The company has partners to manufacture and distribute about 2 billion doses of its experimental Covid-19 vaccine. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. The FDA said that a Covid-19 vaccine would need to show at least 50% efficacy in a placebo-controlled clinical trial while also spelling out other requirements. The first primary objective analysis is based on 170 cases of COVID-19, as specified in the study protocol, of which 162 cases of COVID-19 were observed in the placebo group versus 8 cases in the BNT162b2 group. The vaccine is in phase 1/2 clinical trials in the U.S. and Germany and the first set of results from the studies are likely to be available in the coming weeks. Volunteer participating in phase 3 trial of the Sinovac COVID-19 vaccine in Padjadjaran University, Bandung, West Java, Indonesia. Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that, after conducting the final efficacy analysis in their ongoing Phase 3 study, their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the study’s primary efficacy endpoints. The probability of success (POS) of a clinical trial is critical for clinical researchers and biopharma investors to evaluate when making scientific and economic decisions. In the U.S., 18.4 million doses administered, with 5.44 million doses in the U.K. and 726,786 in Canada 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. Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints, Therapeutic Modalities and Technology Platforms, Small Molecule Product & Process Development, Maintaining Emotional Well-Being During COVID-19, Coronavirus disease (COVID-19) Scientific Resources, Meet our new Chief Patient Officer, Dr. Dara Richardson-Heron, Creating Cures Through Facility Investments, https://www.businesswire.com/news/home/20201118005595/en/. One of the biggest challenges in estimating the success rate of clinical trials is a… For more information, please visit www.BioNTech.de. News18 » News » India » From Vaccine Candidates to Success Rates, All You Wanted to Know About Covid-19 Shot Trials in India. [8] Moderna also provided an update on its phase 2 trials which are currently underway, noting that it had enrolled 350 out of its total planned 600 participants for the study. To date, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine. 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. Among children in the older age group, there was an increased risk of febrile seizures within 7 days after any of the vaccine doses. [2] While this does not change the fundamental picture for Moderna, index funds that track the Nasdaq will start buying the stock, bidding up the stock price in the near-term. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. +49 (0)6131 9084 1074 Separately, there was also a report that Moderna was delaying the start of its Phase 3 trials, although this was denied by the company. In comparison, Johnson and Johnson and Pfizer are down year-t0-date. For phase 3 to the new drug application - a stage just before approval - the POS stands at 58%. Johnson & Johnson (+5% YTD return, $390 billion market cap): The pharmaceutical giant could begin phase 1 trials for its coronavirus vaccine by September 2020, at the latest. 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. This press release features multimedia. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment across their pre-set routes leveraging Pfizer’s broad distribution network. Efficacy and safety: On December 8, The Lancet published an interim analysis of four of Oxford’s phase three trials. The company is expected to receive as much as $483 million in U.S. federal government funding for its vaccine development. You may opt-out by. gained FDA approval to begin phase 2 clinical trials. See How It’s Powering New Collaboration and What-Ifs For CFOs and Finance Teams | Product, R&D, and Marketing Teams, Led by MIT engineers and Wall Street analysts, Trefis (through its dashboards platform dashboards.trefis.com) helps you understand how a company's products, that you. (Photo Illustration by Jakub Porzycki/NurPhoto via Getty Images), America's Top Givers: The 25 Most Philanthropic Billionaires, EY & Citi On The Importance Of Resilience And Innovation, Impact 50: Investors Seeking Profit — And Pushing For Change. While phase 1 trials are used to ascertain the safety of a vaccine or treatment in humans, phase 2 trials gauge the effectiveness and also provide more data on how safe it is. Treanor JJ, Talbot HK, Ohmit SE, et al. For a discussion of these and other risks and uncertainties, see BioNTech’s Annual Report on Form 20-F filed with the SEC on March 31, 2020, which is available on the SEC’s website at www.sec.gov. [5], German biotech company BioNTech is working on a Covid-19 vaccine in partnership with Pfizer (NYSE: PFE). In comparison, Moderna’s collaboration with Swiss biotech company Lonza could enable it to produce as much as one billion doses per year. Limitations: The study did not account for preclinical development and relied primarily on ClinicalTrials.gov and FDA resources. Moderna (NASDAQ: MRNA) announced that it has started phase 3 trials of its Covid-19 vaccine candidate mRNA-1273 in collaboration with two U.S. government agencies. Did you know that the U.S. government awarded biotech company Novavax $1.6 billion toward the development of its Covid-19 vaccine? In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. ... (RDIF) to conduct Phase 2 and Phase 3 clinical trials of the Sputnik V vaccine developed by Gamaleya Research Institute. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. 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. "Today is a great day for science and humanity. We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world,” said Dr. Albert Bourla, Pfizer Chairman and CEO. Based on current projections, the companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021. Firstly, the competition could be gaining some ground in the vaccine race. Earlier this week, the FDA provided guidelines for the approval of Covid-19 vaccines, indicating that it would not be relaxing any standards. Clin Infect Dis. For more than 150 years, we have worked to make a difference for all who rely on us. Sanofi (-4% YTD return, $120 billion market cap): Sanofi has joined forces with GlaxoSmithKline to develop a coronavirus vaccine. [email protected], Investor Relations Effectiveness of seasonal influenza vaccines in the United States during a season with circulation of all three vaccine strains. Moderna said that it commenced stage 2 trials for its new Coronavirus vaccine candidate mRNA-1273 last week. Novavax (440% YTD return, $1.1 billion market cap): Novavax, a company that focuses on vaccines for infectious diseases, has indicated that it has a vaccine candidate called NVX-CoV2373 that has demonstrated effectiveness against the coronavirus in pre-clinical trials. Find out in our analysis Trefis Theme: Covid-19 Vaccine Portfolio. So how do the Moderna and Oxford-AstraZeneca vaccines’ developments compare? These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech’s efforts to combat COVID-19; the collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine; our expectations regarding the potential characteristics of BNT162b2 in our Phase 2/3 trial and/or in commercial use based on data observations to date; the expected timepoint for additional readouts on efficacy data of BNT162b2 in our Phase 2/3 trial; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the timing for submission of data for, or receipt of, any potential Emergency Use Authorization; the timing for submission of manufacturing data to the FDA; and the ability of BioNTech to supply the quantities of BNT162 to support clinical development and, if approved, market demand, including our production estimates for 2020 and 2021. Larger pharma companies could offer better downside protection compared to Moderna if you’re looking to gain exposure to a Covid-19 vaccine stock. Opinions expressed by Forbes Contributors are their own. These trials will determine if the vaccine protects against Covid-19 and whether it will be cleared for use in the general public. Can Editas Medicine Stock Bounce Back After A 13% Drop In 5 Days ? Phase 1 trials usually involve a few dozen people and are designed to observe whether a vaccine or drug is safe. [Updated 7/21/2020] Does Oxford-AstraZeneca’s Progress With Covid-19 Vaccine Impact Moderna? Recent data show increasing rates of severe ... authorization. While Sanofi will contribute the antigen, GSK will provide its pandemic adjuvant technology, which helps to reduce the amount of vaccine protein required per dose. Moderna is looking to start phase 3 trials for the vaccine this month and has indicated that it could have data from the study by Thanksgiving. Pfizer’s vaccine is now roughly in the same stage as Moderna’s in the clinical trial timeline, with the company making plans for Phase 3 trails. In order to compute the probability of a vaccine development program making it all the way from phase 1 to approval, we consider only the vaccine development programs that have definite outcomes. 2014 Feb;58(3):319-27. doi: 10.1093/cid/cit736. [Updated 6/12/2020] What To Expect As Moderna Plans Phase 3 Trials. This is ahead of the fall timeline previously anticipated for phase 3 trials. Sorry, you need to enable JavaScript to visit this website. The Gamaleya Center. This means that the vaccine, if approved, should be relatively affordable. illustration photo taken in Poland on June 12, 2020. CID 2012; 55(7):951-959. This could at least initially limit the pricing power for a potential Moderna vaccine. 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. Which stocks offer a better risk to reward profile? View source version on businesswire.com: https://www.businesswire.com/news/home/20201118005595/en/, Pfizer: The platform uses extensive data to show in a single snapshot what drives the value of a company's business. This press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. [email protected], Investor Relations On the other hand, big pharma companies such as Johnson & Johnson (up 5% year to date) and Sanofi (down 4%), who remain in the pre-clinical stage, could offer better downside protection, given their highly diversified revenue streams. The clinical-stage biotech company has phase 2 trials underway for its vaccine candidate mRNA-1273 and is expected to commence phase 3 trials in July, in collaboration with the U.S. National Institutes of Health. Repeating the logic for the transitions between phase 2 and phase 3, and between phase 3 and approval, gives 65.4% and 80.1% as estimates of PoS 23 and PoS 3A, respectively. Bitcoin To Space Travel: 5 Eagle Experts Think These Investment Ideas Can Soar In 2021, Earnings, Earnings, And More Earnings: 20% Of S&P 500, Including Tesla, Apple, Report This Week, Three Of The Most Dangerous Stocks For 2021. [7]. The data is based on 20 cases of Covid-19 from 16,000 volunteers given the Sputnik V vaccine … , competition is mounting of November 18, 2020 moving much faster than expected with vaccine. By Jakub Porzycki/NurPhoto via Getty Images ), [ Updated 6/2/2020 ] Moderna Begins phase 3 may be viewed more... 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