Author Topic: Untested Trump Vaccine?  (Read 1015 times)

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Online PeteS in CA

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Untested Trump Vaccine?
« on: August 28, 2020, 09:14:28 AM »
Untested Trump Vaccine?

Like influenza and other viruses, Covid-19 and other Corona virues will never go out of circulation. Thus the long-term "solution" to Covid-19 is to have one or more vaccines for the virus (which could be "adjusted" to counter-act future Corona virus outbreaks).

What is this test "Phase" stuff? Phase I is the first human trial, with a few 10s of subjects. It tests whether the vaccine candidate can be effective, and at a dose level with reasonably mild side effects (safety). Phase II involves hundreds of subjects, with a wider range of age and ethnic backgrounds. Phase III involves 10s of thousands of subjects. Phases II and III both continue to look at effectiveness and safety. Phase III is the final pre-approval test phase.

What follows is timelines for the progress of each of the leading vaccine candidate, plus several others whose companies are working with the various Federal agencies. These are far from the only vaccines being developed "out there", but are the ones most likely to be approved earliest by the US FDA. Taking a view at a level above the nutsy-boltsy details, one can see that:

* The Trump Administration is not putting "its" eggs in just one or a very few baskets;

* The Trump Administration has chosen companies from multiple countries - AstraZeneca is UK/Sweden; BioNTEch is German; Sanofi is French;

* A great deal of attention has not only gone into development and testing, but the US government has also assisted the vaccine companies with production capacity in the US and with necessaries such as vials and syringes; potential bottlenecks have been anticipated and addressed.

AstraZeneca (Oxford) - Phase III

April 17, 2020 - NIH announced a public-private partnership with leading biopharmaceutical companies to speed up the development of coronavirus vaccines and therapies; https://www.nih.gov/news-events/news-releases/nih-launch-public-private-partnership-speed-covid-19-vaccine-treatment-options

April 23, 2020 - University of Oxford researchers began Phase I trial of a COVID-19 vaccine; https://www.ox.ac.uk/news/2020-04-23-oxford-covid-19-vaccine-begins-human-trial-stage , https://www.bbc.com/news/health-52394485 , https://www.vaccitech.co.uk/oxford-covid-19-vaccine-begins-human-trial-stage/

April 23, 2020 - Vaccitech and the University of Oxford announced an agreement with biopharmaceutical company AstraZeneca for the further development, large-scale manufacture and potential distribution of Oxford's COVID-19 vaccine; https://www.vaccitech.co.uk/vaccitech-and-oxford-university-announce-landmark-partnership-with-astrazeneca-for-the-development-and-large-scale-distribution-of-the-covid-19-vaccine-candidate/

April 30, 2020 - AstraZeneca and Oxford University announce agreement for COVID-19 vaccine; https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/astrazeneca-and-oxford-university-announce-landmark-agreement-for-covid-19-vaccine.html

May 21, 2020 - Trump Administration’s Operation Warp Speed accelerates AstraZeneca COVID-19 vaccine to be available beginning in October; https://www.hhs.gov/about/news/2020/05/21/trump-administration-accelerates-astrazeneca-covid-19-vaccine-to-be-available-beginning-in-october.html

May 21, 2020 - Under Operation Warp Speed, US secures 300 million doses, almost a third, of potential AstraZeneca COVID-19 vaccine; https://business.financialpost.com/technology/u-s-secures-300-million-doses-of-potential-astrazeneca-covid-19-vaccine-3 , https://www.hhs.gov/about/news/2020/05/21/trump-administration-accelerates-astrazeneca-covid-19-vaccine-to-be-available-beginning-in-october.html

May 21, 2020 - Under Operation Warp Speed,  AstraZeneca received support of more than $1B from the US Biomedical Advanced Research and Development Authority for development, production, and delivery of the vaccine, starting in the fall; development Phase III clinical trial with 30,000 participants and a paediatric trial; https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/astrazeneca-advances-response-to-global-covid-19-challenge-as-it-receives-first-commitments-for-oxfords-potential-new-vaccine.html

May 22, 2020 - University of Oxford researchers began Phase II/III trial of a COVID-19 vaccine; https://www.ox.ac.uk/news/2020-05-22-oxford-covid-19-vaccine-begin-phase-iiiii-human-trials

June 24, 2020 - AstraZeneca began a vaccine trial in South Africa; https://thehill.com/policy/international/504328-large-scale-coronavirus-vaccine-trial-begins-in-south-africa , https://www.wits.ac.za/covid19/covid19-news/latest/the-first-covid-19-vaccine-trial-in-south-africa-begins.html , https://www.ovg.ox.ac.uk/news/trial-of-oxford-covid-19-vaccine-in-south-africa-begins

July 1, 2020 - Trial of Oxford/AstraZeneca vaccine began in Brazil; https://www.ovg.ox.ac.uk/news/trial-of-oxford-covid-19-vaccine-starts-in-brazil , https://www.labroots.com/trending/microbiology/18040/oxford-covid-19-vaccine-enters-phase-3-clinical-trials ; approved June 2, https://www.ox.ac.uk/news/2020-06-04-brazilian-health-regulatory-agency-approves-trial-oxford-covid-19-vaccine

July 20, 2020 - Oxford University COVID-19 vaccine produced both antibodies and T-cells in patients; https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/covid-19-vaccine-azd1222-showed-robust-immune-responses-in-all-participants-in-phase-i-ii-trial.html

August 31, 2020 - AstaZeneca began Phase III testing of its Covid-19 vaccine in the US; https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/development-of-covid-19-vaccine-azd1222-expands-into-us-phase-iii-clinical-trial-across-all-adult-age-groups.html

September 4, 2020 - The Oxford/AstraZenaca Covid-19 vaccine began Phase I/II testing in Japan with 250 subjects planned; https://www.dailymail.co.uk/news/article-8697471/Oxfords-coronavirus-vaccine-enters-human-trials-Japan.html

October 23, 2020 - The FDA today authorised the restart of Phase III trials in the US, following the resumption of trials in the UK, Brazil, South Africa, and Japan in recent weeks; https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/fda-authorises-restart-of-the-covid-19-azd1222-vaccine-us-phase-iii-trial.html

November 21, 2020 - AstraZeneca announced that an independent Data Safety Monitoring Board determined that the analysis met its primary endpoint showing protection from COVID-19 occurring 14 days or more after receiving two doses of the vaccine; one dosing regimen showed 62% efficacy while the other 90%; AstraZeneca will immediately submit the data to authorities around the world that have a framework for conditional or early approval; https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/azd1222hlr.html , https://www.vaccitech.co.uk/oxford-university-breakthrough-on-global-covid-19-vaccine/

November 25, 2020 - AstraZeneca and Oxford University acknowledged a manufacturing error and an age group distribution issue affecting the calculated efficacy of their Covid-19 vaccine; https://www.nbcnewyork.com/news/coronavirus/astrazeneca-manufacturing-error-clouds-vaccine-study-results/2746793/

November 26, 2020 - AstraZeneca CEO said that further research was needed on its COVID-19 vaccine after errors affecting the calculation of the efficacy of its vaccine were revealed; the additional testing may not affect regulatory approval in Europe; https://medicalxpress.com/news/2020-11-additional-astrazeneca-vaccine-company.html

 
Inovio - Phase I

March 24, 2020 - Ology Bioservices, Inovio Partner To Manufacture COVID-19 Vaccine With $11.9M DOD Grant; https://ir.inovio.com/news-releases/news-releases-details/2020/Ology-Bioservices-Inovio-Partner-To-Manufacture-COVID-19-DNA-Vaccine-With-119-Million-Department-of-Defense-Grant/default.aspx

April 6, 2020 - INOVIO Started Phase I Clinical Trial Of Its COVID-19 Vaccine; https://ir.inovio.com/news-and-media/news/press-release-details/2020/INOVIO-Initiates-Phase-1-Clinical-Trial-Of-Its-COVID-19-Vaccine-and-Plans-First-Dose-Today/default.aspx

April 28, 2020 - Inovio announced that its Phase I US clinical trial for its COVID-19 DNA vaccine is fully enrolled, with all 40 healthy volunteers having received their first dose; https://ir.inovio.com/news-releases/news-releases-details/2020/INOVIO-Completes-Enrollment-in-the-Phase-1-US-Trial-of-INO-4800-for-COVID-19-DNA-Vaccine-Interim-Results-Expected-in-June/default.aspx

June 23, 2020 - INOVIO announced it has received $71 million funding from the DOD for large-scale manufacture of the company's devices that deliver vaccine directly into the skin; https://ir.inovio.com/news-releases/news-releases-details/2020/INOVIO-Receives-71-Million-Contract-From-US-Department-of-Defense-To-Scale-Up-Manufacture-of-CELLECTRA-3PSP-Smart-Device-and-Procurement-of-CELLECTRA-2000-for-COVID-19-DNA-Vaccine/default.aspx

September 8, 2020 - Inovio announced that Thermo Fisher Scientific has signed a letter of intent to manufacture INOVIO's DNA COVID-19 vaccine; https://ir.inovio.com/news-releases/news-releases-details/2020/INOVIO-Adds-Thermo-Fisher-Scientific-To-Global-Manufacturing-Consortium/default.aspx

November 16, 2020 - Inovio announced that it has received clearance from the FDA to proceed with the Phase 2 segment of its planned Phase 2/3 clinical trial for its COVID-19 vaccine candidate; the trial will be funded by the DoD; https://ir.inovio.com/news-releases/news-releases-details/2020/INOVIO-Announces-Initiation-of-Phase-2-Segment-of-its-Phase-23-Clinical-Trial-for-its-COVID-19-DNA-Vaccine-Candidate-INO-4800-Trial-Will-Be-Funded-by-the-U.S.-Department-of-Defense/default.aspx

December 07, 2020 - Inovio announced it has dosed its first subject in a Phase 2 clinical trial of its COVID-19 vaccine candidate, as part of its Phase 2/3 clinical trial; https://ir.inovio.com/news-releases/news-releases-details/2020/INOVIO-Doses-First-Subject-in-Phase-2-Segment-of-its-INNOVATE-Phase-23-Clinical-Trial-for-INO-4800-its-DNA-Medicine-to-Prevent-COVID-19/default.aspx

 

Janssen Research/Johnson & Johnson - Phase III

February 18, 2020 - HHS to work with Janssen Research to develop a Covid-19 vaccine; https://www.hhs.gov/about/news/2020/02/18/hhs-janssen-collaborate-to-develop-coronavirus-therapeutics.html

March 13, 2020 - Janssen Pharmaceutical entered collaboration with the Beth Israel Deaconess Medical Center (BIDMC) for development of a COVID-19 vaccine; https://www.jnj.com/johnson-johnson-announces-collaboration-with-the-beth-israel-deaconess-medical-center-to-accelerate-covid-19-vaccine-development

March 30, 2020 - HHS accelerated clinical trial of a potential coronavirus vaccine developed by Janssen Research & Development; https://www.hhs.gov/about/news/2020/03/30/hhs-accelerates-clinical-trials-prepares-manufacturing-covid-19-vaccines.html

March 30, 2020 - Johnson & Johnson announced selection of a lead COVID-19 vaccine candidate and an expansion of the partnership between the Janssen Pharmaceutical and BARDA; https://www.jnj.com/johnson-johnson-announces-a-lead-vaccine-candidate-for-covid-19-landmark-new-partnership-with-u-s-department-of-health-human-services-and-commitment-to-supply-one-billion-vaccines-worldwide-for-emergency-pandemic-use

April 17, 2020 - NIH announced a public-private partnership with leading biopharmaceutical companies to speed up the development of coronavirus vaccines and therapies; https://www.nih.gov/news-events/news-releases/nih-launch-public-private-partnership-speed-covid-19-vaccine-treatment-options

April 23, 2020 - Johnson & Johnson announced a collaboration between the Janssen Pharmaceutical and Emergent BioSolutions, Inc. to support the manufacturing of its COVID-19 vaccine; https://www.jnj.com/johnson-johnson-announces-collaboration-to-expand-manufacturing-capabilities-for-its-covid-19-vaccine-candidate-in-support-of-the-companys-goal-to-supply-more-than-one-billion-vaccine-doses-globally

June 10, 2020 - Janssen Pharmaceutical accelerating its Phase I/IIa trial of its COVID-19 vaccine to the second half of July; https://www.jnj.com/johnson-johnson-announces-acceleration-of-its-covid-19-vaccine-candidate-phase-1-2a-clinical-trial-to-begin-in-second-half-of-july

July 30, 2020 - Janssen Research (Johnson & Johnson) COVID-19 vaccine began Phase I/IIa clinical trial in the US and Belgium; https://www.jnj.com/single-dose-of-johnson-johnson-covid-19-vaccine-candidate-demonstrates-robust-protection-in-pre-clinical-studies

August 5, 2020 - Johnson & Johnson announced an agreement between its Janssen Pharmaceutical Companies and the US government for large scale domestic manufacturing and delivery of 100 million doses of Janssen's Covid-19 vaccine, subject to successful testing and with an option to purchase an additional 200 million doses; https://www.janssen.com/johnson-johnson-announces-agreement-us-government-100-million-doses-investigational-covid-19-vaccine , https://www.hhs.gov/about/news/2020/08/05/hhs-dod-collaborate-with-johnson-and-johnson-to-produce-millions-of-covid-19-investigational-vaccine-doses.html

September 23, 2020 - Johnson & Johnson announced the start of its Phase III trial for its COVID-19 vaccine candidate developed by its Janssen Pharmaceutical Companies; the trial will enroll up to 60,000 volunteers across three continents; https://www.jnj.com/johnson-johnson-initiates-pivotal-global-phase-3-clinical-trial-of-janssens-covid-19-vaccine-candidate ; https://www.janssen.com/johnson-johnson-initiates-pivotal-global-phase-3-clinical-trial-janssens-covid-19-vaccine-candidate

September 25, 2020 (updated October 4th) - Johnson & Johnson's Covid-19 vaccine produced T-cells as well as antibodies; https://www.jnj.com/johnson-johnson-posts-interim-results-from-phase-1-2a-clinical-trial-of-its-janssen-covid-19-vaccine-candidate

October 23, 2020 - The independent Data Safety and Monitoring Board overseeing the Johnson & Johnson Covid-19 vaccine study recommended resuming trial recruitment; after consultation with the US FDA, preparations to resume the trial in the US are now underway; https://www.jnj.com/our-company/johnson-johnson-prepares-to-resume-phase-3-ensemble-trial-of-its-janssen-covid-19-vaccine-candidate-in-the-us , https://www.janssen.com/johnson-johnson-prepares-resume-phase-3-ensemble-trial-its-janssen-covid-19-vaccine-candidate-us

November 15, 2020 - In addition to the single-dose regimen 60K participant Phase III study, Janssen has now initiated a two-dose regimen 30K participant Phase III study; https://www.janssen.com/johnson-johnson-initiates-second-global-phase-3-clinical-trial-its-janssen-covid-19-vaccine , https://www.jnj.com/johnson-johnson-initiates-second-global-phase-3-clinical-trial-of-its-janssen-covid-19-vaccine-candidate

December 17, 2020 - The Janssen COVID-19 single-dose vaccine candidate Phase III trial is now fully enrolled with approximately 45,000 participants; https://www.janssen.com/johnson-johnson-announces-its-first-phase-3-covid-19-vaccine-trial-ensemble-fully-enrolled


Moderna - Phase III

January 7, 2020 - NIH and Moderna agreed to work on developing a vaccine against what came to be called Covid-19; https://www.hhs.gov/about/news/2020/12/18/hhs-dod-statements-fda-authorization-moderna-vaccine.html

January 13, 2020 - Moderna produced its first "prototype" sample of its vaccine; https://nymag.com/intelligencer/2020/12/moderna-covid-19-vaccine-design.html

January 22, 2020 - Pharmaceuticals company Moderna working with US government to develop vaccine; https://www.cnbc.com/2020/01/22/moderna-is-working-on-a-vaccine-for-chinas-deadly-coronavirus.html , https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-funding-award-cepi-accelerate-development

February 26, 2020 - Experimental vaccine submitted for testing; Moderna, https://www.cnn.com/2020/02/25/business/moderna-coronavirus-vaccine/index.html

March 16, 2020 - Phase I testing begins of Moderna's experimental coronavirus vaccine; at Kaiser Permanente Washington Health Research Institute, https://www.kpwashingtonresearch.org/news-and-events/recent-news/news-2020/kaiser-permanente-launches-coronavirus-vaccine-study-seattle , https://www.hhs.gov/about/news/2020/03/16/hhs-secretary-azar-statement-on-launch-of-phase-1-covid-19-vaccine-trial.html , https://www.nih.gov/news-events/news-releases/nih-clinical-trial-investigational-vaccine-covid-19-begins

March 27, 2020 - Emory University began enrolling participants for a Phase I clinical trial of Moderna's potential coronavirus vaccine; https://news.emory.edu/stories/2020/03/coronavirus_vteu_modernastart/index.html

April 16, 2020 - Moderna awarded up to $483M by BARDA to accelerate development of mRNA coronavirus vaccine; https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-award-us-government-agency-barda-483-million

April 16, 2020 - Enrollment was completed for Moderna's Phase I trial and additional test groups were added to the trial; https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-award-us-government-agency-barda-483-million

May 6, 2020 - The FDA approved the start of Phase II testing of Moderna's vaccine; https://investors.modernatx.com/news-releases/news-release-details/moderna-receives-fda-fast-track-designation-mrna-vaccine-mrna

May 12, 2020 - Moderna receives FDA Fast Track designation for coronavirus vaccine; https://investors.modernatx.com/news-releases/news-release-details/moderna-receives-fda-fast-track-designation-mrna-vaccine-mrna

May 29, 2020 - Moderna announces first participants dosed in Phase II study of coronavirus vaccine; https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-first-participants-each-age-cohort-dosed-phase

June 11, 2020 - Enrollment of the younger adults group of Moderna's Phase II trial was completed; https://investors.modernatx.com/news-releases/news-release-details/moderna-advances-late-stage-development-its-vaccine-mrna-1273

June 25, 2020 - Moderna and Catalent announced collaboration for fill-finish of Moderna's Covid-19 vaccine; https://investors.modernatx.com/news-releases/news-release-details/moderna-and-catalent-announce-collaboration-fill-finish

July 8, 2020 - Enrollment of the older adults group of Moderna's Phase II trial was completed; https://investors.modernatx.com/news-releases/news-release-details/moderna-completes-enrollment-phase-2-study-its-mrna-vaccine

July 9, 2020 - Moderna and ROVI announce collaboration for outside-of-the-US Fill-Finish Manufacturing of Moderna’s COVID-19 Vaccine; https://investors.modernatx.com/news-releases/news-release-details/moderna-and-rovi-announce-collaboration-ous-fill-finish

July 14, 2020 - Moderna's Covid-19 vaccine produced T-cells as well as antibodies; https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-publication-new-england-journal-medicine , https://www.nejm.org/doi/full/10.1056/NEJMoa2022483

July 26, 2020 - Moderna announced a modification to its contract with BARDA for additional funding to support late development, including the expanded Phase III study of its COVID-19 vaccine; https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-expansion-barda-agreement-support-larger-phase

July 27, 2020 - Moderna announced announced that the Phase III study of its COVID-19 vaccine has begun dosing participants; the randomized, placebo-controlled trial will include some 30,000 US participants; https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-phase-3-cove-study-mrna-vaccine-against-covid

August 11, 2020 - Moderna announced that the U.S. government has secured 100 million doses of Moderna's Covid-19 vaccine; https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-supply-agreement-us-government-initial-100 , https://www.hhs.gov/about/news/2020/08/11/trump-administration-collaborates-with-moderna-produce-100-million-doses-covid-19-investigational-vaccine.html

October 22, 2020 - Moderna announced that it has completed enrollment of 30,000 participants in the Phase 3 study of its COVID-19 vaccine candidate, in collaboration with NIAID (part of NIH) and BARDA (part of the US Department of HHS); to date, more than 25,650 participants have received their second vaccination; https://investors.modernatx.com/news-releases/news-release-details/moderna-completes-enrollment-phase-3-cove-study-mrna-vaccine

November 16, 2020 - Moderna announced that the independent, NIH-appointed Data Safety Monitoring Board for the Phase 3 study of its vaccine candidate against COVID-19 has informed Moderna that the trial has met the statistical criteria in the study protocol for efficacy, with a vaccine efficacy of 94.5%; https://investors.modernatx.com/news-releases/news-release-details/modernas-covid-19-vaccine-candidate-meets-its-primary-efficacy

November 30, 2020 - Moderna announced that the primary efficacy analysis of the Phase 3 study of its Covid-19 vaccine confirms the high efficacy of 94.1% of the first interim analysis; Moderna is submitting for an EUA with the FDA and apply for Conditional Marketing Authorization with the European Medicines Agency; https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-primary-efficacy-analysis-phase-3-cove-study

November 30, 2020 - The FDA scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee on Dec. 17 to discuss the request for emergency use authorization for a COVID-19 vaccine from Moderna; https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-announces-advisory-committee-meeting-discuss-second-covid-19-vaccine

December 10, 2020 - Moderna announced that the first adolescent participants have been dosed in the Phase 2/3 study of Moderna’s COVID-19 vaccine in adolescents ages 12 to less than 18; https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-first-participants-dosed-phase-23-study-covid

December 11, 2020 - US government exercised its option to purchase an additional 100 million doses of Moderna’s COVID-19 vaccine; https://investors.modernatx.com/news-releases/news-release-details/us-government-exercises-1st-option-additional-100-million-doses , https://www.hhs.gov/about/news/2020/12/11/trump-administration-purchases-additional-100-million-doses-covid-19-investigational-vaccine-moderna.html

December 17, 2020 - The FDA's Vaccines and Related Biological Products Advisory Committee recommended that the FDA grant an Emergency Use Authorization for the Moderna’s COVID-19 vaccine; https://investors.modernatx.com/news-releases/news-release-details/moderna-receives-fda-advisory-committee-vote-supporting , https://www.fda.gov/news-events/press-announcements/fda-statement-vaccines-and-related-biological-products-advisory-committee-meeting-0

December 18, 2020 - Moderna's vaccine received Emergency Use Authorization from the FDA; https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-fda-authorization-moderna-covid-19-vaccine-us , https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid



Novavax - Phase III

May 25, 2020 - Novavax Began Phase I/II Clinical Trial of COVID-19 Vaccine; https://ir.novavax.com/news-releases/news-release-details/novavax-initiates-phase-12-clinical-trial-covid-19-vaccine

June 4, 2020 - Novavax announced an up to $60M contract with the US DOD for Novavax’ COVID-19 vaccine; https://ir.novavax.com/news-releases/news-release-details/novavax-awarded-department-defense-contract-covid-19-vaccine

July 7, 2020 - HHS and DOD announced a $1.6 billion agreement with Novavax for commercial-scale manufacturing of the company’s COVID-19 vaccine, purchase of 100M doses; https://www.hhs.gov/about/news/2020/07/07/hhs-dod-collaborate-novavax-produce-millions-covid-19-investigational-vaccine-doses-commercial-scale-manufacturing-demonstration-projects.html , https://ir.novavax.com/news-releases/news-release-details/novavax-announces-16-billion-funding-operation-warp-speed

July 23, 2020 - Novavax and FUJIFILM Diosynth Biotechnologies announced today an agreement to manufacture COVID-19 vaccine, with the first batch already started at FUJIFILM's facility in North Carolina; https://ir.novavax.com/news-releases/news-release-details/novavax-and-fujifilm-diosynth-biotechnologies-initiate-large

July 27, 2020 - As part of the agreement between Novavax and FUJIFILM and of Operation Warp Speed, mass production of the Novavax COVID-19 vaccine will be done at FUJIFILM's Texas A & M University facility; https://www.kxxv.com/brazos/u-s-chooses-texas-a-m-bio-manufacturing-center-for-production-of-covid-19-vaccine-candidates , https://www.hhs.gov/about/news/2020/07/27/hhs-reserves-and-rapidly-expands-manufacturing-capacity-for-covid-19-vaccines-at-texas-center.html

August 17, 2020 - Novavax announced the beginning of a Phase IIb clinical trial in South Africa of its COVID-19 vaccine candidate; https://ir.novavax.com/news-releases/news-release-details/novavax-initiates-efficacy-trial-covid-19-vaccine-south-africa

August 24, 2020 - Novavax announced that the first volunteers have been enrolled in Phase II of its clinical trial of its Covid-19 vaccine; https://ir.novavax.com/news-releases/news-release-details/novavax-initiates-phase-2-portion-phase-12-clinical-trial-covid

September 2, 2020 - Novavax's Covid-19 vaccine produced T-cells as well as antibodies; https://ir.novavax.com/news-releases/news-release-details/novavax-announces-publication-phase-1-data-covid-19-vaccine

September 24, 2020 - Novavax announced that it has initiated its first Phase 3 study in the UK to evaluate the efficacy, safety and immunogenicity of Novavax’ COVID-19 vaccine along with Novavax’ adjuvant; https://ir.novavax.com/news-releases/news-release-details/novavax-initiates-phase-3-efficacy-trial-covid-19-vaccine-united

November 09, 2020 - Novavax announced that the FDA has granted Fast Track Designation for the Company’s COVID-19 vaccine; https://ir.novavax.com/news-releases/news-release-details/novavax-covid-19-vaccine-granted-fast-track-designation-us-fda


Pfizer/BioNTech - Phase II/III

March 16, 2020 - Pfizer announced partnership to develop BioNTech’s mRNA-based COVID-19 vaccines; https://www.pfizer.com/news/press-release/press-release-detail/pfizer_and_biontech_to_co_develop_potential_covid_19_vaccine

April 17, 2020 - NIH announced a public-private partnership with leading biopharmaceutical companies to speed up the development of coronavirus vaccines and therapies; https://www.nih.gov/news-events/news-releases/nih-launch-public-private-partnership-speed-covid-19-vaccine-treatment-options

April 22, 2020 - Pfizer and BioNTech announced approval to begin Phase I/II trial of BioNTech’s COVID-19 vaccines in Germany; https://www.pfizer.com/news/press-release/press-release-detail/biontech_and_pfizer_announce_regulatory_approval_from_german_authority_paul_ehrlich_institut_to_commence_first_clinical_trial_of_covid_19_vaccine_candidates

April 29, 2020 - Pfizer and BioNTech announced that the first cohort of BioNTech’s Phase I/II clinical trial has been dosed; https://www.pfizer.com/news/press-release/press-release-detail/biontech-and-pfizer-announce-completion-dosing-first-cohort

May 5, 2020 - Pfizer and BioNTech announced that the first participants have been dosed in the US in the Phase I/II clinical trial; https://www.pfizer.com/news/press-release/press-release-detail/pfizer_and_biontech_dose_first_participants_in_the_u_s_as_part_of_global_covid_19_mrna_vaccine_development_program

July 13, 2020 - Pfizer Inc. and BioNTech announced that two of the companies’ COVID-19 vaccine candidates received Fast Track designation from the US FDA; both are currently undergoing Phase 1/2 clinical studies; https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-granted-fda-fast-track-designation-two

July 20, 2020 - BioNTech and Pfizer announced initial data from their Phase I/II trial showed the COVID-19 vaccine produced both antibodies and T-cells in patients; https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-early-positive-update-german

July 22, 2020 - Pfizer and BioNTech announced an agreement with the US HHS Department and the DoD under Operation Warp Speed to begin delivering 300 million doses of COVID-19 vaccine in 2021, with the US government receiving 100 million doses of the vaccine; https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-agreement-us-government-600 , https://www.bloomberg.com/news/articles/2020-07-22/pfizer-biontech-receive-u-s-order-for-covid-vaccine , https://www.hhs.gov/about/news/2020/07/22/us-government-engages-pfizer-produce-millions-doses-covid-19-vaccine.html

July 27, 2020 - Pfizer and BioNTech announced the start of a global Phase II/III clinical study of its COVID-19 vaccine, which will include up to 30,000 participants; https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-choose-lead-mrna-vaccine-candidate-0

August 12, 2020 - Pfizer and BioNTech announced that they have submitted an amended protocol to the FDA to expand the enrollment of their Phase III COVID-19 vaccine trial to up to approximately 44,000 participants, allowing for the enrollment of new populations; the company expects to reach its initial target of up to 30,000 participants next week; https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-propose-expansion-pivotal-covid-19

November 9, 2020 -  Pfizer and BioNTech announced their mRNA-based SARS-CoV-2 vaccine has demonstrated evidence of efficacy against COVID-19; the first interim efficacy analysis conducted by an external, independent Data Monitoring Committee concluded that the vaccine efficacy rate was above 90% at 7 days after the second dose; https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidate-against

November 18, 2020 - Pfizer and BioNTech announced that, after conducting the final efficacy analysis in their ongoing Phase 3 study, their COVID-19 vaccine candidate met all of the study’s primary efficacy endpoints; analysis of the data indicates a vaccine efficacy rate of 95% (p<0.0001) in participants without prior SARS-CoV-2 infection;  the companies also announced that the safety milestone required by the FDA for Emergency Use Authorization (EUA) has been achieved; Pfizer and BioNTech plan to submit a request within days for an EUA; https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine

November 20, 2020 - Pfizer and BioNTech announced they will submit a request today to the FDA) for Emergency Use Authorization (EUA) of their SARS-CoV-2 vaccine candidate, which will potentially enable use of the vaccine in high-risk populations in the US by mid-late December 2020; https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-emergency-use-authorization

November 20, 2020 - The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee on December 10 to discuss the request for EUA of a COVID-19 vaccine from Pfizer and BioNTech; https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-announces-advisory-committee-meeting-discuss-covid-19-vaccine

December 10, 2020 -  Pfizer and BioNTech announced that the US FDA Vaccines and Related Biological Products Advisory Committee voted 17 to 4 in support of the FDA granting Emergency Use Authorization (EUA) for the companies’ COVID-19 vaccine; https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-fda-advisory-committee-vote

December 11, 2020 - The FDA granted Emergency Use Authorization to the Pfizer/BioNTech vaccine; https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19 ; https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-celebrate-historic-first-authorization

December 23, 2020 - Pfizer and BioNTech announced an agreement with the U.S. government to supply an additional 100 million doses of the companies’ COVID-19 Vaccine from production facilities in the US; as in the original July 2020 agreement, $1.95 billion will be paid for the additional doses; https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-supply-us-100-million-additional-doses , https://www.hhs.gov/about/news/2020/12/23/trump-administration-purchases-additional-100-million-doses-covid-19-investigational-vaccine-pfizer.html


Sanofi - Phase I/II

March 27, 2020 - Sanofi and Translate Bio collaborate to develop COVID-19 vaccine; https://www.sanofi.com/en/media-room/press-releases/2020/2020-03-27-07-00-00 https://investors.translate.bio/news-releases/news-release-details/sanofi-pasteur-and-translate-bio-collaborate-develop-novel-mrna

April 14, 2020 - Sanofi and GSK to develop a COVID-19 vaccine; https://www.sanofi.com/en/media-room/press-releases/2020/2020-04-14-13-00-00

April 17, 2020 - NIH announced a public-private partnership with leading biopharmaceutical companies to speed up the development of coronavirus vaccines and therapies; https://www.nih.gov/news-events/news-releases/nih-launch-public-private-partnership-speed-covid-19-vaccine-treatment-options

July 31, 2020 - Sanofi and GlaxoSmithKline announced an agreement under Operation Warp Speed for funding clinical trials and delivery of 100 million doses, with an option for 500 million more doses; https://www.gsk.com/en-gb/media/press-releases/sanofi-and-gsk-selected-for-operation-warp-speed-to-supply-united-states-government-with-100-million-doses-of-covid-19-vaccine/ , https://www.hhs.gov/about/news/2020/07/31/hhs-dod-partner-sanofi-gsk-commercial-scale-manufacturing-demonstration-project-produce-millions-covid-19-investigational-vaccine-doses.html

September 3, 2020 - Sanofi and GSK started the Phase 1/2 clinical trial for their adjuvanted COVID-19 vaccine; https://www.sanofi.com/en/media-room/press-releases/2020/2020-09-03-07-00-00 , https://www.gsk.com/en-gb/media/press-releases/sanofi-and-gsk-initiate-phase-12-clinical-trial-of-covid-19-adjuvanted-recombinant-protein-based-vaccine-candidate/

December 11, 2020 - Sanofi and GlaxoSmithKline announced a delay in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in older adults by increasing the concentration of the antigen; https://www.gsk.com/en-gb/media/press-releases/sanofi-and-gsk-announce-a-delay-in-their-adjuvanted-recombinant-protein-based-covid-19-vaccine-programme-to-improve-immune-response-in-the-elderly/ ; https://www.sanofi.com/en/media-room/press-releases/2020/2020-12-11-07-00-00


Vaxart - Phase I

January 31, 2020 - Vaxart Announces start of development of Covid-19 oral vaccine; https://investors.vaxart.com/news-releases/news-release-details/vaxart-announces-initiation-coronavirus-vaccine-program

March 18, 2020 - Vaxart announced today an agreement with Emergent BioSolutions to help develop and manufacture Vaxart’s Covid-19 oral vaccine; https://investors.vaxart.com/news-releases/news-release-details/vaxart-announces-it-entered-agreement-emergent-biosolutions

June 26, 2020 - Vaxart’s COVID-19 Vaccine Selected for the U.S. Government’s Operation Warp Speed; https://investors.vaxart.com/news-releases/news-release-details/vaxarts-covid-19-vaccine-selected-us-governments-operation-warp

August 10, 2020 - Vaxart filed for permission to start Phase I testing of its oral Covid-19 vaccine; https://investors.vaxart.com/news-releases/news-release-details/vaxart-announces-ind-filed-covid-19-vaccine

August 14, 2020 - Vaxart announced that the FDA has reviewed of the Company’s Investigational New Drug (IND) application and approved a Phase 1 clinical trial of its oral COVID-19 vaccine candidate; enrollment will start in September; https://investors.vaxart.com/news-releases/news-release-details/vaxart-announces-fda-clearance-ind-application-oral-covid-19

October 13, 2020 - Vaxart announced the first subject has been dosed in its Phase 1 study of its oral tablet COVID-19 vaccine candidate; https://investors.vaxart.com/news-releases/news-release-details/vaxart-announces-dosing-first-subject-phase-1-clinical-trial-its


General Support Activities

March 18, 2020 - HHS announced a partnership to develop a high-speed fill-and-finish process for vaccines and injectable drugs for the Strategic National Stockpile; https://www.hhs.gov/about/news/2020/03/18/hhs-announces-new-public-private-partnership-to-develop-us-based-high-speed-emergency-drug-packaging-solutions.html

May 12, 2020 - ApiJect Systems awarded $138M for pre-filled COVID-19 vaccine syringes; https://www.upi.com/Defense-News/2020/05/12/ApiJect-Systems-awarded-138M-for-syringes-for-COVID-19-vaccine/5001589324444/

June 1, 2020 - HHS adds $628 million to contract with Emergent BioSolutions to secure CDMO contract manufacturing capacity for Operation Warp Speed; https://www.hhs.gov/about/news/2020/06/01/hhs-adds-628-million-contract-emergent-biosolutions-secure-manufacturing-capacity-operation-warp-speed.html

June 10, 2020 - Under the DPA, Operation Warp Speed funded increased manufacturing capacity at Corning and SiO2 Materials Science for vials for COVID-19 vaccines and treatments and for future needs; https://www.hhs.gov/about/news/2020/06/11/operation-warp-speed-ramps-up-us-based-manufacturing-capacity-for-vials-for-covid-19-vaccines-and-treatments.html

July 8, 2020 - Becton, Dickinson announced the formation of a public-private partnership with BARDA, part of HHS, to develop new manufacturing lines for hundreds of millions of syringes and needles to support current and future pandemic vaccination efforts; https://www.bd.com/en-us/company/news-and-media/press-releases/2020-07-08-bd-partners-with-u-s-government-on-70-million-manufacturing-infrastructure-project-for-mass-vaccination-campaigns

August 4, 2020 - Under the DPA, DOD in coordination with HHS signed a $104 million contract with Duopross Meditech Corporation, Cardinal Health Inc., Gold Coast Medical Supply, LP, HTL STREFA Inc., Quality Impact, Inc., and Medline Industries, Inc. to procure 500M syringes and safety needles for Covid-19 vaccinations; https://www.defense.gov/Newsroom/Releases/Release/Article/2302139/dod-awards-104-million-for-procurement-of-syringes-in-support-of-us-covid-19-va/

August 14, 2020 - HHS and DoD announced that under Operation Warp Speed, McKesson Corp. will be the distributor of Covid-19 vaccines and related supplies; https://www.hhs.gov/about/news/2020/08/14/trump-administration-collaborates-mckesson-covid-19-vaccine-distribution.html , https://www.defense.gov/Newsroom/Releases/Release/Article/2313808/trump-administration-collaborates-with-mckesson-for-covid-19-vaccine-distributi/

September 2, 2020 - The director of the CDC asked US state governors to prepare for large-scale distribution of a Covid-19 vaccine by November 1st; the distribution would be carried out by McKesson Corp.; https://www.nbcnews.com/news/us-news/cdc-tells-states-prepare-large-scale-distribution-covid-19-vaccine-n1239149

September 8, 2020 - CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi announced a pledge to uphold the integrity of the scientific process in their work towards regulatory filings and approvals of COVID-19 vaccines; https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/biopharma-leaders-unite-to-stand-with-science.html , https://www.janssen.com/biopharma-leaders-unite-stand-science , https://www.jnj.com/biopharma-leaders-unite-to-stand-with-science , https://www.merck.com/news/biopharma-leaders-unite-to-stand-with-science/ , https://investors.modernatx.com/news-releases/news-release-details/biopharma-leaders-unite-stand-science , https://ir.novavax.com/news-releases/news-release-details/biopharma-leaders-unite-stand-science , https://www.pfizer.com/news/press-release/press-release-detail/biopharma-leaders-unite-stand-science ; this was the companies' response to - and anticipating further - politically motivated attempts to create doubt of the vaccine(s) likely to be approved in the near future

September 9, 2020 - HHS authorized state-licensed pharmacists to order and administer, and state-licensed or registered pharmacy interns acting under proper supervision to administer, COVID-19 vaccinations to persons ages 3 or older; https://www.hhs.gov/about/news/2020/09/09/trump-administration-takes-action-to-expand-access-to-covid-19-vaccines.html

October 13, 2020 - HHS and DoD announced an agreement with Cytiva to expand the company’s manufacturing capacity for consumable products such as liquid and dry powder cell culture media, cell culture buffers, mixer bags, and XDR bioreactors that are essential in producing COVID-19 vaccines; https://www.hhs.gov/about/news/2020/10/13/trump-administration-expands-manufacturing-capacity-cytiva-components-covid-19-vaccines.html

October 16, 2020 - HHS and DoD announced agreements with CVS and Walgreens to provide and administer COVID-19 vaccines to residents of long-term care facilities nationwide with no out-of-pocket costs; https://www.hhs.gov/about/news/2020/10/16/trump-aministration-partners-cvs-walgreens-provide-covid-19-vaccine-protect-vulnerable-americans-long-term-care-facilities-nationwide.html

October 21, 2020 - HHS issued guidance authorizing qualified pharmacy technicians and State-authorized pharmacy interns to administer COVID-19 vaccines when made available, and COVID-19 tests; https://www.hhs.gov/about/news/2020/10/21/trump-administration-takes-action-further-expand-access-vaccines-covid-19-tests.html

November 12, 2020 - HHS announced partnerships with large chain pharmacies and networks that represent independent pharmacies and regional chains to get safe and effective vaccines supported by Operation Warp Speed into communities and to people as quickly as possible with no out-of-pocket costs; https://www.hhs.gov/about/news/2020/11/12/trump-administration-partners-chain-independent-community-pharmacies-increase-access-future-covid-19-vaccines.html
« Last Edit: January 05, 2021, 07:33:15 PM by PeteS in CA »
Think of the Press as Democratic Operatives with Bylines and it All Makes Sense - Glenn Reynolds, Instapundit blog

Democracy is the theory that the common people know what they want, and deserve to get it good and hard. - H.L. Mencken

A government which robs Peter to pay Paul can always depend on the support of Paul. - George Bernard Shaw

Public opinion has most shallow eyes. - Euripides, "Medea"

All that is gold does not glitter,
Not all those who wander are lost; - J.R.R. Tolkien, The Fellowship of the Ring

Online PeteS in CA

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« Last Edit: August 31, 2020, 09:20:53 AM by PeteS in CA »
Think of the Press as Democratic Operatives with Bylines and it All Makes Sense - Glenn Reynolds, Instapundit blog

Democracy is the theory that the common people know what they want, and deserve to get it good and hard. - H.L. Mencken

A government which robs Peter to pay Paul can always depend on the support of Paul. - George Bernard Shaw

Public opinion has most shallow eyes. - Euripides, "Medea"

All that is gold does not glitter,
Not all those who wander are lost; - J.R.R. Tolkien, The Fellowship of the Ring

Online PeteS in CA

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Re: Untested Trump Vaccine?
« Reply #2 on: September 25, 2020, 09:29:17 AM »
Because Democrat leaders have begun to politicize Covid-19 vaccines, vaccine companies that have been working with the US government have responded in a couple of ways. Many, on September 8th, made this public announcement that they are testing their products to the proper standards.

CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi announced a pledge to uphold the integrity of the scientific process in their work towards regulatory filings and approvals of COVID-19 vaccines:

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/biopharma-leaders-unite-to-stand-with-science.html

https://www.janssen.com/biopharma-leaders-unite-stand-science

https://www.jnj.com/biopharma-leaders-unite-to-stand-with-science

https://www.merck.com/news/biopharma-leaders-unite-to-stand-with-science/

https://investors.modernatx.com/news-releases/news-release-details/biopharma-leaders-unite-stand-science

https://ir.novavax.com/news-releases/news-release-details/biopharma-leaders-unite-stand-science

https://www.pfizer.com/news/press-release/press-release-detail/biopharma-leaders-unite-stand-science

The companies that are doing the final pre-approval test phase have posted their FDA approved test protocols online:

AstraZeneca - https://s3.amazonaws.com/ctr-med-7111/D8110C00001/52bec400-80f6-4c1b-8791-0483923d0867/c8070a4e-6a9d-46f9-8c32-cece903592b9/D8110C00001_CSP-v2.pdf

Moderna - https://www.modernatx.com/sites/default/files/mRNA-1273-P301-Protocol.pdf

Pfizer - https://pfe-pfizercom-d8-prod.s3.amazonaws.com/2020-09/C4591001_Clinical_Protocol_0.pdf

Johnson & Johnson - https://www.jnj.com/coronavirus/covid-19-phase-3-study-clinical-protocol

It's reprehensible that Democrat "leaders" are politicizing Covid-19 vaccines, casting doubt on the vaccines solely for political gain. Doing this is very likely to cost lives among people who buy into the Democrats' cynical political tactic. As pathetic as it is that pharmaceuticals companies have been to defend their professionalism and their products - the companies developed the vaccines, not President Trump, and the companies and partnering hospitals and universities are performing the testing, not President Trump - they are doing so.
« Last Edit: September 25, 2020, 09:32:04 AM by PeteS in CA »
Think of the Press as Democratic Operatives with Bylines and it All Makes Sense - Glenn Reynolds, Instapundit blog

Democracy is the theory that the common people know what they want, and deserve to get it good and hard. - H.L. Mencken

A government which robs Peter to pay Paul can always depend on the support of Paul. - George Bernard Shaw

Public opinion has most shallow eyes. - Euripides, "Medea"

All that is gold does not glitter,
Not all those who wander are lost; - J.R.R. Tolkien, The Fellowship of the Ring

Online Smokin Joe

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Re: Untested Trump Vaccine?
« Reply #3 on: September 25, 2020, 09:48:53 AM »
But more dead people means more Democrat voters.

However they get that way.

Either way, the Dems will blame Trump...It's all they got.
How God must weep at humans' folly! Stand fast! God knows what he is doing!
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Of all tyrannies, a tyranny sincerely exercised for the good of its victims may be the most oppressive. It would be better to live under robber barons than under omnipotent moral busybodies. The robber baron's cruelty may sometimes sleep, his cupidity may at some point be satiated; but those who torment us for our own good will torment us without end for they do so with the approval of their own conscience.

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Offline Cyber Liberty

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Re: Untested Trump Vaccine?
« Reply #4 on: September 25, 2020, 10:08:38 AM »
Of my various rels, I have a SIL who is the most vociferous Trump-hater, and she's an anti-vaxer too.
December 11, 2020:  "Government of the people, by the people and for the people has finally perished from the Earth."
I will NOT comply.
 
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Online PeteS in CA

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Re: Untested Trump Vaccine?
« Reply #5 on: September 25, 2020, 10:46:24 AM »
Of my various rels, I have a SIL who is the most vociferous Trump-hater, and she's an anti-vaxer too.

Anti-Vax-ism isn't a partisan thing that I've seen. Beyond saying that, 888mouth .
Think of the Press as Democratic Operatives with Bylines and it All Makes Sense - Glenn Reynolds, Instapundit blog

Democracy is the theory that the common people know what they want, and deserve to get it good and hard. - H.L. Mencken

A government which robs Peter to pay Paul can always depend on the support of Paul. - George Bernard Shaw

Public opinion has most shallow eyes. - Euripides, "Medea"

All that is gold does not glitter,
Not all those who wander are lost; - J.R.R. Tolkien, The Fellowship of the Ring