COVID-19 Situation Report
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Capitol Hill Steering Committee on Pandemic Preparedness & Health Security – June 16

Join us on Wednesday, June 16, at 1:00pm ET for the webinar Global Vaccine Access: Challenges and Opportunities. Speakers will evaluate where things stand in terms of global access to COVID-19 vaccines and the urgent need to expedite global vaccine distribution to save lives and reduce the risk that variants pose. Global vaccination approaches will be considered, including bilateral or multilateral agreements, additional donations of vaccines or money to COVAX, investments in globally distributed manufacturing sites, and other useful solutions. To register, click here.
EPI UPDATE The WHO COVID-19 Dashboard reports 176 million cumulative cases and 3.8 million deaths worldwide as of 5:30am EDT on June 15. The WHO reported declining weekly global incidence and mortality for the sixth consecutive week. The weekly incidence last week decreased 12.6% from the previous week, and it is the lowest weekly total since mid-February. If the global trend continues on this trajectory, the weekly incidence next week will reach the lowest value since October 2020. Global weekly mortality fell nearly 2% from the previous week. Most of the continuing decline is a result of trends in the WHO’s Southeast Asia and Europe regions.

Global Vaccination
The WHO reported 2.2 billion doses of SARS-CoV-2 vaccines administered globally as of June 14, and 914 million individuals have received at least 1 dose. Our World in Data reported 2.42 billion cumulative doses administered globally, an increase of 10% compared to this time last week. The global daily doses administered has exhibited an overall decline since its peak on June 4, down from a high of 35.8 million doses per day to 32.6 million. Our World in Data estimates there are 733 million people worldwide who are fully vaccinated, corresponding to approximately 9.4% of the global population, although reporting is less complete than for other data. On June 10, China reported its cumulative number of fully vaccinated individuals for the first time*, 223 million, causing the global total to jump from 484 million on June 9 to 713 million on June 10 and the global coverage to jump from 6.2% to 9.2%
*June 10 is the only report from China currently included in the OWID database.

The US CDC reported 33.3 million cumulative COVID-19 cases and 597,343 deaths. The cumulative incidence in the US accounts for approximately 10% of the entire US population. After briefly leveling off following the Memorial Day holiday weekend, daily incidence is once again decreasing. The current average (12,223 new cases per day) is the lowest since March 26, 2020. Daily mortality is once again decreasing as well, after a brief bump following Memorial Day. At 331 deaths per day, the daily mortality is at its lowest point since March 28, 2020.

US Vaccination
The US has distributed 374 million doses of SARS-CoV-2 vaccines and administered 311 million. Similar to daily incidence and mortality, the average daily vaccine doses administered* is once again declining, as routine reporting resumes following the Memorial Day holiday. The US is averaging 978,023 doses per day, and 653,441 people are achieving fully vaccinated status per day.

A total of 174 million individuals in the US have received at least 1 dose of SARS-CoV-2 vaccine, equivalent to 52.5% of the entire US population. Among adults, 64.5% have received at least 1 dose, and 7.7 million adolescents aged 12-17 years have received at least 1 dose. A total of 145 million people are fully vaccinated, which corresponds to 43.7% of the total population. Among adults, 54.4% are fully vaccinated, and 4.1 million adolescents aged 12-17 years are fully vaccinated. Progress has largely stalled among adults aged 65 years and older: 86.8% with at least 1 dose and 76.4% fully vaccinated. In terms of full vaccination, 75 million individuals have received the Pfizer-BioNTech vaccine, 58 million have received the Moderna vaccine, and 11 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.

On May 25, we compared state-level vaccination coverage and observed notable differences between states as well as some regional trends. At that time, the states at the top of the list were reporting full vaccination coverage that was nearly double the coverage in states at the bottom. This week, we will update that analysis to see if the differences have increased or decreased over the past several weeks. On May 25, 3 states were reporting full vaccination coverage of 50% or greater, which has since increased to 11. Previously, 6 states reported 31% or lower; today, only 2 states are reporting less than 31% (and only 1 with less than 30%). The median value for full coverage increased from 39% (interquartile range [IQR]: ~34-44%) to 43%, with most states currently reporting between approximately 37-49%. The lower bound of the IQR increased 3 percentage points (pp), but the upper bound increased by 5pp, illustrating that the states with the highest coverage are increasing their advantage over the lower states.

Since May 25, the disparities in coverage at the state level have increased, with the top states now reporting more than double the partial and full coverage as the bottom states. Previously, full coverage ranged from 26.5% in Mississippi to 52.7% in Vermont—not quite double. Today, Vermont and Mississippi retain their respective ranks, but at 61.9%, Vermont is now reporting more than double Mississippi’s 28.1% coverage. Vermont’s full coverage increased by 9.2pp since May 25, while Mississippi’s only increased 1.6pp over that period. In terms of partial coverage, Vermont is again #1 nationally, with 72.4% of the population receiving at least 1 dose, and it is reporting more than double the 34.9% coverage in Mississippi.

States’ rankings for full vaccination coverage continue to largely align with their rankings for partial coverage. In fact, only 7 states have rankings that differ by more than 5 places between the 2 lists. Minnesota ranks 6 places higher in terms of full vaccination than partial, jumping from #20 to #14. The remaining 5 states rank lower for full vaccination. Hawai’i and Illinois both fall 9 places. Hawai’i drops from #3 to #12, and Illinois from #16 to #25. Pennsylvania and Utah both fall 8 places, #9 to #17 and #34 to #42, respectively. California falls 7 places, from #12 to #19, and Arizona falls 6 places, from #28 to #34.

In terms of full vaccination, the Northeast region continues to represent most of the states reporting the highest coverage, including all of the top 7 states and 8 of the top 10. Most states in the South region continue to report among the lowest coverage, representing the bottom 3 states as well as 9 of the bottom 12. Of the states in the South region, Maryland (#8; 52.0%), Virginia (#15; 48.4%), and Delaware (#20; 46.3%) are reporting the highest coverage, and interestingly, all 3 are located on or near the Northeast region border. The Midwest and West regions are spread more evenly throughout the rankings. The West has more variation—spanning #9 Washington (as well as #11-13) to #47 Wyoming (as well as #42-43). Conversely, Midwestern states are largely clumped in the middle—with all 12 states falling between #14 Minnesota and #38 Missouri.

As we have reported over the past several weeks, vaccination among adults aged 65 years and older has largely stalled at the national level, with the full coverage holding relatively steady at 76.4% and partial coverage at 86.8%. As with coverage among the entire population, we can observe marked differences at the state level in terms of coverage among older adults, although the magnitude of the differences are generally smaller, due in part to the overall higher coverage across all states. Full vaccination coverage among older adults ranges from Utah with 60.5% to Vermont with 92.7%. In total, 17 states are reporting greater than 80% coverage among older adults, and only 7 are reporting less than 70%. The median coverage is 77.6%, and most states fall between approximately 72-82%. In terms of the relative difference, Vermont is reporting 1.5 times the lowest coverage among older adults (ie, 92.7% compared to 60.5% in Utah), but it is reporting 2.2 times the lowest coverage among the entire population (61.9% compared to 28.1% in Mississippi).

The Johns Hopkins Coronavirus Resource Center is reporting 33.5 million cumulative cases and 599,950 deaths in the US as of 10:30am EDT on June 15.

NOVAVAX VACCINE Novavax on June 14 reported preliminary efficacy data for its investigational SARS-CoV-2 vaccine. Based on data from a phase 3 clinical trial involving nearly 30,000 participants, the vaccine’s overall efficacy is estimated to be greater than 90% in preventing moderate and severe COVID-19 disease. The vaccine also demonstrated 93% efficacy against variants of concern/interest (VOCs/VOIs) and 100% efficacy against non-VOC/VOI variants. This places the Novavax vaccine on par with currently authorized vaccines. Like most other SARS-CoV-2 vaccines, the Novavax vaccine is a 2-dose regimen, but it uses a much different platform. The Novavax vaccine uses nanoparticles composed of synthetic SARS-CoV-2 spike proteins to mimic the surface of a SARS-CoV-2 viral particle and stimulate an immune response. The press release did not present the full clinical trial data, but Novavax committed to publishing its full analysis via preprint servers and in a peer-reviewed manuscript.

Reportedly, Novavax may apply for an Emergency Use Authorization (EUA) from the US FDA in the third quarter of this year; however, with multiple existing EUAs for SARS-CoV-2 vaccines, the FDA may direct Novavax to instead apply for full licensure. Novavax is also evaluating options for international authorization, including in the UK, the EU, India, and South Korea. Novavax has partnered with international manufacturers, such as the Serum Institute in India and SK Biosciences in South Korea, and agreed to supply 1.1 billion doses to low-and middle-income countries. In an effort to close the gap in global vaccine access, Novavax expects to produce 100 million doses by the end of the third quarter 2021 and 150 million doses by the end of the year. The Novavax vaccine can be stored in standard refrigerators, reducing logistical challenges for distribution and administration, which could provide an advantage, particularly in low-resource settings. In conjunction with international vaccination efforts, researchers expect that Novavax shots, due to their unique formula, may be particularly useful as boosters in the future.

DELTA VARIANT As countries around the world continue to expand vaccination efforts, there is growing concern that the Delta variant of concern (B.1.617.2; VOC) could cause significant problems before many countries can achieve sufficient vaccination coverage. The Delta variant is the most recent VOC designated by the WHO and US CDC. Reportedly, the current COVID-19 surge in southeastern China is being driven by the Delta variant, and other countries are adapting COVID-19 restrictions in order to mitigate the risk from this VOC. Emerging evidence indicates that the Delta variant poses an elevated risk for severe disease compared to others, and it is believed that the variant is largely responsible for India’s largest surge, which peaked in early May. The Delta variant also represents an increasing proportion of COVID-19 cases in the US—up to 6%, compared to 1% only a month ago—and the UK at 91% of new cases. In response to increasing prevalence of the Delta variant, the UK is extending existing COVID-19 restrictions for another 4 weeks—shifting the expected date from June 21 to July 19—which will allow for accelerated vaccination efforts before taking further steps to ease restrictions.

Emerging data indicate that existing vaccines, including the Pfizer-BioNTech and AstraZeneca-Oxford vaccines, are effective in preventing severe disease and hospitalization. Analysis published by Public Health England, based on real-world cases, indicates that the vaccines are 96% and 92% effective in preventing hospitalization, respectively, which is on par with the protection conferred against the Alpha variant (B.1.1.7). Notably, however, several countries that are using vaccines developed in China have reported increased “breakthrough” infections, potentially stemming from increased circulation of the Delta variant, including Seychelles and Mongolia. Dr. Scott Gottlieb, former US FDA Commissioner, expects that full vaccination will provide high levels of protection against the Delta variant.

G7 SUMMIT COMMITMENTS Recognizing that the world’s interconnectedness means the “COVID-19 pandemic is not under control anywhere until the disease is under control everywhere,” G7 leaders agreed to a collective goal of ending the pandemic in 2022 at the end of its 3-day summit in England.

In the Carbis Bay Declaration, G7 leaders committed to sharing at least 870 million SARS-CoV-2 vaccine doses directly with low- and middle-income countries over the next year, aiming to deliver at least half by the end of 2021, primarily through the COVAX facility. The leaders also highlighted financial commitments made to the Access to Covid-19 Tools Accelerator (ACT-A) and COVAX since the beginning of the pandemic, which, when taken together with vaccine donations, equate to more than 2 billion vaccine doses. Prior to the summit, US President Joe Biden and British Prime Minister Boris Johnson announced donations of 500 million and 100 million vaccines, respectively. Canada is expected to pledge up to 100 million doses, and other G7 nations likely will follow suit. 

Additionally, the declaration addresses access to and production of COVID-19-related tools by expressing support for voluntary licensing, technology transfers, tiered pricing, and not-for-profit global and regional production capabilities, with an emphasis on Africa, although it does not address patent waivers for such products. The leaders committed to continuing to strengthen the WHO by supporting its leadership role in the global health system; boosting SARS-CoV-2 global surveillance and genomic sequencing, pledging to sequence at least 10% of all new cases and sharing that information in existing databases; and urging the World Bank and other multilateral development banks to speed their financial support, especially to ACT-A and its partners, including the Global Fund and Unitaid.

The meeting of G7 leaders was anticipated to be a landmark summit with war-footing levels of commitment to end the COVID-19 pandemic, but many experts, NGOs, and health advocates expressed disappointment that the nations did not commit to a more detailed plan. WHO leadership and health campaigners welcomed the vaccine donations, but some called the summit an “historic missed opportunity” and a “failure,” criticizing leaders’ commitments, which fall far short of the at least 11 billion doses needed to vaccinate the world’s population. UN Secretary-General António Guterres called on G7 nations to do more than pledge vaccine doses, saying a global vaccination plan based in logic and delivered with a sense of urgency would better help vaccinate people in LMICs and prevent new and potentially more dangerous SARS-CoV-2 variants from developing. 

MANDATORY VACCINATIONS A federal judge in Texas on June 12 dismissed a lawsuit brought by 117 employees of Houston Methodist Hospital challenging the hospital’s SARS-CoV-2 vaccine requirement. In a 5-page ruling, US District Judge Lynn Hughes upheld the vaccination mandate, underlining that the requirement broke no federal law and criticizing the plaintiff’s arguments as false, irrelevant, and reprehensible. Houston Methodist is among the first hospital systems in the country to mandate its employees receive a SARS-CoV-2 vaccine, and the decision marks an early test for how similar employer-mandated vaccine policies may fare in the courts. Notably, the US Equal Employment Opportunity Commission earlier this year issued guidance for employers wishing to require vaccines for on-site workers. Houston Methodist welcomed the judge’s decision, and a lawyer for the plaintiffs said the employees would appeal the ruling. 

SARS-COV-2 ORIGINS With continued international attention on the origins of SARS-CoV-2, the G7 in its June 13 Carbis Bay Declaration called for the WHO to convene “a timely, transparent, expert-led, and science-based” Phase 2 COVID-19 Origins study, including investigations in China. While the scientific community continues to investigate the origins of SARS-CoV-2, conclusively determining the source of any new human virus remains elusive. Frequently, this line of scientific inquiry can point only to a group of possible viral ancestors, and pinpointing the exact virus requires an enormous database of samples, collection of which takes time, rigor, and some luck.

A group of researchers on June 9 published data on 411 bat samples collected from China’s Yunnan province between May 2019 and November 2020, identifying 24 full-length coronavirus genomes, including 4 novel viruses related to SARS-CoV-2. The researchers note the study highlights the significant diversity of bat coronaviruses at the local level, underscoring the difficulties in attempting to identify a single-source viral origin of the COVID-19 pandemic. The debate over whether SARS-CoV-2 escaped a Chinese laboratory or even originated in the country continues to fuel geopolitical discussion over China’s role in the pandemic, including its potential involvement in cover-ups, and could impact China’s global status over the long term, depending upon investigational findings. Researchers note that future pandemic preparedness hinges on scientists’ ability to conduct epidemiological surveillance and understand viral emergence through well-funded inquiry.

REBOUND OF RESPIRATORY VIRUSES Masking has been a vital component in the global public health response to the COVID-19 pandemic. However, as many US states achieve higher levels of vaccination, several state and local governments are relaxing mask measures, a consequence of which is a resurgence of common respiratory viruses. Cases of seasonal cold and respiratory syncytial virus (RSV) have made a comeback in states that have relaxed masking policies. Still, incidence of these seasonal respiratory viruses was markedly lower over the past year than in previous years, reinforcing the efficacy of masks in protecting against a broad spectrum of respiratory infections, not only SARS-CoV-2. For comparison, the CDC reported 1 pediatric death due to influenza in 2020 compared to 199 in 2019. Experts hope that some continuation of public health precautions will help keep these numbers lower than in previous years, especially as children return to in-person learning in the fall. Some parents are encouraging their children to continue wearing masks at school, even following SARS-CoV-2 vaccination, as a way to minimize colds among their families. 

VACCINATION ADVERSE EVENTS A higher-than-expected number of people under age 30, especially young men, have experienced heart inflammation, also called myocarditis or pericarditis, following their second dose of SARS-CoV-2 mRNA vaccine, including the Pfizer-BioNTech and Moderna vaccines. According to data from the US CDC, 226 confirmed cases of heart inflammation among people 30 or younger were reported to the U.S. Vaccine Adverse Event Reporting System as of May 31, compared with an expected 10 to 102 cases for that age range based on background incidence among the US population. Of those cases, most occurred among men and most have recovered fully from their symptoms. The CDC said it is continuing to investigate the cases and has not concluded there is a causal relationship between the vaccines and cases of heart inflammation. The agency is scheduled to hold a meeting of its Advisory Committee on Immunization Practices on June 18 to evaluate myocarditis or pericarditis following mRNA vaccination and assess the benefit-risk balance.

J&J-JANSSEN VACCINE PRODUCTION J&J-Janssen’s 1-dose SARS-CoV-2 vaccine has hit another obstacle in its rollout and manufacturing efforts in the US. Federal regulators recently informed J&J that 60 million doses of its vaccine are unusable due to possible contamination during the manufacturing process. According to sources familiar with the situation, the US FDA is expected to allow the use of around 10 million doses, distributed with a warning that regulators cannot guarantee the vaccine was produced following good manufacturing practices. The doses were made at an Emergent Biosolutions facility in Baltimore, Maryland, which already has documented several manufacturing problems. Previously, regulators found that workers at the plant contaminated around 15 million doses of the J&J-Janssen vaccine with one of the components of the AstraZeneca-Oxford vaccine, which also is produced at the facility. Following this incident, Emergent Biosolutions was stripped of its authority to operate the plant, and J&J was placed in charge of manufacturing its own vaccine at the facility. The repercussions of these problems are ongoing, as the US plans to export millions of doses of the J&J-Janssen vaccine to bolster international vaccination administration. Canada recently rejected a shipment of 300,000 J&J-Janssen vaccine doses following a safety review. These doses had been held since April following the initial contamination event.

SARS-COV-2 ARRIVAL IN THE US Researchers from the All of Us initiative today published findings (Clinical Infectious Diseases) from a SARS-CoV-2 serological study conducted in early 2020. The study included more than 24,000 participants from across all 50 US states (part of existing All of Us research efforts), who provided specimens from January 2-March 18, 2020. The researchers identified 9 seropositive participants, including 7 who provided specimens prior to the first confirmed case in their state. The first 12 cases of COVID-19 in the US all had recent travel to China or had close contact with travelers, and the earliest reported symptom onset was January 14, 2020. The study provides further support for the idea that SARS-CoV-2 was circulating in the community prior to the first reported cases. Early testing strategies that restricted eligibility to individuals with recent travel history to high-risk areas (e.g., China)—as well as emphasis on early travel restrictions to prevent the introduction of COVID-19—likely hindered early disease surveillance and response activities in the US.

US SUPPLY CHAIN Although the COVID-19 pandemic remains far from over, some are calling on the US to evaluate structural vulnerabilities in the nation’s supply chain, particularly for medical supplies including personal protective equipment (PPE). In the early stages of the pandemic in the US, hospitals and other healthcare facilities were forced to ration vital PPE and bid for additional supplies at prices far above market value. Federal efforts to distribute PPE from the Strategic National Stockpile also were fraught with miscalculations, resulting in unequal and inequitable distribution. Writing in a STAT News opinion piece, U.S. Major General (retired) John Wharton, who most recently served as commanding general of the US Army Research, Development and Engineering Command at Aberdeen Proving Ground, proposes measures to help prevent similar disparities in future public health emergencies. First, the US federal government should create and fund a monitoring and dissemination network for PPE, medicines, and other medical supplies. Second, the US should increase domestic manufacturing of PPE and medical supplies to decrease reliance on overseas manufacturing capabilities. The ability to monitor, manufacture, and distribute PPE and other vital medical supplies when and where they are needed will better prepare the US against future stresses to its supply chain system.