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Moderna submits data to FDA seeking authorization for COVID-19 booster shot

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Moderna submits data to FDA seeking authorization for COVID-19 booster shot with less than three weeks to go until roll out on September 20

  • Moderna has submitted data to the FDA as it seeks authorization of its COVID-19 vaccine booster shot
  • The White House has announced plans to make boosters available for Americans starting September 20
  • Moderna’s vaccine has been administered 145 million times in the U.S., and has fully vaccinated 65 million people
  • Data from the Mayo Clinic has found the vaccine’s effectiveness falls to 76% against the Delta variant 


Moderna has submitted official data for their COVID-19 booster dose to the U.S. Food and Drug Administration (FDA) for review, the company announced Wednesday.

The Cambridge, Massachusetts, based company is seeking authorization for their shots only weeks before September 20, a date the White House has pegged for the start of booster shot roll outs.

Moderna reports that its third shots brings people to a higher antibody level than they had after receiving two shots, despite immunity having waned for at least six months for everyone in the trial.

Health officials in the U.S. are hoping the booster shots can shore up Americans’ protection against future variants of the virus. 

Moderna has submitted data to the FDA for authorization of its COVID-19 booster shot. The White House hopes to begin rolling out the shots starting September 20. (File photo)

Moderna has submitted data to the FDA for authorization of its COVID-19 booster shot. The White House hopes to begin rolling out the shots starting September 20. (File photo)

”We are pleased to initiate the submission process for our booster candidate,’  said Stéphane Bancel, Moderna CEO, said in a statement. 

‘We remain committed to staying ahead of the virus and following the evolving epidemiology of [COVID-19]. 

‘We will continue to generate data and transparently share to support governments and regulators as they make evidence-based decisions regarding future vaccination strategies.’ 

Moderna’s COVID-19 vaccine has been used 145 million times, and over 65 million people have been fully vaccinated with it. 

The White House announced on August 18 that Covid booster shots would soon begin to roll out to shore up protection against the virus.

Officials cited the waning immunity the current crop of COVID-19 vaccines have, combined with the Delta variant’s ability to cause breakthrough cases as the reason why boosters are needed.

The CDC released three studies that found the potential decline of immunity from the vaccines over time.

Effectiveness of the Moderna (yellow) vaccine began to drop in June and July as the 'Delta' variant became more prevalent in Minesota. Moderna had an effectiveness of 76% against the strain

Effectiveness of the Moderna (yellow) vaccine began to drop in June and July as the ‘Delta’ variant became more prevalent in Minesota. Moderna had an effectiveness of 76% against the strain

One study from the Mayo Clinic in Minnesota found the Moderna vaccine is only 76 percent effective against the Delta variant.

A second study found that vaccines’ effectiveness against COVID-19 diagnoses dropped from 96 percent to 80 percent in New York state between May 2021 and July 2021.

The third study found the effectiveness of the shots against infections in nursing home residents was 75 percent. Post-Delta, this had fallen to 53 percent.

While the shot’s ability to defend a person from contracting the virus decreases over time, fully vaccinated people are still very unlikely to suffer hospitalization or death from COVID-19.

However, White House officials said they have concerns the decline of the vaccines’ effectiveness will continue. 

Booster shots will be available to Americans eight months after they received their second dose.

Moderna’s vaccine received approval on December 18, meaning the earlier adopters of the vaccine will be eligible for the third shots starting September 20.

Boosters for the Pfizer-BioNTech vaccine, which was approved slightly before the Moderna shots on December 11, are planned to roll out on the 20th as well.

Pfizer and BioNTech submitted data for their booster shots to the FDA on August 16.

In total, 62 percent of all Americans have received at least one dose of a vaccine and 53 percent are fully vaccinated.

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