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 238.5 million cumulative cases and 4.86 million deaths worldwide as of October 13. Global weekly incidence decreased by 6.7% compared to the previous week, and mortality fell by 9.5%.

Global Vaccination
The WHO reported 6.36 billion cumulative doses of SARS-CoV-2 vaccines administered globally as of October 10. A total of 3.63 billion individuals have received at least 1 dose, and 2.64 billion are fully vaccinated. Analysis from Our World in Data indicates that the overall trend in global daily vaccinations continues to decline, down to fewer than 23 million doses per day*. The global trend continues to closely follow Asia. Our World in Data estimates that there are 3.78 billion vaccinated individuals worldwide (1+ dose; 47.97% of the global population) and 2.80 billion who are fully vaccinated (35.56% 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.

The US CDC reports 44.5 million cumulative COVID-19 cases and 716,370 deaths. The US has passed a peak in terms of daily incidence. The most recent high was 161,711 new cases per day on September 1, and the trend began to decline slightly before the Labor Day holiday weekend. The current average is approximately 86,181 new cases per day and appears to be decreasing. Daily mortality also appears to have passed a peak, down from a recent high of 1,815 on September 15 to 1,252 on October 12*. 
*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.

According to an analysis published October 13 by the Peterson Center on Healthcare and the Kaiser Family Foundation, COVID-19 continues to be a leading cause of death in the US. While daily mortality is now falling, COVID-19 was the second leading cause of death in the US in September 2021, behind heart disease, according to the analysis based on US CDC and other data. The majority of COVID-19-related deaths have been among unvaccinated individuals.

US Vaccination
The US has administered 404 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 is now declining after a recent peak on October 1*. There are 217.6 million individuals who have received at least 1 dose, equivalent to 65.6% of the entire US population. Among adults, 78.5% have received at least 1 dose, as well as 14.7 million adolescents aged 12-17 years. A total of 187.9 million individuals are fully vaccinated, which corresponds to 56.6% of the total population. Approximately 68% of adults are fully vaccinated, as well as 12.1 million adolescents aged 12-17 years.
*Due to delays in reporting, estimates for the average daily doses administered are less accurate for the most recent 5 days. The most current average provided here corresponds to 5 days ago.

VACCINE BOOSTERS The US FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is meeting today to discuss Moderna’s request for authorization of an additional dose of its SARS-CoV-2 vaccine and on October 15 to discuss a similar request from J&J-Janssen. Any recommendations the committee makes are used to help the FDA make decisions but are not binding. Moderna has asked regulators to authorize an additional half-dose of its vaccine for adults aged 65 and older—a decision which appears to already be made based on questions submitted to the committee—and individuals at high risk of severe COVID-19, similar to the authorization granted last month for the Pfizer-BioNTech vaccine. An FDA briefing document released this week suggests that a booster dose of Moderna’s vaccine administered at least 6 months from the second dose increased antibody levels in recipients. However, the difference of the levels before and after the booster dose was not wide, and the agency did not take a position on whether the extra dose was necessary. The panel also will discuss the risk of post-vaccination myocarditis and other adverse reactions and whether data show efficacy of the Moderna vaccine is waning. In separate documents submitted to the FDA, Moderna said a half-dose (50μg) additional shot provided similar increases in antibody levels as the full dose (100μg) but with fewer side effects.

During the second day of meetings, VRBPAC will consider whether data presented by J&J-Janssen supports a booster dose for its single-dose SARS-CoV-2 vaccine, and when the additional dose should be administered. In a briefing document released October 13, the FDA said there “may be a benefit” in giving a second dose about 2 months after the primary dose and made it clear that while the J&J-Janssen vaccine provides protection against severe COVID-19, it is less effective than the mRNA vaccines from Moderna and Pfizer-BioNTech. However, the agency questioned the sample sizes of the studies showing a benefit and did not provide a clear conclusion on whether the panel would recommend booster doses for certain populations. 

VRBPAC also likely will discuss “mixing and matching” vaccines but is not expected to make recommendations on the approach. Highly anticipated results from a US NIH-sponsored study were posted to the preprint server medRxiv on October 13, suggesting that recipients of the J&J-Janssen vaccine might produce a more intense immune response to a booster dose of an mRNA vaccine than an additional dose of the J&J-Janssen vaccine. Individuals who initially received either the Moderna or Pfizer-BioNTech vaccines and received a third dose of either shot showed similarly strong immune responses, according to the study, which is not yet peer-reviewed. The US CDC’s Advisory Committee on Immunization Practices (ACIP) is scheduled to meet next week to discuss the FDA’s recommendations on booster doses. If regulators eventually decide to permit mixing and matching vaccines, the FDA will have to amend the authorizations of both mRNA vaccines to permit them to be used to boost the J&J-Janssen vaccine. 

US TRAVEL REQUIREMENTS The US plans to ease travel restrictions in November for fully vaccinated individuals crossing its land borders with Canada and Mexico, marking a reopening to travelers and tourists after being closed for more than 18 months. Unvaccinated individuals will continue to be banned from crossing the country’s northern and southern borders for nonessential travel. The new rules—which coincide with and are similar to recently updated guidance for air travelers—will be implemented in phases, with vaccinated visitors traveling for nonessential reasons to be allowed to cross land borders in November, and all inbound travelers, whether essential or nonessential, needing proof of vaccination by January 2022. Canada reopened its US border to nonessential travel by fully vaccinated US residents in August, and Mexico never closed its northern border. Several US Members of Congress representing border states welcomed the rule changes, as closures had separated cross-border families and wrought financial tolls on border cities. Notably, the US will keep in place a separate immigration policy that allows the government to deport or turn away any migrants who are seeking asylum or economic opportunity. 

VACCINE MANDATES Since US President Joe Biden announced SARS-CoV-2 vaccination requirements for federal workers and contractors, healthcare systems, and employers with 100 or more employees, most workers have chosen to be vaccinated, despite some predictions mandates might worsen labor shortages by prompting widespread resignations. The requirements boosted vaccination rates by at least 20 percentage points, White House officials said on October 13. Aerospace company Boeing and Southwest Airlines are the latest large corporations to announce their employees must be vaccinated or receive exemptions by December 8, in compliance with new federal guidelines expected to be finalized soon. However, confusion arose for Texas-based Southwest and American Airlines, as well as other companies, on October 11, as Texas Governor Greg Abbott signed an executive order extending bans on COVID-19 vaccine mandates by any entity in the state, including private employers, and broadening reasons for exemptions. A previous executive order from Governor Abbott bans vaccine requirements by government agencies, cities, counties, and school districts in the state. Both Southwest and American indicated they will maintain their vaccine requirements for employees. Most other companies also likely will follow the federal rule, as federal law takes precedence over state law under the Supremacy Clause of the US Constitution. But questions over the conflicting laws remain.

In Florida, the state Department of Health levied a fine of more than US$3.5 million on Leon County for requiring county employees to be vaccinated, in violation of a state law. Under the law, government agencies can be fined US$5,000 for each violation of requiring vaccination as a condition of employment. The state said Leon County violated the law 714 times, for each of its employees, accruing a fine of US$3.57 million it must pay within 30 days. The Leon County administrator called the ban politically motivated and vowed to enforce the county vaccine mandate “using any remedies available.” 

In New York, a federal judge on October 12 issued a preliminary injunction barring state health officials from interfering with employers who allow religious exemptions to state-imposed vaccination mandates for all healthcare workers. Judge David N. Hurd of the Northern District said the state overreached by barring all religious accommodations in its mandate and wrote that the 17 healthcare workers who filed the lawsuit were likely to succeed. New York Governor Kathy M. Hochul vowed to appeal the ruling. The case (Dr. A et al v. Hochul) provides a test for strict vaccine mandates covering healthcare workers. At least 23 states require SARS-CoV-2 vaccination for healthcare workers.

SARS-COV-2 ORIGIN The WHO on October 13 announced 26 proposed members of its new Scientific Advisory Group for the Origins of Novel Pathogens (SAGO), which is tasked with creating a global framework to define and guide investigations into the origins of emerging and re-emerging diseases of epidemic and pandemic potential, including SARS-CoV-2. The scientists, hailing from 26 different nations, have expertise in a wide range of areas, from molecular biology to animal health and include 6 members of the previous 10-person joint WHO-China mission that investigated the COVID-19 pandemic’s origins and issued inconclusive findings more than 6 months ago. The WHO said the renewed effort might be the “last chance” to find the virus’s origins, but some questioned whether an advisory board will have the power to make inroads with China, which has not been a very cooperative partner. This week, Chinese officials said the country plans to test up to 200,000 blood bank samples from the city of Wuhan, where the virus was first identified in December 2019. The samples have been in storage for 2 years and could help provide clues as to when and where the virus first appeared in humans. 

In an editorial published the same day in Science, WHO leadership encouraged that all origin possibilities be investigated, including the so-called “lab-leak theory” that the virus inadvertently escaped a laboratory in Wuhan. Notably, the previous WHO investigation deemed that theory “very unlikely.” Chinese officials continue to encourage researchers to look in other countries for clues but have said they will work within the framework of SAGO. The WHO plans to finalize the SAGO members following a 2-week public consultation period. Although the window of opportunity for finding the origins of the current pandemic is closing, and many questions remain unanswered, learning more about the origins of SARS-CoV-2 could help prevent the next outbreak.

FLU SEASON Medical professionals and public health experts worldwide are urging everyone to receive their flu vaccine in advance of what could be a particularly severe flu season this coming winter. Last year, SARS-CoV-2 appeared to displace most of the circulating seasonal influenza viruses with 1 pediatric flu death in the US for 2020 compared to 75-150 pediatric deaths in previous seasons. This year, experts are warning of a “twindemic” of COVID-19 and flu cases, as pandemic restrictions are easing. Since there were relatively few cases of flu last year, experts worry that immunity against the flu will be lower in the general population this year, potentially resulting in more cases and hospitalizations. Unlike with SARS-CoV-2 vaccines, flu vaccines are approved for children 6 months and older. Combined with effective respiratory disease control measures, such as masking and physical distancing, it is doubly important this year to obtain a flu vaccine. A recent study published in PLoS One suggested that flu shots could have protective effects against COVID-19 severe outcomes. In a retrospective cohort of more than 74,000 patients hospitalized with COVID-19, those who had received a flu vaccine had significantly lower risks of sepsis, stroke, and subsequent emergency department visits for COVID-19-related outcomes. More studies are needed to further examine this possible correlation, but the results are encouraging to solidify the case for all eligible persons to get their flu vaccine. 

CUREVAC CureVac announced October 12 that it is withdrawing its first-generation SARS-CoV-2 mRNA vaccine candidate, CVnCoV, from the current approval process with the European Medicines Agency (EMA) to instead focus on developing second-generation mRNA vaccine candidates in collaboration with GlaxoSmithKline (GSK). The company also terminated an advance agreement with the European Commission (EC) for the sale of 405 million doses of the vaccine after approval. The announcement represents the seventh vaccine candidate to be abandoned after clinical trials, in part due to the success of mRNA vaccines from Pfizer-BioNTech and Moderna.

ABUSE OF SCIENTISTS A self-selecting survey by Nature of more than 300 scientists who have spoken publicly about COVID-19 in media interviews or on social media found 15% said they had received death threats, with nearly 60% of those surveyed saying they had faced other forms of harassment or abuse. Notably, most researchers said their experiences with media interviews were positive but those who reported the highest frequency of personal attacks or trolling were also the most likely to indicate a reduced willingness to speak with the media in the future. Nature predicts that these results could have a “chilling effect” on science communication.