Lipid Nanoparticle developer Acuitas Therapeutics is founded

Acuitas Therapeutics is a private company incorporated in British Columbia, Canada. They were founded in February 2009 (initially as AlCana Technologies). Their "goal is to apply nanotechnology delivery solutions to improve the therapeutic options available to patients."  They are the developers of the lipid nanoparticle (LNP) used to delivery mRNA code into cells. [1, 2] By 2013 they used "rational design" to synthesize "over 200 novel cationic lipids and then screened these in an in vivo model system".  The process starts with "a key lipid component of stable nucleic acid lipid particles (SNALP)" and has "resulted in the identification of LNP compositions with greatly improved potency and therapeutic index". [5] They have "partnered with Alnylam Pharmaceuticals [USA], the University of British Columbia [Canada], IRAP and others on several research and development programs relating to systemic delivery of nucleic acid therapeutics. " Acuitas owns intellectual property (IP) rights to LNP technology for development of protein replacement therapeutics. In 2013 the company found "proof of concept" using mRNA that coded for luciferase, that the Acuitas LNP traveled to the liver when administered intravenously and the cells manufactured and expressed luciferase. [3] Acuitas Therapeutics' lipid nanoparticles are labelled ALC-0315 and ALC-0159 [4] and..> READ MORE

FDA authorises higher storage and transport temp. for Pfizer vaccine

On February 25, 2021 in a press release the FDA authorised "alternative" storage and transport temperatures for Pfizer-BioNTech's COVID-19 vaccine vials, to now allow the undiluted vials to be stored at "conventional temperatures commonly found in pharmaceutical freezers" for up to 2 weeks.  This move makes the vaccine more widely available. This  follows Pfizer's Feb. 19 press release stating they have data to support higher temperatures, other than the sub-zero ( -80ºC to -60ºC (-112ºF to -76ºF)) that was required upon launch.  These ultra-low temperatures, to keep the mRNA stable, caused transport and storage logistical issues, plus many vaccines were being thrown before used up as they fell outside of the usage guidelines. Since November 2020, Moderna's vaccine, which also uses mRNA technology, only required a normal freezer temperature of " 2° to 8°C (36° to 46°F) for 30 days".

US remove vaccine allocation for states

On January 12, 2021 The US government reversed course and is now releasing its entire cache of COVID-19 vaccines to states — including doses previously reserved for second shots, Health and Human Services (HHS) czar Alex Azar, reasoned this to be because they "now believe that our manufacturing is predictable". The two vaccines currently authorised, Pfizer & Moderna, require a second doses, 21-28 days following the first dose. "The Trump administration had been holding back millions of doses to ensure that those who received the first shot would get their second." States are now encouraged "to immediately open up immunizations to everyone age 65 and older."
Adverse Events - news, reports, analysis
Posted inPandemic-Response

Post-jab AE Topics

Adverse Events following COVID-19 injections is a big topic. I am re-organising pages to make content easier to publish and locate. This page will capture the reverse-chronological order format of videos and articles relating to general breaking news and data…
9 September 2022Posted inPandemic-Response
Effectiveness of Vaccine Efficacy
Posted inCOVID-19 Vaccines

Vaccine Effectiveness

All COVID-19 vaccines are alleged "safe and effective"! "Safe and effective" is a catch-all marketing phrase used for all vaccines. A "rare" side effect, which can include death, still makes it safe in the eyes of the authorities! Putting "safe"…
8 September 2022Posted inCOVID-19 Vaccines

FDA approves bivalent vaccine on “faith” not data

On August 31, 2022 the FDA announced the emergency use authorisation of the new COVID-19 bivalent booster vaccine formulations both Moderna and Pfizer-BioNTech with NO human trials and NO advisory panel consultation, hopefully it will work!  The formulation contains the mRNA spike protein code for the extinct original Wuhan strain plus "one in common between [!!!] the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2".  They will be referred to as "updated boosters" [1, 2] "The company has tested the BA.5-specific vaccine only on [eight] mice, so far, and is relying on data from both the BA.1 human trials and the BA.5 mice trials for their submission for authorisation".  A vaccine expert John Moore says “to rely only on mouse data (for authorisation) would be unprecedented"!  But both of these vaccines do not contain the mRNA code use in this new EUA. FDA Commissioner Robert Califf tweeted, "As we know from prior experience, strain changes can be made without affecting safety."  He is considering this new technology vaccine the same as an influenza "strain change", but is ignoring the trail of destruction. The following day on September 1, 2022, CDC's ACIP committee recommend the use of the new..> READ MORE

Israel: Myocarditis in young men potentially caused by Pfizer vaccine

On April 23, 2021 the Times of Israel article of leaked report, authored by senior ministry officials led by Prof. Dror Mevorach, revealed they  were investigating a potential link between the Pfizer-BioNtech vaccine and cases of myocarditis particularly in men under 30.  At the time there were 62 cases found out of 5 million vaccinated — most after their second dose and two resulted in death. [1, 2, 3] In the following weeks, social media reports of heart problems in young men seems higher that the alleged "rare" that officials would have you believe, and this is from Moderna and J&J vaccines too. Then on May 27, 2021 the CDC report (following a May 17 VaST meeting [7]) they are investigating 'mild' reports of potential heart problems following COVID-19 vaccination - in young adults and adolescents following COVID-19 vaccination. They said there have been "relatively few" reports of myocarditis and "most cases appear to be mild," [4, 5] The CDC noted that mRNA vaccines, which are made by Moderna and Pfizer-BioNTech, are potentially causing the problem. The NIH state the background "incidence of myocarditis is approximately 1.5 million cases worldwide per year. Incidence is usually estimated between 10 to 20..> READ MORE

FDA warns of increased risk of heart inflammation post-jab

On June 25, 2021 the FDA update the patient and provider Fact Sheets for Moderna & Pfizer-BioNTech's mRNA COVID-19 vaccine to warn and reflect "the suggested increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination"..."particularly following the second dose and with onset of symptoms within a few days after vaccination.” [1, 2, 8] Two days prior, on June 23, 2021 ACIP met to discuss the rising incidence of myocarditis (heart inflammation) but despite alarming data, [5] they didn't advise to halt the vaccine in this age group. [4] Since March 2021 there has been documented increasing incidences of fit and healthy athletes suddenly collapsing and dying, but also in the general population. [6, 7] Dr McCullough, a cardiologist, says there's no such thing as "mild" myocarditis from the vaccines.  Once heart cells are damaged, that's permanent.  An elevated troponin level from natural infection is transient and should not be confused with vaccine induced myocarditis. [3]
Pregnancy loss - miscarriage, stillbirth, spontaneous abortion
Posted inCOVID-19 Vaccines

Pregnancy loss

This page will capture links pertaining to pregnancy loss (miscarriage, spontaneous abortion, stillbirth) and Birth rate decline occurring in the time that the COVID-19 vaccine trials were ran and the vaccine rollout. Interviews, articles, FOIAs anything relevant to pregnancy loss,…
31 August 2022Posted inCOVID-19 Vaccines