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      mRNA technology for vaccines and more: An Ars Frontiers recap

      news.movim.eu / ArsTechnica · Tuesday, 30 May, 2023 - 22:55 · 1 minute

    Ars' John Timmer (left) with Karin Bok (center) and Nathaniel Wang (right).

    Enlarge / On May 22, John Timmer (left) moderated a panel featuring Karin Bok (center) and Nathaniel Wang (right) for the Ars Frontiers 2023 session titled, "Beyond COVID: What Does mRNA Technology Mean for Disease Treatment?" (credit: Ars Technica)

    The world of biomedicine has developed a lot of technology that seems a small step removed from science fiction, but the public isn't aware of much of it. mRNA-based vaccines, though, were a big exception as a lot of the public tracked the technology's development as a key step toward emerging from the worst of the pandemic and then received the vaccines in droves.

    mRNA technology has a lot of potential applications beyond COVID, and we talked a bit about those during the "Beyond COVID: What Does mRNA Technology Mean for Disease Treatment?" panel at last week's Ars Frontiers event. We've archived the panel on YouTube; if you want to focus on the discussion about mRNA therapies, you can start at the 1-hour, 55-minute mark .

    mRNA is a nucleic acid molecule that instructs the cell to make specific proteins. When used as vaccines, the instructions call for a protein produced by a pathogen, such as a virus. "It helps put up a wanted poster for the immune system," was how Nathaniel Wang, co-founder and CEO of Replicate Bioscience put it.

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      Rare myocarditis after COVID shots: Study rules out some common culprits

      news.movim.eu / ArsTechnica · Tuesday, 9 May, 2023 - 22:15 · 1 minute

    Heart scan.

    Enlarge / Heart scan. (credit: Getty | BSIP )

    The mRNA-based COVID-19 vaccines have proven remarkably safe and effective against the deadly pandemic. But, like all medical interventions, they have some risks. One is that a very small number of vaccinated people develop inflammation of and around their heart—conditions called myocarditis, pericarditis, or the combination of the two, myopericarditis. These side effects mostly strike males in their teens and early 20s, most often after a second vaccine dose. Luckily, the conditions are usually mild and resolve on their own.

    With the rarity and mildness of these conditions, studies have concluded, and experts agree that the benefits of vaccination outweigh the risks—male teens and young adults should get vaccinated. In fact, they're significantly more likely to develop myocarditis or pericarditis from a COVID-19 infection than from a COVID-19 vaccination. According to a large 2022 study led by researchers at Harvard University and the Centers for Disease Control and Prevention, the group at highest risk of myocarditis and pericarditis after vaccination—males aged 12 to 17—saw 35.9 cases per 100,000 (0.0359 percent) after a second vaccine dose, while the rate was nearly double after a COVID-19 infection in the same age group, with 64.9 cases per 100,000 (0.0649 percent)

    Still, the conditions are a bit of a puzzle. Why do a small few get this complication after vaccination? Why does it seem to solely affect the heart? How does the damage occur? And what does it all mean for the many other mRNA-based vaccines now being developed?

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      Florida officials deleted data, stats from dubious COVID analysis: report

      news.movim.eu / ArsTechnica · Friday, 7 April, 2023 - 22:05

    Florida surgeon general Joseph Ladapo speaks at a press conference.

    Enlarge / Florida surgeon general Joseph Ladapo speaks at a press conference. (credit: Getty | Paul Hennessy )

    Florida health officials deleted key data and statistics from a state analysis on the safety of mRNA COVID-19 vaccines, falsely making them appear unsafe for young men, according to draft versions of the analysis obtained by the Tampa Bay Times through public records requests .

    The final analysis, which was widely criticized for its poor quality and dubious conclusions , was the basis for a statewide recommendation by Surgeon General Joseph Ladapo last October that young men, ages 18 to 39, should not receive an mRNA COVID-19 vaccine. The analysis—posted on the Florida Department of Health's website with no authors listed—claimed to find "an 84% increase in the relative incidence of cardiac-related death among males 18-39 years old within 28 days following mRNA vaccination."

    Ladapo, who has a history of fearmongering about COVID-19 vaccines , touted the analysis, saying in a press release at the time that "these are important findings that should be communicated to Floridians.”

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      Missouri House advances bill to limit nonexistent vaccine microchips—just in case

      news.movim.eu / ArsTechnica · Thursday, 23 March, 2023 - 19:54 · 1 minute

    A person wearing a tinfoil hat on September 20, 2019.

    Enlarge / A person wearing a tinfoil hat on September 20, 2019. (credit: Getty | Bridget Bennett )

    In the latest efforts by Republican lawmakers to enshrine into law Americans' right to freely spread deadly infectious diseases to each other, the Missouri House this week advanced a bill that would bar governments, schools, and employers from mandating certain vaccines—as well as things like vaccine microchips, which do not exist.

    The bill, HB 700 ( PDF ), was sponsored by Rep. Bill Hardwick, a Republican from Waynesville. Hardwick told the St. Louis Post-Dispatch that he believed people " lost their minds " during the COVID-19 pandemic, and that legally barring officials and employers from requiring life-saving vaccination, even among health care workers, feels "like it's the right thing to do."

    The bill specifically bars requirements for people to receive COVID-19 vaccines. But it doesn't stop there. It also bars any requirements for people to receive "a dose of messenger ribonucleic acid (mRNA)," thus barring requirements for any future mRNA-based vaccines, should they be needed in upcoming pandemics or outbreaks. It also bars requirements for "any treatment or procedure intended or designed to edit or alter human deoxyribonucleic acid (DNA) or the human genome," and "any mechanical or electronic device" that would be placed "under the skin."

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      Tweaking COVID vaccines to fight variants won’t require big trials, FDA says

      Beth Mole · news.movim.eu / ArsTechnica · Friday, 5 February, 2021 - 22:06

    Tweaking COVID vaccines to fight variants won’t require big trials, FDA says

    Enlarge (credit: Getty | Congressional Quarterly )

    With concerning coronavirus variants erupting around the world, the US Food and Drug Administration is ironing out how to rapidly review vaccine tweaks that better protect against the mutants—and the regulatory agency is turning to its experience with annual flu shots to do so.

    In a statement late Thursday, the regulatory agency said it is actively hashing out what kind of “streamlined” clinical data makers of authorized COVID-19 vaccines could submit. The agency expects to have a draft of its guidance in the next few weeks.

    The announcement suggests that makers of authorized vaccines will not be required to submit reams of data from large, months-long clinical trials, as they did for their initial authorizations. Still, data on any altered vaccine—however pared down—would still have to be enough to convince FDA scientists that a next-generation shot is safe and effective against variants. Vaccine alterations may include changes to the initial vaccine design or additions of new vaccine components, the FDA said.

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      Two allergic reactions to Pfizer vaccine lead to warning in UK

      Financial Times · news.movim.eu / ArsTechnica · Wednesday, 9 December, 2020 - 17:33

    Margaret Keenan, 90, who was the first patient in the United Kingdom to receive the first of two doses of the Pfizer-BioNtech Covid-19 vaccine, reacts as she talks with Healthcare assistant Lorraine Hill, while preparing to leave University Hospital Coventry, in Coventry on December 9, 2020, a day after receiving the vaccine.

    Enlarge / Margaret Keenan, 90, who was the first patient in the United Kingdom to receive the first of two doses of the Pfizer-BioNtech Covid-19 vaccine, reacts as she talks with Healthcare assistant Lorraine Hill, while preparing to leave University Hospital Coventry, in Coventry on December 9, 2020, a day after receiving the vaccine. (credit: Johnny Weeks | Getty Images)

    People with a significant history of allergies should not receive the Pfizer/BioNTech coronavirus vaccine, the UK medical regulator has said, after two NHS staff experienced an adverse reaction.

    June Raine, chief executive for the Medicines and Healthcare products Regulatory Agency (MHRA), told a UK parliamentary committee that the two individuals had the allergic reaction shortly after receiving the vaccine and that the regulator was investigating. Both people had a history of serious allergies and carried adrenalin pens.

    “We know from the very extensive clinical trials that this wasn’t a feature but if we need to strengthen our advice . . . we get that advice to the field immediately,” Dr. Raine said.

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      We’ll need more than one vaccine to beat the pandemic

      WIRED · news.movim.eu / ArsTechnica · Saturday, 14 November, 2020 - 12:17 · 1 minute

    Close-up photograph of a gloved hand holding a tiny bottle of clear liquid.

    Enlarge / A medical worker holds a bottle of a candidate COVID-19 vaccine developed by Oxford University that is being tested in a trial in Soweto, South Africa. (credit: Getty | Gallo Images )

    On Monday, a press release from the transnational pharmaceutical company Pfizer dropped a rare spark of hope into the ongoing misery of the Covid-19 pandemic. Yes, new infections have hit an all-time high in the United States, and, yes, cities and states around the world are walking back their reopenings. But Pfizer says it has results from a massive clinical trial showing that its vaccine against the disease works, and works well. The release touted “a vaccine efficacy rate above 90 percent,” and it announced the company’s intention to seek from the US Food and Drug Administration an authorization to start giving people shots. The company’s ready to make 50 million doses this year and 1.3 billion doses in 2021.

    That’s an ember of hope, but it’s sitting under a bucket of cold water, ready to pour. The Pfizer vaccine is finicky—hard to make, transport, and deliver. Because of desperate need, it’s in short supply even before it becomes available—1.3 billion doses is several billion short of what the world needs. The press release wasn’t peer-reviewed science, and it lacked critical details about how the vaccine works, and on whom. Even the simple fact of this vaccine’s existence, some analysts have argued, might jeopardize the testing and success of potentially better vaccines down the line, a case of the imperfect being the enemy of the good.

    Before the ember dies out completely, here’s a theory: No. The Pfizer vaccine’s imperfections make it a perfect prime mover, because if it works as well as the company says, it’ll help people now and require research into more, better, different vaccines for later. All the things nobody knows about the Pfizer vaccine mean that the door is wide open. “Whether its effects are durable, whether it’s effective in the elderly, whether it has safety issues, the cold chain issues, the ability to have access,” says Wayne Koff, president and CEO of the nonprofit Human Vaccines Project, “all that points to the need for a number of vaccines.”

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