Thursday, December 23, 2021

December 23: 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.

Our team is taking a short break for the holidays. We will resume publishing the COVID-19 Situation Report on January 6, 2022.

We would like to thank you, our supporters and colleagues, for helping make our work possible and stronger by utilizing our resources, attending our events, reading our COVID-19 situation reports, and learning alongside us.

We are encouraged by the strength and resilience of our community, and hopeful that a brighter future is ahead. (Read a summary of our 2020 COVID-19 response work and about our work in 2021.)

EPI UPDATE The WHO COVID-19 Dashboard reports 275 million cumulative cases and 5.36 million deaths worldwide as of December 22. Global weekly incidence increased for the ninth consecutive week, up 4.7% from the previous week. Europe’s surge, which is believed to be largely driven by the Omicron variant, appears to be peaking, and the trend in Africa continues to accelerate sharply, setting a new weekly record (90,450 new cases; +55% from the previous week). The overall trends in the Americas and the Western Pacific are increasing as well. Global weekly mortality decreased for the second consecutive week, down 5.2% from the previous week. With 46,554 new deaths, last week's total fell slightly below the average since mid-October, but it is unclear whether this is the beginning of a longer-term trend, particularly in the context of increasing trends in weekly incidence.

Global Vaccination

The WHO reported 8.4 billion cumulative doses of SARS-CoV-2 vaccines administered globally as of December 20. A total of 4.38 billion individuals have received at least 1 dose, and nearly 3.5 billion are fully vaccinated. Analysis from Our World in Data indicates that the overall trend in global daily vaccinations increased from mid-October (21.3 million doses per day) through mid-December (39.9 million). Daily vaccinations have decreased since December 15, down to 34.5 million, but it is unclear whether this is a result of short-term fluctuations or the start of a longer-term trend.* Our World in Data estimates that there are 4.49 billion vaccinated individuals worldwide (1+ dose; 57.1% of the global population) and 3.77 billion who are fully vaccinated (47.9% 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

On December 16, the US officially surpassed 800,000 cumulative COVID-19 deaths. The US CDC is currently reporting 51.3 million cumulative cases and 807,397 deaths. The US reported 288,381 new cases on December 20 and 204,913 on December 21, surpassing 200,000 new cases in a single day for the first time since January 18. The December 20 total is the second-highest single-day total since the onset of the pandemic. These 2 reports caused the average daily incidence to jump from 135,911 new cases per day to 161,261, a 19% increase in only 2 days. The current average is the highest since September 5 and only 1.8% below the United States’ second-highest peak in September 2021 (164,241). Daily incidence has increased by a factor of 2.5 since the most recent low on October 24 (64,162), and the trend appears to be accelerating. The sharp increase at the national level is a result of similar trends across states in multiple regions of the country. Analysis by The New York Times indicates that the daily incidence has more than doubled in 7 states—plus Puerto Rico (+1,302%) and Washington, DC (+541%)—over the past 2 weeks, including Florida (+509%) and Hawai’i (+670%) that have increased by a factor of 5 or greater.*

Daily mortality continues to increase steadily, up to 1,223 deaths per day, an increase of more than 20% since before the US Thanksgiving holiday weekend.*

Following a cybersecurity incident, Maryland suspended reporting for COVID-19 data. As of December 20, approximately 2 weeks after the incident, the state reported that 90% of its COVID-19 data have been restored. Maryland’s COVID-19 dashboard is once again available, and it has resumed reporting to the CDC.

*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.

Genomic sequencing data from the CDC show a rapid increase in the prevalence of the Omicron variant across the US. At the national level, the estimated prevalence increased from 0.1% the week of November 27 to 0.7% the week of December 4. In the 2 weeks since then, the prevalence surged to an estimated 73.2% nationwide, replacing Delta as the dominant variant.** Additionally, 8 of the 10 HHS regions are reporting Omicron prevalence greater than 50%, including 5 with greater than 90%: Regions 2 (New York/New Jersey), 4 (Southeast), 5 (Midwest), 6 (South), and 10 (Pacific Northwest).

**US CDC Nowcast projection.

US Vaccination

The US has administered 499 million cumulative doses of SARS-CoV-2 vaccines. Daily vaccinations peaked on December 6, with 1.71 million doses administered per day. The trend has declined steadily since then, down to 1.36 million doses on December 17—a 20% decrease over that period.* A total of 241 million individuals have received at least 1 vaccine dose, equivalent to 72.8% of the entire US population. Among adults, 85.0% have received at least 1 dose, as well as 22.2 million children under the age of 18. A total of 204.8 million individuals are fully vaccinated**, which corresponds to 61.7% of the total population. Approximately 72.7% of adults are fully vaccinated, as well as 17.2 million children under the age of 18. Since August 13, 63.2 million fully vaccinated individuals have received an additional or booster dose, including 55.8% 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.

**Full original course of the vaccine, not including additional or booster doses.

US OMICRON PREDICTIONS & PLAN Analysis from the University of Washington predicts that a new surge in COVID-19 incidence driven by the Omicron variant could produce nearly 3 million new cases per day in the US during the peak. Similarly, retired US NIH Director Dr. Francis Collins warned that the US could see as many as 1 million new cases per day as Omicron spreads. Some evidence suggests that daily incidence could peak quickly, possibly within the next 4-5 weeks, and that Omicron infections are associated with a lower risk of hospitalization and severe disease when compared to Delta. However, experts warn it is impossible to predict how individual countries’ populations and healthcare systems will be impacted by surges in Omicron cases. Individuals who are unvaccinated and have never been exposed to SARS-CoV-2 may still be at risk of severe disease. A large increase in COVID-19 cases also still runs the risk of overwhelming healthcare systems in the US and abroad.

On December 21, US President Joe Biden gave a speech on his administration’s plans to respond to Omicron. The plan includes procuring 500 million rapid tests for free shipment to US residents, beginning in January. This represents a pivot for the administration, which recently said people would have to seek reimbursement from their healthcare insurance plans for tests purchased on their own. Experts said the new policy is a step in the right direction but noted that countries such as the UK and Germany have been distributing billions of test kits and recommending citizens check their status twice a week. The US would need to ship 2.3 billion tests monthly to hit this same benchmark. Biden also announced plans to deploy more federal aid to hospitals and testing sites, including military personnel, ventilators from the national stockpile, and more ambulances and teams of paramedics to aid in transporting patients. President Biden called on unvaccinated individuals to fulfill their “patriotic duty” and seek out the shots, encouraged fully vaccinated individuals who are eligible to get a booster, and said those who are vaccinated should go ahead with holiday celebrations with friends and family. Meanwhile, WHO Director-General Dr. Tedros Adhanom Ghebreyesus encouraged people worldwide to cancel their holiday plans, saying, “An event canceled is better than a life canceled.”

US AUTHORIZES ORAL ANTIVIRALS The US FDA this week authorized the use of 2 oral, at-home antiviral therapies for COVID-19, a significant step in treatment of the disease that comes as the number of new cases begins to surge in the US, driven primarily by the Omicron variant of concern (VOC). The agency today authorized the use of the oral antiviral molnupiravir, developed by Merck and Ridgeback Biotherapeutics, for COVID-19 patients aged 18 years and older who have a positive SARS-CoV-2 viral test result, are within 5 days of symptom onset, are at high risk of severe disease or hospitalization, and who cannot access or do not qualify for alternative authorized COVID-19 treatments. Molnupiravir reduced the risk of hospitalization among high-risk patients by 30%, according to clinical trail data, but some experts are concerned over the potential for side effects and the development of drug resistance. The drug is not recommended for use during pregnancy, and men and women of childbearing age are recommended to use birth control, with men suggested to continue using it for 3 months post-administration. Molnupiravir—administered as capsules taken twice a day for 5 days—works by causing errors in the virus’s genetic code, disabling its reproduction capacity but also raising concerns that it could cause mutations in people who take it or lead to new variants.

On December 22, the FDA authorized the first oral antiviral to treat COVID-19 patients. The emergency use authorization (EUA) is for Pfizer’s Paxlovid—a new antiviral called nirmatrelvir co-packaged with the older antiviral ritonavir—that is taken as tablets twice a day for 5 days. Paxlovid is indicated to treat mild-to-moderate COVID-19 in individuals ages 12 and older weighing at least 40 kg (about 88 pounds) who have a positive SARS-CoV-2 test result and are at high risk of progression to severe disease. Administration of the pills, which are available by prescription only, should be started within 5 days of symptom onset and could be available to patients as early as this weekend, although initial supplies will be limited due to manufacturing constraints. Pfizer’s clinical trial results (not yet peer-reviewed) showed Paxlovid reduced the overall risk of hospitalization by 88% if started within 5 days of symptom onset, and the company’s laboratory studies show the pills should be effective against Omicron.

The authorizations come as healthcare providers face the realization that 2 of the 3 authorized monoclonal antibody treatments—previously shown to be highly effective at keeping high-risk patients out of the hospital—are not working against Omicron. The European Medicines Agency (EMA) has made recommendations for both Paxlovid and molnupiravir (known as Lagevrio outside of the US) for use in certain COVID-19 patients, paving the way for authorization in Europe.

CONVALESCENT PLASMA The results of a clinical trial evaluating antibody-rich plasma as an outpatient treatment for people with symptomatic COVID-19 was posted as a preprint to medRxiv on December 21, reopening debate over the use of convalescent plasma therapy. The study, conducted in the US and led by researchers from Johns Hopkins Medicine and the Johns Hopkins Bloomberg School of Public Health, showed outpatient treatment with convalescent plasma, when given within 8 days of symptom onset, reduced the risk of hospitalization by 54% compared with the placebo-control group. The trial primarily used plasma collected before vaccines were widely available and ended prior to the arrival of the Omicron SARS-CoV-2 variant in the US. However, the authors of the study believe that antibody-rich plasma could be an effective treatment against Omicron and other variants if taken from patients who are fully vaccinated and recovered from a breakthrough case of COVID-19. Individuals who fall into this category are believed to have higher levels of neutralizing antibodies than either individuals who are only vaccinated or only recovered from previous infection.

The study’s data come only a few weeks after the WHO recommended against the use of convalescent plasma to treat COVID-19. The WHO recommendation was made using information from 16 clinical trials with more than 16,000 participants that indicated convalescent plasma does not improve chances of survival or reduce the risk of needing mechanical ventilation. In the US, convalescent plasma is available under a US FDA emergency use authorization (EUA) to treat hospitalized COVID-19 patients early in the course of disease. The authors of the current study hope their results will prompt the WHO and FDA to revisit their guidance, especially because most of the currently authorized monoclonal antibody treatments might prove useless against Omicron and convalescent plasma is relatively easy to produce in low- and middle-income countries.

VACCINE INEQUITY In 2022, the international community must focus on global vaccine equity in order to end the COVID-19 pandemic. This past year saw vaccination goals fall far short, particularly in low- and middle-income countries (LMICs), in what has been called a “year of vaccine inequity” and a “failure for humanity.” Public health experts warn that the rapid spread of the Omicron variant could cause further setbacks in efforts to end vaccine inequity, leaving large populations unvaccinated and providing circumstances in which SARS-CoV-2 could continue to mutate. Additionally, the effects of these inequities will be felt for decades: 8 out of 10 people pushed into poverty during the pandemic are estimated to live in the poorest nations, and socioeconomic inequalities—such as access to schools and healthcare—will worsen for women and girls. Access to vaccine supplies, capacity to deliver the shots, and vaccine hesitancy all must be addressed in order to improve global vaccination rates. The world has the tools necessary to end the pandemic in 2022, but unless those tools are implemented effectively, including vaccinating the world’s population, the next year will not see the end of the current pandemic and we will remain unprepared for the next pandemic. 

WHO Director-General Dr. Tedros Adhanom Ghebreyesus this week warned that widespread vaccine booster programs could prolong the pandemic, increase inequity, and provide a false sense of security in the face of Omicron. The WHO issued an update to its interim guidance on boosters, saying nations considering booster vaccination policies should consider their strategic and programmatic priorities; data on the performance of booster doses; how targeted booster dose administration could prevent healthcare system strain; and importantly, how booster programs impact globally limited vaccine supplies. Notably, Israel this week became the first country to begin rolling out a fourth dose of SARS-CoV-2 vaccine to certain populations, including adults ages 60 and older, medical workers, and people with compromised immune systems. Other nations might be considering similar policies on boosters. In the US, a group of more than 80 Democratic lawmakers has requested at least US$17 billion be included in the fiscal year 2022 appropriations omnibus to support global vaccination, testing, and treatment of COVID-19. In a US House of Representatives select subcommittee hearing on December 14, experts warned that continued inequity in vaccine access will continue to threaten the global population, including in the US, and prolong social and economic recovery

US LIFE EXPECTANCY Life expectancy for the US population in 2020 dropped 1.8 years over 2019—down to 77 years in 2020 from 78.8 years in 2019—the largest single-year reduction in more than 75 years, according to new data from the US CDC’s National Center for Health Statistics (NCHS). The top 10 causes of death in 2020 were heart disease, cancer, COVID-19, unintentional injuries (including drug overdose), stroke, chronic lower respiratory diseases, Alzheimer’s disease, diabetes, influenza and pneumonia, and kidney disease. The drop in life expectancy was driven by increases in mortality due to COVID-19, unintentional injuries, heart disease, homicide, and diabetes. Of the 10 leading causes of death in 2020—which accounted for 74.1% of all deaths in the US in 2020—9 remained the same as in 2019, although 5 causes switched rank. Heart disease and cancer remained the top 2 leading causes. COVID-19 debuted in the ranking list in 2020, becoming the third leading cause of death and pushing suicide off the list. This is the first time a novel disease has entered the top 10 causes of death so quickly, and many feel much of the elevated death rate in 2020 is attributable directly or indirectly to COVID-19, as people might have had underlying conditions worsened by COVID-19, had limited access to health care, or feared accessing emergency or maintenance care.

In total, more than half a million more US resident deaths were recorded in 2020 than in 2019, and COVID-19 was the underlying cause of death for 350,831 people, representing 10.4% of the total number of deaths in 2020. The decrease in life expectancy was larger for men—2.1 years, from 76.3 years in 2019 to 74.2 years in 2020—than for women—1.5 years, from 81.4 in 2019 to 79.9 in 2020. Notably, age-adjusted death rate increases from 2019 to 2020 were highest among racial and ethnic minorities, reflecting an increased risk of death from COVID-19. The greatest increases in death rate were seen among Hispanic males (42.7%), Hispanic females (32.4%), non-Hispanic Black males (28.0%), and non-Hispanic Black females (24.9%), compared with non-Hispanic White males (13.4%) and non-Hispanic White females (12.1%). Death rates for non-Hispanic Black males were highest in 2020—1,399 deaths per 100,000 people—and lowest among Hispanic females—570 per 100,000. On a positive note, the infant mortality rate (IMR) decreased 2.9% from 558.3 infant deaths per 100,000 live births in 2019 to reach a record low of 541.9 in 2020.

US SPORTS As daily COVID-19 incidence and the prevalence of the Omicron variant surge in the US, professional and collegiate sports have been forced to rapidly adapt their COVID-19 protocols and mitigation plans. 

National Hockey League: The NHL postponed a number of games already this season due to COVID-19 outbreaks on affected teams. But this week, the league suspended all games and team activities through Saturday, December 25, starting the scheduled Christmas break 2 days early. Including the games during this period, the NHL has postponed 50 games since the season began on October 12. Notably, more than 15% of all NHL players are currently under the league’s COVID-19 protocols. The NHL and the NHL Players Association also announced that NHL players will not be participating in the 2022 Winter Olympic Games in Beijing, China, due to the disruptions to the NHL schedule. The NHL is expected to reschedule postponed games during that period.

National Football League: At the start of the season, the NFL (American football) announced that it would not reschedule games due to COVID-19, but last week, it reversed its position due to more than 150 players and coaching staff testing positive across multiple teams. The league rescheduled 3 games last week, moving an extra game to Monday and 2 games to Tuesday. In response to increasing positive tests, the NFL updated its COVID-19 protocols in an effort to allow players to return sooner after a positive test. Following a number of asymptomatic or mild cases among NFL players, including those infected with the Omicron variant, the NFL shifted from weekly testing for vaccinated players to “a random cadence” or if a player develops symptoms. Less frequent testing will allow more players to be available, but it will likely miss some asymptomatic infections, including individuals who could be infectious. Additionally, vaccinated, asymptomatic players may be able to return to practice and games sooner under the new protocol.

National Basketball Association: While the NHL and NFL are updating their COVID-19 protocols and adjusting the league schedule, the NBA reportedly intends to continue with its season. While some NBA games have been postponed, NBA Commissioner Adam Silver indicated that there are no plans to suspend the season. Additionally, the NBA currently does not have any plans to update its COVID-19 protocols to allow players to return sooner after a positive test. The NBA suspended 7 games over the past week alone, and more than 90 players are under the league’s COVID-19 protocols. Commissioner Silver commented that approximately 90% of new cases are a result of the Omicron variant.

College Football: As the NCAA looks ahead to the College Football Playoff (CFP), it announced that the National Championship could be decided by forfeit if teams are unable to compete due to COVID-19. If teams are unable to play in the CFP semifinals, there is no opportunity to reschedule the game. That team would be forced to forfeit, and their opponent would move on to the championship game, and if neither team is able to play, the winner of the other semifinal game would automatically be declared the National Champion. If teams in the championship game are unable to play, that game could be moved from January 10 to as late as January 14. If the game cannot be held by then, a team that cannot play would forfeit and its opponent would be declared the National Champion. If neither team can play, then the National Championship will be vacated for this season. In preparation for the CFP, several of the competing teams have implemented additional protective measures to reduce the risk of COVID-19 impacting the coaches and players. The University of Alabama has reportedly reinstated its original COVID-19 protocols, including mask use and physical distancing at team facilities. Similarly, the University of Michigan restored masking and physical distancing as well as grab-and-go meals, and the players reportedly received booster doses of the SARS-CoV-2 vaccine as a team on December 22.

Wednesday, December 22, 2021

Belvidere Superintendent hired to become Warren Township's superintendent starting July 1, 2022


By Nick Landi

BELVIDERE (WREX) — Belvidere School District Superintendent Daniel Woestman will resign after Warren Township High School District named him its new leader.

Woestman was hired to become Warren Township's superintendent starting July 1, 2022. The district is located in Gurnee.

Under Woestman's leadership, Belvidere has been recognized at the state and national levels for its career readiness programs, increases in early-college opportunities for high school students, positive work environment, and continuous improvement structures, according to a news release from Warren Township.

"I am honored by the opportunity to be part of the Warren Township High School community," Dr. Woestman said in a news release. "High schools are such an important part of every community, and I hope to continue the strong traditions that are part of the WTHS history. I'm excited to work and learn alongside the great people that make this district the amazing place it's known to be."

Woestman has 15 years of experience in public education leadership that includes work at Rockford Public Schools and Hononegah High School. He was chosen from a field of 40 candidates in a nationwide search.

Belvidere School District has not named a replacement for Woestman at this time.

Above is from:  https://www.wrex.com/news/top-stories/belvidere-superintendent-hired-to-lead-gurnee-area-school-district/article_6f589248-6361-11ec-a2d9-3f93376685dd.html

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Warren Township High School

DISTRICT 121 | GURNEE, ILLINOIS

 


Superintendent Search


December 22, 2021

Dear Warren Township High School District 121 Families and Community:

The Board of Education is pleased to announce that Dr. Daniel “Danny” Woestman, has been hired to serve as the Superintendent of Schools beginning July 1, 2022.  He will fill the position currently held by Dr. John Ahlgrim, who has led the District since 2015 and will be retiring at the end of this school year.

The WTHS School Board is excited and fortunate to have Dr. Woestman join the Warren Township High School team.  As our new Superintendent, Danny’s experience and positive energy will be a great addition to both our school and our community.

With 15 years of experience in education, Dr. Woestman is currently the Superintendent of Schools at Belvidere School District 100.  Under Dr. Woestman's leadership, Belvidere has been recognized at the state and national levels for their career readiness programs, increases in early-college opportunities for high school students, positive work environment, and continuous improvement structures.

Before taking that position, Dr. Woestman served for five years in leadership roles at Rockford Public Schools as an Assistant Superintendent and Director of Accountability. He also served as an Assistant Principal at Hononegah Community High School.  He began his education career as an English teacher at Hononegah Community High School in northern Illinois and Springville High School in Utah. 

"I am honored by the opportunity to be part of the Warren Township High School community," Dr. Woestman said. "High schools are such an important part of every community, and I hope to continue the strong traditions that are part of the WTHS history. I'm excited to work and learn alongside the great people that make this district the amazing place it's known to be."

District 121’s Board of Education conducted a national search for the incoming superintendent.  The process included an online survey to develop a candidate profile that served as a guide during candidate screening and subsequent interviews.  The search firm received applications from 40 candidates and narrowed the field to six semi-finalists who interviewed with the Board of Education.  The top two candidates returned for interviews with District administration, union representatives, parents and community members and their feedback was provided to the Board of Education to take into consideration for the final interviews. 

Thank you to everyone who participated in this most important process. 

Sincerely,

Board of Education
Warren Township High School District 121

Tuesday, December 21, 2021

November 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.

RISE OF OMICRON The Omicron variant of concern (VOC) has become the predominant variant across North America and Europe, while the rest of the world braces for the eventual takeover. The WHO announced on December 18 that 89 countries have now reported Omicron within their borders, with high likelihood that cases are in many other countries but have simply not yet been confirmed. While the Delta VOC previously overtook other circulating variants to become the predominant SARS-CoV-2 variant, Omicron’s rise in these regions occurred precipitously, within 1 month after it was first reported in South Africa on November 24. While preliminary data out of South Africa indicated that infection with the Omicron variant was less likely to lead to hospitalization, the sheer number of cases resulting from the highly transmissible variant appear to be causing significant healthcare strain and societal disruption.

In the US, Omicron now accounts for 73.2% of the total number of SARS-CoV-2 infections, compared to 1 week ago when it accounted for only 12.6% of all infections. As of December 20, 48 states, Puerto Rico, and Washington, DC, have reported cases of Omicron; South Dakota and Oklahoma have yet to report cases. This rapid increase in Omicron cases has startled public health officials. With cases currently doubling every 1.5 to 3 days, healthcare facilities are bracing for a surge in hospitalizations, with some regions already experiencing these challenges. In the Northeast, where cases are currently surging, states like Rhode Island and Maine are reporting that their hospitals are being strained to their limits. As community members seek medical care in high numbers, healthcare staff are also testing positive for SARS-CoV-2, further exacerbating the strain on resources. Some states are activating their National Guards to help bolster medical, testing, and vaccination efforts. With testing lines wrapping around city blocks and holiday travel quickly approaching, public health officials are urging all who are able to get fully vaccinated and receive their booster shots. US President Joe Biden is set to address the nation tonight and is expected to announce plans to supply free tests and more aid for hospitals.

Outside of the US, other countries are facing the same challenges with the added difficulties of lower vaccination rates due to decreased access and supply. While most world leaders seem hesitant to initiate lockdowns akin to the initial March 2020 responses, many are implementing restrictions in an effort to slow the entry of Omicron into their nations. Israel has banned travel to North America and many European countries, while Asia Pacific island nations are moving to close their borders to international travelers or at least increase surveillance and quarantine measures for inbound travelers. In many European countries where Omicron is already spreading at high rates, some leaders are considering implementing stricter measures ahead of the holiday season. In the UK, Prime Minister Boris Johnson stated he is considering a number of measures, including lockdowns, as COVID-related hospitalizations rise. Regardless of strategy, all countries are trying to accelerate their vaccination programs to prevent a collapse of their healthcare systems.



VACCINE EFFICACY As the Omicron variant of concern (VOC) continues to rapidly spread around the world, preliminary data all of the vaccines appear to provide protection against severe disease, but most of the SARS-CoV-2 vaccines used worldwide may offer little defense against infection from the highly contagious variant. According to a not-yet-peer-reviewed analysis from Imperial College London, Omicron can largely evade vaccine-induced immunity or immunity from a past infection, with the risk of reinfection estimated to be 5.4 times greater than that with the Delta VOC. The researchers estimated that vaccine effectiveness (for AstraZeneca-Oxford and Pfizer-BioNTech vaccines) against symptomatic Omicron infection is between 0% and 20% after 2 doses and between 55% and 80% after a booster dose. Preliminary laboratory results from Moderna released this week in a press release showed a 50 μg booster dose—the same formulation authorized as a booster by the US FDA—produced a 37-fold increase in neutralizing antibodies compared with the primary 2-dose series, while a full 100 μg dose booster produced an 83-fold increase over 2 doses. The full dose had slightly more side effects than the half dose. Pfizer-BioNTech earlier this month announced a booster dose of their vaccine also helped increase neutralizing antibodies against Omicron. All of the studies are preliminary and do not take into account the full spectrum of the human immune response.

Still, some experts are saying that a 3-dose vaccination schedule will be necessary and some evidence shows the time between a second and third dose can be shortened from 6 months to 3 months. Several countries—such as South Korea, UK, Thailand, Belgium, France, Singapore, Taiwan, Italy, and Australia—have decreased the required wait time between doses to between 3 and 5 months to prepare for the arrival of Omicron. Others—including the US, South Africa, and Germany—are sticking to a 6-month schedule. Though there is some concern that shortening the gap could compromise immune response to vaccinations, others say a 6-month interval is arbitrary and urge booster doses sooner to counter waning antibody levels. Many uncertainties remain about how pre-existing immunity, whether from vaccination or previous infection, will help during infection with Omicron, and some evidence suggests Omicron-specific vaccine boosters will be necessary. While many higher-income nations are focused on vaccinating, and boosting, their populations, only 8% of the populations in low-income countries have received at least 1 dose of vaccine. It is important that the international community not lose focus on global goals pertaining to vaccine access and administration.

OMICRON SEVERITY An initial study (unpublished) on the severity of the SARS-CoV-2 Omicron variant of concern (VOC) conducted in South Africa suggests that adults are approximately 30% less likely to be hospitalized due to severe COVID-19 now than during the Delta surge. Health experts from the region also claim that hospitalized patients are less likely to end up on ventilators or require intensive care, on average, than during previous surges of COVID-19. However, scientists and public health officials have been quick to point out that the mild reactions to Omicron in South Africa may not be seen in Europe and the US. A large percentage of the South African population is young, by comparison, and many already have some immunity to SARS-CoV-2 due to prior infection during previous surges or vaccination. This immunity is believed to be a prominent factor driving the reduced disease severity observed in South Africa. In the US, researchers from the Covid-19 Modeling Consortium at the University of Texas at Austin looked at 18 different scenarios for Omicron, warning that under the most pessimistic model, “Omicron could lead to the largest healthcare surge to date, unless measures are taken to slow spread.” The data have not yet been peer-reviewed.

As such, concerns over hospital capacity are rising, as many individuals are expected to travel and spend time with family during the holiday season, increasing the risk of transmission of the highly contagious VOC. US states such as New York and New Jersey are already reporting high hospitalization rates and an increased demand for testing. The US Department of Health and Human Services (HHS) reports that more than 76% of ICU beds are currently in use, with 21% of those beds being used for COVID-19 patients. Additionally, Regeneron and Eli Lilly are warning that their antibody treatments for COVID-19 might be less potent against Omicron. The US reported its first Omicron-related death on December 20. The UK offers an unsettling potential lens into the future for the US. The UK Health Security Agency reports at least 14 deaths due to Omicron and 129 hospitalizations as of December 20, up from 7 and 85 on December 18. While it remains too early to tell the damage Omicron will inflict, the growing number of deaths and hospitalizations indicate that the variant should not be viewed as a slightly worse form of the common cold.

NOVAVAX VACCINE Following months of manufacturing delays, the 2-dose SARS-CoV-2 vaccine from biotechnology company Novavax, NVX-CoV2373, received conditional marketing authorization by the European Commission on December 20 and an emergency use listing (EUL) from the WHO on December 17. In Europe, the vaccine is known as Nuvaxovid and is the fifth vaccine to receive authorization to prevent COVID-19 in adults aged 18 years and older. Novavax expects to begin shipping the vaccine to the European Union in the first quarter of 2022. The WHO’s EUL—the ninth for a SARS-CoV-2 vaccine—is for a version of the vaccine manufactured and marketed by the Serum Institute of India (SII), under license from Novavax, known as Covovax. The WHO listing allows the COVAX facility to distribute the vaccine with hopes of bolstering global vaccine supply. Covovax—an adjuvanted, recombinant spike protein nanoparticle vaccine—is less expensive and simpler to manufacture than some of the other vaccine types and easier to distribute, as it can be stored for 6 months in normal refrigeration.

The New England Journal of Medicine last week published results from a phase 3 clinical trial testing the vaccine in nearly 30,000 adults in the US and Mexico, showing vaccine efficacy against symptomatic infection to be 90.4%, with 100% efficacy against moderate-to-severe disease. Most of the COVID-19 cases sequenced in the study were caused by B.1.1.7 (Alpha), and the vaccine’s efficacy against any variant of concern (VOC) or interest was 92.6%. The vaccine’s efficacy against the new Omicron VOC is unknown, but having another effective vaccine is important in helping to control the pandemic. In November, Indonesia was the first country to grant emergency use authorization (EUA) to the Novavax vaccine, followed by the Philippines. The company has plans to apply for an EUA with the US FDA by the end of the year.

PFIZER-BIONTECH VACCINE IN YOUNG CHILDREN Pfizer-BioNTech last week released an update on its ongoing phase 1/2/3 study evaluating their SARS-CoV-2 vaccine among children ages 6 months to under 5 years of age. An immunogenicity analysis showed that 1 month after the second 3 µg dose of the vaccine, participants aged 2 to under 5 did not show a robust immune response to the lower-dose shots when compared to the immune responses seen in older teens and young adults. The companies said the trial will continue but they plan to evaluate a third 3 µg dose of vaccine administered at least 2 months after the second dose to all age groups in the study, with the hope that a 3-dose regimen will elicit more protective immune responses. The companies said no safety concerns have arisen. The data have not been released publicly and many questions remain, including what the immune response was in the 2 to under-5 age group, if any.

The shift in plans also pushes back the companies’ expected timeline to submit results to the US FDA from the end of this year to the second quarter of 2022, if the results are positive. They also announced plans to test a third dose of the already authorized 10 µg formulation in children ages 5 to 12 years; a trial to evaluate a third dose of 10 µg or 30 µg in adolescents ages 12 to 17 in order to assess safety and immunogenicity; and the development of an Omicron variant-specific vaccine. The companies also last week filed with the FDA to request that adolescents ages 12 to 15 years be included in the vaccine’s full approval, with filings in the European Union and other regulatory authorities expected soon. The Pfizer-BioNTech vaccine, known as Comirnaty, received full FDA approval as a 2-dose (30 µg) regimen for individuals ages 16 years and older in August.

“TEST TO STAY” GUIDANCE The US CDC on December 17 said unvaccinated students exposed to a person with COVID-19 can remain in school if they are tested twice in the week following exposure and both tests are negative. The new guidance, known as “test to stay,” is an effort to keep children in school instead of having to quarantine at home and miss class, while also alleviating the burden on parents to arrange child care. The new protocol—which should be used as one method in a layered prevention approach—is based on 2 studies published in the CDC’s Morbidity and Mortality Weekly Report (MMWR), one examining the policy in Los Angeles County, California, and the other in Lake County, Illinois. The studies were conducted prior to the detection of the fast-spreading Omicron variant of concern, but CDC officials said they have confidence the mitigation strategy will work and will update guidance as needed. Agency officials also urged parents to vaccinate their children if they are eligible, as it remains the best way to prevent infection or severe disease. Under current CDC guidance, vaccinated people do not have to quarantine after a known exposure unless they have symptoms but should be tested 5-7 days after the exposure and wear a mask until testing negative.

US VACCINE MANDATES A federal appeals court last week lifted the stay on the Biden administration’s “vaccine or test” COVID-19 mandate for businesses with 100 or more employees, prompting confusion over whether companies need to comply with the Occupational Safety and Health Administration (OSHA) temporary rule. Following the order, several appeals were filed with the US Supreme Court requesting Justice Brett Kavanaugh, who has jurisdiction over the appeals court that lifted the stay, to consider the rule and immediately enjoin enforcement of the rule. Justice Kavanaugh likely will refer the case to the full court, and the justices have not acted on the emergency request. The Supreme Court asked the Biden administration to file its response by December 30, and the court is expected to make a decision in early 2022. Separately, the Biden administration has asked the court to stay lower-court decisions enjoining enforcement of a Centers for Medicare and Medicaid Services (CMS) vaccine mandate for healthcare workers. The Supreme Court has generally supported vaccine mandates implemented by state governments and universities but shown more nuance when considering federal pandemic-related rules.

Meanwhile, the US Armed Forces are beginning disciplinary actions, including dismissals, for members of the military who have not yet been vaccinated. As many as 20,000 troops risk being discharged. The US Department of Defense also is requiring members of the National Guard to be vaccinated against COVID-19. But governors from 5 states—Iowa, Wyoming, Alaska, Mississippi, and Nebraska—are pushing back on the mandate, arguing in a letter that National Guard members fall under the jurisdiction of their state, unless they are federally deployed, and would therefore not be subject to federal mandates. The Defense Department has not responded to the letter. Notably, the department last month rejected a request from Oklahoma Governor Kevin Stitt to exclude the state’s National Guard members from the federal mandate, instead releasing new guidance saying members who refuse vaccination will receive a general officer memorandum of reprimand, which could be grounds for administrative separation.

MODERNA VACCINE PATENT DISPUTE Moderna has paused a dispute with the US government by not taking the final step in obtaining a patent for technologies used in its SARS-CoV-2 mRNA vaccine. The company said making the payment to obtain the patent “could interfere with further discussions aimed at an amicable resolution” with the US National Institutes of Health (NIH) and wanted to “avoid any distractions” in ongoing collaboration amid efforts to respond to the quickly spreading Omicron variant of concern (VOC). At issue is who should be credited with developing the genetic sequence technology used in the company’s mRNA vaccine. Scientists from Moderna and NIH worked quickly in early 2020 to invent the technology, but Moderna has disputed claims that the NIH researchers are co-inventors. Moderna maintains that only its scientists deserve credit and has filed an application to pursue a patent at a later date. Moderna is projected to bring in as much as US$18 billion in sales of the vaccine this year and has been under increasing pressure to share its vaccine technology with low- and middle-income countries in order to increase global supply. At this time, it is unclear whether Moderna’s decision to pause its patent application has implications for the US government’s global vaccination strategy.