Pfizer Seeks Approval of COVID-19 Booster but FDA, CDC Are Unconvinced

Pfizer and BioNTech executives have met with federal health officials to emphasize that vaccinated people need COVID-19 booster shots — but the FDA and the Centers for Disease Control and Prevention (CDC) say that’s not what the science shows, at least not yet.

The companies are preparing to seek approval for their booster in the U.S. within weeks and say they think people will need a third dose six to 12 months after getting their initial vaccines.

Pfizer and BioNTech cited information from Israel showing that their vaccine remained effective against the Delta variant in preventing hospitalizations and serious illness yet has declining effectiveness at preventing milder cases.

But the FDA and the CDC have said, in a rare joint statement, that “Americans who have been vaccinated don’t need a booster shot at this time.”