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Moderna seeks FDA approval of booster dose of its vaccine

2021-09-01T23:24:45.694Z


Moderna said that her booster dose raises the levels of antibodies against covid-19 that begin to decrease six months after vaccination.


Israel offers booster doses to people over 12 years old 0:35

(CNN) -

The COVID-19 vaccine maker Moderna said Wednesday it submitted data to the U.S. Food and Drug Administration (FDA) to support the administration of a dose of booster your vaccine six months after your second injection.

Moderna is the second vaccine manufacturer to apply for a third dose of its vaccine, after Pfizer / BioNTech.

What about booster doses?

1:22

"We are pleased to begin the process of submitting (data) for our 50-microgram booster candidate to the FDA. Our request is supported by data generated with the 50-microgram dose of our covid-19 vaccine, showing a robust antibody response against the delta variant, "Moderna CEO Stéphane Bancel said in a statement.

"We remain committed to staying one step ahead of the virus and to following the evolution of the epidemiology of SARS-CoV-2."

  • Moderna's Vaccine Shows 93% Efficacy Over 6 Months, Company Says

The company used data from a phase 2 study in which 344 interested participants were offered a booster dose six months after their second dose.

"The concentration of neutralizing antibodies had decreased significantly before the booster was applied, at approximately six months," the company said.

The boost raised antibody levels above what had been set as the benchmark for emergency use authorization.

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What about booster doses?

1:22

"After a third dose, a similar level of neutralizing antibody concentration was achieved in all age groups, especially older adults (65 years and older)," the company said.

"The safety profile after the third dose was similar to that seen previously for dose 2 of [the vaccine] mRNA-1273. These data will be submitted for a peer-reviewed publication."

The antibodies appeared to work against the variants of interest, including the beta (B.1.351), gamma (P.1), and delta (B.1.617.2) variants.

Modern vaccine against covid-19

Source: cnnespanol

All news articles on 2021-09-01

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