Biontech and Pfizer submit data for booster to FDA

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German company Biontech and its U.S. partner Pfizer have submitted initial data for approval of a booster vaccine against coronavirus to the U.S. Food and Drug Administration. In the coming weeks, these data from a Phase 1 trial should also be submitted to the European Medicines Agency (EMA) and other authorities, the companies announced yesterday. Additional data are expected to follow.

Participants in the Phase 1 trial would have received a booster vaccination eight to nine months after the second dose. Compared with a two-dose vaccination, the study found “significantly higher neutralizing antibody titers” in people who received booster shots – against both the original virus and the delta variant, among others.

Last week, the FDA had already approved a booster vaccine for people with weakened immune systems. More than half of the population of around 330 million people in the USA have been fully vaccinated to date.

  • source: orf.at/picture: pixabay.com
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