On April 23, 2019 the Johns Hopkins Center for Health Security publishes a report titled “Vaccine Platforms: State of the Field and Looming Challenges“.  The project was sponsored by Facebook’s co-founder, Dustin Moskovitz’s “Open Philanthropy Project“, which coincidentally also sponsored the Event 201 coronavirus simulation. [1, 2, 3]

“[O]ver the past several years, [vaccine] platform technologies have been developed that could make it possible for multiple vaccines to be more rapidly produced from a single system.”  In the report “the researchers describe major scientific and policy issues related to vaccine platforms” and “it provides recommendations aimed at helping realize the potential benefits of vaccine platform technologies” such as mRNA vaccines.

To date “there has been little in-depth analysis of platform vaccine technologies as a distinct class of technologies and approaches.”   If these vaccine platform could be accepted by regulators and policy makers it would open the flood gates for investors and development, not to mention the promoted “urgent need for vaccines to combat emerging infectious disease outbreaks.”

On February 11, 2020, the US Health & Human Services (HHS), the parent body of the FDA, announced a collaboration with Janssen Research & Development, part of Johnson & Johnson, to help “develop coronavirus therapeutics, as well to “expedite development of vaccines that protect against the 2019 novel coronavirus”

The Biomedical Advanced Research and Development Authority (BARDA), headed by Rick Bright [1, 2, 3], is part of HHS & ASPR, they will collaborate with Janssen to identify compounds that have antiviral activity against SARS-CoV-2 as an initial step in developing new treatments.

BARDA will share research and development costs and expertise to help accelerate Janssen’s investigational novel coronavirus vaccine into clinical evaluation.

On April 9, 2020 WHO released their Solidarity Vaccine Trial protocol an ” international randomised trial of candidate vaccines against COVID-19″, those candidates that meet the WHO’s criteria.    To coordinate the evaluation of more than 70 vaccines which are currently in development, and 3 in clinical trial as of April 11, 2020.

This WHO vaccine acceleration initiative is headed by Andrew Witty, former CEO of GlaxoSmithKline. [2, 3]

It is unknown what will happen to global vaccine production and supply if the WHO prioritise the same vaccine candidates as the US Warp Speed initiative! [1]

On 23 April 2020 the first 12 study subjects are vaccinated with the BioNTech mRNA vaccine candidate after Germany regulator approves Phase I/II clinical trial. [1]

On April 30, 2020 a pre-print paper by Korber et al, (now peer reviewed) had identified 14 mutations in the Spike (S) protein of the SARS-CoV-2 virus. [1, 2]

This is highly consequential as the Spike protein “mediates infection of human cells and is the target of most vaccine strategies and antibody-based therapeutics.” Mutations in this region of the virus “may confer selective advantages in transmission or resistance to interventions”

It was noted that this mutation of “Spike D614G is of urgent concern” They first identified G614 mutation in Italy sample on February 20, 2020 where it “began spreading in Europe” and found “when introduced to new regions it rapidly becomes the dominant form” indicating highly transmissible.

Noteworthy also is they found “evidence of recombination between locally circulating strains” in the S943P mutation, meaning an infected person is infected with multiple virus strains, not just one, and the stains can re-combine their genetic material to form new “recombinant” virus strains.

On May 15, 2020, following March 2, 2020 discussions with pharmaceutical executives, President Trump announced a U.S. public-private partnership, the Operation Warp Speed Vaccine Initiative (OWSVI), to accelerate the development, manufacture, and distribution of COVID-19 vaccines, therapeutics, and diagnostics collectively known as countermeasures.  With the aim of delivering 300 million doses of a safe, effective vaccine for the entire population of the United States with an effective vaccine “before the end of the year.” [1, 2, 3, 4, 5, 6]

“President Trump’s vision for a vaccine by January 2021 will be one of the greatest scientific and humanitarian accomplishments in history, and this is the team that can get it done,” said HHS Secretary Alex Azar.

OWS is headed by ex GSK’s & ex Moderna’s director Dr Moncef Slaoui, [7] with projects led by:

• Vaccines: Peter Marks, M.D., Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research.
• Therapeutics: Janet Woodcock, M.D., Director of the FDA’s Center for Drug Evaluation and Research.
• Diagnostics: Bruce Tromberg, Ph.D., Director of the NIH’s National Institute of Biomedical Imaging and Bioengineering.

At this point Dr Anthony Fauci is not confident a vaccine will be effective.  A warp speed vaccine could be deadly.

Eleven days earlier the EU hosted a global pledging event where the US abstained.

The statistics are that only 1 in 15 vaccines that enter phase II trials is ever licensed, and the average development time for vaccines is usually measured in decades. [2]  On June 5, 2020, OWSVI had chosen 5 vaccine candidates: Moderna, Oxford/AstraZeneca, Johnson & Johnson, Merck and Pfizer, the first three having already received $2.2 billion in federal funding.

Pfizer chose not to participate in the OWS government ran, DOD program (though they did have a contract), as a consequence, in 2024 they left themselves open to being sued by US States – EXCERPT

As early as May 22, 2020 the lack of infectious cases of COVID-19 was identified by Adrien Hill from Oxford’s Jenner institute when he said to Science mag “…we’re beginning to run out of good trial sites to do vaccine efficacy studies—even the U.S. is plateauing,” …People are going to fight for that site to get the vaccine tested before it runs out.”  The disappearance of Ebola cases in November 2015 was a major problem for vaccine developers!

Then on June 10, 2020 the Washington Post reported that Oxford University officials who were rushing to “develop coronavirus vaccines are alerting governments, health officials and shareholders” that declining numbers of new infections may be getting too small to quickly determine whether vaccines work!

“Even as new cases are growing worldwide, transmission rates are falling in Britain, China and many of the hardest-hit regions in the United States — the three countries that have experimental vaccines ready to move into large-scale human testing in June, July and August.”

Volunteers need to be exposed to someone infected with the virus to determine if the vaccine works.

In a press release on June 30, 2020 the US FDA issued guidance to manufacturers “help facilitate the timely development of safe and effective vaccines to prevent COVID-19” in order to win regulatory approval. [7]

“The guidance also discusses the importance of ensuring that the sizes of clinical trials are large enough to demonstrate the safety and effectiveness of a vaccine. It conveys that the FDA would expect that a COVID-19 vaccine would prevent disease or decrease its severity in at least 50% of people who are vaccinated.” Also the vaccine companies would be required to monitor the vaccine’s performance after approval for any emerging safety problems. [1, 2, 3]

“If you had a 60 or 70 percent effective vaccine and everybody took it, you might actually be reaching toward herd immunity and potentially then dampen down this pandemic,” Dr George Poland of the Mayo Clinic said on Nov 3, 2020.

As a comparison the flu vaccine effectiveness which “can vary widely from year to year has been anywhere from 20% to 60% effective over the last decade.

According to GlobalData on April 9, 2020 the WHO sets two vaccine success benchmarks for vaccines.  “Preferably, the vaccine should have at least a 70% efficacy on a population basis with durability for at least a year for reactive use in an outbreak and/or protection for those with a high ongoing risk. The lower success bar is about 50% efficacy with at least a six-month durability”. [4]

They go on to state: “The 50% success bar, while low, is acceptable, as it would likely be enough to ease the pressure on frontline healthcare resources but it may not be high enough to reach herd immunity.”[6]

FDA commissioner Dr Stephen Hahn in a JAMA interview on July 30, 2020, stated “We all want a vaccine tomorrow. That’s unrealistic. And we all want a vaccine that’s 100% effective. Again, unrealistic,” Hahn said “we said 50%, and the reason was because we felt that that was a reasonable floor given the pandemic.” [5]

A couple of days earlier, Dr Anthony Fauci said he would like 60% meaning on average the vaccine reduces a person’s risk of SARS-CoV-2 infection by 60%.

Dr. Doran Fink from the FDA explains at the July 29, 2020 ACIP meeting the criteria necessary for the FDA to be able to issue a COVID-19 vaccine with Emergency Use Authorisation (EUA).

The key point being that there has to be “No adequate, approved, and available alternative“. [@2:57]

On September 8, 2020, Oxford/AstraZeneca (A/Z) “voluntarily” halted their COVID-19 vaccine Phase III clinical trial after a previously health, UK trial participant, came down with an unexplained suspected vaccine reaction. [1]

The following day A/Z CEO announced the female trial participant had experienced neurological symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis, that can cause muscle weakness, paralysis, pain and bladder problems.

It was only a week earlier, on August 31, 2020 that the US began the AstraZeneca Phase III trials. [2]

On October 26, 2020 AstraZeneca resumed their US Phase III trials after an “independent safety board reviewed the incident and determined the participant’s illness was unrelated to AstraZeneca’s coronavirus vaccine candidate”, though in the UK they resumed earlier on September 15th.

On September 22, 2020 the CDC’s COVID-19 Vaccine Planning Unit (VPU) presented their plan, once the vaccines rolled out, to conduct active “enhanced safety monitoring for COVID-19 vaccines in early phase vaccination” through smartphone and email-based web surveys, in addition to VAERS.

The CDC introduced the Vaccine Safety Assessment For Essential workers (V-SAFE) phone app at vaccine roll-out, initially intended for health workers, though was made available to the general public to download and register.   For the first week participants would get prompted to enter post vaccination information, then weekly up to [only] 6 weeks – this is called active surveillance. [2]

The purpose of the V-SAFE app “is to rapidly characterize the safety profile of COVID-19 vaccines when given outside a clinical trial setting.” Data submitted to V-SAFE  is “collected, managed, and housed on a secure server by Oracle,” a private, third-party computer technology company who receives the data in deidentified form. [3]

The US Vaccine Adverse Events Reporting System (VAERS) is “the US early warning safety monitoring system”, co-managed by the CDC and FDA, with an established baseline yearly reporting rate. [1]  The management of vaccine safety has historical issues!

By December 2021 the CDC refuse, through FOIA, to release the deidentified V-SAFE data to the public which Oracle is allowed to manage!

From leaked emails and reports to Trial Site News in June 2022, it indicates that as early as November 10, 2020, the European regulatory agency (EMA) staff, who oversees the evaluation of medicinal products for the European Union, had reason to be concerned about the rushed speed of the regulatory process with respect to robustness of assessment, plus they were aware of potential issues with Pfizer-BioNTech’s vaccine batch integrity.

The emails reveal that regulatory bodies like the FDA, MHRA, EMA and Health Canada knew of the differences in batches, regarding % mRNA integrity and the presence of uncharacterised fragments of RNA in batches (“impurities”), making the ‘safety and efficacy’ of the COVID-19 vaccine an unknown and could account for the variation in adverse reactions to batch/lot numbers.

Knowing these issues the regulators granted various designations of emergency use authorisation a few weeks to months later – which would not pass normal regulation.

In a press release on November 9, 2020, Pfizer-BioNTech announce their preliminary phase 3 clinical trial data suggests their COVID-19 vaccine is more than 90% effective. [1, 2]

Then they announced via press release on November 18, 2020, that the final analysis of their COVID-19 vaccine Phase III clinical trial data showed it was 95% effective and with no safety concerns, stating:

“Primary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose;170 confirmed cases of COVID-19 were evaluated, with 162 observed in the placebo group versus 8 in the vaccine group”.

“Efficacy was consistent across age, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94%,”  [1]

Those results had yet to be peer reviewed, but the media ran with the claim. Pfizer filed for emergency use authorization with the FDA “within days” of this announcement.

On November 27, 2020 Australia’s Therapeutics Goods Administration (TGA) state on their website that they “will rigorously assess any COVID-19 vaccine for safety, quality and effectiveness before it can be supplied in Australia.”

On March 29, 2018 the Therapeutics Goods Act 1989 was amended to include a Provisional Registration clause to allow products to enter the system on limited data, not allowed for normal registration.  The clause was sold on the intent of providing life-saving medication to cancer patinets, and to have our regulatory system was in line with the rest of the world – with a fast-track, emergency-like provision!

On December 2, 2020, the Pfizer-BioNTech COVID-19 vaccine was “temporarily authorised“, by UK’s Medicines and Healthcare products Regulatory Agency ( MHRA), becoming the first COVID-19 vaccine to be authorised anywhere in the world, “paving the way for mass vaccination”. [1, 2]

The vaccine was reported to offer “up to 95% protection against Covid-19 illness”.  Pfizer’s CEO stated on December 3, 2020 that Pfizer don’t know if the vaccine will prevent transmission – the entire purpose of a mass vaccination campaign.

The governments authorisation “follows months of rigorous clinical trials and a thorough analysis of the data by experts at the MHRA who have concluded that the vaccine has met its strict standards of safety, quality and effectiveness”, contradictory to Pfizer FOIA documents.

On 30 December “the cheaper and easier-to-distribute Oxford-AstraZeneca  COVID-19 vaccine” was approved.  A third vaccine, produced by Moderna, was approved for use in the UK in January 2021. Finally, Janssen’s single-dose vaccine was approved in May 2021, although it is yet to be used. [1, 2]

On December 3, 2020, just one day after the UK became the first country to grant emergency use authorisation for Pfizer-BioNTech’s COVID-19 vaccine, it was reported that Pfizer’s CEO Albert Bourla said in an interview with NBC that the company is “not certain” if their vaccine will prevent transmission, “I think this is something that needs to be examined” he said. [1, 2]

On December 9, 2020 the European Medical Agency (EMA) was the subject of a cyberattack which was revealed that “COVID-19 medicines and vaccines” [1] data was stolen.  This included “email screenshots, EMA peer review comments, Word documents, PDFs, and PowerPoint presentations”, of which some of those documents related to “the regulatory submission for Pfizer and BioNTech’s COVID-19 vaccine candidate, BNT162b2.” [2]

Nineteen days after the hack, on December 21, 2020, the EMA granted Conditional Marketing Authorization (CMA) to Pfizer-BioNTech, for the very vaccine in question – which the hack reveals that the EMA regulators had at the time over 100 regulatory objections.

On of the biggest objection was reported by a BMJ investigation published on March 10, 2021, that revealed by November 23, 2020 the EMA “regulators had major concerns over unexpectedly low quantities of intact mRNA” …”between the clinical batches and proposed commercial batches—from around 78% to 55%.”  Revealing concerning batch integrity instability. [3, 4, 5, 6]

The first COVID-19 vaccine administered in America was to Sandra Lindsey, an ICU nurse, in New York City on December 14, 2020.

After months of vaccine development, two companies, Pfizer-BioNTech and Moderna applied to the FDA for Emergency Use Authorization (EUA).  To receive approval, the companies’ data had to be reviewed by the Centers for Disease Control and Prevention (CDC) and its Advisory Committee on Immunization Practices (ACIP), which determined that health care workers and long-term care residents should be the first groups to receive the vaccine. [1, 2, 3, 4]

In a press release on December 10, 2020 the FDA assured the public that they would proceed “without sacrificing our rigorous scientific standards for safety and effectiveness.”  “The FDA recognizes that transparency and dialogue are critical to building public confidence in COVID-19 vaccines.” “The FDA is considered the “gold standard” regulator of medical products. The process that the FDA uses to review is respected worldwide…”

On December 10, 2020 The FDA’s Center for Biologics Evaluation and Research’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), “made up of independent scientific and public health experts from around the country”, met in open session to discuss the request for EUA of a “COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH”  (Pfizer-BioNTech) “for the prevention of COVID-19 in individuals 16 years of age and older.”  Which they approved on December 11, 2020..

ACIP met December 11& 13, 2020 “to review the Pfizer-BioNTech vaccine and recommended moving forward with its distribution to anyone over age 16. The FDA issued an EUA on Saturday 12th following the meeting and notified the CDC and Operation Warp Speed to coordinate distribution plans.”

On December 17, 2020  VRBPAC met again to discuss the EUA of the Moderna COVID-19 Vaccine “for the prevention of COVID-19 in individuals 18 years and older.”  The following day on December 18, 2020 the FDA grants EUA to Moderna. [5]

Americans were assured by Operation Warp Speed that “Vaccines will help prevent the spread of COVID-19 and bring this pandemic to an end”

The CDC state that “Clinical trials provide data and information about how well a vaccine prevents an infectious disease and about how safe it is.  The FDA evaluates these data, as well as manufacturing information, to assess the safety and effectiveness of vaccines. FDA then decides whether to approve a vaccine or authorize it for emergency use in the United States.”

At a December 19, 2020 ACIP meeting, the CDC’s advisory board, Dr Thomas Clark presented slides which showed that more than 2 in 100 vaccinated were experiencing an adverse reaction. [1, 2]  At this time “272,001 doses of vaccine have been administered” in the US, of which some healthcare workers have experienced serious reactions. [4, 5]

The CDC’s V-safe Active Surveillance for COVID-19 Vaccines data slide showed of 112,807 registrants with a recorded 1st dose, 3,150 of these experienced a “Health Impact Event” which means they were “unable to perform normal daily activities, unable to work, required care from doctor or health care professional”.  That is 2.79% of vaccinated actively surveilled were adversely affected post injection of just the first dose. [3]

On January 27, 2021 the CDC (in an email obtained under Freedom of Information) defined a COVID-19 “vaccine breakthrough case” as

“a patient who has SARS-CoV-2 RNA or antigen detected on a respiratory specimen collected [greater than or equal to] 7 days after completing the primary series of an FDA-authorized SARS-CoV-2 vaccine” [1, 2]

Though in retrospect, we learn CDC’s Dr Fisher as early as December 21, 2020, only 7 days after rollout begins, he was directed by a superior “to start working on a protocol to evaluate COVID vaccine failures or breakthrough cases.”  Also on January 30, 2021, CDC Director, Dr. Rochelle Walensky, began planting concern about virus variants being a “growing threat” of escaping the protection of vaccines.

On January 27, 2021 at the CDC a 1-page internal document about “vaccine failure” was being distributed by CDC medical officer Dr. Thomas Clark the Epoch Times reveals, but under FOIA it is fully redacted.

On February 2, 2021 in an email, the CDC’s Vaccine Breakthrough Case Investigation Team, led by Dr Fisher and part of the COVID-19 Vaccine Taskforce, alters the definition of a breakthough case to be least 14 days post the completion of a primary dose series of injections.  This instantly eliminates cases and provides an inflated and misleading view of vaccine effectiveness. [3]

“A US. resident who has SARS-CoV-2 RNA or antigen detected on a respiratory specimen collected [greater than or equal to] 14 days after completing the primary series of an FDA-authorized COVID-19 Vaccine.”

On February 4, 2021 the CDC communicated with US States on how to count vaccine breakthrough cases and which to exclude!

It wasn’t until April 15, 2021 that the CDC began reporting vaccine Breakthrough Cases, which included some who were hospitalised and died. [4, 5]

On May 1, 2021 the ” CDC transitioned from monitoring all reported vaccine breakthrough cases to focus on identifying and investigating only hospitalized or fatal cases due to any cause”. [6, 7]

In an email to the Epoch Times it was claimed the “CDC made the change to the definition of a breakthrough infection time period due to the most current data that showed that the 14-day period was required for an effective antibody response to the vaccines.”  At this point the CDC are assuming antibody production is equivalent to “preventing infection”, a theory.  They claimed to have wanted to “eliminate cases where exposure [to the virus] happened before the vaccination response [antibody production] would be effective.”

As Dr Harvey Risch points out to Epoch Times, “If the vaccines don’t work for the first 7 or 14 days or increase risk of getting COVID-19 during that period, that is part of what happens when they [the mass vaccination program] are deployed in a population.”

Dr Jay Bhattacharya told The Epoch Times in an email, the CDC should have warned “recently vaccinated vulnerable older people that they were at higher risk for being infected during that period.”

On February 22, 2021 together Australia’s Prime Minister, the Chief Medical Officer, and the Chief Nursing and Midwifery Officer, officially launched Australia’s COVID-19 vaccination program for groups at higher risk of death due to COVID-19.

On March 5, 2021 Australian TGA’s Access Consortium are considering changing the COVID-19 vaccine’s mRNA code during the pandemic, in a provisionally registered vaccine, and compare is to seasonal influenza vaccine changes, even though they are completely different technologies.

“On public health and scientific considerations, Regulatory Authorities do not consider an updated coronavirus vaccine to be an entirely novel product with the resulting requirement for lengthy full-blown clinical studies.”….”a regulatory approach like for seasonal updates for influenza vaccines can be taken”

“Since an updated vaccine variant will build on a previously authorised parent version with established quality, safety and efficacy; from a public health perspective, it may be justifiable to roll out the new vaccine candidate already in parallel with the previous version in absence of clinical immunogenicity and safety data while these studies are ongoing.”

It appears that since a “booster” has been granted TGA provisional approval, changing the mRNA code may not require much regulatory oversight!!!  Yet a different protein could have profound cytotoxic implications.

It appears the regulatory agency is authorising the “vaccine platform” and not the “active ingredient” which mRNA code will force the body to manufacture.  The body makes the “active ingredient”, that is unique for each vaccine, but apparently not according to the regulators.

On May 20, 2021 Oxfam released a report titled, “COVID vaccines create 9 new billionaires with combined wealth greater than cost of vaccinating world’s poorest countries”. [3, 4]

Topping the list are the CEOs of BioNTech and then Moderna.  The top 2 to 6 are linked to Moderna. Neither company had brought a product to market prior to their brand new technology COVID-19 mRNA vaccine. [1, 2]

The last 3 billionaires are co-founders of CanSino Biologics, manufactures of China’s Ad5-nCoV-S recombinant (Ad5-nCoV) vaccine against COVID-19. [3]

On June 25, 2021 the US FDA announced the addition of a warning “to the patient and provider fact sheets for the Moderna and Pfizer-BioNTech COVID-19 vaccines regarding the suggested increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination.” [1]

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]