the frequency of 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 averages reported here may not correspond to the most recent dates.

Florida in #1 nationally in terms of both total weekly incidence and mortality, representing 22% and 25% of the national total, respectively. Florida is also #1 nationally in terms of per capita weekly incidence with 733 new cases per 100,000 population, 3.5 times the national average (205). Arkansas is #1 in terms of per capita weekly mortality with 4.8 deaths per 100,000 population, nearly 5 times the national average (1.0).

US Vaccination
On August 4, the US surpassed 350 million cumulative doses of SARS-CoV-2 vaccines administered. The current cumulative total is 351.9 million. Daily vaccinations continue to increase slowly, now up to 608,654 doses per day*. The US also surpassed 50% of the total population fully vaccinated. A total of 195.2 million individuals in the US have received at least 1 dose, equivalent to 58.8% of the entire US population. Among adults, 71.1% have received at least 1 dose, as well as 11.7 million adolescents aged 12-17 years. A total of 166.7 million individuals are fully vaccinated, which corresponds to 50.2% of the total population. Approximately 61.1% of adults are fully vaccinated, as well as 8.8 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.

US SURGE The US continues to face a COVID-19 surge, with the most severe burden faced by states in the South and Southeast regions of the country. The national biweekly relative change peaked at more than +160% in late July—the largest relative increase since the initial surge in March/April 2020—but a slight decrease to +119% indicates that the increase is beginning to taper off.

While full vaccination coverage has surpassed 50% nationally, major disparities remain at the state level. Analysis by The Wall Street Journal found that all 12 states that are reporting per capita hospitalizations greater than the national average have full vaccination coverage below the national average. Additionally, all 20 states with full vaccination coverage higher than the national average are reporting per capita hospitalizations below the national average. At the local level, counties with the lowest vaccination coverage also are experiencing much larger surges in mortality, compared to counties with higher vaccination coverage. These statistics illustrate that low vaccination coverage is a driver of the ongoing surge in severely affected states and that the vaccines are providing protection against severe disease, hospitalization, and death.

In severely affected cities and states, the surge is placing a major burden on health systems. In some instances, the current surge is as severe or worse than the United States’ largest surge in January 2021. Hospitals in Houston, Texas, and Orange County, California, are reporting increased wait times for ambulances to drop off patients at emergency departments (ED). Hospitals in some parts of the country faced similar challenges during the January 2021 surge. Texas Governor Greg Abbott issued a statement to the Texas Hospital Association encouraging hospitals to “voluntarily postpone [some] medical procedures” in order to ensure sufficient capacity is available to treat COVID-19 patients, but at least 1 hospital in Houston is already preparing an emergency tent to handle overflow COVID-19 patients.

As schools resume classes, some school districts in states that have banned mask mandates are pushing back against state-level legislation and policies. In Texas, the Dallas Independent School District (ISD), the second-largest in the state, announced it will temporarily require masks for students, employees, and visitors during the surge, defying Governor Abbott’s statewide ban. Reportedly, the Houston ISD is expected to vote on a similar mandate this week. In Florida, Governor Ron Desantis threatened to withhold pay for school administrators that institute mask mandates during the state’s most severe surge to date, including a record high for pediatric hospital admissions.

US MILITARY VACCINE MANDATE SARS-CoV-2 vaccination will be mandatory for all 1.3 million members of the US Armed Forces no later than mid-September, or as soon as the US FDA fully licenses a vaccine, “whichever comes first,” US Secretary of Defense Lloyd J. Austin III said in an August 9 message to all troops. Secretary Austin implored all US Department of Defense (DOD) military, civilian, and contractor personnel to get vaccinated, regardless of a mandate. US President Joe Biden strongly supports the plan and is prepared to issue a waiver to make the shots mandatory if the FDA’s expected timeline for approval of the Pfizer-BioNTech moves past early-September. In a statement, President Biden said vaccinations “will enable our service members to stay healthy, to better protect their families, and to ensure that our force is ready to operate anywhere in the world,” calling out the Delta variant as a threat to unvaccinated populations. In a related memo, Chairman of the Joint Chiefs General Mark Milley called COVID-19 “a threat to force protection and readiness” and reminded troops that vaccine mandates in the military are common. About 73% of active-duty US service members have received at least one SARS-CoV-2 vaccine dose, according to the Pentagon. But without more members fully vaccinated, the military faces challenges in deploying unvaccinated troops to countries that have strict local rules, and an increase in cases among its ranks could harm military readiness. Secretary Austin added that if COVID-19 incidence increases among military personnel, he could act sooner or recommend a different course of action to President Biden. Earlier this month, the DOD recommended an immediate waiver to institute a mandate before FDA approval, but White House officials urged caution and settled on the current plan. 

J&J-JANSSEN VACCINE EFFECTIVENESS Researchers leading the Sisonke clinical trial in South Africa on August 6 presented data showing the J&J-Janssen SARS-CoV-2 single-shot vaccine is highly effective in preventing severe disease and death from COVID-19 among healthcare workers. The Phase 3b study enrolled 477,234 healthcare workers at 122 sites throughout South Africa, administering the J&J-Janssen vaccine between February and May 2021. Data collection ran through July 17, and researchers will continue to monitor participants for another 2 years. Overall, the J&J-Janssen vaccine provided 91-96.2% protection against death from both the Beta and Delta SARS-CoV-2 variants. When the Beta variant was dominant, the vaccine offered 67% protection from hospitalization, and 71% protection against hospitalization when the Delta variant became dominant. When breakthrough cases occurred, healthcare workers experienced mild symptoms and less than 0.05% of those cases resulted in severe disease or death. Two cases of rare blood clots occurred among participants, but both fully recovered. 

The data have not yet been peer reviewed nor published in a scientific journal, but they should alleviate some concerns over the J&J-Janssen vaccine’s effectiveness. Some previous studies suggest the vaccine might not be as effective against the Delta variant, leading some people to seek out an additional vaccine dose; however, the researchers concluded additional doses are not warranted at this time based on the data. J&J-Janssen is expected to release results of a trial evaluating a 2-dose regimen in the coming weeks. South Africa granted conditional approval to the J&J-Janssen vaccine in April, and so far has administered more than 1.85 million doses. The country also uses the Pfizer-BioNTech vaccine and has administered more than 6.77 million doses of that vaccine.

REINFECTION AFTER VACCINATION Among people previously infected with SARS-CoV-2, full vaccination provides additional protection from reinfection, according to an early release study published last week in the US CDC’s MMWR. The findings from the retrospective, case-control study underscore the CDC’s recommendation that all eligible individuals receive a SARS-CoV-2 vaccine. Using several databases, researchers identified 246 case-patients, all adult and Kentucky (US) residents with laboratory-confirmed SARS-CoV-2 infection in 2020 and a subsequent positive nucleic acid amplification test or antigen test result between May 1 and June 30, 2021. They also identified 492 control participants, who were adult Kentucky residents matched on a 1:2 ratio based on sex, age, and date of initial positive SARS-CoV-2 test but who did not have evidence of reinfection during those 2 months in 2021. Notably, the data were collected prior to the Delta variant becoming dominant in the US. Among the case-patients, 20.3% were fully vaccinated, compared with 34.3% of the control participants. Unvaccinated Kentucky residents who were previously infected with SARS-CoV-2 had 2.34 times the odds of reinfection (95% confidence interval [CI]=1.58-3.47) when compared with those who were previously infected but also fully vaccinated. Partial vaccination was not significantly associated with reinfection (odds ratio=1.56; 95% CI=0.81-3.01), according to the researchers. They warned that little is known about the durability of natural immunity after initial infection and noted the study suggests that vaccination offers better protection than the natural immunity developed post-acute infection for people who have recovered from SARS-CoV-2 infection. 

COUNTERFEIT VACCINATION CARDS As more employers, universities, and venues in the US and Europe implement vaccine mandates, officials are warning of a rise in fake SARS-CoV-2 vaccination certificates. According to investigators and cybersecurity experts, the past few weeks have seen a number of ways to purchase counterfeit vaccine cards on social media, messaging apps, and the dark web. While the European Union has a digital vaccine passport system that assigns a unique QR code to each individual, the US relies on paper cards distributed by the US CDC, which are easy to forge and were never intended to be used as proof of vaccination. Some US states are working to implement digital verification systems, but other states have outlawed the use of such systems or implemented punishments for businesses and other entities that ask for proof of vaccination. 

The ease with which US vaccination cards can be forged is alarming both faculty and students at universities and colleges heading back to in-person learning this fall. According to an estimate from the Chronicle of Higher Education, at least 675 colleges and universities now require proof of SARS-CoV-2 vaccination. Many university administrators face challenges in identifying fake vaccination cards digitally uploaded to students’ online portals. The proliferation of counterfeit vaccination cards prompted the US Federal Bureau of Investigation and the US Department of Health and Human Services Office of the Inspector General to issue a statement earlier this year warning the public that buying, creating, or selling fabricated cards is a federal offense. For people in the US with a valid vaccination certificate, there are several options to store the oddly sized CDC card digitally on a smartphone. 

UNAUTHORIZED THIRD VACCINE DOSES In the US, the federal government is expected to release a plan for third SARS-CoV-2 vaccine doses in the coming weeks. In the meantime, there seems to be a growing divide between near-stagnant vaccine hesitancy and people seeking unauthorized additional shots, the latter underlining a heightened anxiety over the Delta variant’s spread. According to reports, some people who received the J&J-Janssen vaccine have received additional doses of another authorized vaccine over fears the single-shot dose might not be as effective as others. And it appears some are going to great lengths to obtain extra doses by falsifying vaccine certificates, lying about their name or health insurance status, or traveling to other cities or states. Most experts stress that further research is warranted to determine the safety and efficacy of second or third doses and whether combining doses of various vaccines will provide substantial protection.

But as the Delta variant continues to drive up the number of new COVID-19 cases worldwide, calls for so-called “booster” doses are highlighting global inequities in vaccine access, as wealthier nations with ample vaccine supplies begin to recommend additional doses for some populations while low- and middle-income countries (LMICs) struggle to obtain sufficient supplies to vaccinate even small proportions of their populations. Worldwide, public health experts, international organizations, and ethicists caution countries against offering booster doses until more data become available and to shore up supplies in LMICs. The WHO last week called for a moratorium on offering additional doses for most people, but it appears several nations—including Israel, Germany, France, the UK, and Russia—will move ahead with plans to offer booster shots to some populations. 

HEART INFLAMMATION FOLLOWING VACCINATION In a research letter published in the peer-reviewed journal JAMA, researchers examined the clinical records of more than 2 million patients who received at least 1 dose of SARS-CoV-2 vaccination within the Providence Health Care System or recorded through state registries in Washington, Oregon, Montana, and Los Angeles County, California (US) in order to identify post-vaccination cases of myocarditis (heart muscle inflammation) and pericarditis (heart membrane inflammation). Of these individuals, 76.5% received more than 1 vaccine dose, 52.6% received the Pfizer-BioNTech vaccine, 44.1% received Moderna, and 3.1% received J&J-Janssen. Overall, 20 individuals had vaccine-related myocarditis (1.0 [95% confidence interval (CI), 0.61-1.54] per 100,000) and 37 had pericarditis (1.8 [95% CI, 1.30-2.55] per 100,000). Of the cases of myocarditis, 75% occurred in males with a median age of 36, happened on average 3.5 days after vaccination, and resulted in hospitalization in 19 of 20 cases. No mortality was reported, and most patients were discharged after approximately 2 days. Of the pericarditis cases, 73% occurred in males with a median age of 59, happened on average 20 days after vaccination, and resulted in hospitalization in 13 of 37 cases. No mortality was reported, and most patients were discharged after approximately 1 day. Notably, the incidence of myocarditis following SARS-CoV-2 vaccination described in the study—10 per million—is higher than the US CDC’s estimate of 4.8 cases per million, suggesting an underreporting of cases to federal databases. The researchers stressed that the hospitalizations resulting from heart inflammation in the study were unremarkable and cautioned that COVID-19-related heart inflammation is much more common. Overall, vaccination remains the most important tool for protecting individuals from severe symptoms of COVID-19.

COVID-19 TREATMENT RESEARCH Research efforts to find treatments for people with mild-to-severe COVID-19 are underway worldwide. The WHO last week announced it is restarting the Solidarity clinical trial—now dubbed SolidarityPlus—to test 3 repurposed drugs in hospitalized COVID-19 patients: the cancer chemotherapy drug imatinib, a chimeric monoclonal antibody called infliximab that is used to treat several autoimmune diseases, and the antimalarial drug artesunate. The first patients are expected to be enrolled soon in Finland, and 40 other countries are in the process of gaining regulatory and institutional review board approvals. The original Solidarity trial began in March 2020, but in October 2020 researchers published interim results showing no benefit for 4 repurposed drugs—remdesivir, hydroxychloroquine, lopinavir, and interferon beta-1a—in hospitalized COVID-19 patients. An independent expert committee chose the 3 new medications at the beginning of this year, but delays due to negotiations with drug manufacturers, as well as regulatory and ethical approval processes, held up the trial’s restart until now.   

In the US, the Duke Clinical Research Institute announced the expansion of a clinical trial testing repurposed medications among people with mild-to-moderate COVID-19 who are recovering at home. Part of the National Institutes of Health (NIH)-funded Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, the ACTIV-6 study is now testing 3 drugs that are FDA-approved for other conditions—the antiparasitic ivermectin, the inhaled steroid fluticasone, and the selective serotonin reuptake inhibitor fluvoxamine—and expects to add other medications over time. The study is recruiting participants ages 30 and older who recently tested positive for SARS-CoV-2 and are experiencing at least 2 COVID-19 symptoms. Notably, the study is completely remote, meaning people recovering from COVID-19 at home can participate from anywhere in the US and do not need to leave their homes while isolating to obtain medication or visit clinics. With only a handful of medications approved or authorized to treat COVID-19, researchers are hopeful these trials can help broaden the tools available to lower the risk of complications, shorten the time of symptoms, or prevent progression to more severe disease.

US/CANADA TRAVEL RESTRICTIONS On August 9, Canada lifted some travel restrictions for fully vaccinated US citizens and permanent residents. However, prospective travelers must adhere to certain pandemic safety standards before being allowed to cross the border. In order to enter Canada, Americans must show proof of a full SARS-CoV-2 vaccine regimen completed at least 14 days prior, a negative molecular SARS-CoV-2 test taken within 3 days of travel regardless of individual vaccine status, and an in-country, 14-day quarantine plan in case symptoms develop. They must also fill out a detailed application on the country’s arriveCAN app before crossing the border. Canadian authorities have issued warnings to prospective travelers that longer wait times can be expected at border crossings. Canada plans to open its borders to visitors from other countries beginning next month, depending on conditions. The US government recently announced plans to extend its border closures with Canada and Mexico for all nonessential travel until at least August 21, but a plan for a phased reopening of the borders is being formulated, according to officials. 

CRUISE LINES & VACCINATION Norwegian Cruise Lines can require passengers to show proof of SARS-CoV-2 vaccination before boarding any of its ships based in Florida, despite that state’s law banning so-called “vaccine passports,” a US District Court judge has ruled. The law, signed by Florida Governor Ron DeSantis in May, fines businesses $5,000 per violation for asking customers to prove they have been vaccinated against SARS-CoV-2. But in an August 8 preliminary ruling, US District Court Judge Kathleen M. Williams of the Southern District of Florida said Norwegian likely will prevail in arguing that the law risks public health and qualifies as an unconstitutional infringement on the company’s First Amendment rights. While Norwegian “has demonstrated that public health will be jeopardized if it is required to suspend its vaccination requirement,” Judge Williams wrote, the “defendant fails to articulate or provide any evidence of harms that the state would suffer if an injunction was entered.” The injunction blocks the state government from enforcing the law against Norwegian, which is scheduled to resume port activity on August 15. In a statement, Norwegian said the order will allow it “to operate in the safest way possible with 100% vaccination* of all guests and crew when sailing from Florida ports.” On August 9, Governor DeSantis said Florida will appeal the ruling to the Eleventh Circuit Court of Appeals.

Cruise ship operators are working to keep up with rapidly changing guidelines as the highly transmissible Delta variant drives an increase in COVID-19 case numbers nationwide, particularly in Florida, where many ships embark. While most cruise lines are requiring passengers to show proof of vaccination, some are adding requirements including proof of a negative SARS-CoV-2 test before boarding and masking in crowded indoor spaces. For all cruise ships operating in US waters, or seeking to operate in US waters, the US CDC has devised a Framework for Conditional Sailing Order (CSO) and Technical Instructions that ships are recommended to follow even when located outside of US waters, as well as a color-coded system for ships. Of the 65 cruise ships listed, 25 are categorized as orange or yellow as of August 9, indicating that those ships have reported COVID-19 cases and the CDC is either monitoring the situation, actively investigating an outbreak, or has concluded its investigation and continues to monitor. The remainder of the listed ships are operating under a green status, meaning they have not reported any COVID-19 cases or COVID-19-like illnesses. If a ship reaches red status, it has been determined through investigation to be “at or above” the threshold for passenger and crew cases and must return immediately to port or delay its next voyage. Notably, cruise lines must report all information on COVID-19 cases aboard ships to the CDC. If a cruise operator chooses not to follow the CSO—which became voluntary under a court order issued in June—the ships are marked as gray but are still required to report cases of illnesses or death due to other causes.  
*In a footnote on its release, Norwegian indicated “limited exceptions” for vaccination requirements may be made due to “valid medical or religious exemptions.” Under the CDC’s CSO, 95% of crew and guests must be vaccinated.