Biden's top-down booster plan sparks anger at FDA

Politico ^ | August 31, 2021 | SARAH OWERMOHLE

[CheshireTheCat]

The Biden administration’s decisions over when to administer coronavirus vaccine boosters are triggering turmoil within the Food and Drug Administration, frustrating regulators and sparking fear that political pressures will once again override the agency’s expertise.

FDA officials are scrambling to collect and analyze data that clearly demonstrate the boosters' benefits before the administration’s Sept. 20 deadline for rolling them out to most adults. Many outside experts, and some within the agency, see uncomfortable similarities between the Biden team's top-down booster plan and former President Donald Trump's attempts to goad FDA into accelerating its initial authorization process for Covid-19 vaccines and push through unproven virus treatments.

On Tuesday, two top FDA vaccine regulators resigned — a decision that one former official said was rooted in anger over the agency’s lack of autonomy in the booster planning so far. A current health official said the pair, Marion Gruber and Philip Krause, left over differences with FDA’s top vaccine official Peter Marks. Now the agency is facing a potential mutiny among its staff and outside vaccine advisers, several of whom feel cut out of key decisions and who view the plan to offer boosters to all adults as premature and unnecessary.

POLITICO spoke to 11 current and former health officials and people familiar with the matter who described growing exasperation with the administration's disjointed process for implementing its booster plan. Those sources said there is little coordination between federal health agencies, even as two top FDA officials try to guide the rollout....

“Many, many, many” providers in southern states with coronavirus case surges are dosing health care workers and patients with boosters absent an FDA approval because of confusion over Biden booster remarks, said Helen Talbot, an infectious-disease specialist at Vanderbilt University and member of CDC’s Advisory Committee on Immunization Practices.....

[Grampa Dave]

We know of 5 people, who are here today probably due to getting this drug.

One is a man and one of our longest time friends. He is 80+ something and is doing great and has rejoined our men’s once a month bridge group.

Next is an 80 something couple, who went from a local ICU to an approved rest home and then discharged and are doing excellent. We have known them for over 40 years. Interesting re this couple. They have a married daughter who lives next door to them with 3 young children. Another adult daughter helped them until t they went to a hospital. No one else in that family caught the crud in spite of a lot of exposure to their parents.

The last one is a PT, late 30’s, who probably gave the wife of the couple above, the crud. He is back working.

The people above didn’t have to worry about getting this treatment. Their ID specialists at two different hospitals arranged for their treatment.

#5 age 55, was one of the many Covid patients unable to get admitted to any Sacramento hospitals during their patient surge earlier this year. He stayed in an ambulance, was treated and went home after a few days. His parents are two of our best friends. One of his nieces is an EMT and a critical care RN. She feels that staying in the ambulance and this drug saved her uncle.

Hopefully, if your or your family need it, you/they can get it.