US Food and Drug Administration scientists said on Wednesday that booster doses of Pfizer’s COVID-19 vaccine may not be needed, even though the third shot generates a higher immune response in recipients.
The FDA staff members said in a document prepared for outside advisors that it is still unproven that the efficacy of Comirnaty – the COVID-19 vaccine Pfizer developed with Germany’s BioNTech SE – is declining.
“Some observational studies have suggested declining efficacy of Comirnaty overtime against symptomatic infection or against the Delta variant, while others have not,” they said in the document.
“However, overall, data indicate that currently U.S.-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States.”
The FDA staff did say the booster dose met pre-specified conditions the regulator had set to show that the shot was generating an immune response.
However, they said in the document that licensure for the boosters should also consider the ability to prevent hospitalization and death, as well as the dynamics of the pandemic in the United States.
The agency released the document on Wednesday for consideration by a committee of outside experts who will meet on Friday to decide whether to recommend if U.S regulators should approve the extra round of shots.
The FDA staff view reflects that of many scientists who have questioned whether the boosters are necessary broadly, even as President Joe Biden has pushed for the additional shots in the face of surging hospitalizations and deaths caused by the highly contagious Delta variant of the coronavirus.
Biden set a Sept. 20 target to begin administering 100 million booster shots in the United States.
After the FDA meets, a panel of advisors to the U.S. Centers for Disease Control and Prevention is planning to meet next week to make its recommendation, according to White House Press Secretary Jen Psaki.
