By LINDA BOYLE
Sec. Robert F. Kennedy Jr. leads the US Department of Health and Human Services. Dr. Marty Makary heads up the Food and Drug Administration. They are reforming the drug/vaccine approval process to ensure gold-standard research is followed.
Dr. Makary, a Johns Hopkins University surgeon and researcher, practices surgical oncology and gastrointestinal laparoscopic surgery.
Just recently, Dr. Makary raised doubts about all Americans needing that seventh Covid booster and questioned the “success of past clinical trials.” Makary stated better data are needed.
“We can’t just extrapolate from a clinical trial from four or five years ago,” he said. “Americans have a very low uptake and a very low confidence of the Covid boosters right now.”
Some 85% of healthcare workers didn’t take that last booster jab, Makary said, and he acknowledged that asking drug companies to change their approach to Covid jabs may mean there will not be a new booster in the fall.
The FDA also is considering whether Covid boosters should only be given primarily to high-risk groups, rather than to all people. It is expected within the next few days the FDA will come out with a statement that Covid jabs will no longer be recommended for children, teens, and pregnant women. This is a huge change.
Using risk assessment, recommendations may be made that only those older than 65 would still need at least two doses a year along with those people who have an underlying health condition that increases their risk.
To satisfy those who may be wanting to still get the seventh booster, they will still have that option.
The CDC’s Advisory Committee on Immunization Practice is expected to vote on this potentially new guidance in June. The panel’s decision will influence how the federal government supports immunizations, including how insurance companies are required to cover vaccines and how doctors talk about the shots to their patients.
In discussing changes to the approval process, Dr. Makary wants to make the rules clear and transparent. There is the expectation that the Emergency Use Authorization, which has been used for the Covid jabs since 2020, will no longer apply to future Covid jabs.
I have often wondered why that rule was still in effect, concerning the fact that then President Biden had declared the pandemic over on May 11, 2023. Why was EUA still used? Oh wait. Best course of action for Big Pharma.
Makary’s approach to Covid-19 jabs certainly is different from the FDA under Biden. During those years, the FDA routinely just rubber stamped the jab’s annual booster.
Makary said that it is his job to “upholding gold standard science and rebuilding public trust, not to save pharma companies tens of millions of dollars.”
Dr. Vinay Prasad was recently appointed director of the FDA’s Center for Biologics Evaluation and Research. His background is in hematology-oncology, and he is professor of Epidemiology and Biostatistics at the University of California, San Francisco.
Prasad is currently meeting with the industry and agency staffers as he prepares to unveil a “massive framework,” that will incorporate the agency’s regulatory stance on vaccines, according to Makary.
There is a lot going on to change the vaccine approval process, to provide the public valuable information to have real informed consent, and to gain public trust. I don’t expect Big Pharma to be too happy. The gravy train is coming to a halt.
Maybe now more legal action will ensue as we learn more about what these vaccine manufacturers hid from Americans.
Mary Holland, CEO of Children’s Health Defense, has been actively “working to protect individual liberties, including the right to bodily autonomy, informed consent and parental rights.”
I am pleased to announce Mary Holland will be one of the speakers at our upcoming Alaskans 4 Personal Freedom (www.AK4PF.org) conference on Oct. 11, 2025, in Anchorage. Stay tuned for more information and save the date!
Linda Boyle, RN, MSN, DM, was formerly the chief nurse for the 3rd Medical Group, JBER, and was the interim director of the Alaska VA. Most recently, she served as Director for Central Alabama VA Healthcare System. She is the director of the Alaska Covid Alliance/Alaskans 4 Personal Freedom.
Covid 19 is a hoax.
If anyone is still taking Covid shots and/or getting their children Covid shots – I genuinely feel sorry for you.
Jeez.