Friday, October 29, 2021

See if you are still in the 16th Congressional District

If you are now in the 11th Congressional District, Bill Foster (D, Naperville) will be your representative (assuming his re-election in 2022)

Adam Kinzinger (R, Channahon) is retiring in the current 16 the District.  Darin LaHood (R, Dunlap in Peoria County) may be running for the new 16th.


Congressman Bill Foster is a scientist and businessman representing the 11th Congressional District of Illinois, a position he’s held since 2013. He also represented the 14th Congressional District of Illinois from 2008 to 2011. He is the only PhD physicist in Congress.

Bill serves on the House Financial Services Committee where he advocates for consumer protections and an economy that works for everyone. In response to the Great Recession, he helped create several important reforms in the financial services and housing markets, including the Dodd-Frank Wall Street Reform and Consumer Protection Act. Bill serves as chairman of the Financial Services Committee’s Task Force on Artificial Intelligence. 

He also serves on the House Science, Space, and Technology Committee where he has fought for evidence-based policies and forward-thinking approaches to some of our country’s most pressing issues, including climate change and energy innovation. He is a champion for sustained federal funding for scientific research.

Bill serves as the chairman of the Science Committee's Investigations and Oversight Subcommittee, which is empowered to investigate and oversee federal scientific research.

In the wake of the devastating COVID-19 pandemic, Bill was named to the House Select Subcommittee on the Coronavirus. The Select Subcommittee is charged with examining the federal government’s response to the COVID-19 crisis, including the use of taxpayer funds to mitigate the public health and economic consequences of the pandemic.

Bill's business career began at age 19 when he and his younger brother co-founded Electronic Theatre Controls, Inc., a company that now manufactures over half of the theater lighting equipment in the United States.

Before he became a Member of Congress, Bill worked as a high-energy physicist and particle accelerator designer at Fermi National Accelerator Laboratory (Fermilab). He was a member of the team that discovered the top quark, the heaviest known form of matter. He also led the teams that designed and built several scientific facilities and detectors still in use today, including the Antiproton Recycler Ring, the latest of Fermilab's giant particle accelerators.

Bill lives in Naperville with his wife Aesook, who is also a physicist. Bill has two grown children, Billy and Christine. Bill's father was a civil rights lawyer who wrote much of the enforcement language behind the Civil Rights Act of 1964.



Congressman Darin LaHood, born and raised in Peoria, serves the constituents of the 18th District of Illinois. Sworn into the US House of Representatives on September 17, 2015, LaHood quickly transitioned into office after his special election win on September 10. He won re-election to serve his third full-term in Congress on November 3, 2020, defeating his opponent with 70-percent of the vote.

The 18th District spans 19 counties across central and west-central Illinois, ranging from McLean County (Bloomington-Normal) to Adams County (Quincy). LaHood serves close to 710,000 constituents.

Prior to his election to Congress, LaHood served four years in the Illinois State Senate, beginning in 2011. LaHood spent more than nine years as a State and Federal Prosecutor. From 2001-2006, he worked for the U.S. Department of Justice as an Assistant United States Attorney in Las Vegas, Nevada. LaHood has also served as an Assistant State's Attorney in Cook County and Tazewell County. From 2006 up until his election to the House of Representatives, he practiced with the Peoria law firm of Miller, Hall & Triggs.

LaHood's record throughout his public service has resonated a strong, conservative record, promoting economic development and fiscal responsibility. LaHood has been an outspoken advocate for creating a better business climate in Illinois to boost the state and national economy, to create jobs for Illinoisans.

LaHood currently serves on the House Ways and Means Committee after being selected by his colleagues in January of 2018. The Ways and Means Committee is the House’s oldest committee and has jurisdiction over all taxation, trade and tariffs, and other revenue-raising measures. He serves on the Ways and Means Subcommittees on Tax Policy and Oversight.

In March of 2021, LaHood was appointed by House Republican Leader Kevin McCarthy to serve on the House Permanent Select Committee on Intelligence. The committee oversees the nation’s intelligence agencies including components of the Departments of Defense, Homeland Security, Justice, State, Treasury and Energy. LaHood serves on the Counterterrorism, Counterintelligence, and Counterproliferation (C3) and the Intelligence Modernization and Readiness (INMAR) Subcommittees.

LaHood also serves on the House Democracy Partnership. He currently co-chairs the US-China working group, the U.S.-Brazil Caucus, the Digital Trade Caucus, the U.S.-Lebanon Friendship Caucus, the Congressional Bus Caucus, and the Congressional Soccer Caucus.

Recognizing the need for reform, LaHood has fought to increase transparency and promote ethical behavior. He looks to build a strong, pro-growth economy, while fighting to reduce a record deficit that threatens the future of our children and grandchildren.

LaHood, a third generation Peorian, graduated from Spalding High School. He earned a B.A. from Loras College and holds a J.D. from The John Marshall Law School. In 2013, he was selected as an Edgar Fellow, a program run by former Governor Jim Edgar, which highlights future Illinois leaders. In 2008, LaHood was recognized in Peoria as a 40 Leaders Under Forty award winner. An avid runner, he has completed five marathons.

Congressman LaHood and his wife Kristen currently reside in Dunlap and are the proud parents of three sons, McKay, Lucas, and Teddy.

Thursday, October 28, 2021

October 28: Johns Hopkins COVID 19 Report

COVID-19 Situation Report

Editor: Alyson Browett, MPH

Contributors: Clint Haines, MS; Natasha Kaushal, MSPH; Amanda Kobokovich, MPH; Christina Potter, MSPH; Matthew Shearer, MPH; Marc Trotochaud, MSPH; and, Rachel A. Vahey, MHS.

EPI UPDATE The WHO COVID-19 Dashboard reports 244.9 million cumulative cases and 4.97 million deaths worldwide as of October 28. Global weekly incidence increased by 4.81% compared to the previous week, and mortality increased by 5.27%. After falling the previous week, these increases show the curve trending upward again, with numbers of new cases and deaths close to where they were at the end of September.

Global Vaccination

The WHO reported 6.7 billion cumulative doses of SARS-CoV-2 vaccines administered globally as of October 25. A total of 3.8 billion individuals have received at least 1 dose, and 2.85 billion are fully vaccinated. Analysis from Our World in Data indicates that the overall trend in global daily vaccinations reached a recent high on October 23 at 28.3 million and are beginning to fall again, down to 23.67 on October 27.* The global trend continues to closely follow Asia. Our World in Data estimates that there are 3.85 billion vaccinated individuals worldwide (1+ dose; 48.97% of the global population) and 2.99 billion who are fully vaccinated (37.79% of the global population).

*The average daily 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 45.57 million cumulative COVID-19 cases and 737,990 deaths. The current daily incidence average is approximately 68,151 new cases per day and appears to be increasing. Daily mortality appears to be falling again, with an average of 1,098 as of October 26.*

*Changes in state-level reporting may affect the accuracy of recently reported data, particularly over weekends. 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 416.2 million cumulative doses of SARS-CoV-2 vaccines. The daily vaccination trend could be beginning to rise again after falling since October 1, with an average 638,768 vaccines administered as of October 22.* We might expect to see increases in this number after the US government last week authorized booster doses for tens of millions more people. There are 220.9 million individuals who have received at least 1 vaccine dose, equivalent to 66.5% of the entire US population. Among adults, 79.7% have received at least 1 dose, as well as 14.9 million adolescents aged 12-17 years. A total of 191 million individuals are fully vaccinated, which corresponds to 57.5% of the total population. Approximately 69.1% of adults are fully vaccinated, as well as 12.45 million adolescents aged 12-17 years. Since August 13, 14.4 million fully vaccinated individuals have received a booster or additional dose of vaccine, including 19.2% of fully vaccinated adults aged 65 or older.

*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.

PEDIATRIC VACCINE As expected, the US FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on October 26 voted to recommend the regulatory agency issue an Emergency Use Authorization (EUA) for the Pfizer-BioNTech vaccine to be available for 28 million US children aged 5 to 11 years. The vote was 17 in favor with one abstention. The FDA is expected to follow the panel’s advice in the coming days, although it is not bound to do so. After the FDA’s decision, the US CDC’s Advisory Committee on Immunization Practices (ACIP) will take up the issue at its next meeting, scheduled for November 2-3. The CDC Director would then issue the agency’s final guidance, potentially making pediatric vaccinations available by the end of next week. The US government has 15 million doses ready to immediately ship to states for distribution to pediatrician offices, hospitals, and pharmacies, and Pfizer-BioNTech announced today that the US has purchased an additional 50 million pediatric doses, which are one-third the dose of the version authorized for people aged 12 and older. Researchers say a SARS-CoV-2 vaccine for children will save lives in that age group and could help keep overall case counts lower, especially if a new variant of concern emerges. But some parents remain concerned over the vaccine’s safety. New data from the KFF COVID-19 Vaccine Monitor show parents of 5- to 11-year-olds are about evenly split, with about 30% saying they will get the shots for their children, one-third saying they will wait, and 30% saying they will definitely not allow their children to get the vaccine.

FOURTH DOSE FOR SOME WITH IMMUNOCOMPROMISE The US CDC updated its guidance on SARS-CoV-2 vaccine booster doses for people who are moderately or severely immunocompromised. Those individuals who received an initial 2-dose series with an mRNA vaccine (Pfizer-BioNTech or Moderna), followed by a third, or “additional,” dose after ≥28 days, may receive a fourth shot—this one considered a booster dose versus the additional dose—at least 6 months after the third dose with any available booster dose (full dose of Pfizer-BioNTech or J&J-Janssen or half dose of Moderna). The agency advised any moderately or severely immunocompromised individual who initially received a single dose of the J&J-Janssen vaccine should receive a single booster dose of any vaccine booster at least 2 months after the initial shot. Notably, if the person initially received the J&J-Janssen shot, they should not receive more than 2 vaccine doses at this time. An estimated 2% of the US population—about 9 million people—are considered to be moderately or severely immunocompromised.

PANDEMIC CONTINUES During its ninth meeting regarding COVID-19, a WHO Emergency Committee of advisors agreed that the pandemic is “far from finished,” 21 months after the group initially named the disease a public health emergency of international concern (PHEIC). Noting that progress has been made in combating the virus, the group called on the international community to use all available tools to mitigate the pandemic’s impacts and recognized the additional burden on addressing humanitarian emergencies, population migration and displacement, and other crises. The committee also expressed concern over challenges responding to the pandemic in the Africa region, including access to sufficient vaccines, diagnostics, and treatments, as well as adequate surveillance and monitoring capabilities. COVID-19 likely will move from a pandemic to an endemic disease at some point in the future, although experts agree that the benchmarks for determining endemicity are unclear. The WHO Emergency Committee will meet again in 3 months, or sooner as needed, to reevaluate the state of the COVID-19 pandemic.

MERCK LICENSING DEAL Merck and the Medicines Patent Pool (MPP) announced a voluntary licensing agreement that will allow MPP to issue sublicenses to permit manufacturers—mostly in Africa and Asia—to make and distribute Merck’s investigational antiviral COVID-19 treatment in 105 low- and middle-income countries (LMICs), following necessary regulatory approvals. Merck is developing the drug, named molnupiravir, in partnership with Ridgeback Biotherapeutics, which acquired the license for the drug from inventor Emory University. Under the deal, Merck, Ridgeback, and Emory will not receive royalties for sales of molnupiravir in LMICs as long as the WHO continues to classify COVID-19 as a public health emergency of international concern (PHEIC). Merck will continue to make the drug for wealthy nations and some middle-income countries, selling it at significantly higher prices. Merck previously licensed production of molnupiravir to several generic drug manufacturers in India, but made the deal with MPP so as not to rely too heavily on production in a single region.

Earlier this month, Merck announced interim Phase 3 clinical trial data showing molnupiravir, which is administered orally, reduced the risk of hospitalization or death by about half in people with mild-to-moderate COVID-19. The companies applied to the US FDA for Emergency Use Authorization (EUA), and the European Medicines Agency (EMA) announced this week it launched a rolling review of the antiviral. If approved for use, the easy-to-administer pill will be the first available that does not need to be administered by injection or infusion and could help curb COVID-19 outbreaks and alleviate pressure on healthcare systems by helping people recover at home. Health experts have voiced concerns over the potential for inequitable distribution of molnupiravir, but this deal, and a US$120 million pledge from the Gates Foundation to support access to the drug for lower-income countries, provide some hope that the rollout of the treatment will not follow along the lines of the vaccines.

BIONTECH VACCINE MANUFACTURING IN AFRICA BioNTech, which developed the Pfizer-BioNTech SARS-CoV-2 vaccine, announced this week it has signed agreements with Senegal and Rwanda to build mRNA vaccine manufacturing facilities, with construction on at least one plant to begin mid-2022. Initially, BioNTech will own and operate the facility, which will be able to produce up to 50 million vaccine doses annually, with capacity expected to expand. Dr. Matshidiso Moeti, Director of the WHO Regional Office for Africa, said the state-of-the-art facilities could be “game-changers” for the continent, although much needs to be done on the continent to improve vaccine access. Health advocates welcomed the announcement but said the effort is too little, too late. Only 6% of the African population is fully vaccinated, and only 5 nations—less than 10% of the continent’s 54 countries—will reach the year-end target of fully vaccinating 40% of their people, WHO announced today. The UN also warned that limited access to necessary commodities—such as auto-disable syringes used to administer the Pfizer-BioNTech vaccine—could further slow the vaccines’ rollout in Africa.

MORTALITY TRENDS Overall, the risk of death from COVID-19 increases with age. But according to a working paper published by the World Bank Group, this reality varies depending upon where one lives. In high-income countries, COVID-19 deaths generally are concentrated among people over age 65, with only 11% of both official deaths and excess deaths occurring among people younger than age 65. In the upper-middle-income nations for which data were available, the mortality curve became flatter, with 40% of official deaths and 37% of excess deaths occurring among people younger than 65. Among the lower-middle-income nations that had available data, 54% of official deaths were among those under age 65.* Notably, the US has a much younger profile of death—for both official COVID-19 deaths and excess mortality—than countries with similar income levels, even after controlling for differences in population age distribution. With flatter mortality curves, developing countries face the loss of large numbers of people of working age, many of whom provided income to their families or were caregivers to children or family members. These losses likely will have long-term social and economic impacts on these nations into the future and underline the importance of equitable vaccine and resource distribution to close the gaps between wealthy and poorer nations.

*Data for excess deaths were not available for lower-middle-income countries, and no data were available for any low-income countries.

FLUVOXAMINE A study published in The Lancet Global Health showed the inexpensive antidepressant fluvoxamine lowered the odds of hospitalization and death when administered to COVID-19 patients early in their symptom onset. The trial, conducted in Brazil, included 741 individuals who received fluvoxamine and 756 who received placebo, 58% of whom were female, and the cohort had an average age of 50. The study included only high-risk patients and those who enrolled were largely unvaccinated, raising questions about the antidepressant's applications as a therapeutic among vaccinated individuals. Additionally, the study mentioned that some patients were unable to fully tolerate the intended study dosage, raising concerns about the most beneficial dose. Nonetheless, the study results represent positive news in continuing global efforts to reduce the need for COVID-19 hospitalization in a more accessible manner. The current cost of a 10-day course of fluvoxamine is about $4, significantly lower than many of the options currently used to treat COVID-19.

AT-HOME RAPID TESTS Earlier this week, the US HHS announced the agency is expanding its efforts to make at-home COVID-19 testing more accessible. HHS will invest US$70 million to help developers move through the regulatory process and develop a plan with the US FDA to streamline authorization decisions in an effort to bring more over-the-counter tests to market. At the federal level, there has been a push to increase the accessibility of at-home diagnostics ahead of the winter season. The administration of US President Joe Biden announced these plans as businesses move closer to having to implement a “vaccinate-or-test mandate.” The goal of the announcements are two-fold: to increase the supply of available tests and potentially lower the price threshold which currently limits their widespread usage. The FDA has authorized several at-home test kits.

PANDEMIC PREPAREDNESS The Global Preparedness Monitoring Board (GPMB) is warning world leaders that the window of opportunity to address the COVID-19 pandemic and prepare for future disease outbreaks is quickly closing, as the world begins to move on to other pressing issues. In its third annual report, GPMB says the failures of the COVID-19 pandemic response were markedly bogged down by geopolitical divisions and closed-door negotiations that neglected to include key stakeholders. GPMB called for renewed international cooperation and outlined 6 recommendations. In November 2021, the World Health Assembly will hold a special 3-day session to discuss the plausibility of developing a "pandemic treaty."

In the US, discussions over the federal government’s response to COVID-19 have been sidelined in the US Congress, as negotiations over US President Joe Biden’s domestic agenda and the federal budget take precedence. Efforts to present a bipartisan bill in the US Senate to bolster pandemic preparedness have been postponed until later this year or early 2022. Public health experts are advocating for improvements to data collection systems and supply chain vulnerabilities that continue to present significant challenges during the COVID-19 pandemic. The Biden administration has indicated it is prioritizing global health security, earlier this month releasing an annual report on strengthening the Global Health Security Agenda (GHSA).

FINANCIAL DRAIN ON HOSPITALS The COVID-19 pandemic has exacerbated existing inequities in healthcare systems and exposed disparities in funding allocations. In a recent study published in JAMA, researchers examined how US federal COVID-19 relief funding was allocated, how CARES Act funding was utilized, and disparities in funding allocations. They found that academic-affiliated hospitals, hospitals with higher pre-pandemic assets, and hospitals with higher numbers of COVID-19 cases received higher levels of funding, while critical access hospitals received lower levels of financial assistance. The lack of transparency behind CARES Act funding allocation possibly resulted in resource-limited hospitals suffering under the demands of the pandemic, and the researchers emphasized the need to base funding allocations on hospitals’ pre-disaster finances in future resource allocations. Hospitals also took an economic hit due to the postponement of elective surgeries during the beginning of the COVID-19 pandemic, according to 2 studies presented at a conference of the American College of Surgeons (ACS). One healthcare system lost 42% of its net revenue in 2020 after delaying surgeries from mid-March to July 2020, while US children’s hospitals lost $1.53 billion due to delays or cancellations of pediatric surgeries. The researchers said the results show the need for long-term financial planning and preparations for sustained operations management during crises. 

Tuesday, October 26, 2021

October 26: Johns Hopkins COVID 19 Report

COVID-19 Situation Report

Editor: Alyson Browett, MPH

Contributors: Clint Haines, MS; Natasha Kaushal, MSPH; Amanda Kobokovich, MPH; Christina Potter, MSPH; Matthew Shearer, MPH; Marc Trotochaud, MSPH; and, Rachel A. Vahey, MHS.

Webinar Available: The COVID-19 pandemic has shown that accurate and timely health-related information is crucial to mounting an effective response to a public health crisis. As can be seen in setbacks during the COVID-19 response, health-related misinformation and disinformation can lead to more infections, deaths, disruption, and disorganization of the effort. The latest session of The Capitol Hill Steering Committee on Pandemic Preparedness & Health Security, titled “Combating Misinformation and Disinformation for COVID-19 and Future Public Health Threats,” evaluated the role misinformation has played in health emergencies and offered solutions to increase trust in future public health messaging. A recording of the webinar is available for viewing.

VACCINES FOR CHILDREN The US FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is meeting today to consider recommending the authorization of the Pfizer-BioNTech SARS-CoV-2 vaccine for children ages 5 to 11 years. Last week, the FDA posted Pfizer-BioNTech’s briefing on the vaccine for this age group, which suggested a 2-dose series of 10μg shots delivered 3 weeks apart—one-third of the adult dose—was 91% effective in preventing symptomatic disease among this younger age group, with low incidence of adverse events. The companies said no cases of heart inflammation were reported in 3-months follow-up after the second shot, although the study population was small. In its own briefing, the FDA said the benefits of the Pfizer-BioNTech vaccine among children ages 5 to 11 clearly outweigh the risks of potential side effects. The FDA’s advisory committee is expected to recommend authorizing the lower-dose Pfizer-BioNTech vaccine for young children today. After the FDA issues a final decision—which usually follows the recommendations of its advisors—the US CDC Advisory Committee on Immunization Practices will make recommendations at its next meeting, scheduled for November 2-3. Following the approval of those recommendations by CDC Director Dr. Rochelle Walensky, children ages 5 to 11 could become eligible for SARS-CoV-2 vaccination by November 3-4.

According to 2 recent studies—one published in the New England Journal of Medicine (NEJM) and the other in the CDC’s Morbidity and Mortality Weekly Report (MMWR)—the Pfizer-BioNTech vaccine is effective at preventing symptomatic COVID-19 disease and related hospitalization in adolescents aged 12 to 18 years. The studies demonstrate the importance of vaccines in protecting children from COVID-19, and they could factor into today’s FDA advisory committee meeting.

On October 25, Moderna announced interim results from its Phase 2/3 KidCOVE study evaluating its SARS-CoV-2 vaccine in children aged 6 to 11 years. According to the company, the data—which are not yet published or peer-reviewed—showed that participants in the 6- to 11-year-old range had a robust immune response to a 2-dose 50μg regimen delivered 4 weeks apart. Side effects included mild to moderate symptoms such as fatigue, fever, headache, and pain at the injection site. The company indicated plans to submit their data to US and European regulators soon, although there is no indication when the FDA might review the vaccine for use in children. Moderna’s vaccine currently is authorized for use in adults, and it is awaiting a response from the FDA to its June request for authorization for children aged 12 to 17.

US TRAVEL POLICIES On October 25, US President Joe Biden issued a proclamation on international air travel requiring nearly all inbound international travelers to be fully vaccinated. Notably, there are exceptions to the new policy: children under 18, those with certain medical conditions, and non-tourists traveling from specific countries with low vaccine access will instead be required to report a negative COVID-19 test prior to departure. There are no religious exemptions for inbound passengers, according to the US CDC, which issued new contact tracing rules the same day. Those travelers staying in the US are expected to receive a vaccine within 60 days, a decision which takes advantage of the large repository of vaccine doses in the country. The travel industry is welcoming these changes to the existing regulations, which issued travel restrictions on a country-by-country basis. With a more uniform travel policy, airlines are looking forward to simpler implementation and logistics moving forward. The new air travel policy will take effect on November 8, and more details on a similar plan to lift travel restrictions on land border crossings are expected later this week.

Additionally, the CDC extended its Framework for Conditional Sailing Order through January 15, 2022. While the CDC makes important recommendations for other forms of travel, CDC maintains authority over whether or not cruise ships are allowed to operate in US waters. Given the short, but fraught, history of COVID-19 on cruise ships, the CDC has taken many steps to work with the cruise ship industry to ensure the safety of passengers and crew. The Framework for Conditional Sailing Order was initially implemented in October 2020 following the expiration of the CDC’s No Sail Order. Since then, the cruise industry has adopted numerous COVID-19 prevention measures, such as masking and testing requirements. The temporary extension states that CDC intends to transition to a voluntary program upon the conclusion of the extension deadline, which will involve close coordination between the CDC and the cruise industry.

US BOOSTER DOSES Tens of millions more people in the US became eligible for SARS-CoV-2 vaccine boosters last week following CDC Director Dr. Rochelle Walensky’s endorsement of the agency’s Advisory Committee on Immunization Practices’ (ACIP) recommendation for booster shots in certain populations. Now, all 3 of the vaccines approved or authorized in the US—all of which remain highly effective in reducing the risk of severe disease, hospitalization, and death—are available for additional or booster doses among certain populations. For those who received primary shots with either the Pfizer-BioNTech or Moderna vaccines, booster doses are available 6 months after the initial series for individuals aged 65 or older and those aged 18 or older who live in long-term care settings, have underlying medical conditions, or work or live in high-risk settings. The Moderna booster is half of the initial shots (50 μg versus 100 μg), while the Pfizer-BioNTech booster is the same dosage. Anyone who received the J&J-Janssen vaccine is eligible to receive a booster dose 2 months following their initial shot. Additionally, the CDC’s recommendations allow for people to choose which of the 3 available vaccines they get for a booster, a strategy known as “mix & match” or heterologous dosing. Notably, health experts emphasized that anyone who received 2 mRNA vaccine doses or a single J&J-Janssen dose are—for now—considered fully vaccinated. Several members of the FDA and CDC advisory panels expressed frustration over the limited data on the safety and efficacy of boosters, how questions were posed to the committees, and a burden to approve the extra doses after they were promised by US President Joe Biden in August.

GLOBAL VACCINE ACCESS The US government has now delivered 200 million SARS-CoV-2 vaccines to more than 100 countries, out of a pledge of 1.1 billion doses. A US Department of State official said many of the donated doses are surplus supply and more needs to be done to increase supply to low- and middle-income countries (LMICs), including manufacturers increasing production and other countries donating excess shots. Notably, the US government continues to deny requests from state or local governments to donate soon-to-expire doses to countries in need. In an agreement facilitated by the US government, Moderna announced it will make up to 110 million of its vaccine doses available at the lowest price to the African Union. The US undoubtedly is a leader in global vaccination efforts, but the government—and other wealthy countries—can and should do more to improve access in LMICs, public health advocates urge.

During comments to reporters last week, White House Principal Deputy Press Secretary Karin Jean-Pierre called on all World Trade Organization (WTO) member states to support a proposal to temporarily waive intellectual property rights for COVID-19 medical products, including vaccines. Formal talks on the proposal—which is endorsed by more than 100 countries—are stalled despite US backing. Notably, 2 senior officials in the administration of US President Joe Biden told The Washington Post that the government lacks the authority to share technology of Moderna's SARS-CoV-2 vaccine, despite the company receiving nearly US$10 billion in federal funding to develop, research, and expand manufacturing of the shots. Last week, the WHO urged the G20 nations, which are holding a summit this week, to increase vaccine donations, and finance ministers from member states of the Asia-Pacific Economic Cooperation (APEC) agreed to take steps to support equitable distribution of vaccines and expand manufacturing. The Kaiser Family Foundation (KFF) updated its Global COVID-19 Vaccine Coverage Tool on October 25, providing data on vaccine coverage by country, income-level, region, and globally, as well as estimates on future vaccine coverage levels.

HEALTHCARE WORKERS As many as 180,000 healthcare workers died of COVID-19 between January 2020 and May 2021, according to estimates from a WHO working paper, which urged nations worldwide to do more to support and protect healthcare workers amid the pandemic. In addition to calling for better access to vaccines for healthcare workers—only 2 of 5 are fully vaccinated globally, with greater disparities between poor and wealthy nations—the WHO warned that an increasing proportion of the workforce faces burnout, stress, anxiety, and fatigue, and the industry faces a worker shortage. A study published in the November issue of the American Journal of Nursing shows that in 2017, prior to the pandemic, 5.5% of 7,378 nurse survey respondents reported having suicidal ideation within the past year, and other surveys have shown that 25% to 50% of healthcare providers report high stress, anxiety, work overload, or symptoms of burnout. In the US, which needs more nurses, shortages in nursing school instructors, clinical sites, and financial resources has led to a bottleneck in available slots for students.

AY.4.2 VARIANT UNDER INVESTIGATION The UK Health Security Agency last week designated the Delta sublineage AY.4.2—commonly known as “Delta Plus”—as a Variant Under Investigation (VUI) and officially named the variant VUI-21OCT-01. The agency made the designation because the sublineage has become increasingly common in the UK in recent months, accounting for approximately 6% of all sequenced Delta cases. Currently, there is no evidence AY.4.2 causes more severe disease, although 2 mutations on the spike protein—A222V and Y145H—could be contributing to an increased growth rate, but more evidence is needed. COVID-19 cases caused by the Delta sublineage have been detected in at least 118 countries, including the US, India, Israel, and Russia. At a briefing last week, US CDC Director Dr. Rochelle Walensky said health officials are keeping an eye on the sublineage but that so far there is no evidence it impacts the effectiveness of vaccines or available treatments.

NEUROLOGICAL IMPACTS Many people who recover from COVID-19 suffer various symptoms of cognitive dysfunction, commonly known as “brain fog,” although the prevalence and severity of these symptoms are not well-known. In a research letter published in JAMA Open Network, researchers from the Icahn School of Medicine at Mount Sinai in New York (US) describe results from a study examining rates of cognitive impairment among 740 COVID-19 survivors who were treated in outpatient, emergency department, or inpatient hospital settings between April 2020 and May 2021. They found that up to nearly one-quarter of recovered patients continue to experience some sort of cognitive impairment 7 months post-infection, including problems with memory, processing speed, executive functioning, attention, or phonetic and category fluency. The researchers note the “considerable implications” for COVID-19 patients’ long-term rehabilitation and occupational, psychological, and functional outcomes. Even younger patients, in their 20s, 30s, and 40s, who had milder cases of the disease reported cognitive impairments, potentially heavily impacting their ability to engage in work, community, and family activities.

Another study published last week in Nature Neuroscience describes how SARS-CoV-2 can damage small vessels in the brain, potentially leading to neurological symptoms in COVID-19 patients. The team of European and US researchers suggest a potential therapeutic target to potentially treat or prevent long-term neurological symptoms of COVID-19.

ASTRAZENECA-OXFORD VACCINE A recent study published in Nature Medicine reports an association between the AstraZeneca-Oxford SARS-CoV-2 vaccine and Guillain-Barre Syndrome (GBS), a rare neurological condition. Researchers estimated that there were 38 extra cases of GBS per 10 million persons receiving the AstraZeneca-Oxford vaccine. The same study also estimated that there were 145 extra cases of GBS per 10 million persons with a positive COVID-19 test. Importantly, while there are some rare complications associated with SARS-CoV-2 vaccines, it appears that the risk of developing these neurological complications is much higher following natural infection with SARS-CoV-2. The study also examined the same outcomes among people who received the Pfizer-BioNTech vaccine, but there was no significant association between this vaccine and GBS. There was, however, a positive association between the Pfizer-BioNTech vaccine and hemorrhagic stroke. The European Medicines Agency previously added GBS as a possible adverse event to the AstraZeneca-Oxford vaccine, and the UK added the warning last week. These new findings support the overall safety of vaccines against SARS-CoV-2 and the importance of protecting oneself against the worst outcomes of infection.

CHINA Chinese health officials announced new lockdowns and other measures to contain several local SARS-CoV-2 outbreaks, with the average number of daily new COVID-19 cases more than doubling since October 16. Officials warned the outbreaks, mainly in the northern part of the country, are expected to worsen. Marathons in Wuhan and Beijing were postponed, with organizers citing the safety of runners, staff, and residents. On October 25, health officials announced children as young as 3 years old will be eligible for vaccination, with at least 5 provinces announcing compulsory vaccination for children. SARS-CoV-2 vaccines from both Sinopharm (2 versions) and Sinovac are authorized for use in children, however the shots have only been used among individuals aged 12 and older until now.

China is one of only a few countries continuing to enforce a zero-COVID policy, and the Chinese government is concerned the outbreaks will spread into Beijing, where the 2022 Winter Olympics are set to begin in February. According to new guidelines released this week, athletes at the games must be vaccinated to avoid a 21-day quarantine, will need to take daily SARS-CoV-2 tests, and will be restricted to a closed loop system dictating travel between venues and interactions with other participants. China already has said international spectators will not be allowed at the Olympics, which are set to run from February 4-20. About 75% of the Chinese population is fully vaccinated, and those who received their last dose at least 6 months ago are eligible for a booster dose.

Thursday, October 21, 2021

October 21: Johns Hopkins COVID 19 Report

COVID-19 Situation Report

Editor: Alyson Browett, MPH

Contributors: Clint Haines, MS; Natasha Kaushal, MSPH; Amanda Kobokovich, MPH; Christina Potter, MSPH; Matthew Shearer, MPH; Marc Trotochaud, MSPH; and, Rachel A. Vahey, MHS.

EPI UPDATE The WHO COVID-19 Dashboard reports 241.4 million cumulative cases and 4.91 million deaths worldwide as of October 20. Global weekly incidence decreased by 2.28% compared to the previous week, and mortality fell by 0.16%. These declines are smaller than those seen since mid-August, showing signs of stabilization.

Global Vaccination

The WHO reported 6.55 billion cumulative doses of SARS-CoV-2 vaccines administered globally as of October 19. A total of 3.7 billion individuals have received at least 1 dose, and 2.77 billion are fully vaccinated. Analysis from Our World in Data indicates that the overall trend in global daily vaccinations reached a recent low on October 17 at 20 million and is beginning to rise, up to 22.25 on October 20.* The global trend continues to closely follow Asia. Our World in Data estimates that there are 3.79 billion vaccinated individuals worldwide (1+ dose; 48.1% of the global population) and 2.88 billion who are fully vaccinated (36.58% of the global population).

*The average daily 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 45.07 million cumulative COVID-19 cases and 728,125 deaths. The current daily incidence average is approximately 75,988 new cases per day and appears to be decreasing. Daily mortality reached a recent low of 1,206 on October 17 but appears to be rising, up to 1,256 on October 19. Since August 13, 11.25 million fully vaccinated individuals have received a booster or additional dose of vaccine, including 15.3% of fully vaccinated adults aged 65 or older.

On October 15, the CDC began reporting hospitalization, infection, and death rates by vaccination status. For all adults aged 18 years and older, the cumulative COVID-19-associated hospitalization rate was about 12 times higher in unvaccinated persons between April 2021 and the end of August. In August, unvaccinated individuals were about 6 times more likely to test positive for SARS-CoV-2 and 11 times more likely to die of COVID-19 than those who were fully vaccinated. Notably, the COVID-19 case and death rates were slightly higher among J&J-Janssen vaccine recipients, followed by Pfizer-BioNTech recipients, and then Moderna. The incidence rate estimates are based on data collected from 16 health departments representing 30% of the US population.

*Changes in state-level reporting may affect the accuracy of recently reported data, particularly over weekends. 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 410 million cumulative doses of SARS-CoV-2 vaccines. The daily vaccination trend rose briefly following authorization of booster doses of the Pfizer-BioNTech vaccine for some populations on September 22 but continues to decline after a recent peak on October 1*. A similar increase in the daily vaccination trend could occur in the coming months as booster doses likely will be made available for millions more people. There are 219.4 million individuals who have received at least 1 vaccine dose, equivalent to 66.1% of the entire US population. Among adults, 79.1% have received at least 1 dose, as well as 14.8 million adolescents aged 12-17 years. A total of 189.7 million individuals are fully vaccinated, which corresponds to 57.1% of the total population. Approximately 68.6% of adults are fully vaccinated, as well as 12.3 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 BOOSTERS As expected, the US FDA on October 20 authorized booster doses of the Moderna SARS-CoV-2 vaccine for certain populations and the J&J-Janssen vaccine for all recipients. The agency also authorized a “mix & match” booster strategy allowing the use of each of the available SARS-CoV-2 vaccines as a heterologous booster dose in eligible individuals who have completed their primary vaccination with a different vaccine. The FDA amended the EUA for the Moderna vaccine to allow for a single half-dose booster for fully vaccinated individuals at least 6 months from their second prime-boost dose who are also aged 65 or older, or aged 18 to 64 and at high risk of severe COVID-19, or aged 18 to 64 and have frequent institutional or occupational exposure to SARS-CoV-2. For the J&J-Janssen vaccine, the FDA authorized a single booster dose for all adult recipients at least 2 months after the primary shot. Additionally, the agency clarified the Pfizer-BioNTech authorization to allow it to be used for heterologous booster doses. The FDA already authorized boosters of the Pfizer-BioNTech vaccine for certain populations, and the companies today released topline results from a Phase 3 clinical trial showing a relative vaccine efficacy of 95.6% among booster dose recipients when compared with those who did not receive a booster. The data are not yet published or peer-reviewed.

In its communications, the FDA did not show preference for any of the vaccines and did not say whether it is better to receive a booster dose with the same vaccine. The US CDC’s Advisory Committee on Immunization Practices is scheduled to vote this afternoon on its own recommendations for the vaccine boosters. Notably, with various populations cleared to get boosters from different vaccines, and the FDA expected to soon authorize a different dose of the Pfizer-BioNTech vaccine for children ages 5 to 11, pharmacies, immunization programs, physicians, and others face challenges in tracking inventory, minimizing waste, and ensuring the correct dose is being given to the correct individual.

US PEDIATRIC VACCINATION PLANNING On October 20, the US White House released a plan for the rollout of SARS-CoV-2 vaccinations for children ages 5 to 11 when the US FDA and US CDC authorize their use. The largest parts of the plan involve the purchasing of 28 million doses of the Pfizer-BioNTech vaccine—enough to cover every child in that age group—and operational changes to make vaccination conveniently located and accessible. To support jurisdictional planning, the CDC published an Operational Planning Guide indicating that as soon as regulatory agencies make a decision, the US government will begin shipping pediatric vaccine formulations, initial allocations of which will be made pro-rata and are available for preorder. The White House plans to distribute the vaccines to 25,000 pediatrician offices and 100 children’s hospitals nationwide, in addition to sending doses to pharmacies and rural health clinics. Additional plans for public education will ramp up closer to the expected time of authorization, potentially the beginning of November. Speaking at a recent White House briefing, Dr. Anthony Fauci, Chief Medical Advisor to US President Joe Biden, reiterated the importance of achieving high vaccine coverage across all eligible age groups, noting data show that children can become infected with and transmit SARS-CoV-2 as readily as adults, although half of them remain asymptomatic.

UK & “DELTA PLUS” Late last week, the UK Health Security Agency released its 25th Technical Briefing on SARS-CoV-2 variants of concern and variants under investigation. Data on a new sublineage of the SARS-CoV-2 Delta variant—newly designated as AY4.2 and sometimes called “Delta Plus”—show incidence has been expanding within the country, accounting for 6% of all samples sequenced. Health officials expect this proportion to increase in the coming weeks, and many in the public health community are watching the sublineage to see how it impacts the COVID-19 epidemiological situation. The UK recently has experienced a drastic increase in new COVID-19 cases, reporting a daily average of 45,461 new cases on October 20, up more than 12,000 cases from 2 weeks ago. Additionally, the number of daily deaths are rising. Reports suggest that an increase in cases among children has been fueling this most recent spike, especially as this age group returned to schools. Notably, vaccine uptake has lagged since early September, although there has been an uptick in average daily vaccinations over the past several days. The UK has a higher vaccination rate than some of its European counterparts, with 79% of the eligible population fully vaccinated.

Public health experts are pleading with the UK government to reinstate COVID-19 restrictions that were rolled back this summer in order to avoid reaching a critical point where the virus becomes much more difficult to contain. The government has pushed back on these calls, saying the UK will not go back to a lockdown scenario and that people should “learn to live with this virus.” In September, Prime Minister Boris Johnson announced a “Plan B” for the country, to be implemented if the National Health Service (NHS) becomes overwhelmed. The plan includes reimplementing some restrictions like mask mandates and vaccine passports but would work to keep major operations running. Others are calling for a “Plan B Plus” that would go a few steps further and include urging people to get vaccinated or get boosters, using the healthcare system wisely, and volunteering to support frontline workers.

BRAZIL A parliamentary commission of inquiry (CPI) in Brazil is recommending that President Jair Bolsonaro be charged with 9 serious offenses—including charlatanism, incitement to commit crimes, the propagation of pathogenic germs, and crimes against humanity—for allegedly intentionally allowing the COVID-19 pandemic to spread unabated through the country and killing hundreds of thousands of people, according to a 1,180-page final draft of its report. The commission’s senators are scheduled to vote on the final report on October 26, and if approved, the accusation of crimes against humanity will be referred to the International Criminal Court for further investigation. The document also recommends criminal charges for at least 65 other people, including current and former government officials and 3 of President Bolsonaro’s sons. While it is unclear whether the accusations will lead to criminal charges, the report could prove damaging to President Bolsonaro’s reelection campaign. President Bolsonaro, a self-confessed vaccine skeptic, pushed unproven treatments, discouraged mask-wearing and encouraged mass gatherings as COVID-19 incidence increased nationwide. Of the 11-member committee, 7 are members of the opposition, suggesting the report will be approved.

MOLNUPIRAVIR Concerns are rising that access to Merck’s yet-to-be-authorized COVID-19 treatment will be limited for low- and middle-income countries (LMICs)—in ways similar to SARS-CoV-2 vaccines—leading the WHO and the Gates Foundation to make commitments to help improve access to the antiviral, called molnupiravir. In a draft document, the WHO-supported Access to COVID-19 Tools Accelerator (ACT-A) outlines plans to procure antiviral drugs to treat up to 120 million patients with mild COVID-19 for as little as $10 per course, although it does not specifically name molnupiravir. The Gates Foundation is committing US$120 million to support the production of generic versions of the still-experimental molnupiravir. Merck has already signed licensing agreements with at least 8 generic drug manufacturers, which will receive various types of incentives from the Gates Foundation to produce the drug as expeditiously as possible. Merck and its partner Ridgeback Biotherapeutics applied for Emergency Use Authorization (EUA) from the US FDA after releasing interim clinical trial results showing the drug cut COVID-19-related hospitalizations and deaths by about half. An FDA advisory committee is scheduled to meet on November 30 to discuss the companies’ EUA request. Although molnupiravir is easy to distribute and can be taken at home, price and availability likely will remain obstacles for poorer nations. Notably, several wealthy nations—including the US and at least 8 Asia-Pacific region nations—already have pre-purchase agreements for the antiviral, potentially setting the stage for access inequities to plague treatments in addition to vaccines.

GLOBAL VACCINE ACCESS The world continues to need more SARS-CoV-2 vaccines, especially in low-income countries that lack sufficient supplies, in part due to wealthy nations’ vaccine hoarding—including oftentimes secretive contracts between vaccine makers and governments—driving global inequalities. According to the International Federation of Pharmaceutical Manufacturers and Associations, global vaccine production is increasing and is expected to reach 12.5 billion doses by the end of 2021 and double to 24 billion doses by June 2022. But more production does not equal equitable distribution, and with many nations beginning vaccine booster initiatives, the onus lies on nations with excess supplies to donate those shots to countries in need. According to a new report from The People’s Vaccine alliance, only 14% of the 1.8 billion vaccine doses pledged for donation have been delivered to low- and middle-income countries (LMICs) to date, and pharmaceutical companies have delivered only 12% of the doses allocated to the COVAX initiative. Global health experts recently encouraged the US to donate its surplus doses, speed up the timeline for delivering the 1 billion doses of the Pfizer-BioNTech vaccine already promised, and use emergency powers under the Defense Production Act to increase vaccine production and force manufacturers to share technology with foreign producers. While the US International Development Finance Corporation is looking into supporting vaccine manufacturing and hubs in South Africa and India, those efforts are expected to produce 2 billion doses by the end of 2022, not quickly enough to meet current global demand.

In a POLITICO opinion piece, 2 senior EU officials warned the bloc is lagging in vaccine donations to LMICs, risking a loss of political influence as well as the emergence of new SARS-CoV-2 variants. Meanwhile, in a recent video address, Pope Francis encouraged vaccine makers to share their patents with producers in LMICs as a “gesture of humanity.” The pharmaceutical industry—along with the EU and other countries—continues to resist a proposal at the World Trade Organization (WTO) to implement a temporary waiver of intellectual property for COVID-19-related medical products, despite support from the US and around 100 other nations. Frustrated with the lack of cooperation, the WHO announced this week it has hired the South African pharmaceutical startup Afrigen Biologics and Vaccines to crack the code on Moderna’s mRNA SARS-CoV-2 vaccine in order to produce a generic version. If successful, Afrigen would serve as a “technology transfer hub,” essentially teaching other companies how to make the vaccine. Moderna, which has said it will not enforce its intellectual property during the pandemic and used US taxpayer funding to develop its vaccine, is under increasing pressure to share its technology.

Reportedly, India has delayed on its plan to resume vaccine exports to fulfill commitments to the COVAX initiative, which stopped in April, one day after the WHO requested additional data to make a decision on an emergency use listing for India’s homegrown vaccine Covaxin. The Serum Institute of India (SII) is contracted to supply hundreds of millions of doses of a version of the AstraZeneca-Oxford vaccine to COVAX and had said those shipments would resume this month.

HEALTH SYSTEM RESILIENCE The COVID-19 pandemic has had a profound impact on health systems worldwide, greatly affecting access to and quality of healthcare services. To better prepare for future pandemics, improve health systems, and work toward health-related Sustainable Development Goals (SDGs), the WHO released a position paper on and 7 recommendations for building resilience and strengthening health security within health systems. The paper calls for the international community and individual nations to invest in health systems, strengthen public health preparedness, and ensure political and public engagement to place health as a central tenet of socioeconomic recovery, growth, and resilience. At an event to launch the paper, Dr. Mike Ryan, Executive Director of the WHO Health Emergencies Programme, called for health to be viewed as an investment, not a cost, and spoke of the importance of thoughtful design in building resilient health systems. The WHO also published a brief highlighting key messages for government officials, leaders outside and within the health sector, and communities.

SEX OF FETUS New research indicates that the sex of a fetus may influence a pregnant person’s immune response when infected with SARS-CoV-2. In 2 studies published in Science Translational Medicine, researchers examined the immune responses of pregnant and lactating individuals to SARS-CoV-2 infection and vaccination, showing they mount robust antibody responses to both but could benefit from booster doses. In an interesting finding, one of the studies found that male placentas switched on more pro-inflammatory immune activation genes than placentas supporting female fetuses. Reduced maternal SARS-CoV-2 specific antibody titers and impaired placental antibody transfer also were seen in pregnancies of male fetuses. Sex-specific changes in both placental innate and humoral immunity indicated male vulnerability to maternal SARS-CoV-2 infection. The new data may provide insight on the previously reported sex differences among COVID-19 patients, including that, in general, males become more severely ill, are 3 times more likely to require intensive care admission, and also have higher odds of death than female patients.