The FDA is a rubber stamp; 4th dose coming.
by Vinay Prasad
The New York Times is reporting this:
Biden Administration Plans to Offer Second Booster Shots to Those 50 and Up
Apparently, they have already decided…
Federal health officials have hotly debated the way forward, with some strongly in favor of a second booster now and others skeptical. But they have apparently coalesced around a plan to give everyone age 50 and up the option of an additional shot, in case of infections surge again before the fall. In the fall, officials say, Americans of all ages, including anyone who gets a booster this spring, should get another shot.
And here is the kicker, advisors are not needed….
Unlike with the first round of regulatory decisions on booster shots, no meetings of the advisory committees of either the F.D.A. or the C.D.C. are planned ahead of the decision on second boosters.
Without the FDA advisory committee, without any data presented, they argue that if you are 50 and over, you need a 4th dose now, and a 5th dose in the fall! The rest of us need our 4th dose in the fall. Wtf!
Let me make a few points:
- The White House is operating at the lowest level of evidence. Just consider the 5th dose recommendation. Not only are there no randomized data, but there also is not even flawed observational data to draw from. The White House will soon approve a 5th, 6th, 7th dose. Albert Bourla, not Bob Calif is now the FDA commissioner.
- The age cut-off of 50 is based on what? Likely it is invented. Practically, it means we will again neglect the very old 80++, and focus on healthy, rich 50-year-olds. What evidence is there that a 50-year-old who had 3 doses and might have had Omicron benefits from the 4th?
- We are still talking about the original Wuhan strain coronavirus vaccine. Sad!
- If Trump had done this, there would be a revolt. Academics would be furious if Trump pressured Gruber and Krause to approve the 3rd dose, so much so that they resigned, and doctors would be upset, that without FDA ad-com, the White House is telling society how many boosters they need of the old, ancestral mRNA
- They are skipping the ad-com because they know many smart people will disagree with them, and consider their plan reckless, and lacking data. These people will give great quotes. Skipping the adcom is not what we do in a democratic, free transparent society.
- The White House is not concerned first and foremost with your health. They have an election this fall. They need numbers to be low. Even if the 4th dose of the vaccine is disputed, if it helps their political fortunes, or at least they think so, it is their incentive to push it. This is why we need independent regulators to make these calls
- There is no one left to resign at FDA
- After the administration ends, I wonder how many officials who made this call will work for, consult for, or join the board of Pfizer and Moderna. The revolving door further undermines public confidence.
In short, the White House is not your doctor, yet they have decided they will act as such. This is a dangerous precedent. The American people will soon be participating in an uncontrolled clinical trial of 4th and 5th doses— possibly with coercive mandates. Not having an advisory committee is a threat to public health. This decision does not bode well.