Moderna Inc asked the U.S. Food and Drug Administration (FDA) on Wednesday to allow the use of its third booster. Coronavirus disease vaccine.
The FDA is considering booster injections of Pfizer and BioNTech SE vaccines, but so far only allows people with weakened immune systems to receive a third dose of Moderna or Pfizer.
The agency said on Wednesday that its group of consultants will meet on September 17 to discuss Pfizer’s intensive injection application, but it is not clear whether they will discuss Moderna’s.
Moderna COVID-19 vaccine is approved by Health Canada for use in children over 12 years old
Moderna said it submitted preliminary data on the use of a booster dose of 50 micrograms for the second vaccine. The original Moderna vaccine contains 100 micrograms of mRNA per injection.
Moderna CEO Stéphane Bancel said in a statement that recipients at the 50 microgram dose had a strong antibody response to the Delta variant.
Although Moderna stated that its COVID-19 vaccine was still about 93% effective within 6 months after the second vaccination, it observed that antibody levels had dropped significantly at this time.
The company said that nearly 350 participants in its initial phase II trial received the third dose of the vaccine, which produced a better immune response than seen after the second dose in its large phase III clinical trial.
Moderna said that the safety of the third dose is similar to that of the second dose.
The company said it expects to submit the data to the European Medicines Agency (EMA) and other regulatory agencies around the world in the next few days.
Due to the highly infectious Delta variant of the virus and evidence of decreased antibody levels in people vaccinated six months later, the number of infections and hospitalizations has surged, and some countries have or plan to provide booster doses to the elderly or people with weakened immune systems.
— Reports by Michael Erman in New Jersey and Manojna Maddipatla in Bangalore, supplementary reports by Mrinalika Roy in Bangalore
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