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.
NEW REPORT The CommuniVax Coalition, led by the Johns Hopkins Center for Health Security at the Bloomberg School of Public Health and the Department of Anthropology at Texas State University, has released a new report, Waypoint on the Path to Health Equity: COVID-19 Vaccination at Month 11. The report draws from the experience of the coalition’s multidisciplinary working group and their 6 local research teams to present equity wins and enabling conditions observed during the first year of COVID-19 vaccine rollout in the US. The authors provide overarching recommendations to sustain hard-fought equity wins achieved during the COVID-19 response, with actionable recommendations for local, state, and federal government officials.
OMICRON EARLY DATA As scientists worldwide continue to learn more about the newly identified SARS-CoV-2 variant of concern (VOC) Omicron (B.1.1.529), early data from South Africa suggest that the VOC could be more transmissible and more likely to evade existing immunity from vaccination or natural infection but may cause less serious illness than previous variants. However, experts cautioned about placing too much emphasis on these early indications because of Omicron's novel nature and information on hospitalizations and deaths typically lag several weeks behind initial outbreaks. In South Africa, where some of the earliest Omicron cases were detected, the variant is spreading at an alarming pace, with a near vertical spike in the number of new COVID-19 cases. One estimate, which is not yet peer-reviewed, shows a doubling time of about 3.3 days, more than twice as quickly as Delta. A preprint report on Omicron’s clinical presentations at a large hospital in South Africa suggests the variant may cause less severe disease, although it is still too early to draw conclusions. 

There are concerns that Omicron could be more transmissible due to its large number of spike protein mutations, some of which have not been seen in other variants. One preprint analysis (not yet peer-reviewed) conducted by the US-based research firm nference speculates Omicron could have acquired a specific insertion mutation (ins214EPE) from the genome of a different virus, such as a seasonal coronavirus that causes the common cold. The researchers said this genetic code, which has not been detected in other SARS-CoV-2 variants, could make the virus more likely to evade some immune system responses and make it more accustomed to human hosts. Another preprint study (not yet peer-reviewed) from South Africa suggests Omicron may carry an increased risk of reinfection, indicating the virus could escape some immune system defenses and raising questions about vaccine-induced immunity. Previous infection offered some protection against the Beta and Delta variants, but reinfections have increased since the emergence of Omicron. Additional research is needed into Omicron’s potential for immune escape, and experts note that existing immunity—whether from previous infection or vaccination—could still provide some protection from severe disease, hospitalization, or death.

MIX & MATCH BOOSTERS A study published online December 2 in The Lancet describes a randomized, controlled trial investigating the reactogenicity and immunogenicity of 7 SARS-CoV-2 vaccines* administered as third dose boosters to 2,878 patients aged older than 30 years who already received a primary 2-dose regimen of either the AstraZeneca-Oxford vaccine at least 70 days earlier or the Pfizer-BioNTech vaccine at least 84 days earlier. Reactogenicity was acceptable and most brands elicited a strong immune response to wild-type virus and the Delta variant, particularly the Moderna and Pfizer-BioNTech vaccines as boosters. A majority of the boosters raised antibody levels and neutralizing responses, even in mix-and-match scenarios, although Pfizer-BioNTech and Moderna produced much higher levels than the other brands. More research is needed into longer-term immune response and protection from infection after booster dose administration, but the findings provide a basis for policymakers who can now recommend people who initially received the Pfizer-BioNTech or AstraZeneca-Oxford vaccines get whichever vaccine booster is available, possibly increasing access to usable booster options.

Another study posted on the medRxiv preprint server (not yet peer-reviewed) on December 5 studied the use of the J&J-Janssen vaccine as a booster for individuals fully vaccinated with the Pfizer-BioNTech vaccine at least 6 months prior. Findings indicate that using the J&J-Janssen vaccine as a booster produced a slower and more sustained response to wild-type virus and Beta and Delta variants, while a Pfizer-BioNTech booster produced a faster and stronger response that dipped more quickly. These results mildly contradict findings from a US National Institutes of Health clinical trial in which a smaller antibody level increase was documented for the J&J-Janssen booster, but this may be due to a difference in timing between second and third dose boosters for the studies. 
*The 7 vaccines used as boosters included those from J&J-Janssen, Moderna, AstraZeneca-Oxford, Pfizer-BioNTech, Novavax, and Valneva, the latter 2 of which are under review in Europe. The investigational SARS-CoV-2 vaccine from CureVac also was used in the study, but the company has since withdrawn the vaccine candidate from the approval process.

US GLOBAL VAX PROGRAM On December 6, USAID announced a new initiative aimed at increasing international coordination of SARS-CoV-2 vaccine administration through identifying and overcoming barriers to access, dubbed the Initiative for Global Vaccine Access (Global VAX). Sub-Saharan Africa was noted as a priority region for the initiative, which will be a whole-of-government effort. USAID Administrator Samantha Power announced that US$400 million from the American Rescue Plan Act will be allotted to the program, adding to the US$1.3 billion that the US already has committed globally for vaccine readiness. Of the new commitment, US$315 million will support country-specific needs for vaccine delivery and administration in low- and middle-income countries (LMICs), and US$10 million will support in-country vaccine manufacturing. The remaining US$75 million will be utilized for additional support of USAID’s Rapid Response Surge Support to deliver life-saving resources to COVID-19 hotspots, including an effort to improve oxygen production and delivery. Global VAX efforts supported by these funds include improving cold chain supply and logistics, service delivery, vaccine confidence and demand, human resources, data and analytics, local planning, and vaccine safety and effectiveness. 

The US is the leading donor of SARS-CoV-2 vaccines to other countries, but a WHO official said on December 5 that the donations “are not enough” and called on other nations to do more. The Biden administration announced that it is sending 9 million vaccine doses to Africa and 2 million vaccines to other areas of the world. Only about 7.5% of the African population is fully vaccinated against COVID-19, compared to the 60% of the US population and 66% of Europeans. With this donation, the US has provided a total of 100 million vaccine doses to Africa and a total of 291 million doses to 110 countries. The announcement was made December 3—with shipments made the same day—and comes 1 day after US President Joe Biden announced new measures to combat COVID-19 through the winter months, both domestically and abroad. Included among those measures is the aim to send more than 200 million vaccine doses abroad in 100 days—focusing on delivery to high-risk countries—and increasing vaccine manufacturing capacity to meet global demand. The latter is 1 of the 3 divisions of funds outlined in the Global VAX initiative. 

NEW YORK CITY VACCINE MANDATES On December 6, New York City Mayor Bill de Blasio announced expansions to the city’s “Key to NYC” program, including a new vaccination mandate that will apply to approximately 184,000 private employers and their in-person employees. The city already has the most sweeping local requirements in the nation, mandating vaccinations for city employees; hospital and nursing home workers; employees and customers aged 12 and older of indoor restaurants, entertainment venues, and gyms; and children engaged in high-risk extracurricular activities such as sports, band, or dance. Under the new expansion, those people will now have to show proof of full vaccination by December 27, and children aged 5 to 11 will be required to show at least partial SARS-CoV-2 vaccination (at least 1 dose for 2 dose regimens) beginning December 14 to visit those venues or engage in high-risk extracurricular activities. Mayor de Blasio noted that there would be exemptions on the basis of medical or religious reasons, but the mandates likely will face legal challenges. Enforcement processes of the mandate are currently unclear but are expected to be announced next week. As of today, 78% of New York City residents have received at least one dose of a SARS-CoV-2 vaccine and 70% of New Yorker City residents are fully vaccinated.

RESTRICTIONS IN EUROPE Tens of thousands of people gathered this weekend in various northwest European cities to protest newly instituted COVID-19 restrictions amid the region’s ongoing surge in cases. In Vienna, Austria, more than 40,000 demonstrators rallied to show disapproval of the government’s recent announcement of a 20-day lockdown and plans to make vaccinations mandatory beginning in February 2022. The Netherlands saw its first major demonstration against restrictions that began last weekend, including nighttime closures of bars, restaurants, and most stores. Two weeks ago, violent protests erupted after the Dutch government announced plans to ban most unvaccinated people from such public places. In Brussels, Belgium, about 8,000 people protested the government’s recent mitigation requirements, including making mask-wearing mandatory for children older than age 6 and closing kindergartens and primary schools beginning December 20. Police had to use water cannons and tear gas to disperse demonstrators who were throwing objects at them at a roadblock. 

In Germany, the government approved plans to make vaccinations mandatory next year and allow only vaccinated and recovered people to access retail shops (excluding essential shops like groceries, pharmacies, and gas stations) and all cultural and recreational events. Additionally, bars and clubs will only be able to operate if the COVID-19 incidence rate is below 350 per 100,000 in a region; most of Germany currently sits above that rate. Police had to break up a protest this past weekend in Frankfurt, and politicians denounced a demonstration that took place on December 3 outside the home of the health minister of Saxony, one of the hardest hit states. And in Greece, Prime Minister Kyriakos Mitsotakis announced that people aged 60 and older are required to get vaccinated or face monthly fines of 100 euros, about US$113, calling the fees “the price to pay for health.” About 69% of the total population in Greece has received at least 1 dose of vaccine. Speaking today at a press conference, WHO Regional Director for Europe Dr. Hans Kluge cautioned countries that are instituting vaccine mandates, saying they should be used as “an absolute last resort” because they risk eroding public confidence and trust of authorities.

EDUCATION LOSSES In a new report, the World Bank, UNICEF, and UNESCO highlight the COVID-19 pandemic’s negative impacts on education efforts worldwide. The report, launched with an online event, also outlines a resilient path forward, including how to accelerate learning recovery. Pandemic-related school closures have affected more than 1.6 billion learners, not all of whom were offered remote alternatives, and an estimated 24 million children are at risk of never returning to education. Because of these impacts, lifetime earnings losses could hit US$17 trillion, representing a 70% increase over a 2020 estimate. Other education gaps have dramatically increased. The proportion of children who experience learning poverty—described as the inability to read and understand age-appropriate text at age 10—could increase nearly 20% in low- and middle-income countries (LMICs) due to the pandemic. The pandemic also has exacerbated inequity, particularly among children with disabilities, children from low-income households, and girls. The report notes the educational impacts could affect gender equity progress, citing a potential 10 million girls who are at risk of early marriage due to school closures. Globally, a mere 3% of governments’ stimulus packages have been allocated to education. The report called for much more funding and investment in the education sector to facilitate learning recovery in an equitable and resilient education system for all youth. 

MONOCLONAL ANTIBODIES FOR PEDIATRIC PATIENTS The US FDA on December 3 expanded the emergency use authorization (EUA) for Eli Lilly and Company’s bamlanivimab and etesevimab—monoclonal antibody treatments administered together—for the treatment of mild to moderate COVID-19 in all younger pediatric patients (birth to <12 years old) who are at high risk of progressing to severe disease, including hospitalization or death. The FDA also authorized the drugs to be used for post-exposure prophylaxis for prevention of COVID-19 in all younger pediatric patients at high risk of severe COVID-19, although the agency noted this should not be considered a substitution for vaccination. The revised EUA is the first for an antibody treatment for young children, as the drugs previously were authorized for pediatric patients aged 12 and older weighing at least 40 kilograms (about 88 pounds). The drugs’ dosages are calculated based on body weight and administered by injection or intravenously at a clinic or hospital. The authorization is based on data from a clinical trial of 125 pediatric patients. Lilly said that more than 700,000 patients have been treated with bamlanivimab or bamlanivimab and etesevimab to date, estimating that the treatment has potentially prevented more than 35,000 hospitalizations and about 14,000 deaths.