Tuesday, August 30, 2022

August 30, 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

WEBINAR TODAY Please join the CSIS Commission on Strengthening America’s Health Security today, August 30, from 4:00 pm to 5:00 pm ET, for a fireside chat with Dr. Rochelle Walensky, Director of the US Centers for Disease Control and Prevention. Drs. Tom Inglesby, Director of the Johns Hopkins Center for Health Security, and Julie Gerberding, CEO of the Foundation for the National Institutes of Health (FNIH), will host and moderate a discussion reflecting on the CDC’s critical role in pandemic preparedness and response, at home and abroad. As part of that, Dr. Walensky will offer details on recently announced plans for major internal reforms to strengthen CDC’s future performance. Register: https://globalhealth.org/event/a-fireside-chat-with-dr-rochelle-walensky-director-of-the-centers-for-disease-control-and-prevention/

1 MILLION DEATHS IN 2022 WHO Director-General Dr. Tedros Adhanom Ghebreyesus announced during an August 25 briefing that 1 million people have died with COVID-19 in 2022 thus far. Expressing disappointment in the mortality toll, Dr. Tedros blamed lagging vaccination rates and urged all countries to step up and improve vaccination access worldwide, particularly among high-risk groups. "We cannot say we are learning to live with COVID-19 when 1 million people have died with COVID-19 this year alone, when we are 2 and a half years into the pandemic and have all the tools necessary to prevent these deaths,” he said. According to the WHO, 136 countries failed to reach the June target of vaccinating 70% of their populations. Among those countries, 66 have vaccination coverage below 40% and 10 are below 10%, leaving one-third of the world’s population unvaccinated.

GLOBAL VACCINATION CHALLENGES Global COVID-19 vaccination rates have stalled recently. While 67.6% of the world’s population has received at least one dose of a vaccine—close to the WHO’s recently missed goal of 70% by mid-2022—only 20.9% of people in low-income countries have received at least one dose. A new report by the health consultancy Matahari Global Solutions, with support from the International Treatment Preparedness Coalition and the People’s Vaccine Alliance, examines progress on uptake of and access to COVID-19 tools across 14 nations—Bangladesh, Democratic Republic of the Congo, Haiti, Jamaica, Liberia, Madagascar, Nepal, Nigeria, PerĂº, Senegal, Somalia (and Somaliland), Uganda, and Ukraine. According to the report, the reasons for slow vaccine uptake in these nations are multifaceted and cannot be blamed solely on skepticism about vaccines, or “vaccine hesitancy,” although it does cite influence from “historical memory of experimentation on Black bodies by white colonizers.” The countries also face a range of challenges that contribute to low uptake, including lack of cold chain storage and healthcare workers, unpredictable supply chains, transportation problems related to deliveries or accessing vaccination centers, and insecurity. The report also outlines inequities in access to other COVID-19 tools such as oxygen, diagnostic tests, and therapeutics and discusses actions still needed to address the current pandemic as well as future health emergencies. Notably, experts from the University of Washington's Institute for Health Metrics and Evaluation (IHME) estimate that thousands of lives could be saved if antivirals to treat COVID-19, such as Paxlovid, were more accessible in low- and middle-income countries.

VACCINE PATENT LAWSUIT Moderna on August 26 filed patent infringement lawsuits in the US and Germany alleging that Pfizer and BioNTech violated 3 patents Moderna filed between 2010 and 2016 on its mRNA technology, foundational in developing the company’s SARS-CoV-2 vaccine, Spikevax. Moderna claims that Pfizer and BioNTech copied that technology without permission to produce their vaccine, Comirnaty. Instead of seeking to remove the Pfizer-BioNTech vaccine from the market, Moderna is seeking monetary damages that could include royalties and lost profits incurred since March 2022, when the company began enforcing patents in wealthier nations after pledging not to do so during the emergency phase of the pandemic. Both Pfizer and BioNTech said the litigation was surprising and they remain confident in the intellectual property supporting their vaccine. Notably, some experts say at least one of the patented inventions Moderna included in the lawsuits was patented by two university scientists 6 years earlier than Moderna’s filing. While the earlier patent could weaken Moderna’s argument, the claim likely will not be completely invalidated. Analysts say the lawsuits point toward Moderna’s efforts to profit from the mRNA platform in future endeavors, including to treat and prevent other infectious diseases, cancers, rare diseases, and autoimmune disorders. The patent battle could drag on for years but is unlikely to impact production of the companies’ vaccines against COVID-19.

ACCESS TO COVID-19 TOOLS Most US residents have been able to access COVID-19 vaccines, treatments, tests, and other tools such as masks for low or no cost, largely because thefederal government has purchased and allocated them to states and providers. However, because the US Congress has not moved to authorize additional funding for the pandemic response, the government can no longer buy the products for free or low-cost distribution. This week, the Biden administration announced it will pause its program to mail free at-home rapid COVID-19 tests to residents because “Congress hasn’t provided additional funding to replenish the nation’s stockpile of tests,” according to a statement on theCovid.gov website.

In the face of dwindling supplies and funding-related tradeoffs, the Biden administration isaiming to preserve the existing supply of rapid antigen tests in anticipation of a fall surge in cases. If congressional funding becomes available, the program will quickly resume distribution, according to an unnamed administration official. Free tests will continue to be available to order as long as supplies last or through September 2, whichever comes first. After that, they will be available through 15,000 federally supported community sites, such as libraries and pharmacies, as well as community health clinics. Additionally, individuals can be reimbursed for the cost of tests through private and public health insurers.

With funds running low, the Biden administration is beginning to shift the cost of tests, vaccines, and therapeutics to health insurers and consumers. Experts caution that the impending commercialization of COVID-19 tools must account for systemic barriers that prevent equitable access to them, particularly among uninsured people. Already, programs meant to improve access to and uptake of vaccinations have folded, in some cases due to congressional resistance to authorize more pandemic response funds, just as the US prepares to launch a fall booster campaign with updated vaccines. However, due to a lack of funding, coupled with low demand for vaccination and increasingly relaxed federal guidance on preventive measures, many susceptible populations will continue to face barriers in accessing COVID-19 preventive measures and other healthcare.

VACCINE EFFECTIVENESS AGAINST OMICRON A new analysis in JAMA Network Open provides further support that Pfizer-BioNTech or Moderna booster dose administration following a 2-dose primary series provides protection against severe COVID-19 outcomes caused by the Omicron variant of concern. The cohort study of more than 2.4 million individuals estimated that mRNA booster dose effectiveness against severe COVID-19 during Omicron predominance was 87.4% with no waning up to 6 months after receiving the dose, compared to 69.6% effectiveness against severe COVID-19 following a 3-dose series of inactivated vaccine (ie, Sinovac CoronaVac or Sinopharm COVID-19 vaccines). Data from the US CDC, published August 26 in Morbidity and Mortality Weekly Report (MMWR), similarly emphasized the importance of vaccination, showing that while older Americans above the age of 65 faced greater hospitalization rates during the BA.2 predominant period, unvaccinated individuals had a 3 times greater risk of hospitalization compared to vaccinated individuals.

WASTEWATER SURVEILLANCE Wastewater surveillance is a proven method to track disease outbreaks and has provided an accurate and economical way to provide early detection of COVID-19 levels within communities—and even estimate the number of infected people in a specific area—helping to inform health authorities and policymakers throughout the pandemic. Sewage surveillance also is used to track other diseases, including monkeypox and polio, and experts say building and maintaining the infrastructure to expand wastewater-based disease surveillance should be a public health priority. However, funding for the relatively inexpensive systems is inconsistent, leading to pauses in the disease monitoring that, if continuously and thoroughly conducted, can help communities or entire countries save millions of dollars by quickly responding to disease outbreaks. But many governments, including the US Congress, are reluctant to allocate additional money for wastewater surveillance. In some cases, venture capitalists, nonprofit organizations, or academic institutions are stepping up to fill the gaps. But more funding will be needed to grow wastewater epidemiology to help provide warning signals of future potential disease outbreaks.

CHINA Several of China’s largest cities have imposed full or partial lockdowns amid new COVID-19 outbreaks. The measures impact at least 3 million people in the port city of Dalian and an undisclosed number in Chengde and Shijiazhuang in Hebei province. Though the province surrounds Beijing, the capital city is so far relatively unaffected. Partial lockdowns in other areas of the country are affecting millions more people. Measures include the need to show proof of negative test results within 24 hours to enter residential and public spaces, capacity reductions for public spaces, blanket closures of public entertainment and cultural venues, work-from-home mandates, and limits on the number of people that households may send to shop for daily needs. In many areas, the lockdowns will delay the start of the school year. Amid a heat wave, the workers responsible for enforcing the measuresface significant occupational health and safety risks, such as heat stroke and exhaustion exacerbated by wearing bulky protective suits. The latest curbs reflect the government’s insistence of adhering to its “dynamic zero COVID” policy, often criticized for being unsustainable, disrupting the economy, and negatively impacting the mental health of residents, particularly teenagers and young adults.

Boone County, Illinois's Community Risk Level Has Changed

Boone County, Illinois's Community Risk Level Has Changed

Yahoo/Inbox

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    Tue, Aug 30 at 12:56 PM

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    COVID ALERT FOR

    BOONE COUNTY, ILLINOIS

    Note that as of April 22, 2022, we have updated our scoring to a new framework that shows a location's “Community Risk Level”. Learn more about the framework. All of our previous metrics are still available on our site. See where you can find them.

    COMMUNITY RISK LEVEL DECREASED

    On 08/30/2022

    Image depicting that Boone County, Illinois went from Very high risk to Medium COVID Community Risk Level

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    About

    Covid Act Now provides a 3-color COVID community risk level score for every state, county, and metro in the U.S. The scoring is informed by 3 key metrics: weekly new reported COVID cases, weekly COVID hospital admissions and the percent of staffed inpatient beds occupied by COVID patients. These changes reflect the now decreased risk of severe illness and death from COVID due to vaccines, therapeutics, and past COVID infections, as well as other developments. The framework is based on the CDC's Community Level framework. Learn more about the change.

    To avoid overwhelming your inbox, we only send out Alerts on Tuesday and Friday, and only to locations where the community risk level has changed. For the most up-to-date community risk level assessments, check out the real-time metrics on our site.

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Tuesday, August 23, 2022

August 23, 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 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 future, potentially more severe, globally catastrophic infectious disease pandemic. The deadline is October 3, 2022. For more information: https://www.centerforhealthsecurity.org/our-work/journal/call-for-papers/index.html

OMICRON-ADAPTED BOOSTERS Previous COVID-19 Situation Reports have outlined the United States’ and other countries’ decisions to prioritize SARS-CoV-2 vaccines adapted to newer viral variants for future booster campaigns. New variants are differentiated from the original strain of the virus targeted by initial vaccines, showing significant mutations in portions of the spike protein. This differentiation reduces the effectiveness of current vaccines, as well as natural immunity gained through previous infection, and has contributed to surges in COVID-19 cases in many countries.

For many months, public health experts and scientists have discussed the promise of new vaccines, targeted for specific variants. Both Pfizer-BioNTech and Moderna are primed to offer versions of their COVID-19 vaccines specifically tailored to target various sublineages of the globally predominant Omicron variant. The UK became the first country to approve a bivalent COVID-19 vaccine for use as a booster among adults on August 15, authorizing the use of Moderna’s “Spikevax bivalent Original/Omicron,” which targets both the original SARS-CoV-2 strain and the Omicron BA.1 variant. Canada this week announced it has secured 12 million doses of an Omicron-adapted vaccine from Moderna, and the government is currently reviewing bivalent vaccine submissions from both Moderna and Pfizer-BioNTech, with decisions expected in about 2 weeks. Vaccines under review are targeting the original virus and earlier Omicron lineages.

In the US, the government has agreed to purchase 66 million doses of Omicron-adapted vaccines from Moderna and 105 million from Pfizer-BioNTech, but those vaccines are expected to target the original virus and the BA.4 and BA.5 subvariants instead of BA.1. Pfizer and BioNTech this week requested emergency use authorization (EUA) from the US FDA for the companies’ Omicron BA.4/BA.5-adapted vaccine for individuals aged 12 years or older, despite the lack of new clinical data on the shot. In the same announcement, the companies said a trial investigating the safety, tolerability, and immunogenicity of the Omicron BA.4/BA.5-adapted bivalent vaccine is expected to start this month. The companies have provided the FDA with preclinical and manufacturing data on the vaccine, but they have not yet made that information public. Despite the later start researching and making a US supply, the companies say the mRNA platform is well-suited for quick adaptations and federal health officials remain steadfast that the newer bivalent vaccines will be available by mid-September.

Current projections suggest that any person aged 12 or older who has completed a primary COVID-19 vaccination series will be eligible to receive these booster doses when they become available. This projection could change as data come in and are considered, and eligibility could differ among any authorized vaccine boosters. Scientists agree that these new booster doses likely will help improve the nation’s immune protection, but some question how well they will work given that oftentimes, the version of a virus to which an individual has an initial immune response can impact responses to future variants and vaccines. Additionally, many public health experts are worried that the prevailing “COVID is over” sentiment in many countries will negatively impact uptake of vaccine boosters.

NOVAVAX VACCINE EUA On August 19, the US FDA expanded its emergency use authorization (EUA) of Novavax’s protein-based COVID-19 vaccine to include adolescents. The FDA initially authorized the 2-dose primary series vaccine for adults in July, demonstrating 90% efficacy, and the shots will now be available for individuals aged 12 to 17, among whom it showed 80% clinical efficacy. The 2 doses are given 3 weeks apart. The Novavax vaccine uses a more traditional, protein-based technology that teaches the immune system to recognize small, modified pieces of the coronavirus spike protein. This older technology is also used in vaccines for hepatitis B, HPV, and pertussis. The Novavax vaccine also contains the Matrix-M adjuvant, which helps to induce a broader immune response. In July, the company announced that the vaccine shows “broad” immune response to circulating variants, including Omicron BA.4 and BA.5. However, Novavax is also working on an updated version of the vaccine that specifically targets the Omicron variant and subvariants. The company intends to file for authorization for a bivalent vaccine later this year.

PAXLOVID REBOUND The US FDA has requested that Pfizer conduct a study examining an extended course of its antiviral Paxlovid among individuals who experience a rebound of COVID-19 after taking an initial 5-day course. The FDA wants to know if a second 5-day course of the antiviral would help prevent disease rebound, and has requested that Pfizer produce initial results of such a trial by September 30, 2023. While Pfizer claims that disease rebound following Paxlovid treatment remains rare, several high-profile cases have prompted the FDA’s request for further study into the phenomenon.

INCUBATION PERIOD According to a study published August 22 in JAMA Network Open, the incubation period of COVID-19 has decreased gradually as SARS-CoV-2 has continuously evolved and mutated, producing variants with different enhanced transmission and virulence. The incubation period is the interval between exposure and development of symptoms and is an important epidemiologic indicator for understanding transmission. Based on the authors’ meta-analysis, the initial “wild type” strain first detected in Wuhan, China, in 2019 had an incubation period of approximately 5.2 days. Later in 2020, the Alpha variant that quickly became dominant in the UK had an incubation period of about 5 days. The Beta variant was identified shortly after and showed a shortened incubation period of 4.5 days, followed by the Delta variant with 4.41 days. The incubation period for Omicron infection is currently 3.42 days. While a decrease in incubation period often is associated with more severe disease, the decrease with COVID-19 means it makes it much more difficult to control transmission, because the faster someone becomes contagious, the faster an outbreak spreads. Knowledge of this key epidemiological parameter is helpful not only in reducing local transmission but also in understanding presymptomatic transmission.

HOME ANTIBODY TESTS The advent of home antigen tests for SARS-CoV-2 were an important step in helping people gain real-time knowledge of their infection status so they could isolate at home and hopefully stop chains of transmission. Now scientists are working to develop at-home antibody tests to help people determine their level of protection from infection and whether they might need an additional vaccine booster. A new study published this week in Cell Reports Methods describes a finger-prick test to detect neutralizing antibodies against SARS-CoV-2. If the test holds up to large-scale testing, it could provide an inexpensive way for people to learn how well-protected they are against the virus, although they might still be susceptible to newer viral variants capable of evading certain immune system responses.

UK COVID-19 INQUIRY Officially launched in July, the UK COVID-19 Inquiry is an independent panel established to examine the UK’s response to and impact of the COVID-19 pandemic and provide lessons for future pandemic preparedness and responses. Now, a coalition of 9 health and development nongovernmental organizations (NGOs) are calling for the inquiry to expand beyond its focus on the domestic response to also consider in what ways the UK government’s response contributed to growing global inequities during the pandemic. The NGOs—including Oxfam GB, Save the Children UK, MĂ©decins Sans Frontières UK, and Health Poverty Action—sent a letter on August 22 requesting an expansion of the investigation. Another signatory, RESULTS UK, released a report August 16 outlining and assessing various UK government actions in response to the pandemic and providing recommendations for the UK government, including the UK COVID-19 Inquiry be broadened. Inquiry representatives have not yet indicated whether they will expand their examination.

In related news, several US Republican lawmakers have vowed to investigate the role certain individuals played in the US COVID-19 pandemic response if they gain control of the House of Representatives or Senate next year. One figure is Chief Medical Advisor to the White House and NIAID Director Dr. Anthony Fauci, who formally announced his retirement from public service this week.

IRAN In an investigation, the Washington Post outlines how members of Iran’s government and the domestic pharmaceutical company Barkat pushed through the approval of a yet-unproven COVID-19 vaccine during the country’s worst SARS-CoV-2 surge. The company failed to deliver an agreed upon 50 million doses, and most Iranians were vaccinated with a Chinese-produced vaccine. Nevertheless, Barkat’s profits soared, and the company appears to have compensated government officials who sat on its board and pushed the vaccine’s approval.

Thursday, August 18, 2022

August 18, 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

EPI UPDATE The WHO COVID-19 Dashboard reports 592 million cumulative cases and 6.45 million deaths worldwide as of August 18. According to the WHO weekly epidemiological update for August 17, the number of new weekly cases decreased by 24% during the week of August 8-14, compared to the previous week. The number of new weekly deaths decreased by 6%, compared to the previous week.

At the regional level, the number of new weekly cases decreased across all six regions: African (-38%), European (-38%), Eastern Mediterranean (-30%), Western Pacific (-18%), Americas (-17%), and South-East Asia (-11%). The number of new weekly deaths increased in the Western Pacific (+31%) and South-East Asia (+12%) regions and decreased or remained stable in the African (-33%), European (-25%), Eastern Mediterranean (-7%), and Americas (-4%) regions.

UNITED STATES

The US CDC is reporting 93 million cumulative cases of COVID-19 and 1,033,332 deaths. The current 7-day moving average of new daily cases is down over last week, dropping to 98,940 on August 16 from 107,899 on August 9. The average daily mortality remains relatively stable, at 398 on August 16. Daily mortality has remained above or around 400 since July 12.** New national ensemble forecasts of new and total deaths predict that the number of newly reported COVID-19 deaths will remain stable or have an uncertain trend over the next 4 weeks, with 1,800 to 5,000 new deaths likely reported in the week ending September 10, 2022, and a total of 1,046,000 to 1,055,000 COVID-19 deaths predicted to be reported by this date.

Both new hospital admissions (-3.5% over the past week) and current hospitalizations (-5.3%) decreased over the previous week, potentially reflecting a downward trend to the latest surge driven by the Omicron BA.5 subvariant. New national ensemble forecasts predict that the number of new daily confirmed COVID-19 hospital admissions will remain stable or have an uncertain trend, with 2,600 to 9,700 new confirmed COVID-19 hospital admissions likely reported on September 9, 2022.

BA.5 is now projected to account for 88.8% of sequenced specimens in the US. The BA.4 sublineage accounts for about 5.3% of cases, while the BA.4.6 sublineage accounts for 5.1% of cases. Together, BA.2.12.1 accounts for only about 0.8% of cases. According to the estimate, Omicron variants represent all new cases in the US.

**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.

US RESPONSE The US appears to have entered somewhat of a COVID-19 plateau. While there are signs that the latest surge caused by the Omicron BA.5 subvariant might be slowing—the average number of daily infections and hospitalizations are falling—an average of about 400 people have died of the disease every day for the past month. US officials have indicated that Omicron-adapted vaccine boosters could be available for everyone aged 12 and older within the next month, but the US FDA and CDC must act first to authorize and recommend a new vaccine booster. Experts have mixed opinions regarding an FDA plan to base its authorization decision on studies involving mice instead of humans. The UK this week approved a new bivalent booster from Moderna that targets both the original SARS-CoV-2 strain as well as the original Omicron variant, BA.1. The FDA rejected BA.1 bivalent booster versions earlier this year, instead calling on vaccine manufacturers to develop bivalent boosters targeting the Omicron BA.4 and/or BA.5 subvariants.

The federal government has already secured millions of doses of these not-yet-authorized bivalent vaccine boosters from Moderna and Pfizer-BioNTech, but the White House recently announced it is making plans to no longer buy vaccines, treatments, or diagnostic tests, as early as this fall. Without additional funding from the US Congress to purchase those products, availability will shift to the commercial market, raising questions about equitable access. However, the Biden administration is expected to extend the COVID-19 public health emergency for another 90 days in mid-October, which likely would ensure expanded Medicaid coverage, telehealth services, increased payments to hospitals, and other pandemic measures remain in place into early 2023. Meanwhile, the US CDC has loosened its COVID-19 guidance and public health agencies are adapting lessons learned during the pandemic to address other—possibly more pressing—public health and equity challenges, signaling what many see is an attempt to enter a “new normal.”

US CDC REORGANIZATION US CDC Director Dr. Rochelle Walensky on August 17 announced a large-scale reorganization and pivot for the agency, after receiving the results of an external review of the institution that she initiated in April. The review was led by James Macrae, a long-time senior official with the US Department of Health and Human Services, the parent agency of CDC, and was based on 120 interviews with key informants inside and outside the institution. Findings from the review are not yet public. Dr. Walensky announced that, according to the review, the future success of the CDC depends on pivoting from a slower, more academic institution to a swift emergency response agency, providing actionable information to the public and other health authorities in an appropriate and understandable fashion. Initial agency changes to institute this vision include revamping the website, creating a new equity office, creating a new executive council to oversee the overall new vision, hastening time to publication for data needed for response decisions, prioritizing budget allocation for the agency, and promoting staff according to public health impact. Additionally, officials responding to public health crises would now be required to stay in their positions for at least 6 months, and more staff would be trained for those roles as well. Dr. Walensky also is seeking greater authority for the CDC to collect data from states, more quickly finance external partners during health crises, and develop more competitive benefits for prospective staff recruitment. Outside experts have praised the proposed changes to the agency’s vision but some remain skeptical as to whether the proposed shifts are possible or will be enough to address the missteps of the agency during the COVID-19 pandemic.

IMMUNITY AGAINST OMICRON Various studies have indicated that prior SARS-CoV-2 infection may provide some protection against or reduce severity of future infection. However, new studies suggest that prior infection with an Omicron variant may provide increased protection against BA.4 or BA.5 compared to prior infection with Alpha, Beta or Delta variants—although outside experts note the comparison may not be fair because immunity wanes over time. A new preprint study posted August 17 to medRxiv supports this criticism, as it documented rapid waning of protection from an earlier Omicron variant infection against BA.5, particularly 3-5 months post-infection. Furthermore, another study published in Nature Communications suggests that protection post-Omicron infection (BA.1) declines more quickly among unvaccinated individuals compared to their vaccinated counterparts. Altogether, this growing body of literature emphasizes the continued importance of COVID-19 vaccination and the widespread variations in protection based on disease history, and the findings should be taken into consideration for future response planning.

LONG COVID RESEARCH RESULTS People with post-COVID conditions, or long COVID, and their advocates continue to push for more research and clinical treatments for the mix of—and far from uniform—lasting symptoms that make up the condition. Recent developments include a preprint study, posted to medRxiv this month, evaluating the distinguishing symptoms of long COVID. Notably, the researchers found that those with the condition had lower levels of the stress hormone cortisol, in addition to the often-present cognitive deficits—sometimes known as “brain fog”—and fatigue. Similar results have been reported in previous studies, including one published in Cell, which also documented “exhausted T-cells” that result in chronic inflammation indicative of several long COVID symptoms. Impaired memory, fatigue, shortness of breath, and trouble concentrating were among key complaints of participants of a study published August 12 in Clinical Infectious Diseases that followed patients for 12-18 months after infection. Overall, 43% of participants experienced persistent symptoms after mild COVID-19. Researchers also noted that shortness of breath and the number of experienced symptoms at the 12 month mark were significantly linked to specific SARS-CoV-2 spike protein-specific immune responses.

In a 2-year study published August 17 in The Lancet Psychiatry, Oxford researchers retrospectively assessed the risks of 14 neurological and psychiatric diagnoses after SARS-CoV-2 infection among 1.25 million patient records, including children. The researchers matched the COVID-19 patients with patients who had different respiratory infections and found that while common mood disorders typically returned to baseline after 1-2 months in both groups, adults with COVID-19 had an increased risk of psychotic disorder, brain fog, dementia, and epilepsy or seizures by the end of the second year of the follow-up, compared with adults with other respiratory diseases. Children also were at an increased risk for brain fog, in addition to insomnia, intracranial hemorrhage, ischemic stroke, psychotic disorders, and seizures. Children, however, experienced a finite horizon of 75 days for brain fog, nor were they at an increased risk for mood or anxiety disorders in the 6 months following SARS-CoV-2 infection. The study also accounts for the rise of 3 viral variants. The emergence of the Delta variant increased risks of ischemic stroke, seizures, cognitive deficit, insomnia, and anxiety disorders, as well as an increased death rate. The death rate following Omicron emergence was lower than just before, but the risks of neurological and psychiatric symptoms remained similar. Risk profiles remained similar just before and after the emergence of the Alpha variant. The studies all point to the need for more attention to be given to the post-infection risks of SARS-CoV-2, as well as other viruses.

WASTEWATER SURVEILLANCE The COVID-19 pandemic helped bolster an existing surveillance system for infectious diseases: wastewater testing. The method is now being used to track not only older diseases such as norovirus, but also new and emerging viruses including SARS-CoV-2, monkeypox, and polio. Several US states and jurisdictions have taken steps to launch or expand wastewater surveillance programs to provide a better understanding of circulating SARS-CoV-2 levels and variants. The New York Times this week published an interactive exploration into how these systems work and the steps involved in extracting results.

MASKING & INFECTIOUS AEROSOLS Healthcare workers are at an increased risk of SARS-CoV-2 infection, with many required or choosing to wear personal protective equipment such as masks. Those who always wore respirator masks rather than surgical masks had a 40% lower likelihood of infection, irrespective of cumulative exposure, according to a study published August 15 in JAMA Network Open. Among 2,919 healthcare workers included in the study, 749 (26%) tested positive for SARS-CoV-2 between September 2020 and September 2021. Among those with patient exposure, test positivity was 21% among workers wearing respirators compared with 35% among those who used surgical masks or a mix of masks (OR, 0.49; 95% CI, 0.39-0.61). The study was conducted in Switzerland prior to the predominance of the Omicron variant, so the results might not be applicable to newer, more transmissible variants.

A July 29 preprint study posted to medRxiv shows that viral shedding (measured as RNA copies) in exhaled breath aerosol was significantly greater during infections with the more highly transmissible SARS-CoV-2 Alpha, Delta, and Omicron variants than with the ancestral strain and variants not associated with increased transmissibility, even among people who are up to date on vaccinations. The researchers documented the highest viral shedding from a person with Omicron infection. They said the findings provide additional evidence that inhalation of infectious aerosols is the dominant mode of SARS-CoV-2 transmission and support the importance of continued mitigation efforts such as improving indoor air hygiene through ventilation, filtration, and air disinfection, and wearing masks or respirators.

PANDEMIC-RELATED FRAUD The US government has appropriated US$5 trillion in relief programs aimed at helping businesses and individuals during shutdowns due to the COVID-19 pandemic. However, that funding came with minimal oversight leading to an unprecedented amount of fraud, with billions of dollars stolen by thousands of people, through unemployment payouts or business assistance. Now, federal investigators and prosecutors are trying to identify and charge people who committed such crimes, with 500 people working on pandemic-fraud cases across at least 21 government agencies, as well as the FBI, Secret Service, Postal Inspection Service, and the Internal Revenue Service. But with tens of thousands of ongoing investigations, officials are concerned some crimes may never be prosecuted. New laws extend the statute of limitations for some pandemic-era fraud from 5 years to 10 years, and officials hope the extensions will help them find and prosecute more offenders. The costs of loose rules and lax oversight should provide lessons for future pandemic preparedness responses to include planning and prevention efforts for fraud.

UNIVERSAL HEALTHCARE Countries with or close to achieving universal health coverage (UHC)—a system under which all individuals and communities receive needed health services without suffering financial hardship—saw smaller declines in routine childhood vaccinations during the COVID-19 pandemic, according to a study published August 16 in PLOS Medicine. Countries included in a “high UHC index” group had a 2.7% smaller reduction in childhood immunization coverage during 2020 when compared to countries with lower UHC Service Coverage Index rankings. Additionally, a study published August 17 in The Lancet Regional Health found that primary health care coverage in Brazil mitigated socioeconomic disparities in accessing SARS-CoV-2 vaccination. Taken together, these studies provide evidence that UHC guarantees more equitable access to vaccinations and suggest that policymakers should continue to advocate for working toward the goal of achieving access to safe, effective, quality, and affordable healthcare services for all.

Tuesday, August 16, 2022

August 16, 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

INDOOR AIR WORKSHOP The Environmental Health Matters Initiative (EHMI) of the National Academies of Sciences, Engineering, and Medicine will host its first virtual workshop in a 3-part series onIndoor Air Management of Airborne Pathogens on August 18 from 11:30 am to 3:30 pm EDT. These workshops—follow ups to the 2020 workshop on the airborne transmission of SARS-CoV-2—will explore strategies needed for airborne disease control and risk reduction in enclosed places by drawing on accumulated community and institutional knowledge, on-the-ground observations of indoor environments management during the pandemic, and novel and promising scientific discoveries. For more information and to register, visithttps://www.nationalacademies.org/event/07-21-2022/indoor-air-management-of-airborne-pathogens-lessons-practices-and-innovations.

UK APPROVAL OF BIVALENT VACCINE BOOSTER The UK became the first country to approve a bivalent COVID-19 vaccine for use as a booster among adults, as many countries plan late-2022 booster drives to hopefully broaden population immunity to SARS-CoV-2 before winter. The adapted bivalent vaccine is an updated version of Moderna’s original monovalent mRNA vaccine, known as “Spikevax bivalent Original/Omicron.” The vaccine targets the original SARS-CoV-2 strain and the Omicron BA.1 variant, a combination which produces significantly more Omicron BA.1-specific neutralizing antibodies than the original monovalent vaccine and may generate BA.4 and BA.5 neutralizing antibodies at a rate 1.69 times higher than the original vaccine, according to trial data from Moderna. The UK Joint Committee on Vaccination and Immunisation (JCVI) published guidance this week for which vaccines should be used during the UK’s fall COVID-19 booster campaign. For adults, the JCVI recommends using either the newly approved Spikevax bivalent Original/Omicron vaccine, one of the original Moderna or Pfizer-BioNTech booster shots, or, in exceptional circumstances, the Novavax Matrix-M adjuvanted wild-type vaccine (Nuvaxovid). The JCVI also offered advice that a single type of booster be used where possible to facilitate deployment and mobilization.

Drug regulators in the EU may meet as soon as September 1 to consider approving a bivalent vaccine that targets the original SARS-CoV-2 strain and BA.1 and could meet later in the month to review a bivalent vaccine using the original strain and BA.5. Meanwhile, US government health officials have indicated they plan to wait for bivalent vaccines capable of targeting the original SARS-CoV-2 strain and the newer BA.4 and BA.5 Omicron subvariants. The Biden administration is aiming to begin a COVID-19 booster shot campaign for all adults in September, but there remain many considerations for regulators to work through before recommending a booster. One of these considerations is that vaccine-induced immunity can wane over time, so the timing of a booster campaign is important. However, many experts agree that getting a booster too early is better than not getting one at all.

NOVAVAX BOOSTER EUA APPLICATION Novavax announced August 15 that it has submitted an application to the US FDA for emergency use authorization (EUA) of its recently authorized SARS-CoV-2 vaccine as a booster dose. If authorized, the booster dose could be administered to qualifying adults who previously received full courses of Novavax or other SARS-CoV-2 vaccines. The Novavax vaccine is an adjuvanted protein-based vaccine, a more traditional vaccine technology than the platform used in mRNA vaccines. Experts have hoped that this tried-and-true formulation may convince more unvaccinated people to receive their primary courses, although uptake in the US has been slow. Based on clinical trial results, the Novavax vaccine appears to remain relatively effective against SARS-CoV-2 variants, including the Omicron and Delta variants of concern. It is less clear how effective this formulation is against BA.5 specifically, but vaccine experts have been looking forward to Novavax’s EUA booster submission to provide another tool in the fight against the wide variety of Omicron subvariants.

BCG VACCINE The Bacillus Calmette-GuĂ©rin (BCG) vaccine continues to offer protection from tuberculosis infection into adulthood when given at birth. The vaccine, which has been in use for nearly 100 years, is routinely given to newborns worldwide but is not part of the standard childhood immunization program in the US. Research has shown that neonatal BCG vaccination confers off-target, nonspecific protection against unrelated infectious diseases in early childhood, and the vaccine has been used in clinical trials to examine its effectiveness to reduce the impact of COVID-19, but with little positive outcome. Now, a small, double-blind, placebo-controlled study published in Cell Reports Medicine by researchers from Massachusetts General Hospital suggests the BCG vaccine is highly effective in protecting patients with type 1 diabetes from COVID-19. The researchers found that 12.5% of the group that received placebo shots and 1% of the group that received 3 BCG doses met the criteria for confirmed COVID-19, yielding an efficacy of 92%. Additionally, the BCG group had fewer infectious disease symptoms and lesser severity, and fewer infectious disease events per patient, including COVID-19. The study provides a basis for additional research into the BCG vaccine’s broad-based infection protection, including against SARS-CoV-2 variants.

US CDC COVID-19 GUIDANCE Late last week, the US CDC updated its guidance on COVID-19 vaccination, quarantine, isolation, and testing. The new “streamlined” guidance is in response to broader levels of immunity among the population, from previous infection or vaccination or both, and the availability of effective COVID-19 prevention and management tools that can reduce the risk for medically significant illness and death. The guidance places significant onus on individuals to assess their personal risk and take steps to prevent infection, transmission, or serious outcomes for themselves or others. One of the most significant changes is that persons who are exposed to SARS-CoV-2 and not up to date on their vaccinations no longer need to quarantine. Instead, the CDC recommends they wear a mask in indoor settings for 10 days after exposure and take a test on day 5. The CDC also removed its recommendations for social distancing, test-to-stay programs, and cohorting of students in schools.

These changes have been met with varied reactions, from acceptance to outrage. Expressing concern over the relaxed guidance, many public health experts cite continuing risk from the predominant BA.5 subvariant; the risk of future, possibly more virulent, variants; and declining adherence to personal protective measures that might inhibit their reinstatement if a new wave of infections begins. On the other hand, many members of the general public and institutional decision makers welcomed the simplified guidance as a sign that COVID-19 should not continue to overburden daily routines, particularly as we move closer to the fourth year of the pandemic. Though 3 years of heightened precautions is a long time to expect a global population to remain vigilant against disease, many public health experts believe the CDC is sending the wrong signal at the wrong time. Of particular controversy is CDC’s “Community Levels” metric that is being used to influence its decision making. Because this indicator is influenced more by hospitalizations than transmission, certain areas can appear as if there is less circulating virus than there actually is. Some argue that community transmission* should be more heavily weighted in decision making, especially while highly transmissible variants are circulating.

*To see community transmission levels, change the “Data Type” dropdown menu to “Community Transmission.”

SERIAL TESTING The US FDA this week recommended that people use serial testing—taking multiple COVID-19 tests over several days—to reduce the risk of a false-negative result and to help prevent people from unknowingly spreading the SARS-CoV-2 virus to others. People who test negative on an at-home antigen test should take a second or third test to confirm their result, even if they do not have symptoms. Specifically, the FDA recommends the second test be taken 48 hours after the first test. For those without symptoms but with a known exposure, the agency goes further to say that a third test should be taken another 48 hours after the second test to be even more confident of a negative result. Repeated testing is not a new concept, but this updated recommendation demonstrates the need for continued vigilance in driving down SARS-CoV-2 transmission. While not at odds with the US CDC’s new COVID-19 guidance on quarantine and isolation, the FDA’s recommendation does appear to place more emphasis on assuring lower likelihood of person-to-person transmission following exposure.

US SCHOOLS On August 11, the US CDC released new operational guidance for K-12 schools, early education programs, and daycares to support safe  in-person learning during the ongoing COVID-19 pandemic. The new guidelines largely loosen protocols and leave more of the decision-making responsibility in the hands of local officials. Notably, several states—including California, Colorado, Washington, and West Virginia—have issued their own guidance or taken steps to facilitate testing and vaccinations at schools. Few districts are implementing vaccination mandates for students, as Americans are divided over whether such requirements are needed.

The CDC’s guidance recommends that school staff and students stay up-to-date on vaccinations, stay home when sick, practice proper hand hygiene and respiratory etiquette, and that schools optimize and improve ventilation and clean surfaces at least once a day. The guidance also discusses masking, testing, quarantine, and other mitigation strategies, particularly in relation to local community levels or outbreaks. Though the CDC notes that wearing well-fitting masks reduces the risk of spreading SARS-CoV-2 in schools—with a recent preprint study providing additional supporting evidence—the agency only recommends masking in schools located in localities where SARS-CoV-2 “Community Levels” are high. Additionally, most students no longer are advised to quarantine if they have been exposed to someone with COVID-19 but they should wear a mask for 10 days and get tested. The new guidelines also drop the recommendations for routine testing in K-12 schools, although schools located in areas where COVID-19 Community Levels are high may consider implementing screening testing programs. Approximately 40% of counties in the US are currently experiencing high COVID-19 Community Levels, while “Community Transmission” is high in nearly 94% of the country, according to CDC data.

The CDC’s more relaxed guidelines coincide with increased concern about the social, economic, and mental welfare of students who have had limited social interactions over the last few years. Some of the social concerns expressed by parents include students experiencing depression due to extended isolation, students experiencing distress due to missing key social milestones and events, and suicidal ideation in student populations. Economic concerns stem from the pandemic-related disruption in education. Experts estimate that each year of education can add 10% to an individual’s expected lifetime earnings. As a result, disruptions in education due to the pandemic could mean that the current generation of students might be less competitive when they enter the workforce. Concerns about the mental welfare of students have increased due to reports of more emergency room visits linked to mental health among young people, more reports of eating disorders among adolescent girls, and emotional disturbances that can last for years or decades after a traumatic event.

PREGNANCY COVID-19 directly affects people’s health, but the early pandemic also impacted how and when people accessed health care, with lockdowns, workforce shortages, and supply chain issues forcing many to skip or delay routine medical appointments. A retrospective cohort study published August 12 in JAMA Network Open that included more than 1.6 million pregnant patients in 463 hospitals found that the number of live births decreased by 5.2% during the first 14 months of the pandemic compared with the previous 14 months. Additionally, there were increased odds of maternal death during delivery hospitalization (from 5.17 to 8.69 deaths per 100,000 pregnant patients; OR, 1.75; 95% CI, 1.19-2.58), as well as small but significant increased odds of certain pregnancy complications, including gestational hypertension (OR, 1.08; 95% CI, 1.06-1.11), obstetric hemorrhage (OR, 1.07; 95% CI, 1.04-1.10), preeclampsia (OR, 1.04; 95% CI, 1.02-1.06), and preexisting chronic hypertension (OR, 1.06; 95% CI, 1.03-1.09). While it is unclear whether COVID-19 infection directly caused any of the complications, the study’s authors suggested that missed or delayed prenatal visits may have led to some pregnancy complications going undetected or unmanaged and that increased societal stress could have contributed to the increase in hypertension issues.

Prior to vaccines becoming available in late 2020, mis- and disinformation campaigns to discredit the vaccines had already taken hold and especially created uncertainty among pregnant people. Part of what allowed disinformation to flourish was that pregnant people were not included in the initial clinical trials of SARS-CoV-2 vaccines, creating a dearth of safety data that led to pregnant people having some of the lowest vaccination rates among adults when the vaccines were first authorized. Subsequently, many pregnant people, or those looking to become pregnant, chose to delay or forego vaccination, sometimes with dire outcomes. Unvaccinated pregnant women with COVID-19 have a higher risk of stillbirth and other pregnancy complications, including maternal death, than those who are vaccinated. Multiple studies have shown that the vaccines are safe before and during pregnancy and that SARS-CoV-2 infection can have deleterious impacts on pregnant individuals, including heart complications.

An observational cohort study—conducted in Canada and published last week in The Lancet Infectious Diseases—found that not only were mRNA SARS-CoV-2 vaccines safe for pregnant women, but vaccinated pregnant women reported fewer serious health events than non-pregnant women in the week following vaccination and a similar number of events as a group of unvaccinated pregnant women. Though there are many scientific, legal, and ethical considerations related to research associated with pregnancy and including pregnant people, researchers are working to identify these challenges and develop strategies to overcome them. 

INCARCERATED POPULATIONS Several large California (US) counties are ending initiatives meant to keep more nonviolent offenders out of jail to lower incarcerated populations during the COVID-19 pandemic amid rising crime. Los Angeles, San Diego, and Santa Clara counties are among those that recently stopped issuing zero bail for people who committed certain nonviolent felony offenses. Similar public health measures instituted nationwide, meant to depopulate jails to avoid COVID-19 outbreaks, brought the US jail population to its lowest level in nearly a decade, according to federal statistics. But rising crime rates are forcing more progressive district attorneys to end such practices, leading to rising jail populations, which remained below their pre-pandemic levels as of the end of 2021. Incarcerated populations have been disproportionately impacted by COVID-19. In California, nearly half of state prisons had 3 to 4 times more COVID-19 cases than the general population.

WESTERN PACIFIC Officials in the Marshall Islands have declared a national health disaster due to the arrival of the highly transmissible Omicron SARS-CoV-2 variant, shifting from a prevention to mitigation strategy. More than 4,000 people have tested positive in a population of about 60,000 in the past week, and the test positivity rate is about 75% in the capital city, Majuro. The Marshall Islands, with a population of about 59,000, was one of the last countries to claim to be COVID-free because of its strict quarantine rules, and until about one week ago, the nation had not recorded a single case of community transmission. About 70% of the nation’s residents are vaccinated. The health disaster declaration provides the government access to emergency funding and the ability to institute several public health measures, including closing schools. While officials have not instituted lockdowns, many people are choosing to stay at home to prevent further community transmission.

Further south in the Pacific Ocean, the number of new COVID-19 cases in New Zealand dropped to its lowest level in 6 months and the average number of hospitalizations is down, showing hopeful signs the winter wave of infections is subsiding. Cases there spiked in mid-July, when deaths from COVID-19 were essentially on par with those from heart disease, the country’s leading killer. About 90% of people aged 12 years and older have completed a primary vaccination series, according to the New Zealand government. In neighboring Australia, there are signs the recent Omicron surge is in decline there as well. However, the number of hospitalizations and the 7-day average of COVID-19-related deaths remain high, and an unknown number of people are suffering long-term impacts of COVID-19 infection. Wait lists for specialized long COVID rehabilitation clinics are now more than 5 months, and experts in Australia are calling for a nationally coordinated approach to address the condition. Infectious disease experts cautioned that while the worst of the winter surge might have passed, there will be future surges and people should continue to wear masks to help mitigate disease transmission. According to the Australian government, 96% of people aged 16 years and older have received at least 2 doses of vaccine.