Several medical experts accused the Food and Drug Administration (FDA) of putting out “extremely misleading” guidance on receiving a booster vaccination shot against COVID-19.
The FDA released a video Wednesday of Dr. Peter Marks, the director of the Center for Biologics Evaluation and Research at the FDA, recommending that people who have been vaccinated in addition to recovering from COVID-19 receive a third vaccine shot, commonly referred to as a booster shot.
“People who had COVID-19 early on in the pandemic had a different variety, a different variant of COVID-19 than what is circulating right now, and we know that you need high levels of immunity such as those that would be provided by a booster,” Marks said in the video.
“So if you’ve been vaccinated and have also had COVID-19, it’s probably also a good idea to get a booster, and in that case, you should talk to your healthcare provider and ask them when the time is right for you to get that booster, but getting that booster can help prevent you from getting into further trouble with a new variant down the line,” he continued.
If you’ve had #COVID19, but you haven’t had a booster yet, our own Dr. Peter Marks wants “Just a Minute” of your time. pic.twitter.com/9dZFMXTOsk
— U.S. FDA (@US_FDA) January 5, 2022
Dr. Vinay Prasad of the University of California San Francisco and Dr. Marty Makary of Johns Hopkins University hammered Marks and the FDA over the guidance. Prasad said in a Twitter thread (hyperlink added):
This is madness. In the video he asserts that if you’ve been vaccinated with two doses and had COVID, you should get a booster. But he himself knows there is no evidence to support that claim. He could have demanded it from the company. But did not[.]
But perhaps the worst argument comes in the beginning of the video where he says if you’ve had COVID long ago, you’ve been exposed to an older ancestral strain. Therefore you should get the booster. However, the booster is a construct made of… Older ancestral strain[.]
FDA had the ability to ask companies to run robust randomized control trials powered for clinical endpoints for boosters. They have abdicated that responsibility. And now engage in low levels of evidence aka storytelling to change the public’s behavior. It’s sad to watch.
PS they only abdicated the responsibility after the director and deputy director resigned in protest.
In the old days it was the companies that did the off label promotion and the FDA fined them. Times have changed.
Makary responded to Prasad, asking “Can we report this to twitter as misinformation?” The Johns Hopkins surgeon also posted a response of his own to the FDA video, accusing the federal government of ignoring the “overwhelming data on natural immunity.”
“This is so disappointing to see. It’s extremely misleading and based on the dogma that antibody titers are the key indicator of protection. Many government doctors have lost their scientific objectivity. And sadly ignore the overwhelming data on natural immunity,” Makary said.