COVID-19 Situation Report
UPDATE: Starting next week, the COVID-19 Situation Report will be delivered to your inbox on Tuesdays and Thursdays. We will no longer include detailed epidemiological analysis each week, but we will continue to provide in-depth looks at important and emerging trends as necessary, including for new variants of concern. We appreciate your support as our COVID-19 Situation Report continues to evolve.

We want to thank Matthew Shearer, MPH, who served as the lead editor of the Situation Report since January 2020. His attention to detail and critical lens helped shape these updates.
EPI UPDATE The WHO COVID-19 Dashboard reports 236 million cumulative cases and 4.82 million deaths worldwide as of October 7.

Russia continues to report new records in terms of daily mortality, as its current surge becomes its second largest to date. After surpassing 800 deaths per day for the first time in late September, the trend has continued sharply upward. Russia is now reporting 886 deaths per day, a 15% increase since mid-September and still increasing. Russia reported 910 deaths each on October 6 and 7, its highest single-day totals to date. Russia’s daily incidence is also increasing rapidly, up nearly 40% since early-to-mid September.

Syria is combatting its largest surge to date. Syria’s daily incidence increased from 5 new cases per day on July 23 to more than 350 in late September, increasing by a factor of 70 over that period. The surge appears to have peaked several days ago at more than double the previous record—161 in late March 2021. The daily incidence appears to have fallen sharply over the past several days, but it is still in excess of 275. Daily mortality surged as well, increasing from fewer than 1 death per day in early August to 11.6 in late September. Similar to daily incidence, the trend decreased sharply over the past several days—as low as 8.3 on October 3 before jumping back up to 10.3 on October 4—which potentially indicates that reporting delays could be a factor in the sharp downward trends. Syria’s current daily mortality is 9.6 deaths per day.

Global Vaccination
The WHO reported 6.26 billion cumulative doses of SARS-CoV-2 vaccines administered globally as of October 6. A total of 3.59 billion individuals have received at least 1 dose, and 2.61 billion are fully vaccinated. Analysis from Our World in Data indicates that the overall trend in global daily vaccinations continues to decline steadily, down from the most recent high of 42 million doses per day on August 30 to fewer than 25 million—a 40% decline over that period*. The global trend continues to closely follow the trend in Asia. In terms of total daily vaccinations, Africa has been on par with Europe and North and South America since late September, with more than 1.5 million doses administered per day. Africa’s average appears to have decreased sharply over the past several days, which could be a function of reporting. On a per capita basis, Africa has nearly reached the daily progress in Europe, with approximately 0.2 daily vaccinations per 100 population. Our World in Data estimates that there are 3.64 billion vaccinated individuals worldwide (1+ dose; 46.3% of the global population) and 2.73 billion who are fully vaccinated (34.7% of the global population).
*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 44.0 million cumulative COVID-19 cases and 707,065 deaths. Daily incidence continues to decline, down to approximately 95,000 new cases per day, which is the lowest average since August 2. Daily mortality is declining as well, down from the most recent peak of 1,764 deaths per day on September 15 to 1,431 on October 6*.
*Changes in state-level reporting may affect the accuracy of recently reported data, particularly over the weekend or for states that are reporting mortality by date of death. In an effort to reflect the longer-term trends, the numbers reported here may not correspond to the most recent dates.

US Vaccination
The US has administered 399.6 million cumulative doses of SARS-CoV-2 vaccines. The daily vaccination trend continues to increase, up from approximately 603,000 doses per day on September 23 to more than 858,000 on October 1, a 42% increase over that period. The current average is the highest since June 17*. The timing of this increase corresponds to the FDA authorization and CDC recommendations regarding third doses of the Pfizer-BioNTech vaccine for many adults.

There are 216.3 million individuals in the US who have received at least 1 dose of SARS-CoV-2 vaccine, equivalent to 65.1% of the entire US population. Among adults, 78.0% have received at least 1 dose, as well as 14.8 million adolescents aged 12-17 years. A total of 186.6 million individuals are fully vaccinated, which corresponds to 56.2% of the total population. Approximately 67.6% of adults are fully vaccinated, as well as 12.1 million adolescents aged 12-17 years. A total of 6.8 million “booster” doses (ie, third doses of the Pfizer-BioNTech or Moderna vaccine) have been administered nationwide**. Adults aged 50 years and older have received 5.7 million of the “booster” doses, including 4.4 million among adults aged 65 years and older.
*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.
**The second dose of the Pfizer-BioNTech, Moderna, AstraZeneca-Oxford, and other 2-dose vaccines is technically a booster dose as well (ie, part of a prime-boost regimen), but here, we are specifically addressing additional “booster” doses administered beyond the original full vaccination regimen.

Following the authorization and recommendations regarding third doses of the Pfizer-BioNTech and Moderna vaccines (“booster” doses) in late September, daily vaccinations have increased at the national level. As has been the case throughout the US COVID-19 epidemic, these trends vary widely between states and regions. Analysis from The Washington Post indicates that the national average for daily vaccinations increased 28% over the past week. A total of 30 states are reporting increases greater than the national average, including 11 states with +50% or greater. Notably, Utah (+81%), Texas (+84%), Delaware (+92%), and Vermont (+130%) are all reporting greater than +75%. Illinois and Colorado are reporting the national average (+28%), and the remaining 18 states are reporting less, including 4 states with declining trends***: New York (-1%), Alaska (-10%), Mississippi (-11%), and Alabama (-21%).

The regional trends are slightly less clear than for previous vaccination and epidemiological analyses. Based on the distribution of states with respect to the national average, it is not surprising that most regions have more states reporting higher. Notably, all 6 of the HHS Region 5 states (Midwest) are reporting above the national average, including Michigan and Wisconsin with greater than +50%. All but one state in Regions 1, 7, 8, and 10 are reporting greater than the national average. The lone exceptions are Maine (0% change), Missouri (+16%), South Dakota (+8%), and Alaska (-10%), respectively. On the opposite end of the spectrum, 7 of the 8 states in Region 4 (Southeast) are reporting less than the national average, including Mississippi and Alabama with downward trends. As with other percent change analyses, the magnitude of the difference is highly impacted by the previous level of activity. States that were already reporting high daily vaccinations tend to exhibit less relative change than those reporting lower averages due to the larger denominator, which will certainly impact the trends we observe this week. 
***Maine is reporting a decrease of less than 1%, which we are categorizing as no change.

IMPACT OF US VACCINATION MANDATES The White House t released a report this week detailing the impact that vaccine requirements have had on increasing vaccine uptake in the US. According to the report, vaccine requirements helped to increase vaccine uptake in the healthcare, corporate, and education sectors, reduce disease transmission and severity, and, therefore, increase economic output. The report also argues that vaccine requirements increased labor participation, a talking point of White House officials over the past few months. The report notes that at least 25% of all US businesses have implemented federal vaccination requirements ahead of deadline and underscores the positive impacts vaccines have had and will continue to have toward ending the COVID-19 pandemic. US President Joe Biden spoke about vaccine requirements at an event in Elk Grove Village, Illinois, on October 7, praising corporations, workers, and unions for coming together to fight COVID-19 and calling on more businesses to require vaccinations. It will be important to monitor changes in specific industries, as several companies have had to fire or place on unpaid leave workers who refuse to get vaccinated, and some experts say the nation has entered the “Great Resignation,” with millions of Americans resigning or considering quitting their jobs.

AT-HOME TEST KITS Surging demand for over-the-counter (OTC) at-home SARS-CoV-2 antigen tests, as well as point-of-care rapid tests—driven by requirements for unvaccinated employees to undergo weekly testing and parents’ need to test schoolchildren—is squeezing the US supply and driving up costs. In a move aimed at scaling up availability of at-home rapid tests, the US White House this week announced it will purchase an additional US$1 billion worth of the tests in order to quadruple the number of tests available in the US by December. The move follows a previous US$2 billion investment announced in September meant to supply rapid tests to community health centers, food banks, and schools. Expanding access to testing is part of US President Joe Biden’s 6-pronged COVID-19 action plan announced September 9. Lack of access to testing in the US could be contributing to the virus’s spread, as government-subsidized rapid testing is widely available in several other countries—including Britain, France, and Germany—making it easier for people to determine whether they are infected after a known exposure or when experiencing symptoms. 

Additionally, the US Department of Defense announced it has awarded 6 contracts worth US$2.78 billion to purchase 150 million at-home and 400 million point-of-care COVID-19 test kits to supply health centers, nursing homes, colleges and universities, and other outlets. On October 4, the US FDA authorized the use of ACON Laboratories’ Flowflex COVID-19 Home Test, a rapid antigen test that shows results within 15 minutes and retails for less than US$10. The test—the eighth rapid test available in the US—will help increase the availability of at-home tests, a White House official said. Also this week, Australian company Ellume recalled nearly 200,000 of its test kits over concerns they have a higher-than-expected false-positive rate. Overall, about 427,000 test kits were affected by the problem, including some provided to the Department of Defense, but about half of those were already used.

US COVID-19 RESPONSE FUNDING The US Department of Treasury this week ordered Arizona Governor Doug Ducey to stop using federal pandemic funding to fund 2 new education grants that are open only to schools without mask mandates, in line with a state law enacted in June. In a letter, US Deputy Treasury Secretary Adewale Adeyemo said the state grant programs’ conditions “undermine evidence-based efforts to stop the spread of COVID-19” and asked the state to explain how it will “remediate” the problems, or face administrative or other action. Governor Ducey’s office indicated they are reviewing the letter and will respond. Arizona is one of at least 8 states that have laws or executive orders banning school mask mandates. 

In Florida, one of those states, the State Board of Education on October 7 voted to withhold funding from 8 school districts that have implemented mask requirements despite a state ban and accepted recommendations from Florida Education Commissioner Richard Corcoran to withhold state funds equivalent to local school board members’ salaries and any amount the district receives in federal grants meant to backfill funding to districts with mask mandates. Ahead of the meeting, several districts—including Hillsborough, Sarasota, and Indian River counties—loosened their mask requirements to avoid funds being withheld. Several lawsuits challenging the state’s ban are moving through the courts, and the US Department of Education continues civil rights investigations in Florida and other states with mask mandate bans to determine whether the policies violate the rights of students with disabilities. According to a survey by Burbio, only about 3% of school districts nationwide are banned from implementing mask requirements and three-quarters of the largest districts had mandates at the beginning of October. School districts and parents are wondering what comes next, with the US FDA set to discuss vaccines for children ages 5 to 11 and a future existence with COVID-19 a near certainty.  

PEDIATRIC VACCINE As expected, Pfizer and BioNTech on October 7 requested the US FDA grant Emergency Use Authorization (EUA) for use of its SARS-CoV-2 vaccine in children ages 5 to 11. The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) already scheduled an October 26 meeting to discuss the request. If the FDA authorizes the vaccine, about 28 million US children would become eligible for vaccination. The companies are proposing giving children a 2-dose regimen of 10μg doses administered 21 days apart, one-third of the adult dosage. Last month, the companies submitted to the FDA topline results from a Phase 2/3 clinical trial including 2,268 pediatric participants that showed a favorable safety profile and “robust neutralizing antibody responses.” While the FDA could work quickly to review data on the vaccine for younger populations, its availability will depend upon whether the companies can provide evidence they are able to appropriately manufacture and label a new pediatric formulation. Notably, children under age 18 accounted for 26.7% of reported weekly COVID-19 cases in the US for the week ending September 30, a disproportionate share of cases given they make up about 22.2% of the total US population, according to the American Academy of Pediatrics (AAP).

PRE-EXPOSURE PROPHYLAXIS AstraZeneca on October 5 submitted a request to the US FDA for an Emergency Use Authorization (EUA) of its investigational long-acting antibody combination drug AZD7442 for the prevention of symptomatic COVID-19. The monoclonal antibodies—given as a 2-dose subsequent injection—are designed to remain in the body for up to a year and could be used in people who do not mount a strong immune response to a SARS-CoV-2 vaccine and those who have been advised to not take the vaccine, or as an extra precaution among certain populations, such as military personnel. In August, AstraZeneca said ADZ7442 reduced the risk of symptomatic COVID-19 by 77% when compared to a placebo in a Phase 3 trial including 5,197 participants, more than 75% of whom had comorbidities. The trial data are not yet published or peer-reviewed. If the FDA grants an EUA, the antibody therapy would be the first of its kind to be authorized as a pre-exposure prophylaxis option. In September, the FDA authorized Regeneron’s monoclonal antibody combination for post-exposure prophylaxis.

POST-VACCINATION MYOCARDITIS Researchers with Kaiser Permanente published a research letter in JAMA Internal Medicine examining acute myocarditis in adult members of Kaiser Permanente Southern California following vaccination with a SARS-CoV-2 mRNA vaccine between December 2020 and July 2021. Of the nearly 2.4 million individuals who received at least 1 dose of vaccine, the researchers identified only 15 confirmed cases of myocarditis. Two (2) of the cases happened after administration of the first dose and 13 occurred after the second dose for an observed incidence of 0.8 cases per 1 million first doses and 5.8 cases per 1 million second doses over a 10-day observation window. Notably, all of the cases occurred in men ages 20 to 32 (median age 25), but none required intensive care unit (ICU) admission and none were readmitted to the hospital for myocarditis following discharge. Overall, incidence of post-vaccination myocarditis was rare in the study’s diverse population.

A second paper published in the New England Journal of Medicine highlights similar data from approximately 5.1 million individuals vaccinated in Israel. Researchers retrospectively analyzed data on hospitalized cases of myocarditis that occurred from December 2020 to May 2021. They observed 283 myocarditis cases, with 142 cases occurring after receipt of the Pfizer-BioNTech vaccine. Of those 142 cases, 95% presented with mild symptoms. The highest incidence rate—13.73 cases per 100,000 persons—was recorded among male recipients ages 16 to 19 following their second vaccine dose. Researchers of both studies agreed that the risk of myocarditis remained low following mRNA vaccination but the rate of myocarditis in young men receiving a second dose warrants further investigation. 

Both studies support some countries’ decisions to recommend that children aged 12 and older receive only a single dose of mRNA vaccine. While the Israeli study looked exclusively at those who received the Pfizer-BioNTech vaccine, data from the Norwegian Institute of Public Health (NIPH) suggest similar concerns for young men who received Moderna’s vaccine. While still rare, myocarditis occurred more frequently in young men who received a second dose of the Moderna mRNA vaccine, the data show. NIPH recommends that all individuals under age 18 be vaccinated with the Pfizer-BioNTech vaccine and that men under age 30 should also consider choosing that vaccine. Other Nordic countries, including Finland and Sweden, have followed suit, limiting their use of the Moderna vaccine in young adults. Denmark also said it was limiting use of the vaccine but later retracted that statement, noting the vaccine is still available for people under age 18.
VACCINE EFFECTIVENESS A study published in the peer-reviewed journal The Lancet on October 4 shows that a decrease in effectiveness of the Pfizer-BioNTech SARS-CoV-2 vaccine may be due to waning immunity rather than the Delta variant escaping the vaccine. The study examined 3.4 million individuals over the age of 12 years who were members of Kaiser Permanente Southern California. Outcomes were determined by measuring positive PCR tests and hospital admissions related to COVID-19. The vaccine was 93% effective at preventing infection with the SARS-CoV-2 Delta variant 1 month after vaccination, but that protection fell to 53% at 4 months post-vaccination. The vaccine was 97% effective at preventing infection with non-Delta SARS-CoV-2 one (1) month after vaccination, but that protection fell to 67% at 4-5 months post-vaccination. Study leader Dr. Sara Tartof noted that waning protection from infection for both Delta and non-Delta variants points to overall waning immunity and not Delta variant escape. If Delta were able to escape the vaccine, 1-month protective effectiveness against the variant would have started low and remained low. According to the study, the vaccine remained 93% effective at preventing COVID-19-related hospitalization for all age groups up to 6 months. The authors noted it is possible that lower viral loads after vaccination could overestimate vaccine effectiveness against the Delta variant due to failed genomic sequencing. 

POST COVID-19 CONDITION On October 6, the WHO released a case definition of post COVID-19 condition—also referred to as post-acute sequelae of COVID-19 (PASC) or “long COVID”—based on interviews with international subject matter experts and COVID-19 patients. The effort identified 12 domains that were important for establishing a clinical case definition: SARS-CoV-2 infection, laboratory confirmation of infection, a 3-month minimum from onset of symptoms, a 2-month minimum for duration of symptoms, a set of common symptoms, a minimum number of present symptoms, clustering of symptoms, the time course of symptoms, sequelae of COVID-19 complications, no possible alternative diagnosis, applicability of definition to various populations, and an impact on everyday functioning. Long COVID symptoms include “brain fog,” chest pressure, depression, fatigue, fever, heart palpitations, and shortness of breath, among myriad others. The WHO noted that a separate case definition for long COVID may be necessary for children. 

A separate study published in the peer-reviewed journal Cardiovascular Diabetology reported the discovery of microclots containing inflammatory molecules that are resistant to fibrinolysis by the enzyme trypsin in patients with long COVID. The clots contained fibrinogen, which aids clot formation, and alpha 2-antiplasmin, which prevents the breakdown of blood clots. The study authors said the clots may indicate a broader impact on the cardiovascular system and further research is needed into anti-clotting therapies for long COVID.  

LATIN AMERICA Although daily COVID-19 incidence is trending downward in Latin America, regional health officials this week expressed concern over the situations in several countries and called on nations to place more focus on a “One Health” approach to more quickly detect and respond to emerging diseases. Overall, about 37% of the population in Latin America and the Caribbean are fully vaccinated. Some nations, such as Chile (74%) and Uruguay (75%), have fully vaccinated more than 70% of their population, but at least 10 countries sit at rates below 25%, including Venezuela (21%), Guatemala (16%), Jamaica (10%), Nicaragua (5%), and Haiti (0.2%). Pan American Health Organization (PAHO) Director Dr. Carissa F. Etienne said the international community must work urgently to close the gap in vaccine availability, the primary factor in lower vaccination rates in both regions. She announced PAHO has struck deals with vaccine manufacturers Sinopharm, Sinovac, and AstraZeneca for doses to be delivered this year and next. On October 6, a WHO official blamed wealthy nations for buying up the global supply and vaccine producers for not prioritizing delivery of doses to the COVAX facility, which will not meet its goals for delivering shots to Latin America and the Caribbean this year. Dr. Etienne also pointed to vaccine hesitancy as one factor in lower vaccination rates, with widespread misinformation regarding the vaccines’ safety also playing a role.

MODERNA VACCINE FACILITY IN AFRICA Only 9 of Africa’s 54 nations met a WHO goal to vaccinate 10% of their population against SARS-CoV-2 by the end of September, and the continent remains far behind others in efforts to reach 40% of its people by the end of the year, with only about 4.5% overall coverage. Efforts to increase vaccine supply on the continent continue, and there were at least 12 established or planned SARS-CoV-2 vaccine production facilities in 6 African countries as of last month. This week, Moderna announced it will invest $500 million in a “state-of-the-art” mRNA vaccine production facility in an African country, with the goal of producing 500 million 50µg doses of vaccines—for COVID-19 and other diseases—annually. The selection process for a country and site is expected to begin soon, but completing construction and validation likely will take 2-4 years, a timeline that does not address Africa’s current vaccine access challenges.

Notably, the Moderna facility will be able to fully manufacture mRNA vaccines on the continent, the first vaccine producer to do so. In July, Pfizer-BioNTech announced a deal with a South African company to “fill and finish” mRNA SARS-CoV-2 vaccines on the continent, with ingredients shipped in from other countries. Moderna’s announcement comes amid ongoing debate between pharmaceutical companies and governments about temporary intellectual property rights waivers. However, talks regarding waivers are deadlocked at the World Trade Organization (WTO), despite the support of more than 100 countries. Additionally, anonymous sources report that tension is growing between Moderna and the administration of US President Joe Biden, with the company showing reluctance to make additional commitments to the US government to increase international vaccine donations.

WHO VACCINATION STRATEGY The WHO on October 7 launched its “Strategy to Achieve Global COVID-19 Vaccination by Mid-2022,” with a goal of vaccinating 40% of the world’s population against SARS-CoV-2 by the end of 2021 and 70% by mid-2022. At a press briefing announcing the strategy, WHO Director-General Dr. Tedros Adhanom Ghebreyesus said the current disparities in vaccination coverage are wholly due to gaps in allocation and that the new goals would only be met if wealthy countries and vaccine producers prioritize contracts for the COVAX facility and the African Vaccine Acquisition Trust (AVAT). To reach the 2022 goal, at least 11 billion vaccine doses are needed, Dr. Tedros noted, and more than 6 billion already have been administered worldwide. Speaking at the same event, UN Secretary-General Antonio Guterres called vaccine inequity “immoral” and “stupid” and urged countries—including G20 nations set to meet later this month—to commit US$8 billion to ensure equitable vaccine distribution by this year’s end.  

COVAX REVIEW The Bureau of Investigative Journalism and STAT today published an account of the global COVAX collaboration, founded in April 2020 to serve as a conduit of SARS-CoV-2 vaccines—an “insurance policy” for most nations but a “lifeline” for low-income countries amid the COVID-19 pandemic. The article presents reviews of confidential internal documents and accounts of officials from at least 12 countries, who expressed confusion and frustration over COVAX’s operations and commitments. COVAX has fallen short of its goal to provide 2 billion doses in 2021, contributing less than 5% of all vaccine doses administered globally. The story highlights the misalignment of leadership and power in global efforts to end the COVID-19 pandemic.