Pfizer-BioNTech Seeks FDA Authorisation for 3rd COVID Shot

Pfizer and BioNTech have recently announced that they would seek regulatory authorization for a third dose of their Covid-19 vaccine. The decision was taken based on drop-offs in efficacy seen in Israel after six months. The companies believe people may need a third dose within 6 to 12 months after full vaccination. Initial data from an ongoing trial revealed that a third shot pushed antibody levels five to 10 times higher against the original coronavirus strain and the Beta variant, first found in South Africa, compared to the first two doses alone.

The companies expect to publish more definitive data soon and in a peer-reviewed journal and plan to submit the data to the FDA, EMA, and other regulatory authorities in the coming weeks.

In addition, the companies expect that a third dose will perform similarly well against the highly virulent Delta strain, which is quickly becoming globally dominant.

Out of caution, the companies are also developing a Delta-specific vaccine, and they also anticipate the clinical studies will begin in August, subject to regulatory approvals.

While protection against severe disease remained high across the entire six months, a decline in efficacy against symptomatic illness over time and the continued emergence of variants are expected. The FDA and US CDC released a joint statement saying that they are studying “whether or when a booster might be necessary.”

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