Moderna seeks US authorization for COVID-19 vaccine booster | Inquirer News
Close  

Moderna seeks US authorization for COVID-19 vaccine booster

/ 09:45 AM September 02, 2021
FILE PHOTO: COVID-19 vaccinations in Dublin

FILE PHOTO: Vials of coronavirus disease (COVID-19) vaccines of Pfizer-BioNTech, Moderna and AstraZeneca are pictured at St. Mary’s Hospital, in Phoenix Park in Dublin, Ireland, February 14, 2021. REUTERS/Clodagh Kilcoyne

Moderna Inc on Wednesday asked the U.S. Food and Drug Administration (FDA) to allow the use of a third booster dose of its COVID-19 vaccine.

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.

ADVERTISEMENT

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.

FEATURED STORIES

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.

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.

Subscribe to our daily newsletter

By providing an email address. I agree to the Terms of Use and acknowledge that I have read the Privacy Policy.
Read Next
Don't miss out on the latest news and information.

Subscribe to INQUIRER PLUS to get access to The Philippine Daily Inquirer & other 70+ titles, share up to 5 gadgets, listen to the news, download as early as 4am & share articles on social media. Call 896 6000.

TAGS: COVID-19 vaccine booster shot, Moderna, United States, US FDA
For feedback, complaints, or inquiries, contact us.

Subscribe to our daily newsletter

By providing an email address. I agree to the Terms of Use and
acknowledge that I have read the Privacy Policy.



© Copyright 1997-2021 INQUIRER.net | All Rights Reserved

We use cookies to ensure you get the best experience on our website. By continuing, you are agreeing to our use of cookies. To find out more, please click this link.