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Pfizer And Biontech To Submit Initial Data To FDA To Support Booster Dose Of COVID-19 Vaccine

Published: 08/16/2021 15:42 GMT
BioNTech SE - ADR (BNTX) - Pfizer and Biontech Announce Submission of Initial Data to U.S. FDA to Support Booster Dose of Covid-19 Vaccine.
Phase 1 Safety and Immunogenicity Data in Individuals Who Received a Third Dose of Pfizer-biontech Vaccine (bnt162b2) Show a Favorable Safety Profile and Robust Immune Responses.
Booster Dose Elicited Significantly Higher Neutralizing Antibody Titers Against Initial Sars-cov-2 Virus (wild-type), and Beta and Delta Variants, Compared to Levels Observed After Two-dose Primary Series.
After Booster Dose, Neutralizing Titers for Variants Were Similar to Wild-type.
Given High Levels of Immune Responses Observed, a Booster Dose Given Within 6 to 12 Months After Primary Vaccination Schedule May Help Maintain a High Level of Protection Against Covid-19.
These Data Also Will Be Submitted to European Medicines Agency (ema) and Other Regulatory Authorities in Coming Weeks.