July 27: Johns Hopkins COVID 19 Report

COVID-19 Situation Report

The Center also produces US Travel Industry and Retail Supply Chain Updates. You can access them here.

EPI UPDATE The WHO COVID-19 Dashboard reports 194.1 million cumulative cases and 4.16 million deaths worldwide as of 12:28 EDT on July 26. Global weekly incidence increased for the fifth consecutive week, a 7.89% increase over the previous week. Global weekly mortality increased for the third consecutive week, a 20.77% increase compared to the previous week.

Global Vaccination

The WHO reported 3.7 billion doses of SARS-CoV-2 vaccines administered globally as of July 26. The WHO reports a total of 1.44 billion individuals have received at least 1 dose, and 672 million are fully vaccinated. Analysis from Our World in Data shows that the global daily doses administered is up, now at 33 million doses per day, driven by increases in Asia. Our World in Data estimates that there are 2.14 billion vaccinated individuals worldwide (1+ dose; 27.5% of the global population) and 1.08 billion who are fully vaccinated (13.9% of the global population).

UNITED STATES

The US CDC reported 34.4 million cumulative COVID-19 cases and 608,528 deaths. Daily incidence continues to increase, now up to 42,226 new cases per day, which is nearly 3.7 times the most recent low on June 19 (11,467) and is still increasing steadily. Daily mortality also continues to increase, up to 239 deaths per day, which is more than 45% higher than the most recent low on July 10 (164).

US Vaccination

The US has administered 342.2 million cumulative doses of SARS-CoV-2 vaccines. Daily vaccinations are increasing slowly, now up to 471,948 doses per day*. A total of 188.7 million individuals in the US have received at least 1 dose, equivalent to 56.8% of the entire US population. Among adults, 69% have received at least 1 dose, as well as 10.5 million adolescents aged 12-17 years. A total of 163.2 million individuals are fully vaccinated, which corresponds to 49.1% of the total population. Approximately 60% of adults are fully vaccinated, as well as 8.1 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 value provided here corresponds to 5 days ago.

US HOSPITALIZATIONS The number of COVID-19-related hospitalizations is beginning to rise in most US states, following increasing numbers of COVID-19 cases driven by the spread of the more transmissible Delta variant. Nationally, hospitalization rates remain low overall, nowhere near the previous pandemic peaks. But the increases in hospitalizations are high and rising in parts of the country that have low vaccination rates, including Florida, Nevada, Arkansas, and Missouri. Some Florida hospitals are seeing the highest number of COVID-19 patients since the beginning of the pandemic, and the pace of this surge is accelerating rapidly. One hospital in Missouri said its increase in patients occurred nearly 5 times as fast as last fall’s surge. An estimated 97% of hospitalized patients are unvaccinated. Patients also are skewing younger, with 69% under the age of 65, according to CDC data as of July 17. Some hospitals are scrambling to find space for intensive care patients, trying to address personnel shortages, and attempting to maintain adequate supplies of medical equipment such as ventilators.

According to new projections released last week by the COVID-19 Scenario Modeling Hub—a consortium of researchers working with the US CDC to track the pandemic—the current US surge will continue throughout the summer and into the fall. In the most likely of 4 scenarios, there would be around 60,000 new cases and about 850 deaths per day, with 70% of eligible Americans vaccinated. Currently, the US is averaging around 42,000 new cases per day and about 250 deaths per day. Nationwide, 57.5% of eligible people are fully vaccinated. The researchers encouraged state and local leaders to take note of the projections, urging them to reimplement mask mandates and physical distancing requirements that could help lessen the surge’s impact.

US GOVERNMENT RESPONSE As the number of new COVID-19 cases continues to rise in the US, the US government is examining further tactics to contain the pandemic. Last week, the White House purchased an additional 200 million doses of the Pfizer-BioNTech vaccine. The purchase is in anticipation that additional doses will be recommended for certain populations and that the vaccine could “soon” be authorized for use in children ages 5-11. The US government also hinted at reinstated mask recommendations.

Overall, the US government is focused on improving national vaccination rates, particularly in communities with low coverage where most new COVID-19 cases are in unvaccinated individuals. On July 22, the government announced US$100 million for rural health clinics to develop vaccine confidence and outreach efforts. Additionally, the US Department of Health and Human Services will invest US$1.6 billion from the American Rescue Plan to support COVID-19 testing and mitigation activities in vulnerable communities. These funds will address the rise in cases among unvaccinated people by detecting, diagnosing, tracing, and mitigating the spread of SARS-CoV-2 in homeless shelters, correctional facilities, and other hard-hit and high-risk areas. In recognizing the 31st anniversary of the Americans with Disabilities Act, the government announced a package of guidance and resources to support individuals experiencing “long COVID,” also known as post-acute sequelae of COVID-19. According to the guidance, long COVID can be considered a disability under certain federal civil rights laws, thereby allowing federal protections and resources for adults and children impacted by long-lasting symptoms of COVID-19.

As the US government focuses on challenges to the nation’s domestic recovery from the pandemic, including rising consumer prices and turbulent financial markets, officials from the US Agency for International Development who are responsible for making the US an “arsenal of vaccines” are struggling to help other countries acquire resources and distribute SARS-CoV-2 vaccines, COVID-19 therapeutics, and personal protective equipment. At issue is more than US$1 billion the White House diverted from the agency in June to pay for the purchase of 500 million additional doses of the Pfizer-BioNTech vaccine, meant to supplement the 80 million vaccine doses the government has already allocated for donations abroad, according to unnamed officials. But the unexpected shift in funding, and the wait time for those doses to be delivered, has put pressure on the US government to maintain its status as a leading donor of COVID-19 assistance. USAID officials tasked with vaccine distribution abroad continue to advocate for increased resources from the White House and US Congress in order to assist countries in need.

VACCINATION MANDATES As the Delta SARS-CoV-2 variant sweeps across the US, more jurisdictions and companies are considering strengthening public health measures to mitigate the virus’s impact. This includes vaccination mandates for employees. On July 26, California, the country’s most populous state, became the first in the nation to announce that all state employees and on-site public and private workers in health care and high-risk congregate settings will be required to show proof of vaccination or submit to mandatory once-or-twice weekly testing. State employees are required to submit vaccination documentation by August 2, and health care and congregate-setting facilities must be in full compliance by August 23. Unvaccinated workers also will be required to wear appropriate PPE. A few hours earlier, New York City, the nation’s largest city, announced that all 340,000 municipal employees of the city, including police officers and teachers, will be required to be vaccinated or start weekly testing by September 13. As of August 2, any employee who is unvaccinated must wear a mask indoors at all times or risk termination. In their announcements, both California Governor Gavin Newsom and New York City Mayor Bill De Blasio encouraged other local governments and private sector employers to implement vaccination mandates.

The Department of Veterans Affairs on July 26 became the first federal agency to implement a vaccination mandate, requiring 115,000 of its frontline healthcare workers to show proof of full vaccination within the next 8 weeks. In its announcement, the VA referenced several organizations that support vaccine mandates. Many of those groups—including the American Medical Association, the American Nurses Association and 55 other groups representing millions of doctors, nurses, pharmacists, and other healthcare workers—issued a joint statement early on July 26 calling for all healthcare and long-term care employers to require their employees to be vaccinated for SARS-CoV-2. The statement cites highly contagious variants, including the Delta variant, and “significant numbers” of unvaccinated people as drivers for rising numbers of COVID-19 cases, hospitalizations, and deaths in the US. The groups also called on other employers across the country to implement policies to encourage vaccination. As we have previously reported, vaccination mandates for employees of a hospital system (Bridges et al v. Houston Methodist Hospital et al) and students of a university (Ryan Klaasen et al v. The Trustees of Indiana University) so far have been upheld in US federal district courts. An appeal from one of those cases is expected, and additional legal challenges likely will result from these, and future, vaccination mandates.

MODERNA VACCINE FOR ADOLESCENTS The European Medicines Agency’s Committee for Medicinal Products for Human Use on July 23 approved the Moderna SARS-CoV-2 vaccine (known as Spikevax in Europe) for use in children aged 12 to 17 years. The vaccine already is authorized for adults aged 18 and older, but it is the first time this vaccine has been authorized for people under age 18. According to the EMA, data from more than 3,700 children ages 12 to 17 showed the vaccine produced an antibody response comparable to the one seen in young adults aged 18 to 25 years. The younger group also experienced similar mild-to-moderate side effects. The agency noted that the trial was unable to detect new, uncommon side effects or evaluate the risk of known ones, including the inflammation of heart muscle and tissue, because of the relatively small number of study participants, but added that the “benefits of Spikevax in children aged 12 to 17 outweigh the risks.” Until now, the Pfizer-BioNTech was the only option for children aged 12 and older in Europe. The US FDA currently is considering whether to authorize the Moderna vaccine for the same age group.

VACCINE TRIALS FOR CHILDREN The US FDA reportedly has urged 2 SARS-CoV-2 vaccine makers, Pfizer-BioNTech and Moderna, to expand the size of their clinical trials among children aged 5 to 11 years in order to assess whether the rare side effects of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart) that have been seen in young adults shortly following vaccination also appear in this younger age group. Federal regulators requested the companies include at least 3,000 children in their studies, reportedly about double the original number of participants. Moderna confirmed its plans to expand the size of its pediatric clinical trial and expects to have data on its vaccine’s use among children ready to submit to the FDA in winter 2021 or early 2022. Pfizer-BioNTech indicated it does not plan to alter its original timeline of submitting a request for the FDA to expand authorization to 5-to-11-year-old children by the end of September, and presenting data for younger children, aged 6 months to 2 years, in October or November. The FDA last month added warnings about the potential for myocarditis and pericarditis to patient and provider fact sheets for both the Moderna and Pfizer-BioNTech vaccines.

LONG COVID/PASC IN CHILDREN Children’s National Hospital (US), in collaboration with the US NIH’s National Institute of Allergy and Infectious Diseases, announced on July 25 they are launching a large, multi-year study to examine the long-term effects of COVID-19 and multisystem inflammatory syndrome in children (MIS-C) following recovery from acute SARS-CoV-2 infection. The study will enroll up to 1,000 children and young adults under age 21 who have recovered from confirmed infection with SARS-CoV-2, with or without symptoms, or MIS-C, as well as up to 1,000 household contacts who will serve as a control group, and 1 parent or guardian per participant to complete questionnaires. Surveys will gather information about quality of life, social impact, and any long-term physical impacts of the virus, and researchers also plan to detail the role of genetics; duration and quality of immune responses following infection; so-called “long COVID,” also called post-acute sequelae of COVID-19 (PASC); and MIS-C.

In the US, more than 4.1 million children have tested positive for SARS-CoV-2, and nearly 500 have died. In the week ending July 22, children accounted for 16.8% of reported weekly COVID-19 cases nationwide. Black, Hispanic/Latino, and Native American children have been hardest hit, accounting for 3 out of 4 deaths among patients under age 21. According to researchers, between 2% and 10% of recovered children have long-term symptoms, and about 2 out of 3 children who develop MIS-C are Black or Hispanic/Latino. The US$40 million study is one of many NIH is supporting to understand the range of SARS-CoV-2 effects on children. Little is known about why some children experience long-term symptoms following COVID-19 recovery, just as long COVID-19 is not well understood in adults. It is hoped that these controlled clinical trials will provide more answers about how these conditions can be more effectively treated and, possibly, prevented.

GLOBAL VACCINE ACCESS The World Bank and the COVAX facility on July 26 announced a new financing mechanism to help improve access to SARS-CoV-2 vaccines for low- and middle-income countries (LMICs), where vaccination rates are lagging. Countries that are seeking to purchase vaccines through the COVAX advance market commitment cost-sharing system via Gavi, the Vaccine Alliance, are facing hurdles in guaranteeing their own payments. Now, COVAX will be able to negotiate advance purchase agreements with vaccine makers based on aggregated demand across several of the 92 LMICs that participate in the advance market commitment, using financial backing from the World Bank and other multilateral development banks. The mechanism should enable more countries to receive bulk vaccine purchases at a lower cost, instead of relying solely on donations through COVAX, and countries would be able to select specific vaccines that align with their preferences. Additionally, it will allow for more transparency regarding vaccine availability, pricing, and delivery schedules, World Bank President David Malpass noted in a statement. Under the AMC cost-sharing arrangement, COVAX plans to provide up to 430 million additional vaccine doses for delivery between late 2021 and mid-2022. COVAX has already delivered nearly 153 million doses to 137 countries, but that number is far below its 2021 goal of 2 billion doses. The new financing mechanism comes amid growing concern over the widening gap in global vaccine access, with experts hoping the arrangement will facilitate vaccine deliveries to countries in need.

VIETNAM LOCKDOWN On July 23, Vietnam’s capital city of Hanoi began a 15-day lockdown amid a spike in new COVID-19 cases. The country’s health ministry reported 7,968 new cases on July 24, a record daily increase and up from the previous day’s count of 7,307. With the addition of Hanoi’s 8 million people, about one-third of Vietnam’s 100 million people are now on lockdown. Residents in larger cities, like Ho Chi Minh City and Hanoi, are no longer allowed to congregate in groups of more than 2 people and are only allowed to leave their homes for food, medication, or in the case of an emergency. According to Our World in Data, Vietnam has fully vaccinated only 0.4% of its population and is taking steps to procure more vaccine doses. On July 25, the country announced it received 3 million doses of the Moderna vaccine from the US through COVAX. Vietnamese officials are in talks with US officials about the domestic production of mRNA vaccines, which could begin late this year or in early 2022, with the goal of producing 100 to 200 million doses a year. The government also indicated it is considering authorizing the domestically produced Nanocovax vaccine. A phase 3 clinical trial testing the vaccine is ongoing, but results are not yet available.

FRANCE HEALTH PASS The French Parliament on July 26 approved a law mandating special health passes for entry to all restaurants, trains, planes, and some other public venues and requiring vaccinations for all healthcare workers and other essential workers such as firefighters beginning September 15. In order to obtain a health pass, people must show digital or paper proof of full vaccination, results of a recent negative SARS-CoV-2 test, or documentation of recent recovery from acute COVID-19. More than 160,000 people demonstrated around France over the weekend to protest the legislation requiring health passes. France President Emmanuel Macron welcomed peaceful demonstrations but added they will not make the pandemic disappear. “My message is simple: to get vaccinated,” he said. Nearly 60% of the French population has received at least 1 dose of vaccine, but the number of new daily COVID-19 cases has risen sharply since the beginning of the month. The Constitutional Council is expected to review the law next week to determine whether it complies with the country’s Constitution.

NFL COVID-19 RULES The US National Football League (NFL) sent a strong message to its 32 teams last week, encouraging clubs to convince players to get vaccinated for SARS-CoV-2 and alerting them that games having to be cancelled due to a COVID-19 outbreak among unvaccinated players would be forfeited and counted as a loss. According to a memo, the league intends to play its entire 272-game schedule over 18 weeks and would not add a “19th week” to accommodate games that cannot be rescheduled during the 18-week regular season. If a game is cancelled due to an outbreak and cannot be rescheduled, neither team’s players would receive their weekly salary and the responsible team would cover all financial losses. Additionally, vaccinated players or staff who test positive but are asymptomatic can return to the field after 2 negative tests 24 hours apart; however, unvaccinated individuals who test positive would be required to complete a 10-day isolation period. Unvaccinated players are required to undergo daily testing, physically distance, wear a mask indoors, and be prohibited from gathering with the team for media events or outside of official team activities, such as at nightclubs, bars, or house parties. If unvaccinated players violate the gathering rules, the NFL and clubs are permitted to issue fines of up to US$50,000 for a first offense, and more for further violations. For violating other COVID-19 protocols, such as not wearing a mask when required, players could be fined US$14,650 every time a transgression occurs. According to the memo, more than 75% of players are in the process of being vaccinated and more than half of the teams have vaccination rates of more than 80% of players. With the NFL placing the burden on teams and players to get vaccinated or else face significant economic consequences, it will be interesting to see if teams can reach near-100% vaccination rates.

July 23: Johns Hopkins COVID 19 Report

COVID-19 Situation Report

The Center also produces US Travel Industry and Retail Supply Chain Updates. You can access them here.

EPI UPDATE The WHO COVID-19 Dashboard reports 192.3 million cumulative cases and 4.14 million deaths worldwide as of 11:11am EDT on July 23.

Countries around the world are combating new COVID-19 surges, generally believed to be driven, in part, by increasing prevalence of the Delta variant (B.1.617.2). Unlike in previous surges, there do not appear to be strong regional trends, with the countries facing the largest surges distributed around the world. In fact, looking at the biweekly trends, there are approximately 50 countries where daily incidence has more than doubled, and they are spread across nearly every continent and region, with the notable exceptions of Central and South America.

In terms of total daily incidence, there are 15 countries reporting more than 10,000 new cases per day, including 6 reporting more than 25,000. Among these countries, 5 are in Asia (including Iran in the Eastern Mediterranean region), 4 are in Europe, 3 are in South America, and 2 are in North America. South Africa is the only African country, and none are in Oceania. Ten (10) of these countries are reporting increasing daily incidence over the past 2 weeks, including the US (+142%), Spain (+146%), and France (+287%), which more than doubled over that period. India and Argentina have exhibited decreasing trends since at least mid-June, and Brazil, Colombia, and South Africa passed their respective peaks since the beginning of July. These 16 countries account for nearly 75% of the global daily incidence. Among the countries with available data on the Delta variant, all* are exhibiting sharp increases in Delta prevalence over the past several months. India, where the variant was first reported, was first in March, and Delta prevalence began increasing in most of the other countries by late May/early June. Of the 10 countries with data available for July 12 or later, 8 are reporting higher than 70%, including 6 higher than 90%.

*Argentina does not have data available after May 17.

Similarly, the top countries in terms of per capita daily incidence represent most regions around the world. Among the top 20 countries, nearly half (9) are in Europe, 4 are in Africa, 3 are in Latin America and the Caribbean, and 3 are in Asia. Fiji is the only country in Oceania, and none are in North America. Argentina, Colombia, Malaysia, Spain, and the UK are on both lists, and considering their large populations compared to the other top per capita countries, this further illustrates the severity of their respective epidemics. All but 5 countries—Argentina, Colombia, Mongolia, Namibia, and Seychelles—are reporting increasing daily incidence over the past 2 weeks, including 9 that more than doubled over that period. Notably, Malta’s daily incidence increased nearly 1,500% over the past 2 weeks (peaking at more than 3,000% on July 16), bringing its daily average to approximately 200 new cases per day—up from 1 in mid-June. Only a small handful of these countries have data available regarding the prevalence of the Delta variant, and 4 of the 8 countries were also among the highest total daily incidence. All of these countries** reported major increases in Delta prevalence starting in May, and 5 of the 6 countries with data available for July 12 or later are reporting 80% or higher.

**With the exception of Argentina, which has no data available after May 17.

Global Vaccination

The WHO reported 3.57 billion doses of SARS-CoV-2 vaccines administered globally as of July 20. The WHO reports a total of 1.37 billion individuals have received at least 1 dose, and 656 million are fully vaccinated. Analysis from Our World in Data shows that the global daily doses administered fell sharply once again, now down to 29.1 million doses per day. Our World in Data estimates that there are 2.09 billion vaccinated individuals worldwide (1+ dose; 26.9% of the global population) and 1.05 billion who are fully vaccinated (13.5% of the global population).

UNITED STATES

The US CDC reported 34.2 million cumulative COVID-19 cases and 607,684 deaths. With more than 40,000 new cases per day, the US surpassed both the peak of the initial surge—31,327 on April 12, 2020—and the low reported following the summer 2020 surge—35,082 on September 13, 2020. The current average is more than 3.5 times the most recent low on June 19 (11,467) and is still increasing steadily. Daily mortality also continues to increase, up to 223 deaths per day, which is more than 40% higher than the most recent low on July 11 (159). Notably, the proportion of emergency department patients diagnosed with COVID-19 has tripled since June 21, up from 0.6% to 1.8%, which is an indication of increasing burden on health systems*.

*In an effort to provide a more accurate analysis of the current epidemiology, we are largely focusing on longer-term trends, as the most recent data are more likely to be affected by changes in the frequency of state-level reporting, particularly over the weekend.

The US CDC added a new feature to its COVID-19 Data Tracker, which displays a combination of vaccination coverage and per capita weekly incidence at the county level. The 2-dimensional coloring scheme will take some time to interpret, but it is fairly clear that the major US COVID-19 hotspots are Missouri, Arkansas, and Louisiana, where counties are reporting lower vaccination coverage and higher weekly incidence. Alabama and Mississippi are exhibiting similar trends, but to a lesser degree. Many counties in Florida are reporting elevated weekly incidence, even with higher vaccination coverage than in neighboring states. No data are available for Texas.

US Vaccination

The US has administered 340 million cumulative doses of SARS-CoV-2 vaccines. Daily vaccinations are increasing slowly, now up to 446,613 doses per day*. A total of 187 million individuals in the US have received at least 1 dose, equivalent to 56.4% of the entire US population. Among adults, 68.6% have received at least 1 dose as well as 10.2 million adolescents aged 12-17 years. A total of 162 million individuals are fully vaccinated, which corresponds to 48.8% of the total population. Approximately 59.7% of adults are fully vaccinated, as well as 7.9 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 value provided here corresponds to 5 days ago.

DELTA VARIANT The US CDC continues to sound the alarm about the rapid spread of the SARS-CoV-2 Delta variant within the United States. Earlier this week, CDC Director Dr. Rochelle Walensky shared that the Delta variant now makes up 83% of domestically sequenced SARS-CoV-2 cases. This is a dramatic rise from the beginning of the month, when the Delta variant made up about half of sequenced cases within the US. There has been a corresponding rise in the number of new COVID-19 cases and related deaths throughout the month, especially impacting unvaccinated parts of the population. In a press conference earlier this week, Dr. Walensky warned that the Delta variant is one of the “most infectious respiratory viruses we know of,” urging individuals to get vaccinated. The CDC has made it clear that this will be another pivotal moment in the United States’ COVID-19 response, cautioning that many communities with low vaccination rates may face challenges of overwhelmed health care systems if preventative actions are not taken. 

US CDC ACIP MEETING The US CDC’s Advisory Committee on Immunization Practices (ACIP) on July 22 concluded the benefits of the J&J-Janssen SARS-CoV-2 viral vector vaccine outweigh the risks of some people developing the rare neurological disorder Guillain-Barré syndrome (GBS) after receiving the shot. Earlier this month, the US FDA updated the J&J-Janssen vaccine’s label to warn of a possible increased risk of GBS. According to data presented at the meeting, the FDA’s Vaccine Adverse Event Reporting System (VAERS) recorded 100 preliminary reports of GBS after J&J-Janssen vaccination as of June 30, out of 12.6 million doses administered at that time. Of those cases, 95 required hospitalization, 1 person died, and 5 cases were non-serious. Dr. Hannah Rosenblum, a researcher with the CDC National Center for Immunization and Respiratory Diseases’ Division of Viral Diseases, presented data showing the risk of vaccine recipients developing GBS remained low when compared to the number of COVID-19 cases and deaths prevented by vaccination. The CDC plans to update its guidance for the J&J-Janssen vaccine to recommend that patients with a history of GBS first consider the 2-dose mRNA vaccines from Pfizer-BioNTech and Moderna, if possible. However, some panel members pointed out there are risks associated with those vaccines as well, including myocarditis and pericarditis, and that information on all of the risks associated with SARS-CoV-2 vaccines should be made available so people can make the best choice for themselves.

The ACIP also considered whether to recommend additional, or “booster,” doses of SARS-CoV-2 vaccines for people who are immunocompromised, who represent about 2.7% of the US population. Dr. Sara Oliver with the CDC National Center for Immunization and Respiratory Diseases presented data based on several small studies looking at vaccine response among immunocompromised people and additional doses in this population. Although emerging data suggest an additional SARS-CoV-2 vaccine dose in immunocompromised people enhances antibody response and increases the proportion who respond, the panel did not make an official recommendation on additional shots and will continue to review available data. Dr. Oliver also noted that serologic or cellular immune testing outside of research studies is not recommended in the US at this time. Some panel members expressed concern over immunocompromised patients getting additional vaccine doses without an official recommendation to do so, saying “the issue is almost running away from us.” Although another ACIP meeting is not yet scheduled, the panel is expected to meet again in August.

GAO PREPAREDNESS & RESPONSE REPORT The US is concurrently responding to and recovering from the COVID-19 pandemic, with an ongoing national vaccination campaign and widespread loosening of public health measures amid a recent increase in cases. Recognizing this balance as “fragile,” the US Government Accountability Office (GAO) on July 19 released its 7th comprehensive report on the COVID-19 pandemic, providing an additional 15 recommendations to various US government agencies. Previous reports included a total of 72 recommendations on COVID-19, with agencies agreeing to implement 57 of them and having fully implemented 16 to date. The most recent report makes several recommendations related to national pandemic preparedness, including advice to the CDC to develop a plan to enhance surge capacity for laboratory testing and establish contracts for the manufacturing and deployment of diagnostic test kits prior to public health emergencies. The GAO also made suggestions to the US Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) regarding the organization and oversight of the country’s Strategic National Stockpile (SNS), which provides medical supplies and other materials to respond to a broad range of emergencies. Several other recommendations relate to the oversight, timely use, and integrity of COVID-19 relief funds allocated to HHS, the US Department of Education, US Department of the Treasury, US Office of Management and Budget (OMB), and Internal Revenue Service (IRS). According to GAO, if effectively implemented, the recommendations “can help improve the government’s ongoing response and recovery efforts as well as help it to prepare for future public health emergencies.”

EXPIRING VACCINES With demand for SARS-CoV-2 vaccination largely leveling off in the US over the past 3 weeks, millions of SARS-CoV-2 vaccine doses are set to expire in the next few months. Several states and some global health experts are calling for the excess doses to be redistributed to other countries, but so far the US government has rejected those requests, citing legal and logistical challenges. However, states are now able to request a specific number of vaccine doses instead of having doses distributed to them based on their population. Delayed reporting, everyday wastage, and waning demand, including those who did not go back for second doses, are among the sources for a pile up of inventory. The FDA previously extended the shelf-life of the Pfizer-BioNTech and J&J-Janssen vaccines, and some hope an additional extension for the Pfizer-BioNTech vaccine will be approved. Meanwhile, the federal stockpile of vaccine doses continues to grow, with approximately 390 million of the 1.41 billion doses purchased by the US having been delivered, and another 562 million doses from Moderna, Pfizer-BioNTech, and J&J-Janssen expected to be delivered by the end of 2021. The White House has pledged to donate 80 million doses of its vaccine supply, and will purchase an additional 500 million doses for low- and lower-middle-income countries. But some experts note the doses currently sitting in states are ready to be administered, not waiting to be manufactured, and those doses could have a positive impact in other countries if states were permitted to redistribute them. 

VACCINE MANDATES As SARS-CoV-2 vaccines become more widely available, some organizations, schools, and businesses are considering making them mandatory. This week, a US federal judge ruled to uphold a mandatory vaccination policy implemented by Indiana University, which would require SARS-CoV-2 vaccination for students, faculty, and staff before returning to campus this fall. The ruling acknowledges that the university has the authority under the Fourteenth Amendment to the US Constitution to pursue reasonable measures to protect the “public health for its students, faculty, and staff.” The students who filed the original suit are reportedly appealing the judge’s ruling.

On July 22, the American Hospital Association, the country’s largest association of hospitals and health systems, issued a statement in support of mandatory SARS-CoV-2 vaccination for healthcare workers. The statement argues that the vaccines have been demonstrated to be both safe and effective, and they play a critical role in protecting the health of both healthcare workers and their patients, many of whom are at elevated risk of severe COVID-19 disease. There have been several notable examples of hospitals firing employees who refused the vaccine, and the issue will certainly receive ongoing attention, especially until the vaccines receive full FDA approval.

VACCINE EFFICACY AGAINST VOCs A recent bioRxiv preprint study compared neutralizing antibody titers elicited by the 3 SARS-CoV-2 vaccines authorized for emergency use by the US FDA against pseudotyped variants of concern (VOCs) and variants of interest (VOIs). The small study compared blood samples from 17 people who had the 2-dose mRNA vaccines from Pfizer-BioNTech and Moderna and 10 people who received the single-dose viral vector vaccine from J&J-Janssen. Overall, the study showed a high level of antibody cross-neutralization elicited by the Pfizer-BioNTech and Moderna vaccines against VOCs but significantly decreased neutralization by antibodies generated by the J&J-Janssen vaccine. Because the study was conducted using blood samples, it might not reflect real-world performance, but the results counter previous reports of the J&J-Janssen vaccine’s efficacy against the Delta variant. The authors of the bioRxiv study, which is not yet peer-reviewed, said they hoped the findings did not discourage people from getting the J&J-Janssen vaccine but that future recommendations included advice for an additional second dose of that vaccine or an mRNA vaccine. The authors also called for continued surveillance of breakthrough infections to help determine the real-world effectiveness of the vaccines.

Another study evaluating vaccine effectiveness against the Delta variant was published July 21 in the New England Journal of Medicine. This study compared the effectiveness of the Pfizer-BioNTech mRNA vaccine and AstraZeneca-Oxford viral vector vaccine against the Alpha and Delta variants. Following 1 dose of the 2-dose vaccines, effectiveness was notably lower among persons with the Delta variant (30.7%) than among those with the Alpha variant (48.7%), with the results similar for both vaccines. Following a second dose, the Pfizer-BioNTech vaccine was 93.7% effective against Alpha and 88% effective against Delta. The AstraZeneca-Oxford vaccine after 2 doses was 74.5% effective against Alpha and 67% against Delta. The researchers note the differences in effectiveness between the vaccines are considered modest and support public health efforts to maximize uptake of the full 2-dose regimen to protect against VOCs.

REAL-WORLD VACCINE EFFECTIVENESS A study published July 20 in the Annals of Internal Medicine details a test-negative case-control study examining the short-term effectiveness of authorized SARS-CoV-2 mRNA vaccines in preventing infections. The research team used data collected through the US Department of Veteran Affairs’ (VA) COVID-19 Shared Data Resource, a national database containing extensive demographic, clinical, pharmacologic, laboratory, vital sign, and clinical outcome information derived from multiple validated sources. The researchers identified all individuals who tested positive for SARS-CoV-2 infection between December 15, 2020 and March 4, 2021, and matched them with control participants who had similar factors such as sex, age, race, BMI, and geographic location, but who had tested negative for SARS-CoV-2. The main measure of interest was vaccine effectiveness 7+ days after the second vaccine dose, but the researchers also examined vaccine effectiveness among those who received only 1 dose of either the Pfizer-BioNTech or Moderna vaccines.

The team identified 54,360 matched pairs of veterans. Among those who tested positive, 18% had been vaccinated, compared with 32.8% of those who tested negative. Overall, the vaccines showed 97.1% effectiveness among those who received the second dose at least 7 days prior. Among those who received only 1 dose, effectiveness was 85% overall. The research team concluded the SARS-CoV-2 vaccines being employed by the VA provided a high level of protection against infection. However, they noted several limitations of the study, including a predominantly male study population, a lack of data for currently circulating SARS-CoV-2 variants of concern, and a short follow-up period.

HEALTH EFFECTS OF LOCKDOWNS Researchers continue to explore the potential unintentional health impacts of COVID-19-related lockdowns. A commentary published in BMJ Global Health explores this question, comparing the costs of such lockdowns to their effectiveness in preventing COVID-19. The research team examined the issue through 4 main lenses: short-term mortality, disruption of health services, impacts on mental health, and the effect that lockdowns had on global health programs.

When examining a global dataset containing information on short-term mortality, the research team suggested that lockdowns were not associated with an increase in short-term mortality. The team specifically used Australia and New Zealand as examples, as both countries imposed strict COVID-19 lockdowns, maintained low numbers of COVID-19 cases, and had no excess mortality in 2020. When looking at disruption of health services, a topic that has garnered much attention throughout the pandemic, the authors noted that while there were notable disruptions, it was difficult to disentangle whether the lockdowns or the COVID-19 pandemic itself was the driving factor. The research team posited similar points around mental health, including suicide, stating that it was difficult to disentangle the mental health impacts of dealing with the COVID-19 pandemic with the mental health impacts of lockdowns, both of which increased increased isolation, anxiety, and stress. Lastly, the research team acknowledged that lockdowns did disrupt ongoing global health programs but, again, it was difficult to ascertain if the damage done by these disruptions outweighed the benefits associated with the COVID-19 lockdown interventions. Overall, the authors acknowledged that public health lockdowns have a real cost, but suggested they do not impart excess harm to populations facing a public health threat like COVID-19.

INDIA MORTALITY Researchers at the Center for Global Development published findings from an analysis that aimed to estimate the true COVID-19 mortality in India. India surpassed 400,000 cumulative reported deaths on July 1, but some experts are concerned that this total may be a substantial underestimate of the true COVID-19 burden, due to deficiencies in how the Indian government records mortality data—for COVID-19 and otherwise. The researchers took several approaches to estimating India’s COVID-19 mortality, including estimating excess mortality based on official death data, utilizing age-adjusted case fatality ratios and seroprevalence data, and a household-level longitudinal survey.

The mortality estimates they obtained based on these 3 methodologies ranged from 3.4 million to 4.9 million deaths, and while there are major differences between each estimate, all 3 are at least 8.5 times higher than the official data. Notably, the 3 methodologies yielded much different results for the first and second waves in India. While the second wave is generally believed to be more severe, 2 of the 3 methodologies estimate more deaths for the first wave than the second, perhaps a function of its longer duration. While these findings do not provide a definitive estimate of India’s COVID-19 mortality, this study and similar efforts continue to highlight the undercounting of COVID-19 deaths in countries around the world, and it could be years after the pandemic ends before we have a clear understanding of the global burden.

AFRICA The pace of new COVID-19 cases in Africa has slowed following an 8-week surge driven by the Delta variant, but the reprieve could be short-lived, according to the WHO Regional Office for Africa. The continent-wide decline of 1.7% this week was driven by a steep drop in the number of new cases reported in South Africa, where nationwide violence interrupted testing and, likely, reporting. The WHO warned that removing the country’s data would show an overall 18% increase in cases on the continent, creating an unbroken 9-week wave. Hospitals are overwhelmed, with few if any available intensive care unit beds, oxygen supplies are rapidly dwindling, and healthcare workers are stretched thin. South Africa stands as an example of how the long-term impacts of pandemic lockdowns on personal income, food security, and supply chains can exacerbate political instability, with the eruption of violent riots and looting in the wake of former President Jacob Zuma’s arrest earlier this month. The violence taxed an already overburdened healthcare system and disrupted COVID-19 testing and vaccination sites that were finally gaining momentum. Government officials and scientists warn the mass protests and disruptions to healthcare access could lead to another rise in COVID-19 cases, hospitalizations, and deaths.

Only about 1.5% of Africa’s population is fully vaccinated, and the continent has received less than 2% of the world’s SARS-CoV-2 vaccine doses. Data from the new Global Dashboard for Vaccine Equity estimate that African nations could add $38 billion to their gross domestic product (GDP) forecast for 2021 if they had vaccination rates similar to those in high-income countries. The inequity is creating a “two-track” pandemic and recovery, as high-income nations with higher vaccination rates are projected to recover more quickly while low- and middle-income countries (LMICs) that have not been able to access vaccines might not witness pre-pandemic growth levels until 2024, according to the UN Development Programme (UNDP), one of the dashboard’s sponsors, along with WHO and the University of Oxford. Global vaccine inequity will continue to grow under the status quo, a new analysis from the Kaiser Family Foundation shows. According to the analysis, low-income countries would need to increase their daily vaccination rate by nearly 19 times to reach 40% coverage with at least one dose by the end of the year. Ultimately, ensuring widespread vaccination will improve immunity among the global population and help bring the pandemic under control, but exactly how higher-income nations plan to increase vaccine supplies to LMICs remains an unresolved question.

VACCINE MANUFACTURING IN AFRICA Pharmaceutical company partners Pfizer and BioNTech on July 21 announced they signed a letter of intent with the Biovac Institute (Biovac)—a Cape Town, South Africa-based biopharmaceutical company—to help manufacture the Pfizer-BioNTech SARS-CoV-2 vaccine exclusively for the 55 nations of the African Union (AU). Under the plan, Biovac will “finish and fill” vaccine doses, obtaining large batch ingredients from Europe, blending the product, and filling and packaging vials for distribution, with the goal of producing more than 100 million doses annually. Pfizer-BioNTech will immediately begin to provide technology transfers, including on-site development and equipment installation, with the expectation that Biovac will be incorporated into the supply chain by the end of 2021 and begin producing finished doses in 2022. The agreement represents the first time an mRNA vaccine will be produced in Africa. Another South African firm, Aspen Pharmacare, already is producing the J&J-Janssen viral vector SARS-CoV-2 vaccine in the country, providing the same “fill and finish” services with the capacity to make more than 200 million doses each year.

The announcement received positive responses from some experts, while others called for more to be done to kickstart vaccine manufacturing in Africa. Africa CDC Director John Nkengasong said the move should be celebrated as another step in “the collective action to address technology transfer and intellectual property.” But Strive Masiyiwa, AU Special Envoy and Coordinator of the Africa Vaccine Acquisition Task Team (AVATT) initiative, called on large pharmaceutical firms to license production of SARS-CoV-2 vaccines on the continent rather than create piecemeal deals. WHO Regional Director for Africa Dr. Matshidiso Moeti also called for more local production of vaccines in Africa in order to prepare for future disease outbreaks.

Late last month, the WHO, along with Biovac, Afrigen Biologics and Vaccines, a network of universities, and the Africa CDC, established an mRNA vaccine technology transfer hub in South Africa to act as a training facility for the production of mRNA vaccine raw materials in Africa. However, neither Pfizer, BioNTech, nor Moderna, which makes another mRNA SARS-CoV-2 vaccine, has voiced support for the hub. Additionally, Pfizer reiterated the current deal with Biovac is only among the 3 companies and does not represent a government-supported technology transfer or compulsory licensing agreement. Pfizer CEO Albert Bourla on July 21 again stated the company’s opposition to a proposal at the World Trade Organization that would allow for patent waivers on SARS-CoV-2 vaccines, saying it would discourage innovation and collaboration. But BioNTech CEO Uğur Şahin indicated his company continues to evaluate sustainable approaches to supporting the African development and production of mRNA vaccines, which could be used to develop vaccines for other diseases in the future.

SARS-COV-2 ORIGINS Earlier this month, the WHO outlined a proposal for a follow-up investigation in China to identify the origins of the SARS-CoV-2 virus. On July 22, Chinese officials rejected the proposal. The WHO plan would have included additional investigations of laboratory facilities and markets in Wuhan, among other activities. Numerous governments—including the US—and experts have called for additional investigations into the origin of the pandemic, including access to additional data and specimens, arguing that limited access to the necessary data hindered the initial investigation. Following China’s rejection of the WHO proposal, the WHO called for international cooperation regarding investigations into the virus’s origins and emphasized that associated investigations are not intended to assign blame but rather to provide further understanding of how the virus emerged. As we covered previously, the WHO does not have the authority to initiate such an investigation without support from the host country.

OLYMPICS Tokyo reported its highest daily incidence since January, just as the 2020 Summer Olympics Games commence. The Tokyo Metropolitan Government reported 1,832 cases on July 21, only two days before the Olympics opening ceremony. The spike represents over 600 more cases than last Wednesday’s count. Several athletes already have tested positive for SARS-CoV-2 and will miss the Games, including a US beach volleyball player, an alternate for the US gymnastics team, and a Czech beach volleyball player. Vaccination is not required for Olympic athletes, but the Olympic playbook requires anyone going to the Games to submit two negative tests taken on separate days within 96 hours of leaving for Japan regardless of vaccination status. They are tested again upon arrival. Athletes, coaches, and officials are required to take daily antigen tests, followed by a PCR test if the antigen test returns a positive result. The Tokyo public database reports 79 people with Olympic credentials have tested positive. Close contacts of those who test positive will be allowed to train and compete as long as they receive two negative tests within 6 hours of competition.