Plain language summary of Pfizer-BioNTech BNT162b2 vaccine protection against COVID-19 and its safety in participants 12- to 15-years-old

What is this summary about? This is a summary of an article about part of a clinical study for the BNT162b2 COVID-19 vaccine, also called the Pfizer-BioNTech vaccine. The article was published in the New England Journal of Medicine in May 2021. This summary describes how the vaccine worked in participants 12- to 15-years old. The part of the study described in the article is ongoing and expected to finish March 2023. This means that the final results may be different from the results included in this summary. What happened in this study? The part of the study described in this summary included participants 12- to 15-years old who had no serious health issues. The BNT162b2 vaccine had already been studied in participants 16 years of age or older. In this part of the study, the researchers wanted to find out: * How effective and safe the vaccine was in participants 12- to 15-years old. * What the immune response to the vaccine and the vaccine safety were like in 12- to 15-year-olds compared with 16- to 25-year-olds. * How well the vaccine prevented SARS-CoV-2 infections in participants who received the vaccine compared to those who did not. This is also called efficacy of the BNT162b2 vaccine Half of the participants in this study received 2 injections of the BNT162b2 vaccine and half received 2 injections of a placebo in a muscle of the upper arm. The placebo looked like the BNT162b2 vaccine but did not have any active vaccine in it. What were the results? * BNT162b2 had a favorable safety profile. The most common reactions were pain at the injection site, fatigue, and headache. None of the participants had serious reactions to the vaccine. * The 12- to 15-year-old participants' immune system responses to the BNT162b2 vaccine were as good as or stronger than the 16- to 25-year-old participants' immune responses. * The participants who received the BNT162b2 vaccine were less likely to get COVID-19 compared with the participants who got the placebo.Copyright © 2023 The Authors.

Plain language summary of Pfizer-BioNTech BNT162b2 COVID-19 vaccine safety in participants 16 years or older and protection against COVID-19 in participants 12 years or older

What is this summary about?This is a summary of an article about part of a clinical study for the BNT162b2 COVID-19 vaccine, also called the Pfizer-BioNTech vaccine. The article was published in the New England Journal of Medicine in September 2021. The part of the study described in the article began in July 2020 and is ongoing. This means that the final results may be different from the results included in this summary.What happened in this study?The participants in this study received 2 injections of either the BNT162b2 vaccine or a placebo, 21 days apart. The placebo looked like the BNT162b2 vaccine but had no active vaccine in it. None of the trial participants or study teams knew who received vaccine or placebo.What were the results?Most of the reactions to the injections were mild or moderate and lasted for a short period of time. The most common reactions were pain at the injection site, extreme tiredness (fatigue), and headache. These reactions usually happened in the first 7 days after receiving a vaccine dose. A small number of participants had severe reactions to the vaccine.Compared to participants who received the placebo, participants who received the BNT162b2 vaccine were much less likely to become ill if they were infected with the virus that causes COVID-19. The vaccine also had very good efficacy at preventing severe COVID-19.Participants in South Africa who received the BNT162b2 vaccine were less likely to become ill after infection with the beta variant of the virus compared to participants who received the placebo. The beta variant was very common in South Africa when the study was taking place.

Efficacy And Safety Of Bivalent Respiratory Syncytial Virus (RSVpreF) Vaccine In Older Adults

Background. Respiratory syncytial virus (RSV) is an important cause of disease in older adults and is associated with high morbidity and mortality, especially in those with high-risk conditions. Illness can vary from mild upper respiratory tract symptoms to more severe lower respiratory tract disease. After over 50 years of research, there is now hope for an RSV vaccine for any population, including older adults. An investigational bivalent RSV A and B, stabilized RSV prefusion F subunit vaccine (RSVpreF) was assessed successfully in a pivotal phase 3 efficacy study in older adults. (NCT05035212). Methods. The primary efficacy objective of this Phase 3, global, multicenter, randomized, double-blinded, placebo-controlled study was to evaluate the prevention of RSV associated lower respiratory tract illness (LRTI-RSV) in up to 40,000 adults >=60 years of age during the first winter season (September 2021-June 2022). Two primary endpoints were tested sequentially - LRTI-RSV with >=2 and >=3 symptoms. A pre-planned efficacy interim analysis (IA) was to be conducted by an external Data Monitoring Committee (DMC) upon accrual of at least 29 cases of LRTI-RSV with >=2 symptoms. With efficacy demonstrated for cases with >=2 symptoms and sufficient cases with >= 3 symptoms accrued, an efficacy analysis of cases with >= 3 symptoms was to be conducted. The ongoing study is collecting additional safety and descriptive efficacy data. Results. At the time of the IA, approximately 34,000 participants received either RSVpreF 120 mug (60 mug each of RSVpreF from RSV A and RSV B) or placebo (1:1 randomization). Forty-four LRTI-RSV cases with >=2 symptoms were accrued with 11 cases in the RSVpreF group and 33 cases in the placebo group corresponding to a VE of 66.7% (96.66% CI: 28.8%, 85.8%). Sixteen LRTI-RSV cases with >=3 symptoms were accrued with 2 cases in the RSVpreF group and 14 cases in the placebo group corresponding to a VE of 85.7% (96.66% CI: 32.0%, 98.7%). The investigational vaccine was well-tolerated with no safety concerns. Conclusion. Despite unpredictable RSV activity due to the COVID-19 pandemic, the primary objective of the study was met demonstrating that RSVpreF had a favorable safety profile and was highly efficacious in preventing LRTI-RSV with >=2 symptoms and >=3 symptoms in older adults 60 years and older.

Physical fitness and habitual physical activity in children with cystic fibrosis - do they improve with elexacaftor/tezacaftor/ivacaftor therapy?

Objectives: The aim of this ongoing longitudinal study is to examine the effects of elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) on aspects of physical fitness (PF, strength endurance, explosive power, coordination under time pressure, coordination for the precision aspect, trunk flexibility, peak workload, habitual physical activity (HPA, steps/day, intensity), and zscores of FEV1 and BMI in children with cystic fibrosis (CF)). All children have been receiving ELX/TEZ/IVA for 19.2 ± 10.4 (11–33) months. Methods: Six children with CF agreed to participate (3f/3 m) mean age 13 ± 4yrs (9–17 yrs), FEV1 z-score − 1.017 ± 1.817 (-3.2–0.8). PFwas assessed using 5 test items at baseline and 4.51 ± 0.98 years later;strength endurance (PU push-ups, SU sit-ups), explosive power (SLJ standing long jump), coordination under time pressure (JSS jumping side to side), coordination for the precision aspect (BB balancing backward on beams), and trunk flexibility (FB, forward bend). Cycle-ergometry (Godfrey-protocol) was used to determine Wpeak. Lung function was measured by spirometry. Results: Significant improvements were seen in test items representing strength endurance (PU, SU) and coordination under time pressure (JSS) (p < .05). Although HPA expressed as steps/day remained the same, thetime of moderate to vigorous intensity of HPA decreases significantly (p < .05). A slight, not significant, improvement of BMI Z-score was observed (p > .05). No or small changes could be observed for the parameter FEV1 z-score, Wpeak, PF, SLJ, BB and FB (p > 0.05). Conclusion: ELX/TEZ/IVA therapy seems to be a facilitator to increase some aspects of PF. The decrease in intensity of HPA is possibly an effect of the COVID-19 Pandemic that has already been described in healthy and asthmatic children. In this ongoing study, we assume that clearer effects will be shown with a greater number of children included. However, ELX/ TEZ/IVA enhanced muscle strength endurance in children with CF.

COVID-19 vaccine in participants (ptcpts) with cancer: Subgroup analysis of efficacy/safety from a global phase III randomized trial of the BNT162b2 (tozinameran) mRNA vaccine

Background: Patients with cancer are at higher risk of developing COVID-19 disease, adverse outcomes, and increased mortality. Phase III COVID-19 vaccine trials have demonstrated safety/efficacy against COVID-19 and prevented hospitalizations and deaths;however, most excluded ptcpts with cancer. We present phase 3 tozinameran mRNA COVID-19 vaccine trial results from ptcpts with a cancer history at baseline, either ongoing or not, per the Charlson Comorbidity Index and up to 6 months of follow-up. Methods: Between Jul 2020-Jan 2021, 46429 ptcpts ≥12 y at 152 sites in 6 countries were randomized in a placebo-controlled, observer-blinded trial of 2-dose tozinameran, showing 95% protection against COVID-19 and favorable safety (Polack et al NEJM, Dec 2020). After emergency use authorization, ptcpts were allowed to unblind and placebo recipients received vaccine. Data prior to unblinding for crossover up to 13 Mar 2021 are presented for ptcpts ≥16 y for safety and ≥12 y for efficacy. Adverse event (AE) data are controlled for follow-up time before unblinding and reported as incidence rate (IR) per 100-person-y of follow-up. Results: Of ptcpts ≥16 y, 1647 had a prior diagnosis of cancer and were not on active immunosuppressive treatment (755 M;892 F;median age 66 y [range 22-91]). Most common solid cancers included breast (n=458), prostate (n=360), and melanoma (n=210). AEs were reported at IRs of 94.0 (vaccine) and 49.3 (placebo) per 100-person-y;most common AEs were reactogenicity events (injection-site pain [IR: 40.2 vaccine;4.2 placebo];fatigue [IR: 21.4 vaccine;7.6 placebo];pyrexia [IR: 19.8 vaccine;0.7 placebo]). 1 vaccine ptcpt withdrew due to a vaccine-related AE. No vaccine-related deaths were reported. Among ptcpts ≥12 y with cancer, 3 vaccine and 27 placebo recipients developed COVID-19 from 7 days post-Dose 2;vaccine efficacy (VE) was 89.7% (95% CI 66.5-98.0%). This compares favorably with overall VE of 91.1%. Updated results will be presented. Conclusions: Tozinameran has similar efficacy/safety in ptcpts with cancer as in the overall population. These results inform tozinameran use in COVID-19 and in future trials in patients with cancer. Clinical trial identification: NCT04368728. Editorial acknowledgement: Editorial assistance was provided by Erin Bekes, PhD, of CMC AFFINITY, McCann Health Medical Communications, and was funded by Pfizer. Legal entity responsible for the study: Study sponsored by BioNTech, managed by Pfizer. Funding: Pfizer and BioNTech. Disclosure: S.J. Thomas: Financial Interests, Personal and Institutional, Research Grant, Advisory role: Pfizer. J.L. Perez: Financial Interests, Personal, Full or part-time Employment, Stocks/Shares: Pfizer. S.P. Lockhart: Financial Interests, Personal, Full or part-time Employment, Stocks/Shares: Pfizer. S. Hariharan: Financial Interests, Personal, Full or part-time Employment, Stocks/Shares: Pfizer. N. Kitchin: Financial Interests, Personal, Full or part-time Employment, Stocks/Shares: Pfizer. R. Bailey: Financial Interests, Personal, Full or part-time Employment, Stocks/Shares: Pfizer. K. Liau: Financial Interests, Personal, Full or part-time Employment, Stocks/Shares: Pfizer. E. Lagkadinou: Financial Interests, Personal, Full or part-time Employment: BioNTech. Ö. Türeci: Financial Interests, Personal, Research Grant: BioNTech. U. Şahin: Financial Interests, Personal, Research Grant: BioNTech. X. Xu: Financial Interests, Personal, Full or part-time Employment, Stocks/Shares: Pfizer. S.S. Dychter: Financial Interests, Personal, Full or part-time Employment, Stocks/Shares: Pfizer. C. Lu: Financial Interests, Personal, Full or part-time Employment: Pfizer. W. Gruber: Financial Interests, Personal, Full or part-time Employment, Stocks/Shares: Pfizer. All other authors have declared no conflicts of interest.