... Anyway, no reasonable person can expect a full and viable medicine to reach market in 3 months. ...
* BioNTech was founded in 2008, specifically to study and develop mRNA- based vaccines and treatments. Moderna was founded in 2008, specifically to study and develop mRNA- based vaccines and treatments.
*
Janssen Research/Johnson & JohnsonFebruary 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 ; obviously, Janssen began their development research and work before HHS became involved, probably in January.
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.htmlMarch 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-useJuly 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 ; these tests are with human volunteers, not with cells in Petri dishes or with animals.
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-candidateFebruary 28, 2021 - Johnson & Johnson Covid vaccine receives Emergency Use Authorization;
https://www.cbsnews.com/news/covid-vaccine-johnson-and-johnson-authorized-emergency-use/Moderna - Phase IIIJanuary 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.htmlJanuary 13, 2020 - Moderna produced its first prototype sample of its vaccine;
https://nymag.com/intelligencer/2020/12/moderna-covid-19-vaccine-design.htmlMarch 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-beginsApril 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-millionMay 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-mrnaMay 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-mrnaMay 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-phaseJune 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-1273July 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-vaccineJuly 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-phaseJuly 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-covidOctober 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-vaccineNovember 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-efficacyDecember 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-covidNovavaxFebruary 26, 2020 - Novavax announced it is testing several possible Covid vaccine candidates using animals;
https://ir.novavax.com/2020-02-26-Novavax-Advances-Development-of-Novel-COVID-19-VaccineApril 8, 2020 - Novavax announced it has selected a vaccine candidate for clinical trials;
https://ir.novavax.com/2020-04-08-Novavax-Identifies-Coronavirus-Vaccine-Candidate-Accelerates-Initiation-of-First-in-Human-Trial-to-Mid-MayMay 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-vaccineAugust 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-africaAugust 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-covidSeptember 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-unitedNovember 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-fdaIn December 2020 or January 2021 I stopped updating my source file from which I'm C&P-ing selected events/dates, hence this time gap.
July 13, 2022 - Novavax Covid vaccine receives Emergency Use Authorization;
https://covidblog.oregon.gov/novavax-becomes-fourth-covid-19-vaccine-authorized-by-fda/Pfizer/BioNTechMarch 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 ; Pfizer and BioNTech are two separate companies; the purpose of this partnership (and the partnership with Fosun Pharma in China) is production and distribution, capabilities BioNTech lacks; obviously, BioNTech started their development of a Covid vaccine in February or January 2020.
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_candidatesApril 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-cohortMay 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_programJuly 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-twoJuly 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-0August 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-19November 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-vaccineDecember 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-authorizationUnlike traditional dead & weakened virus vaccines, mRNA vaccines (Moderna and Pfizer) and viral vector vaccines (Johnson & Johnson) do not require culturing the target virus, now experimentation with weakened or intact dead target viruses. Developing mRNA vaccines and viral vector vaccines requires knowledge and use of of the DNA sequence of the target virus. This saves considerable time in both development (months) and testing (more months). For example, Moderna had developed its prototype sample within 2 or 3 days of the DNA sequence of the SARS-CoV-2 virus. Similarly, in time savings, Moderna was dosing Phase 1 test participants in March 2020, and BioNTech was dosing Phase 1 test participants in April 2020.
IOW, while Trump's Operation Warp Speed did accelerate the testing process and Emergency Use Authorization accelerated bringing the vaccines into use, a significant amount of R & D and testing time was saved by the nature of the vaccine technologies used by J&J, Moderna, and Pfizer.
Novavax uses the traditional protein sub-unit technology (in use about as long as dead & weakened virus technology). This technology requires culturing the target virus or bacterium to identify characteristic proteins intrinsic to the target, altering cells (bacterium, animal cells, yeast cells, etc.) to produce that protein, culturing those altered cells, and then producing the target protein. Immune response to a protein sub-unit vaccine is less strong than, e.g., a dead or weakened virus, so an adjuvant, a general immune system stimulant, is needed and had to be selected. This probably is reflected in Novavax's slower vaccine development and slower time to testing with human volunteers. Being months behind even J&J probably resulted in Novavax becoming lower in priority, and thus delaying authorization into mid 2022.
Where
"reach market in 3 months" came from mystifies me.