Pfizer and German partner BioNtech said on Monday they had submitted initial data from an early stage trial to U.S. regulators as part of an application seeking authorization of a booster dose of their COVID-19 vaccine.
The data will also be submitted to the European Medicines Agency (EMA) and other regulatory authorities in the coming weeks, the drugmakers said.
In the trial, the third dose elicited significantly higher neutralizing antibodies against the initial SARS-CoV-2 virus compared to the levels observed after the two-dose primary series, as well as against the Beta variant and the highly infectious Delta variant.
All patients received the third shot of the vaccine, BNT162b2, eight to nine months after receiving the second dose.
Results from a late-stage trial evaluating the third dose are expected shortly and will be submitted to the U.S. Food and Drug Administration (FDA), the EMA and other regulatory authorities worldwide, the companies said.
Last week, U.S regulators authorized a third dose of COVID-19 vaccines by Pfizer Inc-BioNTech and Moderna for people with compromised immune systems who are likely to have weaker protection from the two-dose regimens.
