Soon after their arrival in late December 2020, the COVID-19 vaccines turned the pandemic around and opened a path back to normalcy. They prevented about 14.4 million deaths worldwide, according to one estimate.
In a small percentage of people, they also produced side effects.
Over the course of more than a year, The New York Times talked to 30 people who said they had been harmed by COVID vaccines. Their symptoms may turn out to be unrelated to the shots. But they along with more than a dozen experts felt federal officials are not doing enough to investigate their complaints.
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All vaccines carry some risk of side effects. More than 270 million Americans received about 677 million doses of the COVID vaccines, and even rare side effects occurring, say, in just 0.001% of patients might mean thousands of recipients were affected.
Indeed, more than 13,000 have submitted claims to a government fund that compensates people for COVID vaccine injuries. So far, however, only a dozen people have been compensated, nearly all of them for a heart problem caused by the vaccines.
Here are four takeaways from our investigation.
For most people, the benefits of COVID vaccines outweigh any risks.
Even the best vaccines and drugs have some side effects. That does not negate their benefits, nor does it suggest that people should stop taking them.
The rotavirus vaccine, for example, is an unmitigated success, but it can lead to intussusception a life-threatening condition in which the intestine folds in on itself in about 0.02% of children who are vaccinated.
Some side effects caused by the COVID vaccines may be equally rare. Researchers in Hong Kong analyzed that areas health records and found that about 7 of every 1 million doses of Pfizer-BioNTech vaccine triggered a bout of shingles serious enough to require hospitalization.
Other side effects are slightly more common. The COVID vaccines may lead to myocarditis, or inflammation of the heart, in 1 of every 10,000 adolescent males. (Myocarditis is one of the four serious side effects acknowledged by federal health officials.)
Deaths from the vaccines are vanishingly rare, despite claims from some conspiracy theorists that vaccines have led to a spike in mortality rates.
More intensive analysis may indicate that in some groups, like young men, the benefit of COVID shots may no longer outweigh the risks. But for the majority of Americans, the vaccines continue to be far safer than contracting COVID itself.
Federal surveillance has found some side effects but may miss others.
To detect problems with vaccines, federal agencies rely on multiple databases. The largest, the Vaccine Adverse Event Reporting System, is useful for generating hypotheses but contains unverified accounts of harms. Other databases combine electronic health records and insurance claims.
These systems spotted blood-clotting problems associated with the Johnson & Johnson vaccine and a potential risk of stroke after mRNA immunizations, which is still under investigation. But federal researchers trailed Israeli scientists in picking up myocarditis as a problem among young men.
The U.S. health care system is fragmented, with medical records stored by multiple companies that do not collaborate. Electronic health records do not all describe symptoms the same way, making comparisons difficult. Insurance claims databases may have no record of shots administered at mass vaccination sites.
Federal systems may also miss symptoms that defy easy description or diagnosis.
Proving vaccination led to an illness is complicated.
Among the hundreds of millions of Americans who were immunized against COVID, there were deaths, heart attacks, strokes, miscarriages and autoimmune illnesses. How to distinguish illnesses caused by the vaccine from those that would have happened anyway?
The rarer the condition, the harder it is to answer this question.
Merely judging by the timing the appearance of a particular problem after vaccination can be misleading. Most famously, childhood vaccines were mistakenly linked to autism because the first noticeable features often coincided with the immunization schedule.
Serious side effects may first turn up in animal studies of vaccines. But few such studies were possible, given the nations desperate timeline in 2020. Clinical trials of the vaccines were intended to test their effectiveness, but they were far from big enough to detect side effects that may occur only in a few people per million doses.
Most independent studies of side effects have not been large enough to detect rare events, nor to exclude their possibility; others have looked only for a preset list of symptoms and might have missed the rare outliers.
An expert panel convened by the National Academies concluded in April that for most side effects, there was not enough data to accept or reject a link to COVID vaccination.
Understanding the full range of side effects may take years.
Federal health officials acknowledge four major side effects of COVID vaccines not including the temporary injection site pain, fever and malaise that may accompany the shots.
But in federal databases, thousands of Americans have reported that COVID vaccines caused ringing in the ears, dizziness, brain fog, sharp fluctuations in blood pressure and heart rate, new or relapsed autoimmune conditions, hives, vision problems, kidney disorders, tingling, numbness and a loss of motor skills.
Some studies have examined reports of side effects and largely concluded that there was no link. Closer scrutiny may reveal that many, perhaps most, of the other reported side effects are unrelated to immunization. Most of them are also associated with COVID and may be the result of undiagnosed infections. But without in-depth studies, it is impossible to be sure, experts said.
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The National Advisory Committee on Immunization (NACI) released its updated guidelines on Friday on the use of COVID-19 vaccinesduring the upcoming fall season.
Although COVID-19 rates are currently low across the country, NACI said it anticipates a surge in activity during the fall and winter months, aligning with patterns seen in previous years and consistent with the behaviour of other respiratory viruses.
As COVID-19 activity is expected during the upcoming fall and winter months, and COVID-19 disease can compound the impact on the health system of other fall and winter respiratory viruses, NACI continues to provide early guidance on the use of COVID-19 vaccines to facilitate planning by provinces and territories, the guidelines state.
An updated vaccine to replace the current XBB.1.5 vaccine may be available starting in the fall of 2024, depending on the epidemiology of SARS-CoV-2 and recommendations of international advisory groups expected in mid-spring 2024.
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2:54 Health Matters: Yale Public Health researchers recommend annual COVID-19 vaccination
Starting in the fall of 2024, NACI strongly recommends the most recent updated COVID-19 vaccines for previously vaccinated and unvaccinated individuals at increased risk of SARS-CoV-2 infection or severe COVID-19 disease as follows:
All other previously vaccinated and unvaccinated individuals (six months of age and older) who are not at increased risk for SARS-CoV-2 infection or severe COVID-19 may receive the most recently updated vaccine in the fall of 2024.
And for unvaccinated people aged five years of age and older who are moderately to severely immunocompromised, NACI recommends that two doses should be given and an additional dose (for a total of three doses) may be given, regardless of vaccine platform.
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For previously vaccinated individuals, NACI recommends an interval of six months from the last dose, with aminimum interval of three months from the last dose. This minimum will ensure that those who receive a spring 2024 dose (which includes those who are most at risk for severe disease) will be eligible again for an updated fall 2024 dose when it becomes available, NACI said.
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Omicron sublineages of COVID-19 continue to circulate in Canada and globally, NACI said. From sequencing data up to the week of March 10, JN.1 sublineages, are the most prevalent among all positive cases sampled across Canada.
There is not yet sufficient data to determine the best time to start the COVID-19 vaccination program in the fall, although preliminary observations from previous seasons suggest that COVID-19 activity began to increase before fall vaccination campaigns were rolled out, NACI said Friday. In 2023, the national percent positivity of COVID-19 testing began to increase in mid-August.
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In August 2023, after months of low transmission of the virus, COVID-19 started to rise across the country due to two variants on the scene, EG.5, a subvariant of Omicron, and BA.2.86.
Although COVID-19 cases started to spike, the rollout of the fall 2023 boosters did not happen until around October.
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Mr Eve, whose wife, Lisa Shaw, died in May 2021 after having the jab, said he felt it was unjust that families like his could not continue.
Its like the Government and AstraZenecahave wriggled off the hook on a technicality when you just think, come on, what is the right thing to do here?
In my opinion, there is a battle here that needs to be had, but Im not even able to do that anymore, he told The Telegraph.
If I didnt remove my name from the legal action, I wouldnt be covered by the insurance. I could be liable for the drug companys costs, which could run into hundreds of thousands of pounds.
He said he felt utterly bereft.
After abandoning hislegal claim against AstraZeneca, Mr Eve said the 120,000 compensation offered by the Government was insufficient and called for ministers and the drugs company to sit down and have a conversation with families like his.
AstraZenecaand the Government might not have a legal obligation to support us, but they have a moral responsibility, he said.
Independent studies show the AstraZeneca vaccine was effective in tackling the pandemic, saving more than six million lives globally in the first year of the rollout.
The World Health Organisation has said the vaccine was safe and effective for all individuals aged 18 and above and the adverse effect that has prompted the legal action was very rare.
Davanagere/ Gadag: AICC general secretary Priyanka Gandhi Vadra criticised the Narendra Modi government's handling of the Covid-19 vaccination, suggesting a correlation between the vaccines and reported cases of heart attacks among healthy young individuals who received the jab. Addressing an election rally in Davanagere on Friday, Priyanka asserted a connection between the Covid-19 vaccines and the electoral bond controversy. She alleged that the vaccines were produced by a company that had previously made a significant donation of Rs 52 crore to BJP. "Fit and robust youths are experiencing heart attacks despite their good health, attributing it to the vaccines. These vaccines, all produced by a single company, reportedly provided a donation of Rs 52 crore to Prime Minister Modi," she said, citing a recent report. Accusing the central government of corruption, the senior Congress functionary stated, "Whether it's through vaccine dealings or obtaining donations through raids or filing and subsequently retracting cases against individuals, numerous instances highlight this government's corruption."
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"I would not negate the theory," Shreyas Talpade said in an interview.
Quint Entertainment
Published: 05 May 2024, 12:34 PM IST
Shreyas Talpade says his cardiac arrest could be a side effect of the COVID-19 vaccine.
(Photo Courtesy: Instagram)
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Actor Shreyas Talpade, who suffered a massive heart attack in mid-December 2023, recently shared that it could have been a side effect of the COVID-19 vaccine.
In an interview with Lehren Retro, the actor said that he was taking care of his health, and despite that, he suffered a cardiac arrest. He added that he "would not negate the theory" as several people have been facing health-related issues after taking the vaccine.
"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," Shreyas told Lehren Retro.
"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," the actor added.
Speaking about how he isn't sure whether the heart attack was a result of COVID-19 or the vaccine, he further said that he doesn't have "enough proof, and it is pointless to make any statements". Teh actor also said that he wants to "explore what it (the vaccine) has done to our bodies".
Last year, Shreyas collapsed due to a heart attack following the shoot of his upcoming film, Welcome To The Jungle. The actor was admitted to Mumbai's Bellevue Hospital, where he underwent angioplasty.
(At The Quint, we are answerable only to our audience. Play an active role in shaping our journalism by becoming a member. Because the truth is worth it.)
The significant rise in silent heart attack cases worldwidehas been the point of discussion since the COVID-19 pandemic. The topic has again come under light after pharmaceutical giant AstraZeneca admitted that its COVID-19 vaccine Covishieldmay have adverse affect on some vaccine takers, with symptoms like blood clots and dip in platelet levels.This major revelation has led to a lot of theories, with people correlating vaccines and heart issues.
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While the debate continues, Indian actor Shreyas Talpade, who recently suffered a heart attack last year in December has reacted to the theories, hinting that his heart attack may be an impact of the vaccine as well. While the debate continues, Indian actor Shreyas Talpade, who recently suffered a heart attack last year in December has reacted to the theories, hinting that his heart attack may be an impact of the vaccine as well.
Amitabh Bachchan reunites with Rajinikanth, says he's still the same simple, humble person
Talpade follows a healthy lifestyle and takes good care of his diet. So, his heart attack was shocking to all his friends and family.
Talking about the same, Talpade in an interview with Lehren,said, I gave myself a big scare. It was unfortunate, unexpected. I believed I was taking care of my diet, exercise and health. Apparently there are theories about the vaccine as well We have been hearing about people working out or playing and something happening, or a person who is taking care of himself and something happening.
Recalling the time when he suffered a heart attack, Shreyas said, I dont smoke, I am not a regular drinker. I drink perhaps once a month and within limits. 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 I have none of the other factors, I have no diabetes, no blood pressure, then what could be the reason? We have been as careful as possible.
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When asked if his heart attack was the side effect of the COVID-19 vaccine, the Golmaal actor said he would ''not negate the theory.''
He claimed that he started experiencing fatigue and tiredness after the vaccination. While the actor said he's not sure if it was the effect of COVID or the vaccine.
I started experiencing, unknowingly, a little bit of fatigue and tiredness and things like that. There has to be some amount of truth in that, right? I mean we completely cant negate that theory. So maybe it is the Covid or the vaccine, I dont know what. But there is something which is associated post that.
However, the actor said he would do more research to find out whether his heart attack was the result of COVID-19 or the vaccine.
Till the time I dont have enough proof with me, its pointless to make any kind of statement on that, he said.
Commenting further, Shreyas said that he's curious to know what vaccine has done to humans.
I want to know what the vaccine has done to us. I am not sure whether it is Covid or the vaccine. Till I dont have all the facts and proof, it is pointless to make any statements. Nevertheless, I want to know more, he said.
''You never know what goes wrong, when. Apparently, there are some theories which attribute this to the vaccine as well.
He continued, A normal person who is taking good care of himself, still there is something or the other happening with him, then what could be the other reason.''
On Dec 15, Shreyas suffered a heart attack on a film set. The actor was quickly taken to Bellevue Hospital in Mumbai's Andheri area and underwent angioplasty.?
(With inputs from agencies)
A person receives a shot of the COVID-19 vaccine.File Photo | AP
Concerns about the safety of Covid vaccines have returned with pharmaceutical giant AstraZeneca admitting that its vaccine, developed in collaboration with Oxford University, can have a rare but serious side effect. This has raised an alarm in India as it is the same vaccine, manufactured by Serum Institute of India and branded as Covishield, that was administered to a majority of the countrys population; about 175 crore doses of the vaccine were administered. The side effect, called thrombosis with thrombocytopenia syndrome (TTS) in medical literature, is characterised by blood clots and low platelet counts. The first cases of TTS came to light in the early months of vaccination in Europe.
In India, the Government Committee on Adverse Events Following Immunisation is said to have investigated 36 cases of TTS and confirmed 18 deaths in 2021, but it is not clear which vaccine they were linked to. Experts say the admission by AstraZeneca, though serious, need not cause panic as its a rare side effect, rarer still among Asians and South Americans. Besides, they say the risk is high only during the early weeks after vaccination. A study found 8.1 TTS cases per million people vaccinated after the first dose, and 2.3 cases per million after the second dose. It also showed there was a geographical variation in the riskfrom 17.6 per million in the Nordic countries to 0.2 per million in Asia.
A petition has now been filed in the Supreme Court, citing an apparent increase in deaths due to heart attack and sudden collapse after Covid, even among youngsters; the petitioners seek the constitution of an expert panel to study the risks involving the vaccine. Concerns about Covid vaccines are not new and can be traced back to their emergency approval waiving the traditional trial protocols.
While the government acted with the aim of tackling an urgent health crisis, it now has the responsibility of addressing the consequences. All stakeholders involved in the development, distribution and monitoring of vaccines are answerable. While vaccination has saved lives and its benefits outweigh the risks, its important to reassure people about the reliability of the vaccine that was administered to about 90 percent of the adult population. There must be a thorough study in the interest of ensuring accountability and public safety.
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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 isn't especially damning, as the rare conditioncalled thrombosis with thrombocytopenia syndrome, or TTSwas 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. "After all, the vaccine saved many more lives in Britain than were affected by this side effect, so AstraZeneca's admissionof what had already been listedwould 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 blood clot condition reported per 1 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 a perspective on the link between the shot and the health condition.
Amiji's 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 doesn't 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 proteinvery 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. It's 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 isn't 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 person's comorbidities, vascular disease or other secondary considerations. It wasn't 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-vaccinationand it is in a very small percentage of those who received this vaccine, to be clearthe link becomes much more apparent. Now, they're 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 individualsnot in all, but in a very small numberplatelet factor 4 can exaggerate the body's own immune response.
Typically when you see clot formation in the body, it's 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 uptakeabout 150 million peopleof the COVID-19 vaccine, but the majority of people there have received the Pfizer vaccine. This issue is not prevalent in the mRNA vaccinesat least, we haven't seen that level of clot formation here in the United States, where a majority of individuals have been vaccinated either with Moderna's or Pfizer's 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 aren't seeing any other serious or new side effects associated with these vaccines.
4 hours ago
Vaccine "fatigue" has been blamed for a drop in flu jab uptake among NHS workers at a Nottinghamshire trust.
Fewer than three in five workers at Sherwood Forest Hospitals NHS Foundation Trust got the flu vaccine this winter, the Local Democracy Reporting Service (LDRS) said.
Health bosses said that staff having already had multiple jabs was one of the "main reasons" for the drop.
The national NHS flu vaccination target is 80% but only 43% of workers got it.
Vaccine fatigue has also been cited as a reason the rate of administered flu vaccines was dropping nationally, the LDRS said.
All frontline healthcare and social workers are eligible for the flu vaccine through their employer, according to the LDRS which said it was recommended that people get the vaccine annually as it is updated depending on which strains are most prevalent.
At the trust, which runs King's Mill Hospital, Newark Hospital, and Mansfield Community Hospital, fewer than 59% of healthcare staff got the jab - down from 62% in 2023.
Members of the trust's board heard on Thursday that research is being carried out into the growing hesitancy.
Robert Simcox, director of people, said: "One of the main reasons we've found is vaccine fatigue.
"People have had multiple vaccines before and felt unwell, whether it's groggy, tired or sore arms."
He added that accessibility was "also a challenge" and said vaccinations were easier for people to get during the pandemic.
"We need to increase the opportunities for staff to have it any time of day in their place of work," he said.
The LDRS said the meeting was told that the past two flu seasons had been very mild, which may be leading to complacency.
Claire Ward, chair of the board, said: "Healthcare workers should be more receptive to arguments about the importance of vaccination and the bigger public issues.
"We need to communicate the importance, and hopefully it doesn't take a bad winter to increase the uptake."
There are hopes the "holy grail" of flu vaccines could become a reality after a discovery made by Australian researchers. Scientists at the Doherty Institute have identified nine new similarities between different types of the influenza B virus, which can be particularly dangerous for children. Killer T-cells in the immune system each reacted strongly to those nine fragments, which lead researcher Katherine Kedzierska likened to a "target" for future vaccines that aim to fight off all forms of the flu.
"The findings are significant as they pave the way for the design of potential vaccines," the University of Melbourne and Doherty Institute laboratory head said.
"If we can have a universal flu vaccine that would be an enormous breakthrough," Kelly told ABC TV on Tuesday.
"This is especially important for individuals in high-risk groups, including the elderly, pregnant women and people with comorbidities."
Authorities have recorded 42,000 laboratory-confirmed cases of the flu in Australia so far in 2024 and more than 289,000 cases in 2023.
