Thursday, February 2, 2023

February 2, 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

CALL FOR PAPERS In 2023, the Johns Hopkins Center for Health Security journal, Health Security, will issue a special feature that considers threat agnostic approaches to biodefense and public health. We encourage submissions of original research articles, case studies, and commentaries that explore policy gaps, data and data analysis, and implementation, among potential topics. The deadline is March 31, 2023. For more information, visit: https://www.centerforhealthsecurity.org/our-work/journal/call-for-papers/call-for-papers.html

In this issue

> COVID-19 remains international emergency, WHO says, begins discussions on future pandemic preparedness

> US to end emergency declarations on COVID-19 in May; Americans face changes to pandemic-related healthcare coverage

> US House Republicans take action to immediately end pandemic emergency, investigate pandemic fraud

> US FDA advisory committee supports harmonizing COVID-19 vaccines, moving toward annual shots for many

> Positive COVID-19 test no longer needed to access antivirals; concerns raised over potential for viral mutations after Lagrevio treatment

> US FDA withdraws authorization of Evusheld; US CDC urges those with compromised immune systems to take extra precautions

> What we're reading

> Epi update

COVID-19 remains international emergency, WHO says, begins discussions on future pandemic preparedness

WHO Director-General Tedros Adhanom Ghebreyesus on January 30 took the advice offered by the International Health Regulations (2005) (IHR) Emergency Committee (EC) regarding COVID-19 following its 14th meeting last week, announcing that the pandemic remains a public health emergency of international concern (PHEIC) for now but is likely at a “transition point.” The WHO acknowledged that COVID-19 continues to cause a high number of deaths globally, particularly compared to other respiratory diseases; vaccine uptake in low- and middle-income countries remains insufficient; and there remains uncertainty about the possibility of newly emerging variants but recognized the world is in a much better place now than even one year ago, when the Omicron variant of concern was predominant.

In a set of temporary recommendations, the WHO called on nations to continue administering COVID-19 vaccines and incorporating them into routine vaccination programs; improve disease surveillance reporting to the WHO and integrate COVID-19 surveillance into existing systems tracking other disease transmission and viral evolution; improve uptake of and assess the regulatory implications of ending the PHEIC for diagnostics, therapeutics, and vaccines; maintain strong healthcare systems and prepare for future health emergencies; and continue to combat misinformation, adjust international travel measures based on risk assessments, and support research. The EC will meet again in 3 months to reconsider the public health emergency designation.

In related news, the WHO Executive Board, which is holding its annual meetings this week and next, is considering its role in addressing the next global health emergency and how it will fund those activities. A 10-point proposal on improving preparedness and response to health emergencies presented at the meeting by Dr. Tedros received mixed reviews from WHO member states. Additionally, the WHO released a “zero draft” of a pandemic treaty to its 194 member states this week, setting the stage for negotiations over how the world should respond to future health emergencies. One of the most significant measures in the draft document proposes that the WHO reserve 20% of all newly developed pandemic products—diagnostics, vaccines, treatments, and the like—for distribution in lower-income countries. Overall, the draft lays out recommendations for how to make the response to the next pandemic more equitable.

US to end emergency declarations on COVID-19 in May; Americans face changes to pandemic-related healthcare coverage

US President Joe Biden announced this week that he will end both the national emergency and public health emergency declarations for COVID-19 pandemic on May 11, marking a new phase of the federal pandemic response as some of the flexibilities and requirements instituted in the pandemic’s early days will end.* The announcement was made alongside a statement opposing resolutions proposed by US House of Representative Republicans to immediately end the COVID-19 emergency (more on House Republican actions below), saying an abrupt end to the declarations “would create wide-ranging chaos and uncertainty.” Though many US residents are fully vaccinated against the virus and have largely returned to a normal way of life, an average of more than 500 people die of the disease in the US every day, making COVID-19 a leading cause of death, even among children and young people.

Once the emergencies end, some things for people in the US will change, particularly in healthcare. Many Americans have been able to access COVID-19 tests and treatments free of charge under the emergency declarations, but the end of those means a return to the nation’s typically fractured healthcare system. As such, many people—even some who have health insurance or qualify for Medicare or Medicaid—will be responsible for some or all of the cost of these medical countermeasures. Most people will continue to be able to access vaccines and boosters at no cost, but there is no guarantee of full coverage under private insurance or social safety net programs. To make matters more confusing, benefits may vary by insurer or state. Additionally, hospitals will lose pandemic-related emergency funding, and some healthcare data reporting may no longer be required. Unrelated to the emergencies’ ends, pandemic-era boosts to the nation’s Supplemental Nutrition Assistance Program (SNAP) will end this month and continuous Medicaid enrollment will end on March 31.

*Notably, the emergency declaration allowing the US FDA to make emergency use authorizations (EUAs) for COVID-19 medical countermeasures will not end on May 11. The timing to conclude the EUA has yet to be determined.

US House Republicans take action to immediately end pandemic emergency, investigate pandemic fraud

The US House of Representatives’ newly sworn-in Republican majority is swiftly taking actions to reverse or investigate COVID-19 policies from previous years. The House, voting on party lines, recently passed the “Pandemic is Over Act” and the “Freedom for Healthcare Workers Act,” both aimed at bringing certain policies and budget lines for COVID-19 response to a close. The “Freedom for Healthcare Workers Act” would end the vaccine mandate for healthcare workers, an action that US President Joe Biden has already stated he would veto should it pass the US Senate. Republicans have long stated their intentions to end many COVID-19 programs and policies, and continue to take action toward doing so, despite an announcement by President Biden this week that he will end some emergency declarations for COVID-19 on May 11 (see story above).

Republicans also have begun investigations into waste, fraud, and abuse of COVID-19 funding. Of the US$5 trillion total spent on emergency relief throughout the pandemic, experts estimate the amount drained by fraud could be anywhere between tens of billions of dollars to more than US$100 billion, but it will take years to understand the total amount.

US FDA advisory committee supports harmonizing COVID-19 vaccines, moving toward annual shots for many

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met last week to consider streamlining COVID-19 vaccination schedules and formulations. The committee unanimously voted to replace vaccine manufacturers’ (Pfizer-BioNTech, Moderna, and Novavax) original vaccine formulations targeting only the original wild type virus—currently used for the initial 2-dose series—with the new bivalent shots that target both the original strain and the Omicron BA.4 and BA.5 variants. The bivalent vaccines currently are authorized for use as boosters. The change would only affect individuals who have not yet received their initial shots, and there is no timeline on when the switch might occur if the FDA accepts the panel’s nonbinding recommendation. About 69% of the US population has received the full initial vaccine series, and only 15% of the population has gotten a bivalent booster.

While these are some initial steps toward streamlining the COVID-19 vaccination process, there are still many logistical and scientific questions to be answered on how often, how many, and to whom vaccines should be delivered. For many, the newly proposed schedule would follow a model similar to that of annual flu shots, with most receiving an annual COVID-19 vaccine in the fall that has been updated based on the predominantly circulating variant or variants. Some have termed this strategy the “flu-ification” of COVID-19, in that it will be regarded as a seasonal disease. These assumptions may or may not prove to be accurate in the case of COVID-19, as SARS-CoV-2 mutates at a much different rate and with less predictably than the viruses that cause flu. While flu predictions have decades of research to support the selection of the next year’s vaccine strain, SARS-CoV-2 is much less predictable with much less supporting data to make those predictions. It is also unclear whether it will be necessary for everyone to receive a new booster every year. Given existing challenges in the uptake of annual flu vaccines, marketing COVID-19 vaccines on a similar schedule may prove more difficult than anticipated.

Positive COVID-19 test no longer needed to access antivirals; concerns raised over potential for viral mutations after Lagrevio treatment

The US FDA on February 1 revised the emergency use authorizations (EUAs) for the COVID-19 antivirals Paxlovid (nirmatrelvir and ritonavir) and Lagevrio (molnupiravir), removing the need for individuals to test positive for SARS-CoV-2 before receiving the therapies. Now, healthcare providers can prescribe the drugs to those who have a recent known exposure, are having signs and symptoms, and are at high risk of disease progression but test negative for the virus. Though a positive test is no longer a requirement, the FDA continues to recommend direct testing to help diagnose COVID-19.

The move may be meant to address underuse of Paxlovid, and the much less used Lagevrio, but some experts say the move could lead to overuse of the medications. A new preprint study posted to medRxiv is raising concerns among some about the potential of Lagevrio to cause mutations in SARS-CoV-2 that could be passed along and give rise to new variants. The study, which is not yet peer-reviewed, is the latest of several that could change the risk-benefit calculus for the drug. There is no evidence the mutations have led to the emergence of a circulating variant that is more pathogenic or transmissible, but some say this evidence, along with studies suggesting Lagrevio has limited benefits, call into question whether it should be used.

The Chinese government recently cleared Lagrevio, Paxlovid, and 3 homegrown antivirals for the treatment of COVID-19, but questions remain over how well the Chinese antivirals can minimize severe illness and related deaths and how accessible any of the drugs are to the general population.

US FDA withdraws authorization of Evusheld; US CDC urges those with compromised immune systems to take extra precautions

The US FDA last week withdrew its emergency use authorization (EUA) of Evusheld (tixagevimab co-packaged with cilgavimab) until further notice, as data show the monoclonal antibody is unlikely to be active against the majority of SARS-CoV-2 variants currently circulating in the country. The therapy had been authorized for use as pre-exposure prophylaxis of COVID-19 in people aged 12 years and older who are immunocompromised and not expected to have an adequate response to vaccination, as well as individuals with a history of severe adverse reaction to COVID-19 vaccination or who are allergic to certain vaccine components.

The move led the US CDC to recommend those with weakened immune systems take extra precautions to avoid SARS-CoV-2 infection and have a care plan that includes quick testing at the onset of symptoms and rapid access to antiviral treatments if they test positive for COVID-19. While immunocompromised individuals should stay up to date on their COVID-19 vaccinations, if possible, including receiving an updated bivalent booster, the CDC also recommends wearing a high-quality and well-fitting mask, maintaining physical distance of 6 feet or more from others, improving indoor ventilation, and practicing frequent handwashing.

What we’re reading

LONG COVID The first in-person long COVID summit in the US was held last week in Richmond, Virginia, hosted by US Senator Tim Kaine and the US HHS. Some data suggest the percentage of people experiencing long COVID symptoms after acute infection is declining, but the condition continues to have implications for employment and health care. Multiple studies, including a recent one from New York State, show a significant number of people are missing work because of long COVID, as described in coverage from the New York Times, Guardian, CNBC, and The Hill.

LEARNING DELAYS Children experienced learning delays during the COVID-19 pandemic equivalent to about one-third of a school year’s worth of knowledge and skills, according to a global analysis including data from 15 countries and published this week in Nature Human Behavior. Mathematics skills were more heavily affected than reading skills, the study found, and those learning gaps have not been recovered as of May 2022. The pandemic reinforced inequalities in learning, with the authors predicting the pandemic’s effects on learning will be more severe for children in poorer regions. NPR spoke with several college freshmen to get their take on how the pandemic impacted their high school years.

LESSONS FOR FUTURE RESPONSES Several recent commentaries have touched on the importance of drawing lessons from the pandemic for future responses to be more equitable and nuanced. One published in STAT examines shortcomings in collecting epidemiological data in the US that includes race and ethnicity information. A piece in The BMJ argues that a focus on gender is needed to help shape responses to reduce inequalities in job losses and sustained employment precarity after the pandemic. A perspective piece published in the New England Journal of Medicine argues that one of the key lessons of the COVID-19 pandemic is that policymakers must take into account the ways in which population-wide public health recommendations and policies differentially affect various subgroups of the population and take a more differentiated approach, and recognize that who delivers pandemic-related messages matters.

PANDEMIC ORIGINS The US House Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations held a hearing February 1 to discuss biological investigations and attribution science, focused on the public release of a new report from the US Government Accountability Office (GAO) titled, “Pandemic Origins: Technologies and Challenges for Biological Investigations.” Dr. Tom Inglesby, director of the Johns Hopkins Center for Health Security and professor in the Department of Environmental Health and Engineering at the Johns Hopkins Bloomberg School of Public Health, provided testimony on the importance of bioattribution to pandemic preparedness, national security, and growing the US bioeconomy.

Epi update

As of February 2, the WHO COVID-19 Dashboard reports:

  • 754 million cumulative COVID-19 cases
  • 6.8 million deaths
  • 1.5 million cases reported week of January 23
  • 40% decline in global weekly incidence
  • 12,793 deaths reported week of January 23
  • 49% increase in global weekly mortality

Over the previous week, incidence declined in all WHO regions.

UNITED STATES

The US CDC is reporting:

  • 102.2 million cumulative cases
  • 1.1 million deaths
  • 295,140 cases week of January 25 (down from previous week)
  • 3,756 deaths week of January 25 (down from previous week)
  • 8.4% weekly decrease in new hospital admissions
  • 12.5% weekly decrease in current hospitalizations

The Omicron sublineages XBB.1.5 (61%), BQ.1.1 (22%), and BQ.1 (9%) account for a majority of all new sequenced specimens, with various other Omicron subvariants accounting for the remainder of cases.

USEFUL GRAPHICS

The following websites provide up-to-date epidemiological information down to the US county level:



Johns Hopkins University Daily COVID-19 Data in Motion (daily video showing global and US trends)

New York Times Coronavirus in the US: Latest Map and Case Count (US data portrayed in tables, maps, and graphs)

US CDC COVID-19 Integrated County View (click on pulldown menu to view either COVID-19 Community Levels or Community Transmission, as well as other indicators specific to the US)

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