October 6, 2022: Johns Hopkins COVID 19 Situation Report

COVID-19 Situation Report

Editor: Alyson Browett, MPH

Contributors: Clint Haines, MS; Noelle Huhn, MSPH; Amanda Kobokovich, MPH; Aishwarya Nagar, MPH; Christina Potter, MSPH; Matthew Shearer, MPH; Marc Trotochaud, MSPH; and, Rachel A. Vahey, MHS

CALL FOR APPLICATIONS Applications are now open for the Johns Hopkins Center for Health Security’s Emerging Leaders in Biosecurity (ELBI) Fellowship Class of 2023. ELBI inspires and connects the next generation of biosecurity leaders and innovators. This highly competitive, part-time program is an opportunity for talented career professionals to deepen their expertise, expand their network, and build their leadership skills through a series of sponsored events. Applications can be submitted through 11:59pm (ET) November 11, 2022. Learn more about eligibility requirements and application materials here: https://www.centerforhealthsecurity.org/our-work/emergingbioleaders/apply.html

UPCOMING TOWN HALL You are invited to a 2-day virtual town hall to learn about COPEWELL, a free, evidence-based tool that improves community resilience by helping identify gaps in recovery efforts and improve functioning before, during, and after disasters. The COPEWELL framework encourages local governments to partner with a variety of organizations—including healthcare providers, researchers, nonprofit organizations, and others—to holistically prepare and respond to disasters. Hosted by the Johns Hopkins Center for Health Security, the Texas State University Center of Excellence for Community Health and Economic Resilience Research (CHERR), and the Texas Rural Health Alliance, the town hall will be held October 11 and 13, 11:00-12:30pm ET. Register here: https://txstate.zoom.us/webinar/register/WN_ZIFHX4o8Q5SknBLpWSxbiw

EPI UPDATE The WHO COVID-19 Dashboard reports 617 million cumulative cases and 6.53 million deaths worldwide as of October 6. Global weekly incidence remained relatively steady at slightly more than 3 million cases for the fourth consecutive week, decreasing 2% compared to the previous week. Weekly incidence in Europe increased for the third consecutive week, up 18% over the previous week. All other regions reported decreasing trends. Global weekly mortality continued to decrease, for the seventh consecutive week, down 11% from the previous week. Last week’s total—8,491 deaths—was the lowest since the week of March 16, 2020.*

*The WHO dashboard notes that data from the Africa Region are incomplete.

UNITED STATES

The US CDC is reporting 96.3 million cumulative cases of COVID-19 and 1.06 million deaths. Daily incidence continues to decline, down to 44,414 new cases per day, the lowest average since April. Average daily mortality now appears to be decreasing steadily, down from a recent high of 505 deaths per day on August 12 to 330 on October 4.**

**Changes in state-level reporting may affect the accuracy of recently reported data, particularly over weekends. In an effort to reflect the longer-term trends, the numbers reported here may not correspond to the most recent dates.

Both new hospital admissions and current hospitalizations continue to exhibit downward trends, with decreases of 6.9% and 8.1%, respectively, over the past week. Both trends peaked around the end of July, approximately 1 week after the peak in daily incidence.

The BA.5 sublineage continues as the dominant strain in the US, accounting for 81.3% of sequenced specimens; however, its estimated prevalence has decreased for 4 consecutive weeks. Several other Omicron sublineages are exhibiting increasing trends over the past several months. Notably, the BA.4.6 sublineage is up to 12.8%, BF.7 is up to 3.4%, and BA.2.75 is up to 1.4%. Relative to the BA.5 sublineage, these estimates are low, but the increasing trends suggest that these subvariants may have some advantage over BA.5.

EMERGING SUBVARIANTS The SARS-CoV-2 virus continues to evolve, with multiple emerging sublineages of the Omicron variant of concern (VOC) poised to play a dominant role in the next surge. As noted above, several sublineages are increasing in prevalence in the US as the current dominant strain, BA.5, begins to wane. At this point, it is unclear if the next principal variant would be capable of evading immunity conferred by vaccination, including Omicron-specific booster doses, or prior infection with other variants, but researchers are already working to identify key mutations and project their impact. In contrast to previous surges, the forecasted fall/winter surge may not be driven by a single variant, as was the case with the Delta and Omicron surges in 2021 and earlier in 2022. In fact, WHO officials recently indicated that they are currently monitoring more than 300 Omicron sublineages.

Several of these sublineages are particularly concerning, including BQ.1 and BQ.1.1 that evolved from BA.5 and BA.2.275 and XBB that evolved from BA.2. The BQ.1 and BQ.1.1 sublineages are currently circulating in Europe, which could forecast a fall/winter surge in other Northern Hemisphere countries. All 4 of these sublineages exhibit resistance to existing treatments and vaccines, and the XBB sublineage, in particular, threatens to render existing vaccines ineffective. In addition to the risk of global spread of a vaccine-resistant vaccine, the decline in testing volume worldwide and barriers to including at-home test results in SARS-CoV-2 reporting systems could make surveillance problematic. And the general absence of COVID-19 protective measures (eg, physical distancing, mask use) could facilitate community transmission. Additionally, governments seem to be unwilling to commit additional funding to COVID-19 responses, including research on future vaccines and therapeutics, as evidenced in the US government’s struggle to secure funding for Project COVID Shield, the follow-on to Operation Warp Speed to develop advanced SARS-CoV-2 vaccines. The world is simply in a much different place than it was in 2020 and 2021, which elevates the threat from these emerging sublineages.

As opposed to more radical antigenic “shifts”—like those observed with the emergence of the Delta variant or the original Omicron variant—the new sublineages of the Omicron variant are exhibiting more subtle antigenic “drift.” This is similar to the evolution observed in annual seasonal influenza epidemics, although on a much shorter timeline. New sublineages appear to be acquiring many of the same mutations, in various combinations, which signals that they may be converging on a common set of traits. Despite the recent pattern, however, it is still possible that the virus could take a more substantial shift, which could result in the emergence of a new major variant with much different characteristics.

FALL/WINTER SURGE POTENTIAL Experts are keeping an eye on whether the United States will experience a surge in SARS-CoV-2 cases, hospitalizations, and deaths during the fall and winter seasons, a potential that looks increasingly likely.Several factors point to a forthcoming wave: the number of new cases is rising in Europe, and the US historically has followed that region’s trend; several emerging SARS-CoV-2 Omicron sublineages appear to be more capable of evading immune system protection and therapies, as discussed above; individual immunity—from vaccination or prior infection—continues to wane, primary vaccinations have stalled, and booster uptake is slow; and policy and behavioral changes have limited the positive impact of previously implemented mitigation measures, such as mask use and physical distancing.

Fifteen countries in Europe are reporting increasing cases.France is experiencing its eighth wave of COVID-19 andhospitals in the UK report resource constraints amid a new wave. New subvariants of SARS-CoV-2 that are evolutionary descendants of BA.2, BA.4, and BA.5 have emerged and are being tracked by scientists. It is still unknown whether one or more of these new strains will outcompete others and drive a fall or winter surge, but scientists are worried that these new sublineages may be able to evade current monoclonal antibody treatments and natural or vaccine-induced immunity.

Many experts stress that waning immunity could be one of the strongest predictors of a fall/winter surge in COVID-19 cases, especially if there is low uptake of new bivalent booster doses authorized in early September. In July, people aged 50 and older who had a primary series of vaccination and only one booster dose had 2 times the risk of dying from COVID-19 compared with individuals in the same age group who had a primary vaccination series and two booster doses targeting the original wild-type virus, showing the impact of continuous boosters. The new bivalent boosters targeting the original virus and the Omicron BA.4/BA.5 sublineages are expected to hold up similarly well and could help protect individuals from experiencing the most severe impacts of SARS-CoV-2 infection. Notably, however, only 7.6 million people have received an updated booster, according to the US CDC, and polling data from the Kaiser Family Foundation support increased efforts to improve messaging surrounding the new vaccines, including better communication about who is eligible to receive the shots.

Policy and behavioral shifts indicate that the US is eager to reach a post-pandemic state of normalcy even though 400-500 people are dying of COVID-19 daily. Most emergency protections established at the onset of the pandemichave been lifted, and government funds for vaccines, treatments, and testsare quickly dwindling. Many experts have cautioned against dropping COVID-19 mitigation efforts too soon.

Additionally, experts are nervous about the impact of any surge in cases on already stressed healthcare and hospital systems. Increases in demand for care—from COVID-19, influenza, or other illnesses—will challenge hospitals that are overloaded and currently experiencing a limited availability of healthcare workers, many of whom are burnt out, having been driven to the point of exhaustion. Public health preparedness and response strategies will need to reckon with these barriers sooner rather than later, as there is evidence COVID-19 cases are set to rise in the US.Data from the Massachusetts Water Resources Authority show that the amount of SARS-CoV-2 in the state’s wastewater is increasing, as are numbers of new COVID-19 cases in several states.

BIVALENT BOOSTER UPTAKE If 80% of eligible individuals aged 5 and older in the US receive an updated bivalent booster dose by the end of 2022, an estimated 90,000 COVID-19 deaths could be prevented and billions of dollars in health care costs could be saved, according to an updated analysis from the Commonwealth Fund. However, if booster vaccinations continue at their current pace, the nation could experience more than 1,000 deaths per day due to COVID-19 this winter, according to the report, which models several scenarios. Currently, between 400-500 people die each day due to the disease. Undoubtedly, vaccination has helped mitigate the burden of COVID-19, likely preventing millions of deaths and hospitalizations since vaccines became available in late 2020. However, vaccine uptake has stalled in the US, with 68% (225 million) of the total population having received a primary series and 49% (110 million) of those receiving a first booster dose. Around 37% (24 million) of eligible people aged 50 years and older have received a second booster dose, and only 7.6 million people have received an updated booster.

The White House and many public health officials are encouraging eligible individuals to receive SARS-CoV-2 vaccines and boosters, as well as influenza vaccinations, early this fall. After a relatively mild flu season last year, health officials are warning that a severe flu season in Australia could portend a similarly severe season in the US. According to a survey from the National Foundation for Infectious Diseases (NFID), only about half of US adult respondents plan to get a flu vaccine this season, and only one-third said they feel safe getting vaccinations against flu and COVID-19 simultaneously.

Notably, messaging around the COVID-19 vaccination campaign appears to be lacking, with guideline complexity possibly playing a role in confusion regarding eligibility. A recent poll from the Kaiser Family Foundation (KFF) found awareness of the new boosters is relatively modest, with only about half of adult respondents saying they had heard “a lot” (17%) or “some” (33%) about the new boosters, and 40% of fully vaccinated respondents said they were not sure whether the updated booster is recommended for them. Only about one-third of adults say they have already gotten a new booster or intend to do so “as soon as possible,” while two-thirds said they plan to “wait and see,” would get a booster only if required, would “definitely not” get a booster, or are not eligible. In a separate analysis, KFF notes that elevated COVID-19 death rates among older adults compared to younger adults through the summer was due in part to relatively lower booster uptake, compared with primary vaccination, and waning immunity. Another poll, the Forbes Health-Ipsos Monthly Health Tracker, shows 63% of adult respondents familiar with the new booster vaccine are “somewhat likely” or “very likely” to get the shot, with only 28% saying they do not plan to get boosted. As the nation heads into the colder months, vaccinations and boosters remain the best method for mitigating a potential COVID-19 surge this winter.

DISRUPTIONS FOR PEOPLE WITH DISABILITIES For many people in the US who have a disability, the COVID-19 pandemic exacerbated the inequities and disparities they already faced in accessing healthcare. According to a recently published study inHealth Affairs, adult Americans with disabilities experienced significant disparities in delayed and unmet need for medical care during the first year of the pandemic. The study shows that adults with a disability were much more likely than those without disabilities to report delaying medical care, not getting the medical care they needed for non-COVID-19-related issues, and not getting needed medical care at home from a nurse or other health professional because of the pandemic. These disruptions, as well as elevated rates of comorbidities that people with disabilities may experience, could have increased their risk for severe illness or death from COVID-19.

Several factors contributed to adults with disabilities delaying care during the beginning of the pandemic, including lack of access to technology and internet, financial insecurity, reduced availability of public transportation, or inaccessible COVID-19 risk communication formats. For many adults with disabilities who depend on home- and community-based services, pandemic-related disruptions to andlack of COVID-19 relief support for these programs was a significant barrier.The pandemic has exposed health inequities and disparities that people with disabilities—especially those who experience multiple and intersecting forms of marginalization and discrimination—have faced for a long time.

Despite these notable barriers, several inclusive practices and technologies emerged as the US population tried to adapt to pandemic-related disruptions. When schools initially shifted to virtual learning modalities, some teachers implemented creative solutions to support students with disabilities. At a high school in Indiana,teachers provided supportive technologies for students with visual impairments and leveraged the intuitive accessibility of iPads and digital books. Several broad measures implemented during the onset of the pandemic, such as pivoting to remote or virtual work and learning, providing hazard pay for frontline workers, less punitive action against people who needed to cancel tickets or miss work to stay at home due to an illness, holding online events with closed captions and American Sign Language interpretation, and intentional shopping hours for immunocompromised people, allowed people with disabilities and others to adapt to pandemic-related disruptions.

As many in the US move on from the pandemic, people with disabilities are anxious aboutbeing excluded and left behind. This is especially concerning becauseCOVID-19 has increased the number of people with disabilities in the US, as discussed below, thereby necessitating broad policy changes that center disability and help ameliorate individuals’ lived experiences.

LONG COVID/PASC Most US adults experiencing post-acute sequelae of SARS-CoV-2 (PASC), more commonly known as long COVID, have symptoms that interfere with day-to-day activities, according to new data from the US CDC’s National Center for Health Statistics. As of September 26, 14.2% of the more than 50,000 survey respondents said they had experienced long COVID—which is characterized by a host of symptoms including shortness of breath, fatigue, and cognitive difficulties—at some point during the pandemic. Of those with long COVID, 81% said they had some limitations in their daily activities compared to their activities prior to infection. Notably, 1 in 4 adults with long COVID reported significant limitations, with the proportion jumping to nearly 40% of Black or Hispanic/Latino respondents, as well as those already living with disability. The data are limited to adults and do not provide information on whether respondents are vaccinated or the severity of their SARS-CoV-2 infection. Nearly 24 million adults in the US are estimated to currently have long COVID, and researchers are working to define the condition, describe underlying causes, and search for effective treatments. Long COVID is, and likely will remain, a significant cause of disability in the US.

Move over oasis: New multimillion-dollar travel center coming to Belvidere

Rockford Register Star

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Move over oasis: New multimillion-dollar travel center coming to Belvidere

Chris Green, Rockford Register Star - 8h ago

BELIVIDERE — Construction activity is underway on 43 acres for a multimillion-dollar retail development that includes extending Crystal Parkway from Tripp Road to the Interstate-90 exit at Genoa Road.

The development will feature a travel center with a 12,000-square-foot convenience store with three restaurants — Jimmy John's, Wing Stop, and Smoothie King — and a 16-vehicle fuel bay with parking for 65 semi-trucks.

Co-developer Mike MacKinnon of The Heidner Family Office in Hoffman Estates said the venture has been nearly two years in the making.

"It's very exciting," he said. "North of Crystal Parkway we have three retail outlets and right behind that we're in talks right now with several hotel operators who are interested in locating there."

MacKinnon said the first phase of the development is extending Crystal Parkway from Tripp Road to Genoa Road. "This is going to extend the city's gateway all the way to the interstate," he said.

"The fuel center should be operational in the summer of 2023 and the retail development will be completed at the end of 2023 or early 2024 and the hotel will be after that."

MacKinnon said the overall investment is north of $20 million and will bring temporary construction jobs and permanent full- and part-time jobs.

'Staggering' amount of traffic

MacKinnon and Belvidere's Community Development Planner Gina DelRose said the location is ideal because of its visibility and proximity to the interstate to the south and the Walmart Supercenter to the north.

While the new travel center will be close to the Belvidere Oasis, DelRose said there is more than enough vehicle traffic to support the new development.

"The oasis is limited on space," DelRose said. "They can't expand."

She also spoke of an Illinois Department of Transportation freight study that is expected to be released this month and called the amount of daily semi truck freight traffic "staggering."

"If you took every semi truck in the country and drove through Illinois twice, that's how much traffic we have," DelRosa said. "So yeah. We have plenty of semis to share for the new truck stop."

Continued growth in Belvidere

The travel center development is coming on the heels of General Mill's groundbreaking in August for a state-of-the-art 1.3 million-square-foot distribution center at 1210 Irene Road.

Pamela Lopez-Fettes, executive director of Growth Dimensions, a public-private organization in Belvidere that works to ignite economic development throughout the region, worked hand-in-hand with the city to help bring both developments to fruition.

She said Belvidere has a "business friendly" environment noting the city passed the travel center development with incentives "that include some sales tax support."

Lopez-Fettes also said the travel center development is in an enterprise zone.

"So, they get some offset at cost on purchasing materials, building permit fees as well as property taxes," she said.

Chris Green: 815-987-1241; cgreen@rrstar.com; @chrisfgreen

This article originally appeared on Rockford Register Star

Above is from:  Move over oasis: New multimillion-dollar travel center coming to Belvidere (msn.com)

September 27, 2o22: Johns Hopkins COVIF 19 Situation Report

COVID-19 Situation Report

Editor: Alyson Browett, MPH

Contributors: Clint Haines, MS; Noelle Huhn, MSPH; Amanda Kobokovich, MPH; Aishwarya Nagar, MPH; Christina Potter, MSPH; Matthew Shearer, MPH; Marc Trotochaud, MSPH; and, Rachel A. Vahey, MHS

SITUATION REPORT UPDATES The Center’s COVID-19 Situation Report will not be published on September 29 to allow our staff to engage in a team-building event. Additionally, beginning in October (next week!), we will shift to a once-a-week publication schedule. You can expect the report in your inbox around 1pm ET each Thursday. We truly appreciate your continued readership and support.

Support Our Work

UPCOMING WEBINAR The COVID-19 pandemic highlighted disparities in medical readiness between urban and rural communities. On Thursday, September 29, at 1pm ET, join the Capitol Hill Steering Committee on Pandemic Preparedness & Health Security for a webinar titled, Leaving No One Behind: How Can the Federal Government Help Meet the Unique Health Needs of Rural Communities in Pandemics. The session will dive into the unique health needs of US rural communities and how the federal government can aid these communities to be better prepared for a future pandemic. To register, visit:https://jh.zoom.us/webinar/register/WN_ldw-z_72QGik1qv1jC89GQ

CALL FOR PAPERS There is an opportunity to integrate Global Catastrophic Biological Risks (GCBRs) into pandemic preparedness policy and practice. In 2023, Health Security will devote a supplement to GCBRs.  We encourage submissions of original research articles, case studies, and commentaries that discuss lessons learned from the COVID-19 pandemic response and/or key policy and technology advances that could prevent or better prepare for a more severe, globally catastrophic infectious disease pandemic. Deadline is October 3, 2022. Learn more: https://www.centerforhealthsecurity.org/our-work/journal/call-for-papers/index.html

PANDEMIC PREDICTIONS Recent increases in COVID-19 cases in the UK could signal that the US is heading into a fall and winter COVID-19 surge. Historically, the US lags the UK in case trends by about one month, and the UK trend began rising the week of September 17. Some models predict US case trends will continue to decrease into October before beginning to rise, and while current predictions suggest a big increase in infections, the infection-detection rate likely will remain low due to declines in testing. Because the US population has some underlying immunity, and most experts agree the country has the pandemic under control, the death toll is expected to be rather modest.

But this modeling is based on the Omicron BA.5 subvariant, and the emergence of a new variant or subvariant could upend these predictions, particularly if there is a reduction in cross-variant immunity. BA.5 continues to account for the majority of new COVID-19 cases in the US (83.1%), but BA.4.6 (12%) and BF.7 (2.3%), an offspring of BA.5, are beginning to show growth advantage over BA.5. BF.7 has an additional genetic mutation in the spike protein compared with BA.5, which could reduce the efficacy of the monoclonal antibody treatment Evusheld, one of the few remaining therapies effective against BA.4 and BA.5. The mix of variants in the UK appears to be about the same as the US, although epidemiologists are watching to see whether emerging variants such as BQ.1.1 and BA.2.75 grow in proportion.

US President Joe Biden's declaration that the COVID-19 pandemic is "over" during a "60 Minutes" interview on September 18 raised eyebrows among many experts, most of whom agree that while some countries are in a better place than during the first year of the pandemic—exemplified by the fact that many in the US and elsewhere are returning to their pre-pandemic lifestyles—COVID-19 should remain an urgent priority. In the US, around 400 people die every day due to COVID-19, more than triple the average number who die from influenza.

The declaration by President Biden came shortly after WHO Director-General Dr. Tedros Adhanom Ghebreyesus stated that the end of the pandemic was "in sight." Both statements drew condemnation from WHO Senior Advisor Dr. Bruce Aylward, who called on high-income countries comfortable with the state of the pandemic within their borders to increase aid to low- and middle-income countries (LMICs) that are still struggling to get COVID-19 under control and gain access to vaccines, therapeutics, diagnostics, and other tools. Additionally, allowing the SARS-CoV-2 virus to maintain footholds in LMICs and elsewhere could lead to new variants with the ability to escape immunity. There remains much work to do, experts agree, as many health disparities between high-income nations and LMICs persist and will only get worse if aid is reduced or cut off. While some may feel COVID-19 is under control in places like the US, the pandemic is not over.

US CDC INFECTION CONTROL GUIDANCE The US CDC published changes to its guidance on infection prevention and control recommendations for healthcare personnel during the COVID-19 pandemic. One of the major alterations includes ending the overarching recommendation that everyone wear masks in nursing homes and hospitals. Previously, the guidance asked that everyone wear appropriate masks and respirators in these facilities, but the update only maintains that recommendation in communities experiencing high levels of transmission. The CDC said the change was made to reflect the high levels of immunity derived from vaccinations and prior infection, as well as the availability of effective treatments.

Nevertheless, elderly populations have been hit hard by the pandemic and remain among the most vulnerable. There are concerns that the new recommendation could make life even more difficult for elderly and immunocompromised people to safely navigate healthcare settings, potentially leading to fewer care options and increased stress and isolation among populations that already have suffered greatly. Additionally, many public health experts highlighted the importance of masking in the US as the nation heads into its fall and winter seasons and predictions of a new surge in COVID-19 cases. Appropriately worn masks and respirators serve as source controls that can prevent transmission during a season when many people are gathering indoors, but public appetite for new mask mandates is at an all-time low. The CDC’s guidance leaves the responsibility to take actions to protect vulnerable populations in individuals’ hands.

UPDATED BOOSTERS FOR YOUNGER CHILDREN Updated bivalent booster vaccine doses for younger children in the United States likely will be available before the end of this year. On September 23, Moderna announced in a tweet that the company is requesting emergency use authorization (EUA) from the US FDA for its vaccine booster bivalent vaccine that targets both the original strain of SARS-CoV-2 and the BA.4/5 subvariants of Omicron for adolescents aged 12 to 17 years and children aged 6 to 11 years. The company’s application for the youngest children, ages 6 months to under-6 years, is expected to be completed by year's end.

On September 26, Pfizer-BioNTech announced they have completed a submission to the FDA requesting EUA for the companies' Omicron-adapted bivalent booster for children aged 5 to 11 years. The companies also have begun a Phase 1/2/3 study to evaluate the safety, tolerability, and immunogenicity of different doses and dosing regimens of bivalent vaccine in children ages 6 months through 11 years of age. Additionally, they expect to file for marketing authorization of the bivalent booster for children aged 5-11 with the European Medicines Agency (EMA) in the coming days. Bivalent boosters from both Moderna and Pfizer-BioNTech are already authorized for adults and individuals aged 12 years and older, respectively, in the US. The FDA could make a decision on bivalent boosters for younger children before the next meeting of the US CDC's Advisory Committee on Immunization Practices (ACIP), scheduled for October 19-20.

GLOBAL VACCINE SUPPLY Last year, the US government committed to providing 1.1 billion doses of the Pfizer-BioNTech SARS-CoV-2 vaccine to low- and middle-income countries (LMICs). Last week, however, Pfizer and the US government agreed to lower the number of Pfizer-BioNTech SARS-CoV-2 vaccine doses going to LMICs this year, with Pfizer agreeing to reduce its delivery commitment from 1 billion doses to 600 million doses. Pfizer said while it can meet its previous 1 billion dose commitment, the revised commitment reflects reduced demand for vaccine doses in LMICs, barriers in administration, and vaccine hesitancy, and provides more time for the US and its partners to address delivery and administration challenges. The US will retain an option to purchase the additional 400 million doses for its international program after this year. Under the US contract, Pfizer previously delivered more than 400 million vaccine doses to 79 countries through the COVAX initiative.

During earlier stages of the COVID-19 pandemic, many experts criticized high-income countries for hoarding vaccines and other pandemic supplies, thereby perpetuating inequitable access to lifesaving supplies during the height of the pandemic. The COVAX program was designed to ensure equitable access to vaccines and has donatedmore than 1.7 billion COVID-19 vaccine doses to 146 countries. While the program ramped up, demand for SARS-CoV-2 vaccines outmatched the supply of approved products and vaccine manufacturers prioritized bilateral customers. Pfizer executives shared that the global effort to develop, manufacture, and distribute vaccines during the COVID-19 pandemicrevealed important lessons around how to configure supply chains and design tighter logistics strategies for the future. While some countries are declaring an end to the COVID-19 pandemic, supply chain issues persist in many parts of the world, and only 24% of people in low-income countries have received at least one dose of vaccine. The shift in attention away from the pandemic was highlighted last week during the United Nations General Assembly (UNGA) meetings, where discussions about vaccine equity remained notably absent.

Despite slowing vaccine donation efforts, the US government and Pfizer remain committed to providing other critical supplies to LMICs. On the sidelines of the UNGA at the COVID Global Action Plan Ministerial Meeting, the US government announcedplans to establish a clearinghouse of medical supplies to help other countries combat COVID-19, expand its program to distribute therapeutic drugs in 10 countries, expand access to medical oxygen, train healthcare workers in LMICs, and introduce early testing systems that can help healthcare workers identify COVID-19 patients who qualify for treatment. Additionally, Pfizer recentlyannounced its intent to supply up to 6 million treatment courses of Paxlovid, its COVID-19 oral treatment, to the Global Fund as part of its COVID-19 Response Mechanism (C19RM). Depending on local regulatory approvals, 132 Global Fund-eligible LMICs will be able to procure Paxlovid beginning this year. These commitments are a crucial component of a global response to COVID-19, which exposed and continues to worsen concerning gaps in global pandemic preparedness and response systems.

CRYPTIC LINEAGES Nature examines the work of a team of scientists using wastewater surveillance to hunt for the next SARS-CoV-2 variant. In January 2022, the team identified a lineage that shared several mutations with the predominant Omicron variant of concern (VOC) but came from a different branch of the viral family tree. They then traced the cryptic lineage back to one Wisconsin business employing fewer than 30 people. None of the employees tested by nasal swab have shown signs of the lineage, leading the researchers to suspect an individual might be harboring the virus in their gut. While it does not appear the cryptic lineage is spreading, it has gained additional mutations since first being identified. Even if they do not identify the Wisconsin individual in which the virus is evolving, the researchers hope their sleuthing will inform future efforts to identify, track, and forecast emerging SARS-CoV-2, or other virus, variants.

September 19, 2022: Johns Hopkins COVID 19 Situation Report

COVID-19 Situation Report

Editor: Alyson Browett, MPH

Contributors: Clint Haines, MS; Noelle Huhn, MSPH; Amanda Kobokovich, MPH; Aishwarya Nagar, MPH; Christina Potter, MSPH; Matthew Shearer, MPH; Marc Trotochaud, MSPH; and, Rachel A. Vahey, MHS

“PANDEMIC IS OVER” In an interview with “60 Minutes” at the North American International Auto Show in Detroit, Michigan,US President Joe Biden said he believes that the COVID-19“pandemic is over” while simultaneously acknowledging that the disease continues to be a “problem.” Notably, a White House team that reviewed the transcript of the interview, which aired September 18 but was taped last week, did not alert its COVID-19 response team about the declaration,leaving senior federal health officials surprised and without a coordinated response for the immediate reactions. President Biden had not originally planned to make headlines on COVID-19, nor had he discussed an end to the pandemic with his health advisors. The day after the interview aired,US HHS Secretary Xavier Becerra supported the president’s comments, saying that effective vaccines, tests, and treatments put the nation on a better path than earlier in the pandemic and noted the administration is reviewing whether it will renew the national declaration of a public health emergency.

But President Biden’s comments drewswift and sharp reactions from public health experts and appeared tofurther divide opinions over when and how the nation will move out of a pandemic state and into one ofendemicity. Some experts supported the president’s comments, noting that whileCOVID-19 should continue to qualify as a top national priority, much of the nation is settling into a new way of life. Other experts fear that President Biden’s declaration furthermuddles the messaging surrounding the pandemic and comes at aninopportune time, when the US government is rolling out new bivalent vaccine boosters and asking the US Congress for additional emergency spending. Additionally, virologists are seeing signs of viral resurgence, underlining the enormous amount of uncertainty surrounding the future.

While there areno clear markers to the end of a pandemic, some experts point to 2 ways to determine when an outbreak emergency is over: by looking at what the disease is doing physically and psychologically to a population. To be sure, President Biden’s comments reflect a general national sentiment that people want to move on from the pandemic and that the situation differs significantly from 2 years ago. Schools are open;air travel has returned to pre-pandemic levels; workers arereturning to offices at the highest rates since the start of the pandemic, although1 in 3 say they fear infection by working in offices; and COVID-19testing labs and at-home test manufacturers are downsizing, but primarily due to a lack of funding.

However,many, including White House Chief Medical Advisor Dr. Anthony Fauci, are worried thenation is not where it needs to be in order to “live with the virus.” The US continues torecord more than400 daily deaths, and the world countsmore than 1,600 deaths each day. Notably, this means the US accounts for nearly 25% of the worldwide daily COVID-19 mortality, despite representing only 4% of the global population. A significant portion of the US population remains unvaccinated or under-vaccinated, and therefore at elevated risk of severe disease and death. Nationally, 68% of the population has received a primary vaccine series but only35% of those over age 5 have gotten a first vaccine booster dose. The president’s remarks couldfurther hinder efforts to increase vaccination and booster rates ahead of what many expect will be a surge in cases over the winter. Additionally, the pandemic has had crippling health, social, and economic impacts on essential workers and vulnerable populations, such as those who are immunocompromised, and on the estimated 18-23 million US residents who are suffering the long-term physical and mental health effects oflong COVID.

President Biden’s remarks also likely will undercut his administration’s efforts to procure additional emergency spending for COVID-19. The White House has requested US$22.4 billion from the US Congress, but leading Republicans, who werealready skeptical about authorizing additional funding, said the president’s commentsessentially shut the door on negotiations as well as raise questions about other pandemic-related measures. Without additional funds for vaccine, treatment, and diagnostic supplies, or for research into next generation vaccines that could prevent SARS-CoV-2 transmission, the burden to pay for pandemic-related tools and stop chains of transmission will shift to the US public, and it remains to be seen whether federal and state policymakers will learn lessons from this pandemic in order to strengthen public health infrastructure to prepare for the next.

US VACCINATION CAMPAIGN The US Department of Health and Human Services last week released a video advertisement to encourage people to get updated SARS-CoV-2 vaccine booster shots. The ad specifically highlights those who are aged 50 and older, and shares the importance of getting the updated, bivalent vaccines, which are expected to provide additional protection against currently circulating SARS-CoV-2 Omicron subvariants. More than 200 million people are eligible for the new vaccines, however demand has dropped considerably with each new round of shots. More than half of people eligible for previous boosters never got them. Nevertheless, several pharmacies and hospitals in California, Hawaii, and Washington, DC, have reported running out of doses of the updated Moderna booster but expect additional supplies soon.

Additionally, several reports have raised concerns over the potential for vaccine administration errors, particularly among children. While there is no evidence vaccine mix-ups have caused more severe adverse events, the complexity involved in keeping straight up to 11 different vaccine brands and formulations has led the US CDC to produce visual guides for vaccine administrators. The potential for errors further undercuts parents’ already low interest in vaccinating their young children. Only about 410,000 children aged 5 and younger have been fully vaccinated since the vaccines became available for this age group in June, according to CDC data. The number of COVID-19 deaths among children is low, but scientists remain concerned about possible long-term complications of COVID-19 among children. Many physicians, and parents, have cited failures among government and local public health agencies to adequately promote the vaccine, communicate about its availability, and debunk circulating myths. Some health officials are concerned that hesitancy to vaccinate children against COVID-19, as well as other diseases, could lead to future outbreaks of other childhood infections.

Public health experts had hoped that another vaccine option—the adjuvanted protein-based SARS-CoV-2 vaccine from Novavax that uses a more traditional platform—would help win over those who were hesitant to receive the newer mRNA-based vaccines. But since it was authorized in July, uptake remains low, with only 6,278 people fully vaccinated using the Novavax vaccine. Outside of the US, the Novavax vaccine has been approved in 38 other countries, including in Japan and Australia, which each recently approved the vaccine for use as a booster.

EU EMERGENCY SUPPLY CHAIN POWERS The European Commission has shared a proposed rule that would make EU Member States prioritize the production of key goods and services to preserve supply chains in a crisis. The Single Market Emergency Instrument would create a crisis governance framework to prevent market fragmentation, drawing on lessons from the COVID-19 pandemic. Among the interventions available to the European Commission, breaking contracts to facilitate the production and stockpiling of critical products would be an option, as well as repurposing production lines and facilitating expansion to prevent bottlenecks like those experienced during the COVID-19 pandemic and the Russian invasion of Ukraine. The emergency powers of the proposal aim to reorganize supply chains as quickly as possible and support the increase and availability of crisis-relevant goods. The proposal includes fines up to 300,000 euros for companies that share incorrect or misleading information. The effort, which echoes similar efforts in the United States and Japan, will likely face pushback from businesses concerned with the expanded power the ruling is overreaching and intrusive.

VACCINE PRODUCTION IN AFRICA Amid slowing global demand for SARS-CoV-2 vaccines, the world’s largest producers of vaccines for COVID-19—Pfizer-BioNTech and Moderna—continue to face pressure to allow low- and middle-income countries (LMICs) to produce their vaccines after much of the supply was purchased by high-income countries. Under a fill and finish agreement with Pfizer-BioNTech, the South Africa-based Biovac Institute, which is partly owned by the South African government, recently produced its first batch of the companies’ vaccine. The doses, the first of Pfizer-BioNTech’s shots to be produced in Africa, will undergo regulatory review and additional batches are expected to be commercially available next year. Aspen Pharmacare, which is authorized to fill and finish vials of the J&J-Janssen SARS-CoV-2 vaccine under its Aspenovax brand for distribution in Africa, earlier this year cautioned it might have to halt its vaccine production lines because it had not received a single order. At the end of August, Aspen announced it signed a deal with the Serum Institute of India to manufacture and sell 4 Aspen-branded vaccines for Africa, effectively keeping the production lines open. Moderna reportedly is seeking a partner on the continent to produce its SARS-CoV-2 vaccine.

In related news, Moderna has allowed the use of its vaccine in clinical trials to test a shot developed by Afrigen Biologics & Vaccines, another South African biotechnology company working with the WHO as part of its mRNA Vaccine Technology Transfer Hub. Afrigen is working to develop mRNA-based SARS-CoV-2 vaccines to increase production and access for LMICs. Instead of supplying the vaccine directly, Moderna approved the Medicines Patent Pool to provide its vaccine to Afrigen for use in early-stage clinical trials; Pfizer-BioNTech refused a similar request because the companies did not see the need as urgent. Afrigen expects to begin human trials of its mRNA vaccine candidate by May 2023. Additionally, Moderna last week said it is open to supplying the Chinese government with its vaccine, although no final decision has yet to be reached. China has not authorized the use of any foreign-made SARS-CoV-2 vaccines, relying on several domestically produced shots.

TREATMENT ACCESS & UPDATES Amid heightened demand from low- and middle-income countries (LMICs) for expanded access to COVID-19 therapeutics, little progress has been made at the World Trade Organization (WTO) toward reaching an agreement to include COVID-19 therapeutics and diagnostics in a limited deal reached earlier this year to temporarily waive patents on SARS-CoV-2 vaccines. High-income countries, including the UK, Switzerland, EU Member States, and the US, as well as pharmaceutical companies, appear opposed to extending the deal to treatments and tests by the end-year deadline.

Separately, a program aimed at bringing oral COVID-19 antivirals to 10 LMICs in sub-Saharan Africa and Asia—Ghana, Kenya, Laos, Malawi, Nigeria, Rwanda, South Africa, Uganda, Zambia, and Zimbabwe—recently launched. With support from nonprofit organizations and other partners, the COVID Treatment Quick Start Consortium will provide Pfizer’s Paxlovid (nirmatrelvir-ritonavir) through pilot programs to evaluate the best ways to implement test-to-treat programs in areas with limited healthcare resources and infrastructure.

In other treatment news, the European Medicines Agency (EMA) last week extended its authorization of AstraZeneca’s preventive COVID-19 therapy Evusheld (tixagevimab co-packaged with cilgavimab) as a treatment for the disease among adults and adolescents with COVID-19 who do not need supplemental oxygen but who are at increased risk of disease progression. Last month, Japan became the first country to approve the monoclonal antibody for COVID-19 treatment. Several nations already have authorized Evusheld as a preventive therapy among people with compromised immune systems who do not respond to vaccination in several nations, including the US.

Additionally, the WHO last week strongly advised against the use of 2 different antibody therapies—sotrovimab as well as casirivimab-imdevimab—to treat patients with COVID-19 because they have limited clinical activity against currently circulating viral variants. The US FDA previously pulled or limited the use of the drugs, and some experts criticized the WHO for waiting to make the updated recommendation. The WHO expanded its conditional recommendation for the antiviral remdesivir to cover patients with severe COVID-19 and those with non-severe infections but who are at high risk of hospitalization.

Only a handful of COVID-19 therapeutics remain useful against currently circulating SARS-CoV-2 strains. While researchers quickly developed 4 effective treatments for hospitalized COVID-19 patients in the year between January 2020 and February 2021, no new therapies for hospitalized patients have been authorized since February 2021, raising concerns about whether treatment advancements have stalled.