Japan approves first COVID-19 vaccine – Pfizer-BioNTech

Japan's Ministry of Health, Labor and Welfare gave the first "fast-track approval " to Pfizer-BioNTech COVID-19 vaccine on Sunday February 14, 2021 in ages 16 years and older. Stated as "95 percent effective at preventing symptoms of COVID-19". [1, 2] On Wednesday February 17, 2021 it began rollout first with 40,000 healthcare workers who will receive two shots to be administered three weeks apart.  "Of the initial group of health workers, 20,000 will participate in a study to track side effects potentially caused by the vaccine." "A further 3.7 million front-line health workers are to begin receiving the vaccine in March, followed by 36 million people aged 65 or older from April" 2021.  " People with pre-existing conditions such as diabetes or heart disease and those working at elderly care facilities will come next, and then finally the general population." COVID-19 vaccinations began 6 months out from the start of the 2021 Tokyo Olympics and Paralympics In 2020 Japan had no excess death above expected. By April 21, 2021 - Japan PM discussed receiving 50 M additional Pfizer doses, on top of existing agreements for 144 M doses - total 194 M doses, enough for 97 M people. By May..> READ MORE

BioNTech initiates vaccine mRNA code

Following the SARS-CoV-2 genetic sequence made public by the Chinese Center for Disease Control and Prevention on January 10, 2020, BioNTech initiated the development of it's COVID-19 vaccine mRNA sequence of which would become known as "BNT162b2".

Pfizer-BioNTech phase 3 interim results – 90% effective

On November 9, 2020 Pfizer and BioNTech, together with Acuitas Therapeutics (the lipid nano-particle component) all announce their COVID-19 vaccine candidate had "achieved success".  They claimed the "first interim analysis of Phase 3 study" showed "more than 90% effective in preventing COVID-19".  Science by press release! Pfizer's CEO Dr. Albert Bourla stated: “I believe this is likely the most significant medical advance in the last 100 years, if you count the impact this will have in public health, global economy.” "Dr. Scott Gottlieb, a former FDA commissioner and a member of Pfizer’s board, told CNBC the vaccine could be available in limited use as early as late December and widely available by the third quarter of 2021." The press went wild promoting the "stunning" 90% efficacy: [1, 2, 3, 4, 5]

Pfizer-BioNTech announce their vaccine is 95% effective

On November 18, 2020 Pfizer and BioNTech announced the final analysis of their COVID-19 vaccine Phase III clinical trial data shows it is 95% effective with no safety concerns.  Pfizer filed for emergency use authorization with the FDA “within days” of this announcement. “Efficacy was consistent across age, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94%,” Pfizer and its German partner BioNTech said in a joint statement. [1]

BioNTech launches Project Lightspeed to find a vaccine candidate

By mid January 2020 BioNTech starts Project Lightspeed [2] to develop a vaccine against this new coronavirus, several vaccine candidates are selected and initial non-clinical studies are conducted. According to New York Times article, after Dr. Sahin, BioNTech's CEO read an article in the The Lancet that left him convinced that the coronavirus would explode into a full-blown pandemic, scientists at the company, based in Mainz, Germany, canceled their vacations and set to work on what they called Project Lightspeed. [1] By Mid-January 2020 "BioNTech selects several vaccine candidates and conducts initial non-clinical studies." BioNTech then partnered with Pfizer (and Fosun Pharma) in March 17 & 16, 2020 respectively, to co-develop and commercialization of an mRNA-based vaccine. By December 2020, just after 11 months, the FDA awarded Pfizer-BioNTech COVID-19 mRNA vaccine Emergency Use Authorisation (EUA), the first product BioNTech has brought to market. BioNTech vaccine development timeline - HERE

BioNTech CEO predicts mRNA tech for rapid vaccine development

BioNTech's founder and CEO Dr Ugur Sahin was a "Spotlight" speaker at the October 16, 2018 World Health Summit and Grand Challenges  annual meeting, which was held in Berlin, Germany. Other speakers included Bill Gates and Tedros Adhanom Ghebreyesus. In Dr Sahin's speech he said [1, 2] "his company might be able to use its so-called messenger RNA technology to rapidly develop a vaccine in the event of a global pandemic" BioNTech was founded in 2008 by Dr. Sahin with his wife, Dr. Özlem Türeci.  By late 2018 it was still a little known European biotechnology start-ups which mostly focused on cancer treatments. [3]  Like Moderna, BioNTech had never brought a product to market. A month earlier, 0n August 16, 2018 BioNTech announced a partnership agreement with Pfizer to collaborate on an mRNA influenza vaccines. In September 4, 2019 the "Bill & Melinda Gates Foundation invested $55 million to fund its work treating H.I.V. and tuberculosis". Starting September 24, 2019 BioNTech  announces commencement of their Initial Product Offering (IPO). [3, 4] Prior to all this, in 2001, Dr. Sahin and Dr. Türeci founded Ganymed Pharmaceuticals, which developed drugs to treat cancer using monoclonal antibodies, in October 2016 they sold that company..> READ MORE

Pfizer & BioNTech announce vaccine collaboration

On March 17, 2020 Biopharmaceutical New Technologies (BioNTech) and Pfizer announced that the companies have agreed to a letter of intent regarding the co-development and distribution (excluding China due to BioNTech-FoSun Pharma agreement) of a potential mRNA-based coronavirus vaccine aimed at preventing COVID-19 infection.  The collaboration "aims to accelerate global development of BNT162, leveraging expertise and resources of both companies" and "builds on a 2018 agreement to jointly develop an mRNA-based influenza vaccine". "The two companies plan to jointly conduct clinical trials for the COVID-19 vaccine candidates initially in the United States and Europe across multiple sites. BioNTech and Pfizer intend to initiate the first clinical trials as early as the end of April 2020, assuming regulatory clearance." "On March 13, 2020, Pfizer issued a five-point plan calling on the biopharmaceutical industry to join the company in committing to unprecedented collaboration to combat COVID-19." On April 9, 2020 they disclosed additional details of their collaboration with the "aims to rapidly advance multiple COVID-19 vaccine candidates into human clinical testing based on BioNTech’s proprietary mRNA vaccine platforms, with the objective of ensuring rapid worldwide access to the vaccine, if approved."

TGA grants first COVID-19 vaccine Provisional Registration – Pfizer-BioNTech

On January 25, 2021 Australia's TGA grants Provisional Registration for Pfizer Australia Pty Ltd's mRNA COVID-19 Vaccine for 16 years and older, the first vaccine for COVID-19 to receive "provisional approval" in Australia and the first new gene technology vaccine ever used. [1, 2, 3] COMIRNATY (BNT162b2 [mRNA]) COVID-19 Vaccine has provisional approval for the indication below: Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 The use of this vaccine should be in accordance with official recommendations. The decision has been made on the basis of short term efficacy and safety data. [clinical trial] Continued approval depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment. This product, like all provisionally registered products, falls under the TGA black triangle safety monitoring scheme. Pfizer TIMELINE, FOIA documents - HERE