Category: Covid-19 Vaccine

Moderna (MRNA) posted a fourth-quarter profit after beating revenue and earnings estimates. COVID-19 vaccine sales fell by nearly 43% year-over-year. Yahoo Finance Health Reporter Anjalee Khemlani breaks down her interview with Moderna CEO Stphane Bancel, including the pharmaceutical company's plans for its RSV vaccine and where it is integrating AI.

"Last year was a transition year. We right-sized manufacturing, took a big write-off mostly non-cash in the fourth, and now I think we're off to the races we've been gaining share in the US and the objective this year in 2024 is to increase the vaccination rate," Bancel says.

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Editor's note: This article was written by Luke Carberry Mogan.

SEANA SMITH: All right. Well, let's take a look at one of the big movers of the morning. And that is Moderna shares climbing to the upside, up just about 6% after posting a surprise profit in the fourth quarter despite seeing a 43% slump in COVID 19 vaccine sales. Yahoo Finance's Anjalee Khemlani spoke with Moderna's CEO about those results minutes ago. Anjalee, what did you hear?

ANJALEE KHEMLANI: That's right Seana, Moderna surprisingly coming out with the beat this time, despite the fact that we've seen the waning COVID vaccine story play out for it and other companies. But the company is saying that they do see the market for this, they in fact did increase their market share for COVID vaccines in the last quarter. So really a strong story there.

And it has been a year of transition. That's really the takeaway that CEO Stphane Bancel told me earlier today. Listen to what he had to say.

STEPHANE BANCEL: Last year was a transition year. As we said all along last year, we right size manufacturing took a big write off mostly non-cash in the fall. And now I think we're off to the races is, we have been gaining share in the US and the objective this year in 2024 is to increase vaccination rate.

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ANJALEE KHEMLANI: So as you can see that right off of course with 2.2 billion right sizing manufacturing. And then focusing on the RSV vaccine launch, what they expect to happen this year could add to the revenues for the company. In addition, they're working on their combo flu and COVID vaccine. And they also have that partnership, of course, with Marc for the cancer vaccine and all told looking for a strong future.

But it is interesting also to see where Moderna is playing in the market with a focus on vaccines and infectious diseases. Also, at a time where oncology is big. As well as AI, Moderna being one of the first companies to really use AWS to be able to identify the current COVID 19 vaccine.

I asked Stephane whether or not that is an example of how far along the technology is or whether or not it still has a little bit of a drawback. And here's what he had to say.

STEPHANE BANCEL: If you look at large sets of data, to look at patterns on very large sets of data, this is where machine learning today is actually very adapted. And that's the type of use we are doing. We're not using to report financials. This is still done by standard systems like SAP and standard technology.

But when you're dealing with very large sets of data, the ability of machine learning system to look at patterns and to see things that a human cannot see because they're just so much data. That part of the technology, we believe is ready.

ANJALEE KHEMLANI: So as you can hear, definitely some future in there and whether or not the company continues to grow beyond that. What it has in its pipeline is what investors are waiting to see. But still a strong result and still bullish on the potential COVID market is where Moderna currently stands.

SEANA SMITH: All right. Anjalee, thanks so much. We'll be talking with an analyst from Oppenheimer with an outperform rating on the stock here later this hour get his thoughts on this report. All right. Anjalee. Thanks

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Moderna CEO's 2024 goal is to increase US vaccination rate - Yahoo Finance

Moderna (MRNA) posted a surprise beat in its full-year 2023 earnings, with its COVID-19 vaccine sales topping $6.8 billion, just above the company's guidance of $6 billion.

The full-year results were still significantly less than the $18 billion posted the prior year, when the pandemic revenues were still rolling in. For 2024, Moderna has estimated revenues of $4 billion.

CEO Stphane Bancel credits the year's results with ongoing demand for the company's COVID vaccine, despite a waning market in the post-pandemic world.

"Last year was a transition year. We right-sized manufacturing, took a big write-off, mostly non-cash, in the fall, and now I think we're off to the races. The objective this year ... is to increase vaccination rates," Bancel told Yahoo Finance.

The company took a few hits last year from unused COVID-19 doses it had to take back from the US government, as well as right-sizing its manufacturing and physical footprints.

But despite a slowing market, Bancel said he still sees a future for COVID vaccines. He says the elderly are particularly vulnerable every year and may be forgoing COVID shots, but are still getting their flu vaccines.

"We don't have enough people getting their shot. They have to understand, [they have] five times more chance of getting hospitalized" compared to those who get vaccinated, Bancel said, adding that is particularly true for individuals with multiple complicating diseases that make them more vulnerable.

But the risk goes beyond the elderly, as the effects of long COVID that is, symptoms of the disease that persist beyond recovery of the infection have been resulting in an increase of long-term unemployment. Bancel says he wants to help avoid that in the future by ensuring companies are more aware of the benefits of vaccination.

Meanwhile, Moderna is looking to launch its RSV vaccine for older adults this year, and is expecting an FDA decision on the product by May 12. It would join competitors GSK (GSK) and Pfizer (PFE), which launched their own RSV vaccines last year in the same population.

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In addition, the company is looking for clinical trial results on its combination flu and COVID vaccine and continuing its study of a cancer vaccine in partnership with Merck (MRK).

Moderna shares were up nearly 9% Thursday following the results, but are down nearly 40% in the past year.

Anjalee Khemlani is the senior health reporter at Yahoo Finance, covering all things pharma, insurance, care services, digital health, PBMs, and health policy and politics. Follow Anjalee on all social media platforms @AnjKhem.

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Moderna CEO: 2024 is year of growth, with 2023 transition in rearview - Yahoo Finance

COVID-19 Vaccine

Published on: 23 Feb 2024 | Editor: Flora Teoh

Health Feedback is a non-partisan, non-profit organization dedicated to science education. Our reviews are crowdsourced directly from a community of scientists with relevant expertise. We strive to explain whether and why information is or is not consistent with the science and to help readers know which news to trust. Please get in touch if you have any comment or think there is an important claim or article that would need to be reviewed.

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Global COVID Vaccine Safety study identified already-known risks, doesnt show that risks are greater than benefits - Health Feedback

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.

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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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ABC Faces Trial Over 'General Hospital' COVID Vaccination Wrongful Termination Lawsuit - Yahoo News Australia

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.

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Wendy Williams' Aphasia Diagnosis Sparks Vaccine Conspiracy Theories - Newsweek

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.

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What to Know About COVID Rebound - Medscape

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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Are COVID-19 vaccines linked to health issues? - WGN Radio - Chicago

As a primary care physician, I administer vaccines on a regular basis, from flu to tetanus to pneumonia to shingles.

I bring these vaccines out during doctors visits, and I discuss the pros and cons with my patients while the vaccines are being displayed.

I am completely open about potential side effects.

The core vaccine conversation between doctor and patient is a risk/benefit analysis.

Its a discussion, one in which the patient decides.

One of the big mistakes made by the Biden administration with the COVID vaccines is not having this discussion.

Rather than keeping expectations realistic telling folks that the vaccine would lessen the severity of COVID, instead of preventing a patient from getting it the administration forced as many as it could to get the jab through mandates.

Instead of being upfront that there was a slight risk of side effects, the administration put pressure on social-media companies to censor any discussion.

Now we have research data from the Global Vaccine Data Network that details exactly what risks accompany the COVID vaccines.

Morning Report delivers the latest news, videos, photos and more.

The study found what has been shown previously in smaller studies that side effects from the vaccines are mostly mild, but they arent non-existent.

The study showed an association between the MRNA vaccines and rare myocarditis, and between the Oxford Astra Zeneca vaccine which was never approved for use in the United States and pericarditis, Guillain Barre Syndrome and other neurological complications.

The Moderna MRNA vaccine was also associated with a slight increased risk of brain swelling.

Conspiracy theorists will take this as vindication.

It isnt, for the simple reason that the study also determined that the risk of a neurological problem from COVID was more than 600 times higher than from the vaccine.

But such was the mistake of the Biden administrations squashing of dissent that any discussion of side effects makes them look like liars.

The truth is that COVID MRNA vaccines have side effects, including rarely myocarditis, but studies have also shown that they decrease the risk of myocarditis from COVID itself.

The benefits of the vaccines far outweigh the risks, particularly for older Americans.

Its a discussion not a demand we should have had from the beginning.

A discussion that would have been easier had the White House asked primary-care doctors to be the ones to discuss and administer the vaccine.

The vaccine mandates only helped to sow distrust in government, and lowered vaccine acceptance in general.

Which is devastating because vaccines for children, particularly for measles and mumps, have saved millions of lives.

Plus, the public drive to squash any criticism of the vaccine along with downplaying side effects helped lead to a blossoming of conspiracy theories, anger and confusion.

This should be a real lesson for any administration going forward.

Marc Siegel, MD, is a clinical professor of medicine and medical director of Doctor Radio at NYU Langone Health and a Fox News medical analyst.

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Proof That Nixing COVID Vaccine Dissent Backfired - New York Post

Results of a recent peer-reviewed study on COVID-19 vaccines show a slight increase in risks for certain adverse effects up to a month and a half after taking the vaccine.

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Researchers looked for 13 adverse events of special interest that occurred up to 42 days after the Moderna, Pfizer-BioNTech and AstraZeneca vaccines were administered.

Researchers conducting the study, which was published in the journal Vaccine, looked at the medical records of nearly 100 million people vaccinated across eight countries.

The adverse events the scientists looked for included Guillain-Barr syndrome, Bells palsy, convulsions, myocarditis and pericarditis.

Results of the study showed a significant increase in cases of Guillain-Barr syndrome among those who received the AstraZeneca vaccine within 42 days of it being administered, and instances of acute disseminated encephalomyelitis (ADEM), an inflammation of the brain and spinal cord, in those who got their first dose of Modernas vaccine, according to the study.

Rare cases of myocarditis, or an inflammation of the heart, were identified in the first, second and third doses of Pfizer-BioNTechs and Modernas mRNA vaccines.

The highest rate for myocarditis 6.1 times more than expected was seen after the second Moderna dose.

Those conducting the study stressed that the risks of developing the conditions after having COVID-19 greatly outweigh the risks of experiencing the conditions because you get vaccinated.

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 Centivaix Jacob Glanville, who is not involved in the study, told Forbes.

There have been 13.5 billion COVID-19 vaccines administered worldwide since the start of the pandemic, according to Our World in Data.

According to Forbes, the Global COVID Vaccine Safety project, which conducted the study, is supported by the Centers for Disease Control and Prevention and the Department of Health and Human Services. Several of the authors received financial support from or have relationships with government agencies, including the CDC, the New Zealand Ministry of Health and the Canadian Institutes of Health Research, which they disclosed as potential conflicts of interest in reporting the studys results.

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Study: COVID-19 vaccines linked to small increase in risk for heart, brain disorders - Boston 25 News

One of the largest assessments of its kind, spanning 99 million people and investigating reports of adverse reactions following COVID-19 vaccination, found that instances of Guillain Barre Syndrome, myocarditis, pericarditis and cerebral venous sinus thrombosis (CVST) were at least 1.5 times more than expected following inoculation with mRNA and ChadOX1 vaccines. This is in line with previous observations by the World Health Organization and the European Medicines Agency, and was what led to these being classified as rare side effects following the vaccination for COVID-19.

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The data set did not include patients from India. However, a majority of Indians were administered the ChAdOX1 or Covishield vaccines during the pandemic. The need for rapid development and administration of vaccines saw a range of new approaches to vaccination, namely, the use of synthetic viral particles or protein constructs being administered following shortened testing programmes.

Guillain-Barre syndrome is a disorder in which the immune system attacks the nerves. While rarely fatal, it can cause muscular damage and mean prolonged treatment. CVST refers to blood clots in the brain. Myocarditis and pericarditis are inflammation of the heart tissue. All of these are serious conditions and potentially fatal.

The Global Covid Vaccine Safety Project, which made the assessment, compiled electronic healthcare data on adverse events related to COVID-19 vaccines from participants across multiple sites, including Argentina, New South Wales and Victoria in Australia, British Columbia and Ontario in Canada, Denmark, Finland, France, New Zealand, and Scotland.

The analysis involved computing the so called OE ratios or observed versus expected ratios. This means first healthcare providers, having a baseline expectation of how many adverse events are likely given a certain number of vaccinated people, and comparing it with the number of events actually reported to health systems. Expectations are formed based on experience with the rates of vaccination, and reactions observed historically. However, COVID-19 vaccination was an outlier event that saw billions of vaccines administered over a relatively short span. Ratios greater than 1.5 or, in other words, 50% more adverse-reaction reports than what is expected, are considered potential safety signals or necessitating a thorough investigation.

OE ratios >1.5 were observed for Guillain-Barr syndrome and cerebral venous sinus thrombosis (3.23) following the first dose of ChAdOx1 vaccine. Acute disseminated encephalomyelitis showed an OE ratio of 3.78 following the first dose of mRNA-1273 vaccine. The OE ratios for myocarditis and pericarditis following BNT162b2 (Pfizer/BioNTech), mRNA-1273 (Moderna), and ChAdOx1 (Oxford/AstraZeneca/Serum Institute of India) were significantly increased with ratios>1.5, notes the study, published this month in the peer-reviewed journal Vaccine.

As on December 6, 2022 a total of 92,003 Adverse Events Following Immunisation (AEFI) have been reported in India since the start of the COVID-19 vaccination, the Union Health Ministry told Parliament. This is about 0.009% of Indians who took COVID-19 vaccines.

An affidavit by the government to the Supreme Court claimed that compared with India, nearly 0.2% of the people in the United States who received COVID-19 vaccines showed AEFI, as did 0.7% in the U.K.

These ratios are, however, significantly influenced by the strength of the adverse event reporting system in countries. This can significantly vary among countries. There have been studies that show the baseline rate in European states is higher than Asia. This is a combination of both a better reporting system as well as physiological factors. Studies done in one country may not easily translate to another, Chandrakant Lahariya, physician and health policy expert, said.

While our study confirmed previously identified rare safety signals following COVID-19 vaccination and contributed evidence on several other important outcomes, further investigation is warranted to confirm associations and assess clinical significance, the study by the Global Covid Vaccine Safety Project said.

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Global study quantifies rise in blood clots, heart inflammation following COVID-19 vaccination - The Hindu