BNT162b1 / Fosun Pharma, BioNTech, Pfizer - LARVOL DELTA

A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-19 in Healthy and Immunocompromised Adults (clinicaltrials.gov) - P1/2 | N=512 | Completed | Sponsor: BioNTech SE | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4

MINIMAL CHANGE DISEASE FOLLOWING THE SECOND DOSE OF PFIZER-BIONTECH (BNT162B1) FOR SARS-COV-2. COINCIDENCE OR CAUSALITY? (ISN-WCN 2024) - "This is a potential adverse effect that should be considered in patients who have been vaccinated in the past weeks and develop nephrotic syndrome. Given the low incidence of its presentation and the benefit that vaccination provides to the population, it is recommended to continue with vaccination worldwide."

Dyslipidemia • Glomerulonephritis • Hepatitis B • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Lupus Nephritis • Metabolic Disorders • Novel Coronavirus Disease • Oncology • Respiratory Diseases

A web-based genome-wide association study reveals the susceptibility loci of common adverse events following COVID-19 vaccination in the Japanese population. (PubMed, Sci Rep) - "To prevent its spread, mRNA-based vaccines made by Pfizer/BioNTech (BNT162b1) and Moderna (mRNA-1273) have been widely used, including in Japan. Our results may enable the preparation and management of adverse effects by identifying the susceptibility to these adverse events. Furthermore, we obtained valuable data that may lead to a better understanding of the mechanisms of action of the COVID-19 mRNA vaccines."

Adverse events • Journal • Infectious Disease • Musculoskeletal Pain • Novel Coronavirus Disease • Pain • Respiratory Diseases • HLA-DQA1

Frequency And Factors Associated With Adverse Reactions After Administration of Inactivated COVID-19 Vaccine Among Health Workers. (PubMed, Rev Soc Bras Med Trop) - "The evaluation of both systemic and local side effects revealed no significant adverse reactions to the inactivated CoronaVac vaccine (Sinovac Life Sciences, Beijing, China). Our study found that the incidence of systemic and local adverse responses to the CoronaVac vaccination was lower than the rates reported in studies involving the recombinant adenovirus type-5, BNT162b1, and ChAdOx1nCoV-19 COVID-19 vaccines, all of which underwent the World Health Organization LULUC/PQ evaluation process."

Journal • Fatigue • Infectious Disease • Novel Coronavirus Disease • Pain

COVID-19 vaccination exacerbates ex vivo IL-6 release from isolated PBMCs. (PubMed, Sci Rep) - "Ex vivo culturing of isolated PBMCs from individuals vaccinated with the coronavirus disease 2019 (COVID-19) vaccine BNT162b1 revealed a pronounced T cell response in the presence of the receptor binding domain (RBD) of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein...In contrast, LPS-induced ex vivo IL-6 and IL-10 secretions were not affected by vaccination status, as were plasma IL-6 concentrations, complete blood counts, salivary cortisol and α-amylase, cardiovascular measures and psychosomatic health. In summary, our findings are of relevance for many clinical studies ran before/during the pandemic, clearly indicating that consideration of participants' vaccination status is critical, at least when assessing ex vivo PBMC functionality."

Journal • Preclinical • Cardiovascular • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL10 • IL6

Toxicological Assessments of a Pandemic COVID-19 Vaccine-Demonstrating the Suitability of a Platform Approach for mRNA Vaccines. (PubMed, Vaccines (Basel)) - "These findings were generally attributed to the anticipated immune and inflammatory responses to the vaccines, except for hepatocyte vacuolation, which was interpreted to reflect hepatocyte LNP lipid uptake, was similar between candidates and resolved or partially recovered at the end of the recovery phase. These studies demonstrated safety and tolerability in rats, supporting SARS-CoV-2 mRNA-LNP vaccine clinical development."

Journal • Hematological Disorders • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases

Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals (clinicaltrials.gov) - P2/3 | N=47079 | Completed | Sponsor: BioNTech SE | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

The impact of COVID-19 vaccines on male semen parameters: A retrospective cohort study (Fertility 2023) - " Out of 46 patients included in the study, 29 (63%) received the Pfizer-BioNTech (BNT162b1), 16 (34.8%) the Johnson and Johnson (JNJ-78436735/Ad26.COV2S), and 1 (2.2%) the AstraZeneca (AZD1222) (2.2%) vaccines. There is no evidence of a negative impact of COVID-19 vaccination on male semen parameters, which is consistent with the emerging literature on COVID-19 vaccination and male fertility. Hence, COVID-19 vaccinations should not be dismissed based on fear of adverse effects on male fertility parameters."

Retrospective data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Humoral Response After SARS-CoV-2 Vaccination in Kidney Transplant Recipients: Role of Immunosuppression Therapy. (PubMed, Transplant Proc) - "The humoral response to the COVID-19 vaccine in kidney transplant recipients is poor. Factors related with this lack of immunity are recipient age and diabetes, plus MMF therapy, whereas mTORi therapy was associated with a better response to vaccination."

Journal • Diabetes • Hepatology • Infectious Disease • Metabolic Disorders • Novel Coronavirus Disease • Respiratory Diseases • Transplantation

Correlation between post-vaccination titres of anti-Spike antibodies and protection against breakthrough SARS-CoV-2 infection in 7530 UK adults (ERS 2022) - "Findings: Between Jan 12, 2021, and Jan 31, 2022, 300 (4.0%) of 7530 participants reported a breakthrough SARS-CoV-2 infection during 18 weeks of follow-up (220 [4.4%] ChAdOx1 nCoV-19 [ChadOx1] recipients and 75 [3.1%] BNT162b2 recipients). Anti-S IgGAM titres correlate with protection against SARS-CoV-2 infection in vaccinated adults, but exposure factors contribute significantly to risk."

Clinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Innate immune responses to three doses of the BNT162b2 mRNA SARS-CoV-2 vaccine. (PubMed, Front Immunol) - "To explore the effects of SARS-CoV-2-mRNA vaccines on innate immune responses we enrolled 58 individuals who received 3 doses of the BNT162b2 vaccine in a longitudinal study; 45 of these individuals had never been SARS-CoV-2 infected. Notably, ILT-2 expressing NK cells were reduced even more robustly in COVID-19-recovereed vaccines. BNT162b1 mRNA vaccine is known to induce potent adaptive immune responses; results herein show its ability to modulate innate immune responses as well, offering further support to the indication to proceed with worldwide vaccination efforts to end the SARS-CoV-2 pandemic."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • NCAM1

Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals (clinicaltrials.gov) - P2/3 | N=46953 | Active, not recruiting | Sponsor: BioNTech SE | Trial completion date: Feb 2024 ➔ Feb 2023 | Trial primary completion date: Feb 2024 ➔ Feb 2023

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Carotid free-floating thrombus during COVID-19 vaccine era: causality or not? (PubMed, Neurol Sci) - "Herein, we present three patients with ischemic stroke caused by carotid FFT after less than 20 days from administration of mRNA vaccine BNT162b1 (Pfizer/BioNTech) for Severe Acute Respiratory Syndrome-CoronaVirus 2 (SARS-CoV-2). To our knowledge, these are the first cases reporting carotid FTT following SARS-CoV-2 vaccination."

Journal • Cardiovascular • Infectious Disease • Ischemic stroke • Novel Coronavirus Disease • Respiratory Diseases • Thrombosis

Comparison of immune activation of the COVID vaccines: ChAdOx1, BNT162b2, mRNA-1273, BBIBP-CorV, and Gam-COVID-Vac from serological human samples in Hungary showed higher protection after mRNA-based immunization. (PubMed, Eur Rev Med Pharmacol Sci) - "RNA-based vaccines induced the most robust adaptive immune activation against SARS-CoV-2 by promoting a significantly higher T-cell response, anti-spike IgG and neutralization levels. Vector-based vaccines protected against the virus at a comparable level to convalescent patients."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals (clinicaltrials.gov) - P2/3 | N=46949 | Active, not recruiting | Sponsor: BioNTech SE | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immune Persistence and Safety After SARS-CoV-2 BNT162b1 mRNA Vaccination in Chinese Adults: A Randomized, Placebo-Controlled, Double-Blind Phase 1 Trial. (PubMed, Adv Ther) - P1 | "This study showed BNT162b1 maintains a favorable safety profile in younger and older participants in the 6 months after vaccination. This study further extends our understanding of immune persistence and the safety of the BNT162b1 vaccine as a candidate vaccine in the BioNTech pipeline."

Journal • P1 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Longevity of immunity following COVID-19 vaccination: a comprehensive review of the currently approved vaccines. (PubMed, Hum Vaccin Immunother) - "Each one of the AZD1222, Ad26.COV2.S, mRNA-1273 mediates T-cell response immunity at days 14-22, 15, and 43 after the first dose, respectively. Whereas for the BNT162b1 and BNT162b2 vaccines, T-cell immunity is induced 7 days and 12 weeks after the booster dose, respectively."

Journal • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

"CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021 https://t.co/4SpUE6GxvY" (@Templariusz6)

Adverse events

Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals (clinicaltrials.gov) - P2/3 | N=43998 | Recruiting | Sponsor: BioNTech SE | Trial completion date: May 2023 ➔ Feb 2024 | Trial primary completion date: May 2023 ➔ Feb 2024

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

"5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021 Dit is van Pfizer zelf." (@ThePixelChick70)

Adverse events

A Phase 2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of SARS CoV-2 RNA Vaccine Candidate (BNT162b2) Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older Estudio fase 2/3 para evaluar la seguridad, la tolerabilidad y la inmunogenicidad de una vacuna candidata de ARN (BNT162b2) del SARS‑CoV-2, contra COVID-19 en mujeres embarazadas sanas de 18 años de edad y... (clinicaltrialsregister.eu) - P2/3 | N=4000 | Ongoing | Sponsor: BioNTech SE

New P2/3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-2019 in Healthy and Immunocompromised Adults (clinicaltrials.gov) - P1/2; N=512; Active, not recruiting; Sponsor: BioNTech SE; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4

Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals (clinicaltrials.gov) - P2/3; N=43998; Recruiting; Sponsor: BioNTech SE; Phase classification: P3 ➔ P2/3

Clinical • Phase classification • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy Subjects (clinicaltrials.gov) - P1; N=144; Completed; Sponsor: BioNTech SE; Active, not recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • PCR

[VIRTUAL] A RARE CASE OF INTERNAL JUGULAR VEIN THROMBOSIS AFTER MRNA COVID-19 VACCINE (CHEST 2021) - "BNT162b1/BNT162b2 mRNA vaccines have been introduced to the world and early studies reported no safety profile against thrombotic events [1,3]...CASE PRESENTATION: 38-year-old with history of opioid abuse on suboxone received his first BNT162b2 mRNA vaccine on April 18, 2021... The adenovirus SARS-CoV-2 vaccine recently became associated with pathologic thrombosis and, although rare, thrombosis may also be a complication of the mRNA vaccines. Close monitoring and possible prophylactic treatment may be considered in patients receiving these vaccines who are at high risk for thrombosis."

Clinical • Cardiovascular • Hematological Disorders • Infectious Disease • Inflammation • Novel Coronavirus Disease • Oncology • Pain • Pulmonary Disease • Respiratory Diseases • Thrombosis • Venous Thromboembolism