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


Moderna submits booster shot data to FDA in a bid to obtain authorization for a third injection of its COVID vaccine ahead of official rollout on Sept. 20

  • Moderna has filed data with the FDA as it seeks approval for its booster injection for the COVID-19 vaccine
  • The White House has announced plans to make boosters available to Americans starting September 20
  • Moderna’s vaccine has been administered 145 million times in the US and has fully vaccinated 65 million people
  • Mayo Clinic data shows vaccine effectiveness drops to 76% against Delta variant

Moderna has asked the US Food and Drug Administration (FDA) to approve the booster shot for the COVID-19 vaccine before the official rollout on September 20.

The Cambridge, Massachusetts-based company announced Wednesday that it had shared data with the FDA seeking official permission to give people a third dose of its vaccine.

Moderna reports that the third injection takes people to higher antibody levels than they had after receiving two injections. It found that the immunity conferred by the original two-injection vaccine began to wane six months after the second dose was given.

Health officials in the US hope the booster shots could bolster Americans’ protection against future strains of the virus as winter approaches.

Moderna has submitted data to the FDA for authorization of its COVID-19 booster injection. The White House hopes to roll out the filming from September 20. (File photo)

“We are delighted to begin the submission process for our booster candidate,” said Stéphane Bancel, CEO of Moderna, in a statement.

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

“We will continue to generate data and share it transparently to support governments and regulators in making evidence-based decisions about future vaccination strategies.”

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

The White House announced on August 18 that Covid booster shots would be rolled out shortly from September 20 to bolster protection against the virus.

Officials cited the declining immunity offered by the current crop of COVID-19 vaccines, coupled with the Delta variant’s ability to cause breakthrough cases among vaccinated people as the reason boosters are needed.

The CDC has released three studies that showed the potential declines in immunity from the vaccines over time.

The effectiveness of the Moderna (yellow) vaccine began to decline in June and July as the 'Delta' variant became more common in Minesota.  Moderna had 76% effectiveness against the tribe

The effectiveness of the Moderna (yellow) vaccine began to decline in June and July as the ‘Delta’ variant became more common in Minesota. Moderna had 76% effectiveness against the tribe

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

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

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

While the shot’s ability to protect a person from contracting the virus diminishes over time, fully vaccinated people are still highly unlikely to be hospitalized or die from COVID-19.

However, White House officials said they are concerned that the decline in vaccine effectiveness will continue.

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

Moderna’s vaccine was approved on December 18, meaning the previous users of the vaccine will be eligible for the third injections from September 20.

Boosters for the Pfizer-BioNTech vaccine, which was approved a little before the Moderna injections on December 11, are also scheduled to roll out on the 20th.

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

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



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