FDA spurs more debate over boosters
Food and Drug Administration (FDA) scientists on Wednesday did not immediately endorse the evidence that a booster dose of the Pfizer-BioNTech COVID-19 vaccine was necessary for all Americans who received the shot.
The highly anticipated review, posted online ahead of an agency advisory meeting Friday, took a largely neutral tone. Agency staff sounded a skeptical note on the evidence presented by the drug company and noted that all available data has not been submitted or reviewed yet.
“Overall, data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States,” scientists said in a briefing document.
The FDA’s independent panel of experts on Friday will review the evidence from Pfizer and will likely vote on whether there’s enough evidence to show boosters are necessary. FDA staff didn’t tip their hand, so Friday’s debate could be contentious.
The FDA does not have to follow the agency’s advice, but if the agency breaks with the panel’s recommendation it would likely stoke public confusion and raise major questions about political interference.
Pfizer’s argument: In making its case for a third dose, Pfizer argued that protection against COVID-19 infection wanes primarily because of time, rather than because of the delta variant.
Pfizer cited evidence from lab studies as well as real-world data from Israel, which has been administering boosters to people over 60 since the end of July. The country recently expanded boosters to people over age 30.
“The totality of the available data supports the public heath need for a booster [third] dose … at approximately 6 months after the second dose” for individuals 16 years of age and older, Pfizer wrote.
The view from Israel: Citing the Israeli data, Pfizer said that a third dose restores protection from infection to 95 percent in a real-world setting, the same level of protection at the end of the initial dosing regimen. The data was collected from July 1 through Aug. 30, a period when the delta variant was spreading.
Biden administration officials have been making the case for booster shots based on data from Israel, which they say indicates a substantial drop in protection against both infection and severe disease. The U.S. evidence only shows a decrease in protection against mild disease, but not against severe disease. Israeli health officials are scheduled to present data Friday.
