Pfizer Pushes for Booster Approval While FDA and CDC Say Boosters Aren’t Necessary

Pfizer and BioNTech executives are meeting with federal health officials this week 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.

“While protection against severe disease remained high across the full six months, a decline in efficacy against symptomatic disease over time and the continued emergence of variants are expected,” the companies said. Based on “the totality of the data” they have to date, Pfizer and BioNTech believe that a third dose “may be beneficial to maintain the highest levels of protection.”

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.” Some experts are of the view that the Biden administration doesn’t want to launch a vaccine booster program at a time when it is struggling to get Americans to get their first and second shots in many parts of the country.

“FDA, CDC, and [the National Institutes of Health] are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary,” the FDA and CDC said. “This process takes into account laboratory data, clinical trial data and cohort data — which can include data from specific pharmaceutical companies but does not rely on those data exclusively.”

They added that they continue to review any new data as it becomes available and will keep the public informed. “We are prepared for booster doses if and when the science demonstrates that they are needed,” the agencies said. — Suz Redfearn