Health
FDA advisers ‘angry’ that COVID-19 booster shot data wasn’t presented for review
WHAT YOU NEED TO KNOW:
- FDA vaccine advisers were reportedly “disappointed” and “angry” that data on Moderna’s updated Covid-19 booster shot was not presented during meetings last year.
- The data not presented suggested that the new booster shot might not be any more effective at preventing infections than the original shots.
- Advisers told CNN that they raised concerns about a lack of transparency.
Some FDA vaccine advisers say they’re “disappointed” and “angry” that several scientists and the pharmaceutical company Moderna didn’t present a set of data on the updated COVID-19 booster during meetings last year. The meetings were about the discussion of whether the booster should be authorized and made available to the public.
The particular data suggested that the new Moderna booster might not be any more effective than the original shots in preventing COVID-19 infections.
Though data was early and had many limitations, several advisers told CNN that it raised an issue about a lack of transparency.
Nearly $5 billion was spent on the new booster using US taxpayers’ money. It has been administered to more than 48.2 million people in the United States.
“I was angry to find out that there was data that was relevant to our decision that we didn’t get to see,” said Dr. Paul Offit, a member of the Vaccines and Related Biological Products Advisory Committee, a group of external advisers that aids the FDA to make decisions about vaccines. “Decisions that are made for the public have to be made based on all available information – not just some information, but all information.”
In a meeting in June and September of last year, this FDA advisory group advises the U.S. Centers for Disease Control and Prevention (CDC), they were presented with data indicating that the updated vaccine was more efficient than the original one. The panel reviewed videos and transcripts of those meetings and slide presentations made by Moderna, CDC, and FDA officials.
That data not presented to the experts was called immunogenicity data – based on blood work done on study participants to assess how well each vaccine-elicited antibodies fight off the Omicron strain of the virus.
The data that was not presented to the experts: who caught COVID-19 and who did not.
The FDA and CDC advisers told CNN that this infection data wouldn’t make a difference in how they voted due to limitations, but the fact remains that it still should have been presented to them.
“There should always be full transparency,” said Dr. Arnold Monto, a professor of epidemiology at the University of Michigan School of Public Health and acting chair of the FDA advisers’ group. “These data should not be dismissed. They are early, but they indicate that we need to look at them and see what their value is.”
CNN received an email from Moderna spokesman Christopher Ridley, insisting that the pharmaceutical company shared the infection data with the FDA. He added that the study manuscript was released before the FDA’s panel meeting in June “in response to requests that we share an update from the ongoing study.”
Source: CNN
Andrew Casler
January 14, 2023 at 6:40 pm
And we’re just hearing about this now? That’s par for the course. Just like Hunter’s laptop and Joe’s stolen documents. We don’t hear about it until the damage is already done. And people wonder why most Americans don’t trust the government or the press.
Rich
January 16, 2023 at 9:30 am
Isnt moderna pfizer & the fda staffed by the same people?
TYRANNY!
Dorlis Grote
January 16, 2023 at 1:06 pm
Exactly!! I did not trust the vaccine to begin with because I knew it is impossible to develop one in that short time. Most likely they had it in addition to the “escaped” virus both ready to distribute.
ARJAY
January 16, 2023 at 7:36 am
“The FDA and CDC advisers told CNN that this infection data wouldn’t make a difference in how they voted due to limitations, but the fact remains that it still should have been presented to them.”
If the “infection data wouldn’t make a difference in how they voted” WHAT’S the POINT of getting the data?!
So they would have STILL LIED about the safety and efficacy of the so-called-“vaccines”!!
Glen Olcott
January 16, 2023 at 9:23 am
I wouldn’t take that fake vaccine crap if they had a gun to my head. What a bunch of absolute BS!
Dorlis Grote
January 16, 2023 at 1:10 pm
YES! I did not get it, am considered at great risk because of age, 82, diabetes, heart. I kept my immune system strong with organic, C,D,K,Zinc and used common sense, no covid. How do they explain that???
Don
January 16, 2023 at 8:32 am
With all the evidence available on the dangers of the fake vaccine only fools take it and criminals make it and other criminals try to force it to be taken.
Joe
January 16, 2023 at 9:25 am
With or without data you would APPROVE it any way! What an admission of Guilt. So you feel it’s okay to endanger the lives of 48 million people. We must hope your karma is swift and it will come!
Ken Blackman
January 16, 2023 at 12:36 pm
More Commie BS from the LEFT! More Poison for the Brain Washed out of touched People!
CharlieSeattle
January 16, 2023 at 10:05 pm
Arrest Birx, Fauci and all CDC, NIH, WHO, FDA and big pharma and big tech. executives involved.
Fraud and homicide are not included in the total immunity from legal liability agreement under the PREP Act for the big Pharma criminals!
RICO laws apply now! The DOJ better wake the Fk Up and get busy!
Claire Bellefeuille
January 17, 2023 at 2:16 pm
This new vaccine news is very troubling! Someone needs to be responsible for this vaccine sham which affects all nations, placing thousands of people in serious danger.
Paul E.
January 20, 2023 at 9:25 am
After three years of lying to the public, the FDA now wants us to believe they were the good guys. They say that there was info out there that they were not given. What about the info that was hidden from the public for the last three years that you helped hide? Frankly, I wouldn’t be surprised to find out that a bunch scientists didn’t get together and put a dye into a different strain of the flu virus changing its color and called it a deadly virus. They (the FDA) were just as guilty of lying to us just like this person occupying our house on Pennsylvania Ave in DC. Biden reminds me of a banana sitting on a kitchen counter top for days. While the outside looks good- the inside is turning to mush.