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 The FDA is considering booster shots of the Pfizer Inc and BioNTech
SE vaccine, but so far has only allowed people with weakened immune
systems to receive third doses of either the Moderna or Pfizer
shots.
The agency said on Wednesday that a group of its advisers will meet
to discuss Pfizer's booster shot application on Sept. 17, but it is
not clear whether they will discuss Moderna's.
Moderna said it submitted initial data for the use of a 50-microgram
booster dose of its two-shot vaccine. The original Moderna vaccine
contains 100 micrograms of mRNA in each shot.
Recipients of the 50-microgram dose had robust antibody responses
against the Delta variant, Moderna Chief Executive Stéphane Bancel
said in a statement.
Although Moderna has said its COVID-19 vaccine was still about 93%
effective 6 months after the second dose, it has observed that
antibody levels had waned significantly at that point.
It said that nearly 350 participants of its original Phase II trial
were given a third vaccine dose that generated a better immune
response than what was seen after the second dose in its large Phase
III clinical trial.
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 Moderna said the safety profile
of the third dose was similar to that of the
second dose.
The company said it expects to submit data to
the European Medicines Agency (EMA) and other
regulatory authorities around the world in the
coming days.
Several countries are already offering or have
plans to give booster doses to older citizens or
people with weak immune systems as infections
and hospitalization soar due to the highly
contagious Delta variant of the virus and
evidence of waning antibody levels in vaccinated
people after six months.
(Reporting by Michael Erman in New Jersey and
Manojna Maddipatla in Bengaluru, Additional
reporting by Mrinalika Roy in Bengaluru; Editing
by Sriraj Kalluvila and Bill Berkrot)
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