Pfizer and BioNTech to submit EUA application for COVID-19 vaccine booster shot

July 12, 2021

Pfizer and BioNTech plan to submit an application for emergency use authorization (EUA) to the U.S. Food and Drug Administration (FDA) for their COVID-19 booster vaccine candidate, according to a news release from BioNTech.

“Pfizer and BioNTech have seen encouraging data in the ongoing booster trial of a third dose of the current BNT162b2 vaccine,” said the companies, adding that they plan to publish results in peer-reviewed journal.  “Initial data from the study demonstrate that a booster dose given 6 months after the second dose has a consistent tolerability profile while eliciting high neutralization titers against the wild type and the Beta variant, which are 5 to 10 times higher than after two primary doses.”

Pfizer and BioNTech also said they are developing an updated version of the Pfizer-BioNTech COVID-19 vaccine that targets the full spike protein of the Delta variant. The first batch of the mRNA for the trial has already been manufactured at BioNTech’s facility in Mainz, Germany. The Companies anticipate the clinical studies to begin in August, subject to regulatory approvals.

Separately, the FDA and the Centers for Disease Control and Prevention (CDC) issued a statement designed to assure vaccinated Americans that they are protected from COVID-19. The statement may have been prompted by the news from the pharmaceutical companies about the upcoming EUA application.

In the statement, the agencies said, “Americans who have been fully vaccinated do not need a booster shot at this time. FDA, CDC, and NIH (National Institutes of Health) are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary. This process takes into account laboratory data, clinical trial data, and cohort data – which can include data from specific pharmaceutical companies but does not rely on those data exclusively.”

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