COVID-19 Situation Report
Webinar: COVID-19 and Crisis Standards of Care: The Fourth Wave and the Future

COVID-19 has fundamentally changed the delivery of health care services worldwide, forcing difficult choices on health professionals and laying bare many pre-existing health, medical, and public health sector frailties. A fourth wave of the pandemic, driven by the Delta variant, extreme shortages of key resources have again brought the necessity of crisis standards of care to the forefront of the minds of many clinicians and patients. 

This free webinar, hosted by the National Academy of Medicine on September 17 from 1:00-3:00 p.m. EDT, will feature discussions on past and current challenges in ethically allocating scarce resources in the face of surging demand, including the healthcare staffing crisis, and identify possible solutions to real-time issues and ways to ensure fair decisions are made even when systems are strained.

Find more information and register here.
EPI UPDATE The WHO COVID-19 Dashboard reports 225 million cumulative cases and 4.63 million deaths worldwide as of September 13. Global weekly mortality decreased substantially for the first time since early June, falling 12.7% from the previous week. Weekly mortality decreased as well—for the first time since late June*—down 7.3% compared to the previous week.
*With the exception of the week of July 19, when Ecuador reported 8,786 deaths.

Global Vaccination
The WHO reported 5.53 billion cumulative doses of SARS-CoV-2 vaccines administered globally as of September 13. A total of 3.2 billion individuals have received at least 1 dose, and 2.3 billion are fully vaccinated. Analysis from Our World in Data indicates that global daily vaccinations leveled off after a week of sharp decline, holding relatively steady at 32-33 million doses per day*. The global trend continues to closely follow Asia. Our World in Data estimates that there are 3.3 billion vaccinated individuals worldwide (1+ dose; 42.3% of the global population) and 2.4 billion who are fully vaccinated (30.1% of the global population). In terms of 1+ dose coverage, we expect Oceania (42.1%) to surpass the global average in the next several days, which would leave Africa (5.8%) as the only continent below the global average.
*The average doses administered may exhibit a sharp decrease for the most recent data particularly over the weekend, which indicates effects of reporting delays. In an effort to reflect the longer-term trends, the numbers reported here may not correspond to the most recent data.

The US CDC reports 41.0 million cumulative COVID-19 cases and 658,410 deaths. Daily incidence appears to have passed a peak; however, this likely still includes some effects from delayed reporting over the US Labor Day holiday weekend (September 4-6). A similar trend is evident for daily mortality as well. Even with the delayed reporting over the Labor Day weekend, the average daily mortality is still more than 1,000 deaths per day, and we expect the US to surpass 660,000 cumulative deaths in the next 1-2 days. This threshold corresponds to 1 death for every 500 people in the US. The US surpassed 1 death per 1,000 population on December 18, 2020**. The US is #22 globally in terms of per capita cumulative mortality.
**Changes in the frequency of state-level reporting may affect the accuracy of recently reported data, particularly over the weekend. In an effort to reflect the longer-term trends, the numbers reported here may not correspond to the most recent dates.

US Vaccination
The US has administered 381 million cumulative doses of SARS-CoV-2 vaccines, and daily vaccinations peaked at nearly 834,000 doses per day on August 29 and then decreased sharply over the Labor Day holiday weekend. Considering the expected delays in vaccination reporting, it could be another week or so before we can reassess the longer-term trends*. There are 209.7 million individuals who have received at least 1 dose, equivalent to 63.2% of the entire US population. Among adults, 75.7% have received at least 1 dose, as well as 14.1 million adolescents aged 12-17 years. A total of 179.0 million individuals are fully vaccinated, which corresponds to 53.9% of the total population. Approximately 65.0% of adults are fully vaccinated, as well as 11.1 million adolescents aged 12-17 years.
*Due to delays in reporting, estimates for the average daily doses administered are less accurate for the most recent 5 days. The most current average provided here corresponds to 5 days ago.

VACCINE EFFECTIVENESS With about 54% of the total US population vaccinated, public health officials continue to urge people to get vaccinated and protect themselves from severe illness, hospitalization, and death. As daily incidence and mortality continue to rise, including among younger individuals, evidence continues to emerge regarding the effectiveness of SARS-CoV-2 vaccines. Recent studies from the US CDC show that unvaccinated individuals are 10 times more likely to be hospitalized and 11 times more likely to die from COVID-19 than vaccinated individuals, illustrating the effect of SARS-CoV-2 vaccines in terms of preventing severe disease and death. A study conducted by the CDC’s COVID-19 Response Team evaluated vaccine effectiveness after the Delta variant became dominant in the US, based on data collected from June 20-July 17. The researchers found that vaccinated individuals were 4.5 times less likely to be infected with SARS-CoV-2 compared with vaccinated individuals. While the estimated vaccine effectiveness against infection fell from 91% before June 20 to 78% after that date, effectiveness remained greater than 90% against both hospitalization and death.

ARGUMENT AGAINST BOOSTERS In an expert review published September 13 online in the peer-reviewed journal The Lancet, a group of US and international scientists claim current evidence does not support providing booster doses of SARS-CoV-2 vaccines to the general public. The group—including 2 departing US FDA officials and WHO experts—said that any decision to provide additional vaccine doses should be evidence-based, concluding that despite a small drop in protection against symptomatic disease caused by the Delta variant, authorized vaccine regimens continue to provide high levels of protection against severe disease and hospitalization for all major SARS-CoV-2 variants. The authors acknowledged that some additional doses might be needed immediately for certain elderly and immunocompromised populations, but they encouraged prioritizing primary immunizations over booster shots for the general public.

The authors also acknowledged that booster doses might be necessary in the future due to waning immunity or the emergence of a vaccine-resistant variant but that current evidence does not warrant additional doses now because “efficacy against severe disease remains high.” The authors noted that currently available vaccine doses could save more lives and provide better protection against the emergence of new SARS-CoV-2 variants if used in previously unvaccinated populations, especially those in low- and middle-income countries. 

GLOBAL COVID-19 SUMMIT US President Joe Biden plans to call on global leaders to make new commitments to help end the COVID-19 pandemic during a virtual summit to be hosted by the White House next week. The list of goals, obtained by The Washington Post, includes fully vaccinating at least 70% of the world’s population within the next year; improving access to medical supplies and treatments, including the establishment of a US$2 billion strategy to support “oxygen ecosystems”; and forming and financing a global health security financial intermediary fund (FIF) this year. The event, the Global COVID-19 Summit: Ending the Pandemic and Building Back Better, is expected to bring together heads of state, global health experts from non-profit organizations and academia, and private sector representatives, and is scheduled to be held September 22 during the UN General Assembly meetings.  

In related news, the US government reportedly is is in discussions with India to lift its ban on vaccine exports. India is the world’s largest manufacturer of vaccines, but the government halted exports of SARS-CoV-2 vaccines in March 2021 when the country was experiencing a surge in COVID-19 cases. The ban has been particularly hard on lower-income countries (LICs) that expected to receive Indian-produced vaccines through the COVAX facility. India sold or donated about 66 million vaccine doses to nearly 100 LICs prior to the ban, the government claims. According to UNICEF, the US is the largest donor of SARS-CoV-2 vaccines globally, based on publicly available data. The US has donated and delivered more than 114 million doses, followed by China at 34 million. The WHO estimates 11 billion doses are needed to fully vaccinate at least 70% of the world’s population.

US CHILD VACCINATION The number of new COVID-19 cases among children in the US has risen exponentially in recent weeks, according to the American Academy of Pediatrics, causing many parents to become increasingly eager to vaccinate their young kids, especially as they return to school. But none of the available vaccines are authorized for children under age 12, prompting the US FDA this week to warn parents to not seek out SARS-CoV-2 vaccines for children who are not yet eligible and physicians not to use the now fully approved Pfizer-BioNTech vaccine “off-label” in younger patients, as they might need smaller dosages. The regulatory agency said it is “working around the clock” to support the review process necessary to safely and expeditiously authorize or approve a vaccine for children. US health officials say they are hopeful that a vaccine will be available for 5- to 11-year-olds by the end of the year. Pfizer and BioNTech said they plan to present data on their vaccine among younger children “in the coming weeks,” raising hopes that a vaccine could be made available by the end of October. Until the FDA authorizes a vaccine, families should continue taking other precautions, including mask wearing.

PREGNANCY LOSS Pregnant people are at risk of severe illness due to COVID-19, and infection with SARS-CoV-2 during pregnancy is associated with several adverse maternal and neonatal outcomes, including death, stillbirth, and miscarriage. In Mississippi (US), health officials are urging pregnant individuals to be vaccinated after noting they have recorded 72 fetal deaths past 20 weeks’ gestation since the beginning of the pandemic, double the pre-pandemic rate. State officials also are investigating the deaths of 8 infected pregnant people over the past 4 weeks, all of whom were unvaccinated. Only about 25% of pregnant people have been vaccinated during pregnancy since December 2020, according to US CDC data.

Several recently published studies support CDC guidance for pregnant people to get vaccinated, showing that expectant individuals who receive a SARS-CoV-2 vaccine are not at an increased risk of miscarriage. In a research letter published online in the Journal of the American Medical Association (JAMA), researchers concluded that among more than 105,000 pregnancies, miscarriages were no more likely to occur within 28 days of vaccination compared with ongoing pregnancies regardless of which vaccine was received and gestational age. Similarly, in a letter published in the New England Journal of Medicine (NEJM), CDC researchers said that although risk of miscarriage rose with increasing maternal age among vaccinated pregnant individuals, the risk was within the expected range of 11-22% of recognized pregnancies. Additionally, CDC researchers updated a previous NEJM study published in June in response to a letter published last week, finding the estimated risks of miscarriage among vaccinated pregnant people remained consistent with the risk reported in the general population. Taken together, the studies and the real-world data support the need for vaccination of pregnant individuals to help lower the risk of adverse maternal and fetal outcomes amid the pandemic.  

DISRUPTIONS IN HOSPITAL CARE An influx of COVID-19 patients and staffing shortages continue to plague hospitals across the US, with many having to turn away patients or pause certain services. On September 1, a 73-year-old Alabama man died of cardiac complications after emergency staff contacted 43 hospitals in 3 states searching for a cardiac intensive care unit (ICU) bed, as most were full with COVID-19 patients. The man was transported to a hospital 200 miles from his home, where he died. ICUs in Alabama have been at-capacity in recent weeks amid a surge in cases due to the highly contagious Delta variant and low vaccination rates. In the man’s obituary, his family urged people to get vaccinated “in an effort to free up resources for non-COVID-related emergencies.” Recent data from the US CDC show that unvaccinated people are more than 10 times more likely to be hospitalized and 11 times more likely to die from COVID-19 than people who are vaccinated.

In Washington state, already-stressed hospitals are taking on even more COVID-19 patients from neighboring Idaho, where some hospitals in the northern part of the state are operating under crisis standards of care. Some leaders in Washington—where indoor masking is mandatory and many workers are required to be vaccinated—are expressing frustration over Idaho’s lack of aggressive efforts to confront the pandemic, even amid a surge in cases, saying the situation is an example of how one state's crisis can intensify a crisis in another.

The situation helps to spotlight the importance of vaccination, but in some states, even vaccine requirements are backfiring. A hospital in upstate New York said it will “pause” infant deliveries on September 24 after 6 maternity unit employees resigned over the state’s SARS-CoV-2 vaccination requirements for all hospital and long-term care facility workers. Though the employee vaccination rate among Lewis County Health System employees is 73%, 165 employees remain unvaccinated with the September 27 deadline to get at least one shot looming. The health system’s CEO said he plans to focus on recruiting healthcare workers who are vaccinated or get assistance from the state to be able to restart deliveries in the county.

ENGLAND VACCINE PASSPORTS England has abandoned its previously announced plan to implement a SARS-CoV-2 vaccine passport program by the end of this month that would have required people to show proof of vaccination to enter the country’s nightclubs and certain other crowded venues, UK Health Secretary Sajid Javid told the BBC on September 12. The announcement was made following opposition from some members of Parliament as well as representatives of the hospitality industry, who said such a program would create a burden for businesses and infringe on residents’ rights. Speaking on the Andrew Marr Show, Secretary Javid said the government decided against the passports after “properly” looking at the issue and determining other factors could help keep COVID-19 incidence down, including high vaccine uptake, testing, surveillance, and treatments. Some people suggested the passport proposal simply was a ruse to encourage young people to be vaccinated, although Secretary Javid hinted the government could reverse course again if the number of new cases rises. About 66% of the population of England is fully vaccinated. Several days prior to the announcement, British researchers published a paper in EClinicalMedicine casting doubt on whether vaccination passport programs would incentivize more people to get the shots and calling for additional research into the matter.

FRANCE Former French Health Minister Dr. Agnès Buzyn has been charged with “endangering the lives of others” for her management of the COVID-19 pandemic, after a formal investigation found sufficient evidence to prosecute. Dr. Buzyn, who resigned in February 2020 to run for Mayor of Paris, has come under fire for her initial comments on the pandemic, when she said there was little risk of the new coronavirus first detected in Wuhan, China, spreading among the general population. But before she left her post, Dr. Buzyn backpedaled, warning President Emmanuel Macron that “the tsunami has yet to come.” At a hearing on September 10, Dr. Buzyn said she welcomed “an excellent opportunity for me to explain myself and to establish the truth,” and indicated she plans to appeal. The case, which marks one of the first worldwide where a leading public official is being held legally accountable for their handling of the pandemic, presents a challenge for President Macron, who will be campaigning for reelection over the coming year. 

SARS-CoV-2/INFLUENZA VACCINES With research ongoing into the necessity of SARS-CoV-2 vaccine booster doses, at least 2 pharmaceutical companies are banking on the need for annual shots, similar to influenza vaccinations, and working on combining the 2 vaccines. Moderna on September 9 said it is developing a single shot containing a booster dose for its SARS-CoV-2 vaccine and an experimental flu vaccine. The company said it eventually hopes to add vaccines for other respiratory diseases, including respiratory syncytial virus (RSV), into a single annual shot. On September 8, Novavax announced it has begun a Phase 1/2 clinical trial testing a combination vaccine using the company’s vaccine candidates for seasonal influenza and SARS-CoV-2. Both vaccines have been tested in Phase 3 trials, but neither has received regulatory authorization or approval. Combination vaccines have several potential benefits, including lowering the number of shots needed annually, improving vaccine coverage rates, and reducing costs for healthcare facilities and individuals.

COVID-19 IN GORILLAS Several western lowland gorillas at Zoo Atlanta have tested positive for the Delta variant of SARS-CoV-2 after employees of the zoo noticed some members of the gorilla population exhibiting symptoms such as coughing, nasal discharge, decreased appetite, and decreased activity. A total of 20 gorillas live in 4 troops at the zoo, and officials said that 18 of them were experiencing varying degrees of symptoms. Sam Rivera, Senior Director of Animal Health for Zoo Atlanta, said the gorillas are receiving the best care possible and that at-risk members of the population are being treated with monoclonal antibodies. The gorillas will be provided with the Zoetis SARS-CoV-2 vaccine specifically designed for animals when they recover. Zoo Atlanta also announced plans to vaccinate their Bornean orangutan, Sumatran orangutan, African lion, and clouded leopard populations. 

Zoo Atlanta expressed concern that the infections occurred despite rigorous safety measures when team members interact with great ape populations. Viral transmission likely happened due to interactions with an asymptomatic but infected team member who was fully vaccinated and donning the appropriate personal protective equipment. The team member did not test positive until after the incident. The zoo provided further assurance that safety measures such as the use of N95 masks, increased ventilation, modified cleaning protocols, and social distancing barriers between the gorillas and team members have been implemented. The distance between the gorillas and visitors to the zoo would make zoonotic transmission of the disease unlikely, and the US CDC states that animals are not a significant source of disease transmission to humans.