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FDA's Failure to Safeguard the Public Resulted in an Irreparable Erosion of Trust

FDA's Failure to Safeguard the Public Resulted in an Irreparable Erosion of Trust
theepochtimes.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from theepochtimes.com Daily Mail and Mail on Sunday newspapers.

United-states , American , Bergstad-larsen , Myrup-thiesson , Lewis-novack , Amyc-sherman , Yasmeen-senussi , Xiaofang-li , Alanaf-ogata , Davidr-walt , Lindseyr-baden , Nat-neurosci

COVID-19 mRNA Vaccine Contaminated by Mystery DNAs and Truncated mRNAs: Health Implications

COVID-19 mRNA Vaccine Contaminated by Mystery DNAs and Truncated mRNAs: Health Implications
theepochtimes.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from theepochtimes.com Daily Mail and Mail on Sunday newspapers.

Denmark , United-states , Danish , American , Bergstad-larsen , Olofsson-falla , Kevin-mckernan , Myrup-thiesson , Alanaf-ogata , Lindseyr-baden , Lewis-novack , Nat-neurosci

Pulling Back the Curtain: mRNA Lipid Nanoparticle Design Created Potential for Clotting and Triggering Immune Overdrive

Pulling Back the Curtain: mRNA Lipid Nanoparticle Design Created Potential for Clotting and Triggering Immune Overdrive
theepochtimes.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from theepochtimes.com Daily Mail and Mail on Sunday newspapers.

South-korea , United-states , South-korean , American , Kateryna-kon-shutterstock , Xiaofang-li , Myrup-thiesson , Davidr-walt , Lindseyr-baden , Bergstad-larsen , Alanaf-ogata , Lewis-novack

A Deeper Dive Into the Role of Spike Protein in Myocarditis and Blood Clotting After COVID-19 Vaccination

A Deeper Dive Into the Role of Spike Protein in Myocarditis and Blood Clotting After COVID-19 Vaccination
theepochtimes.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from theepochtimes.com Daily Mail and Mail on Sunday newspapers.

Hong-kong , United-states , America , American , Marina-morigi , Lindseyr-baden , Jaitham-shutterstock , Megan-powell , Jan-jekielek , Alanaf-ogata , Xiaofang-li , Lewis-novack

Safety of BA.4-5 or BA.1 bivalent mRNA booster vaccines: nationwide cohort study

Objective To examine the association between the omicron adapted bivalent mRNA covid-19 booster vaccines received as a fourth dose and risk of adverse events.

Design Nationwide cohort study.

Setting Denmark.

Participants 2 225 567 adults aged ≥50 years who received three covid-19 vaccine doses during the study period, 1 January 2021 to 10 December 2022.

Main outcome measures The main outcome measure was rates of hospital visits for 27 different adverse events in a 28 day main risk period after vaccination with a bivalent omicron adapted mRNA booster vaccine as a fourth dose compared with reference period rates from day 29 after the third or fourth vaccine dose and onward.

Results 1 740 417 adults (mean age 67.8 years, standard deviation 10.7 years) received a bivalent mRNA vaccine as a fourth dose. Fourth dose vaccination with a bivalent mRNA vaccine was not associated with a statistically significant increased rate of any of the 27 adverse outcomes within 28 days (eg, incidence rate ratio of 0.95, 95% confidence interval of 0.87 to 1.04 for ischaemic cardiac events based on 672 v 9992 events during the compared 28 day risk and reference period, respectively), nor when analysed according to age, sex, or vaccine type, or when using alternative analytical approaches. However, post hoc analysis detected signals for myocarditis (statistically significant in female participants), although the outcome was rare and findings were based on few cases. No risk of cerebrovascular infarction was found (incidence rate ratio 0.95, 95% confidence interval 0.87 to 1.05; 644 v 9687 events).

Conclusions The use of bivalent mRNA vaccines as a fourth vaccine dose against covid-19 was not associated with an increased risk of 27 different adverse events in adults aged ≥50 years.

No additional data available. Owing to data privacy regulations in Denmark, the raw data cannot be shared.

Denmark , Danish , Anders-hviid , Emilia-myrup-thiesson , Drug-administration , Centers-for-disease , Us-centers-for-disease , Danish-ministry-of-health , Danish-health , Pfizer , Niklas-worm-andersson , Myrup-thiesson

Comparative effectiveness of bivalent BA.4-5 and BA.1 mRNA booster vaccines among adults aged ≥50 years in Nordic countries: nationwide cohort study

Objective To estimate the effectiveness of the bivalent mRNA booster vaccines containing the original SARS-CoV-2 and omicron BA.4-5 or BA.1 subvariants as the fourth dose against severe covid-19.

Design Nationwide cohort analyses, using target trial emulation.

Setting Denmark, Finland, Norway, and Sweden, from 1 July 2022 to 10 April 2023.

Participants People aged ≥50 years who had received at least three doses of covid-19 vaccine (that is, a primary course and a first booster).

Main outcome measures The Kaplan-Meier estimator was used to compare the risk of hospital admission and death related to covid-19 in people who received a bivalent Comirnaty (Pfizer-BioNTech) or Spikevax (Moderna) BA.4-5 or BA.1 mRNA booster vaccine as a fourth dose (second booster) with three dose (first booster) vaccinated people and between four dose vaccinated people.

Results A total of 1 634 199 people receiving bivalent BA.4-5 fourth dose booster and 1 042 124 receiving bivalent BA.1 fourth dose booster across the four Nordic countries were included. Receipt of a bivalent BA.4-5 booster as a fourth dose was associated with a comparative vaccine effectiveness against admission to hospital with covid-19 of 67.8% (95% confidence interval 63.1% to 72.5%) and a risk difference of –91.9 (95% confidence interval –152.4 to –31.4) per 100 000 people at three months of follow-up compared with having received three doses of vaccine (289 v 893 events). The corresponding comparative vaccine effectiveness and risk difference for bivalent BA.1 boosters (332 v 977 events) were 65.8% (59.1% to 72.4%) and –112.9 (–179.6 to –46.2) per 100 000, respectively. Comparative vaccine effectiveness and risk difference against covid-19 related death were 69.8% (52.8% to 86.8%) and –34.1 (–40.1 to –28.2) per 100 000 for bivalent BA.4-5 booster (93 v 325 events) and 70.0% (50.3% to 89.7%) and –38.7 (–65.4 to –12.0) per 100 000 for BA.1 booster (86 v 286) as a fourth dose. Comparing bivalent BA.4-5 and BA.1 boosters as a fourth dose directly resulted in a three month comparative vaccine effectiveness and corresponding risk difference of –14.9% (–62.3% to 32.4%) and 10.0 (–14.4 to 34.4) per 100 000 people for admission to hospital with covid-19 (802 v 932 unweighted events) and –40.7% (–123.4% to 42.1%) and 8.1 (–3.3 to 19.4) per 100 000 for covid-19 related death (229 v 243 unweighted events). The comparative vaccine effectiveness did not differ across sex and age (</≥70 years) and seemed to be sustained up to six months from the day of vaccination with modest waning.

Conclusion Vaccination with bivalent BA.4-5 or BA.1 mRNA booster vaccines as a fourth dose was associated with reduced rates of covid-19 related hospital admission and death among adults aged ≥50 years. The protection afforded by the bivalent BA.4-5 and BA.1 boosters did not differ significantly when directly compared, and any potential difference would most likely be very small in absolute numbers.

Owing to data privacy regulations in each country, the raw data cannot be shared.

United-kingdom , North-carolina , United-states , Norway , Canada , Finland , Sweden , Denmark , Israel , Norwegian , Swedish , Finnish

Comparative effectiveness of heterologous third dose vaccine schedules against severe covid-19 during omicron predominance in Nordic countries: population based cohort analyses

Objective To investigate the comparative vaccine effectiveness of heterologous booster schedules (ie, three vaccine doses) compared with primary schedules (two vaccine doses) and with homologous mRNA vaccine booster schedules (three vaccine doses) during a period of omicron predominance.

Design Population based cohort analyses.

Setting Denmark, Finland, Norway, and Sweden, 27 December 2020 to 31 December 2022.

Participants All adults aged ≥18 years who had received at least a primary vaccination schedule of AZD1222 (Oxford-AstraZeneca) or monovalent SARS-CoV-2 wild type (ancestral) strain based mRNA vaccines BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna), in any combination.

Main outcome measures The main outcome measure was country combined risks of covid-19 related hospital admission and death with covid-19 and additional outcomes of covid-19 related admission to an intensive care unit and SARS-CoV-2 infection. During a period of omicron predominance, these outcomes were compared in those who received a heterologous booster versus primary schedule (matched analyses) and versus those who received a homologous mRNA vaccine booster (weighted analyses). Follow-up was for 75 days from day 14 after the booster dose; comparative vaccine effectiveness was calculated as 1–risk ratio.

Results Across the four Nordic countries, 1 086 418 participants had received a heterologous booster schedule of AZD1222+BNT162b2 or mRNA-1273 and 2 505 093 had received a heterologous booster schedule of BNT162b2+mRNA-1273. Compared with the primary schedule only (two doses), the vaccine effectiveness of heterologous booster schedules comprising AZD1222+BNT162b2 or mRNA-1273 and BNT162b2+mRNA-1273 was 82.7% (95% confidence interval 77.1% to 88.2%) and 81.5% (78.9% to 84.2%) for covid-19 related hospital admission and 95.9% (91.6% to 100.0%) and 87.5% (82.5% to 92.6%) for death with covid-19, respectively. Homologous mRNA booster schedules were similarly associated with increased protection against covid-19 related hospital admission (≥76.5%) and death with covid-19 (≥84.1%) compared with previous primary course vaccination only. When a heterologous booster schedule was compared with the homologous booster schedule, vaccine effectiveness was 27.2% (3.7% to 50.6%) for AZD1222+BNT162b2 or mRNA-1273 and 23.3% (15.8% to 30.8%) for BNT162b2+mRNA-1273 schedules against covid-19 related hospital admission and 21.7% (−8.3% to 51.7%) and 18.4% (−15.7% to 52.5%) against death with covid-19, respectively.

Conclusion Heterologous booster schedules are associated with increased protection against severe, omicron related covid-19 outcomes compared with primary course schedules and homologous booster schedules.

No additional data available. Owing to data privacy regulations in each country, the raw data cannot be shared.

United-kingdom , Denmark , Copenhagen , Køavn- , Finland , Norway , Sweden , Danish , Finnish , Swedish , Norwegian , Karolinska-institutet

Pulling Back the Curtain: mRNA Lipid Nanoparticle Design Created Potential for Clotting and Triggering Immune Overdrive

In this series, "Promise or Peril: Alarming COVID-19 mRNA Vaccine Issues," we explore how the introduction of mRNA ...

South-korea , United-states , American , South-korean , Marina-morigi , Megan-powell , Lewis-novack , Yasmeen-senussi , Xiaofang-li , Alanaf-ogata , Olofsson-falla , Davidr-walt

Health Implications of Poor COVID-19 mRNA Testing: Miscarriage, Vision Loss, Immunotoxicity

In this series, "Promise or Peril: Alarming COVID-19 mRNA Vaccine Issues," we explore how the introduction of mRNA ...

Japan , United-states , Australia , Japanese , American , Australian , Lewis-novack , Olofsson-falla , Lindseyr-baden , Nat-neurosci , Xiaofang-li , Megan-powell

FDA Overhaul Needed for New Vaccines and mRNA Therapies

The pandemic has ended, but the introduction of the COVID-19 vaccines which use mRNA technology, signifies the start ...

Australia , Japan , United-states , Japanese , American , Australian , Amyc-sherman , Olofsson-falla , Yasmeen-senussi , Bergstad-larsen , Davidr-walt , Lewis-novack