Federal regulators warned on Thursday they
may not have enough data to recommend
boosters for anyone except certain recipients
of the Pfizer vaccine by late September.
Dr. Janet Woodcock, the acting commissioner of the Food and Drug Administration, and Dr. Rochelle P. Walensky, who heads the Centers for Disease Control and Prevention...made their argument in a meeting [on Thursday, see below] with Jeffrey D. Zients, the White House pandemic coordinator. Several people who heard about the session said it was unclear how Mr. Zients responded.By throwing his stapler and coffee mug at them.
Less than three weeks ago, Mr. Biden said that contingent on F.D.A. approval, the government planned to start offering boosters the week of Sept. 20 to adults who had received their second shot of the Pfizer-BioNTech or Moderna vaccine at least eight months ago.
...“The plan is for every adult to get a booster shot eight months after you got your second shot,” he said on Aug. 18, adding, “It will make you safer, and for longer. And it will help us end the pandemic faster.”
...Both Dr. Woodcock and Dr. Walensky helped craft the plan and publicly endorsed it. Some public health experts have said that by doing so, they increased pressure on scientists weighing the evidence for boosters within their respective agencies to go along with the administration’s strategy.
...
From WaPo: Now, Woodcock and Walensky, who have faced criticism for endorsing a plan before FDA approval, have warned that their agencies may need more time to make a determination about recommending boosters for people who received the Moderna vaccine.
...
Narrowing the booster plan could confuse the public and create a perception that federal vaccine policy is in some degree of disarray. But some public health experts will most likely welcome it.
They have been arguing strenuously that the administration lacks the data to justify a broad rollout of extra shots and should instead concentrate on vaccinating the roughly 25 percent of Americans who are eligible for shots but remain unprotected. And some have said that senior Biden officials, including the leaders of health agencies, wrongly cornered regulators by announcing a strategy before they could conduct a full review.
This week, two of the F.D.A.’s top vaccine regulators announced that they would be leaving the agency this fall, apparently partly because of frustration with the administration’s booster plan. Dr. Marion Gruber, who directs the agency’s vaccines office, and her deputy, Dr. Philip Krause, have told people there was not nearly enough data to justify offering extra shots to the general population starting in just weeks.
...
...Dr. Vivek Murthy, the surgeon general, said in an interview on Thursday that a few studies have suggested a dip in protection against severe disease over time. “Our feeling was that if we waited several more months we would see protection against hospitalizations and deaths break down,” he said.
In an interview published Thursday on WebMD.com, Dr. Woodcock echoed that view, saying that the trend of breakthrough infections has led health officials to believe at some point, “we are going to see hospitalizations and more serious disease” among fully vaccinated people. When that happens, she said, “we want to be ready” with the booster plan.
THURSDAY WAS THE SAME DAY WOODCOCK AND WALENSKY TOLD THE WH NO BOOSTERS FOR NOW! THEY TELL THE PUBLIC ONE THING AND THE WH THE OPPOSITE! Ah, I am despondent.
