Nio, Li Auto, and Xpeng: Which Chinese EV Stock Is The Best Value? “The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic. 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. Days after Pfizer revealed the first interim Phase 3 … Jasmina Alatovic 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. Phase 2 trials may be viewed as more crucial compared to other phases for a couple of reasons. The observed efficacy in adults over 65 years of age was over 94%. “With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world.”, “We are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against COVID-19 can be achieved very fast after the first 30 µg dose, underscoring the power of BNT162 in providing early protection,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. Early results from trials of a Covid vaccine developed in Russia suggest it could be 92% effective. Without up-to-date estimates of the POS, however, investors may misjudge the risk and value of drug development, leading to lost opportunities for both investors and patients. [Updated 6/12/2020] What To Expect As Moderna Plans Phase 3 Trials. 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. The company could have a leg up over rivals in terms of production capacity and distribution reach and has indicated that it aims to supply over one billion doses globally through the course of 2021 if the vaccine proves safe and effective. View source version on businesswire.com: https://www.businesswire.com/news/home/20201118005595/en/, Pfizer: Among children in the older age group, there was an increased risk of febrile seizures within 7 days after any of the vaccine doses. 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. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For phase 3 to the new drug application - a stage just before approval - the POS stands at 58%. [5], German biotech company BioNTech is working on a Covid-19 vaccine in partnership with Pfizer (NYSE: PFE). [email protected], BioNTech: Four of Pfizer’s facilities are part of the manufacturing and supply chain; St. Louis, MO; Andover, MA; and Kalamazoo, MI in the U.S.; and Puurs in Belgium. The company has partners to manufacture and distribute about 2 billion doses of its experimental Covid-19 vaccine. This would be a real concern for Moderna investors, who have bid the stock up 4x this year, in anticipation of potential profits from the vaccine candidate. Rio Tinto Rises 36% In 3 Months; Stay Patient To Earn More. I want to thank all the devoted women and men who contributed to this historically unprecedented achievement. Based on historical data, the probability of success for a drug … This means that the vaccine, if approved, should be relatively affordable. American biotech company Moderna has announced on June 11 that will start final stage of covid-19 vaccine trial in July. Did you know that the U.S. government awarded biotech company Novavax $1.6 billion toward the development of its Covid-19 vaccine? All Rights Reserved, This is a BETA experience. Moderna has also announced a collaboration with Switzerland based Lonza Group for manufacturing its vaccine, producing as much as 1 billion doses each year. Based on historical data, the probability of success for a drug moving from phase 1 of clinical trials to phase 2 stands at about 63%, while the metric is sharply lower at 31% for phase 2 to phase 3 progression. Russian researchers suggest their vaccine is both safe and 92 percent effective at protecting against COVID-19. [Updated 5/15/2020] Moderna’s Recent Progress. PubMed PMID: 22843783. external icon The developers - Pfizer and BioNTech - … Copyright © 2002-2021 Pfizer Inc. All rights reserved. Moderna (NASDAQ: MRNA) stock has jumped by almost 40% over the last two days (including after-hours trading Tuesday), driven by two positive developments. Manufacturing & Distribution: AstraZeneca could have an edge over Moderna when it comes to manufacturing and distribution. The company is expected to receive as much as $483 million in U.S. federal government funding for its vaccine development. Moderna (+160% YTD return, $16.8 billion market cap): Moderna was the first to begin phase 1 clinical trials for its RNA-based vaccine. Moderna (NASDAQ: MRNA) has outlined plans for phase 3 clinical trials for its Covid-19 vaccine candidate mRNA-1273, which will begin in July and is expected to include about 30,000 participants. Medical syringe is seen with Moderna company logo displayed on a screen in the background in this ... [+] illustration photo taken in Poland on June 12, 2020. In comparison, Moderna’s collaboration with Swiss biotech company Lonza could enable it to produce as much as one billion doses per year. Clin Infect Dis. 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. +49 (0)6131 9084 1074 [1] This comes about a week after Moderna released similar progress on its Covid-19 vaccine candidate mRNA-1273. This puts Moderna well ahead of rivals in the clinical trial timeline - rival biotech Inovio’s candidate is in phase 1, while many other U.S. based players remain in the pre-clinical phase. These data also will be submitted to other regulatory agencies around the world. 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. Clinical Trial Timeline: Oxford and AstraZeneca have been combining the stages of their clinical trials and are carrying out late-stage phase 2/3 trials in the UK, Brazil, and South Africa. Moderna (NASDAQ: MRNA) stock has declined by close to 10% over the last two trading days. Find out more in our dashboard analysis Johnson & Johnson Valuation: Expensive Or Cheap? Overall, the pharma industry is moving much faster than expected with Covid-19 vaccine development. The company could have a leg up over rivals in terms of production capacity and distribution reach, as it says it would be able to produce as much as 900 million doses by early 2021. Can Editas Medicine Stock Bounce Back After A 13% Drop In 5 Days ? Moderna says that it could begin phase 2 trials as early as Spring 2020, with phase 3 trials potentially starting as early as the Fall. You can play with assumptions, or try scenarios, as-well-as ask questions to other users and experts. Analysis of the data indicates a vaccine efficacy rate of 95% (p<0.0001) in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. 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. ... (RDIF) to conduct Phase 2 and Phase 3 clinical trials of the Sputnik V vaccine developed by Gamaleya Research Institute. (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. The company intends to enroll a total of 600 participants in the study, up from 45 participants in the phase 1 study. Data on whether the candidate vaccines protect against illness, and for how long, won’t come until large Phase 3 trials, slated to start as soon as this month, begin returning results this fall. [Updated 6/2/2020] Moderna Moves To Crucial Phase 2 Trials. 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. Pfizer shares traded 9% higher to a new 52-week high price after the company reported that interim data from its Phase 3 COVID-19 vaccine trial with BioNTech showed a 90% success rate in participants without prior evidence of SARS-CoV-2 infection. You may opt-out by. A review of unblinded reactogenicity data from the final analysis which consisted of a randomized subset of at least 8,000 participants 18 years and older in the phase 2/3 study demonstrates that the vaccine was well tolerated, with most solicited adverse events resolving shortly after vaccination. 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. Epub 2012 Jul 25. 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. 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. Inovio Pharmaceuticals (+255% YTD return, $1.7 billion market cap): Inovio, a small biotech company started phase 1 clinical trial for a DNA-based novel coronavirus vaccine earlier this month. Separately the experimental vaccine has also received fast-track designation from the U.S. FDA, essentially helping to speed up the regulatory process. +1 (212) 733-3901 Oncology drugs have a puny 3.4% success rate, while vaccines for infectious diseases have a … viability. 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. illustration photo taken in Poland on June 12, 2020. Phase 3 trials will primarily study the efficacy of the vaccine in preventing symptomatic Covid-19 disease and secondarily, the prevention of severe cases of Covid-19 which require hospitalization. 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. Pfizer and BioNTech plan to submit the efficacy and safety data from the study for peer-review in a scientific journal once analysis of the data is completed. For more than 150 years, we have worked to make a difference for all who rely on us. 2014 Feb;58(3):319-27. doi: 10.1093/cid/cit736. The probability of FDA approval after submitting a New Drug Application (NDA) or Biologic License Application (BLA), taking [email protected], Investor Relations 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. About Pfizer: Breakthroughs That Change Patients’ Lives. Phase 1, 2, and 3 trials: Clinical trials typically take place in three stages. NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- 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. As shown, the overall probability of success for all drugs and vaccines is 13.8%. The company is making plans to produce up to 1.3 billion vaccine doses in 2021. We routinely post information that may be important to investors on our website at www.Pfizer.com. Phase 1 trials usually involve a few dozen people and are designed to observe whether a vaccine or drug is safe. 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. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. Find out more in the Trefis Theme: Coronavirus Vaccine which details key financial, valuation, and returns metrics for the companies. [Updated 6/25/2020] Where Do Key Vaccine Efforts Stand Currently? Efficacy was consistent across age, gender, race and ethnicity demographics. German biotech player BioNTech and Pfizer who are collaborating on a Covid-19 vaccine, released encouraging preliminary early-stage data on their vaccine candidate noting that it was well-tolerated and that it generated significant levels of antibodies in people. They can be used be as temporary storage units for 15 days by refilling with dry ice. Potential Pricing: AstraZeneca has said that it would make the vaccine available globally on a non-profit basis, through the course of the current pandemic. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Dr. Albert Bourla, Pfizer Chairman and CEO. The trial will continue to collect efficacy and safety data in participants for an additional two years. Consistent with earlier shared results, older adults tended to report fewer and milder solicited adverse events following vaccination. Limitations: The study did not account for preclinical development and relied primarily on ClinicalTrials.gov and FDA resources. These risks and uncertainties include, but are not limited to: the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; the ability to effectively scale our productions capabilities; and other potential difficulties. Phase 1 trials usually involve a few dozen people and are designed to observe whether a vaccine or drug is safe. While Moderna was seen as one of the leaders in the vaccine race, rivals are also catching up quickly. American biotech company Moderna has announced on June 11 that will start final stage of covid-19 vaccine trial in July. We believe we have achieved this with our vaccine candidate BNT162b2 in all age groups studied so far and look forward to sharing further details with the regulatory authorities. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Treanor JJ, Talbot HK, Ohmit SE, et al. Moderna said that it commenced stage 2 trials for its new Coronavirus vaccine candidate mRNA-1273 last week. While the company is ahead of larger firms in getting to human trials for its vaccine candidate, it could remain a speculative bet for investors, given its relatively limited revenue streams (just $4 million in revenue over 2019). Moderna has made significant progress with its Coronavirus vaccine candidate - mRNA-1273 - in recent weeks, as it gained FDA approval to begin phase 2 clinical trials while noting that it was finalizing the protocol for a phase 3 study, which is expected to begin early summer. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law. News18 » News » India » From Vaccine Candidates to Success Rates, All You Wanted to Know About Covid-19 Shot Trials in India. Sanofi (-4% YTD return, $120 billion market cap): Sanofi has joined forces with GlaxoSmithKline to develop a coronavirus vaccine. Sylke Maas, Ph.D. View the full release here: https://www.businesswire.com/news/home/20201118005595/en/. J&J may also offer downside protection versus clinical-stage biotechs like Moderna, given its diversified revenue streams. Should You Book Profits In Pacific Biosciences of California After A Massive 13x Rally? The Gamaleya Center. On Monday, Pfizer and its German partner BioNTech indicated that they also started late-stage trials for their Covid-19 vaccine, which could involve up to 30,000 participants. 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/. The products discussed herein may have different labeling in different countries. These trials will determine if the vaccine protects against Covid-19 and whether it will be cleared for use in the general public. Media Relations 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. The second-lowest phase transition success rate was found in Phase III (58.1%, n=1,491). To date, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine. This is ahead of the fall timeline previously anticipated for phase 3 trials. 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. However, the trials should be quicker, as Moderna said it is looking to start phase 3 trials by July. Surprisingly, the founders of Trefis discovered that along with most other people they just did not understand even the seemingly familiar companies around them: Apple, Google, Coca Cola, Walmart, GE, Ford, Gap, and others. 4-MIN READ. Recent data show increasing rates of severe ... authorization. But this number masks a wide variation by therapeutic area. TreSecondly, there are some concerns regarding the timeline for the potential approval of Moderna’s vaccine. For more details on the stock price and fundamental performance of some of the key U.S. listed companies developing a coronavirus vaccine, view our COVID Vaccine Portfolio. [6] There is also a possibility that phase 3 trials could begin as early as July, per the Wall Street Journal. Overall, the two companies appear to be roughly at the same stages in the clinical timeline. The information contained in this release is as of November 18, 2020. 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. Did you know Moderna stock is up over 3x this year, while BioNTech is up 40% driven by progress on Covid-19 vaccines? This information—including product information—is intended only for residents of the United States. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. 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. Find out in our analysis Trefis Theme: Covid-19 Vaccine Portfolio. [email protected], Investor Relations Chuck Triano At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. Sorry, you need to enable JavaScript to visit this website. CID 2012; 55(7):951-959. A vaccine trial is a clinical trial that aims at establishing the safety and efficacy of a vaccine prior to it being licensed. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. Pfizer and BioNTech plan to submit a request within days to the FDA for an EUA based on the totality of safety and efficacy data collected to date, as well as manufacturing data relating to the quality and consistency of the vaccine. While the development uses messenger RNA technology similar to Moderna, this effort focuses on not just one, but four prototypes. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. That said, the stock could have significant downside risk as well, as the company does not have any other products in the market, besides a flu vaccine that is in the late stages of development. What does Moderna’s Pipeline Beyond The Covid-19 Vaccine look like? 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. The companies have developed specially designed, temperature-controlled thermal shippers utilizing dry ice to maintain temperature conditions of -70°C±10°C. There were 10 severe cases of COVID-19 observed in the trial, with nine of the cases occurring in the placebo group and one in the BNT162b2 vaccinated group. Volunteer participating in phase 3 trial of the Sinovac COVID-19 vaccine in Padjadjaran University, Bandung, West Java, Indonesia. 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. Airline stocks are soaring after Pfizer/BioNTech reports a 90% effective rate for its COVID-19 vaccine. [3] More specifically, after two doses, the vaccine produced neutralizing antibodies - which are key to fighting the virus - that were 4x higher than what was found in patients who had recovered from coronavirus infections. 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. For more information, please visit www.BioNTech.de. 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. 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. Earlier this week, the FDA provided guidelines for the approval of Covid-19 vaccines, indicating that it would not be relaxing any standards. % driven by Progress on its Covid-19 vaccine stock influenza vaccines in the vaccine, is. Establishing the safety and efficacy of a company 's business testing stocks the Best value California after 13... Be relaxing any standards stage 2 trials produce up to 1.3 billion vaccine doses 2021... & Johnson ’ s vaccine is expected to receive as much as $ 483 million in funding secured! Biggest challenges in estimating the success rate was found in phase III trials the... Trial that aims at establishing the safety and efficacy of a vaccine trial in July relaxing any standards other for... Updated 7/29/2020 ] Moderna Begins phase 3 trial, the two companies appear to be roughly at the stages. Should be relatively affordable, as Moderna said that it commenced stage 2 trials may be to! 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Updated 7/21/2020 ] does Oxford-AstraZeneca ’ s Pipeline Beyond the Covid-19 vaccine development pick Johnson & Johnson Pfizer... Other childhood vaccines equally weighted basis ( RDIF ) to conduct phase 2 trials may be more tricky for companies... 5/15/2020 ] Moderna ’ s Promising new data on phase 1 study Pfizer ( NYSE: PFE ) Reserved this. An equally weighted basis you need to enable JavaScript to visit this website,... Usually involve a few dozen people and are designed to observe whether a vaccine trial is a trial! ( NYSE: PFE ) regarding the timeline for the study, from! Development and relied primarily on ClinicalTrials.gov and FDA resources be cleared for use in the United during... Play with assumptions, or try scenarios, as-well-as ask questions to other users and experts, employees... The pharma industry is moving much faster than expected with Covid-19 vaccine candidate mRNA-1273 ) stock has declined close! 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