Reuters.- Moderna Inc on Wednesday petitioned the U.S. Food and Drug Administration (FDA) to allow the use of a third booster dose of its Covid-19 vaccine.
The FDA is studying the possibility of administering a booster dose of the vaccine from Pfizer Inc and BioNTech SE, but has so far only allowed people with weak immune systems to receive third doses of the Moderna or Pfizer vaccines.
The agency said Wednesday that a group of its advisers will meet to discuss Pfizer’s booster injection request on Sept. 17, but it is unclear whether they will discuss Moderna’s.
Moderna said it presented initial data for the use of a 50-microgram booster dose of its two-shot vaccine. Moderna’s original vaccine contains 100 micrograms of mRNA in each injection.
Recipients of the 50-microgram dose elicited robust antibody responses against the Delta variant, Moderna CEO Stéphane Bancel said in a statement.
While Moderna has claimed that its Covid-19 vaccine was still around 93% effective six months after the second dose, it has observed that antibody levels had dropped significantly.
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The company said that nearly 350 participants in its original phase II trial received a third dose of the vaccine that elicited a better immune response than seen after the second dose in its large phase III clinical trial.
Moderna added that it expects to present the data to the European Medicines Agency (EMA) and other regulatory authorities around the world in the coming days.
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