Month: July 2022

Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults – ScienceDirect

Sept 2, 2022

Abstract

Introduction

In 2020, prior to COVID-19 vaccine rollout, the Brighton Collaboration created a priority list, endorsed by the World Health Organization, of potential adverse events relevant to COVID-19 vaccines. We adapted the Brighton Collaboration list to evaluate serious adverse events of special interest observed in mRNA COVID-19 vaccine trials.

Methods

Secondary analysis of serious adverse events reported in the placebo-controlled, phase III randomized clinical trials of Pfizer and Moderna mRNA COVID-19 vaccines in adults (NCT04368728 and NCT04470427), focusing analysis on Brighton Collaboration adverse events of special interest.

Results

Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI −0.4 to 20.6 and −3.6 to 33.8), respectively. Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95 % CI 2.1 to 22.9); risk ratio 1.43 (95 % CI 1.07 to 1.92). The Pfizer trial exhibited a 36 % higher risk of serious adverse events in the vaccine group; risk difference 18.0 per 10,000 vaccinated (95 % CI 1.2 to 34.9); risk ratio 1.36 (95 % CI 1.02 to 1.83). The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000 (95 % CI –23.2 to 37.4); risk ratio 1.06 (95 % CI 0.84 to 1.33). Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients: risk difference 13.2 (95 % CI −3.2 to 29.6); risk ratio 1.16 (95 % CI 0.97 to 1.39).

Discussion

The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes. These analyses will require public release of participant level datasets.

https://www.sciencedirect.com/science/article/pii/S0264410X22010283?utm_source=substack&utm_medium=email

Did Lockdowns Cause Increased Mortality Rates?

Sept 2, 2022

STORY AT-A-GLANCE

https://www.mercola.com/

  • Emerging statistics on excess mortality rates paint an alarming picture. Far more people died in 2021, after the rollout of the COVID shots, and in 2022, than during the height of the COVID pandemic in 2020
  • Mainstream media are trying to divert your attention from the elephant in the room — mass injection with experimental gene transfer technology — to anything and everything but that
  • The Telegraph blames the unexplained excess deaths on lockdown effects. Many didn’t have access to routine medical care during lockdowns, and are now dying from chronic diseases that went untreated
  • U.K. Office for National Statistics (ONS) data released August 16, 2022, show excess deaths in England and Wales were, as of August 5, 14.4% higher than the five-year average, which works out to 1,350 more deaths per week than normal. A majority of these excess deaths were cardiovascular in nature — a primary adverse effect of the COVID jabs
  • In the U.S., we lost 349,000 younger Americans to something besides COVID and non-natural death between April 3, 2021 and August 13, 2022, and that’s not counting the tens of thousands of death records that the CDC has inexplicably deleted. As much as 15% to 25% of the death reports that could indicate a COVID jab death are missing. Other data show that during the fall of 2021, Millennials, aged 25 to 44, had an 84% increase in excess deaths

https://articles.mercola.com/sites/articles/archive/2022/09/02/lockdown-mortality-rate.aspx?ui=36a038ce42a69d95af0bf71924615c461ba66bd7ce617ed65823a1256e445941&sd=20220505&cid_source=dnl&cid_medium=email&cid_content=art1HL&cid=20220902&mid=DM1251818&rid=1593591544

Regular physical activity linked to reduced risk of COVID-19

August 29, 2022

  • Regular physical activity may be linked to a lower risk of developing COVID-19.
  • Individuals who exercise regularly may be less likely to experience severe symptoms of COVID-19 and less likely to be hospitalized or die because of the disease.
  • 2.5 hours of moderate-intensity exercise or 75 minutes of vigorous-intensity exercise each week provides the best protection.

A 2021 Kaiser Permanente study of about 49,000 people with COVID-19 found that regular physical activity was strongly associated with a reduced risk for severe outcomes from the disease.

With a new systematic review and meta-analysis published recently in the British Journal of Sports Medicine, a team of Spanish researchers set out to evaluate the current evidence on the effect of habitual physical activity on COVID-19 outcomes.

https://www.medicalnewstoday.com/articles/regular-physical-activity-linked-to-reduced-risk-of-covid-19

FDA Authorizes New COVID Shot Boosters Without Proper Testing

August 31, 2022

The U.S. Food and Drug Administration (FDA) has authorized new boosters today for the Moderna and Pfizer-BioNTech COVID-19 shots, even though the companies have not completed trials on human subjects and without the injections going before an advisory panel of doctors. 

The FDA announced today that it has “amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination. The bivalent vaccines, which we will also refer to as ‘updated boosters,’ contain two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2.” 

https://lc.org/newsroom/details/083122-fda-authorizes-new-covid-shot-boosters-without-proper-testing-1

COVID-19 Gibberish Mode – by Mathew Crawford

August 27, 2022

We’re not just at the “making shit up” stage of the pandemic, but at the “making goofy and contradictory shit up” phase in which massive internal contradictions are abundant, but the authorities know how to control the messaging by aiming it exactly where it needs to be to influence behavior.

https://roundingtheearth.substack.com/p/covid-19-gibberish-mode?utm_source=email