Category: Covid-19 Vaccine

Pfizer-BioNTechs COVID-19 vaccine was highly effective in preventing severe COVID-19 infections in children and adolescents during the Delta and Omicron variants, according to a large, national study recently published in the Annals of Internal Medicine.

According to the Centers for Disease Control and Prevention, more than 15.6 million U.S. children were reported to have tested positive for COVID-19 since the onset of the pandemic and the age group represents less than 1 percent of total COVID-19 deaths.

Vaccination rates among children vary widely by state, according to the American Academy of Pediatrics, ranging from 3 to 45 percent having received their first dose.

The new study included data from more than 200,000 young people from childrens hospitals around the country during the Delta and Omicron waves of the pandemic. During the Delta wave, the BNT162b2 vaccine was found to be more than 98 percent effective against infection in children under 18 compared to those who were unvaccinated, according to the study. During Omicron, effectiveness against documented infection among children was estimated to be 74 percent compared to unvaccinated counterparts.

The BNT162b2 vaccine was most effective in preventing severe COVID-19 infections and hospitalizations, according to the study. Investigators found no significant side effects of the vaccine, but did find that vaccine effectiveness waned over time, especially during the Omicron period of the pandemic.

The results show that the BNT162b2 vaccine was a safe and effective way to prevent COVID-19 and the complications that can come with a serious infection, said Ravi Jhaveri, MD, division chief and the Virginia H. Rogers Professor of Infectious Disease in the Department of Pediatrics, who was a co-author of the study.

The main takeaway is an important result that comes up in virtually every study thats done on this: vaccination has a really powerful protective effect against COVID-19, Jhaveri said. There may be subtle differences depending on what variant and what era youre looking at, but the bottom line is that for children, theres a really powerful effect.

Moving forward, Jhaveri hopes to study the effectiveness of vaccines in preventing long COVID in children, he said.

What we want to do is to better define the protective effects of vaccines for post-COVID syndromes, including the long COVID fatigue and the multi-system, inflammatory syndrome that we saw in children, Jhaveri said. Were really working hard to try to see if we can show that the vaccine protects against those sequelae.

The study was funded by the National Institutes of Health and the RECOVER: Researching COVID to Enhance Recovery initiative.

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COVID-19 Vaccines Highly Effective for Children During Delta and Omicron Waves, Study Finds - News Center - Feinberg News Center

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A Case of Combination of IgA Nephropathy and Interstitial Nephritis After COVID-19 Vaccination - Cureus

In a recent study published in the journal JAMA Pediatrics, researchers carried out a large cohort study to investigate the association, if any, between in-utero exposure to COVID-19 vaccination and subsequent neurodevelopmental delay in infants. The cohort comprised 2,261 and 1,940 babies ages 12 and 18 months, respectively, with the Ages and Stages Questionnaire used to assess neurodevelopment rates across five parameters. Mixed-effects logistic modeling of results failed to find significant differences between observed and expected neurodevelopmental rates, highlighting the safety of COVID-19 vaccines administered during pregnancy on the neurological health of offspring.

Study:In Utero Exposure to Maternal COVID-19 Vaccination and Offspring Neurodevelopment at 12 and 18 Months.Image Credit:Prostock-studio/ Shutterstock

The coronavirus disease 2019 (COVID-19) pandemic represents an unprecedented loss of human life and economic collapse. Since its emergence in Wuhan, China, in late 2019, the virus has been responsible for a death toll of nearly 7 million, with more than 700 million individuals infected thus far. The medical and scientific panic induced by the pandemic spurned intensive research for a means to combat the disease, either by curing it or preventing its acquisition/transmission, resulting in the rapid development of anti-viral vaccines against the conditions causative pathogen the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Despite extensive fast-track preclinical trials of prospective vaccines, a focal risk group, namely pregnant women, was excluded from large-scale clinical trials due to mounting concerns over the negative impacts of vaccines on mothers and their to-be offspring. Even now, following the acute pandemic phase, little literature is available on the outcomes of during-pregnancy vaccinations for the next generation.

Sources of vaccine hesitancy include unknown risks to the fetus. Although a popular concern linking childhood vaccination and risk of autism spectrum disorder has been debunked, misinformation persists.

A popular argument against maternal vaccination is potential developmental issues with their offspring, with neurodevelopmental disorders the most often cited. Historically, vaccinations against influenza and rubella have been observed to have long-term, often life-long, adverse impacts on the neurological and psychiatric health of individuals with in-utero exposure. The trickle-down effect of this vaccine hesitancy is arguably the most significant factor in the dearth of knowledge and overabundance of misinformation regarding vaccination reception during pregnancies.

Despite being poorly studied in the context of COVID-19 vaccinations, neurodevelopmental disorders have been well-characterized. The term refers to a cohort of behaviorally defined conditions typically characterized by the early emergence of cognitive, language, motor, or social development abnormalities.

A range of genetic and environmental factors may underlie neurodevelopmental disorders, and fetal exposure to maternal inflammation represents a potential source of risk that has found increasing support from converging lines of epidemiologic and animal model evidence.

In the present study, researchers used data from a large prospective study representative of the United States of America (US) and Puerto Rico, comprising 2,487 mothers and 4,201 infants. Methodologies and outcomes are reported using the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guidelines. Participant recruitment was conducted between May 2020 and August 2021 and initially comprised 7,880 individuals. Study inclusion criteria included age (above 18 years) and questionnaire completion status.

Data collection comprised demographics (including self-reported ethnicity), medical history (including SARS-CoV-2 infection status), vaccination status (including type of vaccine received and number of booster doses), and three questionnaires. The Ages and Stages Questionnaire, third edition (ASQ-3), was used to measure the infants outcomes of interest five parameters encompassing the five neurodevelopmental subdomains: 1. Communication, 2. Fine motor, 3. Gross motor, 4. Social-, and 5. Problem-solving skills. The Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder (GAD-7) questionnaires were used to measure maternal outcomes.

Vaccination, either with mRNA vaccines or viral-vector vaccines, was considered the study exposure. Mixed-effects logistic regression models constituted statistical analyses and were used to reveal the relationship between vaccination and subsequent neurodevelopment.

Of the 7,780 participants who initially enrolled in the study, 2,487 met the inclusion criteria and were included in the analyses. Most participants identified as White (89.3%) with a mean age of 33 years. 68% of participants reported receiving vaccinations during their pregnancy, 76.2% of which were mRNA vaccinations.

Notably, this study could not reveal any association between in-utero COVID-19 vaccine exposure and subsequent adverse neurodevelopment (stunted or delayed) outcomes. Encouragingly, neither offspring nor their mothers were found to experience any unexpected neurological outcomes, even when adjusting models to account for demographics and medical histories. SARS-CoV-2 infection status was also observed to have no significant bearing on the rate of neurodevelopment.

These findings highlight the importance of ongoing extensive prospective studies, especially in newborns and infants, to improve real-time mother and child care.

As our basic science colleagues tease out the dynamic mechanistic underpinnings of in-utero exposures, together we can transform these early data into knowledge to promote the health and well-being of our communities.

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Study confirms safety of COVID-19 vaccination during pregnancy for infant neurodevelopment - News-Medical.Net

Americans look to you as the highest public health official in the land; it would speak volumes if, in addition to other actions, you appealed directly to residents and their family members, Katie Smith Sloan, president of industry group LeadingAge, wrote in a Dec. 22 letter to Becerra.

More than 170,000 nursing home residents have died since Covid arrived four years ago. But after the all-hands-on-deck effort to vaccinate elderly people in 2020 and 2021, Americas most vulnerable citizens are now largely on their own.

Sloan gave Becerra a to-do list to help the homes: allow them to make small vaccine orders that fit slackening demand, enlist hospitals in the vaccination campaign, permit the industry to bill Medicare more for administering the shots, and come up with a message that works.

A day later, at the second meeting, Becerra didnt offer new aid, but did reiterate the federal rules requiring homes to offer vaccines.

Weve chased down all these to-do items for three years running I dont think theyve had the impact, one senior administration official, granted anonymity to discuss the administrations response, said of the nursing homes demands. The person said the agency would examine the latest requests and continue to work with the industry, but was skeptical it would radically change the outcome even if the administration acceded to them.

I dont think this letter with the items in it, even if we checked off every box, would all of a sudden, magically change the vaccination rate, the official said.

Nursing home residents, because of their age and underlying conditions, are particularly vulnerable to Covid-19.

When the first Covid shots arrived in nursing homes late in 2020 in government-run clinics, almost every resident chose vaccination a massive relief, given the outsize death toll in the homes to that point.

[The administration] had the major pharmacies that were on board. They brought the clinics to the nursing homes and by and large, the residents received their vaccines, David Grabowski, professor of health care policy at Harvard Medical School, recalled.

But that success has faded along with the broader vaccination campaign.

Theres no clear answer why, but two shifts have likely contributed, according to industry and government leaders.

First, interest in vaccination has declined as they proved unable to halt transmission, as have disagreements over who needs an annual shot even as theres consensus among experts that elderly people do.

Second, the administration stopped buying and managing distribution of the shots starting with the rollout of the updated vaccine last September.

The move coincided with the administrations decision to end the public health emergency, which justified the move to shift responsibility to insurers, pharmacies, doctors offices and the other private health care organizations that manage other vaccinations.

For nursing homes, that means they have to source the shots and manage how theyre given, creating logistical and reimbursement challenges.

Though government and industry leaders agree that a number of other factors could also be at play, the result is clear: Only 38 percent of nursing home residents have gotten the most recent shot a significant drop from the initial vaccination campaign.

Theres a wide variation among states. Both North and South Dakota report more than 60 percent of nursing home residents are vaccinated whereas only 20.1 percent of Arizona nursing home residents are.

And Covid continues to claim lives in the homes nearly 600 residents died in the first two weeks of 2024. As of Jan. 14, more than 14,700 Covid-19 cases were confirmed among nursing home residents since the start of winter a much lower rate of cases than in previous years.

People in the administration point to discrepancies across states as reason to believe providers could do more.

At some homes, most residents are vaccinated, at others almost no one, leading Becerra to remind nursing home executives that they are legally required to at least offer shots to their residents.

We know they can do it, the administration official said. Better is possible.

And the administration can point to facilities, such as those in the Dakotas, that have vaccinated most of their residents.

Its absolutely about that trust, said Dr. Jeremy Cauwels, who oversees the Good Samaritan Society, South Dakota-based Sanford Healths long-term care provider.

He said yearslong relationships with patients were powerful enough to overcome vaccine skepticism. In some Sanford-owned facilities, he said uptake is over 90 percent.

Sloan acknowledged that some homes are doing a better job than others in vaccinating residents more than half of residents at LeadingAge facilities have had the latest shot indicating that the facilities can help boost trust.

But she also said she has noticed the administration doing less to persuade Americans to get vaccinated than it did in the past.

One of the things that we talked to the secretary about was really the role that HHS in particular can play in using its bully pulpit as the primary public health communicator in the country, Sloan said. That, to me, is a huge, huge role.

Centers for Disease Control and Prevention Director Mandy Cohen told POLITICO in October that getting nursing home residents vaccinated was a top priority for her agency given the risk they face.

Leading up to this virus season, and throughout the fall, CDC worked with other federal agencies, state and local health departments, and health care partners to address vaccine access issues and encourage uptake. We expect to see improvement, an agency spokesperson wrote in an email.

But some in the administration also said that its appropriate that the shift from a government-run distribution system to one managed by the private sector should also mean a shift away from the governments pandemic role promoting vaccination.

There was some thought that maybe it might be better if the messaging came from the manufacturers and from private entities, the senior official said, believing that the hard sell from the administration was merely reinforcing vaccine skepticism in some communities.

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Covid killed 170000 in nursing homes. Most residents still haven't gotten the latest shot. - POLITICO

In a recent article published inBMC Public Health,researchers analyzed the association between time-varying coronavirus disease 2019 (COVID-19) vaccination rates and COVID-19 case-hospitalization risk (CHR), a proxy for disease severity at an individual level and disease burden on healthcare systems at the population level across various severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant waves in the United States (U.S.).

Study:Association between vaccination rates and COVID-19 health outcomes in the United States: a population-level statistical analysis. Image Credit:Nhemz/Shutterstock.com

There were 1.1 million deaths in the U.S. due to COVID-19 by 1 March 2023. COVID-19 vaccines most effectively curbed the disease and its impact, including the socioeconomic burden on the country's people and health care system.

However, studies evaluating the effectiveness of COVID-19 vaccines relied upon individual-level data confounded by unquantified factors and inconsistent quality.

So, for the U.S., high-resolution data was unavailable at the population level, reflecting the real-world relative associations between available COVID-19 vaccines and COVID-19 CHR over time.

The present study used Generalized Additive Models (GAMs) to investigate the relationship between COVID-19 vaccination rates and CHR in 48 U.S. states between 19 April 2021 and 1 March 2022.

The study model captured nonlinear dynamics, accounting for dynamic (time-changing) and static (temporally constant) factors potentially contributing to COVID-19 CHR and disease transmission.

The former were natural immunity derived from previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, government policies, activity-related engagement levels in the population, and local healthcare infrastructure.

In contrast, the latter comprised the social vulnerability index (SVI), race/ethnicity, comorbidities, and healthcare expenditures of each state, considered significant in previous studies.

Additionally, the model reported COVID-19 case incidence rates (CIR) as a distinct outcome variable. The study framework used a variable transformation method to capture the spatial variations in relative associations.

The study period spanned the pre-Delta, Delta, and Omicron waves of COVID-19, and they evaluated all of these independently in this study.

The study results point to several key findings concerning population-level COVID-19 vaccine effects in the U.S.

The GAMs using relative COVID-19 CHR (RCHR) as an outcome variable showed deviance explained values between 46.8% and 72.3% for variant waves.

Moreover, the correlation between observed and predicted RCHRs displayed strong positive correlations ranging from 0.67-0.81.

Population-level vaccination was significantly associated with reduced COVID-19 CHR.

Intriguingly, past SARS-CoV-2 infections (one to four months old) displayed robust negative associations with RCHR across different waves; however, this effect remained variable and inconsistent at both individual and population levels.

Activity-related engagement levels in the population (e.g., gym visits), government policies, and local healthcare infrastructure added to the explanatory power of the study model, favoring the significance of considering these on population-level outcomes of COVID-19 vaccines.

However, their associations were inconsistent over time and across different variants. For instance, the association between COVID-19 CHR and hospital visits transitioned from negative to positive between the pre-Delta to Delta and Omicron waves.

Moreover, the observed correlation between the relative weekly testing rate and RCHR was negative and decreased from the pre-Delta wave to the Omicron wave.

Additionally, U.S. states with higher SVI consistently showed higher RCHR, and Medicaid spending per person showed a consistent negative association with RCHR.

The GAMs using RCIR as the outcome variable demonstrated lower performance, suggesting a more dynamic relationship concerning COVID-19 transmission, particularly during the Omicron wave.

The deviance explained for Model Omicron-Booster-RCIR was 17%, suggesting that booster vaccination conferred additional protection against severe COVID-19 during the Omicron waves. However, their effect on Omicron infection itself was limited.

The study provides robust evidence of the efficacy of COVID-19 vaccines against COVID-19 CHR across various variant waves in the United States.

Despite the emergence of new variants, vaccines remained effective and remarkably mitigated adverse outcomes of COVID-19 and its socioeconomic burden on healthcare systems. Thisdata could help inform future public health policies in the U.S.

Future studies should identify other factors that may capture the dynamics of COVID-19 transmission during the Omicron period.

Furthermore, studies should investigate the complex and evolving nature of COVID-19 transmission.

Read more:

Effects of varying COVID-19 vaccination rates on population-level health outcomes across variant waves in the U.S. - News-Medical.Net

The coronavirus disease 2019 (COVID-19) pandemic increased the risk of severe disease and death in multiple categories, including very young infants and pregnant women. The rollout of effective vaccines in late 2020 was posited to prevent severe disease and death, even after acute infection. During this time, vaccination was advised in pregnancy to protect both mother and baby through the transplacental delivery of the antibodies.

However, the differences in protection conferred by maternal COVID-19 vaccination among preterm and full-term babies remain unclear. A new study published in JAMA Network Open reports on the levels of maternal-origin antibodies to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in preterm babies.

Study:Timing of Maternal COVID-19 Vaccine and Antibody Concentrations in Infants Born Preterm. Image Credit: SciePro / Shutterstock.com

COVID-19 vaccines have successfully reduced the number of serious illnesses and deaths related to the disease during pregnancy. With vaccination, outcomes like hospitalization, admission to the intensive care unit (ICU), and deaths have significantly declined from the increased rates observed with COVID-19 in pregnancy.

Prior research indicated that vaccinated pregnant women have a lower risk of illness, hospitalization, admission to critical care units (CCUs), stillbirths, and neonatal death as compared to non-vaccinated pregnant women. The antibodies induced by the vaccine are primarily targeted against the viral spike antigen and cross the placenta through active transfer.

Fetal blood contains steadily increasing concentrations of maternal immunoglobulin G (IgG) antibodies transferred across the placenta from 10% of maternal concentrations by mid-pregnancy to 50% by 28-32 weeks. Maternal vaccination against COVID-19 may protect the baby against severe COVID-19; however, there remains a lack of data confirming that maternal vaccination provides sufficient levels of protective anti-spike antibodies in preterm deliveries.

The current study aimed to measure and compare anti-spike antibody levels in cord blood samples from preterm and full-term deliveries with maternal blood samples. To this end, the current study comprised a prospective cohort of pregnant women from whom blood samples were collected, along with cord blood samples from their newly delivered infants between February 2021 and January 2023.

All participants had two or more doses of a messenger ribonucleic acid (mRNA) COVID-19 vaccine prior to delivery. None of the study participants had current or prior COVID-19.

Of the 220 participants, with a median age of 34, there were 36 and 184 preterm and full-term deliveries, respectively. Over 80% of the study participants were White, 12% Asian, and 2% and 6% were Black and Hispanic, respectively.

Women who delivered preterm had a higher body mass index (BMI) value of about 32 as compared to 30 for those who delivered full-term. Women with higher BMI values were also associated with an increased risk of diabetes prior to conception, pre-eclampsia, and chronic hypertension.

The median gestational age for preterm infants was 35 weeks as compared to 39.5 weeks for full-term infants. About 66% of preterm infants were delivered through Cesarean section as compared to 33% of full-term infants.

About 120 and 100 women received two or three vaccine doses each, respectively, before delivery. Among those who delivered preterm infants, about 70% had three or more vaccine doses, compared to 40% for full-term infants.

The time from the last vaccine dose to delivery was about 16 weeks, with the median gestational age at the time of the last dose being 25 weeks for both preterm and full-term pregnancies.

The concentration of anti-spike antibodies in maternal blood was 674 with two doses and more than 10-fold higher at 8,169 with three or more doses. The corresponding concentrations in cord blood samples were 1,000 and about 10,000, respectively.

Maternal blood antibody concentrations were higher in pregnancies that ended prematurely as compared to full-term deliveries. However, cord blood antibody levels were lower in preterm infants, which led to a lower cord-to-maternal antibody ratio in preterm deliveries.

This difference between pregnancies ending in full-term and preterm deliveries was not observed for either maternal antibody levels or cord-to-maternal blood antibody ratios after adjusting for the time of pregnancy at which vaccination was performed. The peak ratio was observed at about 10 weeks from the last vaccine dose.

When adjusted for the time of vaccination and number of vaccine doses, there was no association between preterm delivery and antibody levels.

Cord blood antibody levels in infants born to women who received at least three doses of a COVID-19 mRNA vaccine were ten times higher than in infants born to women who received two doses. Nevertheless, this finding did not correlate with gestational age at the time of delivery. Furthermore, there was no significant difference in antibody levels in cord blood between preterm and full-term deliveries.

While the association of three or more vaccine doses with higher antibody concentrations has been previously reported, this is the first time that it has been compared between preterm and full-term infants.

Despite lower antibody transfer ratios in preterm infants, an increased number of vaccine doses before delivery could improve the final concentration of cord blood antibodies. Thus, it is recommended that the booster dose be administered before the third trimester in women at risk for preterm delivery, while others may receive it approximately 10 weeks before the estimated date of delivery.

Maternal antibody concentrations appeared more important than delivery gestational age in determining cord antibody levels.

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Maternal COVID-19 vaccination equally benefits preterm and full-term babies - News-Medical.Net

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As the COVID-19 pandemic raged throughout the country in 2020, politics, memes and public messaging converged to dramatically influence individuals' decisions regarding the in-development COVID vaccines, according to a new article by researchers at the University at Albany's Massry School of Business and Washington State University's Carson College of Business.

In "Reexamining health messages in the political age: The politicization of the COVID-19 pandemic and its detrimental effects on vaccine hesitancy," published in the Journal of Consumer Affairs, authors Ionnis Kareklas, Devipsita Bhattacharya, Darrel D. Muehling and Victoria Kissekka examine how voters' political leanings informed their decision to receive a COVID-19 vaccine.

"We explore how radically opposing viewpoints regarding the pandemic may have eroded public trust in government institutions and health science during the months leading up to the 2020 U.S. presidential election," said Kareklas, associate professor and chair of Marketing at UAlbany, who led the investigation.

The authors also reviewed how memes on social media played a role in affecting viewers' attitudes toward health care, especially whether they would get a COVID-19 vaccine. Analysis of the researchers' data revealed that survey respondents relied heavily on social media to get trustworthy vaccine information, yet most vaccination-related memes were anti-vaccine.

Along with survey data, Kareklas and his team analyzed 18,000 tweets containing pictures of COVID-19 anti-vaccine memes/pictures from Twitter between Oct. 30 and Nov. 11, 2020.

They found that the memes generally fell into three categories:

The memes often incorporated logical or rhetorical fallacies, including appealing to anger, suppressing evidence, misleading vividness or deliberate lies.

"These findings from Twitter, along with those of our first survey, prompted us to consider further the potential impact of meme-based, politically persuasive communications on individuals' COVID-19 vaccination decisions," said Kareklas.

The third study assessed participants' level of trust in medical, scientific evidence and government institutions, with the goal of determining if public sentiment could be swayed.

"Here, we observed a striking dichotomy between Trump and Biden voters," continued Kareklas. "Specifically, while Biden (compared to Trump) voters were significantly more likely to indicate that their trust in government had decreased in the last four years, Trump (compared to Biden) voters were significantly more likely to indicate their trust in medical, scientific evidence had decreased. Such polarized positions regarding these vital public health institutions (i.e., science and government) further documents the politicization of health science."

These political and philosophical divisions have created an environment where it has become increasingly challenging for health agencies to fulfill their mission to protect the nation, both during the pandemic and in similar future situations, according to the researchers.

"The private and public disagreements among politicians and health experts made it especially difficult to have a coherent policy for addressing the pandemic and consistent messaging regarding how to combat COVID-19," said Kareklas.

The findings do suggest, however that, consistent with the source credibility literature, messaging campaigns that feature a highly credible spokesperson who is perceived to have high levels of expertise and trustworthiness could differentially influence individuals who are hesitant to trust government institutions.

According to former CDC director Tom Frieden, who participated in the focus group, several focus group participants changed their minds about taking the vaccine after hearing the facts without political spin from doctors, as opposed to taking advice from politicians.

More information: Ioannis Kareklas et al, Reexamining health messages in the political age: The politicization of the COVID19 pandemic and its detrimental effects on vaccine hesitancy, Journal of Consumer Affairs (2023). DOI: 10.1111/joca.12553

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Study explores how opposing viewpoints may have impacted vaccine hesitancy - Phys.org

Pong Moji / iStock

A randomized clinical trial conducted in three Asian countries found that a shorter, individualized course of antibiotics guided by clinical response was non-inferior to usual care for patients with ventilator-associated pneumonia (VAP), researchers reported yesterday in The Lancet Respiratory Medicine.

The trial, conducted in 39 intensive care units at six hospitals in Nepal, Singapore, and Thailand, enrolled VAP patients who had been mechanically ventilated for 48 hours and were administered culture-directed antibiotics. Patients were assessed until fever resolution for 48 hours and hemodynamic stability, then randomly assigned to individualized short-course treatment (7 days or less) or usual care (8 days or more). The primary outcome was a 60-day composite end point of death or pneumonia recurrence, with a prespecified non-inferiority margin of 12%.

A total of 461 patients (median age 64 years, 39% female) were enrolled, with 232 randomized to the short-course treatment group and 229 to the usual-care group. Median antibiotic treatment duration for index episodes of VAP was 6 days in the short-course group and 14 days in the usual-care group. In the intention-to-treat population (460 patients), 41% of patients in the short-course group met the primary end point, compared with 44% in the usual-care group, for an absolute risk difference of 3% (one-sided 95% confidence interval [CI], to 5%).

The results were similar in the per-protocol population. Although non-inferiority was met in both analyses, superiority compared with usual care was not established.

In the per-protocol population, antibiotic side effects occurred in 8% of patients in the short-course group, compared with 38% in the usual-care group (absolute risk difference, 31%; 95% CI, 37% to 25%).

The investigators say that the results are noteworthy, because very few trials of antibiotic treatment for VAP have been conducted in low- and middle-income settings, where high rates of VAP are a major driver of antibiotic use and contribute to the presence of multidrug-resistant organisms.

"This strategy based on simple parameters is readily applicable in low-income and middle-income countries and could have a considerable impact on reducing overall antibiotic prescribing, potentially curbing the spread of antimicrobial resistance among the most vulnerable patients," they wrote.

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WHO grants emergency listing for Corbevax COVID vaccine - University of Minnesota Twin Cities

Photo taken on Dec. 8, 2022 shows an exterior view of the headquarters of the European Centre for Disease Prevention and Control (ECDC) in Stockholm, Sweden. (Photo by Wei Xuechao/Xinhua)

Approximately 5.5 million of the vaccine doses were given to people aged 80 or over during the period from Sept. 1, 2023 to Jan. 15, 2024, the ECDC said.

STOCKHOLM, Jan. 26 (Xinhua) -- Around 19.4 million people aged 60 or older in European countries have received a vaccine dose against COVID-19 since September 2023, the European Centre for Disease Prevention and Control (ECDC) said on Friday.

The ECDC has stressed the urgency of revaccinating the elderly against COVID-19. Approximately 5.5 million of the vaccine doses were given to people aged 80 or over during the period from Sept. 1, 2023 to Jan. 15, 2024, the ECDC said.

Vaccination efforts should continue to focus on protecting people at risk of progression to severe disease, for example, people aged over 60 years, other vulnerable individuals irrespective of age, and pregnant women, the ECDC said in a press release.

Healthcare workers should also be considered as a priority group for COVID-19 revaccination, the ECDC added.

The median COVID-19 vaccination coverage among those aged 60 and over was 11.1 percent, with high variation among countries, the ECDC reported.

People walk on a road in Stockholm, Sweden on Jan. 17, 2024. (Xinhua/He Miao)

In three of the 24 reporting countries, coverage was above 50 percent in this age group.

Among those aged 80 and older, the median coverage for vaccination was 16.3 percent, with eight of the 24 countries reporting coverage above 50 percent. Meanwhile, one country had coverage above 80 percent in this age group: Denmark with 88.2 percent.

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ECDC calls on revaccinating elderly against COVID-19 - Xinhua

Study site, population, and study design

The COVID-19 Outcomes in Mother-Infant Pairs (COMP) study is a longitudinal cohort study of pregnant patients who had SARS CoV-2 during gestation and their infants7,13. Pregnant individuals, 16 years old or older, with confirmed SARS-CoV-2 infection by nasopharyngeal reverse transcription polymerase chain reaction (RT-PCR), antigen (Ag) or serology during gestation were eligible for enrollment, regardless of preexisting conditions. Participants were primarily recruited by the Department of Obstetrics at the University of California, Los Angeles (UCLA) from 15 April 2020 to 31 August 2022. Beginning in April 2020, all women admitted to UCLA labor and delivery were screened for SARS-CoV-2 by nasopharyngeal swab. Two-hundred and twenty-one pregnant individuals, aged 16 to 56 years old, and 227 SARS-CoV-2 exposed fetuses were enrolled in our study. This resulted in 199 live births following in utero exposure to COVID-19. Maternal-infant pairs were followed longitudinally until the infants reached 6 months of age. The UCLA Medical Center comprises of multiple teaching hospitals, including tertiary and quaternary referral centers, and services the Los Angeles region in Southern California.

Informed consent for participation was obtained for all participants prior to enrollment. If a participant was incapable to provide consent (i.e., due to an acute hospitalization or intubated), consent was provided by a surrogate decision maker and the participant was re-consented once they regained capacity. Information was obtained directly from participants using RedCap survey software and from clinical chart review using EPIC. Our study was approved by the UCLA Internal Review Board (IRB).

Our primary outcome was neonatal RD, which was defined as infants with at least two of the following: respiratory rate of 60 breaths per minute, retractions, nasal flaring, or central cyanosis. Infants were considered premature if they were born at a gestational age less than 37 weeks. Maternal COVID-19 severity was determined by NIH classification14. Briefly, maternal critical illness describes patients with respiratory failure (requiring mechanical ventilation) or signs of multiple organ failure; severe illness was defined as patients with oxygen saturation (SpO2)<94% on room air, a ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2)<300mmHg, a respiratory rate >30 breaths/min, or lung infiltrates >50%; moderate illness was defined as individuals with evidence of lower respiratory disease on clinical assessment or imaging with a SpO294% but did not require supplemental oxygen; mild illness describes symptomatic patients without shortness of breath, dyspnea or abnormal chest imaging; and asymptomatic individuals showed no symptoms14. Women were considered vaccinated if they received at least one dose of an mRNA COVID-19 vaccine prior to infection. Women who received the Janssen/Johnson & Johnson COVID-19 during pregnancy were not included (n=1).

Maternal race and ethnicity were operationalized into three categories (Black, Hispanic, and Latina; Asian, Mixed-Race, and Other; or White) based on self-reported racial identity. We acknowledge that race is a social construct and our categorizations may not adequately reflect an individuals identity. However, we included race in our univariate analysis given the history of systemic racism that has contributed to poor maternal outcomes among black women in the United States43. None of the mothers in our study self-identified as non-binary or transgender, therefore we have used gendered language in our text to refer to pregnant persons.

We compared the demographics of infants born with and without RD using one-way t-tests. We considered variables related to infant characteristics (sex, delivery method, prematurity, low birth weight), maternal predictors (maternal age, ethnicity, preexisting medical conditions), pregnancy complications (e.g., preeclampsia, gestational hypertension, chorioamnionitis, etc.), and COVID-19 predictors (maternal vaccination, trimester of infection, severity, symptoms, treatment, viral variant). The Fisher exact statistical test was used to obtain p-values. We did not adjust for multiple comparisons in our bivariate analyses because it was exploratory. Next, we conducted logistic regression analyses on neonatal RD, prioritizing variables that were significant in the previous t-tests and based on clinical suspicion of intermediate variables and effect modifiers. The following variables were used as predictors in our univariate analysis: maternal ethnicity, trimester of infection, COVID-19 severity, maternal vaccination status, and binary prematurity. We selected variables to include in our final model using a backwards selection and WALDs test. As recommended by ref. l44, we initially included all variables in a model and eliminated each variable above the p-value threshold of 0.25. This process was repeated until the remaining variables had p values below the threshold. We considered potential collinearity or lack of independence among predictor variables using chi-squared tests for independence. Similarly, our final multivariable model did not include maternal COVID-19 severitydespite evidence of significance in univariate regression modelsbecause of the known association between COVID-19 severity and vaccination status. Including both COVID-19 severity and vaccination status would have likely attenuated the strength of our findings. In order to evaluate whether prematurity mediates the effect of maternal COVID-19 on neonatal respiratory distress, we utilized the Valeri and Vanderweele mediation analysis45. Approximately 18% of the risk of neonatal respiratory distress is mediated by prematurity, although not statistically significant (p=0.3). Our final model for neonatal RD included binary maternal vaccination status and infant prematurity as predictors. Finally, we conducted a chart and imaging review to better characterize features of infant RD born to women infected with COVID-19 during pregnancy.

We performed a post-hoc power analysis in which we calculated the power achieved in our study based upon the false positive rate, the effect size of maternal COVID-19 vaccination prior to infection in protecting against adverse perinatal outcomes, and the number of pregnant individuals in our cohort. To carry out the calculation, we needed to supply a value for the effect size that was independent of our cohort. According to a systematic review and meta-analysis, rates of adverse perinatal outcomes were 15% higher in unvaccinated pregnant individuals than among those who were vaccinated46. Therefore, our post-hoc power analysis assumed that the rate of such outcomes would be at least 15% higher among pregnant women who were not vaccinated. The null hypothesis was that the rates of adverse outcomes would be the same among vaccinated and unvaccinated pregnant people. In the present cohort of 227 pregnancies, approximately one-third of the participants were vaccinated before COVID-19 infection.

We carried out a post-hoc power analysis using G*Power 3.1.9.447. Our calculations assumed a 5% false-positive rate and used a two-tailed test of the difference in proportions between the vaccinated and unvaccinated groups. The results indicated that our analysis had 90% power, in other words, the chance of rejecting the null hypothesis if it was false was 90%. This rate is reasonably high and we believe it provides support for our conclusions about this cohort.

Data was analyzed using R language48. Statistical analysis was conducted using a combination of epiDisplay package49, tableone package49, stats base package, and aod package50.

The present data is reanalyzed from a dataset previously published by our group7. We conducted a proteomic reanalysis to explore potential associations between respiratory distress and canonical pathways possibly associated with SARS CoV-2 in a subset of infants for whom proteomics was performed. We analyzed a subset of 45 SEU infants born in the first year of the pandemic (April 2020 to March 2021) matched to seven control infants born to unexposed healthy women at the pandemic onset, for a total of 52 infants (Fig.1). Controls were from a convenience sample of healthy mothers who did not have SARS-CoV-2 exposure and for whom infant specimens were available. Infants were matched based on gestational age. This analysis utilizes peripheral infant blood specimens collected between 24 and 48h of life. This timeframe was selected to coincide with routine bilirubin checks in order to minimize blood draws. The SEU infant cohort was clustered according to RD outcome and gestational age, resulting in four groups: no RD term infants (n=27), no RD preterm infants (n=3), RD term infants (n=4), and RD preterm infants (n=11). Significant differentially expressed proteins between healthy and the four COVID-19-exposed infant groups were determined by two-tailed Mann Whitney U test using the R base package, t.test, considering fold-change 2 and FDR-adjusted p value<0.05. Enrichment analysis was conducted using the online platform Enricher51. Comparisons between multiple groups using 1-way ANOVA with uncorrected Fishers test in GraphPad Prism v9.4.0. Network and pathways analyses were performed using QIAGEN Ingenuity Pathway Analysis (IPA) v01-19-007,42.

This research was conducted locally in Los Angeles, California and was approved by the UCLA Internal Review Board. The authors come from diverse socioeconomic backgrounds and have expertise in a variety of disciplines across medicine and public health. This manuscript cites prior studies from across the United States, including Los Angeles, with an emphasis on sources about maternal and child health. Our results are locally relevant with the goal of providing physicians and patients more information about the benefits of COVID-19 vaccination. Furthermore, it can help guide future research and understandings of the long-term sequelae of SARS-CoV-2.

The roles and responsibilities of the authors were agreed upon prior to conducting the analysis. This project and future projects have been designed with special attention to continue to train medical students, medical residents and fellows, graduate students, and post doctorial researchers.

The data collection process and analysis methods did not result in increased stigmatization, incrimination, discrimination, or other personal risks to our study participants. This study did not cause increased health, safety, or security risks to the researchers or participants. No animal welfare, environmental protection, or biorisk-related regulations were violated by our study. Our study did not involve the transfer of biological materials, cultural artefacts, or associated traditional knowledge.

Further information on research design is available in theNature Portfolio Reporting Summary linked to this article.

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