We routinely post information that may be important to investors on our website at www.Pfizer.com. Media Relations "The reason that they are two-dose vaccines is that the second doses give you a titer of neutralizing antibodies, virus-specific neutralizing antibodies that is almost 10 growth fold greater than after the first dose," he told CNBC. Efficacy was consistent across age, gender, race and ethnicity demographics. Got a confidential news tip? Study: COVID vaccines safe during pregnancy 07:10. The companies have developed specially designed, temperature-controlled thermal shippers utilizing dry ice to maintain temperature conditions of -70°C±10°C. “These achievements highlight the potential of mRNA as a new drug class. 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. They can be used be as temporary storage units for 15 days by refilling with dry ice. The Pfizer vaccine trials included thousands of people carrying extra weight, and the jab worked to protect them from severe Covid and death. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech’s efforts to combat COVID-19; the collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine; our expectations regarding the potential characteristics of BNT162b2 in our Phase 2/3 trial and/or in commercial use based on data observations to date; the expected timepoint for additional readouts on efficacy data of BNT162b2 in our Phase 2/3 trial; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the timing for submission of data for, or receipt of, any potential Emergency Use Authorization; the timing for submission of manufacturing data to the FDA; and the ability of BioNTech to supply the quantities of BNT162 to support clinical development and, if approved, market demand, including our production estimates for 2020 and 2021. In 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. This information—including product information—is intended only for residents of the United States. 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. A large study published in the New England Journal of Medicine in February found Pfizer's vaccine was 94% protective against symptomatic Covid. The study was conducted across eight U.S. locations: Phoenix, Tucson, and other areas in Arizona; Miami, Florida; Duluth, Minnesota; Portland, Oregon; Temple, Texas; and Salt Lake City, Utah. Researchers analyzed results from thousands of COVID-19 tests carried out each week as part of hospital … +1 (212) 733-7410 At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. "COVID-19 vaccination is recommended for all eligible persons.". The health-care personnel and other essential workers in the study, which was published Monday, had no previous laboratory documentation of Covid-19 infection. 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. [email protected], Investor Relations Sign up for free newsletters and get more CNBC delivered to your inbox. Copyright © 2002-2021 Pfizer Inc. All rights reserved. Pfizer’s COVID-19 Vaccine Reduces Viral Load: Study Preliminary results from an Israel-based study suggest that one dose of the vaccine reduces infectiousness—a key factor in … 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. These data also will be submitted to other regulatory agencies around the world. The study had limitations, the CDC said, adding that delays in shipments could reduce the sensitivity of virus detection of Covid-19 tests. Jasmina Alatovic 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. Possible side effects. Israeli Study: Pfizer Coronavirus Vaccine Is 91 Percent Effective at Preventing Infection A joint study with Israeli HMO Maccabi and the Technion, which included data from 1.7 million Israelis, shows protection against coronavirus peaks 35 days after first jab, at 99.3 percent Neutralizing antibodies play an important role in defending cells against the virus. I want to thank all the devoted women and men who contributed to this historically unprecedented achievement. In general, the side effects observed during the clinical trials are similar to what you might have with other vaccines. Its findings said that in people with obesity, the effectiveness of the vaccine is 95 per cent, just as it is in people with a lower BMI. The interim vaccine effectiveness findings for both vaccines in real-world conditions complement and expand upon the vaccine effectiveness estimates from other recent studies, the CDC said. The CDC findings were published just minutes before the agency's director, Dr. Rochelle Walensky, told reporters during a press briefing that the U.S. is facing "impending doom" as daily Covid-19 cases begin to rebound once again, threatening to send more people to the hospital even as vaccinations accelerate nationwide. 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. New Delhi: Pfizer-BioNTech’s Covid-19 vaccine can prevent both symptomatic and asymptomatic infection in working-age adults, a new study claims. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. "These findings indicate that authorized mRNA COVID-19 vaccines are effective for preventing SARS-CoV-2 infection, regardless of symptom status, among working-age adults in real-world conditions," the U.S. agency wrote in the study. 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. Media Relations Overall, the study has shown that the Pfizer-BioNTech BNT162b2 vaccine starts preventing individuals from COVID-19 after 12 days following the first-inoculation in a two-dose vaccine regimen. 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. Secondly, and more importantly, scientists also detected so-called T cells, another important part of the immune response that usually provides longer-lasting immunity, he said. 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 evidence from clinical trials, the Pfizer-BioNTech vaccine was 95% effective at preventing laboratory-confirmed COVID-19 illness in people without evidence of previous infection. This press release features multimedia. White House chief medical advisor Dr. Anthony Fauci has repeatedly said over the past few months that the U.S. should stick to the two-dose regimen. Two doses are better than one, the CDC said, adding that the vaccines' effectiveness jumped to 90% two weeks after the second dose. [email protected], Investor Relations View the full release here: https://www.businesswire.com/news/home/20201118005595/en/. To date, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine. The trial will continue to collect efficacy and safety data in participants for an additional two years. We will continue to work with our partners and governments around the world to prepare for global distribution in 2020 and beyond.”. 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. Scientists in Israel identified six cases in a new study of patients developing a skin rash known as herpes zoster after receiving the Pfizer vaccine. Get this delivered to your inbox, and more info about our products and services. The data comes from 627,383 users of the Zoe Covid Symptom Study app who self-reported systemic and local effects within eight days of receiving one or two doses of the Pfizer vaccine … A single dose of Pfizer and BioNtech’s COVID-19 vaccine could significantly reduce the risk of transmission of the virus, a U.K. study has found. COVID-19 vaccines developed by Pfizer with BioNTech and Moderna reduced the risk of infection by 80 per cent two weeks or more after the first of two shots, according to … For more information, please visit www.BioNTech.de. Read CNBC's latest coverage of the Covid pandemic: Fauci says U.S. should see a turning point in the pandemic 'within a few weeks', U.S. to share 60 million doses of AstraZeneca Covid vaccine with other countries, Biden administration set to relax outdoor mask guidance, Photos show the deadly toll of Covid in India as coronavirus cases top 17 million. [email protected], BioNTech: The observed efficacy in adults over 65 years of age was over 94%. Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints. 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. There are also remaining questions about the highly contagious variants and whether the vaccines will protect mild to moderate forms of the disease, he said. He said studies have shown immunity appears to be actually more "durable" after the second dose, meaning protection may last longer. Primary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose;170 confirmed cases of COVID-19 were evaluated, with 162 observed in the placebo group versus 8 in the vaccine … +49 (0)6131 9084 1513 or +49 (0)151 1978 1385 Here's a comparison study of Pfizer, Moderna, and J&J vaccines. 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. A single dose of Pfizer’s or Moderna’s Covid-19 vaccine was 80% effective in preventing infections, according to a new CDC study. 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. COVID-19 Vaccine Efficacy: A Comparison Study Of Pfizer, Moderna, And J&J Vaccines Which is the most effective COVID vaccine in the world is what many people have been asking. 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. 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, Meet our new Chief Patient Officer, Dr. Dara Richardson-Heron, Creating Cures Through Facility Investments, https://www.businesswire.com/news/home/20201118005595/en/. Based on studies in about 44,000 participants, the Pfizer-BioNTech COVID-19 vaccine was 95% effective in preventing COVID-19 beginning 1 week after the second dose. In a release, the companies reported that their two … 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. NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- The Pfizer vaccine against COVID-19 is effective and safe for people suffering from autoimmune inflammatory rheumatic diseases, according to a study … A single dose of Pfizer's or Moderna's Covid-19 vaccine was 80% effective in preventing infections, according to a new CDC study. Data is a real-time snapshot *Data is delayed at least 15 minutes. Researchers found that 21 days after a single dose of either the Oxford-AstraZeneca or the Pfizer-BioNTech vaccine, new Covid infections — both symptomatic and … Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. For more than 150 years, we have worked to make a difference for all who rely on us. Pfizer COVID-19 vaccine is 90% effective for at least 6 months and protects against South Africa variant, study shows A Division of NBCUniversal. CDC will continue to provide updates as we learn more about how well the Pfizer-BioNTech vaccine works in real-world conditions. 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. 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. 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. The COVID-19 vaccine developed by Pfizer (PFE.N) and BioNTech (22UAy.DE) is effective at preventing symptomatic and severe disease in people with … Scott Gottlieb: US has a chance to prevent a fourth wave, Dr. Rochelle Walensky, told reporters during a press briefing that the U.S. is facing "impending doom" as daily Covid-19 cases begin to rebound once again. +1 (212) 733-3901 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. 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. © 2021 CNBC LLC. 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. The team analysed data from 627,383 users of the ZOE Covid Symptom Study app who self-reported systemic and local effects within eight days of receiving one or two doses of the Pfizer vaccine … The effectiveness of partial immunization was seen two weeks after the first dose, according to the CDC, which looked at nearly 4,000 health-care personnel, first responders and front-line workers between Dec. 14 and March 13. A single dose of Pfizer's or Moderna's Covid-19 vaccine was 80% effective in preventing coronavirus infections, according to a new Centers for Disease Control and Prevention study of vaccinated health-care workers. Wednesday, November 18, 2020 - 06:59am. Since then, millions of people have been vaccinated, including the elderly, care workers and frontline NHS staff. Global Business and Financial News, Stock Quotes, and Market Data and Analysis. The Pfizer/BioNTech’s COVID-19 vaccine may not provide as much protection against a variant that was first discovered in South Africa, according to a preliminary study … About Pfizer: Breakthroughs That Change Patients’ Lives. Amy Rose BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The COVID-19 vaccine from Pfizer Inc and BioNTech SE was able to neutralize a new variant of the coronavirus spreading rapidly in Brazil, according to a laboratory study … Sylke Maas, Ph.D. Chuck Triano However, he said he worries that people will now think one dose of the vaccines is "good enough" and won't return for a second shot. This press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. 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. 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. Pfizer is confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world. 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. “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. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. All Rights Reserved. Among the 3,950 participants in the study, 2,479, or 62.8%, received both recommended doses, and 477, or 12.1%, received only one dose, the CDC said. 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. [email protected]. View source version on businesswire.com: https://www.businesswire.com/news/home/20201118005595/en/, Pfizer: Two doses are better than one, federal health officials said, adding that the vaccines' effectiveness jumped to 90% two weeks after the second dose. 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. +49 (0)6131 9084 1074 April 1, 2021 9:05 AM EDT On April 1, Pfizer-BioNTech released results from the longest study yet of their COVID-19 vaccine. Dear Participant, Today, Pfizer and BioNTech announced the results of the first interim analysis from our COVID-19 vaccine study. 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. NIH begins study of allergic reactions to Moderna, Pfizer-BioNTech COVID-19 vaccines Adults interested in participating in this trial should visit ClinicalTrials.gov and search under study identifier NCT04761822 for study locations and contacts. We want to hear from you. BioNTech’s German sites will also be leveraged for global supply. 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. The products discussed herein may have different labeling in different countries. “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. Please do not use the NIAID media phone number or email address to try to enroll in this trial. The new CDC findings are likely to bolster arguments from some health experts and public health officials that the U.S. should prioritize giving Americans just one dose of the vaccines before moving on to second doses, accelerating the pace of vaccinations across the nation. 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. The majority of the participants were female, white and had no chronic medical conditions, according to the CDC. The infection rate among participants who were vaccinated was 0.04, compared with 1.38 for those who were not vaccinated. There's no evidence to suggest that the Pfizer and Moderna COVID-19 vaccines pose risk during pregnancy, according to a … The information contained in this release is as of November 18, 2020. Unlike Johnson & Johnson's vaccine, which requires one dose, Pfizer's and Moderna's vaccines require two shots given three to four weeks apart. A single dose of the Pfizer or AstraZeneca COVID-19 vaccine cut the spread of coronavirus within a household by up to 50% in a new study.. People who had one dose of either vaccine … 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. Sorry, you need to enable JavaScript to visit this website. Officially called the BNT162b2 vaccine, the inoculation was studied among a sample population when the B1.1.7 variant of the coronavirus was dominantly circulating in the UK. Here’s what we know so far about the after effects of the Pfizer COVID vaccine February 4, 2021 The Pfizer/BioNTech COVID-19 vaccine began rollout in the UK on 8th December. Consistent with earlier shared results, older adults tended to report fewer and milder solicited adverse events following vaccination. Investigating a population in southern Sweden, a new study has found that a single dose of the vaccine is only about 42% effective in preventing coronavirus disease 2019 (COVID … Dr. Paul Offit, a voting member of the FDA's Vaccines and Related Biological Products Advisory Committee who reviewed both Pfizer's and Moderna's vaccine for emergency use authorization, said the CDC study overall is "good news.". The coronavirus variant first discovered in South Africa is able to evade some of the protection of the Pfizer-BioNTech vaccine, according to a new Israeli study. 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. Therapies to people that extend and significantly improve their Lives the products discussed herein may have different labeling different. 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