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.

Jonna Lorenz

Investigators in Ireland have shed light on resistance to 

 with a recent study that screened the immune systems of women who were accidentally exposed to hepatitis C virus in the 1970s but didn’t develop the disease.

, included women who were exposed to anti-D immunoglobulin that was contaminated with HCV between 1977 and 1979. Those who remained seronegative had enhanced TLR3-type interferon response and increased inflammatory cytokine production compared with those who became infected.

“In this study, analysis of records from the women who received vials of highly infectious batches of HCV-contaminated anti-D, but remained PCR negative and antibody negative, suggest that up to 50% of women in the Irish cohort might be resistant to HCV infection,” wrote the study authors, led by Jamie A. Sugrue, a PhD candidate at Trinity College in Dublin. “This has major public health considerations; it is likely that HCV infectivity, as well as infectivity of other viral infections, is overestimated if individuals without a detectable antibody response are overlooked.”

Previous research estimated resistance to infection at about 10% among more diverse populations engaged in high-risk behaviors.

“A key point to emphasize is that our cohort is entirely female, and it is well documented that females have greater resistance to infection by several viruses, including HCV,” the authors noted.

The study included 34 women who were identified as exposed seronegative (ESN), who lacked evidence of past infection despite known exposure; 48 women who spontaneously resolved (SR) infection; 50 sustained virological responders (SVR) who had previous chronic infection that was cleared with therapy; and 102 unexposed controls.

With blood samples donated by 18 ESN participants and 36 seropositive participants, the investigators profiled antibodies against all known human viruses, using ELISpots to profile IFN-γ T cell responses to HCV peptides and VirScan to assess the history of viral exposure. Whole blood stimulation was performed to assess antiviral responses through cytokine analysis and NanoString transcriptomics.

“We describe an enhanced TLR3-type I interferon response in ESNs compared with seropositive women,” the authors wrote. “We also identify increased inflammatory cytokine production in response to polyIC in ESNs compared with seropositive women. These enhanced responses may have contributed to innate immune protection against HCV infection in our cohort.”

Anti-HCV Ab positivity was highest among women in the SVR group, and anti-HCV T cell responses were detected in the SR and SVR groups.

The authors noted increased reports of liver disease among those in the SVR group—66% compared with only 6% in the SR group and 3% in the ESN group. SR and SVR participants also reported higher incidence of chronic fatigue and fibromyalgia.

Strengths of the study included that participants were well matched—all female, all Rhesus D negative, similarly aged, and had all been pregnant. However, the study results may not be generalized to the wider population

“Our findings of increased resistance among females have major public health implications,” the study authors wrote. “Our biological findings reaffirm the importance of IFN-I in the control of viral infection and begin to provide evidence that heterogeneity in the human immune response has real world effects that may translate to differential susceptibility to infection.”

The lab of Cliona O’Farrelly, professor of comparative immunology at Trinity’s School of Biochemistry and Immunology and 

, will now focus on resistance to other viral infections, including COVID-19. The lab has joined the COVID Human Genetic Effort.

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Resistance to hepatitis C infection may be much greater than previously thought, according to new research by investigators at Trinity College Dublin that revealed associated biological factors.

Type I Interferon Response Linked to Resistance to HCV Infection


Monoclonal antibody (mAb) treatment for COVID-19 seems safe during pregnancy, according to a new study that found that adverse events after mAb treatment were mild and rare, but effectiveness was disappointing.

The retrospective, propensity score-matched, cohort study, published in 

, included 944 pregnant participants positive for SARS-CoV-2 infection enrolled at the University of Pittsburgh Medical Center Health System from April 30, 2021, to January 21, 2022.

Investigators evaluated monoclonal antibody treatment with bamlanivimab and etesevimab, casirivimab and imdevimab or sotrovimab compared with no mAb treatment.

“Importantly, mAb treatment seems safe in pregnancy with respect to drug-related adverse events and obstetric-associated outcomes (that is, gestational age at delivery, birthweight, stillbirth, NICU admission, hypertension, severe maternal morbidity, and maternal ICU visit),” the study authors, led by Erin K. McCreary, PharmD, of the University of Pittsburgh School of Medicine, wrote.

Median age was 30 and 79.5% of participants were white. Median gestational age at COVID-19 diagnosis or treatment was 179 days, 69% received sotrovimab, and 62% were fully vaccinated.

Mild drug-related adverse events were reported in eight (1.4%) patients treated with mAb, and no severe reactions related to mAb infusions were reported. Average gestational age at delivery was the same (273 days) among those who received mAb treatment and those who were untreated. Average birthweight was 3290 grams in the treatment group and 3240 among those untreated. There were no deaths in the treatment group and one among those untreated.

“In pregnant persons with mild to moderate COVID-19, adverse events after mAb treatment were mild and rare,” the study authors wrote. “There was no difference in obstetric-associated safety outcomes between mAb treatment and no treatment among persons who delievered.”

The study found no significant differences in COVID-19 outcomes between those treated with mAb and those untreated based on a composite of hospitalizations, emergecy department visits or mortality at Day 28.

“In the total population, the risk ratio for mAb treatment of the composite 28-day COVID-19–associated outcome was 0.71 (95% CI, 0.37 to 1.4). The propensity score-matched risk ratio was 0.61 (95% CI, 0.34 to 1.1),” the authors noted.

The study authors noted that the frequency of hospitalizations and deaths were lower than those of the general population, potentially reflecting the younger age, fewer comorbidities and high rate of vaccination of the study group.

“The neutral finding from effectiveness models may be due to the sample size of the cohort or the absence of a true treatment effect,” the authors wrote.

The study couldn’t evaluate risk-adjusted outcomes for pregnant people with higher risk for COVID-19 complications such as comorbidities or unvaccinated status.

More patients in the treatment group (14, or 2.5%) were hospitalized for non-COVID-19-related issues than in the untreated group (2, of 0.5%), but there was no difference in the propensity-matched cohort.

Limitations of the study included the possibility of underrepresentation of drug-related adverse events, which were patient and parovider reported.

 conducted at Yale University School of Medicine also found that sotrovimab was safe and well-tolerated among pregnant people and neonates.

A recent study by investigators at the University of Pittsburgh School of Medicine found few mild adverse events from monoclonal antibody treatment among pregnant people with COVID-19, but no difference in COVID-19 outcomes.

Monoclonal Antibody Treatment for COVID-19 in Pregnant People Seems Safe

The European Commission approved Sanofi and GlaxoSmithKline’s COVID-19 booster vaccine VidPrevtyn Beta, the first next-generation, protein-based adjuvanted COVID-19 booster approved in Europe, for use in adults age 18 and older.

The vaccine includes the Beta variant antigen and GSK’s pandemic adjuvant and is indicated for adults who have previously received an mRNA or adenoviral vaccine.

“Today’s approval validates our research in developing a novel solution for the COVID-19 pandemic,” Thomas Triomphe, executive vice president, vaccines for Sanofi, 

. “As we’re ready to start first shipments, VidPrevtyn Beta will be an important new option to protect propulations against multiple strains of COVID-19.”

Earlier this year, Sanofi and GSK announced 

positive results from two immunobridging trials

 of their booster–the VAT02 Immunogencity & Safety Study and the COVIBOOST (VAT013) study.

The studies showed that VidPrevtyn produced 15-fold antibodies against the D614 parent virus of COVID-19 and 30-fold against the Beta variant when used as a booster in adults with prior mRNA vaccinations.

Against the Omicron BA.1 variant, VidPrevtyn showed a 40-fold increase in antibody titers. Neutralizing antibodies were doubled compared to the booster vaccine based on the original parent COVID-19 virus against Omicron BA.1 and BA.2.

The COVIBOOST study was conducted by the Assistance Publique—Hôpitaux de Paris (AP-HP) included 247 adults aged 18 to 73.

The VAT02 showed that adverse events were mostly mild to moderate, transient and self-resolutive.

The VAT08 Stage 2 Efficacy & Safety Study found 64.7% efficacy against symptomatic SARS-CoV-2 infection, regardless of any prior infection and 75.1% efficacy among those who were previously infected with SARS-CoV-2.

“This EC approval is an important step in providing further vaccine solutions to Europe for the coming winter,” Philip Dormitzer, MD, PhD, global head of research and development, vaccines, at GSK, said in a statement. “Our protein-based, adjuvanted vaccine candidate has the potential to make an important contribution to public health as the pandemic evolves futhers.”

European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) 

 of the booster based on sufficiently robust data on the quality, safety and immunogenicity of the vaccine. The studies found the VidPrevtyn booster to be at least as effective as the Pfizer-BioNTech vaccine at restoring protection against COVID-19.

The most common adverse events were usually mild and cleared up after a couple of days, including pain at the injection site, headache, muscle or joint pain, feeling generally unwell and chills.

CHMP determined that a standard marketing authorization is appropriate for VidPrevtyn Beta after concluding that the benefits of the vaccine outweigh the potential risks.

VidPrevtyn Beta will continue to be monitored for safety and effectiveness.

U.S. federal funds from the Biomedical Advanced Research and Development Authority (BARDA), Administration for Strategic Preparedness and Response at the U.S. Department of Health and Human Services supported the studies of VidPrevtyn in collaboration with the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and the National Institute of Allergy and Infectious Diseases (NIAID).

Other companies continue advancing development of COVID-19 boosters, including 

, heterologous booster that recently began enrolment for phase 3 clinical trials and initiation of rolling submission to the Therapeeutic Goods Administration in Australia for provisional approval.

Sanofi and GlaxoSmithKline are the latest companies to bring their COVID-19 booster vaccine to the marketplace with the European Commission’s approval of VidPrevtyn Beta.

European Commission Approves Sanofi-GSK COVID-19 Booster VidPrevtyn

The use of face masks in schools during the COVID-19 pandemic has been shown to reduce the spread of disease but also has been controversial. A recent study provided evidence against one possible drawback, showing that children wearing face masks are not more likely to touch their faces than those without face masks.

The Back-to-School COVID-19 Simulation Trial, published in 

, included 174 children, aged 5-18 years, at 2 schools in Toronto and evaluated whether wearing a face mask affected hand-to-face contact at a simulated school environment in August 2020.

“In this clinical trial of simulated school attendance, hand-to-face contacts did not differ among students required to wear face masks vs students not required to wear face masks; however, hand-to-mucosa contacts were lower in the face mask group,” the study lead author, Michelle Science, MD, MSc, of the Hospital for Sick Children in Toronto, wrote. “This suggests that mask wearing is unlikely to increase infection risk through self-inoculation.”

The students were divided into 2 groups, with 1 group instructed to bring their own mask and wear it at all times and the other group not required to wear a mask. The investigators evaluated the number of hand-to-face contacts per student per hour on the second day of the 2-day trial.

Investigators monitored the students with 4 cameras in each classroom, assessing 2 60-minute periods—1 in the morning and 1 in the afternoon. A single trained coder assigned to each grade range assessed video footage to record hand contacts with mouth or nose, eyes, glasses, other parts of the face, center of the mask, side or ear loops of the mask along with putting on and taking off the mask.

Investigators found no statistical difference in hand-to-face contacts, with 88.2 contacts per student per hour in the mask group and 88.7 in the control group (rate ration, 1.00; 95% confidence interval, 0.78-1.28; P value = >.99). The study also found:

Hand-to-mucosa contacts were significantly lower in the mask group, with 4.2 contacts per hour compared with 26.8 in the control group (RR, 0.12; 95% CI, 0.07-0.21).

Hand-to-nonmucosa contacts were higher in the mask group, with 84.4 contacts per hour compared with 58.1 in the control group (RR, 1.40; 95% CI, 1.08-1.82).

Hand-to-mask contacts in the mask group were 60.3 per hour.

Masks were removed 102 times in the mask group, for a rate of 0.6 removal per student per hour.

Based on previous studies, the investigators expected to see 30 hand-to-face contacts per hour but were surprised that the rates of hand-to-face touches were nearly 3 times higher.

“This suggests an underestimation in previous studies using less sensitive methods for outcome ascertainment,” the authors wrote.

“These findings have important public health implications,” the authors wrote. “Wearing a face mask did not lead to increased hand-to-face contact, but were associated with reduced hand-to-mucosa contact, which may add protection.”

The authors concluded that the benefits of face masks for infection prevention in children outweigh any potential infectious risks and emphasized the importance of hand hygiene in schools.

Limitations of the study included that coders could not be blind to treatment allocation and the study didn’t include children who require additional resources such as those with medical needs. Some students in the control group wore masks for variable periods of time, but sensitivity analyses removing those who didn’t adhere to their allocation for more than 70% of the time didn’t change the results.

Previous studies have shown that face mask wearing was linked to 

The benefits to children of wearing face masks to prevent COVID-19 outweigh potential infectious risks from face touching, according to a study analyzing hand-to-face contact in a simulated school environment.

Wearing Masks Didn’t Increase Face Touching Among Kids in Simulated School Study


Vaxxinity’s COVID-19 vaccine UB-612 is advancing toward becoming a heterologous booster with enrollment in a Phase 3 clinical trial completed and initiation of a rolling submission to the Therapeutic Goods Administration in Australia for provisional approval.

The Dallas-based company expects to release 

 by the end of the year for the vaccine, which is the first multitope protein/peptide-based vaccine candidate for SARS-CoV-2, designed to activate both B and T-cell responses.

“The potential advantages include well-tolerated safety profile, longer durability, broad coverage across new mutations, and easier distributability,” Ulo Palm, MD, PhD, chief medical officer of Vaxxinity, told 

. “Our goal is to serve the underserved and ensure no one is left behind with a vaccine that we’d choose for our own loved ones.”

The announcement of a rolling submission for provisional approval in Australia follows a similar 

 in September of a rolling submission to the Medicines and Healthcare Products Regulatory Agency in the United Kingdom.

The phase 3 trial, which began earlier this year, is designed to compare the safety and immunogenicity of UB-612 as a heterologous booster dose with a homologous booster with the same vaccine used in the primary series. The study includes about 1000 participants aged 16 and older who have received a primary series of vaccines from Oxford-AstraZeneca, Pfizer-BioNTech, Sinopharm or Sinovac.

Phase 1 and 2 trials of UB-612, which included about 4,000 participants, showed the vaccine was well-tolerated with no serious vaccine-related adverse events and elicited antibody titers comparable to authorized vaccines.

 a booster dose of the vaccine increased neutralizing antibody levels against ancenstral SARS-CoV-2 along with the Omicron BA.1 and BA.2 subvariants by 131-, 61- and 49-fold respectively. Investigators predicted the vaccine’s efficacy against the original SARS-CoV-2 strain at 95%.

“The receptor-binding domain (RBD)- and spike (S) protein-binding IgG antibodies after booster immunization with UB-612 produced high cross-reactivity against multiple SARS-CoV-2 variants, including Alpha, Beta, Delta, Gamma and Omicron, similar to those of approved vaccines and boosters,” Palm said.

UB-612 contains a subunit RBD protein of the spike protein linked to a single chain fragment region of a human IgG1. It also includes five synthetic peptides with epitopes derived from S2, M and N proteins designed to promote B-cell and CD8+ T-cell memory responses. The vaccine includes an aluminum phosphate adjuvant.

“Unlike the first generation COVID-19 vaccines that are based on mRNA, adenovirus, or subunit platforms, UB-612 has an innovative manufacturing platform based on the combination of a subunit protein and a synthetic protein,” Palm said. “This unique combination allowed us to expand the antigenic composition of UB-612 to several other structural proteins in addition to the Spike, which is expected to provide protection through both T- and B-cell immune responses.

“The antigenic composition of UB-612 is designed to restore the protective level of the pre-existing immune responses stimulated by the primary immunization with COVID-9 vaccines. Unlike the existing vaccines, UB-612 recalls only the B-cells specific to the RBD, the key antigenic determinant responsible for stimulation of more than 90% of all SARS-CoV-2 neutralizing antibodies.”

Further research will determine whether UB-612 may offer a more long-lasting response as a booster to authorized vaccines. Immunity has been shown to wane quickly after vaccination with authorized vaccines.

“The most striking finding in the clinical trials was the induction of long-lasting virus- neutralizing antibodies, with the half-life estimated to be over 180 days after the second immunization,” Palm said.

UB-612 can be stored for 24 months at 35 to 46 degrees Fahrenheit, making it easier to transport and store than some vaccines, which could potentially improve vaccine accessibility to make low- and middle-income countries.

The phase 3 study is co-sponsored by the Coalition for Epidemic Preparedness Innovations (CEPI) with up to $9.25 million in funding.

Vaxxinity is moving forward with research to bring its UB-612 COVID-19 vaccine to market as a mix-and-match booster to authorized vaccines.

Phase 3 Trial of Vaxxinity’s COVID-19 Vaccine as a Heterologous Booster Advances


Three months after symptomatic COVID-19 infection, 6.2% of patients had persistent cognitive or respiratory problems or fatigue in 2020 and 2021, a new study found.

, included data from 54 studies and two medical record databases on 1.2 million individuals from 22 countries with symptomatic SARS-CoV-2 infections. Investigators with the Global Burden of Disease Long COVID Collaborators group analyzed the proportion of symptomatic COVID-19 patients who had at least one of three clusters of long COVID symptoms three months after infection.

“Importantly, we have anchored our estimates on the difference between those having experienced a SARS-CoV-2 infection and those not; or by comparing people rating symptoms before and after they had COVID-19,” Theo Vos, PhD, of the Institute for Health Metrics and Evaluation at the University of Washington, told

. “As all these symptoms are common, not correcting would lead to overestimation.”

After adjusting for health status before infection, they found that 6.2% of patients had persistent symptoms, including 3.7% with respiratory problems, 3.2% with persistent fatigue, pain or mood swings, and 2.2% with cognitive problems three months after infection.

“Long COVID is fairly common among those with symptomatic COVID-19; twice more common in women than men and children at half the risk of adult males (and thus a quarter of risk in adult women),” Vos said.

Severe infection, particularly hospitalization in the ICU, was associated with a greater risk for long COVID and for a longer duration of symptoms.

“Multiplying these risks with the large numbers of infections in the world means that in 2020 and 2021 close to 150 million people were affected by these common symptom clusters of long COVID,” Vos said.

The study likely undercounted the proportion of people affected by prolonged symptoms because it didn’t cover the full spectrum of symptoms and missed people with less severe symptoms that didn’t interfere with normal activities, he said.

Women were more likely than men to experience at least one of the three long COVID clusters, which affected 10.6% of women age 20 and older and 5.4% of men age 20 and older. Only 2.8% of patients younger than 20 were affected.

The average duration of symptoms was nine months. Among those experiencing symptoms three months after infection, 15.1% continued to experience symptoms a year after infection.

“While we estimate that majority of cases recover within a year, it still leaves many persons with ongoing symptoms,” Vos said. “Information is not yet there to determine the course of their symptoms beyond 1 year.”

The investigators will update the findings, taking into account research suggesting that the Omicron variant of SARS-CoV-2 was less likelyto lead to long COVID and that vaccination and prior infection provided some protection.

“Countries should prepare to appropriately provide recognition and care for people with long COVID symptoms and (in due time) support those on the path to recovery with support to return to work/school,” Vos said.

Nearly 150 million people were affected by common symptoms of long COVID in 2020 and 2021, according to an analysis of global data on more than 1.2 million people.

Jonna Lorenz

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