1, 2021 - Age-related immune response heterogeneity to SARS-CoV-2 vaccine BNT162b2 Nature.comwww.nature.comAge-related immune response heterogeneity to SARS-CoV-2 vaccine BNT162b2 - Nature.com; COVID-19 vaccine BNT162b1 elicits human antibody and TH1 T cell responses Nature.comwww.nature.comCOVID-19 vaccine BNT162b1 … BNT162b2 encodes more stuff and elicits more immune response. The preclinical data found immunization of rhesus macaques with either the BNT162b1 or BNT162b2 vaccine candidate elicited SARS-CoV-2 neutralizing geometric mean titers 8.2 to 18.2 times that of a SARS-CoV-2 convalescent human serum panel. Trial findings showed that two injections of (Comirnaty) COVID-19 mRNA BNT162b2 vaccine given 21 days apart can prevent 95% of adults aged 16 years and older to develop COVID-19. The best candidate vaccines include vector-based vaccines, nucleic acid … BNT162b1 has been shown to exhibit a broadly similar immunogenicity profile as BNT162b2 (modRNA encoding the full-length SARS-CoV-2 spike glycoprotein, derived from the same nucleoside-modified platform), inducing strong vaccine-induced antibody responses and strong T-cell responses 20. Teratogenicity and Postnatal Investigations) of BNT162b1, BNT162b2 and BNT162b3 by the Intramuscular Route in the Wistar Rat. Summary. BNT162b1 and BNT162b2 are two candidate mRNA vaccines against COVID-19 that elicit high virus-entry inhibition titres in mice, elicit high virus-neutralizing titres in … The publication describes key safety and immunogenicity data from the Phase 1 portion of the U.S. trial for the BNT162b2 and BNT162b1 vaccine candidates. BNT162b1 and BNT162b2 have been shown to elicit similar dose-dependent SARS-CoV-2-neutralizing GMTs, at levels similar to or in excess of those in … 14 days post boost vaccination, low titers of spike-specific binding antibodies (reciprocal endpoint IgG titers of 400–800) could be detected in 4 out of 6 animals ( Figure 1B ). As part of the UK's programme to control the spread of SARS-CoV-2, the Medicines and Healthcare products Regulatory Agency (MHRA) authorised the SARS-CoV-2 mRNA vaccine BNT162b2 (produced by Pfizer–BioNTech; Mainz, Germany) on Dec 2, 2020, for active immunisation to prevent COVID-19 in individuals aged 16 years and older. In this study, safety and immunogenicity of BNT162b1 and BNT162b2 vaccines, when administered in varying dose levels, have been evaluated. BNT162b1 is not anchored on the membrane like BNT162b2 but instead secreted. Overall, the vaccine, given as a two-dose regimen at one of three doses (10 μg, 20 μg, 30 μg) was As such, merely 8% and 17% of participants aged 18–55 or 65–85, respectively, reported fever after a second 30 μg dose. New York, NY and Mainz, Germany, February 1, 2021 (GLOBE NEWSWIRE) — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that preclinical data in non-human primate and mouse models from Pfizer and BioNTech’s mRNA-based vaccine candidates, BNT162b1 and BNT162b2, for the prevention of COVID-19 were published in the journal Nature. Nature publishing an article from BioNTech & Pfizer on their 'BNT162b1' vaccine candidate, versus the medRxiv before. Overall, the vaccine, given as a two-dose regimen at one of three doses (10 μg, In March of the same year, the World Health Organization declared the spread of this virus a public health emergency of international concern. A similar pattern was observed after vaccination with BNT162b2. The vaccine met … The SARS-CoV-2 virus, which causes COVID‑19, was detected in December 2019, and BioNTech began development of a COVID‑19 vaccine on 10 January 2020, when the SARS-CoV-2 genetic sequences were released by the Chinese Center for Disease Control and Prevention via GISAID, triggering an urgent international respons… Ongoing with preliminary results mid-December 2020. The primary endpoint was safety, and immunogenicity was the secondary outcome. In participants 65 to 85 years old, BNT162b1 elicited similar, but milder, local reactions, with mild to moderate injection site pain reported by 92% after Dose 1 and 75% after Dose 2. MAINZ, GERMANY and NEW YORK, September 30, 2020 — BioNTech SE (Nasdaq: BNTX) and Pfizer Inc. (NYSE: PFE) today announced that preliminary, peer-reviewed data from their ongoing German Phase 1/2 Study of BNT162b1 were published online in the journal Nature.BNT162b1 is part of the companies’ mRNA-based vaccine development program Lightspeed against SARS-CoV-2. MAINZ, GERMANY and NEW YORK, September 30, 2020 — BioNTech SE (Nasdaq: BNTX) and Pfizer Inc. (NYSE: PFE) today announced that preliminary, peer-reviewed data from their ongoing German Phase 1/2 Study of BNT162b1 were published online in the journal Nature.BNT162b1 is part of the companies’ mRNA-based vaccine development program Lightspeed against SARS-CoV-2. Herein, we overview molecular aspects of engineering the two lipids nanoparticle-encapsulated, nucleoside-modified mRNAs vaccines for COVID-19, highlighting the main differences between Moderna's mRNA-1273 vaccine and the Pfizer/BioNTech (BNT162b2) vaccine in terms of the strategies followed to optimize their effectiveness and safety. Two candidate mRNA vaccines were tested in phase 1 trials: BNT162b1 and BNT162b2. BNT162b2 vaccinated human participants displayed a favorable breadth of epitopes recognized in T cell responses specific to the SARS-CoV-2 antigen, as compared to the BNT162b1 candidate. BNT162b2 is a candidate vaccine being developed by BioNTech/Pfizer. The significant correlation between receptor-binding domain IgG antibodies and neutralisation titres suggests that IgG antibodies might serve as a correlate of neutralisation. Introduction. With BNT162b2 30 µg and BNT162b1 30 µg, the 50% neutralizing GMTs at 7 and 14 days after the second dose were 1.7–4.6 times the GMT of the convalescent serum panel in younger adults (aged 18–55 years) and 1.1–2.2 times the GMT of the convalescent serum panel … August 20, 2020, … Preclinical data investigated BNT162b2 immunogenicity and anti-viral properties in mice and non-human primates. No older adult who received BNT162b2 reported redness or swelling. The latter was ultimately advanced to Phase 3 trials due to greater tolerability and greather breadth of T-cell epitopes represented. A phase 2 trial compared both BNT162b1 and BNT162b2 in groups of younger (18–55 y) and older (65–85 y) subjects [51]. They show, in SARS-CoV-2-naive individuals, that the antibodies elicited have weak neutralizing activity but potent Fc-mediated effector functions, and in SARS-CoV-2 previously infected individuals, that all responses are significantly boosted. In addition, the safety, tolerability, and immunogenicity of BNT162b2 in both younger and older adults are compared to those of BNT162b1 at 10-µg, 20-µg, and 30-µg dose levels. BioNTech SE: Pfizer and BioNTech Share Positive Early Data on Lead mRNA Vaccine Candidate BNT162b2 Against COVID-19 August 20, 2020, 8:16 PM EDT SHARE THIS ARTICLE Jul. Like Moderna’s mRNA-1273, BNT162b1 is an mRNA vaccine – a novel approach also used in a separate Sanofi/Translate Bio project that saw a $425m fee handed across last month. We studied humoral and B cell responses of 35 HC, 44 DP and 40 KTR. We assessed the safety and immunogenicity of three dose levels of BNT162b1 and BNT162b2. Phase 1 trial for the BNT162b2 … Placebo. Pfizer and BioNtech reported a vaccine efficacy for BNT162b2 It's a better product. 2. In a bit of a surprise move, Pfizer and their partner BioNTech announced yesterday that they were moving their BNT162b2 mRNA vaccine candidate forward into Phase II/III trials. Healthy … Similarly, BNT162b1 and BNT162b2 share the same modRNA platform, RNA production and purification processes, and formulation of lipid nanoparticles . The surprise was because all the publications from this effort so far had been on another one of their four candidates, BNT162b1.. One of these, known as BNT162b1, encodes the SARS-CoV-2 receptor-binding domain (RBD), while the other, BNT162b2, encodes the SARS-CoV-2 … The surprise was because all the publications from this effort so far had been on another one of their four candidates, BNT162b1.. At up to 3 different dose levels. BNT162b2 given as a second dose in individuals prime vaccinated with ChAdOx1-S induced a robust immune response, with an acceptable and manageable reactogenicity profile. The difference is in the mRNA sequences and what's encoded. Data from phase I/II clinical trials showed BNT162b1's immunogenicity and transient mild to moderate adverse effects only (Mulligan et al., 2020). The difference between BNT162b1 and BNT162b2 is that the antigen of BNT162b1 is a trimer- ized RBD, while BNT162b2 contains the prefusion con- formation of the full-length S gene. Pfizer/BioNTech released more data about their actual coronavirus vaccine candidate, BNT162b2. In both younger and older adults, BNT162b1 and BNT162b2 elicited similar dose-dependent SARS-CoV-2–neutralizing antibody GMTs, which were substantially elevated after the … It was found that BNT162b2 was associated with a lower incidence and severity of systemic reactions compared to BNT162b1. bnt162b2 vs bnt162b1 : Related News. Both BNT162b1 and BNT162b2 looked strong as vaccine candidates • However, the totality of data favored the selection of BNT162b2 based on the following findings: A reactogenicity profile that is more favorablethan BNT162b1 in both younger and older adults Systemic events after administration of BNT162b2 were milder than those with BNT162b1. The newly released manuscript describes key safety and immunogenicity data from the U.S. In theory, BNT162b2 should be more immunogenic. No differences between the control and vaccinated groups were noted. No binding antibodies could be detected 14 or 28 days post prime vaccination ( Figure 1B ). Preliminary clinical Phase 1/2 data from nearly 120 patients demonstrated a favorable overall tolerability profile for BNT162b2, as compared to BNT162b1, with generally mild to moderate and transient (1-2 days) systemic events, such as fever, fatigue and chills and no serious adverse events. RCT Phase 2/3 Healthy SARS-CoV-2 DNA negative adults in multiple centres in Argentina, Brazil, Germany, South Africa, Turkey, and the USA N=43448 Some concerns Details: Full description. And it seems pretty clear why they went with it as opposed to the previous candidate, BNT162b1. For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B): Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline at 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, and 162±7 days after the boost immunization. BNT162b2 was selected based on the totality of available data from preclinical and clinical studies, including select immune response and tolerability parameters compared to the BNT162b1 candidate. But the candidate known as BNT162b2 missed an earlier window to be tested in China, as Fosun had rushed into Phase 1 trials of a slightly less satisfactory candidate, BNT162b1, before … It is an mRNA type of candidate vaccine based on the RNA platform. mRNA-1273 has a vaccine efficacy of 94.5% based on the 90 cases of COVID-19 in patients who received placebo and 5 cases in patients who got the coronavirus vaccine. Currently, this COVID-19 candidate vaccine is in clinical evaluation. 1. 2. In theory, BNT162b2 should be more immunogenic. The EUA request includes safety and efficacy data from an ongoing Phase 3 randomized, double-blinded and placebo-controlled trial of BNT162b2 in approximately 44,000 participants. Comment: This is the phase I, placebo-controlled, observer-blinded, dose-escalation trial conducted in the United States in which participants aged 18 - 55 or 65 - 85 were randomized to receive either placebo or one of two vaccine candidates (BNT162b1 or BNT162b2). BNT162b2 vaccinated human participants displayed a favorable breadth of epitopes recognized in T cell responses specific to the SARS-CoV-2 antigen, as compared to the BNT162b1 candidate. In all groups but one, participants received two doses, with a 21-day interval between doses; in one group (100 μg of BNT162b1), participants received one dose. A total of 195 participants underwent randomization. In each of 13 groups of 15 participants, 12 participants received vaccine and 3 received placebo. But the candidate known as BNT162b2 missed an earlier window to be tested in China, as Fosun had rushed into Phase 1 trials of a slightly less satisfactory candidate, BNT162b1, before … The severity of adverse reactions was also reduced in the older versus younger subjects. The study has been submitted to the U.K. government’s Scientific Advisory Group for Emergencies (SAGE) panel. BNT162b2 and Moderna’s COVID-19 Vaccine (mRNA-1273) protect against COVID-19-related hospitalization among adults 65 years and older, according to a new U.S. Centers for Disease Control (CDC) assessment. Immunogenicity and reactogenicity of BNT162b2 booster in ChAdOx1-S-primed participants (CombiVacS): a multicentre, open-label, randomised, controlled, phase 2 trial - The Lancet BNT162b1 is one of four advanced mRNA-based vaccines being developed through "Project Lightspeed," a joint program between Pfizer and BioNTech.1,2 BNT162b1 is a nucleoside modified mRNA (modRNA) vaccine encoding the receptor-binding domain (RBD) of the SARS-CoV-2 spike (S) protein tog… BNT162b2 vaccine induces a robust and rapid antibody response. data include evaluation of 10-µg, 20-µg, and 30-µg dose levels of BNT162b1 in 65–85 year old adults and of an additional 20-µg dose level in 18–55 year old adults. An effective vaccine is needed to halt the spread of the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic. After Dose 1, systemic events reported by participants 65 to 85 years old who received BNT162b2 were similar to those reported by those who received placebo. BioNTech SE: Pfizer and BioNTech Share Positive Early Data on Lead mRNA Vaccine Candidate BNT162b2 Against COVID-19. It is not known how well mRNA vaccines induce B and plasma cell responses in dialysis patients (DP) or kidney transplant recipients (KTR) compared to healthy controls (HC). BNT162b2-elicited sera were also able to neutralize pseudoviruses with diverse SARS-CoV-2 S variants. BNT162b2 demonstrated concurrent induction of high … In participants 65 to 85 years old, BNT162b1 elicited similar, but milder, local reactions, with mild to moderate injection site pain reported by 92% after Dose 1 and 75% after Dose 2. As for the difference between BNT162b1 and b2, the trial for b1 was discontinued because b2 was comparably effective in terms of typical neutralizing titers, with fewer side effects. BNT162b1 has been shown to be one of the more promising RNA-based vaccine candidates currently under study. NCT04368728 BioNTech SE, Pfizer Walsh E, N Engl J Med, 2020 Full text Commentary: RNA based vaccine BNT162b1 10 mcg D1/21 In the United States, the phase 1 trial was then extended to randomize healthy adults age 18 to 55 years and 65 to 85 years to receive placebo or one of the two vaccines, BNT162b1 or BNT162b2 in 2 doses. Results In both younger and older adults, the 2 vaccine candidates elicited similar dose- dependent SARS-CoV-2-neutralizing geometric mean titers (GMTs), comparable to or higher than the GMT of a panel of SARS-CoV-2 convalescent sera. BNT162b2 was associated with less systemic reactogenicity, particularly in older adults. RCT Phase 2/3 Healthy SARS-CoV-2 DNA negative adults in multiple centres in Argentina, Brazil, Germany, South Africa, Turkey, and the USA N=43448 Some concerns Details: Full description. If b1 were the only option, I have very little doubt it would have gotten an Emergency Use Authorization. In both younger and older adults, BNT162b1 and BNT162b2 elicited similar dose-dependent SARS-CoV-2–neutralizing antibody GMTs, which were substantially elevated after the … Such findings were maintained across age groups, genders and ethnic groups. The BNT162b2 vaccine was approved by regulatory agencies based on a phase 2/3 trial that randomized a total of 43 548 participants to receive 2 doses of the vaccine or a control agent at a 21-day interval. But the candidate known as BNT162b2 missed an earlier window to be tested in China, as Fosun had rushed into Phase 1 trials of a slightly less satisfactory candidate, BNT162b1, before early trials data overseas showed BNT162b2 is safer. Hui said he did not regret testing BNT162b1 without waiting for more complete data. Here we report the preclinical development of two vaccine candidates (BNT162b1 and BNT162b2) that contain nucleoside-modified messenger RNA that encodes immunogens derived from the spike glycoprotein (S) of SARS-CoV-2, formulated in lipid nanoparticles. The difference between BNT162b1 and BNT162b2 is that the antigen of BNT162b1 is a trimerized RBD, while BNT162b2 contains the prefusion conformation of the full-length S gene. Systemic events after administration of BNT162b2 were milder than those with BNT162b1. On the surface, Moderna has a slight lead on efficacy. BNT162b2. Binding and neutralizing antibody titers were slightly lower in the older subjects, but still exceeded those in a convalescent panel. Tauzin and Nayrac et al. These two candidates are BNT162b1 and BNT162b2. BNT162b2, which has advanced into a global Phase 3 study, is part of the companies’ mRNA-based vaccine development program against COVID-19. العربية; 中文 (中国) english; français; Русский; News/Update/Help The latter was ultimately advanced to phase 3 trials because it was better tolerated and represented a greater breadth of T-cell epitopes (2). With limited drug treatment options available, research on prophylactic immunization, especially for high-risk groups, became a priority [2]. A two-dose regimen of BNT162b2 (30 μg per dose, given 21 days apart) was found to be safe and 95% effective against Covid-19. In a bit of a surprise move, Pfizer and their partner BioNTech announced yesterday that they were moving their BNT162b2 mRNA vaccine candidate forward into Phase II/III trials. Methods Healthy adults 18–55 and 65–85 years of age were randomized in an ongoing, placebo-controlled, observer-blinded dose-escalation study to receive 2 doses at 21-day intervals of placebo or either of 2 lipid nanoparticle–formulated, nucleoside-modified RNA vaccine candidates: BNT162b1, which encodes a secreted trimerized SARS-CoV-2 receptor-binding domain, or BNT162b2, … In 3 age groups (18 to 55 years of age, 65 … BNT162b2 contains an mRNA that encodes the membrane-anchored full-length SARS-CoV-2 S protein. The difference between the two candidates is that the b1 vaccine encodes the RBD of the Spike domain, presented as a trimer, while the b2 is the full-length Spike with a few mutations to make it more stable. The b1 therefore has more actual RNA molecules in it than the b2, but the lipid nanoparticle formulation is the same. Two candidates of the mRNA vaccine were tested in Phase 1 trials: BNT162b1 and BNT162b2. Markedly impaired anti-BNT162b2 … In both younger and older adults, BNT162b1 and BNT162b2 elicited similar dose-dependent SARS-CoV-2–neutralizing antibody GMTs, which were substantially elevated after the … Patients with kidney failure are at increased risk for SARS-CoV-2 infection making effective vaccinations a critical need. In both younger and older adults, BNT162b1 and BNT162b2 elicited similar dose-dependent SARS-CoV-2–neutralizing antibody GMTs, which were substantially elevated after the … BNT162b1 and BNT162b2 are both nucleoside modified RNAs, formulated in lipid nanoparticles. BNT162b2 vaccinated human participants displayed a favorable breadth of epitopes recognized in T cell responses specific to the SARS-CoV-2 antigen, as compared to the BNT162b1 candidate. Phase 2/3 study of up to 30,000 participants aged 18 – 85 years started in the U.S. and expected to … The BNT162b2 mRNA encodes the same two specific proline substitutions described for mRNA-1273 above. BNT162b2. The data demonstrated a favorable overall tolerability profile for BNT162b2 when compared to BNT162b1. Non-adverse Of note this is the candidate that they bypassed as they believe 'BNT162b2' to have similar to better efficacy and safety. Before COVID‑19 vaccines, a vaccine for an infectious disease had never before been produced in less than several years, and no vaccine existed for preventing a coronavirus infection in humans. Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today shared additional Phase 1 safety and immunogenicity data from their ongoing U.S. study of the BNT162 mRNA-based vaccine program against SARS-CoV-2, which has advanced into Phase 2/3 evaluation. BNT162b1 incorporates nucleoside modified RNA and encodes the receptor domain (RBD) of the SARS-CoV-2 spike protein: of course, this is a key aim for virus-neutralizing antibodies. The difference between BNT162b1 and BNT162b2 is not dosage. Placebo. The progress of a vaccine signifies the perfect therapeutic option for the COVID-19 epidemic, but despite the development of three vaccines, it can still be a long route to normality. Conversely, the BNT162b1 candidate encodes for a secreted trimerized SARS-CoV-2 receptor-binding domain, whereas the BNT162b2 encodes for a membrane-anchored SARS-CoV-2 full-length spike, stabilized in the prefusion conformation [ 5 ]. BioNTech & Pfizer- Nature, "Phase 1/2 study of COVID-19 RNA vaccine BNT162b1 in adults". Han rats, administration of the vaccine candidates BNT162a1, BNT162b1, BNT162b2, or BNT162c1 usingintramuscular(IM) injections weekly for 2 (BNT162c1) or 3 administrations was tolerated without evidence of systemic toxicity. Pfizer Inc. and BioNTech SE announced that two of the companies’ four investigational vaccine candidates from their BNT162 mRNA-based vaccine program (BNT162b1 and BNT162b2) being developed to help protect against SARS-CoV-2 (the virus that causes COVID-19), received Fast Track designation from the U.S. Food and Drug Administration (FDA). * In a Phase 1 study in the U.S., at 7 days after a second dose of 30ug, BNT162b2 elicited SARS-CoV-2–neutralizing geometric mean titers (GMTs) in younger adults (18 … Additionally, the vaccine candidates protected macaques Global literature on coronavirus disease. Trial Objectives, Participants, and Oversight. Pfizer and BioNTech recently selected BNT162b2 as the vaccine candidate to progress to a Phase 2/3 study, which is now enrolling. characterize humoral and cellular responses 3 weeks after a single dose of mRNA BNT162b2 vaccine. BNT162b1 and BNT162b2 are both nucleoside modified RNAs, formulated in lipid nanoparticles. 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