Pfizer Inc. and BioNTech SE on Monday said they have submitted Phase 1 data to the U.S. Food and Drug Administration to support the evaluation of a booster dose of their Covid-19 vaccine.
The partners said individuals in the study who received a third dose showed a favorable safety profile and robust immune responses, with the booster dose eliciting significantly higher neutralizing antibody titers against the initial SARS-CoV-2 virus, as well as the Beta and Delta variants, compared to levels seen after the two-dose primary series.
Pfizer and BioNTech said a booster dose given within six to 12 months after the primary vaccination schedule may help maintain a high level of protection against Covid-19, and that they plan to seek FDA approval of a third dose in individuals ages 16 and older.
Amid a surge in Covid-19 cases tied to the Delta variant, the FDA last week authorized booster shots for certain people with weakened immune systems, and the agency said it was reviewing whether an additional dose may be needed in other people who are fully vaccinated.
Pfizer and BioNTech said they plan to file the Phase 1 study data to the European Medicines Agency and other regulatory authorities in the coming weeks, adding that they shortly expect Phase 3 results evaluating the third dose, which they will also submit to regulators around the world.
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