Updates on the COVID-19 pandemic from the Johns Hopkins Center for Health Security.

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The Johns Hopkins Center for Health Security also produces US Travel Industry and Retail Supply Chain Updates that provide a summary of major issues and events impacting the US travel industry and retail supply chain. You can access them here.
In light of the upcoming holidays, we will be altering the schedule for our COVID-19 updates over the next several weeks:

Tuesday, December 22: Normal briefing
Friday, December 25: No briefing
Tuesday, December 29: 12-month review
Friday, January 1: No briefing
Tuesday, January 5: Normal briefing

We hope you, your friends, and your family have a safe and healthy holiday season.
EPI UPDATE The WHO COVID-19 Dashboard reports 73.28 million cases and 1.65 million deaths as of 4:00am EST on December 18.

In total, 72 countries and territories are reporting test positivity greater than 5%, the benchmark established by the WHO earlier in the pandemic, compared to only 35 countries and territories reporting less than 5%*. Among those reporting greater than 5%, 49 are reporting greater than 10% and 23 are reporting greater than 20%, including Mexico with 40%. A number of countries reporting elevated test positivity are clustered in Central and Eastern Europe, Sub-Saharan Africa, and Central and South America. However, many countries do not consistently report test positivity.

Among those with the highest test positivity, most are reporting relatively steady or decreasing trends in test positivity over the past several weeks. Over the past month, 17 countries and territories have reported test positivity decreases of 5 percentage points or more, including 7 that have reported decreases of 10 percentage points or more. Most notably, Trinidad and Tobago has reported a decrease of 22.3 percentage points over that time. A notable exception is the Democratic Republic of the Congo (DRC). The DRC’s test positivity has tripled from approximately 10% to more than 30%, since late October (and still increasing).
*Many countries do not routinely report test positivity at the national level.

The US CDC reported 16.76 million total cases and 306,427 deaths. Yesterday, the US reported 236,913 new cases, the second highest daily total to date. The US continues to average more than 210,000 new cases per day.

The US reported 3,435 deaths yesterday, the highest single-day total to date*. The US is averaging more than 2,500 deaths per day and still increasing. At this pace, the US could surpass 330,000 cumulative deaths—approximately 1 death for every 1,000 people—in the next 9-10 days. The CDC’s ensemble model projects that the US could surpass 3,000 deaths per day (50% range: 19,082-23,982 weekly deaths; 2,726-3,436 daily deaths) and 375,000 cumulative deaths (50% range: 369,333-384,185) by January 9.
*With the exception of April 15, when New York City reported more than 3,700 previously unreported probable deaths identified since the onset of its epidemic.

In total, 15 states are reporting cumulative mortality in excess of 100 deaths per 100,000 population (or 1 death per 1,000 population)—as well as Washington, DC, and New York City. This includes 4 states, and New York City (292), that are reporting more than 150 deaths per 100,000 population: Connecticut (153), Massachusetts (165), New Jersey (200), and North Dakota (153). With the exception of North Dakota, these states reported some of the earliest cases and were severely affected early in the US epidemic at a time when there were few available treatment options, critical supplies and equipment like ventilators were in short supply, and hospitals and health systems were overwhelmed. Among the rest of the states reporting more than 100 deaths per 100,000 population, several—including Arizona, Indiana, Illinois, Iowa, Mississippi, and North and South Dakota—were more severely affected later in the epidemic, in the summer surge or the ongoing autumn/winter surge. 

The Johns Hopkins CSSE dashboard reported 17.24 million US cases and 311,230 deaths as of 11:30am EST on December 18.

US FDA MODERNA VACCINE MEETING A week after issuing a recommendation to authorize the Pfizer/BioNTech vaccine, the US Vaccine and Related Biological Products Advisory Committee (VRBPAC) recommended that the US FDA issue an Emergency Use Authorization (EUA) for Moderna’s candidate SARS-CoV-2 vaccine, based on Phase 3 clinical trial data. The FDA is expected to issue the EUA within the next day or so, which would make the Moderna vaccine the second vaccine authorized for use in the US. VRBPAC recommended the Moderna vaccine for adults aged 18 years and older, administered in 2 doses spaced 28 days apart. This differs slightly from the Pfizer/BioNTech vaccine, which was recommended for individuals aged 16 and older, with 2 doses given 21 days apart. VRBPAC voted 20-0 in favor of the recommendation, with 1 abstention.

The Moderna vaccine demonstrated an acceptable safety and efficacy profile in Phase 3 clinical trials, with an estimated 95% efficacy among participants under 65 years old. For participants aged 65 years and older, the efficacy decreased somewhat to 86.4%. In addition to demonstrating efficacy in preventing symptomatic COVID-19 disease, the Moderna vaccine also demonstrated efficacy in preventing severe disease, with 30 severe cases of COVID-19 among the placebo group compared to only 1 in the treatment group (which is reportedly still being investigated). One major advantage of the Moderna vaccine over the Pfizer/BioNTech vaccine is its cold chain requirements. The Moderna vaccine can be stored at 36-46°F (2-8°C), which is similar to standard freezers and refrigerators, as opposed to -112°F to -76°F (-80°C to -60°C) for the Pfizer/BioNTech formulation. This would make distribution and storage much less resource intensive for health departments, health systems, and other organizations as they implement mass vaccination operations.

US VACCINATION The complex cold chain logistics required for the Pfizer/BioNTech SARS-CoV-2 vaccine have proven challenging in certain settings in the first week of the United States’ vaccination operations. While the principal concern in planning for the distribution of this vaccine has been ensuring that the vaccine remains cold enough, incidents in Alabama and California demonstrate that allowing the vaccines to get too cold could also be a risk. Reportedly, several thousand doses of the vaccine shipped to Alabama and California were exposed to temperatures below the acceptable threshold of -112°F (-80°C) while en route to the state distribution centers. The issue was identified before the doses were unloaded from the truck, and the doses were “quarantined” while Pfizer and federal health and regulatory officials determine whether they remain viable. Pfizer shipped replacement doses to both states. These incidents highlight how challenges in implementing cold chain logistics can lead to wastage of vaccine doses, which could be particularly impactful when supply and production capacity are limited.

The incidents also highlight the importance of temperature monitoring throughout the vaccine distribution and administration process. Reportedly, Pfizer planned to disconnect the temperature monitoring sensors on the shipment containers once delivered to healthcare providers, which would not allow hospitals, health departments, and other organizations storing the vaccine to monitor temperatures to ensure they are stored properly and thawed in accordance with the requirements necessary to administer the vaccine. In response, the US government awarded a US$25 million contract to the Icelandic company that created the temperature monitoring platform used for Pfizer’s shipping containers. Under the new plan, Pfizer will stop monitoring temperatures after the shipment arrives, and the US government will turn the system on again to resume the temperature monitoring. 

Vaccinating residents in nursing homes and long-term care facilities (LTCFs) will come with unique challenges. Residents and staff of LTCFs account for nearly 40% of COVID-19 deaths in the US, but while LTCF residents are prioritized in the first tier of vaccination, some residents and staff are expressing hesitancy about the vaccine. The concerns include staff members calling in sick due to side effects from the vaccine, which could exacerbate existing staffing shortages, particularly at a time when residents may require increased attention and care due to their own side effects. Additionally, there are questions about how to obtain informed consent for residents who are not capable of providing it themselves. The residents’ legal representatives will be able to provide consent by phone or electronically, but multiple news media reports indicate that there remains uncertainty about the consent process among LTCFs across the country. There are also questions regarding how to conduct make-up vaccination operations for residents and staff who may not be able to be vaccinated during their site’s designated time.

EASTERN MEDITERRANEAN VACCINE AUTHORIZATION Bahrain and the United Arab Emirates (UAE) are the first 2 countries to “grant full approval” for a SARS-CoV-2 vaccine. The vaccine, produced by China’s Sinopharm, reportedly has an efficacy of 86%, but supporting data have not been published publicly. Scientists and researchers around the world have called for clinical trial data to be released in order to better evaluate the vaccine’s safety and efficacy profile. Even China has not yet issued full approval for the vaccine. The UAE announced the vaccine’s approval on December 9 and Bahrain announced its decision shortly thereafter. Following its announcement, Bahrain unveiled its national SARS-CoV-2 vaccination plan and vaccine registration system. Bahrain aims to open 27 vaccination centers nationwide and administer 5,000 vaccinations per day with the aim of increasing to 10,000 per day.

In addition to the Sinopharm vaccine, Bahrain, Kuwait, Oman, and Saudi Arabia reportedly authorized the use of the Pfizer/BioNTech SARS-CoV-2 vaccine.

AUSTRALIAN VACCINE Last week, researchers stopped clinical trials of an Australian candidate SARS-CoV-2 vaccine after HIV tests returned false positive results in multiple participants. The vaccine, developed at the University of Queensland, uses a “small fragment of an HIV protein” as part of a “molecular clamp” mechanism that latches onto the SARS-CoV-2 spike protein. According to a statement by the University of Queensland, participants developed an antibody response to the protein fragment that was sufficient to “interfere with certain HIV tests.” The researchers anticipated that the protein fragment could elicit an immune response, but they did not anticipate that it would be on the scale identified in the Phase 1 trial. At no time was there any risk of vaccine recipients being infected with HIV, and the subsequent HIV testing confirmed that none of the participants were infected. No serious adverse events were identified among the participants.

Identifying these types of issues is exactly what clinical trials are designed to do. This example highlights the challenges that candidate vaccines and other drugs face, and the researchers demonstrated a level of transparency that should generate confidence that the appropriate steps are being taken to ensure that SARS-CoV-2 vaccines are safe and effective.

BRAZIL MANDATORY VACCINATION Brazil’s Supreme Court reportedly ruled that SARS-CoV-2 vaccination could, from a legal standpoint, be “required, but not forced.” Brazil already mandates a number of routine vaccinations, but the Supreme Court decision prompted protests against mandatory vaccination. In São Paulo, where Governor João Doria has supported mandatory vaccination, more than 300 protesters gathered in opposition of a vaccine mandate for SARS-CoV-2. Additionally, the protesters expressed support for Brazilian President Jair Bolsonaro, who has opposed large-scale social distancing and other mitigation policies throughout Brazil’s epidemic. President Bolsonaro recently stated that he will not get vaccinated due to having antibodies following his previous SARS-CoV-2 infection. If Brazil were to mandate vaccination, the exact mechanism by which such a mandate could be enforced is unclear, particularly without support from the president.

Brazil is currently reporting nearly 47,000 new cases per day, the second highest daily incidence globally, behind the US. Brazil’s current surge has already surpassed its first, and it is still increasing. Brazil’s daily mortality is increasing as well, with more than 1,000 deaths reported yesterday—for the first time since September. Cumulatively, Brazil ranks #3 globally in terms of incidence, with 6.18 million cases, and #5 globally in terms of mortality, with nearly 185,000 deaths.

AT-HOME TESTING The US FDA issued Emergency Use Authorizations (EUAs) for 2 new at-home testing products, including the first test that can be performed completely independently of the healthcare setting. The first test, produced by Ellume, is a lateral flow antigen test that can provide results in as few as 20 minutes. The kit can be used to test individuals with or without symptoms, including those as young as 2 years of age. The test was demonstrated to have a sensitivity of 96% and specificity of 100% for symptomatic individuals and a sensitivity of 91% and specificity of 96% for asymptomatic individuals. The Ellume test kit uses an analyzer that provides the results via a smartphone application, which also automatically reports the test results to local public health authorities. Perhaps most notably, the test will be available without a prescription. Ellume announced plans to scale up production of the test kits in 2021, and it is currently planning to sell individual test kits for $30 each.

The second EUA was issued for Abbott BinaxNOW COVID-19 Ag Card Home Test. This test is also a lateral flow antigen test, and it can provide results in as few as 15 minutes, but it requires telehealth supervision to administer. The Abbott test allows the user to see the test results directly via the test, much like an at-home pregnancy test. Notably, this test requires a prescription from a healthcare provider, and it is only authorized for individuals with COVID-19 symptoms. The test has an estimated sensitivity of 91.7% and specificity of 100%. Abbott indicated that it expects to distribute 30 million BinaxNOW tests by the end of March 2021, and the tests will cost $25 each. 

GLOBAL VACCINATION The initiation of mass vaccination programs in countries like Canada, the UK, and the US have drawn additional attention to questions regarding the timeline for global vaccination efforts and vaccine efforts in other countries. Public data has shown that higher-income countries have secured access to more vaccine supply than what is actually needed to fully immunize their populations, while lower-income countries may only be able to vaccinate 20% of their population by the end of 2021. While these countries have theoretically ordered a surplus of vaccine doses, it is likely that not all of the vaccines on order will ultimately receive an authorization from regulatory authorities.

A statement issued by the People’s Vaccine Alliance, which includes Amnesty International and Oxfam among other organizations, warned that large purchases by individual countries could jeopardize the success of collaborative, multilateral efforts like GAVI’s COVAX financing facility, which strives to provide access to vaccines to under-resourced countries. While some higher-income countries—including Canada, which recently authorized the use of the Pfizer vaccine—are major donors for COVAX, the funding may not be able to provide vaccines if the initial supply is concentrated in higher-income countries.

DOWN SYNDROME A recent report finds that Down syndrome, a genetic condition that results from a third copy of chromosome 21, could increase the risk of severe COVID-19. A commentary published in the Annals of Internal Medicine in October reported that the risk of hospitalization for COVID-19 increased 5 times and the risk of death increased 10 times among individuals with Down syndrome, based on a study of 8.26 million people in the UK. The risk increased substantially for individuals aged 40 and older, putting their risk of severe illness on par with individuals aged 80 and older among the general population.

As countries finalize plans and begin implementing mass vaccination efforts, some experts are calling for individuals with Down syndrome to be placed at high priority for vaccination and to receive therapeutics such as monoclonal antibodies. Notably, the UK’s Joint Commission on Vaccination and Immunisation included Down syndrome among other priority health conditions for SARS-CoV-2 vaccination, but the US CDC does not list it among the conditions associated with increased risk of severe COVID-19 disease and death.

US ECONOMIC STIMULUS It appears that momentum is building for US government efforts to finalize an economic relief package in response to its ongoing COVID-19 epidemic. The current effort continues to evolve, but there is reportedly growing support for a US$900 billion relief package. Congressional negotiations are ongoing in conjunction with efforts to finalize the federal budget and avoid a government shutdown. Reportedly, Democrat and Republican leaders have made efforts to compromise in recent days and weeks on some of their biggest priorities. Democrats have withdrawn demands to include additional funding for state and local governments that are facing both decreased income through sales tax and other revenue and increased budgets due to the COVID-19 response, and Republicans have compromised on demands for liability protections for business owners. It remains unclear whether an economic package could include direct payments to individuals like the CARES Act did.

Public support for another economic relief package, the first since the CARES Act in March, is high across the country. A poll conducted by Vox and Data for Progress found that the public prioritizes COVID-19 relief over the size of the US deficit. Delays in government relief packages have led some states to take individual actions. For example, New Mexico recently approved a plan to distribute US$1,200 payments to 130,000 unemployed residents.

EXCESS MORTALITY IN US ADULTS AGES 25-44 Young adults are generally at lower risk for severe disease and death than older adults, and increased activity in the community. However, a recent study found that all-cause excess mortality increased among younger adults in the US from March to July, not all of which was directly attributable to COVID-19. The study, published in JAMA, was conducted by researchers in Arizona, Connecticut, and Massachusetts who evaluated COVID-19 and all-cause mortality data published by the US National Center for Health Statistics (NCHS).

In total, the NCHS reported 76,088 deaths among adults aged 25-44 years during the study period, including 4,535 COVID-19 deaths. Compared to the same months in 2016-2019, the 2020 all-cause mortality was nearly 12,000 deaths above the expected total, an increase of 19%. Notably, however, COVID-19 deaths accounted for only 38% of the increase. The direct impact of COVID-19 on excess mortality varied by US Department of Health and Human Services regions (1-10). For example, in Region 2—which includes New York and New Jersey—the all-cause mortality was 130% hither than expected, and COVID-19 deaths accounted for 80% of the increase. The proportion of excess deaths due directly to COVID-19 was much higher than most other regions. Both New York and New Jersey were severely affected during the initial US surge, so it is not surprising that COVID-19 directly accounts for a large proportion of excess mortality during that period.

The authors did not attempt to determine the cause of the excess mortality not attributed directly to COVID-19; however, they discussed potential contributors. The authors suggest that lower testing rates among younger adults, as they are lower risk and experience milder symptoms, may result in underascertainment and underreporting of COVID-19 deaths among this population. If this is the case, then COVID-19 would directly account for a larger proportion of the excess mortality. Additionally, as we have covered previously, many individuals delayed screening and treatment for health conditions during periods of enhanced social distancing measures (e.g., stay at home/safer at home orders), which some believe contributed to increased mortality for some diseases and conditions. The study period covers the initial COVID-19 surge in the US, and further analysis will be required to account for excess mortality during the summer and autumn/winter surges.

TURKEY COVID-19 REPORTING Beginning November 25, Turkey updated its COVID-19 reporting to include asymptomatic infections. Since July, Turkey had only reported symptomatic cases, and the update increased Turkey’s average daily incidence from approximately 6,000 new cases per day to more than 30,000. As part of this update, Turkey added previously unreported asymptomatic infections to its cumulative total on December 10, increasing its cumulative incidence by more than 800,000 cases. Turkey is now reporting a cumulative total of 1.98 million cases and 17,610 deaths, jumping to #6 globally in terms of total incidence. Turkey’s change in reporting policy comes after months of pressure from the Turkish Medical Association, a nationwide organization of clinicians, which advocated for reporting the full COVID-19 incidence rather than just symptomatic cases.

In response to its ongoing COVID-19 surge, Turkish President Recep Tayyip Erdoğan reportedly announced a 4-day national “lockdown” starting New Year’s Eve in an effort to slow transmission over the holiday weekend. Turkey has used weekend “lockdowns” over the past several weeks in an effort to curb transmission, following a surge in reported mortality. Turkey’s daily mortality has tripled since the end of October—and doubled since November 21—up to 230 deaths per day and still increasing.

CRISIS STANDARDS OF CARE Hospitals across much of the US are experiencing alarming surges in COVID-19 patients. Many intensive care units (ICUs) across the country are already at or exceeding their design capacity, and many more will reach this point in the coming weeks. In an effort to mitigate the impact of the current surge, hospitals are canceling admissions and non-emergency procedures; implementing creative solutions to augment staffing; transferring patients to other facilities, including in other jurisdictions; and even establishing and operating alternate care sites.

The Johns Hopkins Center for Health Security and 7 other national organizations issued a statement calling for immediate action to implement crisis standards of care (CSC) during the current COVID-19 surge. CSC may be necessary when healthcare resource shortages—including staffing, hospital or ICU beds, equipment, and medications—are severe enough that conventional standards and processes for treating patients are not feasible. Many hospitals and localities are experiencing such shortages now. CSC plans ensure that the most good is done for the largest number of people, and using consistent plans can help ensure equity among patients, speed decision-making regarding the allocation of limited resources, and relieve clinicians of the burden of making these difficult decisions on their own. The joint statement recommends key actions for governors, state health departments, and hospitals and health systems to support, plan for, and equitably implement crisis standards of care in the midst of the ongoing national COVID-19 surge.