Neurodevelopmental outcomes at 1 year in infants exposed to COVID-19 in utero

 Key Points

Question  Is COVID-19 exposure in utero associated with increased risk for neurodevelopmental disorders in the first year of life?

Findings  In this cohort study of 7772 infants delivered during the COVID-19 pandemic, those born to the 222 mothers with a positive SARS-CoV-2 polymerase chain reaction test during pregnancy were more likely to receive a neurodevelopmental diagnosis in the first 12 months after delivery, even after accounting for preterm delivery.

Meaning  These preliminary findings suggest that COVID-19 exposure may be associated with neurodevelopmental changes and highlight the need for prospective investigation of outcomes in children exposed to COVID-19 in utero.

Abstract

Importance  Epidemiologic studies suggest maternal immune activation during pregnancy may be associated with neurodevelopmental effects in offspring.

Objective  To evaluate whether in utero exposure to SARS-CoV-2 is associated with risk for neurodevelopmental disorders in the first 12 months after birth.

Design, Setting, and Participants  This retrospective cohort study examined live offspring of all mothers who delivered between March and September 2020 at any of 6 Massachusetts hospitals across 2 health systems. Statistical analysis was performed from October to December 2021.

Exposures  Maternal SARS-CoV-2 infection confirmed by a polymerase chain reaction test during pregnancy.

Main Outcomes and Measures  Neurodevelopmental disorders determined from International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) diagnostic codes over the first 12 months of life; sociodemographic and clinical features of mothers and offspring; all drawn from the electronic health record.

Results  The cohort included 7772 live births (7466 pregnancies, 96% singleton, 222 births to SARS-CoV-2 positive mothers), with mean (SD) maternal age of 32.9 (5.0) years; offspring were 9.9% Asian (772), 8.4% Black (656), and 69.0% White (5363); 15.1% (1134) were of Hispanic ethnicity. Preterm delivery was more likely among exposed mothers: 14.4% (32) vs 8.7% (654) (P = .003). Maternal SARS-CoV-2 positivity during pregnancy was associated with greater rate of neurodevelopmental diagnoses in unadjusted models (odds ratio [OR], 2.17 [95% CI, 1.24-3.79]; P = .006) as well as those adjusted for race, ethnicity, insurance status, offspring sex, maternal age, and preterm status (adjusted OR, 1.86 [95% CI, 1.03-3.36]; P = .04). Third-trimester infection was associated with effects of larger magnitude (adjusted OR, 2.34 [95% CI, 1.23-4.44]; P = .01).

Conclusions and Relevance  This cohort study of SARS-CoV-2 exposure in utero found preliminary evidence that maternal SARS-CoV-2 may be associated with neurodevelopmental sequelae in some offspring. Prospective studies with longer follow-up duration will be required to exclude confounding and confirm these associations.

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2793178?utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_term=060922

Commercial test reveals factors correlated with diminished T cell responses to SARS-CoV-2

 T cell testing using a commercial T cell test, QuantiFERON SARS-CoV-2 RUO, offers insight into the immune response to infection and vaccination of patients with COVID-19 and suggests that age and time from infection are significant factors related to the magnitude of cell-mediated immune (CMI) responses to COVID-19. The findings are presented at ASM Microbe 2022, the annual meeting of the American Society for Microbiology.

Conclusions of the new findings are based on evidence from an observational clinical study involving human subjects conducted from June 2021 to February 2022 in the United States and Netherlands. SARS-CoV-2 T cell tests can provide researchers and clinicians with information about an individual’s ability to fight future COVID-19 infection. QuantiFERON SARS-CoV-2 RUO, a commercial T cell test, detected T cell mediated immune responses in 80% of clinical study subjects who completed COVID-19 vaccination in the previous 24 weeks (6 months). 

When evaluating what factors may associate with poor T cell responses observed after vaccination, only increasing age significantly associated with poor T cell response. Time from vaccination, type of vaccine received, or gender were not associated with T cell response.  In subjects who had been infected with SARS-CoV-2, QuantiFERON SARS-CoV-2 RUO detected T cell responses in 74% of subjects who had been infected in the previous 24 weeks. The only factor associated with poor T cell responses after infection was time elapsed after infection.

“This study reinforces current knowledge connecting increasing age and time from infection with diminished immunity to SARS-CoV-2, which may, in turn, contribute to greater susceptibility to infection and subsequent disease,” said Robin Uchiyama, Clinical Study Lead, Clinical Affairs at QIAGEN and the lead author on the study.  “This work highlights the importance of T cell testing and implementing robust preventative measures against infection, like vaccination, boosters and masking, even after vaccination in older adults or after infection.” 

The QIAGEN-funded work was led by QIAGEN’s Clinical Affairs group based in Germantown, Md. and will be presented at ASM Microbe in Washington, D.C. on Saturday, June 11, 2022.

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ASM Microbe is the annual meeting of the American Society for Microbiology, held June 9-13, 2022, in Washington, D.C.

The American Society for Microbiology is one of the largest professional societies dedicated to the life sciences and is composed of 30,000 scientists and health practitioners. ASM's mission is to promote and advance the microbial sciences.  

ASM advances the microbial sciences through conferences, publications, certifications, educational opportunities and advocacy efforts. It enhances laboratory capacity around the globe through training and resources. It provides a network for scientists in academia, industry and clinical settings. Additionally, ASM promotes a deeper understanding of the microbial sciences to diverse audiences. 

https://www.eurekalert.org/news-releases/955663

Inhaled vaccines offer better protection than nasal sprays

 Inhaled aerosol vaccines provide far better protection and stronger immunity than nasal sprays, McMaster scientists who compared respiratory vaccine-delivery systems have confirmed.

While nasal sprays reach primarily the nose and throat, inhaled aerosols bypass the nasal passage and deliver vaccine droplets deep in the airway, where they can induce a broad protective immune response, the researchers report.

For the study, published online in the journal Frontiers in Immunology, the researchers used a tuberculosis vaccine to compare delivery methods by measuring the distribution of droplets, immune responses and potency in animals.When the vaccine was delivered directly into the lungs it stimulated stronger immune responses, providing much better protection from TB.

"Infections in the upper respiratory tract tend to be non-severe. In the context of infections caused by viruses like influenza or SARS-CoV-2, it tends to be when the virus gets deep into the lung that it makes you really sick," explains Matthew Miller, a co-author of the study who holds the Canada Research Chair in Viral Pandemics at McMaster University.

"The immune response you generate when you deliver the vaccine deep into the lung is much stronger than when you only deposit that material in the nose and throat because of the anatomy and nature of the tissue and the immune cells that are available to respond are very different," says Miller.

"This study for the first time provides strong preclinical evidence to support the development of inhaled aerosol delivery over nasal spray for human vaccination against respiratory infections including TB, COVID-19 and influenza," says Zhou Xing, co-investigator of the study and a professor at the McMaster Immunology Research Centre and Department of Medicine.

More than 6.3 million have people died during the COVID-19 pandemic, and respiratory infections remain a significant cause of illness and death throughout the world, driving an urgent and renewed worldwide effort to develop vaccines that can be delivered directly to the mucous lining of the respiratory tract.

Scientists at McMaster, who have developed a unique inhaled form of COVID vaccine, believe this deep-delivery method offers the best defence against the current and future pandemics.

A Phase 1 clinical trial is currently under way to evaluate the inhaled aerosol vaccine in healthy adults who had previously received two or three doses of an injected COVID mRNA vaccine.

Nasal mist flu vaccines have been shown to be highly effective in children, but much less effective in adults, leaving injectable flu vaccines as the most popular choice for seasonal flu vaccinations.

Previous research by the McMaster team has shown that in addition to being needle-free and painless, an inhaled vaccine is so efficient at targeting the lungs and upper airways that it can achieve maximum protection with a much smaller dose than injected vaccines.

The research is part of Canada's Global Nexus for Pandemics and Biological Threats at McMaster, which brings together an international network of researchers, government, industry, health care and other partners with the goal of finding solutions to the current pandemic, while preparing for future global health threats such as antimicrobial resistance.

Story Source:

Materials provided by McMaster University. Original written by Michelle Donovan. Note: Content may be edited for style and length.

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Journal Reference:

1. Vidthiya Jeyananthan, Sam Afkhami, Michael R. D’Agostino, Anna Zganiacz, Xueya Feng, Matthew S. Miller, Mangalakumari Jeyanathan, Michael R. Thompson, Zhou Xing. Differential Biodistribution of Adenoviral-Vectored Vaccine Following Intranasal and Endotracheal Deliveries Leads to Different Immune Outcomes. Frontiers in Immunology, 2022; 13 DOI: 10.3389/fimmu.2022.860399

https://www.sciencedaily.com/releases/2022/06/220610091359.htm

HCA’s purchase of 5 Utah hospitals from Steward on pause after judge’s order

 

• HCA Healthcare’s deal to acquire Steward Health Care System’s five Utah hospitals has been put on hold after a federal judge issued a temporary restraining order.           
• The two entities would have been able to consummate the deal earlier this week absent the temporary restraining order, which was issued by U.S. District Judge Tena Campbell in Utah on Monday.    
• HCA and Steward can’t proceed with the transaction until 10 days following a ruling on a preliminary injunction, or after a date set by the court, whichever is later.

Dive Insight:

The Federal Trade Commission alleges the merger would minimize competition and ultimately harm patients due to higher prices and lower care quality, according to the complaint filed June 3 in federal court in Utah.   

The temporary restraining order maintains the status quo, preserving competition while the case proceeds to the next step. 

The court now will weigh whether to issue a preliminary injunction and will hear from both parties in the case before issuing a ruling on the injunction.   

HCA already operates six hospitals in Utah’s Wasatch Front, the area surrounding Salt Lake City, the same region in which Steward operates five hospitals. HCA is the second-largest provider of hospital services in the region while Steward is No. 4. The two are head-to-head competitors and have facilities in close proximity to one another, which offer many of the same services.

Altogether there are four healthcare systems providing inpatient services in this region, and according to the FTC, an acquisition of the Steward hospitals by HCA would reduce the number of systems offering inpatient services to three systems.  

The FTC said competition between HCA and Steward for inclusion in narrow-network health plans is “particularly fierce” as Intermountain, the largest system in the region, typically is excluded from these plans, leaving HCA and Steward to compete more closely with one another. 

The FTC argues that competition between the two has resulted in reduced rates charged to insurers, upgraded facilities and improved service offerings.

Ultimately, the transaction would eliminate Steward as the low-cost provider in the region.

HCA will have greater bargaining power as a result of the deal and would command even higher rates from commercial insurers, who are then likely to pass those higher costs on to employers and members in the form of increased premiums, deductibles and copays, the FTC alleges.

The agency now has challenged several hospital deals this year as the Biden administration has promised to crack down on consolidation in the healthcare sector.

https://www.healthcaredive.com/news/hcas-purchase-5-utah-hospitals-put-on-pause-after-judges-order/625111/

NJ judge puts RWJBarnabas Health hospital acquisition on hold

 

• RWJBarnabas Health’s proposed deal to acquire Saint Peter’s Healthcare System has been put on hold following a temporary restraining order issued by a federal judge in New Jersey this week.                 
• The two New Jersey providers cannot proceed with the deal until 10 days after a ruling on a preliminary injunction or until a date set by the court, whichever is later, according to the Monday order signed by Judge John Michael Vazquez.  
• Without the restraining order, the two systems would have been able to move forward with the deal after Thursday, the order explains.    

The Federal Trade Commission has secured two temporary restraining orders this week, putting a pause on two separate healthcare acquisitions in Utah and New Jersey. 

The agency is fresh off two victories: Rhode Island’s two largest health systems scrapped plans to merge in February following the FTC’s challenge, and a federal appeals court sided with the FTC in March, blocking another merger in New Jersey.  

The FTC alleges that RWJBarnabas Health and Saint Peter’s compete head-to-head in New Jersey, particularly in the central part of the state in Middlesex County.

Saint Peter’s hospital is less than one mile away from RWJBarnabas’ flagship hospital, RWJ-New Brunswick. These are the only two hospitals in New Brunswick, one of the largest cities in Middlesex County, the FTC alleges. 

The current competition between the two “incentivizes them to keep prices lower and quality of care higher than they would absent this competition,” according to the administrative complaint.    

After the acquisition, RWJBarnabas would control 50% of the market for hospital inpatient services in Middlesex County. The two remaining competitors would have substantially less market share, the FTC alleges.   

In the case’s next step, a judge will hear from both sides and weigh whether to issue a preliminary injunction to block the deal. 

“The stipulated Temporary Restraining Order (TRO) is a standard part of the judicial process in merger challenges and reflects an agreement between the parties and the FTC that the parties will not close their transaction until the court can hold a hearing on and decide the FTC’s request for a preliminary injunction,” RWJBarnabas said in a statement to Healthcare Dive.

A federal judge in Utah also issued a temporary restraining order this week, putting on hold HCA’s acquisition of five hospitals from Steward Health Care System. 

In that case, the FTC alleges that the acquisition would lessen competition in the region around Salt Lake City while raising prices and lowering the quality of care for patients. 

Also this week, the agency voted to launch an investigation into the practices of drug middlemen, pharmacy benefit managers. 

These actions come as President Joe Biden’s administration has promised to take a tougher stance on healthcare consolidation. 

https://www.healthcaredive.com/news/new-jersey-rwjbarnabas-health-hospital-acquisition-on-hold/625237/

Md. gov sets long-term plan for COVID-19

 Maryland Gov. Larry Hogan outlined a long-term preparedness plan for dealing with COVID-19 on Thursday, with a focus on treatments to keep people out of hospitals and keeping the state ready to respond to virus variants and a potential increase in cases.

Hogan said the state has nearly doubled its “Test to Treat” sites to nearly 90 locations over the last three months to make it easier for people to get tested for the virus.

“Our state public health response has now fully transitioned from an emergency into an ongoing operation of state government,” Hogan said.

The governor also said the state health department is preparing dozens more urgent care and ambulatory care locations to be ready to provide these services by the fall.

Maryland also is aiming to maximize treatments for COVID-19, Hogan said. While therapies are a relatively new tool, they are becoming more prevalent. Although the treatments are not cures, they have a high success rate in keeping people out of the hospital.

“COVID may be with us for a long time into the future, so the very good news is that we have vaccines to protect ourselves and our community and medications to treat this disease safely and effectively,” said Dr. Howard Haft, executive director of the Maryland Primary Care Program.

Officials also gave an update on the state’s preparations for vaccinations for children under 5. Pending federal approval, Maryland will have COVID-19 vaccines available for infants and toddlers as early as June 20. The state completed the first order of those vaccines on Wednesday. The state expects to receive approximately 65,400 doses initially with additional doses to come.

There are about 358,000 Maryland children in the new eligible age group.

“These COVID-19 vaccines, just like the other COVID-19 vaccines we have for other age groups, will help protect our youngest Marylanders against severe illness, hospitalization, or even death from this virus,” said Dr. Jinlene Chan, the deputy secretary for the health department.

https://apnews.com/article/covid-politics-health-larry-hogan-maryland-f4a5ba1a71089241357349fdf1751456

Lawsuit: LA shelter for kids was a den for sexual abuse

 A Los Angeles County-run shelter meant to be a safe space for children as they awaited placement in foster homes was for decades a den for sexual predators among the staff — and some residents — who preyed on children as young as 5, according to a lawsuit filed Thursday by dozens of former residents.

Some of the more than 30 plaintiffs spoke at a news conference and wept and trembled as they detailed abuse and some victims’ attempts to escape the hall’s barbed-wire fences and guarded gates. Among the victims was a 6-year-old boy who in 1990 was molested by a male staffer who locked the boy in a closet as punishment for screaming during the assault, according to the lawsuit.

Jonathan Wright, 39, held up the T-shirt he was given when he first went to MacLaren Children’s Center in El Monte as an 8-year-old. He said he was sexually abused by a physician there.

“To this day, I hate being near doctors,” he said, sobbing.

Staff members often turned a blind eye to the assaults and misconduct at the facility, where children were routinely placed in solitary confinement, drugged and restrained in chairs, the lawsuit said.

(Editor’s note: This story includes discussion of sexual violence. If you or someone you know needs help, please call the National Sexual Assault Hotline at 1-800-656-4673.)

The Associated Press does not typically name victims of sexual assault unless they give their permission.

Octavia Evans said she was 12 when she was abused. She summoned the courage to report it to staff and said they took it to their boss — who was her abuser.

Now 36, Evans addressed any former MacLaren staff members who may have watched the news conference: “We were children, and we were trusting you to care for us — not hurt us.”

The lawsuit, filed Thursday in Los Angeles County Superior Court, seeks a jury trial and unspecified damages. It’s the second to be brought recently against the county in connection with the alleged sexual abuse of foster children at the facility, also known as MacLaren Hall.

The victims’ attorneys say they have more than 200 clients who claim they were abused at the facility. The lawsuit says that county officials in and out of the hall either knew or should have known of the abuse and failed to act.

“MacLaren Hall became a dumping-grounds for society’s most vulnerable, including minors without parents, or minors whose parents who were unable to care for them,” the lawsuit said. “Children were frequently removed from abusive homes and placed at MacLaren Hall only to be re-abused.”

The facility opened in 1961 and was overseen by the county’s probation department and then in 1976 was placed under the purview of the county Department of Children and Family Services. More than 20,000 kids passed through the hall before it closed in 2003.

A lawsuit was filed in May by eight women and four men, including one who was 5 in 1988 when he says he was assaulted by a male staff member in a bathroom.

Children and Family Services issued a statement declining to comment on the lawsuit but said the allegations “will be thoroughly examined.”

“Our department has many safeguards in place to protect children in our care and to hold accountable those who violate laws and policies,” the statement said.

MacLaren was shuttered in 2003 after the American Civil Liberties Union Foundation of Southern California and other organizations filed class-action lawsuits alleging inhumane treatment by staff and a failure to investigate abuse reports. An ACLU report described conditions as “Dickensian,” with children who were so neglected it amounted to “government sponsored child abuse.”

Los Angeles County settled the lawsuit with the ACLU and has paid settlements to some victims.

MacLaren failed to conduct background checks on staff prior to 2001. Once the checks were implemented, 17 staffers were found to have criminal histories that should have disqualified them from being hired, attorney Adam P. Slater said.

“It was medieval in the way it was run. ... MacLaren Hall had more in common with a child prison” than a safe place for children, Slater said.

The plaintiffs were able to file lawsuits because of a California law that took effect in 2020 and suspended for three years the statute of limitations for childhood sex abuse victims to bring cases.

The statute of limitations in California for filing certain felony sexual abuse charges runs out when a child victim turns 40. The sheriff’s department — which polices county facilities — and the district attorney’s office did not immediately respond to requests for comment on whether law enforcement has initiated any criminal investigations on behalf of MacLaren victims.

The victims’ attorneys say they are not aware of a criminal investigation involving MacLaren since the mid-1980s, when five employees were arrested on suspicion of child molestation and selling drugs to children, according to the lawsuit.

https://apnews.com/article/health-los-angeles-business-sexual-abuse-lawsuits-1312681a48a861b366b1bae222d647fc