COVID-19 Situation Report

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EPI UPDATE The WHO COVID-19 Dashboard reports 159 million cases and 3.3 million deaths worldwide as of 4:45am EDT on May 11. The global weekly incidence declined for the first time since early-to-mid February, a decrease of 5% compared to the previous week. Global weekly mortality decreased as well—the first time since early March—down 4% from the previous week. Notably, the weekly incidence decreased in every region with the exception of South-East Asia, and weekly mortality decreased except in South-East Asia and the Western Pacific.

It appears that India’s second COVID-19 wave is peaking. On May 7, India’s average daily incidence decreased for the first time since mid-February, and it decreased for the past 2 days, down to 387,098 new cases per day. Unless India’s daily incidence decreases dramatically, however, we expect it to surpass 25 million cumulative cases in the next 5-6 days. India has reported 249,992 cumulative deaths, and we expect it to pass 250,000 in its next report. Additionally, India reported more than 4,000 deaths on both May 7 and 8. To our knowledge, India is only the third country, after the US and Brazil, to report more than 4,000 deaths in a single day. India’s daily mortality continues to increase, but it appears it may have passed an inflection point over the past week. Based on historical trends, we expect daily mortality to peak in the next 3-4 weeks.

Global Vaccination
The WHO reported 1.21 billion doses of SARS-CoV-2 vaccines administered globally, including 606 million individuals with at least 1 dose. Our World in Data reported 1.32 billion cumulative doses administered globally. This is an increase of 12% over the previous week, slightly less than the 13% weekly increases over the previous several weeks. After a week of declining daily doses administered, the trend is once again increasing, back up to 19.6 million—5% less than the record high (20.67 million on May 1). Our World in Data estimates that there are 319 million people worldwide who are fully vaccinated, corresponding to approximately 4% of the global population, although reporting is less complete than for other data.

The US CDC reported 32.5 million cumulative cases and 578,945 deaths. Daily incidence continues to decrease, down to 38,678 new cases per day, the lowest average since September 16, 2020. On May 9, the US reported just 24,080 new cases, the lowest single-day incidence since June 17, 2020 (23,984). In the period between the first and second surges in the US, the lowest average daily incidence was 34,666 new cases per day. If the US continues on its current trajectory, daily incidence could soon fall below that number. Daily mortality is declining slowly, down to 608 deaths per day. With the exception of holiday reporting anomalies, this is the lowest average since April 2, 2020, early in the first surge.

The CDC categorizes states by Level of Community Transmission—Low, Moderate, Substantial, and High—based on the current average per capita weekly incidence and test positivity. The 4 categories for weekly incidence are 0-9.99, 10-49.99, 50-99.99, and 100 or more new cases per 100,000 population, and the categories for test positivity are 0-4.99%, 5-7.99%, 8-9.99%, and 10% or higher*. If the categories for a given state differ between the 2 metrics, the CDC classifies the state at the higher of the 2 categories. Overall, the CDC classifies the national epidemic as Substantial community transmission, with 81.6 weekly cases per 100,000 population and test positivity of 4.09%. In total, 9 states are classified as Moderate transmission, 27 (and Washington, DC) are Substantial, and 14 are High. No states are classified as Low. Unlike earlier in the US epidemic, there does not appear to be a strong geographic correlation.
*The CDC only reports state-level test positivity as 0-5% and 6-10%, so it is unclear exactly which category states fall into for that part of the assessment. 

Alabama is reporting the lowest per capita weekly incidence, but at 29.5 weekly cases per 100,000, it is still well above the Low category threshold. Alabama is the only state in the Moderate category currently reporting 6-10% test positivity, so while we can infer that it is less than 8% because of the Moderate classification, it would also need to bring that down below 5% before it could achieve the Low classification. Notably, only 10 total states are reporting test positivity of 6-10%, and none are reporting higher than that. Three states in the High category—Indiana (105.0), North Carolina (105.4), and North Dakota (100.1)—are reporting fewer than 110 weekly cases per 100,000, so they could potentially transition in the near future. Among the 27 states currently classified as Substantial, 7 (and Washington, DC) are reporting fewer than 60 weekly cases per 100,000, including Texas and Washington, DC, that are within 10% of the Moderate category threshold. A

US Vaccination
The US has distributed 330 million doses of SARS-CoV-2 vaccine and administered 262 million. Daily doses administered* continues to decrease, down from a high of 3.3 million on April 11 to 2.0 million. Approximately 1.3 million people are achieving fully vaccinated status per day, down from a high of 1.8 million per day on April 12.

A total of 152 million individuals have received at least 1 dose of SARS-CoV-2 vaccine, equivalent to 46% of the entire US population and 58% of all adults. Of those, 116 million are fully vaccinated, which corresponds to 35% of the total population and 44% of adults. Among adults aged 65 years and older, progress has largely stalled at 84% with at least 1 dose and 72% fully vaccinated. In terms of full vaccination, 60 million individuals have received the Pfizer-BioNTech vaccine, 47 million have received the Moderna vaccine, and 9.0 million have received the J&J-Janssen vaccine.
*The US CDC does not provide a 7-day average for the most recent 5 days due to anticipated reporting delays for vaccine administration. This estimate is the most current value provided.

PFIZER-BIONTECH EUA FOR ADOLESCENTS The US FDA on May 10 expanded the Emergency Use Authorization (EUA) for the Pfizer-BioNTech SARS-CoV-2 vaccine to include adolescents ages 12 to 15, making it the first such vaccine available to children under age 16 in the US. The amendment to the original EUA is based on Phase 3 clinical trial results showing the vaccine is safe and effective among that age group. The US CDC Advisory Committee on Immunization Practices will meet on May 12 to review the data on use among 12- to 15-year olds and is expected to recommend the vaccine be used in this age group. Pfizer-BioNTech are testing the vaccine among children aged 2 to 11 and plan to include children aged 6 months to 2 years in the coming weeks. Moderna and J&J-Janssen also are testing their vaccines in children.

On May 7, Pfizer-BioNTech announced they have begun a Biologics License Application with the FDA for full regulatory approval of their SARS-CoV-2 vaccine for individuals ages 16 years and older. The companies will submit data to support the application on a rolling basis, with a goal of achieving full approval in the coming months.   

US CDC TRANSMISSION GUIDANCE On May 7, the US CDC issued a Scientific Brief on SARS-CoV-2 transmission and updated its associated guidance. Notably, the brief describes respiratory fluid as existing along a “spectrum of sizes,” rather than distinguishing between droplets and aerosols. The CDC emphasizes the role that the volume of exposure plays in transmission risk, including the “concentration of virus in the air” and its viability. The guidance notes that transmission risk is the greatest at close proximity to infectious individuals and that the concentration of virus generally “decreases with increasing distance.” The agency concluded certain conditions can increase the risk of infection at longer distances, including enclosed spaces with inadequate ventilation, increased exhalation rates (e.g., when exercising or singing), and prolonged exposure (e.g., more than 15 minutes). The brief emphasizes that exhaled viruses in the air—whether via inhalation or contact with mucous membranes like the eyes, nose, or mouth—remains the greatest transmission risk, and while fomites do pose some risk, they are not a substantial driver of transmission.

The updated guidance does not explicitly distinguish between droplet (i.e., via small respiratory droplets at close distance) and airborne transmission (i.e., via aerosolized respiratory fluid that can remain aloft for longer periods of time and travel longer distances). Previous iterations of the guidance included separate sections for droplet and airborne transmission, describing droplet transmission as more likely than airborne. The new guidance removes any mention of aerosols and airborne transmission entirely. Instead, the CDC discusses them together, as “droplets and very small particles.” Additionally, the CDC removed the term “close contact” and shifted the focus to the type of exposure—i.e., inhalation, splashes/sprays to mucous membranes, and touching mucous membranes. While the update is viewed by many as an improvement, some critics are still calling on the CDC to more explicitly address the risk of aerosol/airborne transmission, particularly for prolonged exposure in indoor spaces.

WHO EUL FOR SINOPHARM VACCINE On May 7, the WHO issued an Emergency Use Listing (EUL) for the Sinopharm vaccine for use among adults 18 years and older, the sixth SARS-CoV-2 vaccine to receive an EUL. The vaccine—an inactivated vaccine administered in 2 doses given 3-4 weeks apart—is produced by Beijing Bio-Institute of Biological Products Company Ltd., a subsidiary of China National Biotec Group. The WHO noted the listing of the vaccine included on-site inspections of the production facility. The designation facilitates many countries’ efforts to speed their own regulatory approval of the vaccine and is a prerequisite for the vaccine to be distributed by the COVAX facility. The vaccine’s storage requirements make it well-suited for use in low-income countries, according to the WHO, and its vials will be the first to include a small sticker that changes color when exposed to heat, allowing healthcare workers to know whether the vaccine is safe to use.

According to the WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), more than 65 million doses of the Sinopharm vaccine have been administered worldwide in the 45 countries/jurisdictions with existing authorizations, with an estimated 79% efficacy at preventing symptomatic COVID-19 among adults ages 18-59. However, SAGE experts did not estimate the vaccine’s efficacy among people ages 60 and older. The Sinopharm vaccine reportedly is the first-ever Chinese-produced vaccine to receive WHO emergency authorization, although the agency next week is expected to consider another Chinese SARS-CoV-2 vaccine from the company Sinovac.

ASTRAZENECA-OXFORD VACCINE British officials have recommended that people under 40 be given options other than the AstraZeneca-Oxford SARS-CoV-2 vaccine when available, due to a small risk of blood clots. According to data analysis from the UK Medicines and Healthcare Products Regulatory Agency (MHRA), the risk of these rare adverse events is slightly higher among younger age groups compared to older adults, and there are no known risk factors for the blood clotting events. In an update to guidance released on April 7 recommending individuals under age 30 be offered an alternative to the AstraZeneca-Oxford vaccine when possible and only where no substantial delay or barrier in access to vaccination would arise, the UK’s Joint Committee on Vaccination and Immunisation on May 7 expanded that guidance to adults ages 30-39 who are not at increased risk of COVID-19 complications. MHRA Chief Executive June Raine stressed the benefits of the AstraZeneca-Oxford vaccine continue to outweigh the risks for the vast majority of people. UK public health officials hope to vaccinate the entire adult population by the end of July. 

NOVAVAX EUA APPLICATION In quarterly earnings results announced May 10, US-based pharmaceutical company Novavax indicated it does not plan to file for US FDA Emergency Use Authorization for its SARS-CoV-2 vaccine until July at the earliest but expects to have the application process complete in the US, UK, and Europe by the third quarter of 2021. The company could announce safety and efficacy data on the vaccine this month, although manufacturing delays have impacted clinical trial progress. Novavax CEO Stanley Erck said the company hopes to have production slowdowns resolved by the fourth quarter, with plans to produce up to 3 billion doses worldwide next year with partner Serum Institute of India. However, the Serum Institute, the world’s largest vaccine maker, has been unable to deliver on its promises of vaccine production for several companies, including AstraZeneca, which has served the company a legal notice over the delays. These delivery delays are heavily impacting supply to the COVAX facility, which is committed to delivering 2 billion doses of SARS-CoV-2 vaccine to low- and middle-income countries in 2021. On May 6, Gavi, the Vaccine Alliance, one of the co-leaders of COVAX, signed an advance purchase agreement with Novavax for 350 million doses of its vaccine to begin delivery in the third quarter. However, with the Serum Institute saying it has “temporarily deferred” some of its delivery commitments and offering refunds for at least one bilateral purchase agreement, it remains to be seen whether the companies can deliver on their obligations.

SOUTH ASIA India’s second wave remains the most severe COVID-19 situation in the world, although it does appear to be peaking. Amid continued calls on Prime Minister Narendra Modi to reinstitute a nationwide “lockdown,” including from White House Chief Medical Advisor Dr. Anthony Fauci, some states are implementing their own restrictions. Reportedly, approximately half of India’s states have implemented a full “lockdown,” and the rest have implemented varying degrees of restrictions.

Neighboring Nepal also is facing its largest COVID-19 surge on a similar trajectory to India’s. Notably, Nepal’s daily incidence has surged from 500 new cases per day on April 16 to more than 8,600 on May 10, a 17-fold increase in less than 4 weeks. Much like India, Nepal’s health system is struggling to manage the wave, so much so that the Ministry of Health issued a statement indicating that it was “losing control of the situation.” Perhaps the most concerning aspect of the current surge is Nepal’s high test positivity. Since mid-March, test positivity surged from 2% to 45%, which indicates that testing is not sufficient to fully capture the scope of the epidemic and that the reported incidence likely is well below the actual total.

Bangladesh, another of India’s neighbors, recently detected its first cases of COVID-19 caused by an emerging SARS-CoV-2 variant first reported in India. The B.1.617 variant is characterized by 3 mutations that are believed to confer increased transmissibility and resistance to existing vaccines. On May 10, the WHO announced that it classified B.1.617 as a variant of concern, although the US CDC still classifies it as a variant of interest. Some preliminary research (preprint) provides some evidence that the B.1.617 variant exhibits “reduced neutralization” to existing vaccines, but further study is needed to more fully characterize the variant’s attributes.

MORTALITY DUE TO COVID-19 As we have covered previously, limitations in public health surveillance and reporting can result in an undercount of COVID-19 deaths. The Institute for Health Metrics and Evaluation recently shifted its modeling approach to use total mortality due to COVID-19, as opposed to official COVID-19 mortality reports. The new approach accounts for historical seasonal fluctuations as well as temporal and geographic variations in testing capacity and reporting. It also takes into account the early months of the pandemic, when a higher proportion of deaths or cases were uncounted, and because of the disproportionate impact on long-term care facilities, COVID-19-related deaths among older individuals may have been overlooked. Additionally, the model aims to estimate the proportion of excess deaths that are due directly to COVID-19 by accounting for changes in historical trends during the pandemic. In order to do this, IHME researchers consider 6 drivers of all-cause mortality that relate to the pandemic and physical distancing requirements, including increases in mortality due to the reduced utilization of healthcare services for non-COVID-19 conditions, increases in deaths due to mental health disorders and drug use, decreases in reported deaths due to cardiovascular and respiratory diseases and accidental injury, and fewer deaths due to other respiratory illnesses, especially influenza. The new IHME model estimates more than 900,000 total COVID-19 deaths in the US, more than 50% higher than official figures. The estimates for some countries—including Azerbaijan, Belarus, Japan, and Kazakhstan—are more than 10 times the reported total. On a global scale, the model estimates nearly 7 million total COVID-19 deaths, more than double the 3.24 million deaths reported at the time of publication.

MENTAL HEALTH Mental health experts are concerned over potential long-term ramifications of the COVID-19 pandemic on the psychosocial health of people worldwide. For some, prolonged feelings of anxiety or depression, a lack of social connection, job uncertainty, or food insecurity during the pandemic are unlikely to dissipate with the loosening of social restrictions. A disproportionate impact could be seen in some individuals, including LGBTQ+ people or those who experience violence at home, as well as Black, Latinx, and Indigenous communities more heavily affected by the pandemic. Another notable population of interest is children, whose formative years have been upended by the pandemic, resulting in familial socioeconomic stress, delays in learning, and an increase in mental health issues. In the US, pediatric hospitals are reporting higher proportions of emergency department visits for mental health conditions during the COVID-19 pandemic. Although the US$1.9 trillion American Rescue Plan earmarks US$3.5 billion in block grants for states and organizations to address mental health in communities and the workforce, experts warn the funding might not be sufficient to bolster already under-resourced mental health care in the country.

COVID SOLIDARITY TRIAL The WHO Solidarity clinical trial, launched in 2020 to test various medical interventions for COVID-19 disease, is beginning a randomized controlled trial of three immune regulating drugs that have shown promise in smaller studies. These three drugs—infliximab, imatinib, and artesunate—were selected for their abilities to dampen inflammatory immune responses, preliminary positive efficacy against severe COVID-19, and widespread global availability. The Solidarity trial previously evaluated remdesivir, hydroxychloroquine, lopinavir/ritonavir, and interferon, with all having little to no effect in managing patients hospitalized with COVID-19. In addition to the Solidarity trial, another large international study called REMAP-CAP is exploring various ways to control immune responses in COVID-19 patients. Taken together, researchers hope the trials will identify more treatments to provide additional support to hospitalized COVID-19 patients.

MOUNT EVEREST China is implementing strict measures to prevent new COVID-19 cases on the Tibetan side of Mount Everest, known as Mount Qomolangma in China. The peak of the world’s highest mountain straddles the border of China and Nepal at 29,032 feet above sea level, with climbers able to approach from either the northern Tibetan side or southern Nepalese slope. China banned foreign mountaineers last year due to the pandemic, but it has issued 21 expedition permits this year for nationals to attempt to reach the summit from the Tibetan side. To prevent commingling of climbers from each side who reach the small peak on the same day, China plans to establish a “line of separation” near the border as part of its “zero contact strategy,” according to state media. Details of how this will be accomplished are not yet known. Additionally, the China Tibet Mountaineering Association has set up a checkpoint 300 meters from the Tibetan base camp to test anyone with a permit to enter. Nepal is experiencing a surge in COVID-19 cases, and cases have been detected in the main Nepalese base camp. Last week, Nepalese officials reportedly confirmed 18 COVID-19 cases at the base camp, but anecdotal reports say the number could be nearly double. The Nepal Mountaineering Association has asked climbers and their Sherpa guides to return spent oxygen canisters instead of abandoning them on the mountainside so they can be refilled to help alleviate oxygen shortages.