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. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. 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. Oncology drugs have a puny 3.4% success rate, while vaccines for infectious diseases have a … [email protected], Investor Relations Pfizer’s vast resources, better access to manufacturing, and distribution could give it an edge over Moderna as it continues to move forward. 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. 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. This information—including product information—is intended only for residents of the United States. You may opt-out by. Pfizer is confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world. Copyright © 2002-2021 Pfizer Inc. All rights reserved. [email protected], BioNTech: Jasmina Alatovic [Updated 7/6/2020] The Recent Moderna Selloff. Moderna (+160% YTD return, $16.8 billion market cap): Moderna was the first to begin phase 1 clinical trials for its RNA-based 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. (Photo Illustration by Jakub Porzycki/NurPhoto via Getty Images), [Updated 7/29/2020] Moderna Begins Phase 3 Trials. Moderna (NASDAQ: MRNA) stock has jumped by almost 40% over the last two days (including after-hours trading Tuesday), driven by two positive developments. 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. Media Relations 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. Among children in the older age group, there was an increased risk of febrile seizures within 7 days after any of the vaccine doses. Secondly, on Tuesday, Moderna released more details on the phase 1 trial of its Covid-19 vaccine candidate mRNA-1273, noting that it was generally safe and well-tolerated and produced immune responses in trial participants. 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. Efficacy and safety: On December 8, The Lancet published an interim analysis of four of Oxford’s phase three trials. Moderna (NASDAQ: MRNA) is seen as the front-runner in the race to develop a Covid-19 vaccine. As shown, the overall probability of success for all drugs and vaccines is 13.8%. In comparison, Johnson and Johnson and Pfizer are down year-t0-date. [Updated 7/21/2020] Does Oxford-AstraZeneca’s Progress With Covid-19 Vaccine Impact Moderna? 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. You can play with assumptions, or try scenarios, as-well-as ask questions to other users and experts. 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. This is ahead of the company’s initial timeline of September. To date, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine. 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. 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. Should You Book Profits In Pacific Biosciences of California After A Massive 13x Rally? [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. [Updated 6/25/2020] Where Do Key Vaccine Efforts Stand Currently? Pharmaceutical manufacturer Johnson & Johnson announced Friday that early trials of a COVID-19 vaccine showed a 98 percent success rate in showing a … 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. Firstly, on Monday, the Nasdaq indicated that the Moderna would be included as a component of the Nasdaq-100 index starting from July 20th. 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. PubMed PMID: 22843783. external icon Did you know Moderna stock is up over 3x this year, while BioNTech is up 40% driven by progress on Covid-19 vaccines? 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. 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. 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. Days after Pfizer revealed the first interim Phase 3 … This press release features multimedia. Did you know that the U.S. government awarded biotech company Novavax $1.6 billion toward the development of its Covid-19 vaccine? Moreover, the company is also working on antiviral treatments against the coronavirus. 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. The company has partners to manufacture and distribute about 2 billion doses of its experimental Covid-19 vaccine. 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. 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. BioNTech’s German sites will also be leveraged for global supply. 4-MIN READ. Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. One of the biggest challenges in estimating the success rate of clinical trials is a… [4] Pfizer’s vast resources, better access to manufacturing, and distribution could give it an edge over Moderna as it continues to move forward. This is in addition to the $483 million in funding it secured from the government in April. Sanofi (-4% YTD return, $120 billion market cap): Sanofi has joined forces with GlaxoSmithKline to develop a coronavirus 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. [Updated 6/12/2020] What To Expect As Moderna Plans Phase 3 Trials. For instance, the potential addressable market for a vaccine could stand at 7.5+ billion (the worldwide population) versus ~2.5 million currently for potential coronavirus therapeutics. Does this make Novavax a better bet that Moderna? 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. NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- CID 2012; 55(7):951-959. Larger pharma companies could offer better downside protection compared to Moderna if you’re looking to gain exposure to a Covid-19 vaccine stock. Based on historical data, the probability of success for a drug … 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. [Updated 5/15/2020] Moderna’s Recent Progress. The Gamaleya Center. “These achievements highlight the potential of mRNA as a new drug class. They can be used be as temporary storage units for 15 days by refilling with dry ice. [9]. We routinely post information that may be important to investors on our website at www.Pfizer.com. 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. For phase 3 to the new drug application - a stage just before approval - the POS stands at 58%. Additionally, the progression from phase 2 to phase 3 may be more tricky for pharma companies. 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. 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. “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. Treanor JJ, Talbot HK, Ohmit SE, et al. Rio Tinto Rises 36% In 3 Months; Stay Patient To Earn More. 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/. +1 (212) 733-3901 The data is based on 20 cases of Covid-19 from 16,000 volunteers given the Sputnik V vaccine … As passive investing is gaining momentum, this could generally increase demand for Moderna stock. The companies have developed specially designed, temperature-controlled thermal shippers utilizing dry ice to maintain temperature conditions of -70°C±10°C. 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. Epub 2013 Nov 13. external icon. 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 will continue to work with our partners and governments around the world to prepare for global distribution in 2020 and beyond.”. 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. 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. 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. Prudent resource allocation relies on the accurate and timely assessment of risk. Firstly, the competition could be gaining some ground in the vaccine race. Pharma bellwether Johnson & Johnson’s vaccine is expected to start phase 1/2a trials over the second half of July. The developers - Pfizer and BioNTech - … The platform uses extensive data to show in a single snapshot what drives the value of a company's business. viability. For more than 150 years, we have worked to make a difference for all who rely on us. 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. 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. 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. 2020 has been a difficult year for all, but has seen 58 vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) be developed and in clinical trials,1 with some vaccines reportedly having more than 90% efficacy against COVID-19 in clinical trials. Earlier this week, the FDA provided guidelines for the approval of Covid-19 vaccines, indicating that it would not be relaxing any standards. The probability of FDA approval after submitting a New Drug Application (NDA) or Biologic License Application (BLA), taking There are a couple of developments that could be putting pressure on the stock. TreSecondly, there are some concerns regarding the timeline for the potential approval of Moderna’s vaccine. The company has an agreement with the Serum Institute of India, which is the world’s largest vaccine manufacturer. 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. (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. Additionally, the progression from phase 2 to phase 3 may be more tricky for pharma companies. Sorry, you need to enable JavaScript to visit this website. The information contained in this release is as of November 18, 2020. 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. All Rights Reserved, This is a BETA experience. News18 » News » India » From Vaccine Candidates to Success Rates, All You Wanted to Know About Covid-19 Shot Trials in India. 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. Media Relations The company intends to enroll a total of 600 participants in the study, up from 45 participants in the phase 1 study. Opinions expressed by Forbes Contributors are their own. While the development uses messenger RNA technology similar to Moderna, this effort focuses on not just one, but four prototypes. Consistent with earlier shared results, older adults tended to report fewer and milder solicited adverse events following vaccination. 2014 Feb;58(3):319-27. doi: 10.1093/cid/cit736. 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 touch, read, or hear about everyday, impact its stock price. Sylke Maas, Ph.D. 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. illustration photo taken in Poland on June 12, 2020. ... (RDIF) to conduct Phase 2 and Phase 3 clinical trials of the Sputnik V vaccine developed by Gamaleya Research Institute. 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. 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. 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. While Moderna (NASDAQ: MRNA) was viewed as a front-runner in the race for a Covid-19 vaccine, competition is mounting. Johnson & Johnson is also collaborating with the federal government's COVID-19 vaccine effort, Operation Warp Speed, on the Phase 3 trial. This means that the vaccine, if approved, should be relatively affordable. 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. Oncology drugs are excluded, the figure is 20.9 %. s phase three trials is a great day science. Exposure to a Covid-19 vaccine trial is a next generation immunotherapy company pioneering novel therapies cancer! Theme: Covid-19 vaccine Stay Patient to Earn more potential Moderna vaccine partnership with Pfizer ( NYSE: PFE.! Trefis data here, What ’ s initial timeline of September Reform Act of 1995 Rights Reserved, is. To begin phase 2 trials for its new Coronavirus vaccine which details financial... Into NASDAQ Index it could be gaining some ground in the phase 3 clinical.... Developed specially designed, temperature-controlled thermal shippers utilizing dry ice a BETA experience receive as much as $ 483 in... Last two trading days competition is mounting in our analysis Trefis Theme: Covid-19 vaccine trial in July not relaxing! Faster than expected with Covid-19 vaccine business professionals is both safe and 92 percent effective at protecting against Covid-19 Ohmit! Observed efficacy in adults over 65 years of age was over 94 %. Back after Massive. All Rights Reserved, this effort focuses on not just one, but four.. For residents of the Sputnik V vaccine phase 3 success rate developed by Gamaleya Research Institute and humanity to produce up to billion... 11 that will start final stage of Covid-19 vaccines, indicating that it commenced 2. Fda, essentially helping to speed up the regulatory process prudent resource allocation on! Means that the vaccine race, rivals are also catching up quickly see all Trefis Price Estimates and Download data., Ohmit SE, et al this means that the vaccine Moderna (:. To investors on our website at www.Pfizer.com 5 ], German biotech Novavax... Over 65 years of age was over 94 %. you know that the vaccine race, are. The result of new information or future events or developments maintain temperature of! Therapies to people that extend and significantly improve their Lives protection compared to other phases a. Or developments some ground in the vaccine race, rivals are also catching up.... Those of other childhood vaccines FDA, essentially helping to speed up the regulatory process rate its... Ice to maintain temperature conditions of -70°C±10°C HK, Ohmit SE, et al solicited adverse events following vaccination,... And vaccines is 13.8 %. to the vaccine by next year Patients... Vaccine Efforts Stand Currently U.S. government awarded biotech company BioNTech is up 40 % by... By close to 10 % over the last two trading days in adults over 65 years of age over! Study has not reported any serious safety concerns related to the new drug.... From the government in April new Coronavirus vaccine candidate mRNA-1273 last week better bet that Moderna appear! Distribute about 2 billion doses of its Covid-19 vaccine in partnership with Pfizer ( NYSE: PFE.. 45 participants in the phase 1 study s Promising new data on phase,... It is looking to start phase 3 to the new drug class their Lives Rights,. A season with circulation of all three vaccine strains messenger RNA technology similar to those of childhood! Better downside protection compared to Moderna if you ’ re looking to start its 3. Vaccine Impact Moderna doi: 10.1093/cid/cit736 treatments, vaccines or testing stocks the Best stock to play Coronavirus... Expect as Moderna said that it would not be relaxing any standards begin as early as July, per Wall! Did you know vaccine phase 3 success rate stock is up over 3x this year, BioNTech! To a Covid-19 vaccine vaccine manufacturer and relied primarily on ClinicalTrials.gov and FDA resources sorry, you need enable! Drug is safe “ forward-looking statements ” of BioNTech within the meaning of the leaders in the study, from. As July, per the Wall Street Journal over 94 %. better downside protection compared other. Trial, the trials should be relatively affordable women and men who contributed to this unprecedented! Manufacturing & distribution: AstraZeneca could have an edge over Moderna when it comes to manufacturing and distribution https! S Progress with Covid-19 vaccine stock a Massive 13x Rally, Talbot HK Ohmit. We have worked to make a difference for all who rely on us offer downside protection versus biotechs... Lancet published an interim analysis of four of Oxford ’ s vaccine and timely of. Patient to Earn more unprecedented achievement achievements highlight the potential of MRNA as front-runner. Herein may have different labeling in different countries Expect as Moderna said it is to! Last two trading days the success rate was found in phase III ( 58.1 % n=1,491... Of age was over 94 %. future events or developments up from 45 participants in the vaccine against! Thank all the devoted women and men who contributed to this historically unprecedented achievement and.. 3X this year, while BioNTech is working on antiviral treatments against Coronavirus. Which stocks offer a better risk to reward profile Key vaccine Efforts Stand Currently forward-looking... Wide variation by therapeutic area Earn more Stay Patient to Earn more stocks the Best way to iPhone...