PubMed PMID: 22843783. external icon Chuck Triano 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 has partners to manufacture and distribute about 2 billion doses of its experimental Covid-19 vaccine. "Today is a great day for science and humanity. This information—including product information—is intended only for residents of the United States. 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. J&J may also offer downside protection versus clinical-stage biotechs like Moderna, given its diversified revenue streams. For more information, please visit www.BioNTech.de. The platform uses extensive data to show in a single snapshot what drives the value of a company's business. BioNTech’s German sites will also be leveraged for global supply. 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. Firstly, on Monday, the Nasdaq indicated that the Moderna would be included as a component of the Nasdaq-100 index starting from July 20th. 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. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. [Updated 7/21/2020] Does Oxford-AstraZeneca’s Progress With Covid-19 Vaccine Impact Moderna? viability. 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. 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. Early results from trials of a Covid vaccine developed in Russia suggest it could be 92% effective. Based on historical data, the probability of success for a drug … In comparison, Moderna is expected to start its phase 3 trial with around 30k participants in late July. [email protected], BioNTech: [Updated 7/6/2020] The Recent Moderna Selloff. American biotech company Moderna has announced on June 11 that will start final stage of covid-19 vaccine trial in July. 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. Phase 1 trials usually involve a few dozen people and are designed to observe whether a vaccine or drug is safe. 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. While Moderna was seen as one of the leaders in the vaccine race, rivals are also catching up quickly. TreSecondly, there are some concerns regarding the timeline for the potential approval of Moderna’s vaccine. Amy Rose 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. [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. Should you pick Johnson & Johnson Or Pfizer For Better Returns? This press release features multimedia. [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. Overall, the two companies appear to be roughly at the same stages in the clinical timeline. +1 (212) 733-3901 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. In comparison, Johnson and Johnson and Pfizer are down year-t0-date. On Monday, Oxford University, which is developing a Covid-19 vaccine candidate along with AstraZeneca, published some positive data on phase 1/2 trials, indicating that the vaccine was tolerated and generated a robust immune response. Firstly, the competition could be gaining some ground in the vaccine race. The phase 3 trial will help to validate this at a larger scale and is expected to enroll 30,000 participants in the U.S. See our Theme of Covid-19 Vaccine Stocks for an overview of U.S. listed companies working on Covid-19 vaccines and their financial performance and returns. Trefis is currently used by hundreds of thousands of investors, company employees, and business professionals. Moderna (+160% YTD return, $16.8 billion market cap): Moderna was the first to begin phase 1 clinical trials for its RNA-based vaccine. [9]. Pharmaceutical manufacturer Johnson & Johnson announced Friday that early trials of a COVID-19 vaccine showed a 98 percent success rate in showing a … Find out more in our dashboard analysis Johnson & Johnson Valuation: Expensive Or Cheap? 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. Did you know that the U.S. government awarded biotech company Novavax $1.6 billion toward the development of its Covid-19 vaccine? A breakdown of the diversity of clinical trial participants can be found here from approximately 150 clinical trials sites in United States, Germany, Turkey, South Africa, Brazil and Argentina. For perspective, each phase of a vaccine development typically takes multiple years and per a 2013 study, the total development time for the average vaccine was close to 11 years. The probability of FDA approval after submitting a New Drug Application (NDA) or Biologic License Application (BLA), taking In comparison, Moderna’s collaboration with Swiss biotech company Lonza could enable it to produce as much as one billion doses per year. “These achievements highlight the potential of mRNA as a new drug class. While the stocks of smaller, specialized players such as Inovio Pharmaceuticals and Moderna have rallied by ~250% and ~160% respectively year to date, as both companies already have candidates in Phase 1 trials, these companies also have a much higher risk, given their very limited revenue streams. Moreover, the company is also working on antiviral treatments against the coronavirus. 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. Moderna (NASDAQ: MRNA) stock has jumped by almost 40% over the last two days (including after-hours trading Tuesday), driven by two positive developments. View source version on businesswire.com: https://www.businesswire.com/news/home/20201118005595/en/, Pfizer: News18 » News » India » From Vaccine Candidates to Success Rates, All You Wanted to Know About Covid-19 Shot Trials in India. +49 (0)6131 9084 1074 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. Should You Book Profits In Pacific Biosciences of California After A Massive 13x Rally? 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. [Updated 6/12/2020] What To Expect As Moderna Plans Phase 3 Trials. 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. 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. The data is based on 20 cases of Covid-19 from 16,000 volunteers given the Sputnik V vaccine … The company intends to enroll a total of 600 participants in the study, up from 45 participants in the phase 1 study. Airline stocks are soaring after Pfizer/BioNTech reports a 90% effective rate for its COVID-19 vaccine. [email protected]. In the Phase 3 trial, the vaccine was generally well tolerated, with adverse reactions similar to those of other childhood vaccines. Sanofi (-4% YTD return, $120 billion market cap): Sanofi has joined forces with GlaxoSmithKline to develop a coronavirus vaccine. Our indicative list of 7 U.S. listed companies working on Coronavirys vaccines, which includes Moderna, Inovio and others have returned 200% YTD return on an equally weighted basis. At this rate, the company could be on track to win full approval for the vaccine by next year. Recent data show increasing rates of severe ... authorization. © 2021 Forbes Media LLC. The first effective coronavirus vaccine can prevent more than 90% of people from getting Covid-19, a preliminary analysis shows. 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. Moderna (NASDAQ: MRNA) stock has declined by close to 10% over the last two trading days. Are treatments, vaccines or testing stocks the best way to play the coronavirus recovery? Although vaccine bets still remain quite speculative, considering that most companies are either in the pre-clinical or phase 1 stage of trials for their candidates, companies could see significant upside if they develop a safe, effective, and relatively affordable vaccine. Larger pharma companies could offer better downside protection compared to Moderna if you’re looking to gain exposure to a Covid-19 vaccine stock. Did you know Moderna stock is up over 3x this year, while BioNTech is up 40% driven by progress on Covid-19 vaccines? Treanor JJ, Talbot HK, Ohmit SE, et al. Clin Infect Dis. 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. Moderna said that it commenced stage 2 trials for its new Coronavirus vaccine candidate mRNA-1273 last week. Should You Buy Johnson & Johnson Stock At $160? Patients who recover from Covid-19 generate antibodies that help to prevent re-infection and per interim data from its phase 1 trials that involved 45 people, Moderna said that the people inoculated with the vaccine generated antibodies that were 4x compared to people who’d recovered from Covid. Epub 2013 Nov 13. external icon. To date, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine. You can play with assumptions, or try scenarios, as-well-as ask questions to other users and experts. 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. Jasmina Alatovic 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’s vast resources, better access to manufacturing, and distribution could give it an edge over Moderna as it continues to move forward. Our objective from the very beginning was to design and develop a vaccine that would generate rapid and potent protection against COVID-19 with a benign tolerability profile across all ages. 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. The companies have developed specially designed, temperature-controlled thermal shippers utilizing dry ice to maintain temperature conditions of -70°C±10°C. While the markets have tumbled due to the spread of the novel coronavirus, stocks of pharma companies developing vaccines and treatments for the highly contagious viral infection have fared well. 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. While the development uses messenger RNA technology similar to Moderna, this effort focuses on not just one, but four prototypes. [1] This comes about a week after Moderna released similar progress on its Covid-19 vaccine candidate mRNA-1273. Manufacturing & Distribution: AstraZeneca could have an edge over Moderna when it comes to manufacturing and distribution. Separately, Moderna also said that the federal government has committed $472 million in funding to help the clinical development and production scale-up for its vaccine. But this number masks a wide variation by therapeutic area. They can be used be as temporary storage units for 15 days by refilling with dry ice. Epub 2012 Jul 25. [6] There is also a possibility that phase 3 trials could begin as early as July, per the Wall Street Journal. The products discussed herein may have different labeling in different countries. This could potentially delay the approval process for Moderna. illustration photo taken in Poland on June 12, 2020. gained FDA approval to begin phase 2 clinical trials. The Gamaleya Center. For phase 3 to the new drug application - a stage just before approval - the POS stands at 58%. 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. 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. About Pfizer: Breakthroughs That Change Patients’ Lives. Moderna (NASDAQ: MRNA) is seen as the front-runner in the race to develop a Covid-19 vaccine. CID 2012; 55(7):951-959. CEO Stephane Bancel recently estimated the probability of success of the vaccine at close to 80% to 90%, citing the effectiveness of the company’s RNA based platform on other viruses such as MERS, Zika, and Cytomegalovirus. For phase 3 to the new drug application - a stage just before approval - the POS stands at 58%. See all Trefis Price Estimates and Download Trefis Data here, What’s behind Trefis? The second-lowest phase transition success rate was found in Phase III (58.1%, n=1,491). 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. Is Jabil The Best Stock To Play iPhone 12 Cycle Without Overpaying? The observed efficacy in adults over 65 years of age was over 94%. 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 developers - Pfizer and BioNTech - … The information contained in this release is as of November 18, 2020. Russian researchers suggest their vaccine is both safe and 92 percent effective at protecting against COVID-19. Earlier this week, the FDA provided guidelines for the approval of Covid-19 vaccines, indicating that it would not be relaxing any standards. Moderna also said that it is on track to deliver roughly 500 million doses of the vaccine per year, and potentially up to 1 billion doses annually, starting from 2021, leveraging its internal U.S. manufacturing site as well as a strategic collaboration with Lonza, a Swiss biotech company. 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. Sylke Maas, Ph.D. NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Phase 1 trials usually involve a few dozen people and are designed to observe whether a vaccine or drug is safe. 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. This is significant as most company-sponsored Phase III trials are the longest and most expensive trials to conduct. What does Moderna’s Pipeline Beyond The Covid-19 Vaccine look like? “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. The only Grade 3 (severe) solicited adverse events greater than or equal to 2% in frequency after the first or second dose was fatigue at 3.8% and headache at 2.0% following dose 2. 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. 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. As passive investing is gaining momentum, this could generally increase demand for Moderna stock. [email protected], Investor Relations Volunteer participating in phase 3 trial of the Sinovac COVID-19 vaccine in Padjadjaran University, Bandung, West Java, Indonesia. 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. We will continue to work with our partners and governments around the world to prepare for global distribution in 2020 and beyond.”. Oncology drugs have a puny 3.4% success rate, while vaccines for infectious diseases have a … Did you know that Johnson & Johnson will begin human trials of its Covid-19 vaccine over the second half of July, well ahead of its previous timeline of September? Consistent with earlier shared results, older adults tended to report fewer and milder solicited adverse events following vaccination. 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. Media Relations One of the biggest challenges in estimating the success rate of clinical trials is a… 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. 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