The Biden admin's rushed decision to enforce covid booster shots on the population, is getting pushback not only from the FDA, where two top vaccine regulators resigned from the Food and Drug Administration on Tuesday, revealing anger, frustration, and turmoil at the federal agency as it balks at the White House's steamrolling of accepted rules and regulations, but also from Europe.
Overnight, Europe's CDC - the Centre for Disease Prevention and Control (ECDC) - said there was no urgent need for booster doses of COVID-19 vaccines for the fully vaccinated, citing data on the effectiveness of shots.
The comments follow a similar statement from the European Medicines Agency last month that more data was needed on the duration of protection after full inoculation to recommend using booster shots.
The evidence on real-world effectiveness shows that all vaccines authorized in the region are highly protective against COVID-19-related hospitalisation, severe disease and death, the ECDC said. But the agency said extra doses can be considered for people who experience a limited response to the standard regimen, adding that these shots should be treated differently from booster doses.
Germany and France have announced they would begin giving boosters to vulnerable people and the immunocompromised from this month to protect citizens from the more infectious Delta variant.
The U.S. government has also started administering a third dose of Pfizer Inc-BioNTech and Moderna Inc’s vaccines to those with compromised immunity.
And while we doubt that the US will actually bother with such trivia as data and facts, one look at the soaring number of cases in Israel, which not only has the highest vaccination rate but has also mandated booster shots, indicates that something is very wrong with current "scientific" approach to fighting covid.
Just in case you didn’t think the Soviet-style mass vaccination propaganda wasn’t also doubling as a political campaign and was all about “the science”, it seems like a great day to point out that two FDA officials - with a combined total of over 40 years of work experience at the agency - just resigned over the politicization of the vaccination process.
Among those leaving is the director of the FDA's Office of Vaccines Research & Review and the vaccine office's deputy director. Nothing to see here…
Becker's Hospital Review wrote about the resignations this week:
Marion Gruber, PhD, director of the FDA's Office of Vaccines Research & Review, will retire Oct. 31. She's been with the FDA for 32 years. Phil Krause, MD, the vaccine office's deputy director, will leave in November, according to the letter from Peter Marks, MD, PhD, who leads the agency's Center for Biologics Evaluation and Research.
A former senior FDA leader told Endpoints News the two leaders are stepping down from their roles because they're frustrated that the CDC and its Advisory Committee on Immunization Practices are involved in decisions they believe should be the FDA's. The White House's announcement that booster shots would be available Sept. 20, which was made without the FDA's approval, was reportedly what prompted the two leaders to step down.
"FDA is losing two giants who helped bring us many safe and effective vaccines over decades of public service," former FDA acting Chief Scientist Luciana Borio, MD, tweeted about the resignations.
Other reports, like this one from Yahoo, claimed that the two officials were "leaving in anger" over President Biden's plan to roll out booster shots before officials had a chance to approve it.
I can’t help but want to ask: tell me again why the unvaccinated are "crazy" for citing lack of FDA approval as a reason to be tentative about the vaccine?
Because it appears that FDA officials seem to think the agency's approval/buy-in for vaccinations is so important, is has prompted them to resign after decades of working for the FDA.
According to the Yahoo! report, a senior FDA leader said two duo resigned because "they felt that the Centers for Disease Control and Prevention was making vaccine decisions that should have been left to the FDA".
"The source said the final straw was the Biden administration's announcing the booster-shot plan before the FDA had officially signed off on it."
At least it’s nice to know that it isn't just with eviction moratoriums where the CDC is overstepping its boundaries and trying to usurp authority it doesn’t belong having. Remember when the Centers for Disease Control tried to tell people they didn’t have to pay rent?
ARS Technica added to the story this week, revealing that the officials also resigned over intensifying pressure” to approve booster “doses for children under the age of 12.”
Politico, which spoke with 11 former and current health officials, described the situation at the FDA as a "potential mutiny" among agency staff and outside vaccine experts.
Adding to the tension, the upheaval at the FDA comes as parents, caregivers, and teachers anxiously look to the agency to expeditiously review and authorize COVID-19 vaccine doses for young children
For those unfamiliar with just how politicized Covid has gotten, I recently pointed out the vast, changing narrative behind when we can “return to normal” and herd immunity in this article, which lays out Dr. Fauci’s constantly changing narrative to the American public.
Thanks to continued feedback from my followers, I’ve known for more than a year now that large parts of the American public have woken up to the wool being pulled over our eyes from political leaders, as they try to use the pandemic to grab every bit of power they can. Now, it appears that regulatory agencies are catching on, too.
The two FDA scientists that resigned in protest go down in my book as heroes. It is only through consistent actions like these that dissenters to the “official” narrative will start to be heard.
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