Quote: @savannahskol said:
2 top FDA vax regulators resign in protest
......in response to Biden Admin pending policies re: youth vax/booster vaxes.
https://www.politico.com/news/2021/08/31/biden-booster-plan-fda-508149
Pull quote:
"But for now, much of the discord within the agency centers on the administration's decision to push ahead with boosters before FDA's top scientists had a chance to weigh in.
It was “the administration's booster plan; it wasn't the FDA's booster plan,” said Paul Offit, a University of Pennsylvania infectious disease expert who sits on FDA’s vaccine advisory committee. “The administration has kind of backed themselves up against the wall a little bit here.”"
Discord @ the FDA, eh?
Thank goodness we now have a "follow the science" administration.
I can't disagree with this.
White House chief of staff Ron Klain would not give a specific date as to when Covid-19 booster shots would be available to the public but committed to following the science and waiting for full approval from health officials before making a third dose available to those who seek one.
"I would be absolutely clear, no one's going to get boosters until the FDA says they're approved, until the CDC advisory committee makes a recommendation. What we want to do though is be ready as soon as that comes," Klain told CNN's Dana Bash on Sunday's "State of the Union."
"A hundred percent we will wait for FDA approval, we will wait for CDC approval. They will decide which of the vaccines are approved to be used as boosters, they will decide when that approval comes, they will decide who will get it under those approvals. Those are decisions made by FDA and CDC," he added.
Klain said that even if boosters of both shots don't receive full approval before September 20, the administration will be ready to distribute them as soon as that date comes, something he said did not happened under the Trump administration when vaccines were initially given emergency use authorization.
"The most important thing we can do here at the White House, what our Covid response team can do, is to make sure that we have bought the boosters, and we have, and that we have a distribution plan so that as soon as the regulators, the scientists say 'good to go, here's who needs them, here's what's approved,' they will be available probably the very same day that that approval gets given," he said.
Klain disputed reporting that some FDA officials weren't on board with the White House putting out that specific date on when people should expect booster shots, telling Bash that the President and administration have been clear that boosters would only become available after they received full approval.
https://www.cnn.com/2021/09/05/politics/...index.html
Quote: @purplefaithful said:
White House chief of staff Ron Klain would not give a specific date as to when Covid-19 booster shots would be available to the public but committed to following the science and waiting for full approval from health officials before making a third dose available to those who seek one.
"I would be absolutely clear, no one's going to get boosters until the FDA says they're approved, until the CDC advisory committee makes a recommendation. What we want to do though is be ready as soon as that comes," Klain told CNN's Dana Bash on Sunday's "State of the Union."
"A hundred percent we will wait for FDA approval, we will wait for CDC approval. They will decide which of the vaccines are approved to be used as boosters, they will decide when that approval comes, they will decide who will get it under those approvals. Those are decisions made by FDA and CDC," he added.
Klain said that even if boosters of both shots don't receive full approval before September 20, the administration will be ready to distribute them as soon as that date comes, something he said did not happened under the Trump administration when vaccines were initially given emergency use authorization.
"The most important thing we can do here at the White House, what our Covid response team can do, is to make sure that we have bought the boosters, and we have, and that we have a distribution plan so that as soon as the regulators, the scientists say 'good to go, here's who needs them, here's what's approved,' they will be available probably the very same day that that approval gets given," he said.
Klain disputed reporting that some FDA officials weren't on board with the White House putting out that specific date on when people should expect booster shots, telling Bash that the President and administration have been clear that boosters would only become available after they received full approval.
https://www.cnn.com/2021/09/05/politics/...index.html
Huh? ^^^
Who to believe? The left leaning Politico? (the FDA is in discord) or the further left leaning CNN. (It's all good)
Here's a take, from the never-Trump NationalReview.
Whatever Happened to ‘Follow the Science’? From the start of the pandemic, writers at National Review and elsewhere have argued that governors and presidents cannot set policy just by “following the science.” Science has no legitimate way of assessing the public’s tolerance for certain measures and intrusions. Nor does it have the ability to weigh competing and contrary claims of political and economic liberty against public-health priorities.
It’s a problem we’ve seen over and over again. Governor Gavin Newsom will try to ward off criticism as illegitimate or troglodyte in nature, because he is “ following the science.” Or some governments will see fit to foreswear responsibility for their own political decisions by inappropriately delegating governance to the public-health bodies that should merely inform them. Even Dr. Anthony Fauci has conflated policy with the findings of science, saying that criticism of him and his contradictory statements is really just criticism of science itself.
But what I wrote 18 (!) months ago remains true: While governments “ought to be informed by science in making their decisions,” it is ultimately the case that “the findings and speculations of epidemiologists (and economists) cannot substitute for political judgment.”
Much more>> https://www.nationalreview.com/2021/09/w...e-science/
Pull quote from the article, as it pertains to this subject:
"I f you think medical regulators tend not to be cautious enough, the resignations of two senior officials over vaccines at the FDA because of political pressure is going to set off a ton of alarm bells.
Or do politicians have a duty to courageously stand up to public opinion when it runs against the advice of our regulators?But it brings up another interesting question. Let’s say that the scientific and medical authorities trying to pump the brakes on the U.K. and U.S. governments’ pharmaceutical interventions are basically right that, in a pure risk-and-reward sense, we don’t have the evidence to recommend juvenile vaccines for COVID, or boosters for the already-vaccinated. Or let’s assume that their determination is at least justifiable.
Even so, do politicians have a right to assess the potential downsides as being too minuscule to hold up? Do they have a right to let the political sentiments of the people, even people who are unnecessarily afraid, weigh on their judgment of what should be, basically, a medical question?
I think I've shown (from left-wing sources):
- scientists (NAMED in the op, not anonymous sources) have admitted to bowing to political pressure re: virus origins
- the MSM (and social media) has overwhelmingly supported the pro-vax view
- even 'neutral' scientists @ the FDA have 'had enough' (of political pressure) re: pro-vax policy
(if'n it makes you feel better, they didn't like the Trump political pressure, either)
'Politics' is all over this topic. Any of you who profess to claim you have the 'right to science' makes me lmao.
We elect representatives, we don't elect scientists.
sorry, not sorry.
Public health policy is at the whim of local politics, just as our Framers (divinely inspired) intended.
And just like the 2020 election, the systems in place hold...
5 reasons why FDA advisers did not recommend Covid-19 booster shots for everyone
"The stated goal of this vaccine has been to protect against serious illness," Dr. Paul Offit, a professor of pediatrics at the Children's Hospital of Philadelphia, told the meeting. "Data shows that these vaccines do exactly that," he added. "It's exactly what you'd expect."They don't see enough evidence to justify booster shots for everyone
"It is my opinion that we need this in our armamentarium -- a booster dose now, particularly for the elderly and (those with) other high-risk conditions -- but I share my colleagues' angst about the sparsity of safety data," said Dr. Mark Sawyer, a professor of clinical pediatrics at the University of California San Diego. "So it's unclear that everyone needs to be boosted, other than a subset of the population that clearly would be at high risk for serious disease," Kurilla said. "It is not clear to me that the data we are seeing now is applicable to the general population."
They would like a lot more data and a chance to look for mistaken conclusionsDr. Philip Krause, deputy director of the FDA's Office of Vaccines Research and Review, noted that Pfizer was using data that had not been reviewed by experts."One of the issues in this is that much of the data that's been presented and being discussed today is not peer-reviewed and has not been reviewed by FDA," Krause said.Krause, along with another FDA vaccine official, Marion Gruber, signed a paper published The Lancet earlier this week that argued it's too soon to start giving people boosters.Kurilla noted that Pfizer's studies relied heavily on measurements of antibodies, without looking at other important aspects of immune response. They are worried about younger adults and teens"We're being asked to approve this as a three-dose vaccine for people 16 years of age and older, without any clear evidence the third dose for a younger person, when compared to an elderly person, is of value," Offit said."If it's not of value, then the risks may outweigh the benefits. And we know the 16-29-year-old is at higher risk of myocarditis," he added.
They think it's more important to get more people to get vaccinated the first time aroundDr. Cody Meissner, a professor of pediatrics at Tufts University School of Medicine, said he didn't think boosters would significantly contribute to controlling the pandemic.
"It is very important that the main message that we still transmit is that we have got to get everyone two doses. Everyone has got the get the primary series," he said. "This booster dose is not likely to make a big difference in the behavior of this pandemic."
"It is a frustrating place to be in when we have in the United States more than adequate supplies of vaccine and yet have been unable to achieve the level of coverage that would result in much better control of the pandemic than we have," said Dr. Melinda Wharton, director of the Immunization Services Division at the US Centers for Disease Control and Prevention.
https://www.cnn.com/2021/09/17/health/fd...index.html
Biden’s Booster Bungle Shows a White House in Dysfunction By PHILIP KLEINSeptember 17, 2021 4:39 PM
By a 16-2 vote, an FDA advisory panel rejected President Biden’s plan to offer boosters to the general public as soon as next week. Putting aside for a moment the arguments for or against booster shots at this stage of the pandemic, the sequence of events on booster shots has revealed a White House in complete dysfunction.
On August 18, Biden announced a plan to start giving booster shots to every American adult starting the week of September 30. “Just remember, as a simple rule — rule: Eight months after your second shot, get a booster shot,” Biden said.
CDC director Rochelle Walensky signed onto the plan, arguing of the vaccines, “We’re starting to see waning in infection. We think that may result soon in waning in severe disease and outcome. We certainly don’t want to see that here. That’s why we’re planning now to get ahead of it before that happens.”
A little more than a week later, on August 27, Biden, speaking with Israeli Prime Minister Naftali Bennett, indicated that the U.S. could actually follow Israel’s lead and speed up the timeline. “We’re considering the advice you’ve given that we should start earlier,” Biden said. “Should it be as little as five months, and that’s being discussed.”
Yet Anthony Fauci had to do damage control two days later, reiterating that, “We’re still planning on eight months.”
But — whether it was five months or eight months — at no point did Biden manage to make sure that his administration was on the same page as the FDA.
A few days later, two of the FDA’s top vaccine experts resigned over the Biden booster shot plan. Jim Geraghty walked through some of the reasons for their skepticism, which they spelled out in a Lancet article.
And today came the vote, which, while not binding, is highly influential in the ultimate FDA decision on boosters.
To be clear, the panel did not uniformly say boosters were a bad idea in all cases, for all time — it recommended the boosters for the elderly, for instance. “It’s likely beneficial, in my opinion, for the elderly, and may eventually be indicated for the general population,” Ofer Levy, a vaccine and infectious disease specialist at Boston Children’s Hospital, said before voting against the Biden plan. “I just don’t think we’re there yet in terms of the data.”
There are arguments both in favor of and against booster shots at this time. But by putting the cart before the horse, Biden guaranteed that any booster strategy that is ultimately pursued will be met by a higher degree of skepticism than it otherwise would have. And it isn’t clear at this point, even if Americans want to diligently follow the science, who they should trust.
Should they trust Fauci, the CDC, and Biden, who are making the case for boosters? FDA experts who are skeptical? Do we think that the usefulness of vaccines erodes within eight months, or do we think that protection is longer lasting?
Is there a neutral party in this? Because there is good reason to distrust everybody. Biden is clearly eager to show he is being aggressive on COVID-19 during the Delta surge, but the FDA has a long history of being overly cautious. There is every reason why pharmaceutical companies would have an interest in promoting boosters. But also, plenty of public health officials are in bed with the global health community, which is concerned about wealthy countries giving booster shots to their populations while poorer countries still haven’t had much access to initial doses.
Even though the question of the necessity of boosters is distinct from the question of whether the vaccines themselves are safe and effective, one can’t help but worry that Biden’s bungled handling of the booster campaign is going to sow further doubt about the vaccine itself among skeptical populations.
https://www.nationalreview.com/corner/bidens-booster-bungle-shows-a-white-house-in-dysfunction/?utm_source=recirc-desktop&utm_medium=homepage&utm_campaign=river&utm_content=featured-content-trending&utm_term=first
Quote: @savannahskol said:
Biden’s Booster Bungle Shows a White House in DysfunctionBy PHILIP KLEINSeptember 17, 2021 4:39 PM
By a 16-2 vote, an FDA advisory panel rejected President Biden’s plan to offer boosters to the general public as soon as next week. Putting aside for a moment the arguments for or against booster shots at this stage of the pandemic, the sequence of events on booster shots has revealed a White House in complete dysfunction.
On August 18, Biden announced a plan to start giving booster shots to every American adult starting the week of September 30. “Just remember, as a simple rule — rule: Eight months after your second shot, get a booster shot,” Biden said.
CDC director Rochelle Walensky signed onto the plan, arguing of the vaccines, “We’re starting to see waning in infection. We think that may result soon in waning in severe disease and outcome. We certainly don’t want to see that here. That’s why we’re planning now to get ahead of it before that happens.”
A little more than a week later, on August 27, Biden, speaking with Israeli Prime Minister Naftali Bennett, indicated that the U.S. could actually follow Israel’s lead and speed up the timeline. “We’re considering the advice you’ve given that we should start earlier,” Biden said. “Should it be as little as five months, and that’s being discussed.”
Yet Anthony Fauci had to do damage control two days later, reiterating that, “We’re still planning on eight months.”
But — whether it was five months or eight months — at no point did Biden manage to make sure that his administration was on the same page as the FDA.
A few days later, two of the FDA’s top vaccine experts resigned over the Biden booster shot plan. Jim Geraghty walked through some of the reasons for their skepticism, which they spelled out in a Lancet article.
And today came the vote, which, while not binding, is highly influential in the ultimate FDA decision on boosters.
To be clear, the panel did not uniformly say boosters were a bad idea in all cases, for all time — it recommended the boosters for the elderly, for instance. “It’s likely beneficial, in my opinion, for the elderly, and may eventually be indicated for the general population,” Ofer Levy, a vaccine and infectious disease specialist at Boston Children’s Hospital, said before voting against the Biden plan. “I just don’t think we’re there yet in terms of the data.”
There are arguments both in favor of and against booster shots at this time. But by putting the cart before the horse, Biden guaranteed that any booster strategy that is ultimately pursued will be met by a higher degree of skepticism than it otherwise would have. And it isn’t clear at this point, even if Americans want to diligently follow the science, who they should trust.
Should they trust Fauci, the CDC, and Biden, who are making the case for boosters? FDA experts who are skeptical? Do we think that the usefulness of vaccines erodes within eight months, or do we think that protection is longer lasting?
Is there a neutral party in this? Because there is good reason to distrust everybody. Biden is clearly eager to show he is being aggressive on COVID-19 during the Delta surge, but the FDA has a long history of being overly cautious. There is every reason why pharmaceutical companies would have an interest in promoting boosters. But also, plenty of public health officials are in bed with the global health community, which is concerned about wealthy countries giving booster shots to their populations while poorer countries still haven’t had much access to initial doses.
Even though the question of the necessity of boosters is distinct from the question of whether the vaccines themselves are safe and effective, one can’t help but worry that Biden’s bungled handling of the booster campaign is going to sow further doubt about the vaccine itself among skeptical populations.
https://www.nationalreview.com/corner/bidens-booster-bungle-shows-a-white-house-in-dysfunction/?utm_source=recirc-desktop&utm_medium=homepage&utm_campaign=river&utm_content=featured-content-trending&utm_term=first
Here's another top quality story by the National Review:
https://www.nationalreview.com/corner/va...it-happen/
Now would that be a real GMO perhaps
I'm not convinced there are too many conservatives here who are anti-vax. Maybe not even olde Savvie.
Whats happening is that conservatives are bashing all that is Biden. And I agree with them on some of their concerns too.
It's the same resentment and anger I had when the mistake called Trump was in office - maybe a few degrees lower in heat than I felt at the time :p
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