Biden's Booster Plan Seen Facing Resistance From CDC Panel, FDA

[JohnSJ]

"Medical experts who advise U.S. regulators on vaccines are chafing at what they perceive as political interference in the review process by the Biden administration.

Last month, the White House announced plans to begin distributing Covid-19 booster shots to Americans Sept. 20. However, the effort still needs the Food and Drug Administration and the Centers for Disease Control and Prevention to sign off. Members of a key panel that advises the CDC on vaccines have pushed back consideration of the plan to mid-September and said this week they were concerned that politics was getting ahead of the process.

It’s “very frightening to me that health-care providers are trying to do the best job that they can, and are taking guidance from HHS and the White House,” said Helen Talbot, a Vanderbilt University professor of medicine and member of the CDC’s Advisory Committee on Immunization Practices, in a meeting Monday.

Pfizer Inc. and BioNTech SE, makers of one of the two vaccines included in the booster plan, filed for authorization for the extra shot last month. Moderna Inc. applied for clearance late Wednesday.

Some short-term data from Israel supports the use of booster shots. Yet the public push by the White House to get a rollout underway has raised concerns the administration is rushing ahead without enough data and regulatory oversight, said Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia. Meanwhile, European health authorities said there’s no urgent need for wide use of boosters, although some countries are offering them.

Deliberation Postponed
“I would be very surprised if the CDC recommended a third dose of the vaccine to the general population,” said Offit, a former member of the CDC’s advisory panel of outside experts that evaluates vaccine data for the agency.


https://www.bloomberg.com/news/articles/2021-09-02/biden-s-booster-plan-seen-facing-resistance-from-cdc-panel-fda

[50 Shades Of Blue]

1. Biden is looking out for us.

[WHITT]

9. Damn Straight

[harumph]

2. I don't remember them being this vocal when Trump politicized

the process.

[JohnSJ]

4. I don't either

[Demsrule86]

8. Some of them are likely Trumpers.

Biden should order the vaccinations and tell them to be quiet. We can't trust them anymore.

[Takket]

3. Every single study/report I've heard about says resistance wains after six months

Are those reports wrong? Do boosters not help? What is the CDC’s concern that would lead them to believe we should not do boosters?

We’ve been talking about boosters since we started with the FIRST shots at the start of the year. What the hell have they been doing all year that we don’t know what to do in September? Israel has a study. Where is our study? We have 200 million data points out there we can collect.

Between this and all the conflicting and confusing mask mandates, I think a leadership change at the CDC is in order. I’m not getting a warm fuzzy that they have a solid finger on the pulse of this pandemic.

[JohnSJ]

5. There seems to be something messed up with the CDC. I remember when the pandemic first appeared

they were telling people masks weren’t necessary. While the reasoning might have been the shortages of masks, they could have been upfront on that, and still said any face covering would be helpful.

I think their reasoning against boosters i suspect is they believe the world needs to be vaccinated first

The main issue with the CDC is mixed messages, and not complete honesty

[Strelnikov_]

11. "The main issue with the CDC is mixed messages, and not complete honesty"

I agree.

Just come out and say,

"masks work, but we need them for medical personnel."

"Boosters are helpful, but we feel the first priority is getting a first dose into everyone, until there is conclusion evidence of the efficacy of boosters."

[Strelnikov_]

7. This appears to be the typical give and take between technocrats and decision makers

During the Tuesday briefing, Walensky acknowledged that while data reviewed by the CDC advisers was currently insufficient, she was confident that there would be enough to support a recommendation prior to the start of the booster plan.

The panel “did not review international data that actually has led us to be even more concerned about increased risk of vaccine effectiveness waning against hospitalizations, severe disease and death -- they will be reviewing that as well,” she said.


The technocrats want to follow the proven routine, which is good, generally. On the other hand, there is a lot of evidence, mainly from overseas, that boosters could reduce infection in the vaccinated. The decision makers, weighing the risk, which appears to be minimal based on overseas experience, are making the call, considering this is a crises.

The only good argument against (to date), IMHO, is that the vaccine is needed for initial doses. The fact that hundreds of thousands of doses (millions?) are being thrown out the US makes this argument moot IMO. That said, why not set up a program. The high risk get boosters, just like they are now. The rest of use participate in a program to use the about to be spoiled doses for boosters. In an era of email and instant messaging it seems like some sort of system could be set up, registering those interested, and notification sent when a shot is available.

[MichMan]

6. So, now we are supposed to ignore the advice of the career medical experts advising the CDC & FDA ?

because they obviously don't understand vaccines ?

[Demsrule86]

10. Some of them are Trumpers...

And they were flat-out wrong about masks.

[WHITT]

12. The Pfizer Vaccine

is licensed by the FDA. Fauci admitted in response to a smart questioner that these were assumed from the getgo to be three-dose vaccines (putting aside J&J), and Moderna will soon follow.

They don't need more "data" or "regulatory oversight", there is no additional "review process" required.

The "political interference" doesn't seem to be coming from the Biden administration, but rather from those that are making that false accusation.

[MichMan]

13. Why weren't three doses recommended from the beginning then?

All that was ever communicated was two.

[WHITT]

14. We've Been Through This

'Vaccine hesitancy'.

Originally, it was supposed to be first shot, then second shot four months later, then third shot four months after that, spanning a year, same as the hepatitis, HPV, and other vaccines. That would allow them to rollout one shot, and the only get to the additional shots later, after many who were initially reluctant would be less concerned.

Except the trials showed they weren't getting the consistent levels of immunity with one dose, so they moved the second up to weeks later.

[MichMan]

15. So they withheld information from people

I can accept honesty and transparency, but draw the line at deliberately omitting the facts

[WHITT]

17. It's A Freakin' Public Health Emergency

The common goal is getting as many people vaccinated as quickly as possible. Easing people in if they're uncomfortable with needles, is hardly a big deal.

[Hugin]

16. The same Talbot was the sole vote against vaccinating the elderly first...

Exact arguments. Almost a cut/paste with the bullshit today.

"When a Centers for Disease Control and Prevention advisory committee voted Tuesday to recommend residents of long-term care facilities should be at the front of the line — with health care providers — for Covid-19 vaccines, the lone dissenting voice came from a researcher who studies vaccines in older adults.

"Helen Keipp Talbot — who is known by her middle name — raised serious concerns during the meeting of the Advisory Committee on Immunization Practices about using the vaccines in the frail elderly, noting there are no data yet to suggest the vaccines work in this population."

From: https://www.statnews.com/2020/12/03/cdc-advisory-panels-lone-dissenter-on-why-long-term-care-residents-shouldnt-receive-covid-19-vaccine-first/