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 250.7 million cumulative cases and 5.06 million deaths worldwide as of November 10. Global weekly incidence increased for the third consecutive week, while global weekly mortality fell slightly over the previous week. Weekly incidence increased by 2.68% compared to the previous week, and mortality decreased by 3.68%. The global cumulative incidence surpassed 250 million cases early this week, with several countries in Europe experiencing record numbers of new cases.

Global Vaccination
The WHO reported 7.08 billion cumulative doses of SARS-CoV-2 vaccines administered globally as of November 8. A total of 3.9 billion individuals have received at least 1 dose, and 3.0 billion are fully vaccinated. Analysis from Our World in Data indicates that the overall trend in global daily vaccinations has decreased over the past week, down to 27.83 million doses per day on November 10 from a recent high of 30.83 million doses per day on November 4.* 

Our World in Data estimates that there are 4.04 billion vaccinated individuals worldwide (1+ dose; 51.34% of the global population) and 3.16 billion who are fully vaccinated (40.13% of the global population). Europe, South America, North America, and Oceania all have fully vaccinated at least 50% of their populations, while Asia sits at 44.52% and Africa lags far behind at 6.34%.
*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.

The US CDC reports 46.6 million cumulative COVID-19 cases and 755,201 deaths, passing 750,000 cumulative deaths on November 4. The current daily incidence average is approximately 74,584 new cases per day and appears to be increasing. The decline in daily mortality appears to have passed an inflection point and appears to be holding relatively steady. The US is currently averaging 1,078 deaths per day.*
*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 434.5 million cumulative doses of SARS-CoV-2 vaccines. The daily vaccination trend reached a recent peak at 1.2 million doses on October 29 but has declined slightly to 1.17 million doses as of November 5.* Since CDC Director Dr. Rochelle Walensky endorsed the recommendation by the CDC’s Advisory Committee on Immunization Practices (ACIP) to authorize use of the Pfizer-BioNTech vaccine in children aged 5 to 11 years, an estimated 1 million elementary-age kids have received their first dose, according to a White House official.

There are 224.7 million individuals who have received at least 1 vaccine dose, equivalent to 67.7% of the entire US population. Among adults, 80.9% have received at least 1 dose, as well as 15.1 million children under the age of 18. A total of 194 million individuals are fully vaccinated, which corresponds to 58.5% of the total population. Approximately 70.3% of adults are fully vaccinated, as well as 12.8 million children under the age of 18. Since August 13, 26.1 million fully vaccinated individuals have received an additional or booster dose, including 32.4% of fully vaccinated adults aged 65 years 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.

PFIZER-BIONTECH BOOSTER Pfizer and BioNTech on November 9 submitted a request to the US FDA to authorize their SARS-CoV-2 vaccine as a booster dose for all adults aged 18 years and older. If the FDA grants an amendment to the existing emergency use authorization (EUA)—which it is expected to do, possibly ahead of the Thanksgiving holiday—all 181.5 million fully vaccinated adults in the US would become eligible for an additional shot. Such a move would represent a turnaround from 2 months ago, when an FDA expert panel overwhelmingly recommended against the companies’ request for booster doses for all adults. Notably, that committee is not scheduled to meet in November, meaning the FDA could grant the request without seeking external advice. Pfizer-BioNTech made the request based on unpublished data from a randomized, controlled clinical trial of more than 10,000 people aged 16 and older who previously received a primary 2-dose series of the vaccine. Among those who received a booster dose, relative vaccine efficacy reached 95.6% when compared to those who did not receive a booster. Currently, a booster dose of the Pfizer-BioNTech vaccine is authorized for individuals aged 65 years and older, individuals ages 18 to 64 years who are at high risk of severe COVID-19 or who have frequent institutional or occupational exposure to SARS-CoV-2, as well as eligible people who completed primary vaccination with a different SARS-CoV-2 vaccine.

Health Canada on November 9 authorized the Pfizer-BioNTech vaccine as a booster dose for all people aged 18 years and older, at least 6 months following the primary 2-dose regimen. A booster dose of the Pfizer-BioNTech vaccine is the same, 30 μg, as those used in the primary series. Mounting evidence shows a third dose of the Pfizer-BioNTech vaccine significantly increases the antibody response among recipients, although it remains unclear how long any resulting immunity lasts. 

MODERNA Moderna and the US National Institutes of Health (NIH) are currently in a dispute over which entity should receive patent rights to the SARS-CoV-2 mRNA vaccine the company and the agency developed in partnership. The collaboration to develop the vaccine was widely hailed as a shining example of successful interaction between public and private entities for the benefit of the global population. However, Moderna’s patent paperwork noticeably does not include the government scientists involved in the vaccine development process as co-inventors. Moderna’s stance on this dispute is that they “reached the good-faith determination that these individuals did not co-invent” the vaccine. The NIH and consumer advocacy group Public Citizen disagree with this assessment, believing that federal scientists were core to the invention of the vaccine and should be included on the patent. The NIH and Moderna currently are engaged in talks to resolve the dispute, but if left unresolved, the issue could be taken into the court system for resolution.

Ownership of patents vital to vaccine manufacturing has implications beyond the financial aspect; decisions about distribution of the product and information-sharing on patented technology fall under the patent owner’s control. Moderna has repeatedly come under fire for not providing technical information with vaccine manufacturers in low- and middle-income countries (LMICs), although the company has said it will not enforce patents during the pandemic. Both Moderna and Pfizer—which developed a SARS-CoV-2 mRNA vaccine in partnership with BioNTech—have limited licensing opportunities with other vaccine manufacturers in an effort to protect their large investments in the technology. But this tight hold on mRNA vaccine technology inhibits other countries with vaccine manufacturing capabilities from negotiating access to the information needed to make the products. Following the successful procurement of ample vaccines for the US population, the US government is now making concerted efforts to send more vaccine doses to the rest of the world. However, those efforts are being significantly stymied by strict contractual language with Moderna that prevents the US from sending doses abroad or sharing manufacturing information. Increased scrutiny on Moderna’s tight grip on vaccine supply and technology have led to promises from the company to play a more significant role in global vaccine distribution, but many have stated these pledges are too little, too late and do not guarantee enough action. Some progress in changing contractual language was made in June, but additional efforts still need to be made to improve worldwide availability of vaccine doses and technology.

AT-HOME TEST RECALL The FDA has issued a recall for additional batches of Australia-based company Ellume’s at-home COVID-19 test kits for potentially false-positive results. This recall is for the same issue that was previously reported in early October and classified as a Class I recall, the most serious recall designation that may result in “serious adverse health consequences or death.” Product batches with a manufacture date between February 24 and August 11, 2021, and distribution dates between April 13 and August 26, 2021, are included in the recall, which includes more than 2.2 million of the 3.5 million tests shipped to the US; Ellume’s previous estimate of faulty tests was 427,000. Those who attempt to use the affected tests will be notified through the app of the recall status, and replacement tests can be requested online. Thus far, the FDA has received reports of 35 false positives from the tests. The Biden administration made a $231.8 million deal with Ellume in February to boost availability of the at-home testing kits in the US, which also helped fund the company’s first manufacturing plant in the US in Frederick, Maryland, with a 500,000 test production capacity per day. The White House made an additional $1 billion allocation for the purchase of the 8 types of at-home testing kits available in the US shortly after the first Ellume recall was publicized. 

VACCINE ACCESS The global rollout of SARS-CoV-2 vaccines continues to face various challenges, including hoarding and inequities in vaccine distribution, unfulfilled pledges, vaccine production backlogs, export restrictions, supply chain disruptions, communication breakdowns, logistical hurdles, and misinformation and hesitancy. Experts warn that if wealthy nations continue to put their own interests ahead of the rest of the world and continue to stockpile vaccines, the COVID-19 pandemic will remain two-pronged, with some nations working toward recovery while others continue to be threatened by ongoing outbreaks. Increasingly, public health officials and policymakers are looking toward the future, highlighting lessons learned from this pandemic and drafting an international treaty on pandemic preparedness and response. 

The fact remains that the world needs to take steps to fix inequities in vaccine access now in order to reach a goal of vaccinating 70% of the world’s population by September 2022. On November 10, US Secretary of State Antony Blinken hosted a virtual COVID-19 ministerial, during which he said the US will step up efforts to boost vaccine production, increase vaccine donations, and fulfill current pledges. He announced the US helped broker a deal between Johnson & Johnson (J&J) and COVAX to help deliver more doses of the J&J-Janssen SARS-CoV-2 vaccine to conflict zones, humanitarian settings, and frontline workers such as UN peacekeepers, including a US donation of 1.5 million doses of surplus supply. Secretary Blinken also announced a new public-private partnership, called the Global COVID Corps, to facilitate private sector companies in lending expertise and resources to support vaccination campaigns, including supply chain management and on-site vaccine administration. Earlier this week, the heads of the International Monetary Fund (IMF), World Bank Group, WHO, and World Trade Organization (WTO) met with the CEOs of vaccine manufacturing companies, acknowledging the urgency of delivering more vaccine doses to low-income countries and calling on G20 nations to join efforts to meet the end-of-year goal to vaccinate 40% of the population in all countries.

The Center for Health security released a report on October 29, Navigating the World that COVID-19 Made: A Strategy for Revamping the Pandemic Research and Development Preparedness and Response Ecosystem, urgently calling on governments, international institutions, and private sector actors to immediately act to address gaps and explore opportunities at each step along the vaccine value chain.

MEASLES In a report published in an early edition of the US CDC’s Morbidity and Mortality Weekly Report (MMWR), researchers from the CDC and WHO voiced concern over diminished progress toward measles elimination, as more than 22 million infants missed their first dose of measles vaccine in 2020 amid the COVID-19 pandemic. Also in 2020, only 70% of children received their second dose. Additionally, 24 vaccination campaigns in 23 countries were planned in 2020 but were postponed due to the pandemic, leaving more than 93 million people at risk for the disease. Notably, reported measles cases decreased more than 80% in 2020 compared to the previous year, but surveillance activities significantly dropped, with the lowest number of specimens sent in for testing in more than a decade. Missed vaccination doses and gaps in disease surveillance programs highlight the largest increase in unvaccinated children in decades and put many more children at risk of contracting the disease. Major measles outbreaks occurred in 26 countries in 2020, accounting for 84% of all reported cases last year. Despite disruptions to immunization services worldwide, 81 countries (42%) maintained their measles elimination status through the end of 2020, but no new countries were verified as having achieved measles elimination.  

PLASTIC WASTE Global plastic waste was a problem prior to the COVID-19 pandemic, and an increase in demand for single-use plastics—especially those used in medical settings—has intensified the problem over the past 2 years, according to a research article published in the Proceedings of the National Academy of Sciences (PNAS). Worldwide, 193 countries have generated about 8 million tons of mismanaged plastic waste (MMPW). Of that waste, nearly 26,000 tons has entered the oceans, where it threatens to have a “long-lasting impact” by disturbing marine life and polluting coasts. The researchers, from China and the US, urged all nations, particularly low- and middle-income countries, to better manage medical and other plastic waste as the pandemic continues. A separate crowd-sourced project is tracking instances of wildlife being killed or disrupted by pandemic-related waste, with researchers noting cases of animal entanglement, entrapment, and ingestion of COVID-19 trash.