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Nina Cosdon is the assistant editor for Contagion. Before joining MJH Life Sciences, she graduated magna cum laude from Denison University in 2021 with a degree in Communication. You can find her reading, hiking, or antiquing, or by emailing her at ncosdon@mjhlifesciences.com.

A new strain of the coronavirus, AY.4.2, has been dubbed the “Delta plus” variant. AY.4.2 appears to be marginally more transmissible than the original Delta variant, but investigators are unsure if it will continue to grow in frequency and overtake Delta.

AY.4.2 is expanding, most notably in the United Kingdom, and is being actively monitored. As early as September 27, 2021, the UK Health Security Agency 

 up to 6% of new cases to AY.4.2. Most recently, AY.4.2 is 

 to account for 10% of new cases in England. 

Because AY.4.2 is so new and concentrated in the UK, it is too early to predict whether it is more transmissible than earlier strains. However, some estimates give AY.4.2 a 10-15% transmission advantage over Delta. Experts say this is too slight to drastically change our emergency response, but it is still unknown whether AY.4.2 causes more severe COVID-19 disease than the Delta variant.

The US does not have as vigilant a sequencing system as the UK, so AY.4.2 may be flying under the radar. However, estimates indicate AY.4.2 currently accounts for 

 and is not causing outbreaks. Unlike Delta, AY.4.2 has yet to be designated a “variant of concern” by the World Health Organization.

, so experts predict that all subsequent variants, like AY.4.2, will descend from Delta.

According to Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, the organization has “identified this sub lineage here in the United States, but not with recent increase frequency or clustering, to date.”

Variants occur when a virus has time to mutate, so experts stressed the importance of getting vaccinated to protect against 

Articles

The new AY.4.2 "Delta plus" COVID-19 variant is gaining prevalence abroad and is estimated to be slightly more transmissible.

What Is Known about the New AY.4.2 “Delta Plus” Variant

Saskia v. Popescu, PhD, MPH, MA, CIC, is a hospital epidemiologist and infection preventionist. During her work as an infection preventionist, she performed surveillance for infectious diseases, preparedness, and Ebola-response practices. She holds a doctorate in Biodefense from George Mason University where her research focuses on the role of infection prevention in facilitating global health security efforts. She is certified in Infection Control and has worked in both pediatric and adult acute care facilities.

It’s hard to imagine that we’re entering our second winter with COVID-19. A second year in a pandemic is one that brings about new challenges and hard realities. According to the Centers for Disease Control and Prevention (CDC) the United States has 

 over 44 million cases of COVID-19, resulting in over 723,205 deaths since the pandemic began. 189.3 million people have been fully vaccinated within the United States, which translates to 57% of the total US population. 66.7% of the US population 12 years and older has been fully vaccinated.

Vaccination is a critical part to controlling COVID-19, especially as we move into the winter months where we are more likely to see transmission spikes due to people moving indoors, more travel, and gatherings. Per the CDC, when breaking down the race/ethnicity aspects of COVID-19 cases within the United States, 52% of cases have been in White people across all age groups, whereas 26.4% have been in Hispanic/Latino and 11.9% in Black, Non-Hispanic individuals. 

When it comes to vaccination, White individuals overwhelmingly account for the highest percentage of people fully vaccinated within the United States. Just as COVID-19 has shed light on social and racial inequities deeply rooted within the country, the rollout of a vaccine during a pandemic has also emphasized those disproportionately impacted by the pandemic. A new study in 

 worked to assess the vaccine acceptance and access among Black and Latinx communities.

Utilizing a community-partnered qualitative study via in-depth focus groups from March 17 to March 29 of this year, participants were from New Haven, Connecticut and within 8 focus groups, including 4 in Spanish. Seventy-two participants volunteered information about their access and acceptance to the vaccine: 50% identified as Black and 38% as Latinx, and 11% as Black and Latinx. A majority (78%) identified as women. The authors noted that “Employment backgrounds reflected the diversity of the New Haven community, including teachers, custodial service workers, and health care workers. Vaccination status of participants is noted.

Identified themes centered around trust and addressing barriers to vaccine access. They were categorized into 3 key themes: (1) pervasive mistreatment of Black and Latinx communities and associated distrust; (2) informing trust via trusted messengers and messages, choice, social support, and diversity; and (3) addressing structural barriers to vaccination access.” Some themes and subthemes, as well quotes include—lasting legacy from historical mistreatment, disparate death, increasing confidence through choice, fact-based information, and a need for transparent and continued communication with the community. 

In terms of addressing structural barriers to vaccination access, respondents shared hurdles like cutting the line and vaccine supply access, “going in circles” sign-up fatigue, and a need for support in Spanish. As the authors noted, “A key finding of this qualitative study was pervasive mistreatment of Black and Latinx communities, rooted in structural racism, that influenced acceptance of COVID-19 vaccines. Tragedies ranging from the US Public Health Services Syphilis Study at Tuskegee to recently reported disparities in maternal mortality and COVID-19–related mortality fueled untrustworthiness in the COVID-19 vaccine and health care systems. Our participants’ perspectives are supported by systematic reviews providing data exemplifying that systemic racism and health care bias are associated with negative health outcomes and lower quality of care. Discrimination and inequitable treatment of Black and Latinx communities by health care systems further drive untrustworthiness related to COVID-19 vaccinations.” 

From a health care perspective, this points to a desperate need to address untrustworthiness and how we can be better allies, advocates, and support systems for Black and Latinx communities.

A new study assessed the vaccine acceptance and access among Black and Latinx communities. 

Addressing Acceptance and Access to COVID-19 Vaccines

 for people with “frequent institutional or occupational exposure” to COVID-19, but there is no definitive consensus of which careers should be considered high-risk.

A recent original investigation published in

 sought to compare the prevaccination COVID-19 incidence of first responders, health personnel, and other essential workers in Arizona.

The study took place from July 20, 2020, to March 14, 2021. Participants were COVID-19 negative, had not been vaccinated, had frequent direct contact with others at work (within 3 feet), worked 20 or more hours each week, and submitted weekly nasal swab specimens for reverse transcriptase polymerase chain reaction analysis. Participants were representative of the Arizona Healthcare, Emergency Response, and Other Essential Workers Study (AZ HEROES), a statewide prospective cohort created to study COVID-19 infection and immunity among frontline and essential workers.

The study cohort was comprised of 1766 Arizona workers 18-85 years of age (mean age 43.8 years); 44.2% were health care personnel, 22.4% were first responders, and 33.4% were other essential workers. Of these, 1093 (61.9%) were female, 401 (22.7%) were Hispanic, and 1530 (86.6%) were White. These cohort demographics were fairly aligned with the investigators’ original sampling targets.

The “first responders” included correctional officers, firefighters, law enforcement (including US Customs and Border Protection), and emergency medical services (EMS) workers. The category “other essential workers” included persons in other work environments that prevented physical distancing, including frontline education, childcare or social work, frontline retail or hospitality, essential operations in government and nonprofit sectors requiring in-person work (postal workers, 911 call center operators), and essential infrastructure workers (waste management, agriculture, utility services).

The investigators used negative binomial regression to model COVID-19 infection by occupation and estimate adjusted and unadjusted incidence rate ratios (IRRs). They utilized the least absolute shrinkage and selection operator (LASSO) method to generate a parsimonious multivariable model. The primary source of exposure studied was occupational hazard, but investigators also assessed sociodemographic factors, health status, and community exposure.

The crude incidence of COVID-19 infection was defined as the total positive COVID-19 cases among participants divided by person-weeks at risk. Person-time was calculated from participants’ date of enrollment through March 14, 2021, and ended on the date of receipt of a positive RT-PCR test or date of first vaccination.

The study found that first responders had a higher incidence of COVID-19 infection than health care personnel and other essential workers, even after adjusting for any confounding factors. Crude incidence of COVID-19 infection per 1000 person-weeks was 6.7 for health care personnel, 13.2 for first responders, and 7.4 for other essential workers. In unadjusted models, first responders had 2 times the infection rate as health care personnel (IRRs, 2.01; 95% CI, 1.44-2.79). However, this risk remained elevated in adjusted LASSO models (IRR, 1.60; 95% CI, 1.07-2.38). First responders with the highest risk were corrections, at 16.0%. Notably, risk of infection among essential workers was no different than health care personnel in unadjusted or adjusted models.

Recent studies suggest COVID-19 incidence has decreased in health care settings due to heightened attention to infection prevention procedures. The investigators recommended that first responder communities enact similar measures, and that first responders be prioritized as a high-risk group during the COVID-19 pandemic.

First responders are twice as likely to become infected with COVID-19 in the workplace as health care workers and other essential workers, and this increases significantly after adjusting for cofounding factors.

First Responders Have a Higher Risk of COVID-19 Infection than Other Essential Workers

 the commencement of a phase 2 clinical trial to study their investigational HIV treatment regimen. The treatment, a combination of islatravir and lenacapavir, is a once-weekly oral regimen designed for people living with HIV who are virologically suppressed and on antiretroviral therapy (ART).

Gilead and Merck first announced they were joining forces to develop potential long-acting HIV treatment options in March 2021, and Jared Baeten, MD, PhD, Vice President of HIV Clinical Development at Gilead Sciences, spoke highly of their joint efforts. “This innovative research collaboration builds on the efforts of both companies to help make the end of the epidemic a reality through continued scientific advances in HIV. Initiating the trial represents an important step forward toward our goal of offering long-acting options that can help address the differentiated needs and preferences of the diverse range of people living with HIV.”

Islatravir (MK-8591), developed by Merck, and lenacapavir, developed by Gilead, both have long half-lives and have documented activity at low dosages in clinical studies. Creating an HIV regimen that requires less frequent dosing is an important step toward making HIV treatment more readily available and accessible.

The phase 2 study, NCT05052996, will evaluate the antiviral effect of an oral weekly regimen of Gilead’s investigational capsid inhibitor, lenacapavir, and Merck’s investigational nucleoside reverse transcriptase translocation inhibitor, islatravir. NCT05052996 is an open-label, active-controlled, multicenter study that will enroll adults 18 years of age and older at 25 sites in the US.

75 patients who meet all eligibility requirements will be randomly allocated 2:1; treatment group 1 will receive oral weekly islatravir (20 mg) and lenacapavir (300 mg) on day 8 after receiving loading doses of islatravir (40 mg) and lenacapavir (600 mg) on days 1 and 2. Treatment Group 2 will receive oral daily B/F/TAF (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets). Participants will receive the investigational drugs for 48 weeks. The primary endpoint the proportion of study participants with HIV-1 RNA viral load greater than or equal to 50 c/mL at Week 24.

After completion of the 48-week trial, participants in Treatment Group 1 will continue to receive an oral weekly combination regimen of islatravir and lenacapavir. They will be reevaluated every 12 weeks. Treatment Group 2 will be switched from daily oral B/F/TAF tablets to the oral weekly combination of islatravir and lenacapavir, beginning with the 2 days of loading doses, and monitored every 12 weeks.

The once-weekly regimen of islatravir and lenacapavir is Merck and Gilead’s first clinical trial since collaborating to develop long-acting HIV treatment options.

Gilead and Merck Begin Phase 2 Trials for Islatravir and Lenacapavir Combination HIV Treatment

Brian P. Dunleavy has been covering health and medical research for more than 25 years, for United Press International and EverydayHealth.com, among other outlets. He is also the former editor of Infectious Disease Special Edition. In addition, he has written on other subjects for Biography.com, History.com, the 

, among others. He holds a master’s degree from the University of Missouri School of Journalism.

“COVID-19 will not be the last ‘Disease X.’”

, written by Maria D. Van Kerkhove, PhD; Michael J. Ryan, MB, BCh, BAO; and Tedros Adhanom Ghebreyesus, PhD, all of the World Health Organization (WHO). In the piece, they extol the WHO’s newly formed Scientific Advisory Group on the Origins of Novel Pathogens (SAGO), which they describe as “an unprecedented opportunity to better guide studies that specifically investigate high-threat pathogens.”

“Disease X” is the organization’s name for as-yet-unknown pathogens that pose a threat to human life.

SAGO’s formation comes at a time when the WHO is facing unprecedented scrutiny over its efforts to investigate the origins of SARS-CoV-2. Chinese authorities have been accused of 

 the international body’s efforts to assess how the virus evolved. At the same time, some have implied that the WHO has been overly deferential to the Chinese government, essentially allowing the latter to 

“Understanding where new pathogens come from is essential for preventing future outbreaks,” Tedros, the WHO’s Director-General, told the media the day the 

Notably, in the commentary, he and his colleagues write that, “a lab accident cannot be ruled out until there is sufficient evidence to do so and those results are openly shared.” To date, Chinese officials have 

 that a lab leak caused the virus to spread to humans.

Ryan, who serves as the WHO’s emergencies director, added in the same press conference that SAGO represents the world’s “last chance to understand the origins of this virus.”

Perhaps not surprisingly, Chinese officials have already warned that the group’s work must not be “

Still, in keeping with other public health initiatives around the world, SAGO will be built around a “robust ‘one health’ approach that brings together the human, animal, and environmental spheres to boost risk identification, reduction, and surveillance in animals and at the human-animal-environment interface,” the WHO officials write.

The effort “must be linked to early action to investigate, characterize, and contain threats” with scientific collaboration and data sharing, they add. At the same time, researchers must work together to develop “systematic processes to study the emergence of these pathogens and their routes of transmission from natural reservoirs to humans,” and to enhance laboratory protocols globally.

“At least 4.8 million people have died from COVID-19,” Van Kerkhove, Ryan and Tedros write. “They and their families are owed answers as to where and how the virus originated. It’s in everyone’s interest to better prepare for the next Disease X.”

The World Health Organization's (WHO) newly formed Scientific Advisory Group on the Origins of Novel Pathogens (SAGO) will lay the groundwork for future identification of future disease threats.

Public Health Watch: WHO Launches New Effort to Investigate Origins of COVID-19

Jonna Lorenz is a freelance journalist with more than 20 years of experience. Her background is in business and health care news, including reporting, editing and research for newspapers and websites.

St. Joseph Mercy Health System launched a program in February to provide infusion of monoclonal antibodies for COVID-19 in patients’ homes.

Health System Partners with Paramedics to Administer Monoclonal Antibodies at Home

. Prior to joining MJH Life Sciences in 2020, he has covered a variety of fields and markets including diabetes, oncology, ophthalmology, IT, travel, and local news. You can email him at 

This recommendation was based off of data showing the vaccine was 90% efficacious in this population, and sets the stage for the first COVID-19 vaccine in the age group. 

FDA VRBPAC Votes to Recommend Pfizer-BioNTech COVID-19 Vaccine in 5 to 11 Year Olds

Carbapenem-resistant Klebsiellae was 92.5% susceptible to a combination of ceftibuten (CTB) and VNRX-5236.

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Healthcare providers are less likely to prescribe HIV PrEP to Black women, largely due to behavioral stereotyping.

Healthcare Providers’ Biases May Be Preventing Black Women from Getting HIV PrEP

The committee is meeting today to review the data presented to them, and will vote to either recommend or not an Emergency Use Authorization in this pediatric population. 

FDA VRBPAC Meeting Today to Discuss the Pfizer-BioNTech COVID-19 Vaccine in 5 to 11 Year Olds

Kevin Kunzmann is the managing editor for 

. Prior to joining parent company MJH Life Sciences in 2017, he worked as a health care and government reporter for The Pocono Record, and as a freelance writer for NJ Advance Media, The Express-Times, The Daily Journal, and more. He graduated from Rowan University with a degree in journalism in 2015. In his spare time, he enjoys reading, cooking, running his dog, and complaining about the Mets. Follow him on Twitter 

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