FABULOUS HOPKINS CITATIONS–ALL OF THEMS – 07/24/2021

If you like facts, you will want to read this article. If you don’t like facts and prefer liviing in a bubble — move on.
Ron Munden

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 

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