Federal Regulators Tell Xiden to…
Federal Regulators Tell Biden to Proceed Slowly on Authorizing Vaccine Booster Shots
Federal health bureaucrats are telling Joe Biden that they don’t have enough data on the safety of making a third shot of the vaccine available to the general public and that the White House should scale back plans to recommend a booster shot to those vaccinated eight months or more.
The White House had said that they would approve a booster shot for most adults on September 20. But the regulators suggest authorizing the booster shot only to the most vulnerable Americans and that only the Pfizer vaccine should be given the green light.
Moderna’s vaccine booster just concluded human trials and the results won’t be known for six to eight weeks. Meanwhile, the necessity of a booster shot for most vaccinated Americans is being questioned.
By announcing the date to begin offering the booster shot without the data being fully studied, the Biden administration is putting enormous pressure on regulators — so much so that two prominent FDA researchers are stepping down at least partly because of the rush to approve the third shot.
But the announcement of a late September target date for starting the booster campaign set off alarm bells inside the F.D.A. — apparently playing a role in decisions by two of its top vaccine regulators, announced this week, to leave the agency this fall.
Both Dr. Woodcock and Dr. Walensky helped draft 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 in their respective agencies to go along with the administration’s strategy.
“Now those agencies are in a box,” said Dr. Steven Joffe, a professor of medical ethics and health policy at the University of Pennsylvania. Doctors, scientists, and the public must “trust in the recommendations and decisions that are made, to be able to point to the F.D.A. and C.D.C. doing their due diligence.”
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But how can anyone trust the FDA when they make a major decision on public health like whether or not to offer a booster shot with incomplete data?
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 significantly bolsters protection. The F.D.A. wants to see the underlying data, to make sure it backs up summaries that the Israeli government has provided.
The necessity of a general booster shot for COVID-19 vaccines is a long way from being proven efficacious. Three studies on breakthrough infections — COVID-19 contracted by people with both vaccine shots — reveals them to be extraordinarily rare, even with the reduced immunity from the vaccines over time.
There’s still a lot to be discovered about the coronavirus and about COVID-19. The government’s eagerness to give everyone a booster when it’s almost certainly not necessary does not help in building faith in the government’s response.
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