Pharmaceutical giant AstraZeneca admitted in court this week that its COVID-19 vaccine can cause a rare but deadly blood-clotting condition that has become the central focus of a class-action lawsuit worth potentially $125 million.
A Northeastern University legal scholar says the admission isnt especially damning, as the rare condition called thrombosis with thrombocytopenia syndrome, or TTS was well-studied prior to the ongoing litigation.
The fact that this had already been listed as a potential side effect reduces its legal impact, says Richard Daynard, university distinguished professor of law and president of the Public Health Advocacy Institute.
Daynard continues: After all, the vaccine saved many more lives in Britain than were affected by this side effect, so AstraZenecas admission of what had already been listed would not seem to be a big deal.
There are 51 cases of TTS associated with the AstraZeneca vaccine cited in the U.K.-based class action suit. The Centers for Disease Control and Prevention notes that there are roughly four cases of the condition reported per one million administered doses of the Johnson & Johnson vaccine which, like the AstraZeneca, is an adenovirus vaccine.
If you received the AstraZeneca vaccine, should you be concerned about TTS? Northeastern Global News spoke to Mansoor Amiji, Northeastern distinguished professor in the departments of pharmaceutical sciences and chemical engineering, to get some perspective on the link between the shot and this rare side effect.
Amijis comments have been edited for brevity and clarity.
There are a couple issues to discuss here. First of all, the AstraZeneca vaccine is an adenoviral DNA vaccine, so it doesnt use the mRNA molecule delivered through the lipid nanoparticles that Moderna and Pfizer developed.
Through a collaboration with Oxford University, the AstraZeneca vaccine was first approved in the United Kingdom. It uses a modified form of what basically is a cold virus, or an adenoviral vector, and the vaccine delivers a DNA molecule that then gets into the human cell and encodes for the spike protein very similar, in terms of the final product, to how the mRNA vaccines work.
In the United Kingdom and other places where this particular vaccine was prevalent, we did see a small number of people develop thrombocytopenia, or blood clotting that is initiated by a protein called platelet factor 4. Its a very rare side effect, but it was seen in a number of cases post-approval of this vaccine back in 2021 and the early part of 2022.
The news this week isnt news to the medical community. The reason it is coming to our attention is because AstraZeneca is now saying that this is a side effect of their vaccine. Initially, they was sort of hand-waving about the connection, saying that the development of the blood clots could be due to other factors, like a persons comorbidities, vascular disease or other secondary considerations. It wasnt clear that it was linked directly to the vaccine itself.
However, when you see that the majority of those who developed this condition did so post-vaccination and it is in a very small percentage of those who received this vaccine, to be clear the link becomes much more apparent. Now, theyre admitting that the vaccine may be responsible.
Like I said before, the adenovirus has a DNA molecule inside it, which is then injected intramuscularly. But when in the bloodstream, this DNA molecule attracts a protein in the blood called platelet factor 4, and in certain individuals not in all, but in a very small number platelet factor 4 can exaggerate the bodys own immune response. Typically when you see clot formation in the body, its a mechanism by which the body is attempting to shield something from everything else in our body. It creates a capsule around the viral particle and recruits more platelets and red blood cells and fibrin, creating a blood clot, and this is referred to as thrombocytopenia.
The U.K., where this lawsuit is ongoing, has a pretty high uptake about 150 million people of the COVID-19 vaccine, but the majority of people there have received the Pfizer vaccine. This issue is not prevalent in the mRNA vaccines at least, we havent seen that level of clot formation here in the United States, where a majority of individuals have been vaccinated either with Modernas or Pfizers mRNA vaccine that is delivered using a lipid nanoparticle formulation.
But in terms of the number of cases of thrombocytopenia and whether this is truly an issue that should worry people, the mechanistic studies have already been conducted, and only a tiny fraction of individuals were affected. Also, we arent seeing any other serious or new side effects associated with these vaccines.
In the last two and a half years, the COVID-19 pandemic has drastically affected millions worldwide. The impact hammers on physical and mental health problems in the post-COVID-19 state1. This phenomenon raises the necessity to investigate the relationship between post-COVID conditions and mental health2. Primarily, the investigation shows that coronavirus has a long-term effect of post-COVID-19 disease on sleep and mental illness, which also opens the door to detecting possible relationships between the severity of COVID-19 at the onset and sleep and mental illness3. Coronavirus affects the brain by bypassing the blood-brain barrier (BBB) in blood or via monocytes which could reach brain tissue via circumventricular organs7. Importantly, research shows a prominent frequency of impaired performance across cognitive domains in post-COVID patients with subjective complaints25. At the same time, the discovery of inflammatory biomarkers in COVID-19 survivors has come into broad light through MRI samples and other means4. One out of five patients hospitalized for COVID-19 was diagnosed with PTSD or subthreshold PTSD at a 3-month follow-up6. Potential contributing factors cause post-COVID-19 patients to suffer from different memory complaints5. Moreover, some psychiatric issues like depression prevail in COVID recovery patients, which causes a 25 times greater risk for suicide than the general population26. A summary of data from last year about the impacts on physical, cognitive, and neurological health disorders in COVID-19 survivors suggests three crucial aspects to manage: nutritional status, neurological disorders, and physical health28. So, the impaired cognitive deficits and emotional distress among COVID-19 patients should be addressed by functional rehabilitation27. Side by side, a brief study is to be analyzed on post-COVID-19 pandemic era mental health issues, vulnerable populations, and risk factors, as well as recommending a universal approach for mental health care and services29. Physiological and Neurological factors have been examined, with 39% classified as Physiological and 61% as Neurological. Neurological factors influence the mind and are connected to a persons mental and emotional state.30. Here anxiety is a major Neurological factor among post-COVID patients with a frequency rating of 8 as shown in Table 2. Anxiety is the most common mental illness in post-COVID1. Physiological factors deal with the functions of a living organism and its parts30. Fatigue is one of the most frequent alterations of post-COVID patients as shown in Table 2. Over the past three years, extensive research has explored physiological and neurological health complications in the aftermath of COVID-19. We reviewed 23 research articles using keywords like mental health, cognitive impairment, and post-COVID trauma. From these studies, we identified 17 health factors associated with COVID infection, including fatigue, forgetfulness, and anxiety. These factors were categorized into two groups: Physiological and Neurological. Notably, 39% are Physiological factors, while 61% are Neurological factors, impacting the mind and emotional well-being30. Here anxiety is a major neurological factor among post-COVID patients with a frequency rating of 8 as shown in the Table 2. Anxiety is the most common mental illness in post-COVID1. Physiological factors deal with the functions of a living organism and its parts30. Fatigue is one of the most frequent alterations of post-COVID patients Table 2.
In this way, all revealed health factors are listed in Table 2 along with references and frequency of presence in those references.
Among the 17 factors we have divided them into two categories, as shown in Table 2;
Physiological factors: Physiological factors deal with the functions of a living organism and its parts30. For example, fatigue is one of the most frequent alterations of post-COVID patients in Table 2. There are 7 physiological factors identified among all post-COVID-19 factors in this study, as shown in Table 2.
Neurological factors: Neurological factors are the one that influences or affects the mind and are related to the mental and emotional state of a person30. For example, anxiety is the most common mental illness in post-COVID1. There are 10 neurological factors identified among all post-COVID-19 factors in this study, as shown in Table 2.
We have given a statistical overview of our data in Fig.2 to make our data more understandable. Data statistics, such as count, min, max, mean, standard deviation, variance, and median, are essential for understanding a dataset. Count shows dataset size, min/max indicates its range, mean reflects central tendencies, standard deviation measures data spread, and variance quantifies overall variability. The median is a robust central measure. These stats form the foundation for data summary, with quartiles, percentiles, skewness, and kurtosis for deeper dataset analysis.
Statistical overview of data.
Feature correlation in Figs.3 and 4 gives a statistical measure that assesses the degree of association or relationship among features (variables) in our dataset. It quantifies how these features tend to vary together, providing insights into their dependencies. The advantages of this feature correlation (pearson) analysis in Fig. 4 (Full information is shown in Fig.5) includes its utility in identifying redundant or highly informative features for best model performance, detection of multicollinearity in regression analysis, simplifying data exploration by revealing hidden patterns and relationships, aiding in model interpretability, and facilitating feature engineering by leveraging the knowledge of feature associations to create new informative variables. Pearson correlation, is a crucial data science tool. It quantifies the strength and direction of the linear relationship between two continuous variables, with values ranging from 1 to 1. This technique is widely employed in statistics and data analysis to uncover connections, patterns, and dependencies within complex datasets.
Pearson correlation value for all to all input features.
Overview of target classanxiety.
TNSE visualization of features for after anxiety.
The chi-square test is one of the methods to find out the association i.e. relationship among the categorical variables. The relationship can be significant or insignificant. The standard P-value is considered as 0.05 and any p-value having less than 0.05 is considered to have a significant association i.e. relationship among variables as shown in Fig.3. In this research, the survey dataset has the responses i.e. level of impact on various physiological & neurological factors. These factors are considered categorical variables. The chi-square test is applyed on all factors and we got P-value for them which is shown in Fig.3. In the Table 3, calculated p-values less than 0.05 are marked with Grey color. These values with corresponding Factors are analysed to possess significant relationships among them.
From the Fig.3, we can see all comparing factors have an association between them, Some basic features association as follows: a. Chest Pain & Unhappiness b. Unhappiness & Forgetfulness c. Depression & vigilance d. Chest pain & confidence e. Confidence & vigilance f. Energy & confidence g. Sleep & attentiveness h. Attentiveness & vigilance i. Sleep & determination j. Determination & vigilance and k. Fear of COVID & energetic
Pearson correlation coefficient is a unit measuring the strength of the linear relationship between two variables. This is represented as the r-value. R-value results in the range from 1 to 1. +1 represents the positive correlations(direct relationship), 0 shows no relationship & 1 represents the negative correlations(inverse relationship). In the research, the physiological & neurological factors of the dataset are depicted as variables. The Pearson correlation coefficient is calculated for all factors, and we got the R-value for them shown in Fig.3. The R-values above 0.05 are considered for positive/direct relation between the factors. This means an increase in one factor may influence and increase the degree of another factor. R-values below 0(in the -ve range) are considered for Inverse relation between factors. This means a Decrease in one factor may influence and Decrease another factor. The Pearson correlation revealed a strong positive relationship between the two variables, with a correlation coefficient of 0.85, indicating a significant and direct association.
Feature importance analysis shown in Fig.3 using the Ordinary Least Squares (OLS) regression model is a valuable technique in data analysis and predictive modeling. In this table, we renamed each feature name and labeled it from 1 to 13. In the context of feature importance, OLS can reveal the impact of each independent variable on the dependent variable. Larger coefficient values indicate stronger feature importance, while coefficients near zero suggest less relevance. This analysis aids in feature selection, helping us focus on the most influential variables for building predictive models or understanding the factors that drive specific outcomes in the data. Based the outcome shown in Table 3, the most important feature is 13(with a score of 1.5447) and the less important feature is 1(with a score -1.0443).
Training algorithm for anxiety analysis.
Firstly, the compiled dataset is used for Statistical Analysis to explore whether any impact exists on the factors due to COVID-19 or not. The dataset possesses the info of both the Before and After conditions of the factors. The x-axis shows the categories/responses of people on how much each factor, like anger, depression, etc is affected. Y-Axis shows the percentage of how many persons are acknowledged in each category. In Fig.4b, we present a comparative view of anxiety before and after COVID-19. The blue color represents the degree of impact for the factors before being affected by COVID-19. The red color represents the status after suffering from the disease.
Before COVID-19 state, no people strongly agreed on having Anxiety over their COVID issue, but the percentage jumped to 16.67% who strongly agreed after suffering from it. The graph follows the same pattern in the subsequent remarks. Comparing the before & after situations, it can be concluded that after suffering from COVID-19, a large number of people got the new problem whereas the people having previous Anxiety issues remained the same/more. In Fig. 4a, we present a complete view of anxiety amount before and after COVID-19.
It is such a factor that shows most of the patients are suffering from depression more after COVID. 23.33% and 36.67% patients either strongly agreed or agreed respectively on this matter. This figure has risen from 16.67% and 20.00% before COVID. While 36.67% disagreed on this matter before COVID the figure came down to only 10.00% after COVID. Depression, in human life, has increased after COVID-19
On the factor of unhappiness, 33.33%, and 26.67% people agreed on their unhappy life before and after COVID respectively. However we see an almost inverse trend on the neutral point of view among the patients. Thus comparing the before & after situation, it can be visualized that after suffering from COVID-19, unhappiness has decreased among the patients.
The degree of confidence before and after the COVID-19 era shows a drastic change in peoples mentality. Before COVID-19 state, 56.67% of people agreed on their degree of confidence but COVID had hit hard on their lifestyle shifting down to 20% confidence degree after COVID. The same trend was seen in the disagreement chart. Comparing the before & after situation, it can be concluded that after suffering from COVID-19, the majority of the peoples confidence in themselves was shattered.
Regarding forgetfulness, double the number of patients either agreed or strongly agreed that they forgot things now more after suffering from it. Thus, COVID has fatally affected the patients memory, resulting in curbing their brains.
Before suffering from COVID, about 60% people agreed that they were more patient in life, but the percentage abruptly dropped to half who decided to be after suffering from COVID. But none Strongly Disagreed in this regard, neither before nor after. Thus comparing the before & after situation, it can be visualized that after suffering from COVID-19, vigilance has decreased by almost half or beyond among the patients.
Before the COVID-19 state, most people (56.67%) agreed about being more energetic, whereas the percentage increased in favor disagreement (36.67% disagree, 10% strongly disagree) in the post-COVID state. Comparing the before & after situations, it can be depicted that after suffering from COVID-19, people are becoming significantly less energetic.
Before COVID-19 state, no people strongly agreed about having chest pain, but the percentage jumped to 23.33% who strongly agreed after suffering from COVID. Comparing the before & after situations, it can be concluded that after suffering from COVID-19, a large number of people got the new problem, whereas the people having previous chest pain history remained the same/more.
Before COVID-19 state, about 36.67% of people agreed that they experienced more sleep, but the percentage decreased to 33.33% who agreed after suffering from COVID. Comparing the before & after situations, it can be concluded that after suffering from COVID-19, experiencing sound sleep conditions shows a sight-decreasing tendency.
Before COVID-19 state, about 43% of people were NEUTRAL about their anger problem, whereas 40% people agreed about the problem. Comparing the before & after situations, it can be concluded that after suffering from COVID-19, most people agreed that their anger has increased.
Before the COVID-19 state, most people (50%) disagreed about having dizziness problems, but the percentage is rising in favor of strongly agree (16.67%) and agree (36.67) in the post-COVID state. Comparing the before & after situations, it can be concluded that after suffering from COVID-19, dizziness is slowly increasing among people after COVID.
Before the COVID-19 state, a few people (3.33%) strongly agreed that they had been impulsive, but the percentage increased to 20% who strongly agreed after suffering from COVID. Comparing the before & after situations, it can be concluded that after suffering from COVID-19, people show a sight-increasing impulsiveness tendency.
Before suffering from COVID, about 60% of people agreed that they were more vigilant, but the percentage abruptly fell to 16.67% who agreed after suffering from COVID. At the same time, disagreement degrees increased in the post-COVID situation. Comparing the before & after situations, it can be visualized that after suffering from COVID-19, vigilance has decreased dramatically among the patients.
Actor Shreyas Talpade has spoken about his health and that his recent heart attack could be a side effect of the Covid-19 vaccine. Speaking with Lehren Retro, Shreyas shared that he took care of his health, and despite that, he had a heart attack. Shreyas added that he couldn't "negate the theory" that people have been facing health issues after taking the vaccine. (Also Read | Shreyas Talpades family shares health update after his heart attack: He looked at us and smiled today)
Talking about himself, Shreyas said, "I don't smoke. I'm not really a regular drinker, I drink perhaps once a month. No tobacco, yes, my cholesterol was a little high, which I was told is normal these days. I was taking medication for that, and it had come down reasonably. So, if all the factors--no diabetes, no blood pressure, nothing, then what could be the reason?
He said that despite being careful about his health if this happens, there must be some other reason. Shreyas continued, I would not negate the theory. It was only after the Covid-19 vaccination is when I started experiencing some fatigue and tiredness. There has to be some amount of truth, and we cannot negate the theory. Maybe it is Covid or the vaccine, but there is something associated post that...It is very unfortunate because we genuinely dont know what we have taken inside our bodies. We went with the flow and trusted the companies. I never heard of such incidents before Covid-19."
Shreyas added that he wants to know what the "vaccine has done with us". He also said that he isn't sure whether it is Covid-19 or the vaccine, adding that since he doesn't have "enough proof, it is pointless to make any statements". He concluded that he wants to "explore what it has done to our bodies".
On December 14, last year, Shreyas suffered a heart attack in Mumbai after complaining about discomfort following the shooting of his upcoming film Welcome To The Jungle. He was admitted to Mumbai's Bellevue Hospital, where he underwent angioplasty.
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Golmaal Again star Shreyas Talpade, who suffered a cardiac arrest last year, in a recent interview taLked about the possibility of the attack being a side effect of COVID-19 vaccine. Speaking with Lehren Retro, Shreyas said, "I don't smoke. I'm not really a regular drinker, I drink perhaps once a month. No tobacco, yes, my cholesterol was a little high, which I was told is normal these days. I was taking medication for that, and it had come down reasonably. So, if all the factors--no diabetes, no blood pressure, nothing, then what could be the reason?
He continued, I would not negate the theory. It was only after the Covid-19 vaccination is when I started experiencing some fatigue and tiredness. There has to be some amount of truth, and we cannot negate the theory. Maybe it is Covid or the vaccine, but there is something associated post that...It is very unfortunate because we genuinely don't know what we have taken inside our bodies. We went with the flow and trusted the companies. I never heard of such incidents before Covid-19."
Last year in December, actor Shreyas Talpade suffered a heart attack. In a chat with ETimes, the actor described his recovery as a second chance at life. Admitting that his revival was nothing short of a miracle, Shreyas shared that he did not see this health setback coming. I was never hospitalised before in my life, not even for a fracture so I didn't see this coming. Don't take your health for granted. Jaan hai toh Jahaan hai. An experience like this changes your perspective towards life. I started doing theatre at 16, became a professional actor at 20. For the past 28 years, I have just been focussing on my career. We take our families for granted. We think we have time. As a nation, we are not high on preventive care," he was quoted as saying.
Speaking about what happened on the fateful day, Shreyas Talpade explained, "We were shooting in Mumbai at the SRPF grounds close to Jogeshwari for Ahmed Khan's Welcome To The Jungle. We were doing army training sequences like swinging on a rope, falling into the water and everything was going smoothlySuddenly, after the last shot, I felt breathless, and my left hand started paining. I could barely walk to my vanity van and change my clothes. I thought it was a muscle pull since we were shooting action sequences. You don't think of the worst-case scenario, right? I had never experienced this kind of fatigue.
Shreyas Talpade played the leading role in Nagesh Kukunoor's 2005 film Iqbal. He is known for his work in hit films such as Om Shanti Om, Dor, Golmaal 3, Kaun Pravin Tambe? and Housefull 2 among others.
The US shared gobsmacking evidence with Britain at the height of the Covid pandemic suggesting a high likelihood that the virus had leaked from a Chinese lab, The Telegraph can reveal.
In January 2021, Five Eyes intelligence-sharing nations were convened to discuss the possibility of a lab leak as the US warned that China had covered up research on coronaviruses and military activity at a laboratory in Wuhan.
In a previously unreported phone call that month, Mike Pompeo, the former US secretary of state, presented evidence that supported the lab leak theory to Dominic Raab, then the Foreign Secretary, and representatives from Canada, New Zealand and Australia.
Speaking to The Telegraph, two Trump administration officials accused Mr Raab and the UK Government of ignoring the lab leak theory because of resistance from government scientists who supported the explanation that the virus had jumped between animals and humans.
Mr Pompeo presented a summary of classified American intelligence reports collected in the early days of the pandemic and compiled by the State Department. The intelligence reports themselves are understood to have been shared separately with the UK via the Five Eyes network between October and December 2020.
We saw several pieces of information and thought that they were, frankly, gobsmacking, said one former official who worked on the intelligence that informed Mr Pompeos report. They obviously pointed to the high likelihood that this was indeed a lab leak.
In one document, which has since been released by the State Department under Freedom of Information laws, US officials warned of consistent stonewalling by China after the virus was first discovered and accused local officials of gross corruption and ineptitude.
The research revealed for the first time that Chinese military officials had worked with the Wuhan Institute of Virology in the years leading up to the pandemic, and that some researchers at the lab had become ill shortly before the virus was first recorded nearby.
It also showed that Chinese scientists had carried out gain of function research at the institute, which has since become a key piece of evidence for the lab leak theory.
The theory has become a divisive topic among scientists and government officials in the years following the pandemic and has prompted two investigations by the World Health Organisation, which China has been accused of obstructing.
British government ministers including Boris Johnson initially dismissed the possibility that Covid had been created by scientists, arguing in June 2021 that the advice that we have had is that it doesnt look as though this particular disease of zoonotic origin came from a lab.
Two former officials claimed the UK had ignored the evidence presented by the US because ministers saw the lab leak claims as a radioactive American political issue fuelled by public disagreement between government scientists and Donald Trump.
Once the thing became fundamentally political, the ability to pursue it internationally really just collapsed because no one else was interested in touching it, said one of the officials. I think [Five Eyes] were kind of annoyed by the way the issue had become treated in US politics.
Both separately named Sir Jeremy Farrar, a member of the Governments Scientific Advisory Group for Emergencies as one of the leading opponents of the lab leak theory within the British government.
A majority of scientific experts have long said that they believe an animal to human interaction was the most likely cause of the first infection.
However, some Government figures, including Michael Gove, have since said that they believe the virus was man-made.
In November, Mr Gove told the Covid Inquiry that there was a significant body of judgment that believes that the virus itself was man-made and that presents its own set of challenges.
Both the FBI and US Department of Energy have said they believe a lab leak is the most likely cause of Covid, while other agencies have said they think it occurred naturally.
Joe Biden, the US president, has said he does not know where the virus started, while the US National Intelligence Council said last year it probably emerged and infected humans through an initial small-scale exposure.
UK ministers are now facing calls to expand the terms of the Covid Inquiry to include an investigation into the origin of the virus.
The Telegraph understands that the call in Jan 2021 was deliberately held on an open line without security encryption in the hope that Chinese intelligence agencies would hear that Western countries were aware of military activity in Wuhan.
We did that deliberatelywe wanted to put pressure on the bad guys, said a State Department source.
Ten days after the call, in which officials said the UK was unwilling to assist with a US-led lab leak investigation or share its own research, the summary compiled by Mr Pompeos officials was released to the public in a fact sheet.
Those involved in the release said they took care to avoid revealing the sources or methods of US spy agencies, and that it was just the tip of the iceberg of the underlying intelligence that had been gathered.
A UK government spokesman said: There are still questions that need to be answered about the origin and spread of Covid-19, not least so we can ensure we are better prepared for future pandemics.
The UK continues to support the World Health Organisation in its expert study of the origins of Covid-19. It is important that China and other countries cooperate fully with the researchers.
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Four years ago this week, there was only one subject on Canadians minds: the incipient COVID-19 pandemic. Schools and businesses were locked down in most of the country. The death count was appalling: close to 1,900 in the first full week of the month. In all, about 4,300 Canadians would die that May with far more brutal waves of infection and death to come.
The story is much different today. Thanks to the rapid development, approval and delivery of vaccines an amazing human accomplishment that isnt celebrated enough COVID-19 has been brought to heel and is now largely seen as just one more viral disease, like the flu or common cold. The availability of home testing kits means most people who become infected by the latest variants of the SARS-CoV-2 virus can manage the disease at home, and never trouble the health care system.
Thats good, but it hides the troubling fact that it is difficult to discern coherent policies at any level of government for continuing the fight against COVID-19, for dealing with its long-term effects, or for preparing for another pandemic.
First and foremost, the pandemic is still going on. While infection rates are stable, there were still 3,320 new cases and 94 deaths from April 7 to April 20, according to federal data. Thats more than six deaths a day. And the number of cases is undercounted, given that many people wont bother to report a positive home test to the government.
As well, there is a continuing long COVID crisis in Canada, in which symptoms sometimes debilitating ones last months or even years. A Statistics Canada report from last December found that 2.1 million people were experiencing long COVID symptoms as of June, 2023.
Meanwhile, vaccination rates have plunged. Barely one in five people had received the recommended dose for their age group and health status as of the end of February, according to federal data. Even the rates for the vulnerable elderly have fallen. Only 55 per cent of people aged 70-79, and 61 per cent of those over 80, have had the recommended dose.
Equally concerning is that there has never been a public inquiry into the handling of the crisis. That means the public can have little confidence that, in a future epidemic or pandemic, there wont be a repeat of Ontarios infamous snafu, where the provincial government put millions of dollars of personal protection equipment into a warehouse after the 2003 SARS epidemic in Toronto, and then let the contents expire without being replaced, contributing to a shortage of PPE in the COVID crisis.
Ottawa has signed a 10-year agreement with a Montreal company to supply N95 respirators and surgical masks, but that hardly counts as a comprehensive plan to build a national stockpile of PPE available to every province.
On the vaccine-supply front, Moderna, one of the developers of the mRNA COVID vaccine, is opening a plant in Montreal this year that will provide Ottawa with a minimum of 30 million doses a year. The facility will also research emerging viruses and develop new vaccines.
But that bit of good news cant hide the fact that there is no joint federal-provincial planning for handling the next pandemic. Its more accurate to say the provinces and Ottawa are operating in their own silos, making little apparent effort to co-operate on a national scale and instead looking after partisan political concerns.
This may well be the most lasting and damaging legacy of the COVID-19 pandemic in Canada: the politicization of science and public-health measures. Where most Canadians feel that governments did what they had to do in a fast-moving crisis, some saw the lockdowns and vaccine mandates as infringements of basic rights that silenced scientific inquiry and public debate.
This space has long argued that Prime Minister Justin Trudeau proposed vaccine mandates on truckers as a wedge issue in the 2021 election. The illegal 2022 trucker occupation in Ottawa, and the Trudeau governments use of the Emergencies Act to end it something a court has since ruled was unjustified was the climax of that tension.
The handling of the COVID-19 crisis remains a bitterly divisive issue in Canada, but no politician at any level seems interested in reconciling the different sides. That, along with the collapse of an effective vaccination strategy and the lack of future-proofing, demonstrate that Canadians and their leaders arent heeding the lessons of the pandemic.
Published May 1, 2024 All Meta Credits
Karl Leif Bates Duke Research
Duke researchers have opened a new avenue in the attack against influenza viruses by creating a vaccine that encourages the immune system to target a portion of the virus surface that is less variable.
Their approach worked well in experiments with mice and ferrets and may lead to more broadly-protective influenza vaccines and less reliance on an annual shot tailored to that years versions of the virus. Even with vaccines, influenza kills about a half-million people each year around the world.
This new vaccine approach, described May 1 in the journal Science Translational Medicine, is part of a 5-year-old effort to develop a longer-lasting universal flu vaccine that would be able to foil all versions of the virus.
Influenza strains are referred to by a shorthand code, H5N1 for example, that describes which flavors of two particular surface proteins it carries. The H (sometimes HA), is hemagglutinin, a lollipop-shaped protein that binds to a receptor on a human cell, the first step toward getting the virus inside the cell. The N is neuraminidase, a second protein that enables a newly made virus to escape the host cell and go on to infect other cells.
On the virus particle, there's five to 10 times more hemagglutinin than neuraminidase, said Nicholas Heaton, PhD, an associate professor of molecular genetics and microbiology at Duke who led the research. If we took your blood to see if are you likely to be protected from a strain of flu, we'd be measuring what your antibodies do to hemagglutinin as the best metric of what's likely to happen to you. The strongest correlates of protection have to do with hemagglutinin-directed immunity.
Vaccines teach the immune system to react to pieces of the virus that have been specifically tailored to the versions of influenza that are expected to be the most threatening in the coming flu season. The reason we need a new flu shot every fall isnt because the vaccine wears out; its because the influenza virus is constantly changing the surface proteins that vaccines target.
Flu shots -- and immune systems -- tend to target the bulb-like head of hemagglutinin rather than the stalk. But the details of that head region also change constantly, creating an arms race between vaccine design and viruses. The stalk, by comparison, changes much less.
A number of groups have gone through and experimentally mutagenized the whole hemagglutinin and asked which areas can change and still allow the hemagglutinin to function? Heaton explained. And the answer is, you can't really change the stalk and expect it to continue to function.
So the Duke team sought to design proteins that elicit an immune response more focused on the stalk rather than the head. The virus has evolved to have the immune system recognize these (features on the head region). But these are the shapes the virus can change. That is an insidious strategy, Heaton said.
Using gene-editing, they created more than 80,000 variations of the hemagglutinin protein with changes in one portion right on the top of the head domain and then tested a vaccine filled with a mixture of these variations on mice and ferrets.
Because of the broad variety of head conformations being presented to the immune system and the relative consistency of the stalks, these vaccines produced more antibodies to the stalk portion of hemagglutinin in response. The opportunity for the immune system to see that (head portion) over and over and over, like it needs to, is compromised because there's diversity there, Heaton said.
In lab tests and animals, the experimental vaccine caused the immune system to respond more strongly to stalk regions because they stayed consistent. This boosted the immune response to the vaccine overall, and in some cases, even improved antibody responses to the head region of the protein as well.
Antibodies against the stalk work differently, Heaton said. Their mechanism of protection is not necessarily to block the first step of infection. So then our idea was, What if we can come up with a vaccine that gives us both? What if we can get good head antibodies and at the same time also get stalk antibodies in case the vaccine selection was wrong, or if there's a pandemic?
Essentially, the paper says, Yes, we can accomplish that, Heaton said.
After a shot of the highly variant vaccine was administered in some experiments, 100 percent of the mice avoided illness or death from what should have been a lethal dose of flu viruses.
The next steps of the research will attempt to understand whether the same level of immunity can be achieved by presenting fewer than 80,000 hemagglutinin variants.
This research was funded in part with a contract from the NIH/National Institute of Allergy and Infectious Diseases (75N93019C00050). It also involved the use of the Duke Regional Biocontainment Laboratory, which received partial support for construction from the NIH/NIAID (UC6 AI058607)
Zhaochen Luo and Nicholas Heaton have a patent on the methods used to create large antigen libraries for this study.
CITATION: Vaccination with Antigenically Complex Hemagglutinin Mixtures Confers Broad Protection From Influenza Disease, Zhaochen Luo , Hector A. Miranda, Kaitlyn N. Burke, M. Ariel Spurrier, Madison Berry, Erica L. Stover, Rachel L. Spreng , Greg Waitt, Erik J. Soderblom, Andrew N. Macintyre, Kevin Wiehe, Nicholas S. Heaton. Science Translational Medicine, May 1, 2024. DOI: 10.1126/scitranslmed.adj4685
Duke University researchers are continuing their efforts to create a better, longer-lasting flu vaccine.
New research announced Wednesday in the journal Science Translational Medicine looked at hemagglutinin. Its the protein that allows the flu virus to attach to a human cell and make a person sick.
Scientists created an experimental vaccine that encouraged the immune system to target different areas of the flu virus to help fight infection.
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In essence what we are trying to do is figure out a way to get our immune systems to see parts of the virus that the virus doesnt want us to see, explained Nicholas Heaton, Ph.D.
Heaton is the study lead. He currently works as an associate professor of molecular genetics and microbiology at Duke.
He explained creating a vaccine that targeted parts of the flu virus that vary less between strains could potentially offer broader protection for different kinds of flu within the same shot.
The approach that we took was to make a really complex mixture of virus proteins where essentially all these epitopes are kind of scrambled to make the immune system have a better chance of seeing parts of the protein they wouldnt normally see, said Heaton.
Current annual flu shots offer protection for roughly six months due to mutations in the virus and varying strains that circulate each flu season. Scientists predict a universal flu vaccine could increase protection by a few years form a single shot.
The new study showed the experimental vaccine was more effective than traditional flu vaccines when given to mice.
Mice were tested in three groups: those given the experimental vaccine, those given a traditional flu shot and a control group.
They were then given lethal doses of two kinds of flu virus. One strain was what the traditional flu shot was tailored directly to fight and the second strain was of a mutation to the virus.
The mice that were given the experimental vaccine had the highest level of protection in both scenarios, losing a very small amount of body weight and surviving, compared to the other two groups.
Heaton said the results are encouraging but notes there is a long way to go before the research develops into a dose regularly used in humans.
Its tempered enthusiasm to some extent, he explained. We have something that out of all the ideas we tested this one is looking really good and really promising.
When asked how long he thought it could be until the research turned into a human vaccine, Heaton hypothesized it could take another decade.
I think this will probably ultimately manifest as a couple different shots for different age groups. There will probably be a couple different shots for babies that do a good job, for adults, for the elderly, said Heaton. You may need to get it once every five years, once every ten years. I would say those type of things are much more reasonable goals.
Heaton says the next step for this study is to continue testing the vaccine against multiple other flu strains in mice to see if the doses continue to be effective.
The U.S. has two vaccines ready should the strain of bird flu circulating in dairy cows begin spreading easily to people, federal health officials said Wednesday. They could begin shipping doses widely within weeks, if needed.
So far, theres no evidence that H5N1 is spreading person-to-person, although one dairy worker in Texas who worked closely with infected cattle had a mild infection and developed conjunctivitis, or pinkeye, in April.
At a briefing Wednesday, government health officials said they are preparing for a potential scenario of H5N1 jumping from animal to person or person to person. The virus has taken off in dairy cows, infecting at least 36 herds across nine states, raising concerns that it could acquire mutations that would make it easier to spill over into humans.
Studies suggest that the vaccines will offer good cross-protection against cattle outbreak viruses, Demetre Daskalakis, director of the National Center for Immunization and Respiratory Diseases, said on the call Wednesday.
Both of the vaccine candidates are already in the nations stockpile in limited quantities, officials said in a previous interview.
The Centers for Disease Control and Prevention also said Wednesday that it is testing blood samples from people previously vaccinated with an influenza vaccine to see if it generates an immune response, although it didnt say which vaccine.
Dawn OConnell, assistant secretary for preparedness and response at the Department of Health and Human Services, told NBC News earlier there are hundreds of thousands of prefilled syringes and vials ready to ship, if needed.
Weve been investing in a library of antigens to move out as quickly as possible should we begin to see a highly transmissible flu strain circulate, OConnell said.
H5N1 doesnt transmit easily between people, although global health officials remain concerned due to its high mortality rate, which hovers around 50%, according to the World Health Organization.
There are no signs the virus is mutating to be more transmissible between people, officials said Wednesday.
Vivien Dugan, who heads the CDC's influenza division, said that the government would begin looking at vaccination if there were alterations in the viruss genetic code that would affect its existing countermeasures. It currently has a number of antiviral medications in supply that target influenza viruses, including Tamiflu.
The people needing vaccination and the number of doses that the U.S. would require would hinge on how the virus changes and how widespread the outbreak becomes, experts say.
Right now, there are over 100 people, most of whom work with farm animals, being monitored for signs of infection, officials said.
Should the U.S. need the vaccines, the federal government could ship out hundreds of thousands of doses within a few weeks, OConnell said.
It could have over 100 million doses shipped within three to four months.
Health officials expect that people will need two doses of that vaccine, OConnell added, meaning 100 million doses is only enough for 50 million people.
Again, given this is a hypothetical, its possible the U.S. may not need that many vaccines. But it could also produce more, if needed, OConnell said.
They are produced using traditional vaccine technology that has been the standard approach to vaccines for decades. However, the process can take months.
OConnell said the U.S. is also pursuing a third vaccine based on the same mRNA-technology used in Pfizers and Modernas Covid vaccines. She added that an mRNA vaccine could be quicker to manufacture because you can switch in and switch out the genetic sequencing very easily.
All three vaccines would also need approval from the Food and Drug Administration before they can be distributed across the U.S.
In a statement, the FDA said it is actively engaged with other federal health agencies in assessing pandemic influenza vaccine candidates should the need for a vaccine arise.
Dr. William Schaffner, an infectious disease expert at the Vanderbilt University Medical Center, said having vaccine candidates on hand is important because it reduces the time needed to get the shots in peoples arms.
During the 2009 H1N1 swine flu pandemic, researchers eventually developed a vaccine to prevent the spread of the virus, but by the time the shots were manufactured and ready to be distributed, the outbreak had already petered out, he said.
Its very good that we have reduced the time necessary to create a vaccine by having candidates already available, should they be needed, he said.
Despite the government having two vaccine candidates, there are still a number of questions, including how much protection the shots would provide against infection and severe illness, said Dr. Judith ODonnell, director of infection prevention and control at Penn Presbyterian Medical Center in Philadelphia.
Theres a lot we dont know about these candidate vaccines and how theyll work, she said.
The U.S. has contracts with three manufacturers for pandemic influenza vaccines: GlaxoSmithKline, CSL Seqirus and Sanofi. One of the vaccine candidates is from CSL Sequirus.
A spokesperson for CSL Seqirus said the company has no data available on vaccine effectiveness because the number of human cases of H5N1 is too low for studies.
However, a phase 2 study testing a vaccine that targets a virus closely related to H5N1 shows that it generates a promising immune response and should cross-react with the H5N1 viruses currently circulating in cattle in the U.S, the spokesperson said.
OConnell said the government has a number of potential adjuvants, substances added to vaccines to boost the immune response, that could be used if needed.
During the pandemic, the virus was typically severe in older adults and people with underlying health conditions. However, the 2009 H1N1 swine flu virus disproportionately affected young people. Its unclear how this strain of H5N1 would affect people because human infections are rare.
ODonnell said that given the amount of vaccine skepticism, as well as vaccine fatigue from the pandemic, the government would also likely need to begin a vaccine campaign to persuade people to get vaccinated.
Its very disheartening to see so much vaccine skepticism and vaccine fatigue, she said.
(Precision Vaccinations News)
Vaccines have proven to be the primary means of reducing influenza infections over decades. Although many people think all flu shots are the same, there are significant differences between cellandegg-based vaccines, which provide different health benefits.
A real-world evidence study published on May 2, 2024, in Open Forum Infectious Diseases showed that a cell-based quadrivalent influenza vaccine (QIVc) was more effective at preventing test-confirmed cases of the flu than the egg-based quadrivalent influenza vaccine (QIVe) over three consecutive flu seasons in the United States (2017-2020).
These new findings show a higher relative effectiveness of QIVc over QIVe in the prevention of test-confirmed influenza, with estimated relative vaccine effectiveness (rVE) of 14.8% for the 201718 season, 12.5% for 201819, and 10.0% for 201920.
"This study exemplifies the value of RWE in generating valuable insights into the effectiveness of influenza vaccines," saidAlicia N. Stein, Director, Real World Evidence, Center for Outcomes Research and Epidemiology, CSL Seqirus, in a press release.
Influenza vaccines produced using egg-based manufacturing can undergo adaptation within the manufacturing process, which may result in a mismatch between the flu strains covered in the vaccine and those identified by the World Health Organization (WHO).
Twice each year, the WHO selects flu stains for the next flu season's influenza vaccines.
"Cell-based technology allows us to provide an exact antigenic match to the WHO's identified strains, helping to improve vaccine effectiveness versus standard egg-based vaccines. These data build on the growing evidence of real-world data that shows the benefits of our cell-based influenza vaccine," addedGregg Sylvester, Chief Health Officer and Head of Medical Affairs at CSL Seqirus.
"At CSL Seqirus, we're continually pushing vaccine technology forward to improve effectiveness and help keep communities healthy."
The U.S. FDA'sVaccines and Related Biological Products Advisory Committeemeton March 5, 2024, and finalized quadrivalent and trivalent influenza vaccineoptions for2024-2025.
As ofMarch 6, 2024,CSL Seqirusreceived the FDA's approval to produceits trivalent influenza vaccines.
Various flu shots shouldbe available in U.S. pharmacies by August 2024.
As of April 6, 2024, an estimated 37million flu shotswere administered in retail pharmacies, andphysicians' medical offices administered about 25million doses.
