COVID-19 Situation Report
Editor: Alyson Browett, MPH

Contributors: Clint Haines, MS; Noelle Huhn, MSPH; Natasha Kaushal, MSPH; Amanda Kobokovich, MPH; Christina Potter, MSPH; Matthew Shearer, MPH; Marc Trotochaud, MSPH; and, Rachel A. Vahey, MHS.
NOTICE We will not publish the COVID-19 Situation Report on Tuesday, June 21, in recognition of the US Juneteenth holiday. We will resume publication on Thursday, June 23.
MONKEYPOX OUTBREAKS UPDATE Read our latest update from June 1 on the monkeypox outbreaks and visit our monkeypox resource page. We will continue to analyze the situation and provide updates, as needed. If you would like to receive these updates, please sign up here.
EPI UPDATE The WHO COVID-19 Dashboard reports 534 million cumulative cases and 6.31 million deaths worldwide as of June 15*. The global weekly incidence increased 4.3% from the previous week, following 3 consecutive weeks of decline. Global weekly mortality increased as well—for the first time since early February**—up 7.1% from the previous week.
*The WHO COVID-19 dashboard indicates that there is a delay in reporting for the African Region, so the current totals may not be complete.
**With the exception of a 1-week spike the week of March 21, which appears to be the result of a reporting anomaly in the Americas and South-East Asia.

The US CDC is reporting 85.7 million cumulative cases of COVID-19 and 1,007,374 deaths. The average daily incidence has plateaued over the past several weeks, holding relatively steady at approximately 100-110,000 new cases per day. Despite the ongoing elevated daily incidence, we have not observed a corresponding increase in daily mortality. Daily mortality has held relatively steady at approximately 275-325 deaths per day since late April*. *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.

Despite the absence of a surge in COVID-19 mortality, both new hospital admissions (+6.5% over the past week) and current hospitalizations (+1.8%) continue to increase. Notably, both trends appear to be tapering off to some degree. Considering the plateau in daily incidence, it is possible that hospitalizations could also remain elevated, rather than peaking and then declining.

Community transmission in the US continues to be driven by the BA.2.12.1 sublineage of Omicron (64.2%), followed by BA.2 (14.2%), BA.5 (13.3%), and BA.4 (8.3%). The prevalence of BA.2.12.1 increased slightly from last week, but the prevalence of BA.4 and BA.5 are increasing more rapidly. These 4 sublineages of the Omicron variant represent essentially all new SARS-CoV-2 infections in the US.

PANDEMIC TREATY On June 14, the WHO published an annotated draft outline of the prospective pandemic prevention, preparedness, and response treaty. The treaty is currently being drafted by an intergovernmental negotiating body representing WHO Member States, with the aim of establishing a global system for building and maintaining resilience to pandemics and other large-scale disease threats. The draft outline does not contain much detail, but it presents a framework of priority topic areas to be included in the treaty. The outline is organized such that it addresses equity, systems and tools, governance and leadership, and financing for the 4 key phases of pandemic readiness: prevention, preparedness, response, and recovery. The draft includes some specific items under some sections as well as placeholders for sections on One Health, access and benefit sharing, scientific cooperation, health literacy, and broader governance issues. The stated goal is to finalize the text of the treaty in time for consideration at the 77th World Health Assembly in 2024, and considerable uncertainty remains regarding the treaty’s final structure and content.

Importantly, independent experts around the world are publishing their own recommendations regarding the scope and content of the treaty. In a letter published this week, Women in Global Health emphasize the importance of including explicit language to protect healthcare workers. They argue that a treaty that focuses solely on government responsibilities and actions, pharmaceutical and non-pharmaceutical supplies and products, and patients would be insufficient to ensure a safe and supportive environment to protect frontline healthcare workers, who are critical for pandemic response. Researchers from Georgetown University (US) emphasize that the treaty should be informed by current available evidence to identify appropriate policies, systems, and capabilities. They outline 12 key elements that should be included in an evidence-based treaty, which broadly address 4 key facets of pandemic resilience: “(1) reducing spillover risk, (2) reducing pandemic risk, (3) reducing pandemic impacts, and (4) ensuring recovery and resilience.” Their 12 key elements address the human/animal/environmental interface, strengthening public health and healthcare systems and capacities, medical countermeasure (MCM) research and development, selecting appropriate government response policies and actions, government transparency and accountability, legal issues, and equity and justice.

PEDIATRIC VACCINE In their June 15 meeting, members of the US FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of authorizing the Moderna and Pfizer-BioNTech SARS-CoV-2 vaccines for use in children aged 6 months to 5 years (21-0 for both vaccines). The 3-dose Pfizer-BioNTech vaccine series demonstrated an overall 80.3% efficacy against symptomatic COVID-19, and the 2-dose Moderna series demonstrated 50.6% efficacy among children aged 6-23 months and 36.8 among those aged 2-5 years. Notably, the top-line efficacy estimate for the Pfizer-BioNTech vaccine is based on only 10 total cases of COVID-19 (7 in the placebo group, 3 in the vaccine group), which contributes to the wide confidence interval, particularly for children aged 6-23 months. The US CDC’s Advisory Committee on Immunization Practices (ACIP) is scheduled to meet June 17-18, and it is expected to issue its recommendation regarding the 2 vaccines. The final FDA authorization and CDC guidance is still required, but it is possible that the first doses for this age group could be available by early next week.

Despite the long-anticipated decision for some parents, it is still unclear how many will choose to vaccinate their youngest children. As health experts have pointed out, infants and preschool-aged children already have a considerable number of recommended routine vaccinations, including several multi-dose series. Adding another 2- or 3-dose series could be a barrier for some parents due to the extra logistical hurdles of additional visits to the doctor’s office. Most states are still anticipating demand for the newest pediatric series and have already ordered millions of doses. Notably, Florida is the only state not to place a pre-order with the federal government. Still, as more evidence continues to surface on the severe illness faced by children hospitalized with COVID-19, many with no underlying health conditions, the scales may tip further in the direction of vaccination. 

PAXLOVID CLINICAL TRIAL On June 14, Pfizer announced plans to halt enrollment in its current clinical trial for Paxlovid, a SARS-CoV-2 antiviral drug. This decision came after preliminary data did not show a reduction in hospitalization and death among “standard-risk” participants—ie, those who do not have underlying health conditions that put them at elevated risk for severe disease and death. The risk decreased by approximately 50%, but it was not a statistically significant benefit. The drug also failed to demonstrate benefit in terms of alleviating COVID-19 symptoms. Due to the lower risk of severe disease and death among these individuals—and therefore, low benefit from the drug—Pfizer elected to terminate the trial. The current Emergency Use Authorization (EUA) for Paxlovid only applies to high-risk patients. Pfizer indicated that it will include data from this clinical trial in its New Drug Application (NDA) for full US FDA approval for use in high-risk patients.

VARIANT-SPECIFIC VACCINE On June 15, Pfizer and BioNTech announced that the European Medicines Agency (EMA) has initiated a rolling review for their variant-specific candidate SARS-CoV-2 vaccine. Major SARS-CoV-2 vaccine manufacturers have been working to update their vaccine profiles as evidence shows diminishing protection against new variants, particularly against the now-dominant Omicron variant. The Pfizer-BioNTech candidate is among the first updated vaccines to begin a formal regulatory review process. With the rolling submission process, the EMA will be able to review data as they become available. The EMA stated that its review will initially focus on manufacturing quality assurance and safety, followed by clinical trial safety and efficacy data as they become available. The announcement also indicated that the companies intend to submit an application to the US FDA in the near future. 

CANADA TRAVEL RESTRICTIONS The Canadian government announced that it will lift some SARS-CoV-2 vaccination requirements for domestic and international travel. Starting June 20, Canada will no longer require vaccination for domestic or outbound air, bus, or rail passengers nor for federally regulated transportation sector personnel. Despite these changes, international travelers may still be subject to vaccination requirements. Notably, Canadian citizens and permanent residents who are not fully vaccinated must provide documentation of a negative SARS-CoV-2 test prior to entering the country, and they are subject to testing and quarantine requirements after their arrival. Travelers who are not citizens nor residents are still required to be fully vaccinated to enter Canada, but vaccination is no longer required for international rail or flights departing Canada. Due to the high risk of transmission, vaccination requirements will remain in effect for cruise ships, and other risk mitigation measures will continue for domestic travel, including mandatory mask use. Canada also announced that it will temporarily suspend mandatory random testing at airports through June 30, in an effort to reduce traveler wait times. Starting July 1, all required testing will be moved off-site to reduce the burden on airports.

UNIVERSAL HEALTH CARE Researchers from several US universities, led by the Yale School of Public Health, published findings from their research on the projected benefit if the US had a universal healthcare system during the COVID-19 pandemic. The study, published in PNAS, found that the US could have prevented nearly 339,000 COVID-19 deaths and saved more than US$105 billion in just hospitalization costs under universal health care, based on excess hospitalizations and mortality attributable to the loss of employer-sponsored insurance and low insurance coverage during the pandemic. At the time the study was conducted, the cumulative COVID-19 mortality in the US was 973,459 deaths, so the projected total benefit of universal healthcare would have reduced US COVID-19 mortality by approximately one-third. In 2020 alone, the researchers estimate that universal health care could have prevented more than 200,000 total deaths, including from COVID-19 and non-COVID-19 causes. The absence of universal health care results in myriad barriers to accessing health services, including screening and testing critical to early diagnosis of COVID-19 and other health conditions as well as preventive services, such as vaccination. And the high cost of care can delay care-seeking behavior, which can result in more severe disease. The additional patient burden from COVID-19 also negatively impacted hospital capacity, which compounds increases in mortality. The researchers argue that the fragmented healthcare system and existing societal vulnerabilities left the US ill-prepared to combat the pandemic.