September 14: Johns Hopkins COVID 19 Report

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.

UNITED STATES

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 hu

September 10: Johns Hopkins COVID 19 Report

COVID-19 Situation Report

Webinar: Community Experiences with CommuniVax: Carrying Equity in COVID-19 Vaccination Forward in Local Areas

As the COVID-19 vaccination campaign continues, it is critical that vaccines are delivered fairly and equitably—so that everyone has access.

Join CommuniVax and the Johns Hopkins Center for Health Security for a webinar that will consider the impact of research and outreach in 4 local areas, which together represent a mix of Black and Hispanic/Latino communities in rural to urban areas. Local leaders and public health officials will hear about these communities and what they have done—and are doing—to address the challenges they are facing related to COVID-19 vaccination and equity.

Please register here.

EPI UPDATE The WHO COVID-19 Dashboard reports 223 million cumulative cases and 4.6 million deaths worldwide as of September 9. Global weekly incidence has held relatively steady at 4.5 million new cases per week for the past 4 weeks. Similarly, global weekly mortality has held steady at approximately 67-68,000 deaths per week over that same period.

Global Vaccination

The WHO reported 5.35 billion cumulative doses of SARS-CoV-2 vaccines administered globally as of September 6. A total of 2.02 billion individuals have received at least 1 dose, and 1.24 billion are fully vaccinated. Analysis from Our World in Data indicates that global daily vaccinations have declined sharply since September 1. Data from the most recent several days have tended to be artificially low due to reporting delays; however, the trend has persisted for more than a week. This indicates that there is an actual decline in daily vaccinations, which appears to be driven by a sharp decline in Asia*. Notably, daily vaccinations in China have decreased by more than 50% since August 29—down from 14.0 million doses per day to 6.5 million—which accounts for the majority of the change in Asia. Our World in Data estimates that there are 3.27 billion vaccinated individuals worldwide (1+ dose; 41.5% of the global population) and 2.32 billion who are fully vaccinated (29.5% of the global population). At the continent level, Oceania (40.5%) is on a trajectory to surpass the global average vaccination coverage (1+ doses), which would leave Africa (5.5%) 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.

Toward the end of 2020, the cumulative global case fatality ratio (CFR) appeared to be approximately 2.3%. At that time, the cumulative CFRs in Africa, Europe, and North America—as well as the global average—were all converging on that number. The CFRs in Oceania (3.0%) and South America (3.3%) were slightly higher but declining slowly, and Asia (1.6%) was slightly lower. Since that time, the trends have shifted at the continent level. South America’s CFR has remained elevated, holding relatively steady at approximately 3.0% since January 2021. Oceania’s CFR decreased slowly through March 2021 before declining much more quickly, falling from 2.9% to 1.3% since that time. Africa’s CFR increased slightly to 2.5% and held relatively steady, and Asia’s fell to a low of 1.3% in May 2021 before rising back to 1.5%. Europe and North America have both tracked closely with the global average, declining slowly in 2021 to approximately 2.0%. In terms of the rolling weekly average, CFR trends have generally decreased since the spring or early summer 2021. While Europe’s current average CFR is lower than it was in late June, it has exhibited a marked increase since early August, up from a low of 0.76% on August 1 to 1.25%. Currently, South America (2.2%) is the only continent reporting CFR greater than 2%, and Oceania (0.7%) is the only continent reporting less than 1%.

CFR varies widely at the national level, with countries ranging from well below 1% to nearly 20%**. A total of 17 countries are reporting cumulative CFRs of 0.5% or less, including Bhutan (0.12%), Laos (0.10%), and Singapore (0.08%) with less than 0.25%. On the other end of the spectrum, 14 countries are reporting cumulative CFRs greater than 4% (more than double the global average), including Mexico (7.7%), Peru (9.2%), and Yemen (18.7%) with greater than 7.5%. Over time, as the cumulative incidence and mortality increased, many countries settled into a relatively consistent cumulative CFR value. The trends were generally higher at the beginning of their respective epidemics and then declined to a steady-state value.

**Vanuatu has reported exactly 25.00% consistently since April 2021, and the actual value of its CFR is unclear.

Despite that overall trend, a number of countries’ CFRs have changed substantially in recent months. Since January 1, 2021, 13 countries have reported increases in their cumulative CFRs of greater than 1 percentage point (pp). Notably, 7 of these countries are in Africa, where many national epidemics faced major COVID-19 surges later than other parts of the world. While Taiwan is not a member of the WHO, it is reporting the largest increase in CFR since January, up from 0.9% to 5.2% (+4.3pp). Over that same period, 14 countries reported decreases in their CFRs of greater than 1pp, including Yemen, which fell from 29.0% to 18.7% (-10.3pp) since January 1. Interestingly, this group includes a relatively balanced mix of countries reporting CFRs that are higher (6) and lower (8) than the global average. The decreases in 2 of these countries—Brunei (0.44%) and Mauritius (0.29%)—brought them below the 1% CFR threshold, each cutting their respective CFRs by more than three-quarters. Australia (from 3.2% to 1.5%), Fiji (4.1% to 1.1%), and Iran (4.5% to 2.16%) also cut their respective CFRs by more than half.

UNITED STATES

The US surpassed 40 million cumulative cases on September 4:

1 case* to 10 million: 288 days

10 to 20 million: 54 days

20 to 30 million: 83 days

30 to 40 million: 165 days

*The US CDC now reports 35 cumulative cases on January 23, 2020, the first day included in the official data.

The US CDC reports 40.5 million cumulative COVID-19 cases and 652,480 deaths. Daily incidence appears to have passed a peak; however, this is likely due, at least in part, to delayed reporting over the US Labor Day holiday weekend (September 4-6). We will have a clearer picture of the longer-term trends next week, once reporting catches up from the holiday. A similar trend is evident for daily mortality as well. At more than 1,000 deaths per day, we expect the US to surpass 660,000 cumulative deaths within the next week. 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**.

**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 378 million cumulative doses of SARS-CoV-2 vaccines, and daily vaccinations peaked at nearly 830,000 doses per day on August 29. The 5-day window during which we expect delayed reporting still includes most of the US Labor Day holiday weekend, but the trend peaked prior to the holiday, which could indicate the early stages of a longer-term downward trend*. In light of the new US vaccination mandates announced on September 9, we will closely monitor trends in daily vaccinations for any effects of the mandates.

There are 208.3 million individuals who have received at least 1 vaccine dose, equivalent to 62.7% of the entire US population. Among adults, 75.3% have received at least 1 dose, as well as 13.9 million adolescents aged 12-17 years. A total of 177.4 million individuals are fully vaccinated, which corresponds to 53.4% of the total population. Approximately 64.5% of adults are fully vaccinated, as well as 10.8 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.

US COVID-19 RESPONSE In a speech delivered on September 9 from the White House, US President Joe Biden laid out a 6-pronged COVID-19 pandemic action plan, including new federal vaccine requirements for about two-thirds of the nation’s federal and private workforce, in an effort to stem the surge caused by the Delta variant and jumpstart economic recovery. President Biden excoriated unvaccinated individuals, saying “our patience is running thin” and blaming them for harming fellow Americans. He also pushed back against the politicization of the pandemic, promising to use the power of the federal government to take on state elected officials who are “undermining” the implementation of vaccination requirements, mask mandates, and other preventive measures.

Under the new plan, all private sector companies employing more than 100 people will be required to mandate vaccination or conduct weekly testing, affecting about 80 million people. Workers at healthcare facilities that receive Medicare or Medicaid funding, about 17 million people, also will have to be vaccinated, extending an earlier requirement for workers at nursing homes to include facilities such as hospitals, home-health agencies, and dialysis centers. President Biden also is requiring all executive branch employees and federal contractors to be fully vaccinated, with no testing option, covering several million more workers. Additionally, employees of Head Start programs and schools run by the Department of Defense and Bureau of Indian Education, about 300,000 people, will be required to be vaccinated.

President Biden announced several other pieces of the plan, including a doubling of fines for travelers who refuse to wear masks in transit stations or on airplanes or trains. The government also is working with manufacturers and large retailers, including Walmart, Amazon, and Kroger, to lower the cost of at-home SARS-CoV-2 tests and distribute the tests to easily accessible sites such as shelters and food banks. The Department of Defense plans to send more teams into hard-hit areas, and the federal government will increase shipments of monoclonal antibody treatments and offer new support to small businesses.

Altogether, President Biden’s plan represents the government’s most aggressive steps yet to urge US residents to get vaccinated and help get the economy back on track. However, several of the new measures are expected to undergo political and legal challenges. Reactions to the announcements were mixed, with physicians praising the efforts to get more people vaccinated, some experts saying the plan could be “too little, too late,” and some politicians saying the measures overstep the government’s authority and are “unconstitutional.” Though the White House has repeatedly said the federal government does not have the authority to implement broad vaccine requirements for the general population or require a federal vaccine passport, the new measures likely will help boost the nation’s vaccination rate.

US PANDEMIC PREPAREDNESS The US government on September 3 released a US$65.3 billion plan to improve the nation’s pandemic preparedness strategy over the next 10 years, to be in a stronger position to handle infectious disease outbreaks such as SARS-CoV-2. The plan, titled “American Pandemic Preparedness: Transforming our Capabilities,” outlines 5 key areas that require urgent attention and provide opportunities, including transforming medical defenses, such as vaccines, therapeutics, and diagnostics; ensuring situation awareness regarding disease threats; strengthening public health systems both domestically and internationally; building core capabilities, including manufacturing and supply chains and regulatory strategies; and managing the mission, with a focus similar to the effort that took astronauts to the moon in the late-1960s. Officials called for an immediate outlay of at least $15 billion to “jump start” the efforts and proposed establishing a centralized “Mission Control” that would draw on US government-wide expertise. US President Joe Biden signed an executive order on January 20 directing a whole-of-government review of US national biopreparedness policies and re-establishing the National Security Council Directorate on Global Health Security and Biodefense, and this plan is a core element of a larger government strategy resulting from that review.

On September 8, the Trust for America’s Health (TFAH) released a report saying that 20 years after the attacks of September 11, 2001, the US remains unprepared for public health emergencies. The report, “2021 Ready or Not: Protecting the Public’s Health from Diseases, Disasters and Bioterrorism,” calls on federal, state, and local policy makers to prioritize health security, amid the ongoing COVID-19 pandemic, raging wildfires in the West, and recent damaging weather events in the South and Northeast. The report makes several recommendations, including calling for more investments in public health infrastructure, workforce, and data systems at all levels.

GLOBAL COVID-19 SUMMIT US President Joe Biden is expected to announce plans for a global COVID-19 summit at the UN General Assembly meetings the week of September 20 to discuss vaccine access for low- and middle-income countries (LMICs). Topics could include how to ramp up vaccine manufacturing and distribution, improve oxygen supplies to countries in need, and cooperation on research and development for COVID-19-related products. According to officials, the Biden administration is setting up talks between the President and other national leaders, but a more formal announcement is expected soon. On September 2, administration officials announced the US government plans to invest $2.7 billion to increase domestic production of SARS-CoV-2 vaccine components as part of President Biden’s pledge to make the US an “arsenal of vaccines for the world.”

Additionally, a group of US lawmakers last week launched the COVID-19 Global Vaccination Caucus to advocate for vaccine manufacturing, production, and distribution in LMICs as a means to increase vaccination rates in those countries.

COVAX FORECAST The COVAX initiative, aimed at guaranteeing global access to SARS-CoV-2 vaccines, on September 8 cut its forecast for vaccine doses available for delivery between now and the end of the year, amounting to more disappointing news for the effort already hindered by production slowdowns, regulatory delays, export bans, and vaccine hoarding by wealthier nations. COVAX said it expects to have access to a total of 1.425 billion vaccine doses by the end of 2021, a number about 25% lower than the initiative’s July forecast. About 1.2 billion of those doses will be made available to 92 low-income countries (LICs) participating in the COVAX Advance Market Commitment (AMC). COVAX’s 2021 goal of delivering 2 billion doses is now projected to be reached in the first quarter of 2022. In its first 6 months of operation, the initiative has delivered more than 240 million vaccine doses, but experts predict 11 billion doses are needed worldwide to slow the spread of the virus.

BOOSTER DOSES WHO Director-General Dr. Tedros Adhanom Ghebreyesus this week doubled down on an appeal for a moratorium on vaccine booster dose programs through the end of September, this time calling on wealthy nations to delay administering third doses to large swaths of their populations through the end of 2021 and instead divert those supplies to low- and middle-income countries (LMICs). Dr. Tedros also said he was “appalled” by a pharmaceutical industry projection that SARS-CoV-2 vaccine production could exceed 12 billion doses by the end of the year and reach 24 billion by June 2022, berating manufacturers for fulfilling bilateral contracts with wealthy nations while low-income countries (LICs) are “deprived of the tools to protect their people.” In a statement regarding the projection, which was conducted by London-based Airfinity, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) called on governments to step up efforts to equitably redistribute doses to LMICs by sharing “a meaningful proportion of their doses in a responsible and timely way through COVAX or other efficient established mechanisms.” About 5.4 billion vaccine doses have been administered globally, but about 80% of those have gone to high- or upper-middle income countries, according to the WHO.

Additionally, 2 of the WHO’s top officials denounced wealthy nations for hoarding SARS-CoV-2 vaccines, treatments, and protective equipment, saying the inequities in distribution are “unfair,” “immoral,” and prolonging the pandemic. The Airfinity model predicts that even if the world’s wealthiest nations vaccinated all those individuals currently eligible and provided third doses to vulnerable populations, they would still have 1.2 billion doses left for redistribution this year. On September 9, Africa CDC John Nkengasong and WHO Africa Regional Director Matshidiso Moeti called on wealthy nations to forego boosters and redirect those extra doses to LICs, particularly on the African continent, which has been struggling to receive adequate supplies.

Notably, in addition to obtaining sufficient vaccine supplies, LICs will need to significantly increase their health expenditures—by almost 57%—to cover the costs of vaccinating 70% of their populations, if a 2-dose regimen costs US$35 and associated distribution cost is US$3.70 per person. These costs—according to estimates from the Vaccine Affordability Index, part of the Global Dashboard on COVID-19 Vaccine Equity supported by the UN Development Programme (UNDP), the WHO, and the University of Oxford—likely will need to be covered by further donations, grants, or loans, as LICs face negative economic consequences due to the pandemic.  

VACCINE DEVELOPMENT The COVID-19 pandemic prompted vaccine development to move at record speed, with more vaccines simultaneously being tested in clinical trials than ever before for any infectious disease. However, the development of next-generation SARS-CoV-2 vaccines is under threat, the Coalition for Epidemic Preparedness Innovations (CEPI) warned in a letter published September 7 in the journal Nature. According to Melanie Saville, CEPI’s Director of Vaccine Research and Development, most SARS-CoV-2 vaccines in use today were tested in placebo-controlled trials among unvaccinated individuals. However, as the number of vaccinated people increases, new vaccine candidates will need to be tested against existing vaccines instead of placebos. Therefore, manufacturers and governments must release doses of these “comparator vaccines” to support clinical trials testing new vaccines, particularly to see how they perform against new viral variants. But with most doses already spoken for in bilateral contracts that specifically spell out how the vaccines are to be used, current demand outpacing supply, and the possibility that a new vaccine will work better than the comparator, there is little incentive to release extra doses for studies. CEPI is working with manufacturers and governments to find workarounds to the issue, but unless a solution is found, the world will remain dependent upon the current vaccines authorized for use, even if new, more dangerous variants emerge.

DENMARK After nearly 550 days with restrictions to limit the spread of SARS-CoV-2, Denmark on September 10 lifted the last of its requirements, including no longer needing digital proof of vaccination to enter certain venues. This was the last of the restrictions, most of which have been lifted slowly since mid-August. The government stopped categorizing COVID-19 as a “socially critical disease,” attributing control of the virus to a successful vaccination rollout, strong epidemic control measures, and the efforts of the Danish people. More than 83% of eligible individuals are fully vaccinated, according to the Danish Health Authority. With fewer than 500 new COVID-19 cases reported daily and a reproduction rate less than 1, officials say they have the virus under control. However, they indicated they are prepared to reinstitute control measures if the number of COVID-19 hospitalizations begins to rise. The WHO has urged caution, warning the global situation remains critical. With large concerts already scheduled and people returning to “normal” life, the world is watching whether Denmark can remain restriction-free.

US HOSPITAL CRISIS STANDARDS OF CARE Hospitals in northern Idaho (US) this week began operating under “crisis standards of care,” allowing healthcare workers to ration care as facilities struggle to handle an influx of COVID-19 patients amid an increase in cases and staff shortages. Notably, Idaho has one of the lowest vaccination rates of any US state. The move, enacted by the Idaho Department of Health and Welfare for 10 hospitals and healthcare systems in the panhandle and north-central regions, allows hospitals to apportion certain resources, such as intensive care unit (ICU) beds, to patients they deem most likely to survive. Other patients will still receive care but might go without some life-saving medical equipment. The region is receiving federal assistance, with a 20-person team from the US Department of Defense, 150 National Guard troops, and about 200 federal contractors, but the state says the additional resources are not enough to handle the current surge.

Officials in neighboring Oregon also have warned the state is close to filling its ICU beds and activating crisis standards of care. Notably, Oregon last year said its crisis standards of care document was discriminatory, and in December 2020 replaced the document with 4 “crisis care principles,” developed with community input. The Oregon Association of Hospitals and Health Systems said the lack of crisis standards is “really troubling,” but the state’s Health Authority asked that providers apply the principles if necessary and noted that hospitals can implement their own crisis care standards and triage guidelines amid a public health emergency.

Officials in both states, as well as others including Louisiana and Texas, also are expressing concern over a rising number of child hospital admissions, as many schools around the country are opening. Pediatric ICUs typically have a smaller number of beds than adult ICUs and are filling quickly nationwide. The increase in childhood COVID-19 hospitalizations has led healthcare providers and hospital executives to implore adults to get vaccinated and use other preventive measures, such as mask wearing and physical distancing, to help protect children, especially those under age 12 who are not yet eligible for vaccination in the US.

VACCINE MANDATES Even prior to US President Joe Biden’s September 9 announcement of federal vaccine mandates, including for larger private companies, several other vaccine mandates in the US made the news over the past week. United Airlines, which announced its mandate in early August, is requiring all employees to be vaccinated by September 27 (5 weeks from the Pfizer-BioNTech vaccine receiving full FDA approval). This week, United announced that employees who receive an exemption will be placed on temporary leave while the airline implements appropriate safety precautions for unvaccinated employees. Those who receive a medical exemption will reportedly be placed on temporary medical leave, and those who receive a religious or personal beliefs exemption will be placed on unpaid personal leave. According to United Airlines officials, more than half of its employees who were unvaccinated when the mandate was announced have been vaccinated since then, an indication that the policy could be encouraging vaccination.

The Los Angeles Unified School District (California)—the United States’ second largest school district, covering nearly 650,000 students—is mandating SARS-CoV-2 vaccination for all students aged 12 years and older. The county school board voted unanimously in favor of the mandate (7-0, with 1 recusal). The school district previously mandated vaccinations for all employees, without a testing option that would allow individuals to opt out of vaccination. The student mandate will be implemented in phases, starting with students who participate in in-person extracurricular activities (eg, band, clubs, sports), who must be fully vaccinated by October 31. All other students must be fully vaccinated by December 19, and students who turn 12 must be fully vaccinated no later than 8 weeks after their 12th birthday. The school district began offering vaccinations at schools via a mobile vaccination clinic on August 30. Notably, the US FDA has issued an Emergency Use Authorization (EUA) for use of the Pfizer-BioNTech vaccine in children 12-15 years old, but none of the currently available vaccines have received full approval for this age group. The announcement was met with opposition from some parents, and anti-vaccine organizations have already indicated that they will file lawsuits that aim to overturn the policy.

SCHOOL MASK MANDATES Legal and legislative battles over mask mandates to help mitigate the spread of SARS-CoV-2 in schools continue across the US. In Florida, a Leon County judge ruled against Governor Ron DeSantis on September 8, allowing school districts to mandate mask use while the case challenging the state’s ban on mask mandates continues. Hours later, DeSantis’ administration filed a 41-page emergency motion asking the 1st District Court of Appeal to allow the executive order prohibiting mask mandates to remain in effect. Reportedly, the parents who filed the initial lawsuit filed their response Thursday evening, but it remains unclear when the appeals court will rule on the motion or the lawsuit itself. At least 13 Florida school districts have implemented mask mandates that do not give parents an option to opt out of the mandate, which violates the executive order. At a September 8 news conference, Governor DeSantis said he expects to win the case on appeal.

More school districts across the country are implementing mask mandates as COVID-19 cases due to the Delta variant surge, in some instances leading to the deaths of teachers. But most allow for medical or parental exemptions, allowing many students to opt out of the requirements—up to 30% in one Tennessee district—even amid rising numbers of COVID-19 cases among children. Advocacy groups, some physicians, and even state and local governments are advising parents how to write exemption letters or use federal disability laws to avoid mask mandates. In Kentucky, both houses of the state General Assembly have advanced bills that would abolish a statewide mask mandate in K-12 schools implemented by Governor Andy Beshear. According to a new USA TODAY/Ipsos poll, about two-thirds of those surveyed support school- or state-implemented mask mandates for teachers (65% of the general public, 64% of parents with school-aged children) and mask mandates for students (65% and 62%, respectively).

HYBRID IMMUNITY A preprint published in bioRxiv is the latest among several studies evaluating hybrid immunity to SARS-CoV-2. Hybrid immunity, which some are calling “superhuman immunity,” can exist in people previously infected with SARS-CoV-2 and who are fully vaccinated, as their immune systems can produce an extremely powerful immune response, including very high levels of antibodies with wide variant-neutralizing capability. For the bioRxiv study, which is not yet peer-reviewed, researchers created ‘polymutant’ spike proteins that resisted polyclonal antibody neutralization to a degree similar to already circulating variants of concern (VOCs). They found that 20 naturally occurring mutations in the SARS-CoV-2 spike protein are enough to confer almost complete resistance to the polyclonal neutralizing antibodies produced independently by convalescents and mRNA vaccine recipients. Notably, however, they found that plasma from previously infected individuals who later received mRNA vaccination neutralized the synthetic ‘polymutant’ as well as related but diverse sarbecoviruses, resulting in the so-called hybrid immunity. The sarbecoviruses included SARS-CoV-1, which caused the 2009 SARS pandemic, two viruses found in pangolins, and one in bats.

Another study published in the New England Journal of Medicine last month found similar results among people who had previous SARS-CoV-1 infection and were vaccinated with the Pfizer-BioNTech SARS-CoV-2 vaccine. This study examined the breadth of antibody cross-neutralization against 10 different sarbecoviruses: 7 from the SARS-CoV-2 clade and 3 from the SARS-CoV-1 clade, which overlap with the viruses included in the bioRxiv study. The individuals produced broad-spectrum antibodies capable of cross-clade neutralization of known VOCs and potentially emerging viruses. Though previous infection together with vaccination might help improve immune responses to future exposure, scientists warn that people should not intentionally expose themselves to infection with SARS-CoV-2.

REDUCED RISK OF “LONG COVID” AMONG VACCINATED Individuals who are fully vaccinated against SARS-CoV-2 appear to have a lower risk of developing post-acute sequelae of COVID-19 (PASC), so-called “long COVID,” than unvaccinated people, even when they experience breakthrough infections, according to a study published in The Lancet Infectious Diseases. Researchers examined data self-submitted by more than 1.2 million adults in the UK who use the COVID Symptom Study phone app, and only included the mRNA vaccines from Pfizer-BioNTech or Moderna and the viral vector vaccine from AstraZeneca-Oxford. Of those fully vaccinated, only 0.2% reported a breakthrough infection. Among those people who received 2 doses of vaccine, the risk of long COVID—defined as having symptoms lasting at least 4 weeks after infection—was reduced by almost half, the risk of hospitalization was reduced by 73%, and the risk of acute symptoms was reduced by 31%. While the researchers noted the study had limitations, including that the data were self-reported, they said it is “encouraging” that the overall proportion of cases who had long-lasting symptoms is reduced among fully vaccinated individuals and called for additional research to better characterize long COVID.

UNREPORTED DEATHS IN NURSING HOMES Due to delays in reporting case and mortality data, researchers suspect that nursing homes, with residents already at high risk of SARS-CoV-2 infection and illness, may have a higher burden of COVID-19 than previously reported in federal data. According to a cross-sectional study published in JAMA Network Open and involving 15,307 US nursing homes in the National Healthcare Safety Network (NHSN), researchers estimate there were more than 68,000 COVID-19 cases and 16,000 related deaths nationally that were not recorded in federal data during the early months of the pandemic, through May 24, 2020. These numbers represent 11.6% of COVID-19 cases and 14% of COVID-19 deaths among nursing home residents in 2020. Overall, a mean of 43.2% of all COVID-19 cases and 39.6% of COVID-19 deaths in nursing homes counted by state health departments went unreported in federal databases, the research suggests. Researchers and policymakers are considering that SARS-CoV-2 outbreaks in nursing homes may have been more onerous than previously believed, and a failure to accurately collect case and death data may have led to inaccurate conclusions about the role of nursing homes in COVID-19 outbreaks.

IVERMECTIN USE IN ARKANSAS JAIL A doctor at an Arkansas (US) jail is under investigation after using the drug ivermectin to treat inmates with COVID-19, reportedly without their consent and despite warnings from the US FDA to not use the drug to treat or prevent the disease outside of approved clinical trials. Several inmates at a Washington County jail said they were told the pills were antibiotics, vitamins, or steroids, not ivermectin, which is an antiparasitic primarily used in livestock. Jail physician Dr. Rob Karas and Washington County Sheriff Tim Helder both confirmed that ivermectin was prescribed to inmates, beginning late last year, but they claimed detainees consented to taking the pills. However, at least 3 inmates said they would never have taken the drug if they knew it was ivermectin, indicating they felt as though they were being experimented on. After hearing from inmates, the American Civil Liberties Union (ACLU) called for the administration of ivermectin to end immediately and said inmates are prepared to file a lawsuit to end the practice. As we previously reported, cases of ivermectin poisoning have risen over the past several weeks, as some conservative lawmakers, groups, and celebrities tout the drug, which has not been proven to work as prevention or treatment of SARS-CoV-2 infection. Even the drug's manufacturer, Merck, released a statement in February announcing that the drug was not effective in treating COVID-19 and should not be used to do so. The Arkansas case is a disturbing example of how jail and prison detainees continue to be dehumanized and exploited for medical experimentation in the US.