Category: Vaccine

The FDA has granted Priority Review to an application to extend the indication of the adjuvanted respiratory syncytial virus (RSV) vaccine (Arexvy; GlaxoSmithKline) to include adults aged 50 to 59 who are at an increased risk of virus onset. Although the vaccine is currently indicated for adults aged 60 and older with lower respiratory tract disease (LRTD), this updated approval would make this vaccine the first available to this patient population.1

Image credit: MargJohnsonVA | stock.adobe.com

Adults can be at a higher risk of contracting RSV due to comorbidities, immune compromised status, or age. In addition, RSV can aggravate prior conditions including asthma, chronic obstructive pulmonary disease, diabetes, and chronic heart failure, which can lead to pneumonia, hospitalization, or death in some cases.

The adjuvanted vaccine consists of recombinant glycoprotein F stabilized in the prefusion conformation (RSVPreF3) and is combined with a proprietary AS01E adjuvant. In addition to being approved in the US, the vaccine is also approved for the prevention of RSV-LRTD in individuals 60 years and older in Europe, Japan, UK, Canada, and other countries.1

The application follows results from a placebo-controlled, observer-blind, multi-country, randomized phase 3 trial (NCT05590403) that evaluated the immune response and safety of this RSV vaccine in adults aged 50 to 59 and included those who were at an increased risk of RSV-LRTD due to underlying medical conditions. The trial enrolled a total of 570 patients aged 50 to 59 who had pre-defined stable chronic diseases that could result in an increased risk of RSV. In addition, the immune responses in a broader group of individuals (n = 570) of the same age without pre-defined conditions were also evaluated. The vaccine group consisted of both healthy adults and adults at an increased risk of RSV, who all received a dose of the RSV vaccine intramuscularly at day 1. Similarly, the placebo group also had both healthy adults and those who were a higher risk of contracting RSV.

Primary end points of the study include group geometric mean titer ratio and seroresponse rate in both groups. Secondary end points include safety and tolerability profiles (eg, adverse events, potential immune mediated diseases) at the studys end (12 months) as well as the frequency of RSVPreF3-specific CD8+ T cells that are assessed at 1 month, 6 months, and 12 months after the administration of intervention.

In addition, a priority review voucher to reduce the FDA review period of a supplemental Biologics License Application by 4 months was also submitted. According to the study authors, the results of the trial will be presented at upcoming conferences. The results were also submitted for peer-reviewed publications.1

References

1. GlaxoSmithKline. GSKs RSV vaccine, Arexvy, accepted under Priority Review in US for the prevention of RSV disease in adults aged 50-59 at increased risk. News release. February 6, 2024. Accessed February 12, 2024. https://www.gsk.com/en-gb/media/press-releases/arexvy-accepted-under-priority-review-in-us-for-the-prevention-of-rsv-disease-in-adults-aged-50-59-at-increased-risk/

2. A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and Above. ClinicalTrials.gov identifier: NCT05590403. Updated July 28, 2023. Accessed February 12, 2024. https://classic.clinicaltrials.gov/ct2/show/NCT05590403

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FDA Accepts Priority Review Application for RSV Vaccine to Prevent Illness in Adults - Pharmacy Times

Lawmakers debated border security and COVID vaccines today under the Gold Dome.

First, senators discussed a Republican-penned resolution allowing Gov. Brian Kemp to allocate resources to help the state of Texas secure the border.

The Senate majority leader blamed the issue on inaction by the federal government, specifically, on President Biden.

Democrats proposed an amendment that placed blame for the issues at the border on Republican policy.

But an emergency on the Senate floor cut the debate short: Sen. Gail Davenport, suffering from an unknown medical issue, was transported to a nearby hospital.

When the session resumed, so did the Democrats criticism of the Republican argument linking illegal immigration to the flood of fentanyl being smuggled into the country.

While the Democratic amendment failed to pass, the resolution did, 31 to 15.

Meanwhile, in the House, members approved a bill that supporters say would help prevent vaccine discrimination in organ recipients. It would bar doctors from denying someone an organ donation based solely on COVID-19 vaccination status.

House Bill 576 received heavy debate. Opponents said it undermines trust in vaccines, and pointed out that doctors often decide who receives an organ based on the best chance of success.

It passed 98 to 71.

The House unanimously passed House Bill 1033, which would increase the penalties for attacking a utilities worker. The minimum prison time would increase to three years.

Another bill cleared the House that would require audits for top of ballot races in Georgia, plus another state race chosen by leaders.

That bill passed 164 to 3.

Lawmakers will reach the halfway point of the session tomorrow, on Day 20.

Kemp is also expected to make an announcement related to border security Tuesday.

Join host Donna Lowry and capitol reporter Sarah Kallis at 7 p.m. on GPB-TV for the 54th season ofGPB'sLawmakers.

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'Lawmakers': Debates over border security and vaccines dominate Day 19 - GPB News

Dr Alessandro Siani

School of Biological Sciences at the University of Portsmouth in the UK.

As climate change causes more extreme weather events, increased rainfall and rising temperatures, itsincreasing the spreadof infectious diseases.

While this claim might sound like scaremongering, it is not a prediction its already happening now in our cities, as exemplified by news reportsof the streets of Paris being fumigatedto limit the spread of tiger mosquitoes known to carry Zika and dengue.

Vaccines are a key tool in the fight against these diseases. They can protect against some tropical and mosquito-borne illnesses, such as Japanese encephalitis, dengue or yellow fever, as well as many diseases that can thrive when drought and flooding reduce access to clean water, such as cholera and hepatitis A.

With newglobal pandemics also predicted to emergewith climate change, vaccines will likely play a key role in mitigating their most devastating impacts.

But troublingly, vaccine hesitancy appears to have increased since the COVID-19 pandemic, and its not just COVID vaccines that are subject to this hesitancy, but vaccines more broadly even those that have been successfully used for decades and led to the near-eradication of some infectious diseases.

TheUK Health Security Agency warned that urgent action should be takento curb the re-emergence of measles outbreaks caused by the decline in MMR (Measles, Mumps, Rubella) vaccine coverage in some communities.

The increase in vaccine scepticism presents a real challenge for healthcare organisations and national governments as they attempt to incorporate a climate resilience lens into their public health plans.

The decline in vaccine confidence was a key finding ofa study I carried out with my student Amy Trantercomparing survey data collected before and after the onset of the pandemic.

We ran two anonymous online surveys of more than 1000 adults in November 2019 and January 2022 respectively, with the aim of investigating public perspectives on the practice of vaccination and the factors that might underpin hesitancy and refusal.

Both surveys asked respondents to indicate their attitudes towards statements including vaccines are safe and I think vaccines should be a compulsory practice.

Because the second survey was carried out after COVID-19 emerged, it contained two additional questions specifically focused on that pandemic.

The results were troubling: They showed that confidence in vaccinations was considerably lower in 2022 compared to 2019 across all demographic groups.

Almost one quarter (23.8 percent) of participants in 2022 reported their confidence in vaccines had declined since the onset of the pandemic.

A decrease in vaccine confidence was found across participants ages, genders, religious beliefs, education levels and ethnicities.

We found that, among our participants, some demographic groups were more vaccine-hesitant than others. In both 2019 and 2022, participants who held religious beliefs were more vaccine-hesitant than agnostic or atheist individuals. Respondents of Black and Asian ethnic backgrounds were also less vaccine-confident than White respondents in both surveys (although for the Asian participants this difference was only statistically significant in the post-pandemic survey.)

There was also a key age-related difference between the 2019 and 2022 groups: while middle-aged (46 to 60-year-old) respondents were more vaccine-hesitant than any other age group in the 2019 cohort, this was no longer the case in 2022, when middle-age participants appeared more confident than those between 18 and 30 years old.

This finding gels withprevious findingsof a separate survey carried out during the Delta wave of COVID, which indicated that younger populations had less willingness to receive vaccinations.

The trend might also reflect the disproportionate severity of COVID in older patients, which may have prompted a higher perception of the infection risk in elderly participants, spurring a greater willingness to get vaccinated.

While the practice of vaccination has been met withcontroversy and oppositionever since its inception, the COVID vaccines were met with particularly heated scepticism and hostility.

The decline in vaccine confidence post-COVID has significant public health implications especially given that vaccine hesitancy was already a key threat to global health even before the pandemic hit.

Today,millions of children remainunvaccinated and therefore vulnerable to numerous vaccine-preventable diseases. We know that climate change disproportionatelyimpacts the most disadvantagedand marginalised groups: in addition to the direct effects of climate change (e.g. floods and droughts), it is the poorest populations in developing countries who will likely suffer the most if vaccine hesitancy drives down vaccination rates.

Thus, rebuilding vaccine confidence must be a priority for all governments and health agencies seeking to build climate-resilient health systems. Ideally, authorities should consider specifically tackling vaccine hesitancy in their plans for climate adaptation.

Health authorities seeking to address vaccine misinformation should be non-judgemental in their approach, and mindful ofcultural and religious factors that might underpin the hesitancy.

Vaccine communication works best when it is culturally appropriate and tailored to the individuals position on the vaccine hesitancy continuum: By engaging with specific groups based on their concerns, discussions can be focused and are more likely to be productive and less confrontational, as researchersfromThe University of Melbournehave found.

Emphasising support for vaccinations, rather than focusing on detractors and conspiracy theories, may also be a wise approach in attempts to overcome vaccine hesitancy,since research showsthat making vaccine uptake visible will encourage vaccine acceptance as a social norm.

Public health campaigns should also emphasise the many success stories linked to vaccination campaigns throughout history, for example the drastic reduction intyphus,cholera, plague, tuberculosis,diphtheriaandpertussisin the early 1900s, the elimination ofpolio,measles, mumps andrubellaacross several regions over the following decades, and the global eradication ofsmallpoxin the 1980s.

Ultimately, it is essential to acknowledge that climate change and vaccine hesitancy are not onlyexistential threats to our species,but also extremely polarising and controversial topics. Considering the enormous political and financial interests at stake think of thebillions spent by fossil fuel lobbiesto spread false narratives denying human impact on climate change dispelling misinformation on these topics is one of the most challenging collective endeavours of our times.

To succeed, it is crucial that governments and health authorities work together with scientists, educators and community leaders to coordinate a response that is global in scale but tailored to individual local communities.

Dr Alessandro Siani is the Associate Head (Students) of the School of Biological Sciences at the University of Portsmouth in the UK. With a research background on cellular and molecular bases of human pathology and a keen focus on science communication, education and pedagogy, he authoredseveral peer-reviewed papersin both biomedical and educational journals.

Originally published underCreative Commonsby360info.

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It's urgent - we must do something about vaccine hesitancy - Cosmos

Brazzaville Nearly 10 000 children in Burkina Faso and Cameroon have now received the RTS,S malaria vaccine since being introduced this year. A wider malaria vaccine rollout is underway this year in several African countries, with Cameroon being the first outside the malaria vaccine pilot programme to do so.

Cameroon launched the vaccine on 22 January 2024. It is being integrated into its national routine immunization programme in more than 500 public and private health facilities across 42 health districts in the countrys 10 regions.

Burkina Faso introduced the vaccine on 5 February, becoming the latest country in the region to kick off the immunization. The game-changing vaccine complements the existing range of malaria control measures to prevent the disease and lower its burden.

Malaria is one of the major health challenges our region faces. The wider rollout of the malaria vaccine marks a significant milestone in advancing the fight against this deadly disease, said Dr Matshidiso Moeti, World Health Organization (WHO) Regional Director for Africa. Were committed to supporting countries to ensure that all eligible children are protected from the devastating impacts of this preventable illness.

The vaccine rollout in the two countries mark the start of a major initiative by the WHO Regional Office for Africas Accelerated Malaria Vaccines Introduction and Rollout in Africa (AMVIRA).

AMVIRA was developed as a response to the planned introduction of the two malaria vaccines (RTS,S and R21) into the routine immunization schedules of 19 countries[1] the Africa region in 2024. Through AMVIRA, WHO in Africa will strengthen the provision of state-of-the-art support to countries in their efforts to effectively and efficiently introduce and rollout malaria vaccines. The initiative also enhances coordination with partners, UNICEF, GAVI, the Vaccine Alliance, and other partners.

In support of countries to ensure smooth introduction, community understanding and acceptance, and strengthened logistics, WHO has deployed 69 experts in immunization, data science and communication, across all 10 regions in Cameroon, as well as in Burkina Faso.

WHO is working with countries to set up comprehensive preparations such as national vaccination policy and guidelines, integrating the new vaccine into the delivery schedule of other vaccines and health interventions, developing an operational roll out plan, training of healthcare workers, investing in infrastructure, technical capacity, vaccine storage, community engagement and demand generation, and ensuring formative supervision, monitoring and evaluation of the process to ensure quality vaccine delivery.

As the malaria vaccine rollout extends to all eligible countries, WHO will continue to ensure that experts are deployed where needed, implement robust monitoring and evaluation mechanisms to track progress, identify challenges and facilitate timely interventions where required. The effective strategies that were witnessed in Cameroon and Burkina Faso are being documented and will be shared with other countries as they prepare for and launch the vaccines.

Malaria burden is the highest on the African continent, which accounted for approximately 94% of global malaria cases and 95% of related deaths in 2022. There were 249 million malaria cases globally in 2022, leading to 608 000 deaths. Of these deaths, 77% were children under 5 years of age, mostly in Africa.

[1] Benin, Burkina Faso, Burundi, Cameroon, DRC, Ghana, Kenya, Liberia, Malawi, Niger, Sierra Leone, Uganda, Central African Republic, Chad, Cote dIvoire, Guinea, Mozambique, Nigeria and South Sudan

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Nearly 10 000 children vaccinated as malaria vaccine rollout in Africa expands - WHO | Regional Office for Africa

The global anti-vaccine movement and vaccine hesitancy that accelerated during the COVID-19 pandemic show no signs of abating.

According to a survey of US adults, Americans in October 2023 were less likely to view approved vaccines as safe than they were in April 2021. As vaccine confidence falls, health misinformation continues to spread like wildfire on social media and in real life.

I am a public health expert in health misinformation, science communication, and health behavior change. In my view, we cannot underestimate the dangers of health misinformation and the need to understand why it spreads and what we can do about it. Health misinformation is defined as any health-related claim that is false based on current scientific consensus.

Vaccines are the number one topic of misleading health claims. Some common myths about vaccines include:

Beliefs in such myths have come at the highest cost.

An estimated 319,000 COVID-19 deaths that occurred between January 2021 and April 2022 in the United States could have been prevented if those individuals had been vaccinated, according to a data dashboard from the Brown University School of Public Health. Misinformation and disinformation about COVID-19 vaccines alone have cost the US economy an estimated US$50 million to $300 million per day in direct costs from hospitalizations, long-term illness, lives lost, and economic losses from missed work.

Though vaccine myths and misunderstandings tend to dominate conversations about health, there is an abundance of misinformation on social media surrounding diets and eating disorders, smoking or substance use, chronic diseases, and medical treatments.

My teams research and that of others shows that social media platforms have become go-to sources for health information, especially among adolescents and young adults. However, many people are not equipped to maneuver the maze of health misinformation.

For example, an analysis of Instagram and TikTok posts from 2022 to 2023 by the Washington Post and the nonprofit news site The Examination found that the food, beverage, and dietary supplement industries paid dozens of registered dietitian influencers to post content promoting diet soda, sugar, and supplements, reaching millions of viewers. The dietitians relationships with the food industry were not always made clear to viewers.

Studies show that health misinformation spread on social media results in fewer people getting vaccinated and can also increase the risk of other health dangers such as disordered eating and unsafe sex practices and sexually transmitted infections. Health misinformation has even bled over into animal health, with a 2023 study finding that 53 percent of dog owners surveyed in a nationally representative sample report being skeptical of pet vaccines.

One major reason behind the spread of health misinformation is declining trust in science and government. Rising political polarization, coupled with historical medical mistrust among communities that have experienced and continue to experience unequal health care treatment, exacerbates preexisting divides.

The lack of trust is both fueled and reinforced by the way misinformation can spread today. Social media platforms allow people to form information silos with ease; you can curate your networks and your feed by unfollowing or muting contradictory views from your own and liking and sharing content that aligns with your existing beliefs and value systems.

By tailoring content based on past interactions, social media algorithms can unintentionally limit your exposure to diverse perspectives and generate a fragmented and incomplete understanding of information. Even more concerning, a study of misinformation spread on Twitter analyzing data from 2006 to 2017 found that falsehoods were 70 percent more likely to be shared than the truth and spread further, faster, deeper and more broadly than the truth across all categories of information.

The average kindergarten student sees about 70 media messages every day. By the time theyre in high school, teens spend more than a third of their day using media.

The lack of robust and standardized regulation of misinformation content on social media places the difficult task of discerning what is true or false information on individual users. We scientists and research entities can also do better in communicating our science and rebuilding trust, as my colleague and I have previously written. I also provide peer-reviewed recommendations for the important roles that parents/caregivers, policymakers, and social media companies can play.

Below are some steps that consumers can take to identify and prevent health misinformation spread:

All of us can play a part in responsibly consuming and sharing information so that the spread of the truth outpaces the false.

Monica Wang is an associate professor of community health sciences at the School of Public Health; she can be reached at mlwang@bu.edu.

This column originally appeared on The Conversation.POV is an opinion page that provides timely commentaries from students, faculty, and staff on a variety of issues: on-campus, local, state, national, or international. Anyone interested in submitting a piece, which should be about 700 words long, should contact John ORourke at orourkej@bu.edu. BU Today reserves the right to reject or edit submissions. The views expressed are solely those of the author and are not intended to represent the views of Boston University.

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POV: Health Misinformation Is Rampant on Social Media - Boston University

All Oregon students must be current on their childhood vaccines by Feb. 21 or risk being sent home from school until they get up to date on their recommended shots.

Exclusion Day falls on the third Wednesday of every February and applies to all children in public and private schools, as well as those who attend preschools, Head Start and certified child care facilities, unless they have a medical or personal exemption. That doesnt include COVID-19 vaccinations, which are not required to attend school, but does include shots that protect against other common childhood illnesses, including measles, polio and whooping cough.

School exclusion warnings letters were sent to about 5,600 families in Multnomah County earlier this week, according to county officials.

A series of catch-up vaccination clinics for students ages 5 to 19 is happening in Portland. Shots will be free to students and their families, regardless of whether they have insurance. Families are encouraged to call 503-988-8939 to make an appointment, but appointments are not required.

The first of the four clinics is happening 10 a.m.-2 p.m. today at the Blazers Boys & Girls Club at 5250 N.E. Martin Luther King Jr. Blvd. The other clinics are happening:

The Oregonian/OregonLive

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Free childhood vaccine catch-up clinics offered in Portland ahead of Exclusion Day - OregonLive

Sometimes it's the simplest solutions that get lost in the kerfuffle of scientific progress.

Since the advent of vaccines more than two centuries ago, researchers have studied all sorts of ways in which inoculation with a weakened pathogen (or parts thereof) can prepare the immune system for a full attack exploring different dosages, vaccine agents, and forms of administration.

In all that time, very few experts have investigated the question: Does it matter which arm gets vaccinated?

Researchers at Oregon Health & Science University (OHSU) suspect that it just might.

It all started in the early days of the COVID-19 pandemic. Healthcare workers participating in studies on immune response to the new COVID-19 vaccines were asking experts at OHSU whether they should switch arms between the first and second jab.

The team wasn't sure what advice to give. Until that time, most scientists had just assumed that it didn't matter.

"This question hasn't really been extensively studied, so we decided to check it out," says infectious disease specialist Marcel Curlin.

When Curlin and his colleagues combed through the scientific literature, they could only find four papers on the topic. And the results were mixed.

One randomized controlled trial among infants found that influenza vaccinations given at 2, 3, and 4 months of age in different arms resulted in higher antibody levels than they did when given in the same arm.

A more recent study in 2023, however, found higher immune responses after giving COVID-19 vaccinations in the same arm as opposed to different arms.

To get a clearer picture, researchers at OHSU tested the antibody levels of 947 participants who received a two-dose COVID-19 vaccination.

Half of the cohort were randomized to get the second dose in the same arm as the first one, while the other half received the staggered jabs in different arms. Four weeks after their second dose, SARS-CoV-2-specific serum antibodies were 1.4 fold higher in those who received the vaccine in different arms.

A subset of 108 people in 54 pairs were matched based on their gender, age, and time of vaccinations, and their blood work was compared.

Serum samples collected in the weeks and months after vaccination showed clear differences between the groups. Four weeks after the second jab, those who received shots in both arms had up to a four-fold increase in SARS-CoV-2-specific serum antibodies compared to those who got shots in just one arm.

What's more, this improved immune response lasted more than a year after the booster was administered.

"It turned out to be one of the more significant things we've found, and it's probably not limited to just COVID vaccines," Curlin hypothesizes.

"We may be seeing an important immunologic function."

Curlin and his colleagues are not yet sure what that special function is, or how it works, but they have an idea.

When a vaccine is given in muscle, the antigens in the medicine are recognized by immune cells, which 'handcuff' the invaders and take them to the lymph nodes for further questioning. This then primes the immune system against this particular antigen by sort of sending out wanted signs of the invader.

The thing is, different sides of the body drain to different lymph nodes, so by triggering an immune response on both sides, the body may be more on guard.

"By switching arms, you basically have memory formation in two locations instead of one," explains Curlin.

That's the opposite to what the 2023 study found. It suggested that same-arm vaccinations better prepared the immune system for COVID-19. The reason for the differing results could be due to the timing of serum blood tests.

The 2023 study tested blood serum just two weeks after the vaccinations were given.

The immune cells that memorize the characteristics of an antigen, however, continue to ramp up and mature for many months after vaccination.

Only at three weeks did researchers at OHSU notice that injections in both arms began to show better results than the same arm, and these benefits improved incrementally, hitting a peak at week 4 and lasting for many months after.

While more research needs to be done to understand the pros and cons of vaccinating different arms, Curlin says he won't hesitate to switch it up for his next booster.

The study was published in The Journal of Clinical Investigation.

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One Simple Change May Dramatically Boost The Effect of COVID-19 Vaccines - ScienceAlert

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Immune Thrombocytopenia After COVID-19 Vaccine Requiring Splenectomy: A Case Report and Review of the Literature - Cureus

Disgraced doctor Andrew Wakefield whose fake anti-vax data has been blamed for the current measles epidemic has set his sights on discrediting the mumps vaccine.

The 67-year-old, who fled to the US after being struck off in the UK for fraudulently connecting the measles, mumps and rubella (MMR) vaccine to autism, is seeking Hollywood fame with his first feature film Protocol-7, which claims the mumps jab causes serious long-term health issues.

The film's extended trailer debuted at the Autism Health Summit in San Antonio, Texas last weekend, with Wakefield telling the conference's 500 guests that the vaccine, which has been used for decades, is 'dangerous'.

Attendees who paid 310 each for the two-day event gasped as scenes showed a child convulsing after receiving a mumps shot.

Wakefield, who divorced his wife of 35 years and later dated supermodel Elle Macpherson, told the crowd: 'It's not just a matter of this vaccine doesn't work the disease [mumps] has become more dangerous precisely because of the vaccine.'

The movie, which will be released on May 31 and is based on a 'true story', stars Julia Roberts's brother Eric as an executive at Merck who goes up against two whistleblowers who claim the pharmaceutical company's mumps vaccine is faulty.

British actor Matthew Marsden, who has appeared in Coronation Street and Rambo, plays Wakefield.

The trailer comes as cases of measles in the UK last week hit a ten-year high amid concerns that attempts to contain the outbreak particularly in the West Midlands are not working because of poor vaccination rates.

Wakefield's now-disgraced paper, published in the medical journal The Lancet in 1998, claimed the MMR jab caused autism and bowel disease in a study of just 12 children. The General Medical Council struck him off after ruling he behaved unethically by using children who showed signs of autism as 'guinea pigs' and subjected them to needless invasive procedures, including colonoscopies.

Since then, Wakefield has reinvented himself in the US as a podcast host and by doing lucrative speaking gigs at anti-vax conferences.

In promotional material for the conference, Wakefield was referred to as 'doctor', while a table bearing merchandise, including 15 'Wakefield was Right' T-shirts, did brisk trade.

Wakefield told the audience: 'Mumps in children is a trivial disease. We do not need a mumps vaccine.'

It is not known if Wakefield was paid for last Saturday's appearance, which was made over Zoom rather than in person because he was sick.

A woman answering the door at an address linked to Wakefield in Austin, Texas, said the disgraced doctor was not giving interviews.

Dr Martin Scurr, a GP and the Mail's Good Health columnist, said Wakefield was exploiting post-Covid fears about vaccines, adding: 'Sadly he has a lot of followers on social media who believe these conspiracy theories.'

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Now disgraced doctor Andrew Wakefield targets mumps vaccine with new Hollywood feature film which claims 'dang - Daily Mail

In the more than three years since COVID-19 vaccines first became available, billions of doses have been administered worldwide, protecting against severe disease and death. Still, social media posts claim the vaccines are causing more harm than good.

A Feb. 4 Instagram post shared a headline from conservative news outlet The Epoch Times that said, "mRNA COVID-19 vaccines caused more deaths than saved: study."

Another Instagram post shared a related headline that said, "Scientists call for global moratorium on mRNA vaccines, immediate removal from childhood schedule." The headline was from the Childrens Health Defense, a legal advocacy organization known for spreading vaccine misinformation. (The organization was created by Robert F. Kennedy Jr., who earned PolitiFacts 2023 Lie of the Year for his movement to legitimize conspiracy theories.)

These Instagram posts were flagged as part of Metas efforts to combat false news and misinformation on its News Feed. (Read more about our partnership with Meta, which owns Facebook and Instagram.)

(Screengrab from Instagram)

The Epoch Times and Childrens Health Defense articles referred to a Jan. 24 research paper that said "for every life saved, there were nearly 14 times more deaths caused by" the mRNA COVID-19 vaccines. Two of the papers authors, Steve Kirsch and Peter McCullough, have often spread misinformation related to COVID-19 and the vaccine.

Experts on infectious diseases and vaccines told PolitiFact that the papers conclusion is based on misleading and false information about the mRNA COVID-19 vaccines. The paper repeats multiple claims that PolitiFact and other fact-checkers have debunked.

The paper "stands in contrast" to the global public health communitys consensus that the mRNA vaccines are safe and effective, said William Schaffner, a Vanderbilt University infectious diseases professor.

"And so, you have to ask why (the paper) is such an outlier," said Schaffner, who is also a spokesperson for the National Foundation for Infectious Diseases. "The reason its an outlier is its a deeply flawed study."

Papers claims about deaths

The peer-reviewed research paper was published on Cureus, which Schaffner called "an obscure journal" that hed never heard of in his 40 years of public health research. A 2022 Emory University study described Cureus as a "predatory" and "controversial" journal.

The paper claimed the Pfizer COVID-19 vaccine saved two lives and caused 27 deaths per 100,000 vaccinations. It said the Moderna vaccine saved 3.9 lives and caused 10.8 deaths per 100,000 vaccinations.

The papers authors based this conclusion on data from the Pfizer and Moderna COVID-19 vaccine clinical trials in the United Statesand reports of adverse effects from the United Kingdom. Although the datasets came from two different countries, the paper said, "it is unlikely that the adverse event rates would be different between the two populations."

The adverse effects reports came from the U.K.s Yellow Card system, which lets members of the public report suspected safety concerns related to vaccines, medicines and medical devices.

This system is similar to the U.S. governments Vaccine Adverse Event Reporting System, which the paper also cites to suggest the COVID-19 vaccines are unsafe.

With VAERS, anyone can report health effects after a vaccination, whether or not those effects are caused by the vaccine, the CDC said. And unlike other government data sources, these reports arent screened before theyre made public, making VAERS fertile ground for vaccine misinformation.

Paper relies on several debunked claims

The paper claims the mRNA COVID-19 vaccines did not undergo adequate safety and efficacy testing.

This is inaccurate. We have rated multiple claims about this False or Pants on Fire, including that mRNA technology was never tested in humans; that the vaccines were released after only two months of testing in healthy humans; and that a safe vaccine cant be developed in eight to 10 months.

The Pfizer-BioNTech and Moderna mRNA COVID-19 vaccines were thoroughly evaluated in clinical trials before receiving emergency use authorization from the U.S. Food and Drug Administration in December 2020. Since then, public health authorities have continued to closely monitor the vaccines safety.

"These vaccines have met rigorous scientific standards for safety and effectiveness. The available data continue to demonstrate that the benefits of these vaccines outweigh their risks," said Cherie Duvall-Jones, an FDA spokesperson.

Another claim in the paper is mRNA vaccines contain "DNA contamination." We previously fact-checked a similar claim and rated it False.

Decades of research has shown that the "biologically insignificant amounts of DNA" in the vaccines pose no known safety risk, said Dan Wilson, senior associate scientist at Janssen, which also developed a COVID-19 vaccine. Wilson also hosts "Debunk the Funk with Dr. Wilson," a YouTube show that covers science misinformation.

Its not unusual for vaccines to contain DNA fragments. The measles, mumps, rubella, varicella and rotavirus vaccines also have minuscule amounts of DNA, said Dr. Paul Offit, director of the Vaccine Education Center and infectious diseases physician at Childrens Hospital of Philadelphia.

The chance that these DNA fragments could integrate into a persons DNA is "zero," Offit said. "So, its just all a lot of hand-waving."

The paper also claims the spike proteins produced by COVID-19 vaccination linger in the body and cause adverse effects. PolitiFact has fact-checked several false claims that the spike proteins are harmful or toxic.

All coronaviruses, including COVID-19, have spikes known as spike proteins on their surfaces, which the viruses use to bind to cells and cause infection, the CDC said.

The mRNA vaccines contain neither the COVID-19 virus nor the spike protein. The vaccines mRNA technology gives the body genetic instructions for producing copies of the spike protein, which are harmless. Then, the body breaks down the mRNA and it leaves the body as waste.

The spike proteins trigger the bodys immune response, sparking antibody production. This helps the body recognize and fight off the real COVID-19 virus in future infections.

Schaffner said the spike protein claim is "far-fetched" because theres no evidence the spike protein produced from the vaccines has caused adverse effects.

COVID-19 vaccines have saved millions of lives

Public health authorities in the U.S.and worldwide have repeatedly found COVID-19 vaccines to be safe and effective.

The World Health Organization reported that as of November, more than 13 billion doses of the COVID-19 vaccine had been administered worldwide. In the U.S. alone, more than 676 million doses of the vaccine had been administered as of May.

In 2021, the first full year the vaccines were widely available, the WHO estimated that COVID-19 vaccinations saved more than 14.4 million lives worldwide.

In rare instances, adverse effects, including myocarditis, or inflammation of the heart muscle, have been linked to mRNA COVID-19 vaccines, the CDC said. Myocarditis cases were more common among adolescent and young men within a week of receiving a second dose of the COVID-19 vaccine. Most patients had mild cases and recovered quickly.

Our ruling

An Instagram post claimed a research paper shows that "mRNA COVID-19 vaccines caused more deaths" than lives saved.

Experts said the papers conclusion is based on false and misleading claims. These claims have been repeatedly fact-checked and rated False by PolitiFact and other news outlets.

The COVID-19 vaccines have been rigorously tested and monitored for years and public health authorities worldwide continue to find them safe and effective. Billions of doses have been administered worldwide. The vaccines have saved millions of lives, and adverse effects are rare.

We rate this claim Pants on Fire!

Link:

Experts say mRNA COVID-19 vaccines have saved millions of lives, not caused mass deaths - PolitiFact