Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with clinical data (including the Phase 3 data that is the subject of this release), including the possibility of unfavorable new preclinical or clinical trial data and further analyses of existing preclinical or clinical trial data; the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial or in larger, more diverse populations upon commercialization; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when any biologics license and/or emergency use authorization applications may be filed in any jurisdictions for BNT162b2 or any other potential vaccine candidates; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine candidate’s benefits outweigh its known risks and determination of the vaccine candidate’s efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners or third-party suppliers; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccine candidate’s ultra-low temperature formulation and attendant storage, distribution and administration requirements, including risks related to handling after delivery by Pfizer; the risk that we may not be able to successfully develop non-frozen formulations; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or have access to logistics or supply channels commensurate with global demand for any potential approved vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine candidate within the projected time periods indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments. Moderna (NASDAQ: MRNA) is seen as the front-runner in the race to develop a Covid-19 vaccine. The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,661 participants to date, 41,135 of whom have received a second dose of the vaccine candidate as of November 13, 2020. While the development uses messenger RNA technology similar to Moderna, this effort focuses on not just one, but four prototypes. What does Moderna’s Pipeline Beyond The Covid-19 Vaccine look like? In addition, the companies announced that the safety milestone required by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been achieved. Did you know that the U.S. government awarded biotech company Novavax $1.6 billion toward the development of its Covid-19 vaccine? The Phase 3 vaccine efficacy trial, known as COVE, was begun under OWS, a multi-agency collaboration led by HHS and the Department of Defense that aims to accelerate the development, manufacturing and distribution of medical countermeasures for COVID-19. Phase 1 trials usually involve a few dozen people and are designed to observe whether a vaccine or drug is safe. The probabilities of advancing from phase 1 to 2, phase 2 to 3, and phase 3 to licensure within the total available follow-up time were 38.2% (CI, 30.7% to 45.0%), 38.3% (CI, 23.1% to 50.5%), and 61.1% (CI, 3.7% to 84.3%), respectively. The company intends to enroll a total of 600 participants in the study, up from 45 participants in the phase 1 study. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. [5], German biotech company BioNTech is working on a Covid-19 vaccine in partnership with Pfizer (NYSE: PFE). This might include you though you may have invested money in these companies, or may have been working with one of them for years as an employee, or have consulted with them as an expert for a long time. Media Relations Good to know, given that the stock is up 3x this year, driven largely by the Coronavirus, meaning that the downside risk could also be considerable. Firstly, on Monday, the Nasdaq indicated that the Moderna would be included as a component of the Nasdaq-100 index starting from July 20th. Our indicative portfolio of 7 U.S. listed companies developing vaccines for Coronavirus has gained a whopping ~130% year-to-date on an equally weighted basis. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. These trials will determine if the vaccine protects against Covid-19 and whether it will be cleared for use in the general public. BioNTech’s German sites will also be leveraged for global supply. Sanofi also has exposure to potential COVID-19 treatments, as the company makes the malaria drug hydroxychloroquine, which is being viewed as a possible treatment, while also testing another treatment in partnership with Regeneron. Moderna (NASDAQ: MRNA) stock has jumped by almost 40% over the last two days (including after-hours trading Tuesday), driven by two positive developments. 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