Sunday, January 30, 2022

Omicron’s Successor is on the way?

Reuters

Explainer-Scientists on alert over rising cases caused by Omicron cousin BA.2

Julie Steenhuysen

Sun, January 30, 2022, 7:06 AM

By Julie Steenhuysen

  CHICAGO (Reuters) - The highly transmissible Omicron variant of the SARS-CoV-2 virus - the most common form of which is known as BA.1 - now accounts for nearly all of the coronavirus infections globally, although dramatic surges in COVID cases have already peaked in some countries.

  Scientists are now tracking a rise in cases caused by a close cousin known as BA.2, which is starting to outcompete BA.1 in parts of Europe and Asia. The following is what we know so far about the new subvariant:

  "STEALTH" SUBVARIANT

  Globally, BA.1 accounted for 98.8% of sequenced cases submitted to the public virus tracking database GISAID as of Jan. 25. But several countries are reporting recent increases in the subvariant known as BA.2, according to the World Health Organization.

  In addition to BA.1 and BA.2, the WHO lists two other subvariants under the Omicron umbrella: BA.1.1.529 and BA.3. All are closely related genetically, but each features mutations that could alter how they behave.

  Trevor Bedford, a computational virologist at Fred Hutchinson Cancer Center who has been tracking the evolution of SARS-CoV-2, wrote on Twitter on Friday that BA.2 represents roughly 82% of cases in Denmark, 9% in the UK and 8% in the United States, based on his analysis of sequencing data from the GISAID database and case counts from the Our World in Data project at the University of Oxford.

  The BA.1 version of Omicron has been somewhat easier to track than prior variants. That is because BA.1 is missing one of three target genes used in a common PCR test. Cases showing this pattern were assumed by default to be caused by BA.1.

  BA.2, sometimes known as a "stealth" subvariant, does not have the same missing target gene. Instead, scientists are monitoring it the same way they have prior variants, including Delta, by tracking the number of virus genomes submitted to public databases such as GISAID.

  As with other variants, an infection with BA.2 can be detected by coronavirus home tests kits, though they cannot indicate which variant is responsible, experts said.

  MORE TRANSMISSIBLE?

  Some early reports indicate that BA.2 may be even more infectious than the already extremely contagious BA.1, but there is no evidence so far that it is more likely to evade vaccine protection.

  Danish health officials estimate that BA.2 may be 1.5 times more transmissible than BA.1, based on preliminary data, though it likely does not cause more severe disease.

  In England, a preliminary analysis of contact tracing from Dec. 27, 2021, through Jan. 11, 2022, by the UK Health Security Agency (HSA) suggests that household transmission is higher among contacts of people infected with BA.2 (13.4%) compared with other Omicron cases (10.3%).

  The HSA found no evidence of a difference in vaccine

, according to the Jan. 28 report.

  A critical question is whether people who were infected in the BA.1 wave will be protected from BA.2, said Dr. Egon Ozer, an infectious disease expert at Northwestern University Feinberg School of Medicine in Chicago.

  That has been a concern in Denmark, where some places that saw high case counts of BA.1 infections were reporting rising cases of BA.2, Ozer said.

  If prior BA.1 infection does not protect against BA.2, "this could be sort of a two-humped camel kind of wave," Ozer said. "It's too early to know if that will happen."

  The good news, he said, is that vaccines and boosters still "keep people out of the hospital and keep people from dying."

  (Reporting by Julie Steenhuysen; Editing by Bill Berkro


Above is fromhttps://www.yahoo.com/news/explainer-scientists-alert-over-rising-130643664.html

Thursday, January 27, 2022

January 27, 2022: Johns Hopkins COVID 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.

From the Center: Call for Papers—Special Feature on Climate Change and Health Security: Health Security will devote a special feature to climate change and its impact upon national and global health security. We encourage submissions of original research articles, case studies, and commentaries, on topics including climate change-related public health emergencies; public health emergency management and climate change; displacement of populations and the health impact of climate change, and more. All manuscripts should be submitted for consideration by March 21, 2022. Learn more here: https://home.liebertpub.com/cfp/special-feature-on-climate-change-and-health-security/378/

EPI UPDATE The WHO COVID-19 Dashboard reports 357 million cumulative cases and 5.61 million deaths worldwide as of January 26. Global weekly incidence increased again last week, up 11.03% over the previous week. This is the 14th consecutive week of increasing weekly incidence, setting another new record with 22.77 million new cases. The Omicron variant drove the greatest percentage increases in the WHO regions of Eastern Mediterranean (+38.58%), South-East Asia (+36.05%), Europe (+19.29%), and the Western Pacific (+1.26%). Both Africa (-31.04%) and the Americas (-2.01%) experienced declines in weekly incidence.

While there is optimism among some public health experts that the rapid rise and fall of the Omicron surge in some regions could usher in an end to the pandemic, the WHO determined last week that the COVID-19 pandemic continues to constitute a Public Health Emergency of International Concern (PHEIC). Other experts warn that as long as the threat of new variants exists, calls for reaching COVID-19 endemicity are misguided.

Meanwhile, global weekly mortality increased for the third week, up 8.49% from the previous week with 53,935 total deaths. The Pan American Health Organization (PAHO) on January 26 warned that the average number of COVID-19-related deaths is up 37% in the region over the previous week.

Global Vaccination

The WHO reported 9.68 billion cumulative doses of SARS-CoV-2 vaccines administered globally as of January 26. A total of 4.7 billion individuals have received at least 1 dose, and 4.0 billion are fully vaccinated. Analysis from Our World in Data indicates that the overall trend in global daily vaccinations continues to decrease, down to 25.08 million on January 26 from a recent high of 38.88 million on December 23.* Our World in Data estimates that there are 4.78 billion vaccinated individuals worldwide (1+ dose; 60.79% of the global population) and 4.12 billion who are fully vaccinated (52.3% 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 is currently reporting 72.3 million cumulative cases of COVID-19 and 870,195 deaths. The US is averaging 627,294 new cases—down from 726,941 on January 20—and 2,246 deaths per day—up from 1,860 one week ago and at the highest level since mid-February 2021.*

*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.

COVID-19 hospitalizations in the US are down 7.7% this week over last, with a 7-day average of 19,640 new hospitalizations per day. The recent surge in current hospitalizations appears to have peaked around January 19, down 1.7% to an average of 142,194 for the week ending January 24. According to analysis from The New York Times, the overall downward trend in hospitalizations belies the reality in some regions, where the number of cases and hospitalizations continue to grow significantly.

US Vaccination

The US has administered 537.2 million cumulative doses of SARS-CoV-2 vaccines. The trend in daily vaccinations continues to decline, down significantly from a recent high of 1.77 million doses per day on December 6 to 760,975 on January 21.*

A total of 251.5 million individuals have received at least 1 vaccine dose, equivalent to 75.8% of the entire US population. Among adults, 87.6% have received at least 1 dose, as well as 25.3 million children under the age of 18. A total of 210.9 million individuals are fully vaccinated**, which corresponds to 63.5% of the total population. Approximately 73.9% of adults are fully vaccinated, as well as 19.9 million children under the age of 18. Since August 13, 85.2 million fully vaccinated individuals have received an additional or booster dose. An estimated 43.5% of fully vaccinated individuals have received a booster, including 63.3% 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.

GLOBAL VACCINE GAP US officials announced on January 26 that the government has shipped a total of 400 million SARS-CoV-2 vaccine doses to 112 countries, part of its efforts to fulfill its pledge to donate 1.2 billion doses. At a briefing, White House COVID-19 Coordinator Jeff Zients noted that the US has donated 4 times more doses than any other country. Still, 5 billion to 6 billion doses are needed in low- and middle-income countries to help protect them against COVID-19, and vaccine access gaps in those areas create fertile grounds for the emergence of new, possibly more dangerous, SARS-CoV-2 variants, the WHO has warned. The divide is stark: about 78% of people in high- and upper-middle-income countries have received at least one dose of vaccine compared with about 10% in low-income nations. According to calculations from the International Monetary Fund (IMF), 86 of 206 countries had immunized less than 40% of their populations as of the end of 2021, far from the fund’s goal of vaccinating 70% of the world’s population in the first half of this year. Experts agree that vaccine inequities led to the emergence of the Omicron variant and warn of future variants if a concerted global effort is not undertaken to manufacture, distribute, and administer more vaccines to prevent the virus from circulating among the unvaccinated. A group of Democratic US lawmakers is calling for the government to immediately provide an additional US$17 billion for global vaccination delivery and infrastructure and to streamline federal efforts to coordinate the nation’s global COVID-19 strategy. Some experts say additional funding could be useful but drumming up international political will is more important. Others warn the next variant—if it is capable of immune evasion—could be like starting from scratch.

US HEALTHCARE UTILIZATION The Omicron variant of concern (VOC) has caused massive surges in COVID-19 cases and, subsequently, in people seeking healthcare. A recent study published in the US CDC’s Morbidity and Mortality Weekly Report (MMWR) examined hospital-associated disease severity markers, including ICU admissions, length of stay, and death. The study found that disease severity, measured by US healthcare utilization, appeared to be lower during the Omicron VOC surge compared to both the Delta VOC surge and the previous winter season. ICU admissions during the beginning of the Omicron surge were 26% lower and 29% lower than during the Delta and winter 2020-2021 surges, respectively. Mean length of hospital stay was also comparatively lower. However, due to the massive number of positive cases, overall staffed hospital bed usage was 7% higher than during Delta and 3% higher than during winter 2020-2021.

The study was not able to directly assess the impact that vaccines had on disease severity markers or hospital stay lengths, but the authors posit that decreased admissions to the ICU and lower overall hospital stays during the Omicron surge can likely be attributed to higher vaccine coverage as well as higher levels of infection-acquired immunity. Supporting this hypothesis, high relative increases in hospital admittance were only observed in children 0- to 4-years-old who are currently not eligible for vaccination. Although people infected with Omicron appeared to require less intensive care at the hospital level, the sheer number of cases and burden on the healthcare system overall required significant resources and resulted in severe strain. The authors state that this analysis “underscores the importance of national emergency preparedness, specifically, hospital surge capacity and the ability to adequately staff local health care systems.”

HEALTHCARE WORKER BURNOUT As the world enters its third year of response to the COVID-19 pandemic, burnout in the global healthcare workforce continues to grow. In the US, a rapid increase in the number of COVID-19 cases due to the Omicron variant of concern (VOC) has led to a record surge of individuals requiring medical attention across healthcare settings. In California, hospitals have canceled operations and other elective procedures and ambulances have experienced backlogs for patient delivery. Healthcare professionals warn that the continued high intensity of care, a limited amount of life-saving countermeasures, and a large number of staff out sick are creating a continuously stressful work environment. Notably, the country has experienced a mass exodus of healthcare workers. In the Southern US, this trend has hit nonprofit safety-net hospitals particularly hard, reducing the capacity of necessary resources for many throughout the region. Earlier this year, the US Department of Health and Human Services (HHS) announced that US$103 million of funding from the American Rescue Plan will be committed to strengthening resilience and addressing burnout in the domestic healthcare workforce. However, STAT reports that another fund meant to support hospitals and clinics during the pandemic has run out of money, after the Biden administration quietly redirected nearly US$7 billion from the fund and used it to buy SARS-CoV-2 vaccines and therapeutics.

Workforce mental health issues are not exclusive to the US. Researchers in Canada analyzed anonymous data from 34,000 physicians working in Ontario. The analysis found a 27% increase in the number of doctors seeking care for burnout or substance misuse in the first year of the pandemic compared with the prior year. Burnout of nurses and other healthcare professionals is a universal issue and has led to wealthier countries recruiting healthcare workers from other less-wealthy countries. This phenomenon has intensified during the Omicron surge, raising many questions about the ethics of the practice.

US VACCINE REQUIREMENTS FOR LARGE EMPLOYERS The US Department of Labor’s Occupational Safety and Health Administration (OSHA) on January 25 withdrew its emergency temporary standard (ETS) that called for employers with 100 or more workers to require their employees to be vaccinated for COVID-19 or undergo regular testing and wear face masks while at work. The withdrawal, which took effect January 26, follows the US Supreme Court’s January 13 opinion that halted enforcement of the rule. In a 6 to 3 decision, the justices concluded that OSHA overstepped its authority in issuing the requirement covering 84 million workers and issued a stay pending a decision from the US Court of Appeals for the Sixth Circuit. Though OSHA withdrew the requirement as an enforceable emergency regulation, the agency said it is maintaining the ETS as a proposed rule. On its website, OSHA stated it is “prioritizing its resources to focus on finalizing a permanent Healthcare Standard” and that it continues to “strongly encourage” workers to be vaccinated.

ISRAEL Israel’s Ministry of Health on January 25 said its vaccine advisory panel has recommended making all adults eligible to receive a fourth dose of SARS-CoV-2 vaccine. If the ministry approves the recommendation, it would be the first country in the world to make a fourth vaccine dose available to all adults. Israel already offers fourth doses to people aged 60 and older, healthcare workers, and people with compromised immune systems. About 600,000 Israelis have already received a fourth dose. Over the weekend, the health ministry shared preliminary data from its own researchers suggesting a fourth dose provides 3 to 5 times as much protection against severe disease in older adults when compared with those in the same age group who had received a booster dose at least 4 months prior. It is not clear when the ministry’s director-general will decide on the panel’s recommendation. Israel is in the midst of a surge in new COVID-19 cases driven by the Omicron variant.

POST-ACUTE SEQUELAE Researchers continue work to learn more about the clinical presentation and duration of persistent symptoms of SARS-CoV-2 infection, known as post-acute sequelae of COVID-19 (PASC) or “long COVID.” Prevalence of the condition—which is characterized by fatigue, shortness of breath, brain fog, stress and anxiety, and other symptoms that last for weeks or years after acute infection—is unknown but estimated to be between 7% to 80% of recovered patients. A study published this week in Cell suggests an association between the development of long COVID and 4 factors, including the presence of certain autoantibodies that mistakenly turn on the body’s own tissues, reactivation of previous Epstein-Barr virus infection, viral load levels in early infection, and having Type 2 diabetes. Because 2 of the factors are virus levels in the blood, the researchers speculate that antiviral administration early in SARS-CoV-2 infection might help lower the risk of longer-lasting symptoms in some people. However, authorized antivirals in the US are in very short supply and difficult to obtain. Additionally, preliminary data from Israel and the UK suggest that people who were fully vaccinated when infected were much less likely to report long COVID symptoms than people who were unvaccinated when infected. Other studies are looking at ways to predict who might be at risk of long COVID and underlying causes of the condition.

In the US, 2 Democratic lawmakers this week sent a letter to the US CDC requesting the agency release data on the number of Americans with long COVID, including information on race, gender, and age. The lawmakers, healthcare providers, and experts nationwide say more data are needed on how many people suffer from long-term symptoms in order to better target resources and provide a more equitable recovery from the pandemic. A recent article published in Nature Medicine examined inequities in understanding and addressing neurological complications of COVID-19 among marginalized US communities, with the authors calling for more equity in COVID-19 research and “a dismantling of structural barriers that perpetuate disparities in clinical care.” Advocates and health experts are pressuring the government for more attention on long COVID, including greater financial assistance, access to disability benefits, and improved healthcare. The US National Institutes of Health (NIH) early last year launched an initiative to identify the causes and means of prevention and treatment of long COVID, but the research is expected to take years. Some say the condition could be contributing to a worker shortage in the US, with a recent analysis from the Brookings Institution estimating that long COVID could account for 15% of the nation’s 10.6 million unfilled jobs.

VACCINATION & FERTILITY New research provides evidence that SARS-CoV-2 vaccination has no negative impact on reproduction—whether conception is achieved through heterosexual intercourse or in vitro fertilization—but men who become infected with the virus appear to have a short-term decline in fertility. In a study published in the American Journal of Epidemiology, researchers from the Boston University School of Public Health found no association between vaccination of males or females with any of the vaccines available in the US—Pfizer-BioNTech, Moderna, or J&J-Janssen—and the likelihood of conception, with fertility rates among female participants with at least 1 dose of vaccine almost identical to rates among unvaccinated female participants. In the same study, researchers report that men who tested positive for SARS-CoV-2 within 60 days of a woman’s menstrual cycle had reduced fertility when compared with men who never tested positive or who tested positive at least 60 days prior to the cycle. Previous research has linked COVID-19 in men to poor sperm quality and other reproductive dysfunction. A separate study, published in Obstetrics & Gynecology, showed that IVF patients who were vaccinated had similar fertilization rates compared with unvaccinated patients after undergoing controlled ovarian hyperstimulation, single frozen-thawed embryo transfer, and other procedures such as egg or mature oocyte retrieval. Additionally, both groups had similar rates of early pregnancy loss. These studies provide further evidence that SARS-CoV-2 vaccination is safe for people who are trying to conceive. The CDC and other medical groups recommend all people trying to become pregnant to get vaccinated.

Separate studies—including one conducted in the US and another in Norway—showed that vaccination can change menstruation cycles, but the impacts are short-lived and small when compared to natural variation. All of the data should be reassuring to pregnant people and those trying to become pregnant as well as the approximately two-thirds of US parents who cite future fertility as a concern when it comes to vaccinating younger children ages 5 to 11. The vaccination rate among this latter cohort remains quite low in the US and the rates vary widely among US states. 

OMICRON-SPECIFIC VACCINES Moderna announced on January 26 it has begun a Phase 2 clinical trial testing an Omicron variant-specific booster candidate. The study will evaluate the booster in 2 cohorts of participants: individuals who received the 2-dose primary series of the company’s mRNA vaccine and individuals who received the primary series plus a 50 µg booster dose. Moderna also announced the publication of neutralizing antibody data against the Omicron variant 6 months after receipt of the authorized booster dose. The study, published in the New England Journal of Medicine (NEJM), shows that the authorized 50 µg booster dose increased Omicron neutralizing titers to 20-fold higher than peak Omicron titers post-dose 2. However, 6 months later, Omicron neutralization declined 6.3-fold from peak titers at day 29 post-boost but remained detectable in all participants. Neutralizing titers against Omicron declined faster after the booster than for the wild-type virus.

Wednesday, January 26, 2022

January 25, 2022: Johns Hopkins COVID 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.

GLOBAL VACCINE & TREATMENT ACCESS The COVID-19 pandemic is at a critical stage, and it is dangerous for the world to assume “we are in the endgame,” WHO Director-General Dr. Tedros Adhanom Ghebreyesus warned at the opening of a WHO Executive Board meeting on January 24. The conditions are ideal for new variants to emerge, but the world can end the acute phase of the pandemic this year by achieving the target of vaccinating 70% of each nation’s population and improving testing and surveillance, Dr. Tedros encouraged. Globally, at least 5.6 million people have died of COVID-19 as the pandemic enters its third year, but only about 10% of people in low-income countries have received at least 1 dose of vaccine.

The global vaccine sharing scheme COVAX announced last week that it has delivered 1 billion SARS-CoV-2 vaccine doses to 144 countries, only half of its goal to deliver 2 billion doses by the end of 2021. The scheme was hampered by wealthier nations’ hoarding of the shots, export restrictions, and numerous changes within the organization. Gavi, the Vaccine Alliance and other partners in the initiative last week warned that COVAX is “basically out of money” and needs at least US$5.2 billion in new funding over the next 3 months to support the quick rollout of already-donated doses and to purchase more vaccines. Leading African public health authorities recently called for donated shots to have a shelf life of at least 3 to 6 months to allow countries time to plan distribution and avoid situations where the doses expire. According to the Africa Centres for Disease Control and Prevention (Africa CDC), approximately 0.5% of the 572 million doses delivered to the continent so far have expired before being administered. Efforts continue to increase vaccine manufacturing in Africa. Last week, South African-American businessman Dr. Patrick Soon-Shiong opened a new vaccine plant in Cape Town to address the lack of capacity.

The Africa CDC said it also is in talks with pharmaceutical companies to increase supplies of COVID-19 treatments. Merck and Ridgeback Biotherapeutics, which make the antiviral molnupiravir, last week said they will provide 3 million courses of the drug to UNICEF for use in low- and middle-income countries (LMICs) throughout the first half of this year. In another development, the Medicines Patent Pool announced agreements with 27 generic drug manufacturers in Africa, Asia, and the Middle East to produce low-cost versions of molnupiravir for use by LMICs. The consumer advocacy group Public Citizen sent a letter to Pfizer on January 24, asking the company to commit to reserve at least two-thirds of its annual supply of the COVID-19 treatment Paxlovid for LMICs, to be purchased at lower prices. Public Citizen said it is trying to discourage a repeat of vaccine inequity as newer treatments become available.

The Center for Health Security is hosting a webinar on Thursday, January 27 at 1pm on this topic. Please join us for Protecting U.S. National Security by Increasing Vaccination Globally.

BOOSTER DOSES Several new peer-reviewed studies provide additional evidence that SARS-CoV-2 vaccine booster doses elicit antibody responses that help protect against severe disease from the Omicron variant. Two of the studies were published in the US CDC’s Morbidity and Mortality Weekly Report (MMWR). The first study examined data on hospitalizations and emergency room and urgent care center visits in 10 states from August 2021 to January 2022, spanning both Delta- and Omicron-predominant periods. In that study, researchers found that vaccine effectiveness (VE) of the 2-dose mRNA vaccine regimens dropped around 6 months after the second dose, during both periods. However, VE increased following a third dose of mRNA vaccine during both waves and was highly protective against emergency room and urgent care encounters (94% during Delta and 82% during Omicron) and hospitalization (94% and 90%, respectively). A second study examined incidence and death rates between April and December 2021, again across both Delta- and Omicron-predominant periods, among unvaccinated and fully vaccinated adults with and without booster doses. In 25 US states, individuals who had received a booster dose of mRNA vaccine had the highest protection against SARS-CoV-2 infection across both periods when compared to unvaccinated and vaccinated but unboosted individuals.

Another study, published in the Journal of the American Medical Association (JAMA) and led by CDC researchers, examined data collected from 4,666 COVID-19 testing sites across 49 US states between December 10, 2021, and January 1, 2022. The findings show that individuals who had 3 doses of vaccine were better protected against both Omicron and Delta variants when compared with those who were unvaccinated and with those who received only 2 vaccine doses, although higher odds ratios for Omicron suggest less protection for Omicron than for Delta. Yet another study, published online in The Lancet, funded by the Brazil Ministry of Health, and conducted by researchers from Brazil and the University of Oxford, shows that a third booster dose of the Oxford-AstraZeneca, Pfizer-BioNTech, J&J-Janssen, or Sinovac (CoronaVac) SARS-CoV-2 vaccines induces a significant increase in antibody levels among individuals who previously received 2 doses of the Sinovac vaccine. The researchers note that the most robust responses were seen in those who received heterologous (mixed) boosters, a finding that could be most relevant to older populations. 

The studies released by the CDC represent the most comprehensive data to date on the impact of booster doses in the US during the pandemic. The data from these reports also indicate that booster doses of the mRNA vaccines provide the most benefit to adults older than 50 years. However, uptake of booster doses has started to slow since the initial days of the Omicron wave despite advice from public health officials to stay “up to date” on vaccinations and recent evidence showing the boosters help prevent severe disease caused by Omicron. In updated data on breakthrough cases, the CDC notes that in November 2021, unvaccinated adults had 13 times the risk of testing positive for SARS-CoV-2 and 68 times the risk of dying from COVID-19 compared with fully vaccinated adults with booster doses.

VACCINE FOR UNDER-5 CHILDREN Many in the US continue to eagerly wait for the authorization of a SARS-CoV-2 vaccine for children under age 5. White House Chief Medical Advisor Dr. Anthony Fauci said last week he hopes the US FDA will soon authorize a vaccine for the youngest children, perhaps within the next month. More than 250 physicians recently sent a letter to the FDA concerning the issue and suggesting 2 options to expedite the process, such as joint decision making for parents and physicians to immunize children with off-label use of the Pfizer-BioNTech 10 μg dose vaccine formulation or removing the age de-escalation barrier to vaccine approval. The letter also urges the FDA to review and authorize the Moderna vaccine for children aged 6 months to 5 years as soon as data become available showing the vaccine is safe and effective, arguing the Moderna vaccine offers better protection against the Omicron variant and severe disease than other vaccines. Pfizer-BioNTech in December announced their plans to submit data to the FDA on a 3-dose study in the first half of 2022, after initial trials of the 3 μg 2-dose regimen given to 2- to 4-year olds did not produce as much of an immune response as it did in other age groups.

The American Academy of Pediatrics reports that, based on state-level data, the number of pediatric cases during the Omicron surge has drastically risen to nearly 5 times the rate of the peak of last winter’s surge. Parents continue to struggle with efforts to keep their children safe, stuck in limbo between daycare closures and child care crises. According to an analysis from the Center for the Study of Child Care Employment, 110,00 fewer people are working in childcare now than in February 2020. Outside of COVID-19 fears, some parents might take solace knowing that the rates of pediatric hospitalizations for other types of infections fell dramatically during the pandemic in England, including a 94% reduction in influenza-related hospitalizations, 90% reduction in measles-related hospitalizations, and an 82% drop in bronchitis-related hospitalizations in children under 14 years of age from March 1, 2020 to June 30, 2021 compared to March 1, 2017 to February 20, 2020. The researchers at the University of Oxford attribute the decreases to a range of behavioral and societal changes implemented to reduce transmission of SARS-CoV-2 and urge continued monitoring of other infections as COVID-19 mitigation strategies evolve. It is not clear whether similar reductions occurred in the US.

OMICRON-SPECIFIC VACCINES Though current SARS-CoV-2 vaccines continue to offer protection against severe COVID-19 disease and death, vaccine manufacturers are working to update the shots to hopefully provide better protection against the Omicron variant. Pfizer and BioNTech announced today they have begun a study to evaluate a SARS-CoV-2 vaccine based on the Omicron variant among adults aged 18 to 55 years. The study will enroll up to 1,420 healthy adults to test the Omicron-based shot as an initial (third shot) or secondary (fourth shot) booster dose or as primary vaccinations in previously unvaccinated individuals.

According to reporting from STAT News, a senior US FDA official said that if the agency moves to update vaccines to better confront Omicron or other variants, it will likely participate in an internationally coordinated program with other regulatory agencies and the WHO to decide if, when, or how to update the shots. The program could operate in a similar way to the one already in place to decide which strains to include in influenza vaccines, the unnamed official said. Even with Pfizer-BioNTech expecting to apply for authorization of an Omicron-specific vaccine by the end of March, the current surge in cases is already waning in Africa, Europe, and the US, suggesting it could end within or close to that timeframe. And while Omicron might remain the globally predominant strain, it is possible future variants will emerge with potentially very different mutations. Already, scientists are tracking an Omicron subvariant called BA.2, which has some new mutations, including several on the spike protein. The variant is not viewed as a “gamechanger,” but it already accounts for most new cases in India, Sweden, and Denmark and has been detected in the US.

COVID-19 THERAPIES On January 24, the US FDA revised the emergency use authorizations (EUAs) for 2 monoclonal antibody treatments—bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab)—to restrict their use to only when a patient is likely to have been infected with or exposed to a variant that is susceptible to these therapies. The treatments have been shown to be highly unlikely to be effective against the Omicron variant of concern (VOC), and because that VOC is currently responsible for more than 99% of COVID-19 cases in the US, “these treatments are not authorized for use in any US states, territories, and jurisdictions at this time,” the FDA said in a statement. As a result, the US Department of Health and Human Services (HHS) has halted distribution of the therapies. However, the therapies could be useful in certain geographic regions or against new variants in the future. The FDA noted other therapies are available and expected to work against Omicron, including the monoclonal antibody sotrovimab, and the antivirals Paxlovid, remdesivir (Veklury), and molnupiravir.

Late last week, the FDA expanded the EUA for the COVID-19 treatment remdesivir to include certain non-hospitalized adults and pediatric patients ages 12 and older with mild-to-moderate disease. Previously, the use of the intravenous antiviral was limited to hospitalized patients. Additionally, the FDA authorized the drug’s use for pediatric patients younger than 12 years of age who weigh at least 3.5 kg but under 40 kg who are at high risk for progression to severe COVID-19, including hospitalization or death. A 3-day course of the drug is recommended as a third option behind the oral antiviral Paxlovid and sotrovimab. A 5-day course of remdesivir is recommended for hospitalized patients who are not on mechanical ventilation or extracorporeal membrane oxygenation (ECMO), while critically ill hospitalized patients should receive a 10-day course.

US VACCINE REQUIREMENTS On January 21, a federal judge in Texas issued a nationwide injunction against US President Joe Biden’s SARS-CoV-2 vaccine requirements for federal government employees, saying the president had exceeded his executive authority in issuing the rule. US District Judge Jeffrey Vincent Brown cited a recent US Supreme Court opinion blocking a different federal rule that would have required employees of companies with 100 or more workers to be vaccinated or submit weekly testing. Notably, the Supreme Court allowed a separate vaccine rule pertaining to workers at medical facilities that receive Medicare or Medicaid funding to remain in force. The US Department of Justice immediately filed notice that it plans to appeal the decision to the US Court of Appeals for the 5th Circuit. The case likely will go to the Supreme Court. At the beginning of December 2021, the Office of Management and Budget said 97.2% of the federal workforce was compliant with the rule, including those who had pending or approved exemptions. The plaintiff in the case, a Nevada-based group called Feds for Medical Freedom, also asked the judge to enjoin the rule applying to federal contractors, but that executive order is already subject to a nationwide injunction. Over the weekend, thousands of anti-vaccination protestors gathered in Washington, DC, for a rally against vaccine mandates.

VACCINE HESITANCY The results of a survey of 1,200 US adults led by researchers from the Ohio State University and published in JAMA Network Open found that vaccine hesitancy has decreased more rapidly among Black individuals than White individuals since December 2020. Hesitancy rates were comparable at the start of the survey, but Black individuals experienced larger increases in intention to vaccinate than White individuals relative to baseline. The belief that vaccines were necessary for protection also increased more among Black individuals than White individuals. The new survey data showing declines in hesitancy among Black individuals suggest there may be other factors to consider, including barriers to access. The study’s discussion notes Kaiser Family Foundation surveys that document the substantial portion of Black individuals who worry about access barriers. For example, 55% of Black individuals (vs 41% of White individuals) are very or somewhat concerned about missing work if the vaccine makes them sick; 37% of Black individuals (vs 24% of White individuals) worry they will have to pay for the vaccine; 23% of Black individuals (vs 16% of White individuals) are concerned about taking time off of work to get vaccinated; and 17% of Black individuals (vs 9% of White individuals) worry about finding transportation to vaccination sites. Though the administration of US President Joe Biden has taken some steps to alleviate such barriers—including paid sick leave and free Uber and Lyft rides to vaccination sites—some people remain unaware of these programs.