(NewsNation) The Centers for Disease Control and Prevention launched a wastewater tracking dashboard Tuesday in an effort to monitor and stop the rapid spread of bird flu, which has been detected in cattle in nine states.
Over 40 cattle herds across the country have confirmed cases of the H5N1 virus, also called bird flu.
The CDC dashboard will track all influenza A viruses from 600 wastewater treatment sites around the country in order to help public health officials pinpoint where the viruses show up most aggressively.
Flu viruses that cause human disease circulate at very low levels during the summer months, so the presence of high levels of influenza A in wastewater during this time could be a reliable indicator that something unusual is going on in a particular area, reported STAT.
As of May 4, data from 189 of the agencys wastewater sampling sites showed that an influenza A virus had been detected at higher-than-average levels in sites, including some in Illinois and Alaska.
Concerns around the spread of bird flu have heightened as the virus becomes more widespread in dairy cows.
Avian influenza, commonly called bird flu, is an infection from a type of influenza virus that usually spreads in birds and other animals, according to the Cleveland Clinic.
The virus usually spreads in birds but can also infect humans if they come in contact with an infected animals body fluid, like spit, respiratory droplets or feces, the medical center said.
It can also be spread if a human breathes in small dust particles in animal habitats or gets it into their eyes, nose or mouth after touching animal body fluids. People who work with poultry, waterfowl and livestock are most vulnerable to catching the virus.
Its extremely rare for the virus to spread from one human to another, according to the Cleveland Clinic.
Researchers still dont know how the recent outbreak of bird flu spread to cattle, but the leading theory is that it has to do with milking machines that could be carrying the virus, Jenna Guthmiller, an assistant professor of immunology and microbiology at the University of Colorado School of Medicine, said in the universitys journal.
She said high levels of the virus have been found in the cows udders, and the infection appears restricted to dairy cows, which furthers this possibility.
Influenza A has never been recorded like this in cows before. Theres the occasional cow infected, but they are not a natural host for influenza A viruses, so this is really quite shocking to the field, she said.
Bird flu has been detected in 42 cattle herds in nine states as of Tuesday, according to federal data.
These states include Michigan, New Mexico, North Carolina, Kansas, Colorado, Idaho, Ohio, South Dakota and Texas.
Researchers at Stanford University and Emory University found high amounts of bird flu viral RNA in archived wastewater samples from three sites in northern Texas, reported STAT. The virus had been present at detectable levels since late February, one month before the state confirmed its first case of bird flu in cattle, the outlet reported.
There has been only one confirmed human case of bird flu this year, which came out of Texas.
The person had direct exposure to dairy cattle presumed to be infected with bird flu and experienced eye inflammation as their only symptom, state officials said.
The CDC is monitoring 260 people who have been exposed to infected dairy cows for flu-like symptoms. Thirty-three people have been tested for the virus, according to agency data.
The agency says the current risk of contracting the virus to the general public is low as these cases are rare in humans.
Right now, the H5N1 bird flu situation remains primarily an animal health issue. However, the CDC is watching this situation closely and taking routine preparedness and prevention measures in case this virus changes to pose a greater human health risk, it said.
According to the CDC, symptoms of bird flu in humans range from eye redness or mild flu-like upper respiratory symptoms to pneumonia, high fever, cough, sore throat, runny or stuffy nose, muscle or body aches, headaches, fatigue, and shortness of breath or difficulty breathing.
Less common signs and symptoms include diarrhea, nausea, vomiting, or seizures, according to the agency.
The virus has been found in high levels in the raw unpasteurized milk of infected cows.
CDC officials warned last week that people who drink raw milk could theoretically become infected if the bird flu virus comes in contact with receptors in the nose, mouth and throat or if they inhale the virus into their lungs.
The Food and Drug Administration and the CDC both have long said that raw milk is one of the riskiest foods people can consume.
Raw milk can be contaminated with harmful germs that can make you very sick, the CDC warned.
But despite those warnings, sales of raw milk have risen.
Since March 25, when the bird flu virus was confirmed in cattle for the first time, weekly sales of raw cows milk have ticked up 21% to as much as 65% compared with the same periods a year ago, according to the market research firm NielsenIQ.
States have widely varying regulations regarding raw milk, with some allowing retail sales in stores and others allowing sales only at farms.
Viral remnants have been found in samples of milk sold in grocery stores, but the FDA said those products are safe to consume because pasteurization has been confirmed to kill the virus.
Bird flu is not transmissible by eating properly prepared and cooked poultry and eggs so these are safe to eat, the FDA has said.
The chance of infected poultry or eggs entering the food chain is extremely low because of the rapid onset of symptoms in poultry as well as the safeguards USDA has in place, which include testing of flocks, and Federal inspection programs, the agency said.
The Associated Press contributed to this story.
A new studypublished in Vaccine reveals that repeated flu vaccination does not appear to significantly weaken the protective effect of annual vaccines in older recipients.
The study looked at confirmed flu cases among those 60 and older in Ningbo, China, over four influenza seasons from 2018 to 2022. The researchers compared 1,976 cases of influenza-positive and 1,976 cases of influenza-negative controls.
In China, annual flu vaccines are recommended for those 6 months and older, but the vaccination rate among the older population remains significantly below the World Health Organization's target of 75%.
To increase vaccination uptake, the local government in Ningbo has funded free influenza vaccinations to residents aged 65 and older since 2020.
The authors of the study wanted to examine the relationship between repeated flu vaccinations and vaccine protectiveness. To do so, each flu-positive patient was matched with a negative control. Participants were considered vaccinated if they received one dose of flu vaccine at least 14days before the onset of symptoms during the corresponding influenza season.
Participants were grouped into four categories: 1) not vaccinated in either the current or prior season; (2) vaccinated in the previous season only; (3) vaccinated in the current season only; (4) and vaccinated in both seasons.
Overall, 11.6% were vaccinated in two consecutive seasons, 16.8% were vaccinated only in the current season, 6.5% were vaccinated only in the previous season, and 65.1% were not vaccinated.
Being older, male, and having hypertension were all factors associated with consecutive vaccination. The authors found no significant increased risk of influenza in consecutively vaccinated participants compared to those receiving the vaccine only in the current season (adjusted odds ratio [aOR],1.22; 95% confidence interval [CI], 0.94 to 1.58).
The risk of influenza was found to be elevated in individuals who received the vaccine only in the previous season (aOR, 1.56; 95% CI, 1.15 to 2.10). The highest risk was in those who had not received the vaccine in either of the consecutive two seasons (aOR, 3.39; 95% CI, 2.80 to 4.09).
Elderly individuals who received the vaccine only in the previous season or those who did not receive any vaccine for two seasons are facing a significantly increased risk of influenza infection.
"While there was a trend towards a reduction in protective efficacy, this difference did not attain statistical significance. Additionally, we have also observed a high degree of stability in this phenomenon across different influenza seasons. On the other hand, elderly individuals who received the vaccine only in the previous season or those who did not receive any vaccine for two seasons are facing a significantly increased risk of influenza infection," the authors concluded.
New Zealands decision to no longer offer free influenza vaccines for all children under 12 will likely wipe out recent gains in uptake. And it will disproportionately affect those living in deprived areas and with a high risk of disease.
Influenza accounts for more than half of all potentially vaccine-preventable hospitalisations of children under 14 in New Zealand. But those living in poorer areas are three times more likely to be hospitalised due to a lung infection.
Health New Zealand recommends annual vaccination for all children from the age of six months. During the 2022 winter season, New Zealands medicines funding agency Pharmac made flu vaccines free for all children aged three to 12. In 2023, this was extended to start at six months of age.
But in 2024, the funding was cut back to the previous criteria. This means only children with a history of significant respiratory illness, certain long-term medical conditions, or those hospitalised for any respiratory illness when aged under four are eligible for free vaccines.
We compared how many New Zealand children received the flu vaccine before (2018-21) and during (2022-23) universal funding and found substantially higher uptake when vaccines were free.
In 2018, before the COVID pandemic and free influenza vaccines for all children, only 4.4% of those under five received the vaccine. The uptake was lower in tamariki Mori (1.9%) and Pacific children (3.1%).
Flu vaccine uptake increased in 2020, likely because of general concern about respiratory illness during the first year of the COVID pandemic. But it declined again in 2021 to below 2018 levels.
Following universal funding in 2022, uptake almost tripled for under-fives (4.4% in 2018 to 12% in 2023). However, there were substantial differences by ethnicity. Uptake was highest in Asian children (21.3%) and lowest in Pacific children (8.0%) and tamariki Mori (4.9%).
The trends by age group give some insight into the impact of funding. In 2022, uptake increased more than two-fold in age groups where all children were eligible for free vaccines. In 2023, we saw a three-fold increase in uptake in the only newly eligible age group (six to 12 months). Overall, 12% of children of all ages except the oldest (nine to 12) were vaccinated.
Focusing flu vaccination funding only on those at the highest risk is a step backwards for New Zealand and will likely reduce uptake. In contrast, Australia has funded flu vaccines for all children aged six months to five years since 2019.
Acute respiratory hospitalisations from any cause are almost three times higher in New Zealand than in comparable countries. A recent report shows influenza accounted for 56% of all potentially vaccine-preventable hospitalisations between 2016 and 2020 in children under 14 years. This is more than varicella, measles, whooping cough and meningococcal disease combined.
It is not just children with medical conditions who get severely sick from influenza. In Australian children under five, less than half of those hospitalised due to influenza had long-term medical conditions, although these children were more likely to require intensive care.
While deaths from influenza are rare in children, over half of US children who died from it during the 2023-2024 winter season were previously healthy.
The effectiveness of the influenza vaccine varies from season to season, depending on circulating strains and how well that years vaccine is matched. But vaccination remains the main way to protect against severe influenza.
Studies in children found the influenza vaccine reduces the risk of hospitalisation by about 50%, and even higher for some influenza strains and years.
Studies in countries comparable to New Zealand (UK, Italy and Finland) looking at the cost effectiveness of flu vaccines found universal funding to be highly cost-effective compared with a high-risk approach.
In 2024, Pharmac stated:
We considered widening access to the flu vaccine [] we would like to fund in the future, depending on available budget.
In contrast, the comparable Australian advisory committee concluded in 2019 that universal influenza vaccination for children under five met its cost-effectiveness criteria.
Influenza causes more illness in young children, including severe disease requiring hospitalisation, than we generally recognise. An age-based universal programme would almost certainly result in substantially higher uptake, including in higher-risk children, than a targeted approach.
We believe the high and inequitable burden of influenza in young New Zealand children and the low cost of influenza vaccines, compared to other vaccines currently funded, should prompt urgent reconsideration of universal funding, at least for children below the age of five.
If universal funding is not considered affordable in the Pharmac budget, the case for restoring free vaccines for all Mori and Pacific children is strong given their high burden of disease.
As for the influenza immunisation programme in general, it is not just about funding. We must engage with the community to raise awareness of the severity of flu in children and the effectiveness and safety of vaccines, along with improving access to immunisation services.
We would like to acknowledge the contribution from colleagues Ewan Smith and Emily Dwight.
ByVinod RMT Balasubramaniam,
Monash Universityin Kuala Lumpur
Clinical trials of a universal influenza mRNA vaccine have begun in the US.
The US National Institute of Allergy and Infectious Diseases has started enrolling volunteers at Duke University in North Carolina to test itsexperimental mRNA-LNP vaccineagainst seasonal influenza, one of several universal influenza vaccine candidates now in the pipeline.Another clinical trialhas begun at the US National Institutes of Healths Clinical Centre in Maryland.
Influenza kills up to 650,000 people around the world each year.
Ninety-nine percent of deaths in childrenunder five years of age in developing countries are due to influenza-related infections, according to the World Health Organization.
The current crop of influenza vaccines haslimitationsin effectively combating thebillion casesof seasonal influenza each year as they provide immunity against only one specific existing strain or mutation. The propensity of flu viruses to mutate into new strains means vaccines must be continuously monitored and reformulated each year.
But a universal influenza vaccine, using mRNA technology which was used with success during the COVID pandemic has the potential to provide broader and longer-lasting immunity against diverse influenza strains.
The technology allows for rapid development and deployment and offers versatility in targeting multiple regions of the influenza virus.
New or mutated influenza variants are always a threat, particularly those originating from animal sources. Pandemics such as theSpanish fluof 1918, which killed 50 million people, and recent outbreaks of theavian influenza(bird flu) viruses underscore the persistent threat posed by influenza.
It also underscores the urgent need for auniversal influenza vaccinecapable of safeguarding against all subtypes of the virus.
In recent years, lipid nanoparticle (LNP)-encapsulated nucleoside-modified mRNA (mRNA-LNP) vaccines have emerged as a potent tool in combating influenza and other infectious diseases.
These vaccines use mRNA created in a laboratory to teach our cells how to make a protein or even just a piece of a protein that triggers an immune response inside our bodies.
The limited efficacy of current vaccines can be attributed to their focus on only generating strain-specific antibodies against the influenza virus hemagglutinin (HA). This is a protein within the virus which causes infection.
To broaden protective immunity, novel vaccine strategies aim to elicit responses against more proteins (fragments of a virus). One promising avenue involves triggering T-cell responses. T-cells are a type of white blood cell and are part of the bodys immune system.
T-cell-mediated immunity not only eliminates infected cells but also correlates with improved outcomes in individuals affected by influenza.Animal studieshave demonstrated the protective role of T-cells against various influenza virus strains.
These vaccines, exemplified by the successful development and global deployment of mRNA-LNP-basedCOVID-19 vaccines, elicit robust T-cell and antibody responses. These vaccines also offer the advantage of rapid production and adaptation to target emerging viral variants.
While several mRNA-LNP influenza vaccines arein development, most prioritise stimulating antibody responses and under-exploit the potential of T-cell immunity.
As shown by COVID-19, mRNA vaccines have demonstrated safety and efficacy in clinical trials forvarious infectious diseases. This instils confidence in the feasibility of developing a universal influenza mRNA vaccine that is safe and effective.
Ongoing advances in mRNA technology, such as improveddelivery systems and stabilisationmethods, further enhance the prospects of creating a universal influenza vaccine that ticks all the boxes.
The mRNA vaccine technology offers several advantages, including rapid development, scalability, and precise design. Two categories of mRNA vaccines exist,conventional and self-amplifyingand both are being explored for their potential to confer broad protection against influenza viruses.
Despite their promise, challenges remain in effectivelydelivering mRNA moleculesinto a vaccine due to their inherent instability. Overcoming these challenges is essential for the successful development of universal mRNA vaccines for influenza.
Dr Vinod Balasubramaniamis Associate Professor (Molecular Virology) at the Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia.
Originally published underCreative Commonsby360info.
FORT WORTH, Texas, May 20, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc (Nasdaq: TFFP) (the Company or TFF Pharmaceuticals), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced that, in collaboration with Cleveland Clinic, the Company is advancing multiple multivalent universal influenza vaccines to protect against seasonal and pandemic viruses into preclinical testing. The decision to advance the vaccine candidates into preclinical testing was based upon the successful completion of formulation testing with stability data on the combination of hemagglutinin (HA) antigens with four different adjuvants. Based on these data, three HA antigen/adjuvant candidate vaccines have been selected for testing in a pre-clinical model at Cleveland Clinic Florida.
Funded through the National Institute of Allergy and Infectious Diseases (NIAID), the purpose of the research collaboration between TFF Pharmaceuticals and Cleveland Clinic is to develop a first-in-class, stable, universal, easy-to-transport and easy-to-stockpile vaccine that would overcome the vaccine failures that result from mishandling, mismatches between predicted and actual seasonal flu strains, and evolutionary changes in influenza viruses across the season. Successful completion of the work funded by the Direct to Phase II SBIR grant will fulfill the IND-enabling requirements to potentially advance to human clinical testing.
A recent survey1 of infectious disease specialists presented at this years ESCMID Global Congress indicates that influenza could represent the next pandemic threat to the global population, said Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals. Working in collaboration with Dr. Ted M. Ross and his colleagues, our goal is to develop a shelf-stable mucosal vaccine with unique characteristics for inhalational delivery and would circumvent the need for cold chain storage which could significantly improve the availability and distribution of potentially life-saving medicine. We look forward to advancing these vaccine candidates into preclinical studies formulated with our Thin Film Freezing technology.
Over the last year, we have generated an impressive body of positive in vitro and in vivo data from these experimental influenza vaccines, enabling us to further advance these promising candidates into additional in vivo preclinical efficacy studies, said Ted M. Ross, Global Director of Vaccine Development at Cleveland Clinic and PI of the Center for Influenza Vaccine Research for High-Risk Populations (CIVR-HRP). Our team at Cleveland Clinic looks forward to advancing this important research, which brings us one step closer toward developing a universal influenza vaccine with the potential to protect patients worldwide.
In June 2023, the Company was awarded a Direct to Phase II Small Business Innovation Research (SBIR) grant of $2.97 million to continue development of a novel, pan-flu multivariant mucosal vaccine using the Companys Thin Film Freezing technology. The purpose of the SBIR is to provide funding to support preclinical and IND enabling studies to advance the development of a shelf-stable dry powder formulation of a novel universal influenza virus vaccine, developed in the laboratory of Dr. Ross, that is more than 75% effective against symptomatic influenza virus infection and protects against groups I and II influenza A viruses, the form of virus that has historically given rise to all known influenza pandemics and that contributes to seasonal flu each year.
Influenza is a contagious viral infection that attacks the respiratory system, infecting the nose, throat and sometimes the lungs. According to the U.S. Centers for Disease Control and Prevention (CDC), influenza has resulted in tens of thousands of deaths annually in the US since 2010 and hundreds of thousands of deaths globally. There is a significant need to improve flu prevention and management programs, and major efforts are under way to develop better and more broadly protective influenza vaccines.
ABOUT TFF PHARMACEUTICALS THIN FILM FREEZING (TFF) TECHNOLOGY TFF Pharmaceuticals proprietary Thin Film Freezing (TFF) technology allows for the transformation of both existing compounds and new chemical entities into dry powder formulations exhibiting unique characteristics and benefits. The TFF process is a particle engineering process designed to generate dry powder particles with advantageous properties for inhalation, as well as parenteral, nasal, oral, topical and ocular routes of administration. The process can be used to engineer powders for direct delivery to the site of need, circumventing challenges of systemic administration and leading to improved bioavailability, faster onset of action, and improved safety and efficacy. The ability to deliver therapies directly to the target organ, such as the lung, allows TFF powders to be administered at lower doses compared to oral drugs, reducing unwanted toxicities and side effects. Laboratory data suggests the aerodynamic properties of the powders created by TFF can deliver as much as 75% of the dose to the deep lung. TFF does not introduce heat, shear stress, or other forces that can damage more complex therapeutic components, such as fragile biologics, and instead enables the reformulation of these materials into easily stored and temperature-stable dry powders, making therapeutics and vaccines more accessible for distribution worldwide. The advantages of TFF can be used to enhance traditional delivery or combined to enable next-generation pharmaceutical products.
ABOUT TFF PHARMACEUTICALS
TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company engaging patented rapid freezing technology to develop and transform medicines into potent dry powder formulations for better efficacy, safety, and stability. The companys versatile TFF technology platform has broad applicability to convert most any drug, including vaccines, small and large molecules, and biologics, into an elegant dry powder highly advantageous for inhalation, or for topical delivery to the eyes, nose and the skin.
SAFE HARBOR
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements in this press release include, but are not limited to, statements by the Company relating to the expectation that the preclinical testing of the Companys multiple multivalent universal influenza vaccine candidates will favorably consistent with formulation testing conducted to date, the expectation that the Company will be able to move its vaccine candidates into the Phase II clinical trial and the benefits of the Companys TFF platform. Forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially, including (i) the risk the preclinical testing of the Companys influenza vaccine candidates will not be favorably consistent with the formulation testing to date, (ii) the risk that the Company may not be able to advance its influenza vaccine candidates to Phase II clinical trials, (iii) success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; (iv) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (v) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, and (vii) those other risks disclosed in the section Risk Factors included in the Companys Quarterly Report on Form 10-Q filed with theSEConMay 14, 2024. The Company cautions readers not to place undue reliance on any forward-looking statements. The Company does not undertake and specifically disclaims any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law.
Investor Relations Contact: Corey Davis, Ph.D. LifeSci Advisors (212) 915-2577 cdavis@lifesciadvisors.com
1 Source: https://medicalxpress.com/news/2024-04-experts-influenza-pathogen-pandemic-potential.html
Paul D. Parkman, a scientist who in the 1960s played a central role in identifying the rubella virus and developing a vaccine to combat it, breakthroughs that have eliminated from much of the world a disease that can cause catastrophic birth defects and fetal death, died May 7 at his home in Auburn, N.Y. He was 91.
A team of researchers at BHU in a one-year follow-up study found out that nearly one-third of 926 individuals who received Bharat Biotech's anti-Covid vaccine Covaxin reported 'adverse events of special interest,' or AESI. An AESI is an event that occurs in some people post immunisation that has the potential to be causally associated with a vaccine product. (Also read: 1 in 3 Covaxin takers reported adverse events, BHU study claims)
Serious AESI, including stroke and Guillain-Barre syndrome, was reported in around one per cent of individuals as per the study. New-onset skin and subcutaneous disorders, general disorders, and nervous system disorders were the three most common disorders observed in adolescents after receiving the vaccine. Guillain-Barre syndrome is an autoimmune disorder that causes weakness in nerves in the arms and legs. An ischemic stroke occurs when the blood supply to part of the brain is blocked or reduced.
The study published in the Journal of Springer Nature looked at the long-term safety of the BBV152 (Covaxin) vaccine in adolescents and adults.
The study that was conducted from January 2022 to August 2023 mentioned that nearly 50 per cent of the sample size complained of infections during the follow-up period, predominated by viral upper respiratory tract infections.
However, Bharat Biotech in a statement in response to the study, said, "several studies have been executed on the safety of Covaxin, and published in peer-reviewed journals, demonstrating an excellent safety track record". The study involved 635 adolescents and 291 adults, who received the BBV152 vaccine.
"The creation of Covid-19 vaccines, such as Bharat Biotech's Covaxin, was essential to contain the pandemic. To guarantee patient safety and successfully address issues, it is crucial to monitor and comprehend the long-term adverse effects, just as with any medical operation," says Dr Vanita Arora, Senior Consultant Cardiac Electrophysiologist & Interventional Cardiologist at Apollo Hospital, Delhi.
Research from Banaras Hindu University and other recent studies have shown that approximately one-third of subjects experienced AESI a year after using Covaxin. The most frequent of these occurrences, which varied in severity, were viral upper respiratory tract infections. Reports of severe AESI, like stroke and Guillain-Barr syndrome, were more worrisome.
Dr Arora shares the possible side effects of Covaxin and whether those who got jabbed needed to worry:
Significant concerns are raised by strokes described as AESI, particularly in patients with cardiovascular risk factors. Although the exact pathophysiological processes relating vaccinations to stroke remain unclear, it is possible that they entail an immune-mediated process that aggravates underlying vascular problems. Patients should be especially careful if they have a history of atrial fibrillation, diabetes, or hypertension. It is advised to keep cardiovascular risk factors under control and to undergo routine follow-ups. It is crucial to consider the danger in its proper context, though, as the risk of severe consequences from Covid-19 alone is still much higher than the rate of stroke following immunisation.
Although the incidence rate of GBS post-Covaxin is minimal, it is worth emphasising that its prevalence is alarming. It is important to educate patients about the early signs of GBS, which include tingling feelings and weakness in the muscles so that they can seek medical assistance as soon as they appear.
"Following Covaxin treatment, adults with pre-existing medical issues seem to be more vulnerable to AESI. Patients suffering from long-term conditions like diabetes, heart disease, and autoimmune disorders should pay special attention to this. These people should keep up their routine health monitoring and notify their healthcare professional right if they experience any unexpected symptoms," says Dr Arora.
"While these adverse effects are important to consider, it's also important to weigh them against the advantages of vaccination. Hospitalisations, fatalities, and a reduction in the severity of Covid-19 infections have all been successfully avoided with the use of Covaxin. Significant Covid-19 consequences, such as chronic heart problems, are frequently more likely to occur than significant AESI, which is a relatively low risk," adds the expert.
"Ideally a vaccine should not have any side effects, but unfortunately we dont have an ideal vaccine to date. Vaccine-related adverse events usually happen rarely and get better with paracetamol and taking fluids. Nonetheless, the advantages of vaccination far surpass the risks by shielding us from severe health complications. AESIs, known as Adverse Events of Special Interest have been raised with certain patients who had Covaxin. If we analyse the effect of Covaxin on fight against COVID and compare them to certain adverse events in few patients, benefits clearly outweigh risk. It's therefore important not to fret or lose hope about these occurrences," says Dr Arunesh Kumar Head & Senior Consultant - Pulmonology and Respiratory Medicine, Paras Health.
(With inputs from PTI)
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Gayle Borne has fostered more than 300 children in Springfield, Tennessee. Shes cared for kids who have rarely seen a doctor kids so neglected that they cannot speak. Such children are now even more vulnerable because of a law Tennessee passed last year that requires the direct consent of birth parents or legal guardians for every routine childhood vaccination. Foster parents, social workers, and other caregivers cannot provide permission.
In January, Borne took a foster baby, born extremely premature at just over 2 pounds, to her first doctors appointment. The health providers said that without the consent of the childs mother, they couldnt vaccinate her against diseases like pneumonia, hepatitis B, and polio. The mother hasnt been located, so a social worker is now seeking a court order to permit immunizations. We are just waiting, Borne said. Our hands are tied.
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Amidst concerns around TTS or Thrombotic Thrombocytopenia Syndrome, the side effect the drug maker has admitted in court documents, one more side effect has come to the fore in connection with AstraZeneca's COVID vaccine.
As per a report, AstraZeneca's COVID vaccine can also cause VITT or Vaccine-Induced Immune Thrombocytopenia and Thrombosis, a blood clotting disorder.
According to the American Society of Hematology, signs of VITT develop 4 to 42 days after vaccination. The key signs are severe headache, visual changes, abdominal pain, nausea and vomiting, back pain, shortness of breath, leg pain or swelling and easy bruising.
World Hypertension Day: Unraveling the escalating crisis of hypertension amongst youth
A 2022 study published in the Journal of Family Medicine and Primary Care, highlights the occurrence of VITT. "Vaccination is supposed to be the most reliable means to end the COVID 19 pandemic, but recently there have been reports of thrombosis and thrombocytopenia in patients receiving the vaccine especially ChAdOx1 nCoV-19 (AstraZeneca University of Oxford and Serum Institute of India). This has been termed as vaccine-induced immune thrombotic thrombocytopenia (VITT), thrombosis with thrombocytopenia syndrome (TTS) and vaccine-induced prothrombotic immune thrombocytopenia (VIPIT)," it says. "The incidence of VITT ranges widely from one case per 26,000 to one case per 127,000 doses of AstraZeneca/COVISHIELD administered in countries like Norway and Denmark reporting the highest rates," the report by researchers from the Department of Medicine, Tata Main Hospital, Bistupur, Jamshedpur, Jharkhand, India adds.
Development of symptoms 442 days after exposure to COVID vaccine.
Venous or arterial thrombosis at any site.
Thrombocytopenia (platelet count <150 109/L).
Positive platelet-factor 4 heparin-induced thrombocytopenia (PF4 HIT) by ELISA.
D-dimer elevated at least four times the upper limit of normal.
In VITT, individuals make antibodies that stick to one of the bodys own proteins called the PF4 or the platelet factor 4. This results in the formation of large structures called immune complexes. A Conversation report explains: These complexes bind to and activate small cells called platelets that are vital for blood clotting. Normally, platelets float around in the blood in an inactive state, but once activated they spread out, get very sticky, and spew out hundreds of different chemicals. In VITT, platelets are strongly activated and this causes blood clots. The blood clots commonly affect the veins surrounding the brain, which is a very unusual and rare site for clots. Many people with VITT reported excruciating headaches, which continue to affect survivors.
Moderna said Friday that the European Patent Office has upheld the validity of one of its key patents, a victory in a continuing dispute with Pfizer and BioNTech over rival COVID-19 vaccines.
Cambridge-based Moderna has been fighting Pfizer and BioNTech in the courts over the partners COVID shot, called Comirnaty. Moderna sued them in 2022 for allegedly copying its messenger RNA technology.
Pfizer and BioNTech, its German business partner, filed a countersuit, alleging that Modernas patent was invalid.
Comirnaty and Modernas vaccine, Spikevax, generated billions of dollars during the pandemic. But revenues have plunged as the health threat receded and there was tepid interest in booster shots.
We are pleased that the European Patent Office decided to maintain the validity of Modernas EP949 patent, one of the key patents currently asserted against Pfizer and BioNTech in various European national courts, Moderna said in a statement to the Globe.
Moderna said it expected that Pfizer-BioNTech will appeal the decision. New York-based Pfizer told Reuters that it was disappointed in the decision and would consider all legal options.
Irrespective of the outcome of this legal matter, we will continue to manufacture and supply the Pfizer-BioNTech COVID-19 vaccine, Pfizer said in a statement to Reuters.
The oral decision was handed down on Thursday, according to the Financial Times, which was the first to report the matter. A written decision is expected to be published in the coming months.
Modernas stock was largely unchanged on Friday, rising 0.17 percent to close at $132.90.
Jonathan Saltzman can be reached at jonathan.saltzman@globe.com.
