+49 (0)6131 9084 1513 or +49 (0)151 1978 1385 Airline stocks are soaring after Pfizer/BioNTech reports a 90% effective rate for its COVID-19 vaccine. 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. The developers - Pfizer and BioNTech - … Rio Tinto Rises 36% In 3 Months; Stay Patient To Earn More. Moreover, the company is also working on antiviral treatments against the coronavirus. Should You Buy Johnson & Johnson Stock At $160? 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. Topline data on the AstraZeneca vaccine from a Phase 3 trial were released in November.Tuesday’s results — the first Phase 3 clinical data for a Covid vaccine … 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. 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. 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). 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. 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/. 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. 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. 2014 Feb;58(3):319-27. doi: 10.1093/cid/cit736. Should You Book Profits In Pacific Biosciences of California After A Massive 13x Rally? 4-MIN READ. The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of November 8, 2020. 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. Find out more in the Trefis Theme: Coronavirus Vaccine which details key financial, valuation, and returns metrics for the companies. Treanor JJ, Talbot HK, Ohmit SE, et al. 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. 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. © 2021 Forbes Media LLC. 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. 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. [1] This comes about a week after Moderna released similar progress on its Covid-19 vaccine candidate mRNA-1273. 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. 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. Johnson & Johnson is also collaborating with the federal government's COVID-19 vaccine effort, Operation Warp Speed, on the Phase 3 trial. Phase 1 trials usually involve a few dozen people and are designed to observe whether a vaccine or drug is safe. Efficacy and safety: On December 8, The Lancet published an interim analysis of four of Oxford’s phase three trials. Firstly, on Monday, the Nasdaq indicated that the Moderna would be included as a component of the Nasdaq-100 index starting from July 20th. You may opt-out by. Moderna COVID-19 vaccine candidate mRNA-1273 is now soon going to commence a 30,000-person phase 3 trial in just a matter of six months after it was created Moderna CEO Stephane Bancel claims that his company’s COVID-19 vaccine has an 80 to 90 percent chance of getting FDA approval Moderna’s most complex offering was a vaccine against cytomegalovirus or CMV. While Moderna was seen as one of the leaders in the vaccine race, rivals are also catching up quickly. "Today is a great day for science and humanity. Larger pharma companies could offer better downside protection compared to Moderna if you’re looking to gain exposure to a Covid-19 vaccine stock. This press release features multimedia. Phase 1, 2, and 3 trials: Clinical trials typically take place in three stages. 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. Epub 2013 Nov 13. external icon. ... (RDIF) to conduct Phase 2 and Phase 3 clinical trials of the Sputnik V vaccine developed by Gamaleya Research Institute. While Moderna (NASDAQ: MRNA) was viewed as a front-runner in the race for a Covid-19 vaccine, competition is mounting. 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. 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. View our indicative themes Coronavirus Treatment Stocks, and Coronavirus Testing Stocks for more details on the stock price and fundamental performance of some of the key U.S. listed companies. Sylke Maas, Ph.D. These data also will be submitted to other regulatory agencies around the world. At this rate, the company could be on track to win full approval for the vaccine by next year. 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. The products discussed herein may have different labeling in different countries. 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. Approximately 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants are 56-85 years of age. Moderna has also announced a collaboration with Switzerland based Lonza Group for manufacturing its vaccine, producing as much as 1 billion doses each year. 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. [Updated 7/14/2020] Moderna’s Promising New Data On Phase 1, Inclusion Into Nasdaq Index. As passive investing is gaining momentum, this could generally increase demand for Moderna stock. About Pfizer: Breakthroughs That Change Patients’ Lives. You can play with assumptions, or try scenarios, as-well-as ask questions to other users and experts. In comparison, Moderna is expected to start its phase 3 trial with around 30k participants in late July. [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. Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. Phase 1 trials usually involve a few dozen people and are designed to observe whether a vaccine or drug is safe. The Gamaleya Center. Sanofi (-4% YTD return, $120 billion market cap): Sanofi has joined forces with GlaxoSmithKline to develop a coronavirus vaccine. 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. Overall, the pharma industry is moving much faster than expected with Covid-19 vaccine development. Jasmina Alatovic [4] Pfizer’s vast resources, better access to manufacturing, and distribution could give it an edge over Moderna as it continues to move forward. See all Trefis Price Estimates and Download Trefis Data here, What’s behind Trefis? The platform uses extensive data to show in a single snapshot what drives the value of a company's business. Manufacturing & Distribution: AstraZeneca could have an edge over Moderna when it comes to manufacturing and distribution. Moderna (NASDAQ: MRNA) stock has jumped by almost 40% over the last two days (including after-hours trading Tuesday), driven by two positive developments. Are treatments, vaccines or testing stocks the best way to play the coronavirus recovery? A vaccine trial is a clinical trial that aims at establishing the safety and efficacy of a vaccine prior to it being licensed. The information contained in this release is as of November 18, 2020. All Rights Reserved, This is a BETA experience. 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. Based on historical data, the probability of success for a drug … 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. Find out in our analysis Trefis Theme: Covid-19 Vaccine Portfolio. 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. This is ahead of the company’s initial timeline of September. Sorry, you need to enable JavaScript to visit this website. 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. 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. In comparison, Johnson and Johnson and Pfizer are down year-t0-date. 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. 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. 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. This is in addition to the $483 million in funding it secured from the government in April. 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. This could potentially delay the approval process for Moderna. 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. Firstly, the competition could be gaining some ground in the vaccine race. 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. Did you know Moderna stock is up over 3x this year, while BioNTech is up 40% driven by progress on Covid-19 vaccines? At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. Pfizer’s vast resources, better access to manufacturing, and distribution could give it an edge over Moderna as it continues to move forward. For phase 3 to the new drug application - a stage just before approval - the POS stands at 58%. We will continue to work with our partners and governments around the world to prepare for global distribution in 2020 and beyond.”. +1 (212) 733-7410 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. Nio, Li Auto, and Xpeng: Which Chinese EV Stock Is The Best Value? Consistent with earlier shared results, older adults tended to report fewer and milder solicited adverse events following vaccination. The probability of FDA approval after submitting a New Drug Application (NDA) or Biologic License Application (BLA), taking Should you pick Johnson & Johnson Or Pfizer For Better Returns? 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. There are a couple of developments that could be putting pressure on the stock. Is Jabil The Best Stock To Play iPhone 12 Cycle Without Overpaying? 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. 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. These trials will determine if the vaccine protects against Covid-19 and whether it will be cleared for use in the general public. Recent data show increasing rates of severe ... authorization. As shown, the overall probability of success for all drugs and vaccines is 13.8%. 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 said that it commenced stage 2 trials for its new Coronavirus vaccine candidate mRNA-1273 last week. 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. They can be used be as temporary storage units for 15 days by refilling with dry ice. Opinions expressed by Forbes Contributors are their own. 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. 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. 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. gained FDA approval to begin phase 2 clinical trials. [Updated 7/21/2020] Does Oxford-AstraZeneca’s Progress With Covid-19 Vaccine Impact Moderna? 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. PubMed PMID: 22843783. external icon Separately, there was also a report that Moderna was delaying the start of its Phase 3 trials, although this was denied by the company. [email protected], Investor Relations This is significant as most company-sponsored Phase III trials are the longest and most expensive trials to conduct. [Updated 7/6/2020] The Recent Moderna Selloff. But this number masks a wide variation by therapeutic area. illustration photo taken in Poland on June 12, 2020. 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. 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. [Updated 6/12/2020] What To Expect As Moderna Plans Phase 3 Trials. The second-lowest phase transition success rate was found in Phase III (58.1%, n=1,491). The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Pfizer is confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world. We routinely post information that may be important to investors on our website at www.Pfizer.com. 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. Pharmaceutical manufacturer Johnson & Johnson announced Friday that early trials of a COVID-19 vaccine showed a 98 percent success rate in showing a … [email protected], BioNTech: “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. This might include you though you may have invested money in these companies, or may have been working with one of them for years as an employee, or have consulted with them as an expert for a long time. Media Relations This could at least initially limit the pricing power for a potential Moderna vaccine. 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. [email protected]. 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. 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. I want to thank all the devoted women and men who contributed to this historically unprecedented achievement. 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. 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