Participation in other studies involving study intervention within 28 days prior to study entry through and including 6 months after the last dose of study intervention, with the exception of non-Pfizer interventional studies for prevention of COVID 19, which are prohibited throughout study participation. • Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years, inclusive, or ≥12 years, inclusive, at randomization (dependent upon study phase). First US COVID-19 vaccine trials in humans. As 2020 ended, we saw a glimmer of hope against the coronavirus disease 2019 (COVID-19) pandemic, with promising safety and efficacy data emerging from clinical trials of several vaccines targeting the COVID-19 causative virus, SARS-CoV-2 (refs 1–5).As a result, the FDA has granted emergency use authorization (EUA) to BNT162b2 and to mRNA-1273, two lipid … Talk with your doctor and family members or friends about deciding to join a study. Effectiveness. Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: As a 2-dose (separated by 21 days) schedule; At various different dose levels in Phase 1; In 3 age groups (Phase 1: 18 to 55 years of age, 65 to 85 years of age; Phase 2/3: ≥12 years of age [stratified as 12-15, 16-55 or >55 years of age]). ICAN FILES NUMEROUS CITIZEN PETITIONS TO THE FDA REGARDING THE SAFETY AND EFFICACY OF THE COVID-19 VACCINES. Pfizer-BioNTech announce positive topline results of pivotal COVID-19 vaccine study in adolescents. Phase III Pfizer COVID-19 Vaccine – August 19, 2020, PHASE III JOHNSON & JOHNSON COVID-19 VACCINE – October 16, 2021. b. such documenting of adverse events and reactions shall last at least twenty-four months for adults, thirty-six months for children and sixty months for infants and toddlers, or such longer duration as appropriate, and in no event end prior to the subject reaching eight years of age; c. it uses an adequate sample size, appropriately powered, in order to (i) detect an increase in rare adverse events or any untoward medical occurrence, whether or not considered vaccine related, and (ii) determine that the rate of adverse events from the vaccine will not exceed the rate of adverse events known to occur from SARS-CoV-2 in the group under review; d. participants are tested for T-cell reactivity to SARS-CoV-2 pre-vaccination and post-vaccination; e. germline transmission tests are conducted for male participants; and, f. HIV incidence will be “monitored at the end of the study and for an appropriate follow-up period” and the trial will “evaluate the levels and distribution of both vector and insert responses in target tissues where HIV acquisition is known to occur.”, ICAN Petition for Reconsideration – March 23, 2021, Efficacy of COVID-19 Vaccines – November 6, 2020. a. reduction in severe COVID-19 (i.e., hospital admissions, ICU admissions, and death) be a primary endpoint; b. PCR tests used to qualify an event of COVID-19 for a trials’ endpoint use a maximum of 24 amplification cycles; c. interruption of transmission (person-to-person spread) be a primary endpoint; and. Found inside – Page ivThis book discusses various components of the innate and adaptive immune response in combating viral infections, presenting the recent advances in our understanding of innate immunity recognition of viruses and highlighting the important ... Is the COVID-19 Vaccine Safe for Infants? Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study. OWS has funded JNJ-78436735 (Janssen), mRNA-1273 (Moderna), and NVX‑CoV2373 (Novavax), V590 (Merck/IAVI), … ... with a sample size of 131 … Dr. Rosenberg M.D. is a Board-Certified Preventive Medicine specialist, trained at Stanford and Columbia Universities, who has devoted much of his life's work to the development and delivery of safe and effective vaccines and is now ... Only the study of the BBV152 vaccine, which was formulated with aluminium and a Toll-like receptor … The FDA denied these requests and ICAN followed-up to let the agency know this is unacceptable given the novel nature of these mRNA vaccines and the current unknowns related to safety. Phase 1 only: Regular receipt of inhaled/nebulized corticosteroids. First US COVID-19 vaccine trials in humans. N Engl J Med. July 2020 – ICAN files a second petition demanding that the vaccine clinical trials track all … Despite the importance of some of ICAN’s demands to the FDA, the agency did not adopt those demands and ICAN pushed back. Found inside – Page 50By vaccine/therapeutics/critical inputs, for each country and over time Research & Development Clinical trials Trial-level data Lab or other studies ... The COVID-19 pandemic started more than a year ago, but until today, we did not have a definitive cure for this disease. The Moderna COVID-19 vaccine is given 28 days after the first dose. 2020 Oct;586(7830):589-593. doi: 10.1038/s41586-020-2639-4. July 2020 – ICAN files a second petition demanding that the vaccine clinical trials track all adverse events for the duration of the trial. Pfizer. ... clinical … This book provides a comprehensive overview of how use of micro- and nanotechnology (MNT) has allowed major new advance in vaccine development research, and the challenges that immunologists face in making further progress. COVID-19 Vaccine Safe For Mom And ... pregnant or breastfeeding weren't included in the initial clinical trials. Regrettably, only a small proportion of the … Now that over half of the U.S. adult population has received at least one dose of the COVID-19 vaccine, the country is expanding its efforts to get kids vaccinated next. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. July 2020 – ICAN files a second petition demanding that the vaccine clinical trials track all … "The dose may be different for younger ages. This book focuses on the remarkable progress in developing vaccines, the amazing effectiveness of the early vaccines, and the challenges of delivering them to the population. The result has been that the Phase II/III clinical trials for COVID-19 vaccines approved by the FDA since June 30, 2020 at least began with a placebo control group. "The dose may be different for younger ages. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. A Phase 3 clinical trial designed to evaluate if an investigational vaccine can prevent symptomatic coronavirus disease 2019 (COVID-19) in adults has begun. Centers for Disease Control and Prevention. What's the Difference Between the 3 Available COVID-19 Vaccines? Please visit the NIH ACTIV vaccines page for a summary of Operation Warp Speed-supported clinical trials of COVID-19 vaccine candidates.. In clinical trials, the Pfizer-BioNTech COVID-19 vaccine was shown to be 95% effective. Now that over half of the U.S. adult population has received at least one dose of the COVID-19 vaccine, the country is expanding its efforts to get kids vaccinated next. THE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID -19) ... For information on clinical trials that are testing the use of the Pfizer-BioNTech ... until the expiry date The PubMed, Medline, and server medRxiv search for publications on clinical trials of COVID-19 vaccines, conducted on the 15 th of March 2021, showed that 5 inactivated whole-virion candidate vaccines formulated with an aluminium adjuvant were in clinical development. A: Efficacy of the Janssen COVID-19 vaccine demonstrated in the clinical trial reflected protection against several emerging SARS-CoV-2 variants of concern, … d. All systemic adverse reactions, adverse events, serious adverse events, medically-attended adverse events, new onset medical conditions, and any other health issue arising or exacerbated post-vaccination shall be documented for each subject post-vaccination for a period of at least twelve months for adults, thirty-six months for children and teenagers, and sixty months for infants and toddlers. N Engl J Med. Epub 2021 May 27. Sign up for our Health Tip of the Day newsletter, and receive daily tips that will help you live your healthiest life. COVID-19 Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. 2025 Guadalupe Street, Suite 260 Viral Vector-Based Vaccines. Data demonstrating that safety risks do not outweigh potential benefits for any age for which the vaccine is approved; c. Data reflecting that the vaccine does not cause DNA integration and germline transmission; d. Data on the safety and efficacy of the vaccine in individuals who currently have or have had a SARS-CoV-2 infection; e. Results of reproductive testing including proper immunological studies looking at potential reactivity of the vaccinated against the Syncytin 1 and 2 proteins; f. PCR tests used to qualify an event of COVID-19 for a trials’ endpoint use a maximum of 28 amplification cycles; and. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Ongoing clinical trials of COVID-19 vaccine in children <12 years are examining a range of vaccine doses that are lower than … This book offers a detailed review of Covid-19 pandemic, its impact on the world and the global efforts to develop effective vaccines against the virus. October 2020 – ICAN files another petition regarding the viral vector vaccine made by Janssen/Johnson & Johnson. Participants who received 58 micrograms of COVID-19 mRNA Vaccine in clinical trials did not report an increase in reactogenicity or adverse events. Informed Consent Action Network THE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID -19) ... For information on clinical trials that are testing the use of the Pfizer-BioNTech ... until the expiry date ICAN then requested that the FDA confirm that the placebo arm will be maintained through the conclusion of the trial in order to maintain the integrity of the trial and the validity of the safety data produced by the trial. Participants who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study. 2021 Jul 15;385(3):239-250. doi: 10.1056/NEJMoa2107456. For general information, Learn About Clinical Studies. The study is designed to primarily evaluate the efficacy, safety, and immunogenicity of mRNA-1273 to prevent COVID-19 for up to 2 years after the second dose of mRNA-1273. The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The candidate vaccines developed by AstraZeneca and Oxford (AZD1222) and the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ-7843672 or Ad.26.COV2.S) are viral vector-based … Abstract: We compare and contrast the expected duration and number of infections and deaths averted among several designs for clinical trials of COVID-19 vaccine candidates, including traditional randomized clinical trials and adaptive and ... Participants ≥16 years of age who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study. The study is designed to primarily evaluate the efficacy, safety, and immunogenicity of mRNA-1273 to prevent COVID-19 for up to 2 years after the second dose of mRNA-1273. Found inside – Page 38However, as of this date, clinical trials are still ongoing. In the absence of any detailed scientific publication proving the effectiveness of the vaccine, ... Found inside“China's Virus-Hit Economy Shrinks for First Time in Decades. ... “Chinese Pharma Offers to Conduct Clinical Trials of Covid-19 Vaccine in Pakistan.”. Previous participation in other studies involving study intervention containing lipid nanoparticles. The study will evaluate the safety, tolerability, and immunogenicity of 3 different SARS-CoV-2 RNA vaccine candidates against COVID-19 and the efficacy of 1 candidate: The candidate selected for efficacy evaluation in Phase 2/3 is BNT162b2 at a dose of 30 µg. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. As 2020 ended, we saw a glimmer of hope against the coronavirus disease 2019 (COVID-19) pandemic, with promising safety and efficacy data emerging from clinical trials of several vaccines targeting the COVID-19 causative virus, SARS-CoV-2 (refs 1–5).As a result, the FDA has granted emergency use authorization (EUA) to BNT162b2 and to mRNA-1273, two lipid … The Phase 3 COVE study was designed in collaboration with the FDA and NIH to evaluate Americans at risk of severe COVID-19 disease and completed enrollment of 30,000 participants ages 18 and older in the U.S. on October 22, including those at high risk of the severe complications of COVID-19 disease. A Phase 3 clinical trial designed to evaluate if an investigational vaccine can prevent symptomatic coronavirus disease 2019 (COVID-19) in adults has begun. In order to describe the boostability of BNT162, and potential heterologous protection against emerging SARS-CoV-2 VOCs, an additional dose of BNT162b2 at 30 µg will be given to Phase 1 participants approximately 6 to 12 months after their second dose of BNT162b1 or BNT162b2. In the midst of a devastating pandemic with high transmissibility and case fatality, the mRNA COVID-19 vaccine trials represent hope of an end to the global burden of COVID-19 infection, hospital utilization, and death. A COVID‑19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), the virus that causes coronavirus disease 2019 ().Prior to the COVID‑19 pandemic, an established body of knowledge existed about the structure and function of coronaviruses causing diseases like severe acute respiratory syndrome (SARS) … All rights reserved. Mulligan MJ, Lyke KE, Kitchin N, Absalon J, Gurtman A, Lockhart S, Neuzil K, Raabe V, Bailey R, Swanson KA, Li P, Koury K, Kalina W, Cooper D, Fontes-Garfias C, Shi PY, Türeci Ö, Tompkins KR, Walsh EE, Frenck R, Falsey AR, Dormitzer PR, Gruber WC, Şahin U, Jansen KU. Only the study of the BBV152 vaccine, which was formulated with aluminium and a Toll-like receptor … March 31, 2021. [Epub ahead of print]. Participants who, in the judgment of the investigator, are at risk for acquiring COVID-19. A Study to Create a Registry of Individuals Who Have Not Had COVID-19, and are Interested in Possible Participation in COVID-19 Vaccine Clinical Trials Rochester, MN The study aims to create a registry of individiauls who have not had COVID-19 but are interested in participating in a COVID-19 vaccine trial. Please visit the NIH ACTIV vaccines page for a summary of Operation Warp Speed-supported clinical trials of COVID-19 vaccine candidates.. ... with a sample size of 131 — the study is the largest to date … History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). Individual Participant Data (IPD) Sharing Statement: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. In clinical trials, the Pfizer-BioNTech COVID-19 vaccine was shown to be 95% effective. Found insideBetween Hope and Fear tells the remarkable story of vaccine-preventable infectious diseases and their social and political implications. A further subset of Phase 3 participants will receive a third, lower, dose of BNT162b2 at 5 or 10 µg. Walsh EE, Frenck RW Jr, Falsey AR, Kitchin N, Absalon J, Gurtman A, Lockhart S, Neuzil K, Mulligan MJ, Bailey R, Swanson KA, Li P, Koury K, Kalina W, Cooper D, Fontes-Garfias C, Shi PY, Türeci Ö, Tompkins KR, Lyke KE, Raabe V, Dormitzer PR, Jansen KU, Şahin U, Gruber WC. ICAN’s demands include that the vaccine be shown to prevent serious cases of COVID-19 (not just mild cases) and that it can stop transmission of COVID-19. Alarming deficiencies in the vaccine clinical trials regarding efficacy endpoints and the use of unreliable PCR testing led ICAN to direct its attorneys to file a petition demanding that all four Phase III COVID-19 vaccine trials amend their efficacy endpoints. Documentation of adverse events and reactions for at least twenty-four months for adults, thirty-six months for children and sixty months for infants and toddlers, or such longer duration as appropriate, and in no event ending prior to the subject reaching eight years of age; b. But not every trial is at the same stage. To further describe potential homologous and heterologous protection against emerging SARS-CoV-2 VOCs, a new cohort of participants will be enrolled who are COVID-19 vaccine-naïve (ie, BNT162b2-naïve) and have not experienced COVID-19. The Moderna COVID-19 vaccine is given 28 days after the first dose. Coronavirus (COVID-19) update: FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in adolescents in another important action in fight against pandemic. a. 2025 Guadalupe Street, Updated May 1, 2014. PREVIOUS CITIZEN PETITIONS FILED REGARDING COVID-19 VACCINES: May 2020 – ICAN files a formal petition demanding the FDA include a placebo control group in all COVID-19 vaccine clinical trials and the FDA thereafter adopted this requirement. On February 27, 2021, the same day the FDA granted emergency use authorization for this vaccine, the FDA replied to ICAN and denied its requests. Here’s where clinical trials on COVID-19 vaccines in children in the U.S. stand, plus when you can expect them to release results. Please visit the NIH ACTIV vaccines page for a summary of Operation Warp Speed-supported clinical trials of COVID-19 vaccine candidates.. Found inside – Page 563Two vaccines made it to clinical development stages (phase 1 studies), ... and to date, three candidate vaccines have completed phase 1 clinical trials, ... Fact Checks These requested data are vital to ensuring both safety and efficacy of a vaccine before it is approved and then, in all likelihood, widely mandated. Several clinical trials testing COVID-19 vaccines in kids are currently underway. The result has been that the Phase II/III clinical trials for COVID-19 vaccines approved by the FDA since June 30, 2020 at least began with a placebo control group. Korin Miller is a health and lifestyle journalist who has been published in The Washington Post, Prevention, SELF, Women's Health, The Bump, and Yahoo, among other outlets. Choosing to participate in a study is an important personal decision. OWS has funded JNJ-78436735 (Janssen), mRNA-1273 (Moderna), and NVX‑CoV2373 (Novavax), V590 (Merck/IAVI), … The Johnson & Johnson “single-dose” covid-19 vaccine is more effective after two doses, the firm said yesterday. Only the study of the BBV152 vaccine, which was formulated with aluminium and a Toll-like receptor … Accurate data reflecting actual risk reduction and number needed to vaccinate to prevent one case of COVID-19. In the midst of a devastating pandemic with high transmissibility and case fatality, the mRNA COVID-19 vaccine trials represent hope of an end to the global burden of COVID-19 infection, hospital utilization, and death. AstraZeneca-Oxford COVID-19 Vaccine: What You Need to Know. A multi-site, Phase 3 clinical trial evaluating an investigational COVID-19 vaccine known as AZD1222 has begun. A Phase 3 clinical trial designed to evaluate if an investigational vaccine can prevent symptomatic coronavirus disease 2019 (COVID-19) in adults has begun. Requirements of COVID-19 Vaccine Manufacturers Prior to Approval. This will provide an early assessment of the safety of a third dose of BNT162, as well as its immunogenicity. Found inside – Page 23We find that COVID-19 vaccines with a private lead sponsor, or involving a ... to enter clinical trials or the number of phases completed by the end of ... Epub 2020 Aug 12. The placebo shall be a saline injection without anything added. How Did Cuba Become the First Country to Vaccinate Young Children? Children as young as 12 are now eligible to receive the Pfizer-BioNTech COVID-19 vaccine. North Texas Infectious Diseases Consultants, P.A. The vaccine, known as MRT5500, is Sanofi’s second Covid-19 candidate in clinical trials, following their protein-based vaccine. Not satisfied with the FDA’s explanations for the denial, ICAN submitted a Petition for Reconsideration on March 23, 2021 which asked that the FDA again review the concerns in the Petition and ICAN’s additional arguments. COVID data tracker. To obtain contact information for a study center near you, click here. Vaccine testing and the approval process. The Phase 3 COVE study was designed in collaboration with the FDA and NIH to evaluate Americans at risk of severe COVID-19 disease and completed enrollment of 30,000 participants ages 18 and older in the U.S. on October 22, including those at high risk of the severe complications of COVID-19 disease. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368728. N Engl J Med. Effectiveness. The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. Epub 2020 Dec 10. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests. The FDA also denied ICAN’s demands with regards to efficacy and ICAN did not accept the FDA’s refusal to require the vaccine manufacturers to determine whether the vaccine prevents infection and transmission as a primary endpoint. Percentage of participants in Phase 1 reporting local reactions [ Time Frame: For 7 days after dose 1 and dose 2 ], Percentage of participants in Phase 1 reporting systemic events [ Time Frame: For 7 days after dose 1 and dose 2 ], Percentage of participants in Phase 1 reporting adverse events [ Time Frame: From dose 1 through 1 month after the last dose ], Percentage of participants in Phase 1 reporting serious adverse events [ Time Frame: From dose 1 through 6 months after the last dose ], Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values [ Time Frame: 1 day after dose 1 ], Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values [ Time Frame: 7 days after dose 1 ], Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values [ Time Frame: 7 days after dose 2 ], Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between baseline and 1 day after dose 1 ], Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between baseline and 7 days after dose 1 ], Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between before dose 2 and 7 days after dose 2 ], In the first 360 participants randomized into Phase 2/3, percentage of participants reporting local reactions [ Time Frame: For 7 days after dose 1 and dose 2 ], In the first 360 participants randomized into Phase 2/3, percentage of participants reporting systemic events [ Time Frame: For 7 days after dose 1 and dose 2 ], In the first 360 participants randomized into Phase 2/3, percentage of participants reporting adverse events [ Time Frame: From dose 1 through 1 month after the last dose ], In the first 360 participants randomized into Phase 2/3, percentage of participants reporting serious adverse events [ Time Frame: From dose 1 through 6 months after the last dose ], In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting local reactions [ Time Frame: For 7 days after dose 1 and dose 2 ], In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting systemic events [ Time Frame: For 7 days after dose 1 and dose 2 ], Percentage of participants in Phase 2/3 reporting adverse events [ Time Frame: From dose 1 through 1 month after the last dose ], Percentage of participants in Phase 2/3 reporting serious adverse events [ Time Frame: From dose 1 through 6 months after the last dose ], Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ], Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ], Percentage of participants 12-15 years of age in Phase 3 reporting adverse events [ Time Frame: From dose 1 through 1 month after the last dose ], Percentage of participants 12-15 years of age in Phase 3 reporting adverse events [ Time Frame: From dose 1 through 6 months after the last dose ], In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting local reactions [ Time Frame: For 7 days after dose 1 and dose 2 ], In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting systemic events [ Time Frame: For 7 days after dose 1 and dose 2 ], In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting adverse events [ Time Frame: From dose 1 through 1 month after the last dose ], In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting serious adverse events [ Time Frame: From dose 1 through 5 or 6 months after the last dose ], In participants, who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting local reactions [ Time Frame: For 7 days after dose 1 (and dose 2) ], In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting systemic events [ Time Frame: For 7 days after dose 1 (and dose 2) ], In participants who receive a third dose of BNT162b2, percentage of participants reporting adverse events [ Time Frame: From the third dose through 1 month after the third dose ], In participants who receive a third dose of BNT162b2, percentage of participants reporting serious adverse events [ Time Frame: From the third dose through 6 months after the third dose ], In participants who receive a third dose of BNT162b2, percentage of participants reporting local reactions [ Time Frame: For 7 days after the third dose ], In participants who receive a third dose of BNT162b2, percentage of participants reporting systemic events [ Time Frame: For 7 days after the third dose ], Noninferiority of the SARS-CoV-2 reference strain neutralizing titers after a third dose of BNT162b2 at 30 µg compared to after 2 doses of BNT162b2, in the same individuals [ Time Frame: 1 month after the third dose ], Noninferiority of the SARS-CoV-2 SA strain neutralizing titers after one dose of BNT162b2SA compared to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2, in the same individuals [ Time Frame: 1 month after the third dose ], Noninferiority of the SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA compared to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2 [ Time Frame: 1 month after the second dose ], In Phase 1 participants, SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs [ Time Frame: Through 2 years after the final dose ], In Phase 1 participants, GMFR in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point [ Time Frame: Through 2 years after the final dose ], Proportion of participants in Phase 1 achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 serum neutralizing antibody levels [ Time Frame: Through 2 years after the final dose ], In Phase 1 participants, SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels, expressed as GMCs [ Time Frame: Through 2 years after the final dose ], Proportion of participants in Phase 1 achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels [ Time Frame: Through 2 years after the final dose ], In Phase 1 participants, GMFR in SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels from before vaccination to each subsequent time point [ Time Frame: Through 2 years after the final dose ], In Phase 1 participants, GMR of the geometric mean of SARS-CoV-2 serum neutralizing titers to the geometric mean of SARS CoV 2 (anti-S1 and anti-RBD) binding antibody levels [ Time Frame: Through 2 years after the final dose ], Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 2 years ], Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 2 years ], Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ], Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 2 years ], Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ], Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 2 years ], Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ], Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 2 years ], Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ], Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 2 years ], GMR of SARS CoV 2 neutralizing titers in the 2 age groups (12-15 years of age to 16-25 years of age) [ Time Frame: 1 month after the second dose ], Incidence of asymptomatic SARS CoV-2 infection based on N binding antibody seroconversion in participants with no serological or virological evidence of past SARS CoV-2 infection or confirmed COVID-19 prior to 1 month after receipt of the second dose [ Time Frame: Through 1 month after the second dose ], Incidence of asymptomatic SARS CoV-2 infection based on central laboratory-confirmed NAAT in participants with no serological or virological evidence (up to the start of the asymptomatic surveillance period) of past SARS-CoV-2 infection [ Time Frame: Through 6 months after the second dose ], Noninferiority of the SARS-CoV-2 SA strain neutralizing titers after a third dose of BNT162b2 at 30 µg compared to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2, in the same individuals [ Time Frame: 1 month after the third dose ], Noninferiority of the SARS-CoV-2 reference strain neutralizing titers after one dose of BNT162b2SA compared to after 2 doses of BNT162b2, in the same individuals [ Time Frame: 1 month after the first dose of BNT162b2SA ], Comparison of the SARS-CoV-2 SA strain neutralizing titers after 1 dose of BNT162b2SA to after a third dose of BNT162b2 at 30 µg [ Time Frame: 1 month after the first dose of BNT162b2SA/third dose of BNT162b2 ], Comparison of the SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2, in the same individuals [ Time Frame: 1 month after the second dose of BNT162b2SA ], Comparison of the SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA to after 2 doses of BNT162b2 [ Time Frame: 1 month after the second dose ], Comparison of the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2SA to after 2 doses of BNT162b2 [ Time Frame: 1 month after the second dose ].
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