Pfizer-BioNTech, Moderna COVID-19 vaccines approved by US FDA

Robert Besser
17 Sep 2023, 07:30 GMT+10

The U.S. FDA-approved the updated COVID-19 vaccines from Pfizer-BioNTech and Moderna for launch later this week for the fall vaccination campaign
The FDA approved the two shots for people aged 12 and above and for emergency use in children aged six months to 11 years
Pfizer and Moderna said their updated vaccines, which target the XBB.1.5 sub-variant of the virus, will be available for most people in the U.S. in the coming days

SILVER SPRING, Maryland: This week, the U.S. Food and Drug Administration (FDA) approved the updated COVID-19 vaccines from Pfizer-BioNTech and Moderna for launch later this week for the fall vaccination campaign, while a third vaccine made by Novavax is still under review.

The FDA approved the two shots for people aged 12 and above and for emergency use in children aged six months to 11 years.

Pfizer and Moderna said their updated vaccines, which target the XBB.1.5 sub-variant of the virus, will be available for most people in the U.S. in the coming days.

In a statement, leading FDA scientist Dr. Peter Marks said, "The public can be assured that these updated vaccines have met the agency's rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated."

Mandy Cohen, director of the Centers for Disease Control and Prevention (CDC), said she expects the new shots to roll out in September.

The approval by the FDA follows a recent rise in cases of the new EG.5 sub-variant of Omicron, nicknamed "Eris," which has begun to spread rapidly in the U.S. and other countries.

Scientists also have raised concerns about the highly mutated BA.2.86 sub-variant, detected in several countries.

Last week, Pfizer and Moderna said that their updated COVID-19 vaccines generated strong responses in testing against BA.2.86.

After the U.S. government ended its COVID-19 public health emergency status in May and handed over the responsibility for vaccinations to the private sector, demand for the vaccine has dropped sharply.