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Pfizer and Valneva Issue Update on Phase 3 Clinical Trial Evaluating Lyme Disease Vaccine Candidate VLA15

Pfizer

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

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Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Adapted Bivalent Vaccine Candidate

Pfizer

1 Adapted Bivalent Vaccine Candidate. 1 Adapted Bivalent Vaccine Candidate. 1 sub-lineage, for individuals 12 years of age and older. 1 as compared to the companies’ current COVID-19 vaccine. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of the vaccine.

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Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design

Pfizer

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level. Emergency Use Authorization .

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Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®

Pfizer

The submission included data from a Phase 2/3 randomized, controlled trial that included 4,526 children 6 months to less than 5 years of age. In the trial, children received the third 3-µg dose at least two months after the second dose at a time when Omicron was the predominant variant. About the Phase 1/2/3 Trial in Children.

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Pfizer and BioNTech Announce U.S. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age

Pfizer

Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial. Food and Drug Administration (FDA) approved the companies’ supplemental Biologics License Application (sBLA) for their COVID-19 vaccine, known as COMIRNATY® (COVID-19 Vaccine, mRNA), to include individuals 12 through 15 years of age.

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Advisory Committee on Immunization Practices Recommends Pfizer’s PREVNAR 20® for Adults Previously Vaccinated with PREVNAR 13®

Pfizer

With more than 26 million adults over the age of 19 who have been previously vaccinated with PREVNAR 13®, today’s ACIP vote recognizes the importance of helping to protect them against the seven additional serotypes contained in PREVNAR 20®,” said Angela Hwang, President, Global Biopharma Business, Pfizer.

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Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19

Pfizer

Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19. Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19. About the Phase 1 Study . Wed, 11/02/2022 - 15:44. INDICATION.