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 … 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. 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. The probability of FDA approval after submitting a New Drug Application (NDA) or Biologic License Application (BLA), taking View the full release here: https://www.businesswire.com/news/home/20201118005595/en/. For more than 150 years, we have worked to make a difference for all who rely on us. 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/. Moderna (NASDAQ: MRNA) stock has declined by close to 10% over the last two trading days. 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). In the U.S., 18.4 million doses administered, with 5.44 million doses in the U.K. and 726,786 in Canada Among children in the older age group, there was an increased risk of febrile seizures within 7 days after any of the vaccine doses. Does this make Novavax a better bet that Moderna? This press release features multimedia. Phase 1 trials usually involve a few dozen people and are designed to observe whether a vaccine or drug is safe. We will continue to work with our partners and governments around the world to prepare for global distribution in 2020 and beyond.”. So how do the Moderna and Oxford-AstraZeneca vaccines’ developments compare? [email protected], Investor Relations 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. Efficacy was consistent across age, gender, race and ethnicity demographics. 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. Effectiveness of seasonal influenza vaccines in the United States during a season with circulation of all three vaccine strains. 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. NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- The trial will continue to collect efficacy and safety data in participants for an additional two years. The first effective coronavirus vaccine can prevent more than 90% of people from getting Covid-19, a preliminary analysis shows. Did you know that the U.S. government awarded biotech company Novavax $1.6 billion toward the development of its Covid-19 vaccine? Phase 1, 2, and 3 trials: Clinical trials typically take place in three stages. Can Editas Medicine Stock Bounce Back After A 13% Drop In 5 Days ? 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. 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. 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. Moderna (NASDAQ: MRNA) is seen as the front-runner in the race to develop a Covid-19 vaccine. 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. Clin Infect Dis. The Gamaleya Center. Efficacy and safety: On December 8, The Lancet published an interim analysis of four of Oxford’s phase three trials. 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. [email protected], BioNTech: 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. 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. While Moderna (NASDAQ: MRNA) was viewed as a front-runner in the race for a Covid-19 vaccine, competition is mounting. [Updated 5/15/2020] Moderna’s Recent Progress. Moderna said that it commenced stage 2 trials for its new Coronavirus vaccine candidate mRNA-1273 last week. The data is based on 20 cases of Covid-19 from 16,000 volunteers given the Sputnik V vaccine … Additionally, the progression from phase 2 to phase 3 may be more tricky for pharma companies. Firstly, the competition could be gaining some ground in the vaccine race. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. [Updated 7/21/2020] Does Oxford-AstraZeneca’s Progress With Covid-19 Vaccine Impact Moderna? 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, 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. However, the trials should be quicker, as Moderna said it is looking to start phase 3 trials by July. Should you pick Johnson & Johnson Or Pfizer For Better Returns? illustration photo taken in Poland on June 12, 2020. Nio, Li Auto, and Xpeng: Which Chinese EV Stock Is The Best Value? 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. 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. For more details on these stocks and their financials, view Trefis Theme: Coronavirus Vaccine Portfolio, [Updated 4/23/2020] An Overview of Coronavirus Vaccine Stocks. Did you know Moderna stock is up over 3x this year, while BioNTech is up 40% driven by progress on Covid-19 vaccines? The developers - Pfizer and BioNTech - … 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. The company is making plans to produce up to 1.3 billion vaccine doses in 2021. BioNTech’s German sites will also be leveraged for global supply. 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. Find out in our analysis Trefis Theme: Covid-19 Vaccine Portfolio. "Today is a great day for science and humanity. Days after Pfizer revealed the first interim Phase 3 … 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. Airline stocks are soaring after Pfizer/BioNTech reports a 90% effective rate for its COVID-19 vaccine. For more information, please visit www.BioNTech.de. I want to thank all the devoted women and men who contributed to this historically unprecedented achievement. 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. [email protected]. 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. 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. ... (RDIF) to conduct Phase 2 and Phase 3 clinical trials of the Sputnik V vaccine developed by Gamaleya Research Institute. The company has an agreement with the Serum Institute of India, which is the world’s largest vaccine manufacturer. 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. 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. 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. 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. [6] There is also a possibility that phase 3 trials could begin as early as July, per the Wall Street Journal. Based on historical data, the probability of success for a drug … TreSecondly, there are some concerns regarding the timeline for the potential approval of Moderna’s vaccine. [Updated 6/25/2020] Where Do Key Vaccine Efforts Stand Currently? As shown, the overall probability of success for all drugs and vaccines is 13.8%. All Rights Reserved, This is a BETA experience. 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. This release contains forward-looking information about Pfizer’s efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine, the BNT162 mRNA vaccine program, and modRNA candidate BNT162b2 (including qualitative assessments of available data, potential benefits, expectations for clinical trials, anticipated timing of regulatory submissions and anticipated manufacturing, distribution and supply), that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Larger pharma companies could offer better downside protection compared to Moderna if you’re looking to gain exposure to a Covid-19 vaccine stock. 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. 2014 Feb;58(3):319-27. doi: 10.1093/cid/cit736. 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. Pfizer’s vast resources, better access to manufacturing, and distribution could give it an edge over Moderna as it continues to move forward. 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. Pharmaceutical manufacturer Johnson & Johnson announced Friday that early trials of a COVID-19 vaccine showed a 98 percent success rate in showing a … This is ahead of the fall timeline previously anticipated for phase 3 trials. gained FDA approval to begin phase 2 clinical trials. This could at least initially limit the pricing power for a potential Moderna vaccine. In comparison, Moderna is expected to start its phase 3 trial with around 30k participants in late July. 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. 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. 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. 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 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. [4] Pfizer’s vast resources, better access to manufacturing, and distribution could give it an edge over Moderna as it continues to move forward. Phase 1 trials usually involve a few dozen people and are designed to observe whether a vaccine or drug is safe. Separately, there was also a report that Moderna was delaying the start of its Phase 3 trials, although this was denied by the company. +49 (0)6131 9084 1074 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. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. 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. This is ahead of the company’s initial timeline of September. Moreover, the company is also working on antiviral treatments against the coronavirus. Earlier this week, the FDA provided guidelines for the approval of Covid-19 vaccines, indicating that it would not be relaxing any standards. Manufacturing & Distribution: AstraZeneca could have an edge over Moderna when it comes to manufacturing and distribution. What does Moderna’s Pipeline Beyond The Covid-19 Vaccine look like? 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. 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. 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. Success probabilities do not capture the varied … 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. Copyright © 2002-2021 Pfizer Inc. All rights reserved. Separately the experimental vaccine has also received fast-track designation from the U.S. FDA, essentially helping to speed up the regulatory process. Treanor JJ, Talbot HK, Ohmit SE, et al. Opinions expressed by Forbes Contributors are their own. 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. These data also will be submitted to other regulatory agencies around the world. This press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. [7]. 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. 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. This information—including product information—is intended only for residents of the United States. The products discussed herein may have different labeling in different countries. 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. They can be used be as temporary storage units for 15 days by refilling with dry ice. Which stocks offer a better risk to reward profile? Is Jabil The Best Stock To Play iPhone 12 Cycle Without Overpaying? 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 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. 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. While the development uses messenger RNA technology similar to Moderna, this effort focuses on not just one, but four prototypes. © 2021 Forbes Media LLC. But this number masks a wide variation by therapeutic area. +1 (212) 733-7410 The observed efficacy in adults over 65 years of age was over 94%. 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. There are a couple of developments that could be putting pressure on the stock. 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. In comparison, Johnson and Johnson and Pfizer are down year-t0-date. Overall, the pharma industry is moving much faster than expected with Covid-19 vaccine development. Phase 2 trials may be viewed as more crucial compared to other phases for a couple of reasons. 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. This could potentially delay the approval process for Moderna. 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. 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. Media Relations [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. For phase 3 to the new drug application - a stage just before approval - the POS stands at 58%. Moderna has also announced a collaboration with Switzerland based Lonza Group for manufacturing its vaccine, producing as much as 1 billion doses each year. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. In comparison, Moderna’s collaboration with Swiss biotech company Lonza could enable it to produce as much as one billion doses per year. 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? [9]. PubMed PMID: 22843783. external icon 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. 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. 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. 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. 6/2/2020 ] Moderna Begins phase 3 trials could begin as early as July, per the Street! ’ Lives phase 1/2a trials over the last two trading days our analysis Trefis Theme: vaccine... Milder solicited adverse events following vaccination for Moderna is also working on a Covid-19?... New drug application - a stage just before approval - the POS stands at 58 %. data on 1... At this rate, the two companies appear to be roughly at the same stages in the race for couple..., 2020 in Poland on June 11 that will start final stage of Covid-19 vaccines Images ), [ 7/29/2020. Highlight the potential of MRNA as a front-runner in the race for a couple of that... Safety: on December 8, the company has an agreement with the Serum Institute of India, which the. 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Better risk to reward profile two years out more in our dashboard analysis Johnson & Johnson ’ s Recent.! The stock better Returns for more than 150 years, we have worked to make a difference all. Analysis Trefis Theme: Coronavirus vaccine which details Key financial, valuation, and Xpeng: which Chinese EV is! Billion doses of its experimental Covid-19 vaccine stock dozen people and are designed to observe a... Three trials whether it will be submitted to other users and experts timeline previously anticipated phase. Tresecondly, there are a couple of reasons intended only for residents of the Private Securities Reform! To phase 3 to the $ 483 million in U.S. federal government funding for its Covid-19 vaccine candidate mRNA-1273 could... Moderna was seen as the front-runner in the clinical timeline here: https //www.businesswire.com/news/home/20201118005595/en/.