Thursday, April 13, 2023

April 13, 2023: Johns Hopkins COVID 19 Situation Report

COVID-19 Situation Report

Weekly updates on COVID-19 epidemiology, science, policy, and other news you can use.

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Announcements

NEW JOURNAL ISSUE The March/April 2023 issue of the Johns Hopkins Center for Health Security journal Health Security is now online. You can find it here:https://www.liebertpub.com/toc/hs/21/2

In this issue

> White House launches US$5 billion program to accelerate COVID-19 vaccine, treatment development in partnership with private sector

> US President Biden signs resolution ending COVID-19 national emergency; public health emergency set to expire on May 11

> US FDA expected to authorize additional bivalent booster dose for older adults, people with compromised immune systems

> Adults self-reporting post-COVID condition more likely to experience trouble accessing healthcare than people without condition

> Study highlights correlation between obesity, COVID-related mortality; more US Army troops developed obesity during pandemic

> Multiple recent studies examine maternal, newborn morbidity, mortality in relation to COVID-19

> What we're reading

> Epi update

White House launches US$5 billion program to accelerate COVID-19 vaccine, treatment development in partnership with private sector

The Biden administration on April 10 announced it is launching a US$5 billion-plus program to accelerate the development of new COVID-19 vaccines and treatments, with a focus on 3 goals: creating long-lasting monoclonal antibodies; speeding the development of vaccines that provide mucosal immunity, such as those administered nasally; and bolstering efforts to develop pancoronavirus vaccines that could protect against current and future SARS-CoV-2 variants as well as other known and emerging coronaviruses. The initiative, dubbed “Project NextGen,” will operate in a similar way to the successful “Operation Warp Speed” program—an US$18 billion initiative that supported the rapid development and distribution of COVID-19 vaccines—by using a cross-cutting government approach and partnering with private sector companies to achieve its goals.

According to administration officials, funding for the initiative, which will be based at the Department of Health and Human Services (HHS), is coming from money saved from contracts costing less than originally estimated. HHS shifted funds intended for COVID-19 testing and other priorities, possibly raising questions from Republicans about why those funds were available, after several funding requests for the program and other COVID-related efforts were refused by the US Congress.

Some of the lab work to develop new therapies and vaccines is already underway; for example, researchers posted a preprint to bioRxiv this week identifying 2 human monoclonal antibodies that neutralize all current SARS-CoV-2 variants of concern (VOCs) by conformational locking. The federal government is working to identify potential private sector partners for Project NextGen, and there is no timetable for when any of the products might come to market. Though some experts feel the program’s goals are unattainable, others say that the unprecedented pace of advancements of vaccine development and testing during the pandemic could usher in a golden era of vaccines, setting the stage for further breakthroughs on everything from other respiratory diseases to cancer.

US President Biden signs resolution ending COVID-19 national emergency; public health emergency set to expire on May 11

US President Joe Biden signed a resolution on Monday that immediately ended the COVID-19 national emergency. The national emergency was first declared in March 2020 under the Trump administration and was set to expire in May. The US House Republicans passed the measure in February, and the US Senate passed it last month with a bipartisan 68-23 vote. The national emergency allowed the federal government to take control over pandemic response and support the country’s health and welfare systems; many measures have already been phased out. Some healthcare policies will be changing with the end of the national emergency, but a separate and more consequential public health emergency regarding COVID-19 will remain in effect until May 11.

Repercussions of ending the national emergency may not be strongly felt across the country; however, once the public health emergency ends in May, many uninsured Americans will lose medical- and social-program support permitted under the emergency and face out-of-pocket costs for COVID-19 treatments, vaccines, and at-home tests. Recent polling reflects the complex feelings Americans have toward ending the emergency and returning to normal life, or a new normal, post-COVID.

US FDA expected to authorize additional bivalent booster dose for older adults, people with compromised immune systems

In the coming weeks, the US FDA is expected to authorize second bivalent COVID-19 vaccine booster doses for people who are at least 65 years old or have weakened immune systems in an effort to protect those who are at higher risk of severe disease. Eligible individuals could receive the additional dose at least 4 months after their first shot of the bivalent booster, which targets the SARS-CoV-2 Omicron subvariants BA.4 and BA.5 as well as the original, wild-type coronavirus. The policy change likely will be “permissive,” meaning individuals will be expected to consult with their healthcare providers about whether to get another dose. The US CDC is expected to quickly endorse the shots, according to officials speaking to media on the condition of anonymity.

Last month, the CDC upheld its recommendations that only one bivalent dose is needed for now. Only 16.7% of the US population has received a first dose of the updated booster. Experts are divided over whether or how often healthy adults should get boosters, but more consensus exists that older adults and people with compromised immune systems should get them more often, as protection wanes over time. And although the bivalent booster formulation available now targets Omicron BA.4 and BA.5, the shots are associated with a lower risk of infection or severe infection with the BQ.1–BQ.1.1 and XBB–XBB.1.5 subvariants, the latter of which currently account for most infections in the US.

Adults self-reporting post-COVID condition more likely to experience trouble accessing healthcare than people without condition

According to an April 10 study published in JAMA Network Open, 22.5% of adults self-reported experiencing post-COVID condition (PCC)—commonly known as long COVID and defined for this study as experiencing symptoms more than 4 weeks after first having COVID-19 that were not explained by another condition or factor—and were more likely to have difficulty getting and paying for healthcare compared to adults without PCC or those never diagnosed with COVID-19. They attributed their unmet needs to healthcare being too costly (27%), inability to get a timely appointment (22%), difficulty getting health plan care authorizations (16.6%), and difficulty finding doctors who accept new patients (16.4%). Moreover, nearly 14% of adults found it challenging to communicate with payers about the cost of care, their network, or the services that their health plans covered. These unmet health needs and lack of access to healthcare may reflect a few obstacles: PCC treatments are still vaguely defined; insurers struggle to identify how to authorize and reimburse PCC treatments; knowledge about how to manage PCC is limited; and social determinants of health may widen preexisting health disparities among survey participants. This ambiguity around defining and characterizing long COVID and PCC makes it difficult for people to seek much-needed treatment.

Though it is difficult to identify why some people who are infected with SARS-CoV-2 experience long COVID while others do not, a growing body of evidence indicates that a persistent, active viral infection with SARS-CoV-2 may drive PCC by lingering long after an initial infection. Fresh concerns have emerged around the long-term prognosis for children and teenagers experiencing long COVID, some of whom suffer from severe symptoms. Some clinicians question whether the condition is real, revealing a need to raise awareness that between 4% and 25% of kids who get COVID-19 develop long COVID, and that it is a real condition. Regardless of patient symptoms and characteristics, experts recommend using patient-centered communication and empathy as a starting point when identifying treatments for people with PCC.

Study highlights correlation between obesity, COVID-related mortality; more US Army troops developed obesity during pandemic

A study published in Scientific Reports this week analyzed data from 142 countries and found a statistically significant positive association between COVID-19 mortality and the proportion of obese individuals in the adult population, regardless of income group or demographic factors such as median age, proportion of elderly, and/or proportion of females. The estimated elasticity of COVID-19 mortality with respect to the proportion of obese individuals was highest in high-income countries; on average, every 1% point increase in the proportion of obese individuals contributed to an additional 1.5% points increase in COVID-19 mortality in high-income countries. The positive association between obesity and COVID-19 mortality remained robust even when considering age, gender, and income.

In related news, a retrospective cohort study of active duty US Army soldiers showed that nearly 10,000 of the nearly 192,000 soldiers included in the study developed obesity between February 2019 and June 2021, pushing the rate to nearly a quarter of the troops studied. Higher rates of obesity could result in decreased health of the US Armed Forces, as overweight and obese troops are more likely to be injured, less likely to endure the physical demands of their jobs, and at risk of missing more work days.

Multiple recent studies examine maternal, newborn morbidity, mortality in relation to COVID-19

The US has the highest maternal mortality rate of developed countries, and the rate rose during the COVID-19 pandemic, disproportionately impacting racial and ethnic minorities and those in rural areas and small cities. Several recent studies examined COVID-19’s effects on maternal and newborn morbidity and mortality.

  • The mortality risk of pregnant patients with COVID-19 at delivery between March 2020 and December 2020 was 14 times higher than those who were not infected with SARS-CoV-2, according to a new analysis published in JAMA Network Open by researchers from the University of Southern California. Existing risk factors for severe COVID-19, such as high blood pressure, cholesterol, and diabetes, also made pregnancy higher risk, with social determinants of health and discrimination also playing a role in the disparity.
  • A booster (third) dose of the Pfizer-BioNTech mRNA COVID-19 vaccine administered during pregnancy was associated with a 53% reduction in the risk of infant hospitalization due to COVID-19 during the first 120 days of life, compared to infants whose mothers received 2 doses, according to a study published in Nature Medicine. The study—conducted in Israel and including infants born between August 24, 2021, and March 15, 2022—also found that shorter durations between COVID-19 vaccinations and infant delivery were associated with greater immune protection. The study’s results highlight the importance of maternal vaccination for newborn health and may support women’s decisions to be vaccinated and, thereby, improve vaccination uptake rates among pregnant women, the researchers note.
  • Infants born to women who had asymptomatic or mild COVID-19 disease during pregnancy did not show any neurodevelopmental delays compared to infants with no exposure to SARS-CoV-2, according to a study conducted by researchers from Columbia University and published in JAMA Network Open. The study included 407 infants aged 5 to 11 months old from New York City, Salt Lake City, and Birmingham, Alabama, and involved telehealth assessments of the infants in their home environments that took place between March 2021 and June 2022. Almost one-third (112) of the infants were exposed to SARS-CoV-2 in utero, with 25% exposed to asymptomatic maternal infection and 74.5% exposed to symptomatic maternal infection, and the researchers found no significant differences in infants exposed to the virus in utero and those with no exposure. The authors concluded that these findings offer helpful information for pregnant individuals who might contract COVID-19 during pregnancy, but further studies with longer-term follow-up are still needed.
  • Notably, however, researchers from UHealth–University of Miami Health System and the University of Miami Miller School of Medicine recently published a case study in Pediatrics showing that SARS-CoV-2 breached the placenta and caused brain damage in 2 newborns. The infants initially tested negative for the virus at birth but had significantly elevated SARS-CoV-2 antibodies detectable in blood, indicating that either antibodies crossed the placenta, or passage of the virus occurred and the immune response was the infant's. Both infants experienced seizures, small head sizes, and developmental delays, and one died at 13 months of age. This is the first study to confirm cross-placental SARS-Cov-2 transmission leading to brain injury in newborns. The researchers recommend pre-pregnancy or pregnancy maternal COVID-19 vaccination as an important defense against infection in newborns.
  • A recent survey conducted by the Annenberg Public Policy Center at the University of Pennsylvania reveals that many women of childbearing age in the US have doubts about the safety and effectiveness of flu and COVID-19 vaccines during pregnancy. According to the results, 53% of women aged 18 to 49 years believe the flu vaccine is safe for pregnant women and their fetuses, while 17% disagree. For the COVID-19 vaccine, 42% of women of childbearing age believe it is safe and effective during pregnancy, while 31% do not. Vaccination status also influenced the results, with vaccinated women expressing more confidence in the vaccines. The survey emphasizes the need to dispel misconceptions and prioritize public health messaging on the importance of vaccination for pregnant women and their infants. The US CDC recommends that pregnant women receive both vaccines.

What we’re reading

COVID ORPHANS Approximately 245,000 children in the US have lost one or both parents to COVID-19, and an estimated 10.5 million children globally have been orphaned by the pandemic, according to the Global Reference Group on Children Affected by COVID-19 and the journal BMJ. Such children, their families, and communities face complex needs—including grief counseling, mental health support, school transitions, and legal guardianship arrangements—but despite the significant implications, those needs have largely been overlooked in policy responses, The Guardian reports. Half of the nearly quarter-million US children who have lost one or both parents live in only 5 states—California, Texas, Florida, New York, and Georgia—according to “Hidden Pain,” a report from the COVID Collaborative. Notably, Black children in the US are twice as likely as White children to have lost a parent or caregiver to COVID-19. Nevertheless, there is no comprehensive national policy to provide assistance to COVID orphans, though some US states, such as California, have developed statewide programs, and independent organizations are working to fill gaps to provide support and programming for children grieving the loss of a parent. Other countries also are grappling with the issue, with some countries using lessons from the HIV/AIDS pandemic to locate orphans and provide social service support, and others—including Mexico, Peru, Colombia, and South Africa—developing programs to give COVID orphans grants or monthly stipends, according to BMJ.

COVID LITIGATION The COVID-19 pandemic’s battlelines appear to be moving from hospitals to the courtroom, Politico Magazine reports, with cases challenging mask and testing mandates, vaccine requirements, quarantine measures, and medical malpractice making up a growing area of US civil law. Public health law experts are concerned such cases will further erode public health authority, making the nation even less prepared for the next pandemic, while lawyers filing the suits worry that when another disease emergency hits, the federal government will attempt to bring back COVID-era restrictions and mandates.

COVID-19 AID TO US HOSPITALS The Republican-led US House Oversight and Accountability Committee is investigating how COVID-19 relief funds, known as the Provider Relief Fund, were distributed to hospitals following a Wall Street Journal report last year showing that much of the aid went to profitable facilities. The committee has requested documents from the US Department of Health and Human Services (HHS) regarding the funds’ distribution, expressing concerns that aid went to profitable hospitals in wealthy areas while rural hospitals struggled financially. The WSJ investigation found that more than 1,200 profitable hospitals received federal pandemic aid even though they likely did not need the funds, while some financially struggling hospitals continued to post losses even after receiving aid. House Republicans have been focusing on pandemic aid waste and fraud in recent investigative efforts.

FLORIDA VACCINE ANALYSIS In October 2022, Florida Surgeon General Dr. Joseph Ladapo—who has drawn criticism for his resistance to COVID-19 mandates and health policies endorsed by the federal government—advised men aged 18 to 39 not to receive mRNA COVID-19 vaccines, counter to recommendations from the US CDC. He based his guidance on a controversial state analysis showing the risk of cardiac-related deaths increased significantly for some age groups after receiving a vaccine; however, that report omitted information showing that SARS-CoV-2 infection could increase the risk of cardiac-related death much more than getting vaccinated, according to drafts of the analysis obtained by the Tampa Bay Times. At least 4 early drafts of the analysis provided a counterpoint to Dr. Ladapo’s assertions, but that information was missing from the final version released by the Florida Department of Health. Several epidemiological experts highlighted concerns and flaws with the state’s final analysis, called on the nonbinding recommendation to be rescinded, and criticized Dr. Ladapo's statements on social media as promoting vaccine hesitancy.

TRADITIONAL VALUES A study by researchers from the University of California-Los Angeles published this week in Scientific Reports found that while people with more traditional or socially conservative values in other countries were more likely to adhere to COVID-19 recommendations, in the United States, people with those values were more likely to dismiss pandemic-related guidance. The researchers—who surveyed nearly 8,000 people in 27 countries across North America, South America, Europe, Asia, and Africa—found that in a majority of countries, individuals’ endorsement of tradition positively correlated with their adherence to costly COVID-19-avoidance behaviors, but the effect was most weakly correlated in the US, Canada, Poland, Austria, and Indonesia. They suggest that US individuals with traditional values perceived threats to the economy and personal liberty more strongly than the threat posed by COVID-19, and that the polarization of discourse around science and trust in the US may have contributed to higher COVID-19 deaths per capita compared with any other highly developed nation. The study emphasizes the need to understand how different cultural values influence responses to health threats such as pandemics and climate change.

ACCESS TO TREATMENTS The WHO, in collaboration with Unitaid and Medicines Law & Policy, this week published a briefing document aimed at supporting countries in accessing affordable COVID-19 treatments. The document provides factual explanations of legal instruments that WHO Member States can use to promote public health and access to COVID-19 therapeutics, while complying with multilateral trade obligations and national legislation. The document also highlights the need for expanding the geographic scope of voluntary licenses to ensure broader access to affordable treatments.

Epi update

As of April 12, the WHO COVID-19 Dashboard reports:

  • 762.8 million cumulative COVID-19 cases
  • 6.9 million deaths
  • 525,841 million cases reported week of April 3
  • 32% decrease in global weekly incidence
  • 2,426 deaths reported week of April 3
  • 57% decrease in global weekly mortality

Over the previous week, incidence declined in Africa (-22%), Europe (-27%), and the Americas (-72%) but increased in the Western Pacific (+14%), Eastern Mediterranean (+48%), South-East Asia (+73%) regions.

UNITED STATES

The US CDC is reporting*:

  • 104.2 million cumulative cases
  • 1.13 million deaths
  • 120,820 cases reported week of April 5 (down from previous week)
  • 1,773 deaths reported week of April 5 (up from previous week)
  • 11.1% weekly decrease in new hospital admissions
  • 12.0% weekly decrease in current hospitalizations

The Omicron sublineages XBB.1.5 (88.3%), XBB.1.9.1 (5.1%), XBB.1.5.1 (2.4%), and XBB (1.9%) currently account for a majority of all new sequenced specimens, with various other Omicron subvariants accounting for the remainder of cases.

*According to the CDC, as of April 1, 2023, the state of Iowa no longer reports aggregate COVID-19 case data to CDC. As a result, case counts from Iowa will no longer be reported at the national, regional, state, or county-levels on COVID Data Tracker or data.cdc.gov.

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