By LINDA BOYLE
The era of the Federal Drug Administration just rubberstamping whatever the pharmaceutical companies send in for the next Covid booster jab is over.
Gone are the days when a booster can be approved for anyone over six months of age when it was only tested on eight mice. No longer will boosters be approved when the “robust” scientific study included only 23 subjects prior to roll out.
There are new sheriffs in town.
An updated framework for drug approvals was instituted by FDA Commissioner Marty Makary and the Center for Biologics Evaluation and Research Director Vinay Prasad. The requirements include the “need for stronger evidence base for boosters in healthy adults and children — a departure from what they described as the Biden Administration’s “repeat-boosters-in-perpetuity strategy.”
When compared to other high-income nations, the US is incredibly more aggressive in attempting to get the jab into anyone six months or older. “The US policy has sometimes been justified by arguing that the American people are not sophisticated enough to understand age- and risk-based recommendations.” Somehow this group of “experts” believed they had to make it as simple as possible because we couldn’t understand different recommendations for different groups. So just say vaccinate everybody — whether it’s needed or not? Wow.
Here are the Covid vax recommendations in other countries.
Vaccine hesitancy has risen largely because people are waking up and not buying the latest covid jab recommendation that it allegedly will stop you from getting sick, or protect you from not getting too sick, ad nauseum. As people line up on one side or the other on the issue, people who got the jab continue to get the disease. People without the jab get the disease. Each can point the finger at the other.
Less than 25% of Americans now take the Covid jab each year. The numbers for children younger than 12 is 10%; to 50% of adults over 75 in the 2024-2025 season. Healthcare workers also are not giving an arm for the jab. Less than one third took part in the 2023–2024 fall booster program.
A study in Clinical Infectious Diseases showed the Covid jab increased your susceptibility to infection. The more jabs you got, the greater the risk for Covid. Furthermore, the study stated that the effectiveness of repeated boosters against whatever variant was most dominant at the time of the booster approval was only 19%.
Some FDA bureaucrats are responding to the procedural changes by looking for another job. Many drug reviewers have opted to recuse themselves in recent months, indicating that they might be meeting with drugmakers regarding potential employment opportunities.
The fact that they are in line for those jobs just shows how close FDA bureaucrats were connected to Big Pharma.
It will continue to get interesting in the next few months. The next meeting of the Advisory Committee on Immunization Practices meets June 24 and 25. The link to the agenda is here. There will be time for public comment.
What their decisions are will surely irritate the anti-vaxxers and the vaxxers. The board must follow “the science” and make recommendations that are founded on scientific data. It must also tell us the side-effects if they approve the jab should you decide to get the shot.
I truly believe in choice — choice that is built on informed consent. Once someone knows the risk, ones own health history, and evaluates whether or not one should take it, a sentient person can decide whether to vaccinate or not.
It is your decision. Not the government’s. Not the mask police’s decision. And not your neighbor’s decision.
Your decision — a novel idea whose time has come.
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.
A perfect example of why a small group in DC (or elsewhere) should not force behavior. Are you listening, democrats?
You mean scientists?
Consensus is not science!
You need to read Justice Thomas takedown of the expert class in last week’s SCOTUS opinion on the TN law banning trans medical intervention for minors. Thomas makes it very clear that the so-called experts do not trump the actions of elected officials. He took a chainsaw to your notion that “science” somehow trumps everything else. “Science” is used like a magical incantation mostly as a vehicle to make people shut up. Fun read. Worth your time. Cheers –
You mean federally-funded and therefore establishment-beholden scientists, who not only can but often do have their own political agendas to push? Scientists who are as corruptible as anyone else? Scientists who are willing to overlook and apologize for non-scientific and anti-scientific policies when those policies align with their own prejudices and self-interests? THOSE scientists?
Sure the ” science” of 6foot distancing, which the so called ” scientists ” admit they pulled from theirintestines