Timeline Data Points relating to COVID-19 Vaccine
Rollout Across the World
This page will pull from the COVID-19 Pandemic TIMELINE all data points relating to the COVID-19 Vaccine Roll out including Boosters shots.
Capturing mostly US, Australia, UK, EU and Israel vaccine rollout.
Best viewed on a large screen!
Data points are continuously added
Study: RNA shown to evade the innate immune system if altered to pseudouridine
DARPA awards Moderna $25M for mRNA development
On October 2, 2013 the US Defense Advanced Research Projects Agency (DARPA) through its “synthetic biology” ADEPT: PROTECT program, awarded Moderna Therapeutics “up to $25 million to research and develop its messenger RNA therapeutics™ platform as a rapid and reliable way to make antibody-producing drugs to protect against a wide range of known and unknown emerging infectious diseases and engineered biological threats.” Much of this funding will be used over the next 5 years to “advance promising antibody- producing drug candidates into preclinical testing and human clinical trials“. [1]
The ADEPT: PROTECT Pandemic Prevention Platform program plans to have the “development and widescale deployment of protective countermeasures” within 60 days from detection of an outbreak.
DARPAs’s Autonomous Diagnostics to Enable Prevention and Therapeutics: Prophylactic Options to Environmental and Contagious Threats – ADEPT: PROTECT program seeks to “enable adaptable, diagnostic devices that decrease the time required to design, manufacture, and rapidly distribute test panels in response to evolving or emerging diagnostic needs.”Moderna’s mRNA “platform has the potential to speed the development and manufacture of treatments that can produce a safer, more reliable and more robust immune response than existing technologies.”
The ADEPT program began in August 2011 when DARPA began investing in “Controlling Cellular Machinery (CCM) “technologies such as nucleic acid vaccines. The hypothesis was that rather than delivering antigens to the immune system, we could deliver genes that encode the antigen and allow the human body to produce the antigen from its own cells, triggering a protective immune response.”
In January 2014 DARPA created a new division called the Biological Technologies Office (BTO), “to explore the increasingly dynamic intersection of biology and the physical sciences” i.e. synthetic biology, neuro-nanotechnology and AI. [2, 3]
“DARPA pioneered the use of the body as a bioreactor to produce prophylactic antibodies to protect against biothreats”. With “[g]ene-encoded antibodies for near-immediate, temporary protection”. [4] This is different to gene-encoded antigen, which Moderna has claimed in 2020 to be a “vaccine”.
Provisional Registration added to TGA legislation
On March 29, 2018 the Australian government added a Provisional Registration (PR) amendment to the Therapeutic Goods Act (1989), of which the TGA Secretary now has overriding power to send a product application through the registration process with only preliminary clinical data. [3]
This decision was publicised on June 26, 2017 as a “Priority review pathway for the registration of novel prescription medicines for Australian patients….[and] will involve faster assessment of vital and life-saving prescription medicines”. With specific eligibility criteria, including no existing alternative products.
The intent of this new registration category was explained in parliament in September of 2017 by Mr Greg Hunt as being intended as an avenue to provide “medicine” to those people with “significant unmet clinical needs for serious conditions”. [8, 9]
The process started October 24, 2014 with the announcment of the MMDR panel of 3 experts to review and report on the regulatory framework of therapeutic goods. [4, 5, 6, 7] The panel recomended a provisional pathway. [13, 14]
The government responded in 2016, noting the “international trends towards allowing earlier access to medicines” especially looking to fast-track “novel and life–saving medicines”, with a seeming emphasis on cancer drugs. [10]
- Provisional registrations are of a limited duration (max 2 years) and require the sponsor to supply ongoing clinical data to support their product.
- All PR products are part of the Black Triangle Scheme where healthcare professionals or consumers should report to the TGA all and any “any unfavourable and unintended sign, symptom or disease” following the use of the product “to help us build up the full picture of a medicine’s safety profile.” It’s not the doctor’s job to determine if a unintended consequence is related or not to the medicine.
- “For provisionally-registered medicines, the black triangle symbol will appear for a period of not less than five years.””
- Such “registrations” are added to the Australian Register of Therapeutic Goods (ARTG), but they are not classed as fully registered, they are still under assessment and may never receive full registration status.
Between 1 April 2018 until 22 June 2021 there has been [12] Provisional Registrations of which 2 are COVID-19 vaccines [1, 2] and 1 is remdesivir.
Immunisation Agenda 2030 – “leave no one behind”
In 2019 the World Health Organisation (WHO) began planning a new decade of vaccines called Immunisation Agenda 2030 (IA2030), superseding the Global Vaccine Action Plan (GVAP), that started in 2011 and expired 2020.
Vaccination or Immunisation, a practice the WHO claims saves “millions of lives every year”, is a component of 14 out of 17 of the United Nations Sustainable Development Goals (SDG). The plan is sold as “Immunization is an investment for the future, creating a healthier, safer and more prosperous world for all” and the intention is to “leave no one behind“, the market has opened up to everyone. [1, 2]
“Immunization is playing a critical role in achieving the Sustainable Development Goals (SDGs). Immunization reaches more people than any other health and social service, making it the foundation of primary health care systems and a key driver toward universal health coverage.” (Now think digital “vaccination certificate” – which will morph into passport)
In August 2020 at the 73rd World Health Assembly the new global vision for vaccines IA2030 was endorsed.
Johns Hopkins promotes Vaccine Platform Technologies
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.”
Moderna/DARPA: First human Phase 1 trial using “mRNA therapeutic”
On September 12, 2019 Moderna announced study findings from their first ever human trial using a “mRNA therapeutic”, mRNA-1944, to encode the antibody protein, CHKV-24, for chikungunya “a mosquito-borne virus that poses a significant public health problem in tropical and subtropical regions”. [1, 2, 3, 4]
“These exciting data demonstrate a new way to address infectious diseases that uses mRNA to make antibodies in humans, establishing a powerful technology that could be deployable in a pandemic setting.”was commented in the press release. ‘[T]he results of this clinical trial validate that approach” DARPA representative stated.
Sponsored by US DARPA, the trial protocol was was first posted on Clinical Trials on February 4, 2019, taking 7 months to complete Phase 1 of the trial in 22 healthy adults, of which 6 received the placebo.
Phase 1 trial was “paused” in May 2020 due to the pandemic.
Novel coronavirus (2019-nCoV) genome sequence is made public
The sequence of the novel coronavirus (SARS-CoV-2) was posted to a public web server on January 10, 2020 [6]
Following China’s Jan 7, 2020 announcement a “viral genome sequence was released for immediate public health support via the community online resource virological.org on 10 January (Wuhan-Hu-1, GenBank accession number MN908947), followed by four other genomes deposited on 12 January in the viral sequence database curated by the Global Initiative on Sharing All Influenza Data (GISAID)”, according to Drosten et al. [4]
According to WHO on 12 January 2020, “China shared the genetic sequence of the novel coronavirus for countries to use in developing specific diagnostic kits.”
The genetic sequence of 2019–nCoV (now SARS-CoV-2), a new coronavirus associated with human respiratory disease in Wuhan, China (collection date 26/12/2019), was published on GISAID for countries to use in developing specific diagnostic kits. [3]
- The University of Sydney coordinated the notice of release of the genome to the world
- The complete genome sequence called SARS-CoV-2 isolate Wuhan-Hu-1
The virus is closely related genetically to SARS-CoV (82%) and to SARS-related bat and civet coronaviruses within the family Betacoronavirus, subgenus Sarbecovirus. [1, 2] The epidemiology of this subgenus is largely unknown, especially outside China.
China’s CDC report that on “January 3, 2020, the sequence of novel β-genus coronaviruses (2019-nCoV) was determined from specimens collected from patients in Wuhan by scientists of the National Institute of Viral Disease Control and Prevention (IVDC), and three distinct strains have been established.”
The genome sequence was published by China’s CDC. [5] The new Betacoronavirus genome sequence was deposited in GISAID (www.gisaid.org) under the accession numbers:
- EPI_ISL_402119
- EPI_ISL_402020
- EPI_ISL_402121
Moderna design mRNA vaccine sequence in one hour
Melissa J. Moore PhD, Chief Scientific Officer at Moderna recaps in a 2022 TED Talk that as soon as Chinese novel-CoV virus gene sequence was made public on January 10, 2020, they “got immediately to work”. [1, 2]
Within 2 days, following discussions with their National Institutes of Health (NIH) partners, they agreed on “which form of spike protein they’d put in their vaccines”. So on January 12, 2020 it “took Moderna’s mRNA design team just one hour to design” the modified mRNA vaccine sequence which was immediately put onto their manufacturing equipment and used in their phase 1 trials.
Remember, Moderna had never brought a product to market and the FDA considered mRNA as a “gene therapy“, yet by 2022 Moore refered to the use of their technology as a “vaccine” when used in a few trial patients who already had cancer (not as a preventative!).
“By January of 2020, we had already manufactured, quality controlled and delivered to several dozen patients personalised cancervaccines. So we had the know-how and the capacity to manufacture vaccines quickly.”
“There is a coming Tsunami of mRNA medicine” [called vaccines?]
US HHS-BARDA announce collaboration with Janssen/J&J on vaccine
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.
Caution warranted for coronavirus vaccines for humans – the animals died!
On February 27, 2020, independent media, The Highwire, alerted [@1:11:30] the public to the potential dangers of a SARS vaccine, base on a 2012 SARS vaccine study in mice. Coronovirus vaccines appear to cause “Pathogenic Priming”, a Disease Enhancement otherwise referred to as Antibody Dependent Enhancement (ADE). What resulted in the animal studies was upon re-infection the mice experienced a cytokine storm followed by death. [1, 2, 3]
The paper concluded “Caution in proceeding to application of a SARS-CoV vaccine in humans is indicated.”
- The same effect has been shown in chickens.
- In addition vasculitis or blood clots were identified in the coronavirus vaccine study in animals.
On March 5, 2020, Dr Peter Hotez warned the US government of “the unique potential safety problems of coronavirus vaccines”, such as with RSV vaccines in the 1960’s where “paradoxical immune enhancement phenomenon” can occur with respiratory virus vaccines, and “we don’t entirely understand the basis of it”! They were confronted with the same “immune pathology” problem with coronavirus vaccine tests done on laboratory animals. The FDA are aware of the problem, these types of vaccines can’t be rushed because of the long-term safety implications. [@1:26:30]
Yet Operation Warp Speed was officially announced 2 months later, .
WHO: Solidarity Vaccine Trial initiative begins
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]
Bill Gates: a vaccine for 7 billion people is the only solution
Self proclaimed health expert, Bill Gates, who has no medical or scientific qualifications, but is a “global health” philanthropist, was interviewed [with seemingly scripted questions] on BBC Breakfast on April 12, 2020 and told us that:
“the thing that will get us back to the world that we had before coronavirus is the vaccine and getting that out to all 7 billion people”
There was no vaccine at this time, they were all experimental and in early trials. And why did all 7 billon need a shot when many people already had been natural infected and mounted an immune response? Could it be because he had investments in the vaccine companies, and would make a fortune if they were force upon the world?
Bill also claimed that “we didn’t simulate this, we didn’t practice” yet in October 2019 his foundation was a co-sponsor of a coronavirus pandemic simulation called Event 201!
Bill is pushing for “global cooperation” and more funding. According to Bill the “rich” countries are now experiencing the “second wave” of “very challenging epidemics”, though he predicted the “developing countries who yet don’t have a large number of cases” are likely to be worst hit because “their ability to isolate” and their health systems are far less than the rich countries. “So the global cooperation is to help those counties“. [1]
Other quotes by Bill:
“And of course the vaccine is a protective, to prevent you from getting sick”
“…so we’re going to have to take something that usually takes 5 to 6 years [to develop] and get it done in 18 months. There is an approach called an RNA vaccine…that looks quite promising…unfortunately the schedule for the [conventional vaccine approach] will probably not be as quick as the RNA platform, that we’ve been funding directly and through CEPI over the last decade.”
“…this is such an unprecedented, very tough thing to deal with. The people like myself and Tony Fauci are saying 18 months [to develop a vaccine], if everything went perfectly we can do slightly better than that, but there will be a trade off, we’ll have less safety testing than we typically would have, and so governments would have to decide do they indemnify the companies… we just don’t have the time to do what we would normally do“
Safety testing: Gates compares rushed drug approval for HIV [someone who is sick or tests positive] to the safety trade-off of fast vaccine development given to healthy people! “…this is a public good, so those [safety] trade-offs…the regulator says go ahead even though you haven’t taken the normal time period”
“I do think now, because this has been so dramatic, ahhh, we weren’t ready for this pandemic but I do think we will be ready for the next pandemic, and using the new tools of science [mRNA platform?] that’s very very doable.“
The host prompts “…are you optimistic that now…there will be a different mindset around the fears around viruses and pandemics”
“…we should be able to have a vaccine in less than a year if we’re on standby with the right factories and the right science…”
“…a big missing piece is funding the research for these type of vaccines…[jumble!]”
“its shocking…how hard its going to be to get back to normal life that we had before”
[Do you think things will go back to normal?] “Once you have a safe and effective vaccine and get that out to all most all of the people on the planet, and build the preparatory systems for the next pandemic…we will go back to normal and economies will recover…innovation will help us not be at such a risk in the years after that.“
Its worth watching the 17 minute INTERVIEW which the “Trusted” BBC have “unlisted” on YouTube.
BioNTech begin Phase I/II human trails
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]
Oxford Uni begin Phase I vaccine clinical trial
The first two volunteers, one control (meningitis vaccine) and the other the vaccine treatment, were injected on April 23, 2020 for the Oxford University Phase I human vaccine clinical trials. [1]
The Oxford researchers started screening healthy volunteers (aged 18-55) in March 2020 for their upcoming ChAdOx1 nCoV-19 vaccine trial in the Thames Valley Region.
Seven days later on April 30, 2020 Oxford University announces partnership with AstraZeneca to help develop and distribute their COVID-19 vaccine.
Spike (S) protein has 14 mutations identified – consequential for vaccines
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.
Oxford monkey study fails to stop viral infection or transmission – but proceed to human trials
On May 13, 2020 Oxford and NIAID scientists published the pre-clinical animal study looking at vaccinated versus un-vaccinated rhesus macaques (monkeys). They “observed a significantly reduced viral load in bronchoalveolar lavage fluid and respiratory tract tissue of vaccinated animals challenged with SARS-CoV-2 compared with control animals, and no pneumonia was observed in vaccinated rhesus macaques.” [1]
But the Oxford/AstraZeneca vaccine in this animal challenge study, “did not provide sterilizing immunity” which is considered the “gold standard for any vaccine.” Vaccinated monkeys could still become infected and had viable virus in their nose which could be transmitted and infect others!
Even though “no evidence of immune-enhanced disease following viral challenge in vaccinated animals was observed”, experience with other vaccines tells us that is not a firm guarantee that such will be the case for humans, states William Haseltine
Based on the observation that their vaccine could “moderate the disease” they proceeded into human clinical trials.
“Operation Warp Speed” announced
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.
Uni Oxford begin Phase II/III vaccine clinical trial
University of Oxford researchers have begun recruiting for the next phase in human trials of a COVID-19 vaccine 10,260 adults and children at partner institutions across the country.
Adult participants in both the Phase II and Phase III groups will be randomised to receive one or two doses of either the ChAdOx1 nCoV-19 vaccine or a licensed vaccine (MenACWY) that will be used as a ‘control’ for comparison.
COVID-19 vaccine developers have a problem – not enough sick people
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.
Fauci: coronavirus vaccines may not provide long-term immunity
When talking with JAMA Editor Howard Bauchner, Dr. Anthony Fauci says there’s a chance the coronavirus vaccines may not provide long-term immunity, if COVID-19 acts like other coronaviruses, “it likely isn’t going to be a long duration of immunity”. [1]
At this point “scientists still don’t fully understand key aspects of the virus, including how immune systems respond once a person is exposed.”
At the same time member of the boards of Pfizer and former FDA commissioner, Dr Scott Gottlieb says expect COVID-19 vaccine to be seasonal like the flu shot.