Category: COVID

Categories : COVID Ethics and LawTags :

US Officials Suppressed Warnings over Flawed COVID Vaccine Safety Algorithm

On By ModernMedia

Investigation reignites questions about what steps were taken to safeguard public health from any unintended consequences of the vaccination rollout

Photo by Mufid Majnun on Unsplash

US health officials knowingly relied on a compromised algorithm to detect signals of harm from mRNA covid-19 vaccines and silenced efforts to fix it, finds an investigation published by The BMJ.

The findings are based on government emails released under the Freedom of Information Act and in response to US Senate investigators, as well as exclusive interviews with public health officials and other scientists by investigative journalist David Willman.

Before rolling out covid-19 vaccines in December 2020, the US Centers for Disease Control and Prevention (CDC) assured healthcare professionals and the public that its Vaccine Adverse Event Reporting System (VAERS) could quickly spot any potentially harmful reactions following vaccination.

The CDC planned to use two “data mining” techniques: “proportional reporting ratios” (PRRs) and an “empirical bayesian” method provided by the Food and Drug Administration (FDA), which operated VAERS jointly with the CDC. The two agencies planned to share and discuss results.

But according to a letter by CDC Director Rochelle Walensky, the agency did not perform PRR analyses until 2022, and both CDC and FDA “chose to rely” entirely on FDA’s bayesian method.

The BMJ can reveal that the FDA’s algorithm failed to signal a potential relationship between mRNA covid vaccination and myocarditis (inflammation of the heart muscle), pericarditis (inflammation of the fluid-filled sac around the heart), Bell’s palsy, tinnitus, and other reported disorders owing to a flaw in the detection methodology.

The problem arose because over 90% of initial VAERS reports were for the new mRNA covid vaccines made by Pfizer and Moderna. If both vaccines elevated the risk of an adverse event like myocarditis in roughly equal amounts, however, the “observed” frequency and “expected” frequency would be similar, resulting in no automated alert.

Internal records show that FDA officials were aware of this limitation before and during the pandemic. Government documents also show that CDC officials were informed during rollout of the vaccines.

In early 2021, FDA medical officer Dr Ana Szarfman, working with statistician William DuMouchel, who had developed the bayesian algorithm, warned top officials about the flaw and proposed an updated algorithm that flagged signals. But Szarfman was asked to “cease and desist.”  Meanwhile, officials continued to cite the lack of system alerts while reassuring clinicians and the public of the vaccines’ safety.

When the CDC finally ran PRR analyses in 2022, CDC director Walensky said results revealed “no additional unexpected safety signals.” Yet the analyses – examined by The BMJ – show hundreds of adverse events that met the agency’s alert criteria, including myocarditis, pericarditis, Bell’s palsy, and tinnitus, which the FDA’s bayesian method had not triggered.

In October 2023, the FDA’s pharmacovigilance chief acknowledged in an email to colleagues that the agency knew – as the vaccines had rolled out more than two years earlier – of the detection deficiency, but did not respond to requests for comment.

Approached by The BMJ, Szarfman insisted that she had not sought to undermine public support for the covid vaccines. Expressing frustration, she noted, “Very few people understand the statistics. That’s the problem.”

DuMouchel said he could not explain officials’ resistance to switch to the updated method, stating, “I think that they were wrong.” He also regretted that FDA officials rejected Szarfman’s proposed fixes for VAERS, adding, “If they had paid attention to Ana, they would have done better.”

Source: The BMJ Group

Categories : COVIDTags :

Should Adults with Autoimmune Rheumatic Conditions Receive Updated COVID Vaccines?

On By ModernMedia
Photo by SHVETS production

In an Arthritis & Rheumatology analysis of data on 60 980 US adults with autoimmune rheumatic conditions who developed COVID between December 2020 and August 2024, those who received booster or updated (2023-2024) COVID vaccines were less likely to be hospitalised for COVID compared to those who received only the initial series vaccines or who were unvaccinated.

Compared with no vaccination, completion of the initial series, booster vaccination, and updated vaccination were associated with 41%, 71%, and 69% lower adjusted odds of COVID-related hospitalisation, respectively. Among patients who had received only the initial vaccine series versus booster/updated vaccine, the absolute risk reduction was 5.6%.

“Our findings provide important real-world evidence that updated vaccines continue to offer substantial protection in this medically vulnerable population,” said corresponding author Maria I. Danila, MD, MSc, MSPH, of the University of Alabama at Birmingham. “These results underscore the need for continued efforts by clinicians, policymakers, and patient advocacy groups to help ensure that these patients remain current with updated COVID vaccines,” added first author Lesley E. Jackson, MD, MSPH, also of the University of Alabama at Birmingham.

Source: Wiley

Categories : COVIDTags :

How Well Do COVID Antivirals Actually Work? Not as Well as We Thought

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Image by Fusion Medical on Unsplash

Laura Edwards, UNSW ; Allen Cheng, Monash University; Bette Liu, UNSW , and James Wood, UNSW

If you’re 70 or older, or 50 or older with underlying health conditions, and have tested positive for COVID, you might have been offered free or subsidised antivirals.

Earlier in the pandemic, these medicines were an important way to reduce the chance of people becoming severely ill with COVID, needing to be hospitalised or dying.

But our new research suggests that with high levels of vaccination and immunity from previous infections, COVID antivirals are no longer working as well.

From no treatment to an effective one

When SARS-CoV-2, the virus that causes COVID, first emerged in late 2019, no treatment was available. Existing influenza antivirals, which had been stockpiled by governments, were ineffective and couldn’t be used.

Scientists rapidly tried to figure out which existing or new drugs could be used. In 2021, two industry-sponsored clinical trials reported promising results.

One was for nirmatrelvir-ritonavir (Paxlovid), which reported an 89% reduction in severe illness. The other was a trial of molnupiravir (Lagevrio), which reported a 30% reduction.

Paxlovid and Lagevrio work by stopping SARS-CoV-2 from replicating. So they need to be taken early in the course of illness – within five days – to be effective.

Both drugs became available in Australia and were listed on the Pharmaceutical Benefits Scheme (PBS) in early and mid-2022. This ensured people most at risk of severe illness had access to drugs at low or no cost.

Paxlovid and Lagevrio are expensive. A course of treatment cost the government around A$1,100 from 2022 to 2025, much more than treatment for influenza, oseltamivir (Tamiflu), which costs only around $40.

Between mid-2022 and mid-2025, the Australian government spent more than $2 billion on Paxlovid and Lagevrio.

What’s different now?

Most Australians have now been vaccinated against COVID and infected with SARS-CoV-2 more than once. This results in hybrid immunity and reduces the likelihood and severity of future infections.

The virus itself has also changed, with the original variants replaced by new ones that appear to be less severe than early in the pandemic.

These changes prompted us to evaluate the more recent evidence.

What did we study and find?

First, we examined randomised controlled trials—the gold standard of evidence. We found eight trials of Paxlovid and Lagevrio, but most were done before people were vaccinated.

When we looked at the two randomised controlled trials in vaccinated people, neither reported a reduction in severe outcomes after taking either Paxlovid or Lagevrio.

The Lagevrio trial reported no statistical difference in hospitalisation or death in people who did and didn’t receive treatment.

The other was a trial of people in hospital who were treated with Paxlovid. It found no difference between people who were treated and those who were not.

There were some nuances to these findings. Randomised controlled trials are expensive and resource-intensive. As COVID went from being the leading cause of death worldwide in 2021 to the 20th in 2023, it became more difficult to justify the costs and recruit enough participants, so some trials were stopped early.

However, two randomised controlled trials of Paxlovid have been published since our work, and neither reported a reduction in hospitalisation or death.

In phase two of our research, we looked at the 35 observational studies, in which researchers can include many more people but can’t control who gets the treatment. We pooled the results from the studies to estimate the effectiveness of each drug against hospitalisation and death.

This meta-analysis found Paxlovid, but not Lagevrio, reduced hospitalisation and death.

Paxlovid was associated with a 40% reduction in hospitalisation and a 67% reduction in death.

Lagevrio wasn’t associated with a significant reduction in hospitalisation, and the results for death were mixed.

Because treatment wasn’t randomised, there may be differences between people who received treatment and those who didn’t. People accessing treatment, for example, may have greater health literacy or access to other health services.

While some studies use methods to adjust for differences in people who do and don’t receive treatment, it’s usually not possible to adjust for every difference.

COVID is still a concern for at-risk groups

SARS-CoV-2, like influenza and respiratory syncytial virus (RSV), remains a common cause of acute respiratory illness in Australia. In 2025, there were:

  • 186,000 cases of COVID reported
  • 178,000 cases of RSV
  • 503,000 cases of influenza.

But the number of COVID, RSV and influenza cases reported is well below the true number, as most people don’t get tested.

COVID is still claiming lives. There were 2,227 deaths involving COVID in 2025. This is more than the 1,784 deaths involving influenza. Three-quarters of deaths were among people 80 and older.

The rates of COVID-related hospitalisations so far this year have been lower than last year, with 839 admissions at “sentinel hospitals” (those chosen to monitor disease trends) in the first half of this year. This compares with 1,740 in the same period last year.

What does this mean?

COVID can still cause severe illness, hospitalisation and death, particularly in older people.

If you test positive for COVID, talk to your primary care doctor about whether antivirals may be appropriate for you.

Our work shows there may be some benefit from Paxlovid. But as the number of cases and the risk of severe illness continue to fall, this benefit is becoming very small.

Given how little evidence there is for Lagevrio, its role in treating COVID should be carefully considered.

Harms of antivirals can include side effects – such as taste changes, nausea and vomiting – and allergic reactions.

Paxlovid can also interact with other drugs, causing serious reactions. It should be avoided, or the dose adjusted, in people with severe liver or kidney disease because it can make these conditions worse.

Australia’s independent Pharmaceutical Benefits Advisory Committee (PBAC) is set to review COVID antivirals later in 2026. It will assess the costs and benefits of Paxlovid and Lagevrio, and it may change its recommendations about who can access the drugs on the PBS.

Our findings support this reassessment.

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Categories : COVID Respiratory DiseasesTags :

How Did the COVID-19 Pandemic Shift Seasonal Surges of Other Respiratory Diseases?

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Study links shifts to buildup of susceptible hosts, explores similar shifts in heart-related deaths

Creative layout featuring scientifically-based 3D renderings of respiratory syncytial virus (RSV). RSV is a common contagious virus that infects the human respiratory tract. Credit: NIAID

 A German analysis explores what underlies shifts in the timing of seasonal surges of respiratory diseases, as well as shifts in surges of heart-related deaths, that occurred after the COVID-19 pandemic began. Michael Sieber and Arne Traulsen of the Max Planck Institute for Evolutionary Biology, Germany, present these findings in the open-access journal PLOS Global Public Health on July 15, 2026.

Rates of respiratory infections such as the flu and RSV typically peak during seasons when transmission rates rise. Rates of death from any cause – not just from infection – follow a similar seasonal pattern.

However, the drivers underlying the exact timing of these surges have been unclear. The COVID-19 pandemic provided a unique opportunity to explore these dynamics, since interventions like social distancing and masking disrupted typical transmission patterns of other respiratory diseases. Sieber and Traulsen analysed data on weekly respiratory infection rates and death rates in Germany, covering the last 14 years. 

The analysis showed that, pre-pandemic, respiratory infections almost always surged for a few weeks February and March. After the pandemic began, intervention efforts tamped down infections, eliminating one seasonal surge. Once infections rose again, surges shifted to December or earlier. Now, these peak weeks are gradually resuming pre-pandemic timing.

Using well-established epidemiological modelling tools, the researchers found that population-level loss of immunity after the skipped seasonal surge led to buildup of susceptible hosts, resulting in higher transmission earlier in the season. That is, seasonal transmission variations present a window of opportunity for a surge, and the size of the pool of susceptible hosts at the start of that window determines when, exactly, the surge occurs.

Similarly, typical seasonal surges in rates of death from any cause – but particularly from cardiovascular disease – also shifted earlier post-pandemic. Thus, respiratory infections may be key drivers of the timing of seasonal surges in cardiovascular deaths. More research is needed to explore this connection, but it aligns with other evidence that respiratory infections are a significant risk factor for cardiovascular disease.

On the basis of their findings, the researchers emphasize the importance of monitoring people’s infection history and improving vaccination coverage.

The authors add: “News stories of an earlier than usual onset of the flu season during the COVID-19 pandemic motivated us to look into the available epidemiological data more closely. We were surprised by the magnitude of the shift in timing of seasonal respiratory infections in Germany, and interested in trying to predict if this would turn out to be a long-term effect of the pandemic or if we should expect a quick return to the normal seasonal timing. The most recent flu seasons confirmed that the seasonal timing indeed shifts back to normal within one or two seasons, most likely due to a return to the pre-pandemic population-levels of immunity to the most common respiratory pathogens. We were even more surprised to see that the seasonal dynamics of all-cause mortality, which is dominated by cardiovascular diseases, closely followed the shift in timing of respiratory infections. This adds to the growing evidence that respiratory infections are an important risk factor for cardiovascular problems.”

Provided by PLOS
 

Categories : COVIDTags :

Commonly Used Drugs Show Limited Benefit for Long Covid Fatigue

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Photo by Andrea Piacquadio

Over-the-counter antihistamines and a prescription anti-inflammatory drug both have a small benefit in reducing long Covid fatigue among people receiving care from specialist long Covid clinics, according to new findings from a large clinical trial led by UCL and UCLH.

The study, published in The Lancet Infectious Diseases, involved nearly 800 adults in England with long Covid who were randomised to either usual care or one of three types of drugs: a combination of antihistamines, colchicine, or rivaroxaban.

The research team found that all groups experienced a meaningful reduction in their self-reported fatigue over 12 weeks (improving an average of 4.3 points on a 40-point scale), supporting the idea that specialist long Covid care can lead to important improvements in symptoms.

Those taking antihistamines and colchicine, but not the blood thinner rivaroxaban, saw a small additional benefit in fatigue reduction at 12 weeks (an extra 1.5 point improvement on the scale). However, this benefit was not sustained at 24 weeks (12 weeks after the participants stopped taking the drugs).

The trial was conducted by a national team of researchers, clinicians and patients across 12 clinics in England and Scotland led by co-chief investigators Professor Amitava Banerjee at UCL and Dr Melissa Heightman at UCLH. More than 30 organisations were involved, with UCLH recruiting around half the patients on this trial and the University of Lancashire Clinical Trials Unit co-ordinating all of the recruiting sites.

Professor Banerjee (UCL Institute of Health Informatics), the corresponding author, said: “We tested potential medicines based on the most promising theories of how to improve long Covid when we started out in 2021. Our findings suggest these drugs alone are unlikely to be the answer to long Covid fatigue. Antihistamines and the anti-inflammatory drug, colchicine, did provide a small benefit, but this did not last once participants stopped taking them and so they are unlikely to improve symptoms over the long term on their own.

“Both antihistamines and colchicine affect the immune system and it may be that they address the immune dysregulation that long Covid has been linked to, but further research is needed to understand the possible mechanism.

“The blood thinner, rivaroxaban, had no benefit and so our results do not support the use of anti-coagulation medicine for long Covid.”

Dr Melissa Heightman, clinical lead for the post-Covid service at UCLH, said: “It is heartening that people had a significant reduction in fatigue across all arms of the trial. This is more than you would expect based on time alone, given that participants had severe fatigue at recruitment and been ill for more than a year on average.

“This level of improvement shows the importance of specialist long Covid care. These services in England offer integrated care from a range of specialties with community-based rehabilitation to develop a plan for a person based on their symptoms and all of the ways the condition affects them.”

Participants of the trial were adults with long Covid who had not been hospitalised. The 12 long Covid clinics ranged from Hull and the Highlands to Leicester and London. Fatigue was assessed with a questionnaire at the start of the trial and then after 12 and 24 weeks.

The trial was open-label, meaning participants knew which drug they were taking (there was no placebo in the non-drug group), and so the researchers were unable to rule out a placebo effect. However, they said the benefit seen in two of the drug groups was unlikely to be caused by placebo alone, given that no such benefit was found for the other drug group (rivaroxaban).

Professor Banerjee said: “We have shown it is possible to conduct a large clinical trial for long Covid and to test treatments as we would for any other condition.”

Professor Danny McAuley, Scientific Director for NIHR Programmes, said: “The NIHR is proud to have funded this vital trial, which highlights the value of specialist care in delivering meaningful relief for long Covid patients. Finding even modest benefits for these inexpensive drugs, which are safe and commonly used for other conditions, is incredibly important to improve the evidence-based treatment of this complex condition. By providing the high-quality data needed to refine clinical approaches, this research ensures that the NIHR is helping to build a clearer, safer path forward for patient care which can be provided in the community.”

Professor Emma Wall, Clinical Research Group Leader at the Crick, Professor of Infectious Diseases at Queen Mary University of London, and academic consultant in Infectious Diseases and Acute Medicine for UCLH,said: “Because long Covid is such a new and complex condition, when it came to designing the trial, we started by listening to what patients were telling us about their symptoms and experiences, then looking for biological signals that might explain them and treatments that might help.

“The value of these results is not only that they suggest a potential treatment approach, but that they help us understand the biology of long Covid itself. Every signal we see in the trial helps us refine our understanding of the immune and inflammatory mechanisms that may be driving the disease, to develop new, better targeted treatments for future trials.”

Source: University College London

Categories : Cardiovascular Disease COVIDTags :

Long COVID Associated with Increased Risk of Cardiovascular Disease

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People with long COVID are at increased risk of developing cardiovascular disease, according to a new study from Karolinska Institutet published in eClinicalMedicine. The results show that the risk of conditions such as cardiac arrhythmias and coronary artery disease is higher even among those who were not hospitalised during the acute infection.

Long COVID has become an increasingly significant health problem worldwide, and a growing number of studies suggest that the condition can lead to secondary cardiovascular diseases. To date, research has mainly focused on people who were hospitalised, whilst the risks for those who stayed at home or were treated at a GP are less well known. In the current study, the researchers investigated how often major cardiovascular events occur in these individuals compared with those without the diagnosis.

Of the just over 1.2 million people aged between 18 and 65 included in the study, around 9,000 had been diagnosed with long COVID, corresponding to 0.7 per cent. Two-thirds of them were women. People who had previously had cardiovascular disease or been hospitalised for COVID-19 were excluded from this group.

During the follow-up period of around four years, people with long COVID were more likely to suffer from cardiovascular disease: 18.2 per cent of women and 20.6 per cent of men experienced some form of cardiovascular event, compared with 8.4 per cent of women and 11.1 per cent of men in the group without long COVID.

When the researchers then adjusted the results for factors such as age, socio-economic status and other known risk factors, the differences remained. Women with long COVID had just over twice the risk of receiving a cardiovascular diagnosis compared with women without long COVID. Men had approximately a third higher risk.

“We found that cardiac arrhythmias and coronary artery disease were more common among both women and men with long COVID. In women, there was also an increased risk of heart failure and peripheral vascular disease. However, no clear association was found between long COVID and stroke,” says lead author Pia Lindberg, a nurse and PhD student at the Department of Medicine, Solna, Karolinska Institutet.

Need to be monitored more systematically

As many people with long COVID never required hospitalisation during their acute infection, there is a risk that secondary conditions may be missed, says Pia Lindberg, pointing out that the results suggest these patients may need to be monitored more systematically.

”Our results show that long COVID can be a risk factor for cardiovascular disease, even in younger people who were previously healthy. This underlines the need for structured follow-up that takes gender differences into account, particularly as cardiovascular disease in women often presents with more diffuse symptoms that can make diagnosis more difficult”, concludes Pia Lindberg.

Source: Karolinska Institutet

Categories : COVIDTags :

Long COVID Brain Fog Far More Common in US than India, Other Nations

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Large study of patients in the US, Colombia, Nigeria and India finds symptom burden highest in high-income countries

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Patients with long COVID-19 in the US report far higher rates of brain fog, depression and cognitive symptoms than patients in countries such as India and Nigeria, according to a large international study led by Northwestern Medicine.

The authors note that higher reported symptom burden in the US may reflect lower stigma and greater access to neurological and mental health care, rather than more severe disease.

The study, the first cross-continental comparison of long COVID neurological manifestations, tracked more than 3100 adults with long COVID evaluated at academic medical centres in Chicago; Medellín, Colombia; Lagos, Nigeria; and Jaipur, India.

Among patients who were not hospitalised during their COVID infections (the majority in the study), 86% in the US reported brain fog, compared with only 63% in Nigeria, 62% in Colombia and 15% in India. Rates of psychological distress showed a similar pattern: Nearly 75% of non-hospitalised patients in the US reported symptoms of depression or anxiety, compared with only 40% in Colombia and fewer than 20% in Nigeria and India.

“It is culturally accepted in the US and Colombia to talk about mental health and cognitive issues, whereas that is not the case in Nigeria and India,” said Dr Igor Koralnik, senior study author and chief of neuro-infectious disease and global neurology at Northwestern University Feinberg School of Medicine.

“Cultural denial of mood disorder symptoms as well as a combination of stigma, misperceptions, religiosity and belief systems, and lack of health literacy may contribute to biased reporting. This may be compounded by a dearth of mental health providers and perceived treatment options in those countries.”

The study was published in Frontiers in Human Neuroscience.

Additional key findings

  •        Brain fog, fatigue, myalgia (muscle pain), headache, dizziness and sensory disturbances (such as numbness or tingling) were the most common neurological symptoms across all countries
  •        Insomnia was reported by nearly 60% of non-hospitalised US patients, compared with roughly one-third or fewer of patients in Colombia, Nigeria and India
  •        Statistical clustering showed clear separation between high- and upper-middle-income (US, Colombia) and lower-middle-income (Nigeria, India) countries

Building on this work, Koralnik and his international collaborators are now studying cognitive rehabilitation treatments for long COVID brain fog in Colombia and Nigeria, using the same protocols developed for patients treated at the Shirley Ryan AbilityLab in Chicago.

By Ben Schamisso

Source: Northwestern University

Categories : Cancer COVIDTags :

mRNA-based COVID Vaccines Improved Responses to Immunotherapy

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Patients with cancer who received mRNA-based COVID vaccines within 100 days of starting immune checkpoint therapy were twice as likely to be alive three years after beginning treatment, according to a new study led by researchers at The University of Texas MD Anderson Cancer Center.

These findings, which include more than 1000 patients treated between August 2019 and August 2023, were presented today at the 2025 European Society for Medical Oncology (ESMO) Congress (Abstract LBA54). The study was led by Steven Lin, MD, PhD, professor of Radiation Oncology, and Adam Grippin, MD, PhD, senior resident in Radiation Oncology.

“This study demonstrates that commercially available mRNA COVID vaccines can train patients’ immune systems to eliminate cancer,” Grippin said. “When combined with immune checkpoint inhibitors, these vaccines produce powerful antitumour immune responses that are associated with massive improvements in survival for patients with cancer.”

How was this association discovered?

The discovery that mRNA vaccines were powerful immune activators came from research conducted by Grippin during his graduate work at the University of Florida in the lab of Elias Sayour, MD, PhD. While developing personalised mRNA-based cancer vaccines for brain tumours, Grippin and Sayour found that mRNA vaccines trained immune systems to eliminate cancer cells, even when the mRNA didn’t target tumours directly.

This finding led to the hypothesis that other types of mRNA vaccines might have the same effect, and the approval and use of mRNA-based COVID vaccines created an opportunity to test this hypothesis. Lin and Grippin initiated a major effort to retrospectively study if MD Anderson patients who received mRNA COVID vaccines lived longer than those who did not receive these vaccines.

How do mRNA COVID vaccines impact immunotherapy responses in cancer?

To better understand the mechanisms at work that can help explain the clinical data, the Lin and Sayour labs at both institutions studied preclinical models. They discovered that mRNA vaccines work like an alarm, putting the body’s immune system on high alert to recognise and attack cancer cells.

In response, the cancer cells start making the immune checkpoint protein PD-L1, which works as a defence mechanism against immune cells. Fortunately, several immune checkpoint inhibitors are designed to block PD-L1, creating a perfect environment for these treatments to unleash the immune system against cancer.

These preclinical observations held up in clinical studies as well. The investigators found similar mechanisms, including immune activation in healthy volunteers and increased PD-L1 expression on tumours in patients who received COVID mRNA vaccines.

While the mechanisms are not yet fully understood, this study suggests COVID mRNA vaccines are powerful tools to reprogram immune responses against cancer.

What are the major implications of this discovery?

“The really exciting part of our work is that it points to the possibility that widely available, low-cost vaccines have the potential to dramatically improve the effectiveness of certain immune therapies,” Grippin said. “We are hopeful that mRNA vaccines could not only improve outcomes for patients being treated with immunotherapies but also bring the benefits of these therapies to patients with treatment-resistant disease.”

A multi-centre, randomised Phase III trial currently is being designed to validate these findings and investigate whether COVID mRNA vaccines should be part of the standard of care for patients receiving immune checkpoint inhibition.

What are the key data from this study on mRNA COVID vaccines and immunotherapy outcomes?

This study included multiple cohorts of several cancer types, evaluating patients who had received an mRNA vaccine within 100 days of starting immunotherapy treatment.

In the first group, 180 patients with advanced non-small cell lung cancer who received a vaccine had a median survival of 37.33 months, compared to 20.6 months in 704 patients who did not receive a vaccine. In a cohort of patients with metastatic melanoma, median survival was 26.67 months in 167 patients who did not receive a vaccine, but it had not yet been reached in 43 patients receiving a vaccine – suggesting a significant improvement.

Importantly, these survival improvements were most pronounced in patients with immunologically “cold” tumors, which would not be expected to respond well to immunotherapy. These patients, who have very low PD-L1 expression on their tumours, experienced a nearly five-fold improvement in three-year overall survival with receipt of a COVID vaccine.

Findings were consistent even when considering independent factors, such as vaccine manufacturer, number of doses, and when patients received treatment at MD Anderson.

Source: University of Texas MD Anderson Cancer Center

Categories : COVID PaediatricsTags :

COVID Controls Linked to Decline in Immunity to Life-threatening Paediatric Infections

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Scientists have uncovered a link between COVID-19 control measures and a surge in serious infections in children following the pandemic.

The findings, which come from a large European study led by researchers at Imperial, suggest that non-pharmaceutical interventions (NPIs) including lockdowns, school closures and social distancing may have inadvertently delayed the development of young children’s immunity to specific infectious diseases, leaving them more vulnerable to severe illness. 

The researchers explain that while this impact was anticipated for viral infections (such as influenza and RSV), a surge in other infections, including the bacterial infection Strep A, had not been expected.

The authors advise the need to carefully weigh the impact of restrictions on children during future pandemics and stress the importance of development and delivery of vaccines to reduce the impact of severe infections across all age groups.  

The findings are published in the journal JAMA Network Open.

Associate Professor Tom Parks from Imperial’s Department of Infectious Disease, co-lead author on the study, said: “During the COVID-19 pandemic there was huge uncertainty about the spread and severity of a new disease and difficult decisions had to be made to protect vulnerable groups, as well as to maintain the health service. Restrictions like lockdowns and social distancing played a vital role in limiting the transmission of the SARS-CoV-2 virus, which undoubtedly, saved countless lives, reduced the impact on health systems including the NHS and bought countries time to roll out vaccine programmes.

“However, our study shows they also disrupted how children built immunity during these critical early years. Children aged 3-4 tested for Strep A immunity after the pandemic were approximately a year behind children tested before the pandemic. This difference in immunity appears to have contributed to the alarming rise in severe Strep A infections seen across Europe during 2022 and 2023.” 

Strep A infections

Strep A (Group A Streptococcus) is a common type of bacteria that typically causes throat infections and scarlet fever. While most infections are mild, in rare cases Strep A can cause invasive infections which can be fatal. Each year, around half a million people, including many children and young people, die around the world because of serious Strep A infections.

Previous research has shown that while rates of Strep A infections fell dramatically during the pandemic, many countries recorded a surge in infection rates once restrictions were lifted.

In the latest study, the team examined immune responses in 452 children aged 0-4 year old across 10 European countries that participated in two EU-funded studies: PERFORM and DIAMONDS.

They found that children aged 3-4 who were exposed to NPIs during the pandemic had significantly lower levels of antibodies to Strep A compared to children of the same age who were sampled before the pandemic. The findings correspond exactly with the age group that experienced the greatest increase in life-threatening Strep A infections after NPIs were removed in England.

The researchers also found similar delays in immunity to respiratory syncytial virus (RSV), another common and potentially serious childhood infection, and a small reduction in immunity to some common cold viruses.

Professor Shiranee Sriskandan, co-director of Imperial’s Centre for Bacterial Resistance Biology and co-lead author said: “Strep A is one of the leading causes of unexpected death from sepsis in otherwise healthy children, and we know that sadly disease progression can be exceptionally rapid, making prevention – rather than intervention – our best option to reduce deaths. This study underlines the importance of immunity among young children in preventing outbreaks of serious strep A infections and highlights the value of developing a vaccine for Strep A.  

Professor Mike Levin, from Imperial’s Department of Infectious Disease, who led the DIAMONDS and PERFORM studies, said: “Many of the children who had Strep A infections also had viral infections at the same time. Children appear to have been vulnerable to several infections all at once most likely because they had encountered fewer infections and so had little chance to build up immunity.”

Source: Imperial College London

Categories : COVIDTags :

Nasal Spray Containing Azelastine Reduces Risk of SARS-CoV-2 Infection by Two-thirds

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A research team at Saarland University has demonstrated in a clinical study that a widely used anti-allergy nasal spray containing the active ingredient azelastine can significantly reduce the risk of infection with the SARS-CoV-2 virus. The results of the placebo-controlled trial involving 450 healthy participants have now been published in JAMA Internal Medicine.

The trial, led by Professor Robert Bals, Director of the Department of Internal Medicine V at Saarland University Medical Center and Professor of Internal Medicine at Saarland University, divided the 450 participants into two groups. The treatment group of 227 individuals used an azelastine nasal spray three times a day over a 56-day period. During that same period, the 223 participants in the control group used a placebo spray three times a day. Robert Bals summarised the key finding as follows: ‘During the observation period, 2.2% of the participants in the azelastine group became infected with SARS-CoV-2; in the placebo group, it was 6.7%—three times as many.’ All infections were confirmed by PCR testing.

In addition to showing a marked reduction in coronavirus infections, the azelastine group also displayed fewer symptomatic SARS-CoV-2 infections, a lower overall number of confirmed respiratory infections, and, unexpectedly, a reduced incidence of rhinovirus infections, another major cause of respiratory illness. In the treatment group, 1.8% developed a rhinovirus infection, compared to 6.3% in the placebo group—a proportion similar to that seen for SARS-CoV-2.

Azelastine nasal spray has been available for decades as an over-the-counter treatment for hay fever. Previous in vitro studies on azelastine had already suggested antiviral effects against SARS-CoV-2 and other respiratory viruses. ‘This clinical trial is the first to demonstrate a protective effect in a real-world setting,’ says Professor Bals.

For Robert Bals, the results suggest practical applications: ‘Azelastine nasal spray could provide an additional easily accessible prophylactic to complement existing protective measures, especially for vulnerable groups, during periods of high infection rates, or before travelling.’ But Professor Bals also stressed the importance of further research: ‘Our results highlight the need for larger, multicentre trials to continue exploring the use of azelastine nasal sprays as an on-demand preventive treatment, and to examine its potential effectiveness against other respiratory pathogens.’

Besides Professor Bals, the randomised, double-blind phase 2 study ‘CONTAIN’ also involved the Institute of Clinical Pharmacy (Professor Thorsten Lehr, Dr. Dominik Selzer), the Institute of Virology (Professor Sigrun Smola), and the Saarbrücken-based pharmaceutical company URSAPHARM Arzneimittel GmbH, which sponsored the study and manufactured the investigational product. The Helmholtz Institute for Pharmaceutical Research Saarland (HIPS) contributed through the research groups of Professor Smola and Professor Bals. The project serves as an excellent example of successful collaboration between academic research, industry partners and public health initiatives in the Saarland region.

Source: Saarland University