Separately the experimental vaccine has also received fast-track designation from the U.S. FDA, essentially helping to speed up the regulatory process. TreSecondly, there are some concerns regarding the timeline for the potential approval of Moderna’s vaccine. Moderna (NASDAQ: MRNA) stock has declined by close to 10% over the last two trading days. For phase 3 to the new drug application - a stage just before approval - the POS stands at 58%. Phase 1 trials usually involve a few dozen people and are designed to observe whether a vaccine or drug is safe. [5], German biotech company BioNTech is working on a Covid-19 vaccine in partnership with Pfizer (NYSE: PFE). 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. 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. 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 … 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. 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. Early results from trials of a Covid vaccine developed in Russia suggest it could be 92% effective. Without up-to-date estimates of the POS, however, investors may misjudge the risk and value of drug development, leading to lost opportunities for both investors and patients. Moderna said that it commenced stage 2 trials for its new Coronavirus vaccine candidate mRNA-1273 last week. 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. “The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic. We 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. American biotech company Moderna has announced on June 11 that will start final stage of covid-19 vaccine trial in July. 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 company is expected to receive as much as $483 million in U.S. federal government funding for its vaccine development. 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. 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 second-lowest phase transition success rate was found in Phase III (58.1%, n=1,491). 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. [6] There is also a possibility that phase 3 trials could begin as early as July, per the Wall Street Journal. 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. 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. This information—including product information—is intended only for residents of the United States. We will continue to work with our partners and governments around the world to prepare for global distribution in 2020 and beyond.”. Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints, Therapeutic Modalities and Technology Platforms, Small Molecule Product & Process Development, Maintaining Emotional Well-Being During COVID-19, Coronavirus disease (COVID-19) Scientific Resources, Meet our new Chief Patient Officer, Dr. Dara Richardson-Heron, Creating Cures Through Facility Investments, https://www.businesswire.com/news/home/20201118005595/en/. The probability of FDA approval after submitting a New Drug Application (NDA) or Biologic License Application (BLA), taking All Rights Reserved, This is a BETA experience. In comparison, Moderna is expected to start its phase 3 trial with around 30k participants in late July. This is significant as most company-sponsored Phase III trials are the longest and most expensive trials to conduct. 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. 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. 2014 Feb;58(3):319-27. doi: 10.1093/cid/cit736. View source version on businesswire.com: https://www.businesswire.com/news/home/20201118005595/en/, Pfizer: 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. Should You Buy Johnson & Johnson Stock At $160? The information contained in this release is as of November 18, 2020. 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. Clin Infect Dis. Manufacturing & Distribution: AstraZeneca could have an edge over Moderna when it comes to manufacturing and distribution. 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. 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. 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 first effective coronavirus vaccine can prevent more than 90% of people from getting Covid-19, a preliminary analysis shows. 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. 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. They can be used be as temporary storage units for 15 days by refilling with dry ice. Effectiveness of seasonal influenza vaccines in the United States during a season with circulation of all three vaccine strains. How many people have been vaccinated? 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. 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. Our indicative portfolio of 7 U.S. listed companies developing vaccines for Coronavirus has gained a whopping ~130% year-to-date on an equally weighted basis. The platform uses extensive data to show in a single snapshot what drives the value of a company's business. Can Editas Medicine Stock Bounce Back After A 13% Drop In 5 Days ? 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. ... (RDIF) to conduct Phase 2 and Phase 3 clinical trials of the Sputnik V vaccine developed by Gamaleya Research Institute. 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. In the U.S., 18.4 million doses administered, with 5.44 million doses in the U.K. and 726,786 in Canada Sylke Maas, Ph.D. You may opt-out by. “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. Additionally, the progression from phase 2 to phase 3 may be more tricky for pharma companies. 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. 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? Efficacy was consistent across age, gender, race and ethnicity demographics. 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. Amy Rose 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. [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. Phase 1, 2, and 3 trials: Clinical trials typically take place in three stages. 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. Russian researchers suggest their vaccine is both safe and 92 percent effective at protecting against COVID-19. 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. 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. Chuck Triano 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. 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. Pfizer’s vast resources, better access to manufacturing, and distribution could give it an edge over Moderna as it continues to move forward. [Updated 7/21/2020] Does Oxford-AstraZeneca’s Progress With Covid-19 Vaccine Impact Moderna? [3] More specifically, after two doses, the vaccine produced neutralizing antibodies - which are key to fighting the virus - that were 4x higher than what was found in patients who had recovered from coronavirus infections. The 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. (If oncology drugs are excluded, the figure is 20.9%.) gained FDA approval to begin phase 2 clinical trials. Moderna has also announced a collaboration with Switzerland based Lonza Group for manufacturing its vaccine, producing as much as 1 billion doses each year. Additionally, the progression from phase 2 to phase 3 may be more tricky for pharma companies. We routinely post information that may be important to investors on our website at www.Pfizer.com. For phase 3 to the new drug application - a stage just before approval - the POS stands at 58%. 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. Recent data show increasing rates of severe ... authorization. The data is based on 20 cases of Covid-19 from 16,000 volunteers given the Sputnik V vaccine … 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. [1] This comes about a week after Moderna released similar progress on its Covid-19 vaccine candidate mRNA-1273. Success probabilities do not capture the varied … While the development uses messenger RNA technology similar to Moderna, this effort focuses on not just one, but four prototypes. The companies have developed specially designed, temperature-controlled thermal shippers utilizing dry ice to maintain temperature conditions of -70°C±10°C. 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. 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. 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. 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 is confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world. This is ahead of the fall timeline previously anticipated for phase 3 trials. 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. 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. So how do the Moderna and Oxford-AstraZeneca vaccines’ developments compare? Days after Pfizer revealed the first interim Phase 3 … Treanor JJ, Talbot HK, Ohmit SE, et al. [email protected]. American biotech company Moderna has announced on June 11 that will start final stage of covid-19 vaccine trial in July. 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. 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. CID 2012; 55(7):951-959. 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. Which stocks offer a better risk to reward profile? Find out more in the Trefis Theme: Coronavirus Vaccine which details key financial, valuation, and returns metrics for the companies. 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. View the full release here: https://www.businesswire.com/news/home/20201118005595/en/. Opinions expressed by Forbes Contributors are their own. [Updated 5/15/2020] Moderna’s Recent Progress. Moderna (NASDAQ: MRNA) stock has jumped by almost 40% over the last two days (including after-hours trading Tuesday), driven by two positive developments. This press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. [email protected], Investor Relations [email protected], BioNTech: Copyright © 2002-2021 Pfizer Inc. All rights reserved. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. Earlier this week, the FDA provided guidelines for the approval of Covid-19 vaccines, indicating that it would not be relaxing any standards. 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. 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. 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. The company has partners to manufacture and distribute about 2 billion doses of its experimental Covid-19 vaccine. Phase 1 trials usually involve a few dozen people and are designed to observe whether a vaccine or drug is safe. J&J may also offer downside protection versus clinical-stage biotechs like Moderna, given its diversified revenue streams. Media Relations About Pfizer: Breakthroughs That Change Patients’ Lives. 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. 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. 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. 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. 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. +1 (212) 733-3901 The products discussed herein may have different labeling in different countries. These data also will be submitted to other regulatory agencies around the world. Does this make Novavax a better bet that Moderna? PubMed PMID: 22843783. external icon Media Relations [Updated 6/12/2020] What To Expect As Moderna Plans Phase 3 Trials. I want to thank all the devoted women and men who contributed to this historically unprecedented achievement. 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. Airline stocks are soaring after Pfizer/BioNTech reports a 90% effective rate for its COVID-19 vaccine. These trials will determine if the vaccine protects against Covid-19 and whether it will be cleared for use in the general public. 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. 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 (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. Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. Sanofi (-4% YTD return, $120 billion market cap): Sanofi has joined forces with GlaxoSmithKline to develop a coronavirus vaccine. Are treatments, vaccines or testing stocks the best way to play the coronavirus recovery? Did you know that the U.S. government awarded biotech company Novavax $1.6 billion toward the development of its Covid-19 vaccine? Firstly, on Monday, the Nasdaq indicated that the Moderna would be included as a component of the Nasdaq-100 index starting from July 20th. Epub 2012 Jul 25. 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. This means that the vaccine, if approved, should be relatively affordable. BioNTech’s German sites will also be leveraged for global supply. The observed efficacy in adults over 65 years of age was over 94%. Among children in the older age group, there was an increased risk of febrile seizures within 7 days after any of the vaccine doses. As passive investing is gaining momentum, this could generally increase demand for Moderna stock. Phase 2 trials may be viewed as more crucial compared to other phases for a couple of reasons. 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. [Updated 7/14/2020] Moderna’s Promising New Data On Phase 1, Inclusion Into Nasdaq Index. 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. Jasmina Alatovic 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. 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. 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. 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. Power for a potential Moderna vaccine developed by Gamaleya Research Institute is on... Additionally, the competition could be gaining some ground in the race for a couple of developments that be... As-Well-As ask questions to other users and experts is safe drives the value of vaccine. 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