Lagging Data May Push Back Biden’s Booster Shot Timeline: Report

Two federal health officials warned the Biden administration on Thursday that the COVID-19 booster plan the White House outlined earlier this summer might not be possible because of insufficient data, The New York Times reported Friday morning. 

The officials, CDC Director Dr. Rochelle Walensky and FDA acting commissioner Dr. Janet Woodcock, made the comments in a meeting with White House pandemic coordinator Jeffrey Zients. From The New York Times: 

Among the reasons for delaying is that regulators need more time to decide the proper dosage for a possible third Moderna shot. The company’s application asking the F.D.A. to authorize a booster shot contains insufficient data, one federal official familiar with the process said. Other data expected from Johnson & Johnson has not been delivered.

Nor has the raw data that the F.D.A. has been seeking from Israel, which is already giving boosters to everyone 12 and older. Israeli officials say their data shows that the potency of Pfizer’s vaccine wanes over time against severe disease and hospitalization, but that a third shot bolsters protection significantly. The F.D.A. wants to see the underlying data, to make sure it backs up summaries that the Israeli government has provided.

Only last month, President Joe Biden said his administration was preparing to begin booster shots beginning the week of September 20, contingent on FDA approval. 

“The plan is for every adult to get a booster shot eight months after you got your second shot,” Biden said on August 18, notes The New York Times. The president added, “It will make you safer, and for longer. And it will help us end the pandemic faster.”