EPI UPDATE The WHO COVID-19 Dashboard reports 643 million cumulative cases and 6.62 million deaths worldwide as of December 8. Global weekly incidence remained relatively stable last week, decreasing 1.3% compared to an increase of 16.8% the previous week. A total of 3.04 million cases were confirmed the week of November 28. Weekly incidence fell over the previous week in Africa (-64%)*, South-East Asia (-27%), Western Pacific (-10%), and the Eastern Mediterranean (-4%). The Americas (+14%) and Europe (+4.5%) regions experienced increasing weekly incidence. Global weekly mortality decreased from the previous week, down 17%.
*The WHO dashboard notes that data from the Africa region are incomplete.
The US CDC is reporting 98.8 million cumulative cases of COVID-19 and 1.08 million deaths. Incidence for the week ending November 30 remained relatively stable over the previous week, falling to 303,101 cases from 306,856 cases for the week ending November 23. Weekly mortality fell significantly for the week ending November 30, with 1,780 reported deaths compared to 2,634 deaths the week ending November 23. The decline could be a result of delayed reporting due to the US Thanksgiving holiday.**
**The US CDC updates weekly COVID-19 data on cases and deaths on Thursdays by 8pm ET.
Both new hospital admissions and current hospitalizations continue to rise, increasing last week by 20% and 18%, respectively, over the previous week.
The Omicron sublineages BQ.1.1 (32%) and BQ.1 (31%) together represent the most dominant subvariants of sequenced specimens. A host of other Omicron sublineages—including BA.5 (14%), BF.7, XBB, BN.1, BA.4.6, BA.5.2.6, BF.11, BA.2, BA.2.75, BA.2.75.2, and others—make up the remainder of cases.
US SENATE COMMITTEE REPORT Initial efforts to curb the novel SARS-CoV-2 outbreak in early 2020 was “one of the worst public health responses in US history,” according to a 242-page report released today by Democrats on the US Senate Homeland Security and Governmental Affairs Committee. The latest of several federal efforts to evaluate the nation’s pandemic response, the report focuses only on the first few months of the pandemic, saying the federal government “failed to heed critical public warnings” and has many longstanding and ongoing “systemic problems” that hamper US government preparedness and response capacities. Those problems include weaknesses in data collection and analysis, insufficient testing capacity, supply chain vulnerabilities, overlapping government roles, and, critically, “insufficient funding across multiple administrations.”
Some of the report’s recommendations will require new legislation and funding, according to the authors, although they did not offer an amount. US CDC Director Dr. Rochelle Walensky in an interview with Roll Call this week said the agency is running out of funding to help stave off a winter COVID-19 surge and for other near-term activities. In addition to calling for more funding, she urged the US Congress to improve CDC’s authority to collect data. The White House last month requested nearly US$10 billion more for short-term pandemic response needs, but lawmakers so far have refused to include additional COVID-19 spending in a year-end funding bill.
MASK USE The US CDC is once again encouraging people to wear masks to help reduce the spread of respiratory illnesses, as hospitalizations rise due to the so-called “tripledemic” of COVID-19, RSV, and flu. The nation appears to be at the start of another COVID-19 wave, with hospitalizations reaching a 3-month high last week. Hospitals are already feeling strain from earlier-than-normal increases in RSV and flu cases and hospitalizations. The US is experiencing the highest levels of hospitalization from flu that it has seen in a decade this early in the season. Experts warn that holiday gatherings present a prime opportunity for respiratory viruses to spread and urge people to take precautions, including mask use, physical distancing, testing, and increased air ventilation. While it is unlikely that widespread mask mandates will return, masking in crowded areas can lower the risk of infection and help decrease the burden on overwhelmed hospitals.
One more reason to don a mask during the colder months could be to help keep your nose warm. A study published this week in the Journal of Allergy and Clinical Immunology suggests that exposure to cold temperatures hinder immune responses in the upper respiratory tract by killing nearly half of the virus and bacteria-fighting cells in the nostrils, allowing viruses or bacteria to evade this initial immune response.
INDOOR AIR QUALITY The Lancet COVID-19 Commission Task Force on Safe Work, Safe Schools, and Safe Travel recently published a report on air delivery rates capable of reducing the spread of airborne diseases indoors. The report states that air filtration and ventilation targets in current building standards were not designed to prevent the spread of airborne diseases, including SARS-CoV-2, and the authors recommend a set of new non-infectious air delivery rate (NADR) targets that could improve overall occupant health and prevent the spread of respiratory illnesses. The NADR targets include a gradient from good to best of 4 air changes per hour, 6 air changes per hour, and greater than 6 air changes per hour. Some research indicates that 5 air changes per hour can reduce the risk of SARS-CoV-2 transmission by approximately 50%.
Additionally, the Board of Directors of the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) this week announced intentions to develop an indoor air quality standard for pathogen mitigation within the next 6 months. ASHRAE’s 2022-2023 President, Farooq Mehboob, further affirmed commitment to the idea that the health and wellbeing of building occupants should be a crucial aspect of building design and operation. The standard is expected to contain aspects related to building design and operation, alternative pathways for clean air, and testing and verification.
The Lancet COVID-19 Commission Task Force report and ASHRAE announcement come at a time when more governments and professional organizations are examining indoor air quality as a means to reduce disease transmission. Mechanical interventions to disease transmission, such as air filtration and ventilation, can be applied throughout an entire building and are not reliant on the individuals' actions to work effectively. The recent increase in attention to indoor air quality has largely been driven by the COVID-19 pandemic, but long-term improvements will continue to reduce the risk of other respiratory diseases such as influenza, measles, RSV, and others.
COST OF TREATMENTS & VACCINES As federal funding to support COVID-19 healthcare runs out, US residents without insurance are finding it increasingly difficult to receive the necessary care that was universally accessible only months ago. The Biden administration’s requests to the US Congress for additional funding for the COVID-19 response so far have been unsuccessful, despite the potential for new variants and a winter surge in cases. The federal government expects to allow manufacturers of COVID-19 vaccines and treatments to move their products to the commercial market by summer 2023, which could further limit access to people without insurance and others who do not have the means to pay.
As a result, public health experts predict that fewer people will seek lifesaving COVID-19 treatments, such as Paxlovid. Paxlovid has been administered at no cost to nearly 6 million US residents, as a result of federal funding; however, with dwindling funding and restrictions preventing Medicare coverage of the treatment, drug pricing is certain to become a substantial barrier for those seeking the therapy. The federal government has been able to purchase Paxlovid for $530 per course—a significantly discounted rate, according to Pfizer, the drug’s manufacturer. Likewise, the Biden administration has announced it no longer has funding to purchase additional COVID-19 vaccines, without action from Congress, and provide them at no cost to consumers. An analysis from KFF shows the cost of the Pfizer-BioNTech and Moderna COVID-19 vaccines is expected to increase at least 3-fold from the pre-purchased federal price when the products reach the commercial market, to approximately US$96 to US$130 per dose.
BIVALENT VACCINES The US CDC last week published its first “real-world” effectiveness data on updated bivalent SARS-CoV-2 mRNA boosters, showing the shots provided significant additional protection against symptomatic SARS-CoV-2 infection among people who previously received 2, 3, or 4 monovalent vaccine doses. Notably, the benefit of the bivalent booster increased with time since receipt of the most recent monovalent vaccine dose. The data were collected from pharmacy-based testing conducted between September 14 and November 11, 2022. Another study, published December 6 in Nature Medicine by researchers from the University of Texas Medical Branch, showed the bivalent boosters elicited a robust antibody response against the Omicron BA.4/BA.5 subvariants but not against the more recent BA.2.75.2, BQ.1.1, or XBB.1 Omicron subvariants, possibly because of their additional mutations in the spike protein. The researchers noted the adaptability of the mRNA platform and suggested future boosters be altered to match newly emerged variants.
In related news, the European Medicines Agency (EMA) this week backed the use of bivalent mRNA vaccines targeting both the original SARS-CoV-2 strain and the Omicron BA.4/BA.5 subvariants as a primary series in previously unvaccinated adults and children. The agency said the decision was based on data suggesting the bivalent vaccines should produce a robust immune response in previously unvaccinated and unexposed individuals and have a similar safety profile to the original mRNA vaccines. This recommendation paves the way for national authorities in Europe to use the bivalent mRNA technology in future vaccine campaigns.
In the United States, Pfizer-BioNTech has asked the US FDA to authorize their bivalent mRNA vaccine for use in children under age 5 as part of the initial vaccine series. Currently, children under 5 receive 3 small doses of the monovalent vaccine formula targeting the original SARS-CoV-2 strain. The series that Pfizer-BioNTech is asking regulators to authorize would replace the 3rd shot in the primary series with a dose of the bivalent vaccine. Pfizer and BioNTech say the new series could help prevent severe illness and hospitalization among children at a time when other respiratory diseases, such as influenza and RSV, are straining hospital systems.
US MILITARY VACCINE MANDATE US House and Senate lawmakers this week released a compromise US$858 billion defense authorization bill that would increase military spending by 8% over fiscal year 2022 levels and rescind the military’s COVID-19 vaccine mandate for service members. The mandate—which required troops to be separated if they refused the vaccine and did not receive a waiver—became a point of contention in recent days’ talks, after conservatives threatened to hold up the bill if the measure was not removed from the final version of the National Defense Authorization Act (NDAA). Both the White House and US Secretary of Defense Lloyd Austin want to keep the vaccine mandate in place to protect the health of military members and national readiness. The White House declined to explicitly state whether US President Joe Biden will sign the annual defense bill if it includes the provision to rescind the mandate. Both the House and Senate need to pass the bill before it heads to President Biden.
CHINA On December 7, China announced significant easing of its strict “zero COVID” policy, including relaxation of frequent mass PCR testing and digital health codes that were required for people to go about their daily life or travel within the country. The changes, released by the State Council in a 10-point plan, also allows those with less severe coronavirus infections to quarantine at home rather than in centralized facilities. The changes, an extension of a November 20-step “optimization” plan aimed at reducing the economic and social costs of restrictions, came after unprecedented protests in more than a dozen cities nationwide over recent weeks. Many residents expressed relief over the policy’s relaxation but some, including health experts, voiced unease over the rapidity of the changes, leaving many concerned that the population is unprepared for what could be an impending surge in cases. Most people in China have not been exposed to the virus, which would have given residents some natural immunity; vaccination and booster rates are lagging, especially among older adults; and the country’s domestically developed vaccines offer suboptimal protection compared to mRNA vaccines. Additionally, some experts say China has not effectively communicated how to move from "dynamic" suppression to mitigation, leaving some people believing they can simply return to pre-pandemic life.
Some are worried a spike in infections will overwhelm the healthcare system and bring a high death toll—as many as 1 million people, according to some models. Already, hospitals are reporting an influx of COVID-19 patients and rationing fever medicines such as ibuprofen and paracetamol because of shortages. The Chinese government appears to be placing some faith in what they say is a “less pathogenic” Omicron variant, but experts warn that all of Omicron’s sublineages remain capable of causing severe disease and post-acute COVID-19 symptoms, particularly in a population with little to no natural immunity. To some experts, it appears China is moving out of its “zero COVID” restrictions without a solid plan—such as strategies implemented by Australia, New Zealand, and Singapore, all of which followed some type of zero COVID approach—and at a time when the dominant viral strains are more transmissible. For now, China—and the world—will have to wait and see how the nation fares.
GLOBAL ACCESS TO MEDICAL COUNTERMEASURES Global demand for COVID-19 vaccines is falling rapidly worldwide. The Board of Directors of Gavi, the Vaccine Alliance, the nonprofit organization that led the COVAX initiative, is set to vote this week on a proposal to allow the vaccine delivery mechanism to lapse sometime in 2023. If approved, no-cost COVID-19 vaccines would be included in Gavi’s standard immunization programming for the 54 low-income nations that traditionally receive the organization’s support, and 37 other middle-income nations would receive a one-time payout to help them establish their own COVID-19 vaccination programs. The Board is also considering other issues, including efforts to bolster or begin routine immunization programs that were delayed during the pandemic and a proposal from the Gavi secretariat to keep a “pandemic preparedness pool” of US$1.8 billion to allow the acquisition of future COVID-19 vaccine doses. Some Board members expressed concern over the latter proposal, saying such a fund could unintentionally broaden Gavi’s mandate and that the organization does not have governance in place to manage those funds.
In related news, the US government has expressed support for extending a December 17 deadline to decide whether the World Trade Organization’s Ministerial Decision on waiving intellectual property protections for COVID-19 vaccines should encompass diagnostics and treatments. US Trade Representative Ambassador Katherine Tai said her agency will ask the US International Trade Commission to investigate certain market dynamics such as pricing, production, access, and supply and demand, a process that usually takes 9-12 months. The move will delay the prospects of a World Trade Organization agreement meant to improve global access to COVID-related medical countermeasures.