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.

October 8: Johns Hopkins COVID 19 Report

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.

UNITED STATES

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.

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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 pan