EPI UPDATE The WHO COVID-19 Dashboard reports 102.94 million cases and 2.23 million deaths as of 11am EST on February 2. The weekly global incidence decreased for the third consecutive week, down to 3.63 million new cases. This is a decrease of nearly 15% compared to the previous week, and it is the lowest weekly total since late October. Weekly global mortality also decreased nearly 4% compared to the previous week, down to 93,803 deaths. Considering the reporting interruptions over the winter holidays, it is unclear exactly when the actual global incidence peaked; however, the decrease in mortality could be an early indication of a longer-term trend corresponding to decreases in incidence starting 2-4 weeks ago.
Our World in Data reports that 101.31 million vaccine doses have been administered globally, a 48% increase since this time last week.
The US CDC reported 26.03 million total cases and 439,955 deaths. The US is currently averaging 3,145 deaths per day, and it could surpass 450,000 cumulative deaths in the next 3-4 days.
National-level daily incidence continues to decrease, down from nearly 250,000 new cases in per day in mid-January to around 150,000. While the daily incidence continues to decrease, the current average is still more than double the peak of the summer surge. Daily mortality is also beginning to show signs of declining. The US has reported decreasing daily mortality for 5 consecutive days, down 5% since January 26. Additional data are needed to determine if this is an early indication of a longer-term trend, but a decrease spanning multiple days is an encouraging sign.
The US CDC reported 49.94 million vaccine doses distributed and 32.22 million doses administered. The US has administered 64.5% of the distributed doses, which is an increase of more than 10 percentage points from Friday’s update (54.1%). In total, 26.02 million people (approximately 7.9% of the US population) have received at least 1 dose of the vaccine, and 5.93 million (1.8%) have received both doses. The US is now averaging 1.36 million doses administered per day, a 20% increase from the previous week. The breakdown of doses by manufacturer remains relatively even, with slightly more Pfizer/BioNTech doses administered (17.36 million; 54%) than Moderna (14.76 million; 46%).
The CDC moved data for vaccination at long-term care facilities (LTCF) to its own dashboard. A total of 3.75 million doses have been administered through the Federal Pharmacy Partnership for Long-term Care Program*, covering 3.14 million individuals with at least 1 dose and 594,857 with 2 doses. The dashboard breaks down the doses by those administered to LTCF residents and those administered to staff. Based on the available data, approximately 60% of the doses have gone to residents and 40% to staff.
*The dashboard only includes data for doses administered through the federal program. It does not report data from West Virginia, which opted out of the program.
RUSSIAN VACCINE Sputnik V, Russia’s primary vaccine candidate, appears to be safe and effective in preventing symptomatic COVID-19, based on preliminary analysis of Phase 3 clinical trial data published in The Lancet. The clinical trials included nearly 20,000 participants, with 75% randomly assigned to receive the vaccine. The researchers identified 16 cases of COVID-19 among the treatment group (14,964 participants) and 62 cases among the placebo group (4,902), corresponding to an overall efficacy of 91.6% in terms of preventing COVID-19 disease, similar to the results for the Pfizer-BioNTech and Moderna vaccines. Notably, the vaccine also exhibited 91.8% efficacy among adults over the age of 60, and no moderate or severe cases of COVID-19 were reported among the vaccinated participants. No serious adverse events were determined to be associated with the vaccine.
The Sputnik V vaccine is administered in 2 doses, administered 21 days apart. It requires the temperature to be maintained at approximately 0°F (-18°C), with short-term storage at 36-46°F (2-8°C). In contrast, ultra-cold storage (approximately -80°F or -62°C) is required for the Pfizer-BioNTech vaccine.
The Russian government came under criticism in August 2020 after making the Sputnik V vaccine candidate available to the public before Phase 3 clinical trials were completed. More than a dozen other countries have already authorized the use of the Sputnik V vaccine.
US VACCINATION The US CDC COVID-19 Response Team published data from the early stages of SARS-CoV-2 vaccination efforts in the US. The first study, published in the CDC’s MMWR, described demographic characteristics among those vaccinated in the first month—December 14, 2020 to January 14, 2021. The researchers analyzed age, sex, and race/ethnicity data for nearly 13 million individuals who received at least 1 dose of the vaccine. The majority of those vaccinated were older adults, with 55% aged 50 years and older, including 13.4% aged 65-74 years and 15.6% aged 75 years and older. Additionally, 63% of those vaccinated were female.
Among 6.7 million individuals with race/ethnicity data, the majority (60.4%) were White*, compared to 11.5% Hispanic/Latinx, 5.4% Black*, 6.0% Asian*, and 2.3% American Indian, Alaskan Native, Native Hawaiian, or Other Pacific Islander* and 14.4% were listed as Multiple races/ethnicities or Other. The researchers indicate that the demographic distributions appear to largely reflect those of the earliest priority populations outlined by the CDC’s Advisory Committee on Immunization Practices, including LTCF residents and healthcare workers. Notably, however, the proportion of Black vaccinees was lower than would be expected considering the racial/ethnic distribution these priority groups.
The second article, also published in the CDC’s MMWR, discussed vaccination coverage among LTCF residents and staff. The researchers evaluated data on nearly 1.3 million individuals vaccinated through the CDC Pharmacy Partnership for Long-Term Care Program from December 18, 2020 to January 17, 2021. Among these individuals, 713,909 were residents and 582,104 were facility staff. In total 12,702 facilities participated in the program, of which 11,460 (90.2%) conducted at least one on-site vaccination clinic. This effort provided at least 1 dose of the vaccine to an estimated 77.8% of residents at these facilities, but only 37.5% of staff. Due to a combination of factors—including age, underlying health conditions, and prolonged close contact in congregate settings—LTCF residents are at elevated risk for infection, severe disease, and death, so it is important to achieve high vaccination coverage at these facilities.
In addition to state and local governments, tribal nations are also scaling up vaccination efforts. The Navajo Nation, one of the most severely affected tribal nations during the US epidemic (29,860 cases), eased its weekend curfew in an effort to expand vaccination. The principal challenges are addressing vaccine hesitancy, particularly among older adults who are at elevated risk, and reaching individuals who live in rural areas that are unable or unwilling to travel to get vaccinated, especially during adverse winter weather conditions. Proactive effort by tribal leadership and health workers has driven substantial progress in terms of vaccination coverage. To date, Navajo Nation has administered at least 1 dose of SARS-CoV-2 vaccine to more than 20% of its population, higher coverage than any US state or territory.
VACCINATION PROTESTS Dodger Stadium in Los Angeles, California, is currently serving as one of the largest mass vaccination sites in the US, but protests by anti-vaccination groups caused the site to be temporarily shut down on Saturday when protesters blocked the entrance to the stadium. Fortunately, the disruption did not result in the cancellation of any appointments, but Governor Gavin Newsom emphasized that protests will not be deterred by protests. Protesters reportedly attempted to intimidate individuals waiting in line and spread misinformation about COVID-19 and the vaccine. New safety measures at Dodger Stadium will clearly delineate where protesters are permitted to be in order to prevent further disruptions to vaccination operations.
GERMANY On January 29, the European Commission issued a conditional marketing authorization (CMA) for the use of the AstraZeneca-Oxford University SARS-CoV-2 vaccine in adults aged 18 and older. While the announcement acknowledged that the clinical trials primarily included adults aged 18-55 years, the CMA did not include an upper age limit. In a decision stemming from a concern about insufficient efficacy data in older adults, Germany authorized the AstraZeneca-Oxford vaccine only for adults aged 18-64. Currently, vaccine eligibility in Germany is limited to residents and staff of long-term care facilities, adults aged 80 years and older, and frontline healthcare workers. Because the AstraZeneca-Oxford vaccine is not authorized for many high-risk individuals due to Germany’s age restrictions, Germany will reportedly review its eligible populations and prioritize use of that particular vaccine in younger healthcare workers and LTCF staff.
Germany has struggled with a slow start to its vaccination campaign, and Chancellor Angela Merkel reportedly met with state governors, EU leadership, and representatives from the pharmaceutical industry yesterday to identify mechanisms to speed progress toward national vaccination coverage. Following the meeting, Chancellor Merkel indicated that Germany still anticipates being able to vaccinate its entire population by September 2021, even if no additional vaccines are authorized for use.
Like many countries around the world, Germany recently instituted travel restrictions in response to emerging, highly transmissible SARS-CoV-2 variants. Notably, non-German citizens arriving from “areas of variant of concern”—currently Brazil, Eswatini, Ireland, Lesotho, Portugal, South Africa, and the UK—will not be permitted to enter the country, even with a recent negative SARS-CoV-2 test. Individuals who are eligible to enter—including German citizens and residents—and recent travel to “high incidence areas” or “virus variant areas” must provide proof of a negative test prior to entry, and all individuals with recent travel to “risk areas”—which covers most countries, including most in Europe—must be tested within 48 hours after arrival. All travelers arriving from places identified as at risk, high-incidence, or variant areas are required to self-quarantine for 10 days after they arrive. The quarantine can potentially be terminated after 5 days, with a negative test. The new restrictions are expected to remain in place through at least February 17.
DRC DRONE VACCINE DISTRIBUTION Drones have previously been used for the delivery of medical supplies, including vaccines, to areas that are remote or difficult to access. The Democratic Republic of the Congo (DRC) recently announced a partnership between VillageReach, Swoop Aero, and the DRC Ministry of Health—“Drones for Health”—will use drone to promote equitable access to healthcare for half a million people in remote communities of the Equateur province. In addition to standard medical supplies, the new program is expected to support SARS-CoV-2 vaccination efforts in the country. These drones will be used to deliver medicine and other supplies to 75 health facilities in the province.
REFUGEES & DISPLACED POPULATIONS Refugees are among the most vulnerable populations in the world, particularly in the midst of a pandemic. Being displaced from their homes and separated from community support systems, refugees and other displaced populations often live in congregate settings without access to clean water or proper sanitary equipment, which exacerbates risk of transmission and severe disease. Furthermore, displaced populations face significant barriers in terms of accessing healthcare, and medical organizations that work with these populations are often underfunded and overwhelmed. King Abdullah II Ibn Al Hussein of Jordan recently announced that the Jordanian government initiated vaccination operations for refugee population in the country. King Abdullah viewed it as part of Jordan’s “global responsibility” and “moral duty” to protect the most vulnerable from COVID-19. The UN Refugee Agency (UNHCR) applauded Jordan’s initiative to include displaced populations in its vaccination program and encouraged other countries to follow Jordan’s example.
In recognition of the disproportionate COVID-19 burden among immigrant populations, many of whom are racial and ethnic minorities, the US Department of Homeland Security (DHS) is committing resources to ensure equal access to SARS-CoV-2 vaccines for undocumented immigrants. A statement issued by DHS emphasized the “public health imperative” in ensuring access to vaccination, regardless of immigration status. While many undocumented immigrants are not refugees, they may face similar stigma and barriers to accessing public health and healthcare. As part of this effort, the Federal Emergency Management Agency will coordinate vaccination clinics that aim to reach “underserved and rural communities,” and federal immigration officials, including Immigration and Customs Enforcement and Customs and Border Protection, “will not conduct enforcement operations at or near vaccine distribution sites or clinics” in order to encourage participation by vulnerable individuals and communities.
A study published in JAMA: Pediatrics provides evidence that pregnant women may be able to pass IgG antibodies against SARS-CoV-2 to their fetus. The study involved 1,417 women who recently gave birth. Among 83 mothers with detectable SARS-CoV-2 antibodies, 72 (86.7%) transferred IgG antibodies to their fetus—as detected in the newborns’ cord blood. IgM antibodies were not detected in any cord blood specimens, and antibodies were not detected in any infants born to mothers without detectable antibodies. The concentration of antibodies in the cord blood was significantly correlated with the concentration in the mother, but the antibodies were successfully transferred by mothers who exhibited symptomatic disease and asymptomatic infection. The study did not explicitly evaluate the ability to transfer antibodies developed as a result of vaccination; however, the researchers indicate that the results align with similar studies on transplacental transfer of vaccine-conferred antibodies for other diseases. Further research is necessary to determine the recommended timing for vaccination of pregnant women in order to achieve sufficient transplacental transfer of SARS-CoV-2 antibodies to the fetus.
US ECONOMIC STIMULUS With the Democratic party now in control of the US House of Representatives, Senate, and White House, pressure is increasing to negotiate additional federal economic relief for the COVID-19 epidemic. US President Joe Biden announced his proposal for a new COVID-19 economic stimulus and recovery package, the American Rescue Plan, which includes US$1.9 trillion in funding. The package includes support for SARS-CoV-2 testing and vaccination efforts ($415 million) and small businesses ($440 million). It also includes $1 trillion in direct support for individuals and families, including another round of stimulus checks and increased and extended unemployment benefits. Additionally, the package includes broader provisions to increase the federal minimum wage and expand access to affordable childcare and healthcare.
While the Democratic party holds a majority in the Senate (with the tie-breaking vote from Vice President Kamala Harris), there are limited options available to pass a funding bill without some degree of Republican support. In hopes of stimulating bipartisan negotiations, 10 Republican Senators visited the White House to outline an alternate funding package, which totals $618 billion. The Republican proposal would include smaller and more targeted direct stimulus checks for individuals; maintain the current $300 federal supplemental unemployment benefits through June, as opposed to $400 through September in the White House plan; and reduce support for schools from $170 billion in the White House plan to $20 billion. The Republican plan would also eliminate funding to expand the national public health workforce; $350 billion in support to state, local, and tribal governments; subsidies for health insurance premiums; and the minimum wage increase. The initial meeting was reportedly productive, and there appears to be interest on both sides to continue negotiations.
As we have covered previously, the large-scale response efforts in many jurisdictions—including testing, surveillance, and vaccination—have posed major financial challenges to jurisdictions across the country. An investigation by STAT News found that senior US government officials under the Trump Administration “actively lobbied Congress to deny state governments any extra funding for the Covid-19 vaccine rollout.” STAT News reports that the primary point of contention reportedly dealt with the speed with which states were using previous federal funding allocations for COVID-19 response.
EMERGING VARIANTS As scientists continue to monitor emerging SARS-CoV-2 variants of concern (VOCs), researchers are identifying new mutations. Of particular concern is the E484K mutation, which consists of an amino acid change in the spike receptor binding domain of the SARS-CoV-2 virus. This change appears to result in increased binding strength of the spike protein to the ACE2 receptor, which is how the virus enters human cells. Notably, the E484K mutation appears to result in increased transmissibility and resistance to monoclonal antibody treatments. This mutation has been identified in several variants of SARS-CoV-2 in different geographic areas, including Brazil and the UK, and it appears to be increasing in prevalence, which suggests increased fitness compared to other mutations. The fact that this mutation has been independently acquired in multiple locations and variants indicates that the E484K changes in the spike gene are broadly advantageous to SARS-CoV-2 and may continue to arise in subsequent variants.
Aside from the E484K mutation, scientists monitoring the B.1.1.7 VOC also must track its prevalence and incidence among the population. Since whole genome sequencing to detect the Δ69-70 mutation is costly and time consuming, the UK’s NERVTAG expert group used existing laboratory PCR-based testing to track the variant. Specifically, the Δ69-70 mutation in the spike gene causes S gene target failure (SGTF) in the ThermoFisher TaqPath assay, resulting in a false negative PCR test from a known positive sample. By looking for SGTF in known positive samples (confirmed by other PCR assays), researchers can monitor the extent of the Δ69-70 mutation in the B.1.1.7 VOC without the need for time- and resource-intensive whole genome sequencing methods.
VACCINE DEVELOPMENT & TESTING Clover Biopharmaceuticals, a Chinese company developing a SARS-CoV-2 vaccine candidate, announced that it is moving forward with Phase 2/3 clinical trials for its candidate SARS-CoV-2 vaccine using an adjuvant manufactured by Dynavax, rather than one produced by GlaxoSmithKline (GSK). According to a press release from Clover, the two adjuvants induced similar immune response in Phase 1 clinical trials, but Clover selected the Dynavax adjuvant for its forthcoming Phase 2/3 clinical trials due to concerns about production capacity for the GSK product. Clover anticipates vaccine production capacity of “hundreds of millions of doses in 2021” and ultimately as high as 1 billion doses per year. Clover expects to have preliminary data available from the Phase 2/3 trials by the middle of 2021.