pfizer – pharma.markets

Pfizer-BioNTech COVID-19 Vaccine Receives FDA Emergency Use Authorization for Children 6 Months through 4 Years of Age

17/06/2022 MaP 0

In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group Three 3-µg doses had favorable safety […]

Pfizer and BioNTech Initiate Rolling Submission for Emergency Use Authorization of Their COVID-19 Vaccine in Children 6 Months Through 4 Years of Age Following Request from U.S. FDA

01/02/2022 MaP 0

With pediatric COVID-19 cases surpassing 10 million and at the request of the FDA, the companies have submitted available data on the safety and efficacy […]

Pfizer and BioNTech Sign New Global Collaboration Agreement to Develop First mRNA-based Shingles Vaccine

06/01/2022 MaP 0

Third mRNA vaccine collaboration between the companies aims to accelerate development of an improved vaccine for shingles, a debilitating, disfiguring and painful disease that affects […]

Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster for Individuals 12 Years of Age and Older

03/01/2022 MaP 0

First emergency use authorization in the United States for a COVID-19 vaccine booster in adolescents 12 through 15 years of age Today’s FDA action also […]

Pfizer and BioNTech Submit Updated Longer-Term Follow-Up Data of COMIRNATY® in Adolescents 12 Through 15 Years of Age to EMA

23/12/2021 MaP 0

In the trial, a two-dose series of COMIRNATY (30-µg per dose) was 100% effective (95% confidence interval [CI, 87.5, 100.0]) against COVID-19, measured seven days […]

Pfizer And BioNTech Submit Supplemental Biologics License Application for U.S. FDA Approval of COMIRNATY® in Adolescents 12 Through 15 Years of Age

17/12/2021 MaP 0

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and […]

Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster for Individuals 16 Years and Older

10/12/2021 MaP 0

PDF Version First emergency use authorization in the United States for a COVID-19 vaccine booster in individuals 16 years and older Pfizer Inc. (NYSE: PFE) […]

Pfizer and BioNTech Provide Update on Omicron Variant

09/12/2021 MaP 0

Preliminary laboratory studies demonstrate that three doses of the Pfizer-BioNTech COVID-19 Vaccine neutralize the Omicron variant (B.1.1.529 lineage), while two doses show significantly reduced neutralization […]

Pfizer and BioNTech Receive Positive CHMP Opinion for COMIRNATY® in Children 5 to under 12 Years of Age in the European Union

25/11/2021 MaP 0

Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the […]

Pfizer and BioNTech Submit Request to Amend U.S. FDA Emergency Use Authorization of Their COVID-19 Vaccine Booster to Include All Individuals 18 and Older

10/11/2021 MaP 0

Submission is based on efficacy and safety data from a Phase 3 randomized, controlled trial with more than 10,000 participants Data show a favorable safety […]

Pfizer And BioNTech to Provide U.S. Government an Additional 50 Million Pediatric Doses of COVID-19 Vaccine to Support Further Preparedness for Future Needs

28/10/2021 MaP 0

PDF Version Doses expected to be delivered by April 2022 Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. government […]

Pfizer and BioNTech Announce Submission of Initial Data to U.S. FDA to Support Booster Dose of COVID-19 Vaccine

16/08/2021 MaP 0

Phase 1 safety and immunogenicity data in individuals who received a third dose of the Pfizer-BioNTech vaccine (BNT162b2) show a favorable safety profile and robust […]