Pfizer and BioNTech clinical studies for a new COVID-19 RNA Booster Dose

A phase 2 study on an improved version of the mRNA vaccine developed by two businesses has started.
Pfizer and BioNTech advance COVID-19 Vaccine Strategy with studies  of “Next-Generation ” vaccine candidate based on enhanced spike protein design.
This is the first of several enhanced-design vaccine candidates that the companies intend to assess as part of a long-term, scientific COVID-19 vaccine strategy in order to potentially stimulate immune responses that are more powerful, longer-lasting, and broader against SARS-CoV-2 infections and linked COVID-19.
BNT162b5 will be evaluated in a U.S.-based study enrolling approximately 200 participants aged between 18 and 55 who have received one booster dose of a U.S.-authorized COVID-19 vaccine at least 90 days prior to their first study visit.
Enhanced profusions spike protein for SARS Cov-2 strains and the Omicron variant are incorporated in the bivalent vaccine BNT162b5.
Estimated Study Completion Date ICMJE : January 26, 2023

Emergency Use Authorization 
Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in individuals 6 months of age and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

On July 28 2022,Strong financial results for the second quarter of 2022 were published by Pfizer Inc. (NYSE: PFE), and several elements of the financial outlook for 2022 were updated. Despite negative effects from foreign exchange, Pfizer maintained its prior revenue estimate for 2022. It also reaffirmed its revenue projection for Paxlovid, its oral COVID-19 therapy, and Comirnaty, the COVID-19 vaccine produced by Pfizer-BioNTech SE (BioNTech).


Source Pfizer