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

Moderna submits booster shot data to FDA in bid to get authorization for for third shot of its COVID vaccine ahead of official September 20 rollout

  • 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 asked the US Food and Drug Administration (FDA) to approve its COVID-19 vaccine booster shot ahead of the official September 20 rollout. 

The Cambridge, Massachusetts, based company announced Wednesday that it had shared data with FDA in order to seek official authorization to give people a third dose of its vaccine. 

Moderna reports that its third shots brings people to a higher antibody level than they had after receiving two shots. It found that immunity granted by its original two-shot vaccine had begun to wane six months after the second dose was given. 

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

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 from September 20 to shore up protection against the virus.

Officials cited the waning immunity the current crop of COVID-19 vaccines have offered, combined with the Delta variant’s ability to cause breakthrough cases among vaccinated people 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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