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Pfizer-BioNTech submit initial data for Covid vaccine booster authorisation

The drugmakers Pfizer Inc and its German partner BioNTech SE have submitted to U.S. regulators the initial data from an early-stage trial toward seeking authorization of a booster dose of their COVID-19 vaccine, they said on Monday. Compared to the two previous doses, the third dose had significantly higher neutralizing antibodies against the initial SARS-CoV-2 virus as well as against the Beta and highly infectious Delta variants.

Study results show that Pfizer’s vaccine efficacy falls over time, showing that 84% efficacy drops from 96% after four months of a second dose. Several countries, including Israel, have already begun to administer booster doses. However, some rich countries are buying booster shots, drawing the ire of health activists who have called for the World Health Organization to halt booster sales until at least the end of September. It was reported by Pfizer and BioNTech that all patients in the trial received BNT162b2 eight to nine months after their second dose.

In the coming weeks, the drugmakers will submit the trial data to the European Medicines Agency and other regulatory agencies. Results from a late-stage trial of the third dose are expected soon, they said.

In the last week, U.S. regulators approved a third dose of COVID-19 vaccines by Pfizer-BioNTech and Moderna Inc for people with compromised immunity who will have weaker protection from two doses.

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