COVID-19 Vaccine
Published on: 23 Feb 2024 | Editor: Flora Teoh
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A Los Angeles Superior Court judge has denied ABCs bid to dismiss the COVID vaccination wrongful termination case filed by a father and son who ran the construction and special effects department for ABCs General Hospital.
James Wahl and his son Timothy Wahl sued ABC in 2021, asserting they were fired from the long-running daytime serial when they refused to get a COVID-19 vaccination on religious grounds. On the heels of Judge Stephen I. Goorvitchs Feb. 20 order denying ABCs motion to dismiss the case, the sides are set to meet March 11 to confer on a trial date.
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Goorvitch rejected ABCs assertion of doubt that the Wahls objection to the COVID vaccination were based in firm religious beliefs. ABC argued that the pairs roles were such that they could not receive an exemption to its strict COVID vaccination policy, given the industry-wide restrictions imposed during the pandemic to allow TV and film production to resume.
The jury, not the judge, must resolve whether Plaintiffs [the Wahls] had genuine religious beliefs and whether Defendant [ABC] could have reasonably accommodated Plaintiffs without posing an undue hardship, Goorvitch wrote.
The judge seemed to question whether ABC had made an effort to accomodate the pair and whether it overstated the risk the Walhs posed to General Hospital cast and crew members.
Defendant argues that Plaintiffs could not have been accommodated because they could not maintain a distance of six feet from others. Interpreting the record in the light most favorable to Plaintiffs, however, they were only in close proximity to others for between 30 seconds to several minutes while Plaintiffs were masked and testing regularly and the people with whom they had contact were vaccinated, Goorvitch wrote. Defendants own evidence suggests that vaccines were highly effective. This gives rise to a triable issue whether Plaintiffs posed an undue risk under these circumstances. Similarly, Defendant argues that the highly contagious Delta variant of the virus was prevalent during the fall of 2021, but again, whether Plaintiffs measures and the cast/crews vaccinations were sufficient is a triable issue. Defendants arguments must be made to the jury.
Story continues
The General Hospital case is part of a flood of post-pandemic litigation between employers and employees over COVID vacciation policies. A lawsuit similar to the Wahls complaint was filed against General Hospital by actor Ingo Rademacher, but it was dismissed by Goorvitch last June because, per the judge, the plaintiff refused to cooperate with the interactive process.
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Wendy Williams' diagnosis with primary progressive aphasia and frontotemporal dementia (FTD) has sparked a conspiracy theory that her condition was caused by one of the COVID-19 vaccines.
Williams' medical team made the announcement on Thursday, sharing that the 59-year-old TV personality received her diagnosis last year after undergoing a "battery of medical tests." Actor Bruce Willis has also been diagnosed with FTD.
"Wendy is still able to do many things for herself," the team said in a press release. "Most importantly she maintains her trademark sense of humor and is receiving the care she requires to make sure she is protected and that her needs are addressed. She is appreciative of the many kind thoughts and good wishes being sent her way."
As fans flocked to social media to discuss Williams' diagnosis, there was an immediate wave of cynicism from a number of vaccine skeptics.
Claims that COVID-19 vaccines cause health problems or increase the chance of death are often made by groups opposed to vaccination and used in conspiracy theories concerning supposed population control.
Many anti-vaccination activists have attempted to link deaths among athletes and other notable figures to being vaccinatedespecially those who otherwise appeared healthy before having a cardiac arrest. The phrase "died suddenly" has become a dog-whistle for such assertions.
Linking Williams to such unfounded claims, Health Nut News blogger Erin Elizabeth shared video footage of Williams telling Dr. Mehmet Oz back in 2021 that she would not be taking a COVID-19 vaccine.
"It is so sad to see people like Wendy Williams, much sharper & laser focused here before the Covid shots," wrote Elizabeth on X, formerly Twitter. "Same goes for Bruce Willis and his decline. We've seen the emerging studies now on what it does to the the brain. Just tragic."
The post, which as of press time has been viewed more than 450,000 times, attracted a flood of comments supporting the theory that Williams' current illness is a result of having eventually taken a COVID-19 vaccine.
However, many others hit back at the suggestion, with one X user responding: "Equally sad to see people unaware of the neurological complications that come from the virus itself. You could use your platform to draw attention to the suffering of millions instead of this f****** garbage."
"It's crazy how stupid you are in thinking that things like dementia never existed prior to the COVID vaccine and now that's your immediate go to for any diagnosis of a person," another pushed back. "What about the thousands of people who have had this prior to the vaccine? No one ever thinks."
"Hold on, wasn't Bruce Willis already in declining health before COVID? Why are the shots to blame?" asked another.
Another told Elizabeth that it was "shameful you're associating without any evidence their health problems stem from C19 shots."
Newsweek has contacted a representative of Williams via email for comment.
Per Mayo Clinic, aphasia "robs you of the ability to communicate" and is known to affect "your ability to speak, write and understand language, both verbal and written." The condition "typically occurs suddenly after a stroke or a head injury. But it can also come on gradually from a slow-growing brain tumor or a disease that causes progressive, permanent damage (degenerative)."
FTD consists of incurable disorders that cause degeneration in the frontal and temporal lobes of the brain, leading to "an inevitable decline in functioning" for the patient, according to the Association for Frontotemporal Degeneration (AFTD). There are currently no treatments to stop progression of the disease.
While FTD shares some symptoms with Alzheimer's disease, the most common type of dementia, there are some key differences. FTD tends to affect people at a younger age, with the onset of most cases occurring from ages 45 to 64.
Williams last hosted the now-defunct Wendy Williams Show in July 2021. She was forced to step back as she faced a variety of health issues. This followed breaks the TV host had to take from filming her show in 2018, 2019 and 2020.
In 2018, the host announced she had been diagnosed with Graves disease, an autoimmune condition in which the immune system begins identifying the thyroid gland as a foreign body and attacking it with antibodies. Symptoms are varied but include fatigue, muscle weakness, tremors, high blood pressure, weight and hair loss and trouble concentrating.
Williams also contracted a breakthrough case of COVID-19 in September 2021, with pictures from the paparazzi showing her in a wheelchair. She further announced a diagnosis of lymphedema in 2019.
As of last April, approximately 366,905,365 Pfizer vaccines had been administered in the U.S., according to Statista. The U.S. Centers for Disease Control (CDC) describes the two mRNA vaccinesPfizer and Modernaas "safe and effective."
The mRNA technology used to create the vaccines had been in development for more than 15 years before the outbreak of the coronavirus epidemic, and both the Pfizer and Moderna versions received full Food and Drug Administration (FDA) approval.
FactCheck.org, a nonprofit website that identifies misinformation in American politics, debunked the claims that COVID-19 vaccines have caused excessive deaths, as alleged by an anti-vaccine group, the Vaccine Damage Project.
Although there were "excess deaths"a higher than expected number of mortalities across the population during a specific time periodin the U.S. in 2021 and 2022, these were linked to cases of COVID-19, along with increased deaths by drug overdose, alcohol and motor vehicle accidents. Many of the 1.3 million excess deaths from February 2021 to April 2023 were due to COVID-19, according to the CDC.
In May 2022, Rep. Marjorie Taylor Greene, a Georgia Republican, posted a screenshot on X from an FDA document that discussed adverse reactions to the Pfizer vaccine. She misinterpreted the page, suggesting that 1,223 people died after receiving the Pfizer vaccine.
Although the reports confirm that 1,223 people died after vaccination, the cause of the death was not verified as being linked to the vaccine and was due to a number of reasons, with no "novel safety concerns or risks requiring label changes" found, according to the document.
On November 3, the FDA defended Pfizer against accusations that the Pfizer-BioNTech vaccine was "contaminated."
A representative told Newsweek: "With over a billion doses of the mRNA vaccines administered, no safety concerns related to the sequence of, or amount of, residual DNA have been identified."
Newsweek is committed to challenging conventional wisdom and finding connections in the search for common ground.
Newsweek is committed to challenging conventional wisdom and finding connections in the search for common ground.
The Centers for Disease Control and Prevention (CDC) and US Food and Drug Administration (FDA) recently released studies examining whether there was an association between the use of oral antiviral treatments for COVID-19 and the occurrence of COVID-19 rebound. COVID-19 rebound is typically described as a recurrence of symptoms or a new positive viral test after testing negative. Researchers found that there was no consistent association between antiviral treatment for COVID-19 (eg, nirmatrelvir-ritonavir) and COVID-19 rebound. Among people at higher risk for progression to severe disease, the substantial benefits of treatment outweigh the risk for COVID-19 rebound.
Current evidence, including randomized controlled trial and observational data, suggests that SARS-CoV-2 rebound occurs initially as a mild illness 3-7 days after resolution of the initial acute illness, occurs in both treated and untreated patients, and is not associated specifically with receiving nirmatrelvir-ritonavir. There was no increased risk for hospitalization or death among people with rebound. Moreover, rebound occurs when there is variable, host-mounted immune response to infection during the course of illness.
A person's risk of experiencing rebound could be related to a range of factors, such as immunosuppression, delayed viral clearance, and overall immune response. Data are limited on risk factors for COVID-19 rebound. One study in the review found that COVID-19 rebound may occur more frequently among persons aged 18-65 years, persons with immunocompromising conditions, and persons who were taking steroids.
Rebound was not associated with drug resistance in the studies examined. It is important to ensure that use of antivirals does not accelerate viral evolution and result in resistant mutations, such as through counseling patients to complete antiviral treatment and monitoring for resistance using molecular analyses.
Two studies demonstrated the shedding of infectious virus during rebound, suggesting that patients with rebound are contagious. CDC recommends that people with rebound re-isolate per CDC guidelines.
For information on providing care to high-risk patients with COVID-19, please visit COVID-19 Treatment Guidelines.
Some observational studies demonstrated a higher frequency of rebound among treated persons (10%-14%) than was reported by the randomized controlled trial EPIC-HR (Supplementary Table). Depending on the definition used, the prevalence of rebound varied. In four studies, including the randomized trial, no statistically significant difference in rebound rates was identified among persons receiving treatment and those not receiving treatment. Persons receiving antiviral treatment might be at higher risk for rebound compared with persons not receiving treatment because of host factors or treatment-induced viral suppression early in the course of illness.
Viral rebound might occur in persons on antiviral treatment because they are at high risk for severe disease and might have host factors, such as immunosuppression, that contribute to the natural variability in viral dynamics. Risk factors for rebound appear to be similar to those for severe disease, but further studies are needed to understand whether persons with certain characteristics or underlying medical conditions are predisposed to experiencing rebound.
Another important consideration is that persons receiving antiviral treatment might be at higher risk of experiencing rebound given the viral suppression related to use of treatment early in the disease course and resumption of viral replication after completion of treatment because of delayed viral clearance. This elevated risk could be due to early discontinuation of antiviral treatment or the need for longer courses of treatment among certain persons, such as those who are immunocompromised.
Two ongoing clinical trials of nirmatrelvir-ritonavir will further characterize the frequency of rebound after different durations of nirmatrelvir-ritonavir treatment among immunocompromised individualsand the potential benefit of nirmatrelvir-ritonavir retreatment among those with posttreatment rebound. The results of these trials should inform recommendations for treatment in the context of rebound.
No. The substantial benefit of antiviral COVID-19 treatment for people who are at high risk for severe disease and who do not have contraindications to the chosen treatment outweighs the risk for rebound. In cases wherein rebound does occur, rebound resolves quickly and is not associated with an increase in severity of symptoms, hospitalization, or drug resistance. Monitoring drug resistance is an important part of postmarketing surveillance of any new medication. To date, resistance to nirmatrelvir-ritonavir has been rare.
As recommended by the National Institutes of Health COVID-19 Treatment Guidelines Panel, rebound should not deter clinicians from prescribing lifesaving treatments that prevent severe illness and death from COVID-19 for eligible patients.
Clinicians should continue to prescribe antiviral treatments for eligible patients given the substantial benefit of reducing the risk for severe illness, hospitalization, and death.
No. It is very important to stay up-to-date with COVID-19 vaccines. COVID-19 vaccination substantially reduces the risk for disease, hospitalization, and death. Antiviral treatments further reduce this risk and provide additional benefits for people who are at higher risk for severe COVID-19 outcomes, regardless of vaccination status. Persons at risk for severe disease include older adults, especially patients aged 65 years or older, patients who aren't up-to-date on COVID-19 vaccinations, and people with certain medical conditions that make them more likely to get very sick with COVID-19, such as weakened immune systems.CDC recommends that everyone aged 6 months or older get an updated (2023-2024 formula) COVID-19 vaccine.
It's important to know that existing vaccines, tests, and treatments still work well against JN.1 as well as other currently circulating variants. Recent laboratory data (here and here) show that the updated 2023-2024 COVID-19 vaccines produce antibodies that protect against JN.1, further indicating that our vaccines should work against this variant. At this time, the spread of JN.1 does not appear to pose additional risks to public health beyond that of other recent variants. CDC is closely monitoring COVID-19 increases domestically and internationally.
All available COVID-19 antivirals are effective against currently circulating variants. FDA provides information about how variants affect SARS-CoV-2 tests on their webpage.
Clinicians should continue to order and dispense US Government (USG)procured nirmatrelvir-ritonavir to allow sufficient time for the specific patient assistance programs to ramp-up.
On November 1, 2023, ritonavir-boosted nirmatrelvir and molnupiravir became commercially available. Eligible patients can get COVID-19 antivirals for free or at a reduced cost even if they do not have insurance. For more information, please visit COVID-19 Therapeutics Commercialization Transition Guide.
Patients with Medicare and Medicaid as well as those who are uninsured will continue to receive nirmatrelvir-ritonavir at no charge through 2024 through the USG Patient Assistance Program (PAP) operated by Pfizer. This includes all patients who are publicly insured through Medicare (with or without Part D, Part B, or Part C and inclusive of Medicare Advantage), Medicaid/Children's Health Insurance Program, TRICARE, and patients insured through the Veteran's Affairs Community Care Network. The USG PAP using USG-procured supply (commercial, New Drug Applicationlabeled) started December 1, 2023 and will end December 31, 2024.
Patient assistance programs that help pay for these drugs are available to people who are underinsured, uninsured, or publicly insured through Medicaid, Medicare, or other programs.
Once they have a prescription, patients may be eligible for reduced or no-cost antivirals through:
Patients that use certain federal entities, includingHealth Resource & Services Administrationsupported health centers such as Federally Qualified Health Centers, Indian Health Service sites, and others, will have continued access to free USG-procured nirmatrelvir-ritonavir and molnupiravir.
Federal law does not require commercial plans to cover all possible COVID-19 treatments or put any limits on patient cost-sharing for any commercial plans if the treatments are covered. Patients should contact their insurer or clinician for more information on treatment coverage. For more information, see COVID-19 Therapeutics Transition to Commercial Distribution: Frequently Asked Questions.
With COVID-19 hospitalizations remaining elevated, it is important that people who get sick and are eligible for antivirals get treatment in the first days of illness because symptoms can change and worsen quickly. Though these antivirals are effective at preventing severe disease, not enough people are taking them. If more eligible people get treatment in a timely manner, we will save lives. Clinicians should continue to prescribe antiviral treatments for eligible patients given the substantial benefit of reducing the risk for severe illness, hospitalization, and death.
Tokyo Medical Center director Kazuhiro Araki, left, receives a dose of COVID-19 vaccine in Tokyo Wednesday, Feb. 17, 2021. Japan's first coronavirus shots were given to health workers Wednesday, beginning a vaccination campaign considered crucial to holding the already delayed Tokyo Olympics. (Behrouz Mehri/Pool Photo via AP)
Dr. Aileen Marty, Infectious Disease Specialist and Professor at Florida International University, joins Bob Sirott to talk about the latest health news. Dr. Marty explains a study that claims some of the COVID-19 vaccines could lead to health issues and what to know about the recent measles outbreak.
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A global study of over 99 million people across eight countries has identified two new harmful but very rare side effects of Covid-19 vaccines, an advance that could lead to better health monitoring of immunised people.
Researchers part of an international collaboration called the Global Vaccine Data Network (GVDN) hosted at the University of Auckland assessed 13 neurological, blood, and heart-related medical conditions to see if there was a greater risk of them in patients after receiving a Covid-19 vaccine.
The study assessed deidentified data of millions of people who received a Covid-19 vaccine, and examined if there is a greater risk of developing a medical condition in various periods after getting a vaccine compared with before the vaccine became available.
It found that some patients had heart inflammation conditions like myocarditis and pericarditis after they took mRNA vaccines, and some had muscle-weakening Guillain-Barr syndrome and a type of blood clot in the brain after taking viral vector vaccines.
Researchers also found signs of inflammation of part of the spinal cord (transverse myelitis) after taking viral vector vaccines as well as inflammation and swelling in the brain and spinal cord also known as acute disseminated encephalomyelitis after some people took viral vector and mRNA vaccines.
CDC easing covid isolation guidance
However, the chances of having a neurological event after infection with the novel coronavirus were up to 617-fold higher than following Covid-19 vaccination, suggesting that the benefits of vaccination substantially outweigh the risks, scientists say.
This multi-country analysis confirmed pre-established safety signals for myocarditis, pericarditis, Guillain-Barr syndrome, and cerebral venous sinus thrombosis, scientists wrote, adding that other potential safety signals requiring further studies were also identified
The size of the population in this study increased the possibility of identifying rare potential vaccine safety signals. Single sites or regions are unlikely to have a large enough population to detect very rare signals, study co-author Kristna Faksov said in a statement.
Researchers are conducting further studies to build upon the current understanding of Covid-19 vaccines to better unravel their safety using big data.
By making the data dashboards publicly available, we are able to support greater transparency, and stronger communications to the health sector and public, Helen Petousis-Harris, another author of the study, said.
While the study identified rare safety signals following Covid-19 vaccination, scientists say further investigation is warranted to confirm associations and assess clinical significance of these findings.
The largest global vaccine safety study has linked COVID-19 vaccines with small increases in health conditions involving the brain, blood, and heart.
The international team of researchers emphasizes that the chances of getting any of these conditions are still very low. It's important to note that extensive research shows COVID-19 vaccines protect against serious illness, death, and long COVID symptoms.
Across just under 100 million COVID-19-vaccinated people in eight countries, potential links called safety signals were identified by comparing observed rates of 13 specific conditions following vaccination to what we'd expect to see based on prior rates, or 'background risk' of the conditions the rates that these conditions are expected to occur in the absence of COVID-19 vaccines.
"The risk up to 42 days after vaccination was generally similar to the background risk for the majority of outcomes," the authors write in their published paper.
The authors say their multi-country analysis confirmed pre-established links between COVID-19 vaccinations and low risks of myocarditis, pericarditis, Guillain-Barr syndrome, and cerebral venous sinus thrombosis. But the enormous size of the study also meant there was a higher chance of them spotting rarer safety signals that prior studies may have missed.
Since the World Health Organization declared the COVID-19 pandemic on March 11, 2020, nearly 7 million people have died from the disease, including more than 1 million in the US. Over 13.5 billion doses of COVID-19 vaccines have been given, with at least 70.6 percent of the world's population having received at least one dose.
Vaccine rollouts usually identify common and moderate side effects, after excluding dangerous ones during clinical trials. But even in huge clinical trials, extremely rare side effects can go undetected.
"This unparalleled scenario underscores the pressing need for comprehensive vaccine safety monitoring, as very rare adverse events associated with COVID-19 vaccines may only come to light after administration to millions of individuals," the authors write.
Their study sought safety signals observed within the 42 days after receiving viral-vector vaccines (such as AstraZeneca) or mRNA vaccines (such as Pfizer-BioNTech). Health datasets from before the COVID-19 vaccines were used to determine the rates of these conditions that were expected in the general population prior to vaccine rollout, and the observed rates were derived from the same dataset after vaccination.
In the wake of viral-vector vaccines, the team discovered a statistically significant rise in cases of Guillain-Barre syndrome; a rare immune system disorder that affects nerves. Within the group that had these vaccines, 66 cases were expected, and 190 were observed. This increase was not seen after mRNA vaccines.
Following a first dose of the AstraZeneca vaccine, there was a 3.2 times greater-than-expected risk of cerebral venous sinus thrombosis (a type of blood clot in the brain) observed in 69 events, compared to an expected 21. The risks were 1.49 times higher after the Pfizer vaccine's first dose, and 1.25 times higher after second doses.
In March 2021, some countries in Europe suspended the AstraZeneca COVID-19 vaccine after observed versus expected analysis identified thrombosis with thrombocytopenia syndrome as a safety signal.
The analysis found a higher risk of heart inflammation called myocarditis after mRNA vaccines, with observed rates highest after a second dose of Moderna's vaccine. These vaccines instruct cells to produce a protein that resembles the SARS-CoV-2 virus, giving the immune system a preview and prompting it to create antibodies to protect the body.
In rare cases, this immune response can result in heart muscle inflammation. Though COVID-19 vaccine-induced instances have mostly been mild, 28 deaths have occurred.
After a first dose of mRNA vaccines, the risk for pericarditis inflammation of tissue surrounding the heart was 1.7 times higher than expected, and it became 2.6 times higher after a fourth dose.
Potential safety signals were found for transverse myelitis (inflammation of part of the spinal cord) after viral-vector vaccines, and for acute disseminated encephalomyelitis (inflammation and swelling in the brain and spinal cord) after both types of vaccines.
Compared to an expected two cases, seven cases of acute disseminated encephalomyelitis were observed after mRNA vaccines.
"The size of the population in this study increased the possibility of identifying rare potential vaccine safety signals," says first author Kristna Faksov, an epidemiologist at the Department of Epidemiology Research in Denmark.
"Single sites or regions are unlikely to have a large enough population to detect very rare signals."
Vaccines have saved countless lives by preventing the spread of the COVID-19 pandemic, and there is strong evidence that they are safe in the majority of cases and effective. A recent study found that if everyone in the UK was fully vaccinated, about 7,180 out of 40,393 severe outcomes (including deaths) from COVID-19 could have been avoided.
"We have a number of studies underway to build upon our understanding of vaccines and how we understand vaccine safety using big data," says Steven Black, an infectious disease scientist at the Global Vaccine Data Network (GVDN).
Anyone can view the methodology and complete results of this analysis on the GVDN's interactive data dashboards.
The study has been published in the journal Vaccine.
The COVID-19 vaccines that emerged as a beacon of hope in the fight against the deadly virus during the pandemic are back in the news again following a new study that has linked the shots to rare brain, heart and blood disorders, Vaccine, a science journal, reported last week.
The journal reported that researchers from the Global Vaccine Data Networka research arm of the World Health Organizationfound that the COVID-19 vaccines aggravated 13 medical conditions that were considered adverse events of special interest."
The study conducted on 99 million vaccinated people from eight countries: Argentina, Australia, Canada, Denmark, Finland, France, New Zealand and Scotland, reported that people who received certain types of mRNA vaccines were found to have a higher risk of myocarditis, which is inflammation of the heart muscle.
Rare cases of myocarditisinflammation of the heartidentified in the first, second and third doses of Pfizer-BioNTechs and Modernas mRNA vaccines: The highest rate was observed after the second dose of Moderna vaccine (with 6.1 times compared to the expected rates), Forbes reported, citing the study.
Pericarditis (another heart condition): Up to 6.9 times increased risk of Pericarditis in individuals who received the third dose of AstraZenecas vaccine. The study reported 1.7 times and 2.6 times increased risks in recipients of Modernas first and fourth doses, respectively.
The study also reported a greater risk of developing a rare autoimmune disorder Guillain-Barre syndrome among those who took the AstraZeneca shots, and had 3.2 times the risk of getting blood clots.
Disseminated encephalomyelitis: The study also reported a 3.8 times greater risk of developing the neurological disorder acute disseminated encephalomyelitis after taking the Moderna vaccine, and a 2.2-fold increased risk after AstraZenecas vaccine.
However, the experts stressed that the benefits of the COVID-19 vaccination far outweigh the risks. They said the likelihood of neurological events or heart inflammation is significantly higher after COVID-19 infection rather than after receiving a COVID-19 shot.
The odds of all of these adverse events is still much, much higher when infected with SARS-CoV-2 (COVID-19), so getting vaccinated is still by far the safer choice," CEO of biotechnology company Centivax Jacob Glanville, who is not involved in the study, told Forbes.
Separately, a parallel study on a small group of people (207) conducted by Christian Medical College, Vellore (Tamil Nadu) during the first wave of the pandemic stated that those who survived COVID-19 in India suffered lung and respiratory problems compared to European and Chinese counterparts, reported News 18.
The study pointed out that while most recovered within a year of COVID-19 infection, others had permanent lung damage.
In a large Indian cohort, we have reported the presence of post-COVID-19 residual lung damage, as assessed by lung function tests, exercise capacity, chest radiography and quality of life measurements. Our population reported relatively higher symptomatology and comorbidities and greater lung function impairment, compared to most published studies. We have shown that post-Covid-19 lung damage results in significant impairment of lung function, quality of life and effort tolerance," said the study.
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Even while the COVID-19 vaccines have been hailed as one of the greatest achievements in modern science, they have been swirled in misinformation perpetuated by anti-vaccine figures and organizations who question their efficacy and robust safety record. The shots have even been wrongly blamed for high-profile health events, like when LeBron "Bronny" James Jr. suffered a cardiac arrest during practice. While research has shown that a COVID-19 infection is linked to an increased risk in myocarditis, which is inflammation of the heart muscle, how and if that translates to causation from vaccines has been widely taken out of context.
But now, a new study, published in the journal Vaccine, examined the potential health effects of the coronavirus vaccines. In its international attempt to separate fact from fiction, scientists have found that there are some links between the vaccines and adverse health effects to be aware of but more research is needed to land on any definitive conclusions.
What we wanted to do was to see if there was any signal to suggest that COVID vaccines might be associated with an increased risk of certain medical events occurring, Helen Petousis-Harris, a co-author of the study and co-director of the Global Vaccine Data Network, told Salon. So what we did was we compared what we would normally expect to see because these events occur all the time what would you normally expect to see, and what are we actually seeing.
Misrepresenting this study doesnt tell the whole story about weighing the risk between being unvaccinated and getting infected with COVID-19.
The study included 99 million people across eight countries and found that the first, second and third doses of Pfizer-BioNTechs and Modernas mRNA vaccines were linked to rare cases of myocarditis. Specifically, people who received a second dose of Moderna vaccine were 6.1 times more likely to have myocarditis. The condition also developed among people who received the Pfizer vaccine while researchers identified that pericarditis had a 6.9-fold increased risk for those who received a third dose of AstraZenecas vaccine.
There was also a 2.5-times increased risk of developing the rare autoimmune disorder called Guillain-Barr syndrome linked to those who received AstraZenecas vaccine. Separate research has found that COVID itself can cause this syndrome at a rate far higher than vaccines.
Petousis-Harris told Salon in general that the researchers werent surprised with the findings, in part because previous research had already pointed to the rare risk associated with vaccination and conditions like myocarditis and pericarditis. But they did pick up something that hadnt been discussed before: a link between AstraZeneca's viral-vector vaccine and acute disseminated encephalomyelitis, a rare condition that causes inflammation and swelling in the brain and spinal cord.
And what that enabled was to take the next step, to a different kind of study, to really ask the question: Is this a problem? she said. Our colleagues in Australia performed a study in 6 million people, which is in the same issue, to look at that, and found that essentially after the viral-vector vaccines, the risk is about less than one extra case per million doses. So very very rare.
Notably, the risk was not observed in the mRNA vaccine design.
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As Salon has previously reported, COVID-19 vaccines changed the course of the pandemic. The mRNA technology, which was novel at the time, allowed for an effective vaccine to be developed in record time. Yet what the scientific community saw as a historic moment for biotechnology turned into a polarizing debate among American lawmakers who fell for conspiracy theories and misinformation surrounding the vaccines marking a pivotal turning point for the anti-vaccine movement. Typically, misinformation about vaccines doesn't appear out of nowhere. There is usually a kernel of truth to it, and the misinformation persists because it lacks context.
Unsurprisingly, this study is already being used to justify long-held concerns about the vaccines. But experts say that doesnt come as a shock and that misrepresenting this study doesnt tell the whole story about weighing the risk between being unvaccinated and getting infected with COVID-19, and getting vaccinated against COVID-19. For example, previous research has found that the risk of myocarditis is seven times higher from getting a coronavirus infection than getting vaccinated.
Glen Pyle, a molecular cardiologist who investigates cardiac injury associated with COVID-19, told Salon via email the most recent study is a great example of the continuous safety monitoring that vaccines are subjected to, and it confirms much of the safety work already done.
For example, with adverse events like myocarditis it shows that these events are very rare, he said. And when we stack these rare risks up against the overwhelming cardiovascular benefits of vaccination, the case for vaccination becomes clear.
Previous research has found that the risk of myocarditis is seven times higher from getting a coronavirus infection than getting vaccinated.
Pyle added that this study highlights the need for public health experts to communicate the risks of vaccination and how common they are in the right context.
For example, myocarditis is a very rare complication that increases primarily in younger males, he said. On the other hand, cardiac arrhythmias are far more common and they increase significantly with infection, but not vaccination in fact, vaccination decreases these risks.
He added there are small but real increases in rare risks after vaccination, compared to large increases in very common risks with COVID-19.
This strengthens the case for vaccination, and why cardiovascular societies throughout the world recommend vaccination, especially for people with cardiovascular conditions. Petousis-Harris said its hard when a study like this is published because risk communication is a complex science on its own.
You have lots of ways you need to communicate this, and I think it's vital to be open and transparent with people, but you also have to work hard at how you are able to present to them, she said. I think it's important to empower our people who are health professionals and vaccinators to be able to confidently have those conversations with people and have the tools that they need to help show people what the risks look like.
She emphasized that any pharmaceutical has risk of side effects.
Probably vaccines are the safest of all pharmaceuticals by a longshot, Petousis-Harris said. One of the challenges is actually expressing how safe they really are. And another challenge is that we have health events happen by chance all the time, and they may or may not be related to a vaccine.
She added that what has become clear is that its been difficult for people to grasp this nuance when it comes to the COVID-19 vaccines.
People are really interpreting anything bad that happens after the vaccine has therefore been caused by the vaccine, Petousis-Harris said. Notably, the study only examines links and associations potential safety signals, its not definitively declaring a cause. Ultimately, if the issue is transparency, this is transparent.
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