Pfizer and BioNTech announced late Thursday that they have seen encouraging data in the ongoing booster trial of a third dose of their COVID-19 vaccine. Initial data from the study demonstrate that a booster dose given six 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, the company said in a statement.
The company added that they expect “to publish more definitive data soon” as and “plan to submit the data to the FDA, (Food and Drug Administration) … and other regulatory authorities in the coming weeks.” While the companies believe a third dose “has the potential to preserve the highest levels of protective efficacy against all currently known variants including Delta, the companies are remaining vigilant and are developing an updated version of the Pfizer-BioNTech COVID-19 vaccine that targets the full spike protein of the Delta variant.”
The Company anticipates the clinical studies “to begin in August, subject to regulatory approvals.” “Based on the totality of the data we have to date, that a third dose may be needed within 6 to 12 months after full vaccination,” they noted. The company stressed, “While protection against severe disease remained high across the full six months, a decline in efficacy against symptomatic disease over time and the continued emergence of variants are expected.” “Based on the totality of the data they have to date, Pfizer and BioNTech believe that a third dose may be beneficial to maintain the highest levels of protection,” the statement affirmed.
CDC Director Dr. Rochelle Walensky warned earlier today that this week, Delta “is estimated to be the most prevalent variant in the United States, representing over 50 percent of sequence samples across the country.”
Source-KUNA